NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

• Citation: 21 CFR Part 558
• Sections: 63

§ 558.3 Definitions and general considerations applicable to this part.

(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is not approved.

(b) The following definitions apply to terms used in this part:

(1) New animal drugs approved for use in animal feed are placed in two categories as follows:

(i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species.

(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species.

(2) A “Type A medicated article” is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients. The manufacture of a Type A medicated article requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.

(3) A “Type B medicated feed” is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type B medicated feed. The maximum concentration of animal drug(s) in a Type B medicated feed is 200 times the highest continuous use level for Category I drugs and 100 times the highest continuous use level for Category II drugs. The term “highest continuous use level” means the highest dosage at which the drug is approved for continuous use (14 days or more), or, if the drug is not approved for continuous use, it means the highest level used for disease prevention or control. If the drug is approved for multiple species at different use levels, the highest approved level of use would govern under this definition. The manufacture of a Type B medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter.

(4) A “Type C medicated feed” is intended as the complete feed for the animal or may be fed “top dressed” (added on top of usual ration) on or offered “free-choice” (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed. The manufacture of a Type C medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter.

(5) A Type B or Type C medicated feed manufactured from a drug component (bulk or “drum-run” (dried crude fermentation product)) requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.

(6) A “veterinary feed directive (VFD) drug” is a drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed pursuant to section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian. Use of animal feed bearing or containing a VFD drug must be authorized by a lawful veterinary feed directive.

(7) A “veterinary feed directive” is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client's animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the Food and Drug Administration.

(8) A “medicated feed” means a Type B medicated feed as defined in paragraph (b)(3) of this section or a Type C medicated feed as defined in paragraph (b)(4) of this section.

(9) For the purposes of this part, a “distributor” means any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD.

(10) An “animal production facility” is a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made.

(11) An “acknowledgment letter” is a written (nonverbal) communication provided to a distributor (consignor) from another distributor (consignee). An acknowledgment letter must be provided either in hardcopy or through electronic media and must affirm:

(i) That the distributor will not ship such VFD feed to an animal production facility that does not have a VFD,

(ii) That the distributor will not ship such VFD feed to another distributor without receiving a similar written acknowledgment letter, and

(iii) That the distributor has complied with the distributor notification requirements of § 558.6(c)(5).

(12) A “combination veterinary feed directive (VFD) drug” is a combination new animal drug (as defined in § 514.4(c)(1)(i) of this chapter) intended for use in or on animal feed which is limited by an approved application filed under section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed under section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian, and at least one of the new animal drugs in the combination is a VFD drug. Use of animal feed bearing or containing a combination VFD drug must be authorized by a lawful VFD.

(13) “Major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats.

(14) “Minor species” means animals, other than humans, that are not major species.

§ 558.4 Requirement of a medicated feed mill license.

(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.

(b) The manufacture of the following types of feed are exempt from the required license, unless otherwise specified:

(1) Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds; and

(2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds.

(c) The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part.

(d) This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows:

Category I

Drug

Assay limits percent 1 Type A

Type B maximum (200x)

Assay limits percent 1 Type B/C 2

Amprolium with Ethopabate

94-114

22.75 g/lb (5.0%)

80-120.

Avilamycin

90-110

7.3 g/lb (1.6%)

80-110.

Bacitracin methylenedisalicylate

85-115

25.0 g/lb (5.5%)

70-130.

Bacitracin zinc

84-115

5.0 g/lb (1.1%)

70-130.

Bambermycins

90-110

800 g/ton (0.09%)

80-120/70-130.

Chlortetracycline

85-115

40.0 g/lb (8.8%)

80-115/70-130.

Coumaphos

95-115

6.0 g/lb (1.3%)

80-120.

Decoquinate

90-105

2.72 g/lb (0.6%)

80-120.

Dichlorvos

100-115

33.0 g/lb (7.3%)

90-120/80-130.

Diclazuril

90-110

182 g/t (0.02%)

85-115/70-120.

Efrotomycin

94-113

1.45 g/lb (0.32%)

80-120.

Iodinated casein

85-115

20.0 g/lb (4.4%)

75-125.

Laidlomycin propionate potassium

90-110

1 g/lb (0.22%)

90-115/85-115.

Lasalocid

95-115

40.0 g/lb (8.8%)

Type B (cattle and sheep): 80-120; Type C (all): 75-125.

Lincomycin

90-115

20.0 g/lb (4.4%)

80-130.

Lubabegron

87-107

908 g/ton

85-115/80-120.

Melengestrol acetate

90-110

10.0 g/ton (0.0011%)

70-120.

Monensin

85-115

40.0 g/lb (8.8%)

Chickens, turkeys, and quail: 75-125; Cattle: 5-10 g/ton 80-120; Cattle: 10-30 g/ton 85-115; Goats: 20 g/ton 85-115; Liq. feed: 80-120.

Narasin

90-110

9.0 g/lb (1.98%)

85-115/75-125.

Nicarbazin (granular)

90-110

9.0 g/lb (1.98%)

85-115/75-125.

Narasin

90-110

9.0 g/lb (1.98%)

85-115/75-125.

Nystatin

85-125

5.0 g/lb (1.1%)

75-125.

Oxytetracycline

90-120

20.0 g/lb (4.4%)

75-125/65-135.

Poloxalene

90-110

54.48 g/lb (12.0%)

Liq. feed: 85-115.

Ractopamine

85-105

2.46 g/lb (0.54%)

80-110/75-125.

Salinomycin

90-110

6.0 g/lb (1.3%)

80-120.

Semduramicin (as semduramicin sodium)

90-110

2.27 g/lb (0.50%)

80-110

Semduramicin (as semduramicin sodium biomass)

90-110

2.27 g/lb (0.50%)

80-120

Tylosin

80-120

10.0 g/lb (2.2%)

75-125.

Tylvalosin

90-110

3.86 g/lb

85-115.

Virginiamycin

85-115

10.0 g/lb (2.2%)

70-130.

Zoalene

92-104

11.35 g/lb (2.5%)

85-115.

1 Percent of labeled amount.

2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.

Category II

Drug

Assay limits percent 1 Type A

Type B maximum (100x)

Assay limits percent 1 Type B/C 2

Amprolium

94-114

11.35 g/lb (2.5%)

80-120.

Apramycin

88-112

7.5 g/lb (1.65%)

80-120.

Carbadox

90-110

2.5 g/lb (0.55%)

75-125.

Clopidol

94-106

11.4 g/lb (2.5%)

90-115/80-120.

Erythromycin

85-115

4.625 g/lb (1.02%)

75-125.

Famphur

100-110

5.5 g/lb (1.21%)

90-115/80-120.

Fenbendazole

93-113

8.87 g/lb (1.96%)

75-125.

Florfenicol

90-110

9.1 g/lb (2.0%)

Swine feed: 85-115 Catfish feed: 80-110. Salmonid feed: 80-110.

Halofuginone hydrobromide

90-115

272.0 g/ton (.03%)

75-125.

Hygromycin B

90-110

1,200 g/ton (0.13%)

75-125.

Ivermectin

95-105

1,180 g/ton (0.13%)

80-110.

Maduramicin ammonium

90-110

545 g/ton (.06%)

80-120.

Morantel tartrate

90-110

66.0 g/lb (14.52%)

85-115.

Neomycin

80-120

20 g/lb (4.4%)

70-125.

Oxytetracycline

80-120

20 g/lb (4.4%)

65-135.

Neomycin sulfate

80-120

100 g/lb (22.0%)

70-125.

Nicarbazin (granular)

90-110

5.675 g/lb (1.25%)

85-115/75-125.

Nicarbazin (powder)

96-104

9.08 g/lb (2.00%)

85-115/80-120.

Novobiocin

85-115

17.5 g/lb (3.85%)

80-120.

Pyrantel tartrate

90-110

36 g/lb (7.9%)

75-125.

Robenidine

95-115

1.5 g/lb (0.33%)

80-120.

Sulfadimethoxine

90-110

Poultry: 5.675 g/lb Fish: 85.1 g/lb

80-115/75-125.

Ormetoprim

90-110

Poultry: 3.405 g/lb Fish: 17.0 g/lb

80-115.

Sulfamerazine

85-115

18.6 g/lb (4.0%)

85-115.

Sulfamethazine

85-115

10.0 g/lb (2.2%)

80-120.

Chlortetracycline

85-115

10.0 g/lb (2.2%)

85-125/70-130.

Sulfamethazine

85-115

10.0 g/lb (2.2%)

80-120.

Tylosin

80-120

10.0 g/lb (2.2%)

75-125.

Sulfaquinoxaline

98-106

11.2 g/lb (2.5%)

85-115.

Tiamulin hydrogen fumarate

90-115

10 g/lb

90-115/70-130.

Tilmicosin

90-110

37.9 g/lb (8.35%)

Swine Type B/C feed: 85-115. Cattle Type B feed: 85-115. Cattle Type C feed: 80-110.

Zilpaterol

90-110

680 g/t (0.075%)

80-110/75-115.

1 Percent of labeled amount.

2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.

(e) When drugs from both categories are in combination, the Category II requirements will apply to the combination drug product.

§ 558.5 Requirements for liquid medicated feed.

(a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed:

(1) Type B feed that is intended for further manufacture of other medicated feeds (§ 558.3(b)(3)) or:

(2) Type C feed that is intended for the following:

(i) Further manufacture of another Type C feed, or

(ii) Top-dressing (adding on top of the usual ration) (§ 558.3(b)(4)).

(b) How is liquid free-choice medicated feed regulated? Liquid free-choice medicated feed is covered by this section and by § 510.455.

(c) What is required for new animal drugs intended for use in liquid feed? Any new animal drug intended for use in liquid feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) or index listed under section 572 of the act. Such approvals under section 512 of the act must be:

(1) An original NADA,

(2) A supplemental NADA, or

(3) An abbreviated NADA.

(d) What are the approval requirements under section 512 of the act for new animal drugs intended for use in liquid feed? An approval under section 512 of the act for a new animal drug intended for use in liquid feed must contain the following information:

(1) Data, or a reference to data in a master file (MF), that shows the relevant ranges of conditions under which the drug will be chemically stable in liquid feed under field use conditions; and

(2) Data, or a reference to data in an MF, that shows that the drug is physically stable in liquid feed under field conditions; or

(3) Feed labeling with recirculation or agitation directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(e) How are chemical and physical stability data to be submitted? The data must be submitted as follows:

(1) Directly in the NADA,

(2) By a sponsor, or

(3) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.

(f) What will be stated in the published approval for a new animal drug intended for use in liquid feed? The approval of a new animal drug intended for use in liquid feed as published in this subchapter will include the following requirements:

(1) The formula and/or specifications of the liquid medicated feed, where the owner of this information requests such publication; and/or

(2) A statement that the approval has been granted for a proprietary formula and/or specifications.

(g) When is a medicated feed mill license required for the manufacture of a liquid medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds:

(1) All liquid medicated feeds that contain a Category II drug, and

(2) Liquid medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications.

(h) What measures are in place to prevent certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, from being diverted to use in liquid feeds? Any product containing any form of bacitracin, oxytetracycline, or chlortetracycline, intended for oral administration via animal feed and/or drinking water, and not approved for use in a liquid medicated feed must include in its labeling the following statement: “FOR USE IN ___ ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.” The blank may be filled in with the words: “DRY FEEDS”, “DRINKING WATER”, or “DRY FEEDS AND DRINKING WATER”.

(i) Can the labeling provisions of paragraph (h) of this section be waived, and how can I apply for a waiver? (1) The labeling provisions of paragraph (h) of this section may be waived if there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed.

(2) To obtain a waiver, you must submit a letter requesting a waiver to the Office of New Animal Drug Evaluation (HFV-100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

(3) The letter must include a copy of the product label; a description of the formulation; and information to establish that the physical, chemical, or other properties of the new animal drug are such that diversion to use in liquid medicated feed is unlikely.

(j) What else do I need to know about the labeling provisions of paragraph (h) of this section? The labeling provisions of paragraph (h) of this section may be implemented without prior approval as provided for in § 514.8(c)(3) of this chapter.

§ 558.6 Veterinary feed directive drugs.

(a) General requirements related to veterinary feed directive (VFD) drugs. (1) Animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) may be fed to animals only by or upon a lawful VFD issued by a licensed veterinarian.

(2) A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD.

(3) Use and labeling of a VFD drug or a combination VFD drug in feed is limited to the approved, conditionally approved, or indexed conditions of use. Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.

(4) All involved parties (the veterinarian, the distributor, and the client) must retain a copy of the VFD for 2 years. The veterinarian must retain the original VFD in its original form (electronic or hardcopy). The distributor and client copies may be kept as an electronic copy or hardcopy.

(5) All involved parties must make the VFD and any other records specified in this section available for inspection and copying by FDA upon request.

(6) All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.”

(b) Responsibilities of the veterinarian issuing the VFD. (1) In order for a VFD to be lawful, the veterinarian issuing the VFD must:

(i) Be licensed to practice veterinary medicine; and

(ii) Be operating in the course of the veterinarian's professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter.

(2) The veterinarian must only issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug.

(3) The veterinarian must ensure that the following information is fully and accurately included on the VFD:

(i) The veterinarian's name, address, and telephone number;

(ii) The client's name, business or home address, and telephone number;

(iii) The premises at which the animals specified in the VFD are located;

(iv) The date of VFD issuance;

(v) The expiration date of the VFD. This date must not extend beyond the expiration date specified in the approval, conditional approval, or index listing, if such date is specified. In cases where the expiration date is not specified in the approval, conditional approval, or index listing, the expiration date of the VFD must not exceed 6 months after the date of issuance;

(vi) The name of the VFD drug(s);

(vii) The species and production class of animals to be fed the VFD feed;

(viii) The approximate number of animals to be fed the VFD feed by the expiration date of the VFD. The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the specified premises by the expiration date of the VFD;

(ix) The indication for which the VFD is issued;

(x) The level of VFD drug in the VFD feed and duration of use;

(xi) The withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval;

(xii) The number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing. In cases where reorders (refills) are not specified on the labeling for an approved, conditionally approved, or index listed VFD drug, reorders (refills) are not permitted;

(xiii) The statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.”;

(xiv) An affirmation of intent for combination VFD drugs as described in paragraph (6) of this section; and

(xv) The veterinarian's electronic or written signature.

(4) The veterinarian may, at his or her discretion, enter the following information on the VFD to more specifically identify the animals authorized to be treated/fed the VFD feed:

(i) A more specific description of the location of animals ( e.g., by site, pen, barn, stall, tank, or other descriptor that the veterinarian deems appropriate);

(ii) The approximate age range of the animals;

(iii) The approximate weight range of the animals; and

(iv) Any other information the veterinarian deems appropriate to identify the animals specified in the VFD.

(5) For VFDs intended to authorize the use of an approved, conditionally approved, or indexed combination VFD drug that includes more than one VFD drug, the veterinarian must include the drug-specific information required in paragraphs (b)(3)(vi), (ix), (x), and (xi) of this section for each VFD drug in the combination.

(6) The veterinarian may restrict VFD authorization to only include the VFD drug(s) cited on the VFD or may expand such authorization to allow the use of the cited VFD drug(s) along with one or more over-the-counter (OTC) animal drugs in an approved, conditionally approved, or indexed combination VFD drug. The veterinarian must affirm his or her intent regarding combination VFD drugs by including one of the following statements on the VFD:

(i) “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.”

(ii) “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.]

(iii) “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.”

(7) The veterinarian must issue a written (nonverbal) VFD.

(8) The veterinarian must send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electronically. If in hardcopy, the veterinarian must send the copy of the VFD to the distributor either directly or through the client.

(9) The veterinarian must provide a copy of the VFD to the client.

(c) Responsibilities of any person who distributes an animal feed containing a VFD drug or a combination VFD drug. (1) The distributor is permitted to fill a VFD only if the VFD contains all the information required in paragraph (b)(3) of this section.

(2) The distributor is permitted to distribute an animal feed containing a VFD drug or combination VFD drug only if it complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug.

(3) The distributor must keep records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years.

(4) In addition to other applicable recordkeeping requirements found in this section, if the distributor manufactures the animal feed bearing or containing the VFD drug, the distributor must also keep VFD feed manufacturing records for 1 year in accordance with part 225 of this chapter. Such records must be made available for inspection and copying by FDA upon request.

(5) A distributor of animal feed containing a VFD drug must notify FDA prior to the first time it distributes animal feed containing a VFD drug. The notification is required one time per distributor and must include the following information:

(i) The distributor's complete name and business address;

(ii) The distributor's signature or the signature of the distributor's authorized agent; and

(iii) The date the notification was signed.

(6) A distributor must also notify FDA within 30 days of any change in ownership, business name, or business address.

(7) The notifications cited in paragraphs (c)(5) and (6) of this section must be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Food Compliance, 12225 Wilkins Ave., Rockville, MD 20852, or email (via attachment): [email protected].

(8) A distributor is permitted to distribute a VFD feed to another distributor only if the originating distributor (consignor) first obtains a written (nonverbal) acknowledgment letter, as defined in § 558.3(b)(11), from the receiving distributor (consignee) before the feed is shipped. Consignor distributors must retain a copy of each consignee distributor's acknowledgment letter for 2 years.

§ 558.55 Amprolium.

(a) Specifications. Type A medicated article containing 25 percent amprolium.

(b) Sponsor. No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.50 of this chapter.

(d) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(e) Conditions of use —(1) Cattle. It is used as follows:

Amprolium in grams per ton

Indications for use

Limitations

Sponsor

(i) 113.5 to 11, 350; to provide 5 milligrams per kilogram of body weight per day

Calves: As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zuernii

Top-dress on or mix in the daily ration. Feed for 21 days when experience indicates that coccidiosis is likely to be a hazard, as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal

016592

(ii) 113.5 to 11, 350; to provide 10 milligrams per kilogram of body weight per day

Calves: As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zuernii

Top-dress on or mix in the daily ration. Feed for 5 days as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal

016592

(2) Chickens. It is used as follows:

Amprolium in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(i) 36.3 to 113.5

Replacement chickens: For development of active immunity to coccidiosis

Feed continuously until onset of production as follows:

016592

Growing conditions

Up to 5 weeks of age

From 5 to 8 weeks of age

Over 8 weeks of age

Amprolium in grams per ton

Amprolium in grams per ton

Amprolium in grams per ton

Severe exposure to coccidiosis

113.5

72.6-113.5

36.3-113.5

(0.0125%)

(0.008%-0.0125%)

(0.004%-0.0125%)

Moderate exposure to coccidiosis

72.6-113.5

54.5-113.5

36.3-113.5

(0.008%-0.0125%)

(0.006%-0.0125%)

(0.004%-0.0125%)

Slight exposure to coccidiosis

36.3-113.5

36.3-113.5

36.3-113.5

(0.004%-0.0125%)

(0.004%-0.0125%)

(0.004%-0.0125%)

Amprolium in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(ii) 36.3 to 113.5

Bacitracin methylenedisalicylate 4 to 50

Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiency

Feed according to subtable in item (i). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(iii) 72.6 to 113.5

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only

Feed continuously as the sole ration; as sole source of amprolium

016592

(iv) 72.6 to 113.5

Bambermycins 1 to 2

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only; and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

016592

(v) 113.5

1. Laying chickens: For prevention of coccidiosis

Feed continuously as the sole ration; as the sole source of amprolium

016592

2. Laying chickens: For treatment of coccidiosis in moderate outbreaks

Feed for 2 weeks

(vi) 113.5 to 227

1. Replacement chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired

Feed continuously from day-old until onset of production; as the sole source of amprolium

016592

2. Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired

Feed continuously as the sole ration; as sole source of amprolium

(vii) 113.5 to 227

Bambermycins 1 to 2

Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired; and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

016592

(viii) 227

Laying chickens: For treatment of coccidiosis in severe outbreaks.

Feed for 2 weeks

016592

(3) Turkeys. It is used as follows:

Amprolium in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(i) 113.5

Bambermycins 1 to 4

Growing turkeys: For prevention of coccidiosis; and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole source of amprolium; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

016592

(ii) 113.5 to 227

Turkeys: For prevention of coccidiosis

Feed continuously as the sole ration; as sole source of amprolium

016592

(4) Pheasants. It is used as follows:

Amprolium in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(i) 159

Growing pheasants: For the prevention of coccidiosis caused by Eimeria colchici, E. duodenalis, and E. phasiani

Feed continuously as sole ration. Use as sole source of amprolium

016592

(ii) [Reserved]

(5) Permitted combinations. Amprolium may also be used in combination with:

(i) Virginiamycin as in § 558.635.

(ii) [Reserved]

§ 558.58 Amprolium and ethopabate.

(a) Specifications. Type A medicated articles containing:

(1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate;

(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.50 and 556.260 of this chapter.

(d) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(e) Conditions of use. It is used in chicken feed as follows:

Amprolium and ethopabate in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(1) Amprolium 113.5 and ethopabate 3.6

Broiler chickens: As an aid in the prevention of coccidiosis

Feed continuously as sole ration; as sole source of amprolium. Not for laying chickens

016592

(2) Amprolium 113.5 and ethopabate 36.3

Broiler chickens and replacement chickens: where immunity to coccidiosis is not desired: As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur

Feed continuously as sole ration; as sole source of amprolium. Not for chickens over 16 weeks of age

016592

(3) Amprolium 113.5 and ethopabate 36.3

Bacitracin 4 to 50

1. Broiler chickens and replacement chickens: where immunity to coccidiosis is not desired; to aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain in broiler chickens raised in floor pens

Feed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard. Not for chickens over 16 weeks of age; do not feed to laying chickens; as sole source of amprolium; not for use as a treatment for outbreaks of coccidiosis. Bacitracin as bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

016592

(4) Amprolium 113.5 and ethopabate 36.3

Bacitracin 4 to 50

2. Broiler chickens: As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for improved feed efficiency

Feed as the sole ration from the time chickens are placed on litter until market weight. Not for chickens over 16 weeks of age; do not feed to laying chickens; as sole source of amprolium; not for use as a treatment for coccidiosis. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter

054771

(5) Amprolium 113.5 and ethopabate 36.6

Bambermycins 1 to 3

Broiler chickens: As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain, improved feed efficiency

Feed continuously as the sole ration; as sole source of amprolium Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

016592

(6) Amprolium 227 and ethopabate 3.6

For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis

Not for laying chickens

016592

(f) Amprolium and ethopabate may also be used in combination with:

(1)-(2) [Reserved]

(3) Chlortetracycline as in § 558.128.

§ 558.59 Apramycin.

(a) Specifications. Type A articles containing 75 grams apramycin (as apramycin sulfate) per pound.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.52 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for apramycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for apramycin shall not be refilled.

(e) Conditions of use in swine —

Apramycin grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(1) 150

For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli

Feed as the sole ration for 14 consecutive days. Withdraw 28 days before slaughter

058198

(2) [Reserved]

§ 558.68 Avilamycin.

(a) Specifications. Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.60 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for avilamycin medicated feeds must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.

(e) Conditions of use. Administer in feed as follows:

(1) Chickens —

Avilamycin in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 13.6 to 40.9

Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens

Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age

058198

(ii) 13.6 to 40.9

Monensin, 90 to 110

Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and as an aid in the prevention of coccidiosis caused by E imeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d)

016592

058198

(iii) 13.6 to 40.9

Narasin, 54 to 90

Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens ; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima .

Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens . To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by No. 058198 in § 510.600(c) of this chapter.

058198

(iv) 13.6 to 40.9

Narasin, 27 to 45 plus nicarbazin, 27 to 45

Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to chickens producing eggs for human consumption. Narasin and nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter

058198

(v) 13.6 to 40.9

Salinomycin sodium, 40 to 60

Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens ; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati .

Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens . Not approved for use with pellet binders. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. Do not feed to laying hens producing eggs for human consumption. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.

058198

(2) Swine —

Avilamycin in grams/ton

Combinationin grams/ton

Indications for use

Limitations

Sponsor

(i) 73

Weaned pigs less than 14 weeks of age: For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs

Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older

058198

(ii) [Reserved]

§ 558.76 Bacitracin methylenedisalicylate.

(a) Specifications. (1) Type A medicated articles containing feed grade bacitracin methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams bacitracin per pound.

(2) Type A medicated article containing feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin per pound.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraph (d) of this section.

(2) No. 069254 for use of product in paragraph (a)(2) of this section as in paragraph (d) of this section.

(c) Related tolerances. See § 556.70 of this chapter.

(d) Conditions of use —(1) Chickens —

Bacitracin in grams per ton

Indications for use

Limitations

Sponsor

(i) 4 to 50

Broiler and replacement chickens: For increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration

054771 069254

(ii) 10 to 25

Laying hens: For increased egg production and improved feed efficiency

Feed continuously as sole ration for the first 7 months of egg production

054771

(iii) 50

Broiler and replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin

Feed continuously as sole ration

054771

(iv) 50

Broiler and replacement chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens

Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding

069254

(v) 100 to 200

Broiler and replacement chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin

Feed continuously as sole ration. Start at first clinical signs of disease. Vary dosage based on severity of infection. Administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 grams/ton)

054771

(2) Turkeys —

Bacitracin in grams per ton

Indications for use

Limitations

Sponsor

(i) 4 to 50

Growing turkeys: For increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration

054771 069254

(ii) 200

Growing turkeys: As an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate

Feed continuously as the sole ration

054771

(3) Swine —

Bacitracin in grams per ton

Indications for use

Limitations

Sponsor

(i) 10 to 30

Growing and finishing swine: For increased rate of weight gain and improved feed efficiency

054771

(ii) 250

Growing and finishing swine: For control of swine dysentery (bloody scours) associated with Brachyspira hyodysenteriae in pigs up to 250 lbs body weight

Feed as the sole ration. Feed 250 grams per ton of complete feed on premises with a history of swine dysentery, but where signs of the disease have not yet occurred or following an approved treatment of the disease condition. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory

054771

(iii) 250

Pregnant sows: For control of clostridial enteritis caused by Clostridium perfringens in suckling piglets

As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory

054771

(4) Cattle —

Bacitracin amount

Indications for use

Limitations

Sponsor

(i) 70 mg per head per day

Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses

Administer continuously throughout the feeding period

054771 069254

(ii) 250 mg per head per day

Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses

Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period

054771 069254

(5) Game birds —

Bacitracin in grams per ton

Indications for use

Limitations

Sponsor

(i) 4 to 50

Growing pheasants: For increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration

054771 069254

(ii) 5 to 20

Growing quail: For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age

Feed continuously as sole ration to quail not over 5 weeks of age

054771 069254

(iii) 200

Growing quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate

Feed continuously as the sole ration

054771

(6) Bacitracin methylenedisalicylate may also be used in combination with:

(i) Amprolium as in § 558.55.

(ii) Amprolium and ethopabate as in § 558.58.

(iii) Chlortetracycline as in § 558.128.

(iv) Clopidol as in § 558.175.

(v) Decoquinate as in § 558.195.

(vi) Diclazuril as in § 558.198.

(vii) Fenbendazole as in § 558.258.

(viii) Halofuginone as in § 558.265.

(ix) Ivermectin as in § 558.300.

(x) Lasalocid as in § 558.311.

(xi) Monensin as in § 558.355.

(xii) Narasin as in § 558.363.

(xiii) Narasin and nicarbazin as in § 558.364.

(xiv) Nicarbazin as in § 558.366.

(xv) Robenidine as in § 558.515.

(xvi) Salinomycin as in § 558.550.

(xvii) Semduramicin as in § 558.555.

(xviii) Zoalene as in § 558.680.

§ 558.78 Bacitracin zinc.

(a) Specifications. Type A medicated articles containing bacitracin zinc equivalent to 10, 25, 40, or 50 grams per pound bacitracin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.70 of this chapter.

(d) Conditions of use. (1) It is used as follows:

Bacitracin zinc in grams per ton

Combinations in grams per ton

Indications for use

Limitations

Sponsor

(i) 4 to 50

Chickens: for increased rate of weight gain and improved feed efficiency

Growing chickens

054771

(ii) 4 to 50

Turkeys and pheasants: for increased rate of weight gain and improved feed efficiency

Growing turkeys and pheasants

054771

(iii) 5 to 20

Quail; for increased rate of weight gain and improved feed efficiency

Growing quail; feed as the Type C feed to starting quail through 5 weeks of age

054771

(iv) 10 to 25

Laying chickens; improved feed efficiency and increased egg production

054771

(v) 10 to 50

Swine; increased rate of weight gain and improved feed efficiency

Growing and finishing swine

054771

(vi) 20

Growing-finishing swine; increased rate of weight gain

In Type C feed

054771

(vii) 20 to 40

Growing-finishing swine; improved feed efficiency

......do

054771

(2) It is used in feed for growing cattle at 35 to 70 milligrams per head per day as follows:

(i) To aid in stimulating growth and improving feed efficiency.

(ii) For increased rate of weight gain and improved feed efficiency; see sponsor 054771.

(3) Bacitracin zinc may also be used in combination with:

(i) Amprolium and ethopabate as in § 558.58.

(ii) Clopidol as in § 558.175.

(iii) Decoquinate as in § 558.195.

(iv) Lasalocid as in § 558.311.

(v) Monensin as in § 558.355.

(vi) Naracin as in § 558.363.

(vii) Nicarbazin as in § 558.366.

(viii) Robenidine as in § 558.515.

(ix) Salinomycin as in § 558.550.

§ 558.95 Bambermycins.

(a) Specifications. Type A medicated articles containing 2, 4, or 10 grams bambermycins per pound.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.75 of this chapter.

(d) Special considerations. (1) Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent.

(2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture.

(e) Conditions of use —(1) Chickens. Use in medicated feed as follows:

Bambermycins in grams/ton

Indications for use

Limitations

Sponsor

(i) 1 to 2

Broiler chickens: For increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration

016592.

(ii) [Reserved]

(2) Turkeys. Use in medicated feed as follows:

Bambermycins in grams/ton

Indications for use

Limitations

Sponsor

(i) 1 to 2

Growing turkeys: For improved feed efficiency

Feed continuously as the sole ration

016592

(ii) 2

Growing turkeys: For increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration

016592

(3) Swine. Use in medicated feed as follows:

Bambermycins in grams/ton

Indications for use

Limitations

Sponsor

(i) 2

Growing-finishing swine: For increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration

016592

(ii) 2 to 4

Growing-finishing swine: For improved feed efficiency

Feed continuously as the sole ration

016592

(4) Cattle.

Bambermycins in grams/ton

Indications for use

Limitations

Sponsor

(i) 1 to 4

Growing beef steers and heifers fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency

Feed continuously at a rate of 10 to 20 milligrams per head per day

016592.

(ii) 2 to 80

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter), and replacement beef and dairy heifers on pasture: For increased rate of weight gain

Feed continuously on a hand-fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed

016592.

(iii) Used as a free-choice Type C medicated loose-mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:

( a ) Specifications.

Ingredient

International Feed No.

Percent

Deflorinated phosphate (20.5% calcium, 18.5% phosphorus)

6-01-080

42.50

Sodium chloride (salt)

6-04-152

20.10

Calcium carbonate (38% calcium)

6-01-069

15.24

Corn distillers dried grains w/solubles

5-28-236

9.57

Magnesium oxide

6-02-756

5.15

Vitamin and trace mineral premix *

.........

3.72

Mineral oil

.........

1.00

Yeast (primary dehydrated yeast)

7-05-533

0.75

Bambermycins Type A article (10 g/lb)

.........

0.60

Iron oxide

6-02-431

0.50

Magnesium sulfate (67%)

6-02-758

0.32

Selenium premix (270 mg/lb) *

.........

0.21

Copper sulfate

6-01-720

0.18

Potassium sulfate (0.33%)

6-06-098

0.16

*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

( b ) Amount per ton. 120 grams.

( c ) Indications for use. For increased rate of weight gain.

( d ) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers). Feed a nonmedicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:

( a ) Amount. Feed continuously to provide 10 to 40 milligrams of bambermycins per head per day.

( b ) Indications for use. For increased rate of weight gain.

( c ) Limitations. Each use in a free-choice Type C medicated feed must be the subject of an approved new animal drug application (NADA) or supplemental NADA as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(v) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers) as follows:

(A) Specifications.

Ingredient

International Feed No.

Percent

Deflorinated phosphate (20.5% calcium, 18.5% phosphorus)

6-01-080

42.50

Sodium chloride (salt)

6-04-152

20.10

Calcium carbonate (38% calcium)

6-01-069

15.45

Corn distillers dried grains w/solubles

5-28-236

9.57

Magnesium oxide

6-02-756

5.15

Vitamin and trace mineral premix *

3.72

Mineral oil

1.00

Yeast (primary dehydrated yeast)

7-05-533

0.75

Bambermycins Type A article (10 g/lb)

0.60

Iron oxide

6-02-431

0.50

Magnesium sulfate (67%)

6-02-758

0.32

Copper sulfate

6-01-720

0.18

Potassium sulfate (0.33%)

6-06-098

0.16

* Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(B) Amount per ton. 120 grams.

(C) Indications for use. For increased rate of weight gain.

(D) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers). Feed a non-medicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(5) Combinations. Bambermycins may also be used in combination with:

(i) Amprolium as in § 558.55.

(ii) Amprolium and ethopabate as in § 558.58.

(iii) Clopidol as in § 558.175.

(iv) Diclazuril as in § 558.198.

(v) Halofuginone as in § 558.265.

(vi) Lasalocid as in § 558.311.

(vii) Monensin as in § 558.355.

(viii) Narasin as in § 558.363.

(ix) Narasin and nicarbazin as in § 558.364.

(x) Nicarbazin as in § 558.366.

(xi) Salinomycin as in § 558.550.

(xii) Zoalene as in § 558.680.

§ 558.115 Carbadox.

(a) Approvals. Type A medicated articles: 2.2. percent (10 grams per pound) to 066104 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.100 of this chapter.

(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(d) Conditions of use. It is used for swine as follows:

(1) Amount per ton. 10-25 grams (0.0011-0.00275 percent).

(i) Indications for use. For increase in rate of weight gain and improvement of feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(2) Amount per ton. 50 grams (0.0055 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis ); increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel tartrate, 96 grams (0.0106 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis ); aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; aid in the prevention of establishment of nodular worm ( Oesophagostomum ) infections.

(ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in complete feeds containing less than 15 percent crude protein.

(4) Carbadox may also be used in combination with oxytetracycline as in § 558.450.

§ 558.128 Chlortetracycline.

(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride, or for products intended for use in milk replacer, chlortetracycline hydrochloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type A medicated article.

(2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article.

(3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.

(c) Related tolerances. See § 556.150 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled.

(3) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”

(4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(vi) of this section must conform to § 510.455 of this chapter.

(5) When manufactured for use as in paragraph (e)(5)(iii) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”

(e) Conditions of use —(1) Chickens. It is used as follows:

Chlortetracycline amount

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 100 to 200 g/ton

Chickens: For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline

Feed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption

054771 066104 069254

(ii) 100 to 200 g/ton

Clopidol, 113.5

Broiler and replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline

Feed continuously as the sole ration from the time chicks are placed in floor pens for 7 to 14 days. Do not feed to chickens over 16 weeks of age. Do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; clopidol as provided by No. 016592 in § 510.600(c) of this chapter

016592

(iii) 100 to 200 g/ton

Decoquinate, 27.2

Chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for control of infectious synovitis caused by M, synoviae susceptible to chlortetracycline

Feed continuously for 7 to 14 days. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(iv) 100 g/ton

Robenidine, 30

Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline

Feed continuously as sole ration. Do not use this product in feeds conta Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter

054771

(v) 200 to 400 g/ton

Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline

Feed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption

054771 066104 069254

(vi) 200 g/ton

Amprolium, 227 and ethopabate, 3.6

For chickens where immunity to coccidiosis is not desired: For prevention of coccidiosis; and for treatment of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline

Use in low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 days; do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter

054771

(vii) 200 g/ton

Decoquinate, 27.2

Broilers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, and E. brunetti; and for the treatment of chronic respiratory disease (air sac infection) and the prevention of synovitis

Feed continuously as the sole ration for no more than 8 weeks. Use in low calcium feed containing 0.8% dietary calcium. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(viii) 200 g/ton

Robenidine 30

Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline

Feed continuously as sole ration. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter

054771

(ix) 500 g/ton

Chickens: For the reduction of mortality due to E. coli infections susceptible to chlortetracycline

1. Feed for 5 days. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal time

054771 069254

2. Feed for 5 days; withdraw 24 hours prior to slaughter. Do not feed to chickens producing eggs for human consumption

054771 066104 069254

(x) 500 g/ton

Monensin, 90 to 110

Chickens: As an aid in the reduction of mortality due to E. coli infections susceptible to chlortetracycline; and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati

Feed for 5 days as the sole ration. Do not feed to laying chickens. Not to be fed continuously for more than 5 days. Do not feed to chickens over 16 weeks of age. Withdraw 24 hours before slaughter. See § 558.355(d) of this chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in § 510.600(c) of this chapter

054771 069254

(xi) 500 g/ton

Robenidine, 30

Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline

Feed continuously as sole ration for up to 5 days. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter

054771

(xii) 500 g/ton

Salinomycin, 40 to 60

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline

For use in low calcium feeds containing 0.8% calcium. Not approved for use with pellet binders. Not to be fed continuously for more than 5 days. Do not feed to laying chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in § 510.600(c) of this chapter

016592 054771 069254

(2) Turkeys. It is used as follows:

Chlortetracycline amount

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 200 g/ton

Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline

Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption

054771 066104 069254

(ii) 400 g/ton

1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline

Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption

054771 066104 069254

2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline

054771 066104 069254

(iii) 25 mg/lb of body weight

Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline

Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption

054771 066104 069254

(3) Swine. It is used as follows:

Chlortetracycline amount

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 50 to 100 g/ton

Swine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline

054771 066104 069254

(ii) 400 g/ton

Breeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline

Feed continuously for not more than 14 days

054771 066104 069254

(iii) 10 mg/lb of body weight

Swine: For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline

Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254 in § 510.600(c) of this chapter

054771 066104 069254

(iv) 10 mg/lb of body weight

Bacitracin methylenedisalicylate, 10 to 30

Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency

Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Chlortetracycline and bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(v) 10 mg/lb of body weight

Bacitracin methylenedisalicylate, 10 to 30

Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency

Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter

054771 069254

(vi) 10 mg/lb of body weight

Tiamulin hydrogen fumarate, 35

For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema ) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by P. multocida sensitive to chlortetracycline

Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254 in § 510.600(c) of this chapter

058198 069254

(4) Cattle. It is used as follows:

Chlortetracycline amount

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) to provide 70 mg/head/day

Growing cattle (over 400 lb): For reduction of liver condemnation due to liver abscesses

Feed to provide chlortetracycline at the rate of 70 mg per animal daily. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal

054771 066104 069254

(ii) 5.83 to 14 g/ton to provide 70 mg/head/day

Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day

Growing beef heifers fed in confinement for slaughter (over 400 lb): For reduction of the incidence of liver abscesses, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 5.83 to 14 g/ton chlortetracycline. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(iii) 7 to 17.5 g/ton

Monensin, 5 to 40

Growing beef steers and heifers fed in confinement for slaughter over 400 lb: For reduction of the incidence of liver abscesses and for improved feed efficiency

Feed as the sole ration to provide 70 mg chlortetracycline per head per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(iv) 7 to 17.5 g/ton

Monensin, 10 to 40

Growing beef steers and heifers fed in confinement for slaughter over 400 lb: For reduction of the incidence of liver abscesses and for prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii

Feed as the sole ration to provide 70 mg chlortetracycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(v) to provide 0.5 mg/lb of body weight daily

Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline

Feed to provide chlortetracycline at the rate of 0.5 mg per pound of body weight daily. Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time

054771 066104 069254

(vi) 33.33 to 50 g/ton to provide 0.5 mg/lb of body weight per day

Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day

Replacement beef heifers over 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for suppression of estrus (heat)

Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 33.33 to 50 g/ton chlortetracycline. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed 24 days. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(vii) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily

Lasalocid, 30 to 600

Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain

Feed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(viii) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily

Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate

Replacement beef heifers on pasture over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 1,100 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 0.5 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(ix) 33.33 to 66.67 g/ton

Monensin, 5 to 40

Growing beef steers and heifers fed in confinement for slaughter over 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for improved feed efficiency

Feed as the sole ration to provide 0.5 mg chlortetracycline per lb. body weight per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(x) 33.33 to 66.67 g/ton

Monensin, 10 to 40

Growing beef steers and heifers fed in confinement for slaughter over 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii

Feed as the sole ration to provide 0.5 mg chlortetracycline per lb. body weight per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xi) 50 to 117 g/ton

Monensin, 7.14 to 40

Growing beef steers and heifers fed in confinement for slaughter under 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for improved feed efficiency

Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xii) 50 to 117 g/ton

Monensin, 10 to 40

Growing beef steers and heifers fed in confinement for slaughter under 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii

Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xiii) 50 to 117 g/ton

Monensin, 7.14 to 40

Growing beef steers and heifers fed in confinement for slaughter: For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for improved feed efficiency

Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xiv) 50 to 117 g/ton

Monensin, >10 to 40

Growing beef steers and heifers fed in confinement for slaughter: For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii

Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xv) to provide 0.5 to 2.0 mg/lb of body weight daily

Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline

In Type C free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section

054771

(xvi) to provide 10 mg/lb of body weight daily

Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline

Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. To sponsor No. 054771 (NADAs 048-761 and 046-699) and to sponsor No. 069254 (ANADA 200-510): May be mixed in the cattle's daily ration or administered as a top-dress. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period. See paragraph (d)(3) of this section

054771 066104 069254

(xvii) to provide 10 mg/lb of body weight daily

Calves (up to 250 lb): For the treatment of bacterial enteritis caused by Escherichia coli susceptible to chlortetracycline

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal

066104

(xviii) 400 to 2,000 g/ton

Monensin, 5 to 40

Growing beef steers and heifers fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for improved feed efficiency

Feed as the sole ration to provide 10 mg chlortetracycline per lb. body weight per day and 50 to 480 mg monensin per head per day. Feed for not more than 5 days, then continue feeding monensin Type C medicated feed alone. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xix) 400 to 2,000 g/ton

Monensin, 10 to 40

Growing beef steers and heifers: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii

Feed as the sole ration to provide 10 mg chlortetracycline per lb. body weight per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of the coccidiosis challenge, up to 480 mg monensin per head per day. Feed for not more than 5 days, then continue feeding monensin Type C medicated feed alone. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xx) 400 to 2,000 g/ton

Monensin, 10 to 200

Beef calves 2 months of age and older: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii

Feed as the sole ration to provide 10 mg chlortetracycline per lb. body weight per day and 0.14 to 1.00 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 200 mg of monensin per head per day. Feed for not more than 5 days, then continue to feed monensin Type C medicated feed alone. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter

016592

069254

(xxi) 400 to 2,000 g/ton

Monensin, 15 to 84

Replacement beef and dairy heifers: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii

For replacement beef and dairy heifers not currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 0.14 to 0.42 mg monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to 100 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. For replacement beef and dairy heifers currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 0.14 to 0.42 mg monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Monensin as provided by No. 058198 or 016592; chlortetracycline by No. 069254 in § 510.600(c) of this chapter

069254, 016592

(xxii) 400 to 2,000 g/ton

Monensin, 15 to 400

Replacement beef and dairy heifers: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; and for increased rate of weight gain

For replacement beef and dairy heifers not currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 50 to 100 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. For replacement beef and dairy heifers currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Monensin as provided by No. 058198 or 016592; chlortetracycline by No. 069254 in § 510.600(c) of this chapter

0692544, 0165924

(xxiii) 500 to 2,000 g/ton to provide 10 mg/lb of body weight daily

Laidlomycin, 5

Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency

Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter

054771

(xxiv) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily

Laidlomycin, 5 to 10

Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency

Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter

054771

(xxv) 500 to 2,000 to provide 10 mg/lb of body weight daily

Lasalocid, 10 to 30

Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency

Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xxvi) 500 to 1,200 g/ton to provide 10 mg/lb of body weight daily

Lasalocid, 25 to 30

Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency

Feed continuously in complete feed to provide 10 mg chlortetracycline per lb body weight and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771

(xxvii) 500 to 4,000 to provide 10 mg/lb of body weight daily

Lasalocid, 30 to 600

Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain

Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xxviii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily

Lasalocid, 30 to 600: Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate

Replacement dairy heifers on pasture less than 20 months of age and replacement beef heifers on pasture: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 10 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254, lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xxix) 500 to 4,000 g/ton

Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline

Hand feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period

054771 069254

(xxx) 500 to 4,000 g/ton

Decoquinate, 12.9 to 90.8

Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii

Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xxxi) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily

Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day

Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xxxii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily

Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day

Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for suppression of estrus (heat)

Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xxxiii) 4,000 to 20,000 g/ton

Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline

Administer as a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal

054771 069254

(xxxiv) 4,000 to 20,000 g/ton

Decoquinate, 90.8 to 535.7

Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii

Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xxxv) 4,000 to 20,000 g/ton to provide 10 mg/lb of body weight per day

Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day

Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated feed for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xxxvi) 4,000 to 20,000 g/ton to provide 10 mg/lb of body weight per day

Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day

Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for suppression of estrus (heat)

Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated feed for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xxxvii) to provide 350 mg/head/day

Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline

Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period

054771 066104 069254

(xxxviii) to provide 350 mg/head/day

Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline

Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period

054771 066104 069254

(xxxix) 50 to 350 g/ton to provide 350 mg/head/day

Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day

Replacement beef heifers under 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for suppression of estrus (heat)

Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 50 to 350 g/ton chlortetracycline for up to 24 days of feeding. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xl) 20 to 350 g/ton

Beef cattle and replacement dairy heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline

Feed to provide chlortetracycline at the rate of 350 mg per head per day. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period

054771 069254

(xli) 20 to 350 g/ton to provide 350 mg/head/day

Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day

Growing beef heifers fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xlii) 20 to 350 g/ton to provide 350 mg/head/day

Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day

Replacement dairy heifers less than 20 months of age and replacement beef heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and suppression of estrus (heat)

Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed 24 days of feeding. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(xliii) 23.3 to 58.3 g/ton to provide 350 mg/head/day

Laidlomycin, 5

Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency

Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter

054771

(xliv) 14.6 to 116.7 g/ton to provide 350 mg/head/day

Laidlomycin, 5 to 10

Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiency

Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter

054771

(xlv) 25 to 42.2 g/ton to provide 350 mg/head/day

Lasalocid, 25 to 30

Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency

Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xlvi) 25 to 42.2 g/ton to provide 350 mg/head/day

Lasalocid, 25 to 30

Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency

Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xlvii) 25 to 100 g/ton to provide 350 mg/head/day

Lasalocid, 10 to 30

Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for improved feed efficiency

Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xlviii) 25 to 100 g/ton to provide 350 mg/head/day

Lasalocid, 10 to 30

Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency

Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(xlix) 25 to 700 to provide 350 g/head/day

Lasalocid, 30 to 600

Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain

Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(l) 25 to 700 g/ton to provide 350 mg/head/day

Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate

Replacement beef heifers on pasture: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(li) 25 to 700 to provide 350 mg/head/day

Lasalocid, 30 to 600

Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain

Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(lii) 25 to 700 g/ton to provide 350 mg/head/day

Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate

Replacement beef heifers on pasture under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(liii) 25 to 2,800 to provide 350 mg/head/day

Lasalocid, 30 to 181.8

Beef cattle weighing under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii

Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(liv) 25 to 2,800 g/ton to provide 350 mg/head/day

Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate

Growing beef heifers fed in confinement for slaughter under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(lv) 25 to 2,800 to provide 350 mg/head/day

Lasalocid, 30 to 181.8

Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii

Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(lvi) 25 to 2,800 g/ton to provide 350 mg/head/day

Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate

Growing beef heifers fed in confinement for slaughter up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See§ 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(lvii) 25 to 2,800 g/ton to provide 350 mg/head/day

Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate

Replacement beef heifers up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(lviii) 500 to 4,000 to provide 10 mg/head/day

Lasalocid, 30 to 181.8

Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii

Hand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771 069254

(lix) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily

Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate

Growing beef heifers fed in confinement for slaughter up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days of feeding. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(lx) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily

Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate

Replacement dairy heifers up to 800 pounds and less than 20 months of age and replacement beef heifers up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppression of estrus (heat)

The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter.

054771

069254

(5) Minor species. It is used as follows:

Chlortetracycline amount

Indications for use

Limitations

Sponsor

(i) 80 mg/head/day

Breeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline

054771 066104 069254

(ii) 200 to 400 g/ton

Ducks: For the control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline

Feed in complete ration to provide from 8 to 28 mg/lb of body weight per day, depending upon age and severity of disease, for not more than 21 days. Do not feed to ducks producing eggs for human consumption

054771 069254

(iii) 10 mg/g of finished feed daily

Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline

Feed continuously for 45 days. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. See paragraph (d)(5) of this section

054771 069254

(6) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

Ingredient

Percent

International feed No.

Dicalcium Phosphate

46.20

6-26-335

Sodium Chloride (Salt)

15.00

6-04-152

Magnesium Oxide

10.67

6-02-756

Cottonseed Meal

10.00

5-01-625

Trace Mineral/Vitamin Premix 1

3.80

Calcium Carbonate

3.50

6-01-069

Dried Cane Molasses

3.00

4-04-695

Potassium Chloride

2.00

6-03-755

Mineral Oil

2.00

8-03-123

Iron Oxide

0.50

6-02-431

Chlortetracycline Type A medicated article (90 gram/lb)

3.33

1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(ii) Amount. 6,000 grams per ton.

(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.

(v) Sponsors. See Nos. 054771 and 069254 in § 510.600(c) of this chapter.

§ 558.140 Chlortetracycline and sulfamethazine.

(a) Specifications. Type A medicated articles containing:

(1) 35 grams (g) per pound (/lb) each, chlortetracycline and sulfamethazine.

(2) 40 g/lb each, chlortetracycline and sulfamethazine.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section.

(2) No. 069254 for use of product described in paragraph (a)(1) as in paragraph (e)(1)(i) of this section.

(3) Nos. 054771 and 069254 for use of product described in paragraph (a)(2) as in paragraph (e)(2) of this section.

(c) Related tolerances. See §§ 556.150 and 556.670 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.

(e) Conditions of use —(1) Cattle —

Chlortetracycline and sulfamethazine amount each

Combination in grams/ton

Indications for use

Limitations

Sponsors

(i) To provide 350 milligrams per head per day

Beef cattle: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever.

Feed for 28 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

054771 069254

(ii) 35 to 105 g/ton, each

Lasalocid, 10 to 30

Beef steers and heifers fed in confinement for slaughter: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for improved feed efficiency.

Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 100 to 300 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

054771

(iii) 35 to 42.2 g/ton, each

Lasalocid, 25 to 30

Beef steers and heifers fed in confinement for slaughter: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for improved feed efficiency and increased rate of weight gain.

Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 250 to 300 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

054771

(iv) 35 to 700 g/ton, each

Lasalocid, 30 to 181.8

Beef cattle up to 800 lb: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for control of coccidiosis caused by Eimeria bovis and E. zuernii .

Hand feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 1 mg lasalocid per 2.2 lb body weight per day up to a maximum of 360 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

054771

(2) Swine —

Chlortetracycline and sulfamethazine amount

Indications for use

Limitations

Sponsors

(i) 100 g/ton of feed each, chlortetracycline and sulfamethazine

Swine: For reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of these diseases during times of stress; and maintenance of weight gains in the presence of atrophic rhinitis

Feed as the sole ration. Withdraw 15 days prior to slaughter

054771 069254

(ii) [Reserved]

§ 558.175 Clopidol.

(a) Specifications. Type A medicated article containing 25 percent clopidol.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.160 of this chapter.

(d) Conditions of use —(1) Chickens —

Clopidol in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsors

(i) 113.5

Broiler chickens and re-placement chickens intended for use as caged layers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

Do not feed to chickens over 16 weeks of age

016592

(ii) 113.5

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.

Feed continuously as the sole ration from the time chicks are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

016592

(iii) 113.5

Bacitracin zinc, 5 to 25

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

Feed continuously as sole ration; bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter

054771 016592

(iv) 113.5

Bambermycins, 1 to 2

Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiency.

Feed continuously as the sole ration. Do not feed to chickens over 16 weeks of age

016592

(v) 227

Broiler and replacement chickens intended for use as caged layers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

Feed continuously as the sole ration; feed up to 16 weeks of age if intended for use as caged layers; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter

016592

(vi) 227

Bambermycins, 1 to 2

Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiency.

Feed continuously as sole ration until 5 days before slaughter. Withdraw 5 days before slaughter or feed 113.5 g/ton clopidol and 1 to 2 g/ton bambermycins during those 5 days before slaughter. Do not feed to chickens over 16 weeks of age

016592

(2) Turkeys —

Clopidol in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsors

(i) 113.5 or 227

Turkeys: As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi.

For turkeys grown for meat purposes only; feed continuously as the sole ration at 0.0125 or 0.025 percent clopidol depending on management practices, degree of exposure, and amount of feed eaten; withdraw 5 days before slaughter

016592

(ii) [Reserved]

(3) Combinations. Clopidol may also be used in combination with:

(i) Chlortetracycline as in § 558.128.

(ii) Lincomycin as in § 558.325.

§ 558.185 Coumaphos.

(a) Specifications. Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.168 of this chapter.

(d) Special considerations. (1) Labeling shall bear the following warning: The active ingredient coumaphos is a cholinesterase inhibitor. Do not use this product on animals simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals.

(2) See § 500.25 of this chapter.

(e) Conditions of use in laying chickens.

Coumaphos in grams per ton

Indications for use

Limitations

Sponsor

(1) 27.2 (0.003 percent)

Laying chickens: For control of capillary worm ( Capillaria obsignata ) and as an aid in control of common round worm ( Ascaridia galli ) and cecal worm ( Heterakis gallinae )

Feed continuously as the sole ration for 14 days. If reinfection occurs, treatment may be repeated, but not sooner than 3 weeks after the end of the previous treatment. Do not feed to chickens within 10 days of vaccination or other conditions of stress.

058198

(2) 36.3 (0.004 percent)

Replacement pullets: For control of capillary worm ( Capillaria obsignata ) and as an aid in control of common round worm ( Ascaridia galli ) and cecal worm ( Heterakis gallinae )

Feed continuously as the sole ration for from 10 to 14 days. Do not feed to chickens under 8 weeks of age or within 10 days of vaccination or other conditions of stress. If birds are maintained on contaminated litter or exposed to infected birds, a second 10- to 14-day treatment is recommended, but not sooner than 3 weeks after the end of the previous treatment. If reinfection occurs after production begins, repeat treatment as recommended for laying flocks.

058198

§ 558.195 Decoquinate.

(a) Specifications. Type A medicated article containing 6 percent decoquinate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.170 of this chapter.

(d) Special considerations. (1) Bentonite should not be used in decoquinate feeds.

(2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section.

(3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises.

(e) Conditions of use. It is used as follows:

(1) Chickens —

Decoquinate in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 27.2

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti

Do not feed to laying hens producing eggs for human consumption

054771

(ii) 27.2

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration; do not feed to laying chickens. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(iii) 27.2

Bacitracin zinc, 10 to 50

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti

Feed continuously as sole ration; do not feed to laying chickens. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter

054771

(2) Cattle —

Decoquinate in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 12.9 to 90.8

Cattle (including ruminating and nonruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E. zuernii

Feed Type C feed or milk replacer to provide 22.7 milligrams (mg) per 100 pounds (lb) of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for human consumption. See paragraph (d)(3) of this section

054771

(ii) 12.9 to 90.8

Monensin, 5 to 30

Cattle fed in confinement for slaughter: For prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiency

Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb of body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter

016592, 054771

(iii) 90.9 to 535.7

Cattle (including ruminating and nonruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E. zuernii

Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section

054771

(3) Minor species —

Decoquinate in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 12.9 to 90.8

1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, and E. bakuensis

Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption

054771

2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni and E. ninakohlyakimovae

Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption

(ii) 90.9 to 535.7

1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, and E. bakuensis

Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption

054771

2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni and E. ninakohlyakimovae

Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption

(4) Decoquinate may also be used in combination with:

(i)-(ii) [Reserved]

(iii) Chlortetracycline as in § 558.128.

(iv) Lincomycin as in § 558.325.

§ 558.198 Dichlorvos.

(a) Specifications. Each pound of Type A medicated article containing 3.1 or 9.6 percent dichlorvos.

(b) Sponsor. See No. 054628 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.180 of this chapter.

(d) Special considerations. (1) Dichlorvos is to be included in meal or mash or mixed with feed in crumble form only after the crumble feed has been manufactured. Do not mix in feeds to be pelleted nor with pelleted feed. Do not soak the feed or administer as wet mash. Feed must be dry when administered. Do not use in animals other than swine. Do not allow fowl access to feed containing this preparation or to feces from treated animals.

(2) Dichlorvos is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. If human or animal poisoning should occur, immediately consult a physician or a veterinarian. Atropine is antidotal.

(3) Labeling for Type A articles and Type B feeds must include a statement that containers or materials used in packaging such Type A articles and Type B feeds are not to be reused and all such packaging materials must be destroyed after the product has been used.

(e) Conditions of use. It is used in swine feed as follows:

Dichlorvos grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 348

Swine up to 70 pounds body weight: For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm ( Trichuris suis ), nodular worm ( Oesophagostomum sp.), large roundworm ( Ascaris suum ) and the thick stomach worm ( Ascarops strongylina ) of the gastrointestinal tract.

Feed as sole ration for 2 consecutive days. For swine from 70 pounds to market weight, feed as sole ration at the rate of 8.4 pounds of feed per head until the medicated feed has been consumed. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 4.2 pounds per head per day for 2 consecutive days.

054628

(ii) 479

Boars, open or bred gilts, and sows: For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm ( Trichuris suis ), nodular worm ( Oesophagostomum sp.), large roundworm ( Ascaris suum ) and the thick stomach worm ( Ascarops strongylina ) of the gastrointestinal tract.

Feed as sole ration at the rate of 6 pounds per head for one feeding.

054628

(iii) 334 to 500

Pregnant swine: An aid in improving litter production efficiency by increasing pigs born alive, birth weights, survival to market, and rate of weight gain. Treatment also removes and controls mature, immature and/or fourth stage larvae of whipworm ( Trichuris suis ), nodular worm ( Oesophagostomum spp. ) large roundworm ( Ascaris suum ), and the thick stomach worm ( Ascarops strongylina ) occurring in the gastrointestinal tract of the sow or gilt.

Mix into a gestation feed to provide 1,000 milligrams per head daily during last 30 days of gestation.

054628

§ 558.205 Diclazuril.

(a) Specifications. Type A medicated article containing 0.2 percent diclazuril.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.185 of this chapter.

(d) Conditions of use —(1) Chickens. For chickens it is used as follows:

Diclazuril grams/ton

Combination grams/ton

Indications for use

Limitations

Sponsor

(i) 0.91

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima

Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption

058198

(ii) 0.91

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima, and for increased rate of weight gain and improved feed efficiency. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima

Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter

058198

(iii) 0.91

Bambermycins, 1 to 2

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima, and for increased rate of weight gain and improved feed efficiency. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima

Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter

058198

(2) Turkeys. For turkeys it is used as follows:

Diclazuril grams/ton

Combination grams/ton

Indications for use

Limitations

Sponsor

(i) 0.91

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption

058198

(ii) 0.91

Bacitracin methylenedisalicylate, 4 to 50

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

058198

(iii) 0.91

Bambermycins 1 to 2

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for improved feed efficiency

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

058198

(iv) 0.91

Bambermycins 2

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

058198

(3) Diclazuril may also be used in combination with virginiamycin as in § 558.635.

§ 558.235 Efrotomycin.

(a) Specifications. Type A medicated articles containing 14.5 grams efrotomycin per pound.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.224 of this chapter.

(d) Conditions of use in swine —

Efrotomycin in grams/ton

Indications for use

Limitations

Sponsor

(1) 3.6

Swine: For improved feed efficiency

Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds

000010

(2) 3.6 to 14.5

Swine: For increased rate of weight gain

Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds

000010

§ 558.248 Erythromycin.

(a) Specifications. Type A medicated articles containing 92.5 grams per pound erythromycin (as the thiocyanate salt).

(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.230 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled.

(e) Conditions of use —(1) Chickens —

Erythromycin in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 92.5

Chickens: As an aid in the prevention of chronic respiratory disease during periods of stress

Feed for 2 days before stress and 3 to 6 days after stress. Withdraw 24 hours before slaughter

061623

(ii) 92.5

Chickens: As an aid in the prevention of infectious coryza

Feed for 7 to 14 days. Withdraw 24 hours before slaughter

061623

(iii) 185

Chickens: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD)

Feed for 5 to 8 days. Withdraw 48 hours before slaughter. Do not use in birds producing eggs for food

061623

(2) Turkeys —

Erythromycin thiocyanate in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 92.5

Turkeys: As an aid in the prevention of chronic respiratory disease during periods of stress

Feed for 2 days before stress and 3 to 6 days after stress

061623

(ii) 185

Turkeys: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD)

Feed for 5 to 8 days. Do not use in birds producing eggs for food

061623

§ 558.254 Famphur.

(a) Specifications. Type A medicated articles containing 13.2 or 33.3 percent famphur.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.273 of this chapter.

(d) Special considerations. Famphur is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(e) Conditions of use. It is used in cattle feed as follows:

Famphur amount

Indications for use

Limitations

Sponsor

(1) To provide 1.1 milligrams per pound (mg/lb) body weight per day

Beef cattle and nonlactating dairy cattle: For control of grubs and as an aid in control of sucking lice

Feed for 30 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter

000061

(2) To provide 2.3 mg/lb body weight per day

Beef cattle and nonlactating dairy cattle: For control of grubs

Feed for 10 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter

000061

§ 558.258 Fenbendazole.

(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.275 of this chapter.

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use —(1) Turkeys.

Amount fenbendazole in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(i) 14.5

Growing turkeys: For the treatment and control of gastrointestinal worms: roundworms, adults and larvae ( Ascaridia dissimilis ); cecal worms, adults and larvae ( Heterakis gallinarum ), an important vector of Histomonas meleagridis (Blackhead)

Feed continuously as the sole ration for 6 days. For growing turkeys only

000061

(ii) [Reserved]

(2) Swine.

Fenbendazole grams per ton

Combination grams per ton

Indications for use

Limitations

Sponsor

(i) 10 to 300

Swine: For the treatment and control of Lungworms: adult ( Metastrongylus apri and M. pudendotectus ); Gastrointestinal worms: adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms ( Ascaris suum ); adult nodular worms ( Oesophagostomum dentatum, O. quadrispinulatum ); adult small stomach worms ( Hyostrongylus rubidus ); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms ( Trichuris suis); and Kidney worms: adult and larvae ( Stephanurus dentatus )

Feed as the sole ration to provide 9 mg/kg of body weight (4.08 mg/lb) over a period of 3 to 12 consecutive days. Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product

000061

(ii) 10 to 300 (to provide 9 mg/kg of body weight)

Bacitracin methylenedisalicylate, 10 to 30

Growing/finishing swine: For the removal and control of adult stage lungworms ( Metastrongylus apri and M. pudendotectus ); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms ( Ascaris suum ); adult stage nodular worms ( Oesophagostomum dentatum, O. quadrispinulatum ); adult stage small stomach worms ( Hyostrongylus rubidus ); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms ( Trichuris suis ); adult and larvae kidney worms ( Stephanurus dentatus ); and for increased rate of weight gain and improved feed efficiency

Feed as the sole ration. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(iii) 10 to 300 (to provide 9 mg/kg of body weight)

Bacitracin methylenedisalicylate, 250

1. Growing/finishing swine: For the removal and control of adult stage lungworms ( Metastrongylus apri and M. pudendotectus ); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms ( Ascaris suum ); adult stage nodular worms ( Oesophagostomum dentatum, O. quadrispinulatum ); adult stage small stomach worms ( Hyostrongylus rubidus ); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms ( Trichuris suis ); adult and larvae kidney worms ( Stephanurus dentatus ); and for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where signs of disease have not yet occurred; or following an approved treatment of the disease condition

1. Growing/finishing swine: Feed as sole ration. Not for use in growing and finishing swine that weigh more than 250 lbs. Diagnosis of swine dysentery should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

2. Pregnant sows: For the removal and control of adult stage lungworms ( Metastrongylus apri and M. pudendotectus ); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms ( Ascaris suum ); adult stage nodular worms ( Oesophagostomum dentatum, O. quadrispinulatum ); adult stage small stomach worms ( Hyostrongylus rubidus ); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms ( Trichuris suis ); adult and larvae kidney worms ( Stephanurus dentatus ); for control of clostridial enteritis in suckling pigs caused by Clostridium perfringens

2. Pregnant sows: Feed as sole ration. Diagnosis of clostridial enteritis should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.

(3) Cattle.

Fenbendazole grams per ton

Indications for use

Limitations

Sponsor

(i) 200 to 1,000

Dairy and beef cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus ); Stomach worms: adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum )

Feed as the sole ration for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves

000061

(ii) [Reserved]

(iii) Top dress medicated feed —(A) Proprietary formulas. The following feed can be manufactured only per an approved proprietary formula and specifications:

Fenbendazole concentration

Indications for use

Limitations

Sponsor

( 1 ) 2.27 g/lb

Beef and dairy cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus ); Stomach worms: adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum )

Feed as a top dress for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves

000061

( 2 ) [Reserved]

(B) [Reserved]

(iv) Free-choice medicated feeds —(A) Proprietary formulas (21 CFR 510.455(e)(2)). The following feeds can be manufactured only per an approved proprietary formula and specifications:

Fenbendazole concentration

Indications for use

Limitations

Sponsor

( 1 ) 12,100 g/ton mineral

Beef cattle on pasture: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus ); Stomach worms: adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum )

Feed free-choice at the rate of 0.0375 lb per 100 pounds of body weight over a 3- to 6-day period to provide a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves

000061

( 2 ) 2.27 g/lb mineral

Beef cattle on pasture: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus ); Stomach worms: adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum )

Feed free-choice at the rate of 0.10 lb (1.6 oz) per 100 pounds of body weight over a 3- to 6-day period, to deliver a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves

000061

( 3 ) 750 mg/lb of protein block (to provide 5 mg/kg body weight (2.27 mg/lb))

Beef cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus ); Stomach worms: adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum )

Feed free choice at a rate of 0.1 pound of block per 100 pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consumption within 16 days following last treatment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves

000061

( 4 ) 750 mg/lb of molasses block (to provide 5 mg/kg body weight (2.27 mg/lb))

Beef cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus ); Stomach worms: adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum )

Feed free choice at a rate of 0.1 pound of block per 100 pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consumption within 11 days following last treatment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves

000061

(B) Published formulas (§ 510.455(e)(1) of this chapter). The following feeds can be manufactured only per one of the formulas and specifications published below:

( 1 ) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations:

Ingredient 1

Percent

International Feed No.

( i ) Free-choice, dry Type C feed:

Salt (sodium chloride)

59.00

6-04-152

Monosodium phosphate

31.16

6-04-288

Dried cane molasses

3.12

4-04-695

Zinc sulfate

0.76

6-05-556

Copper sulfate

0.45

6-01-720

Fenbendazole 20% Type A article

5.51

n/a

( ii ) Free-choice, dry Type C feed:

Salt (sodium chloride)

35.93

6-04-152

Dicalcium phosphate (18.5% P)

32.44

6-00-080

Calcium carbonate (38% Ca)

15.93

6-01-069

Magnesium oxide (56% Mg)

10.14

6-02-756

Zinc sulfate

1.47

6-05-556

Mineral oil

1.00

8-03-123

Dried cane molasses (46% sugars)

0.98

4-04-695

Potassium iodide

0.01

6-03-759

Fenbendazole 20% Type A article

2.10

n/a

( iii ) Free-choice, liquid Type C feed 2 :

Cane molasses 3

80.902

4-13-251

Water

9.36

n/a

Urea solution, 55%

7.05

5-05-707

Phosphoric acid 75% (feed grade)

2.00

6-03-707

Xantham gum

0.20

8-15-818

Trace minerals 4

0.20

n/a

Vitamin premix 4

0.01

n/a

Fenbendazole 20% Type A article

0.278

n/a

1 Formulation modifications require FDA approval prior to marketing. Selenium is not approved for use in the liquid, free-choice formulations described in paragraph (e)(3)(iv)(B) of this section. Free-choice cattle feeds containing selenium must comply with published regulations ( see 21 CFR 573.920).

2 The labeling for the liquid free-choice Type C medicated feed must bear an expiration date of 12 weeks after the date of manufacture.

3 The percentage of cane molasses and water in the formulation may be adjusted as needed to bring the brix value of the molasses to the industry standard of 79.5 brix.

4 The contents of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds.

( 2 ) Indications for use. As in paragraph (e)(3)(i) of this section.

( 3 ) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

(4) Horses.

Fenbendazole grams per ton

Indications for use

Limitations

Sponsor

(i) 4,540

5 mg/kg body weight (2.27 mg/lb) for the control of large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles ( Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), and pinworms ( Oxyuris equi ); 10 mg/kg body weight (4.54 mg/lb) for the control of ascarids ( Parascaris equorum )

Feed at the rate of 0.1 lb of feed per 100 lb of body weight to provide 2.27 mg fenbendazole/lb of body weight in a 1-day treatment or 0.2 lb of feed per 100 lb of body weight to provide 4.54 mg fenbendazole/lb of body weight in a 1-day treatment. All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed. Do not use in horses intended for human consumption

000061

(ii) [Reserved]

(5) Zoo and wildlife animals.

Species/Class

Fenbendazole grams per ton

Indications for use

Limitations

Sponsor

(i) Feral swine ( Sus scrofa ):

90 to 325

For the treatment and control of kidney worm ( Stephanurus dentatus ), roundworm ( Ascaris suum ), nodular worm ( Oesophagostomum dentatum )

Use as a complete feed at a rate to provide 3 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season

000061

(ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae)

50 to 300

For the treatment and control of small stomach worm ( Trichostrongylus spp.), thread necked intestinal worm ( Nematodirus spp.), barberpole worm ( Haemonchus spp.), whipworm ( Trichuris spp.)

Use as a complete feed at a rate to provide 2.5 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season

000061

(iii) Rocky mountain bighorn sheep ( Ovis c. canadensis )

375 to 1,000

For the treatment and control of Protostrongylus spp.

Use as a complete feed at a rate to provide 10 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season

000061

(iv) Wild quail

90.7

For the treatment and control of Gastrointestinal worms: cecal worms ( Aulonocephalus spp.)

Feed for 21 consecutive days. Prior withdrawal of feed is not necessary

000061

(6) Fenbendazole may also be used in combination with:

(i) [Reserved]

(ii) Lincomycin as in § 558.325.

§ 558.261 Florfenicol.

(a) Specifications. Type A medicated articles containing florfenicol in the following concentrations:

(1) 40 grams per kilogram for use as in paragraph (e)(1) of this section.

(2) 500 grams per kilogram for use as in paragraph (e)(2) of this section.

(b) Sponsors. See sponsor numbers as in § 510.600(c) of this chapter.

(1) No. 000061 for use of products described in paragraph (a) of this section as in paragraph (e) of this section.

(2) No. 066104 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.

(c) Related tolerances. See § 556.283 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for florfenicol medicated feeds:

(i) For swine must not exceed 90 days from the date of issuance.

(ii) For fish must not exceed 6 months from the date of issuance.

(3) VFDs for florfenicol shall not be refilled.

(4) Type A medicated articles and medicated feeds intended for use in fish shall bear the following: “Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.”

(e) Conditions of use —(1) Swine —

Florfenicol in grams/ton of feed

Indications for use

Limitations

182

For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Streptococcus suis , and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.

Feed continuously as a sole ration for 5 consecutive days. The safety of florfenicol on swine reproductive performance, pregnancy, and lactation have not been determined. Feeds containing florfenicol must be withdrawn 13 days prior to slaughter.

(2) Fish —

Florfenicol in grams/ton of feed

Indications for use

Limitations

(i) 182 to 2,724

Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri

Feed as a sole ration for 10 consecutive days to deliver 10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

(ii) 182 to 2,724

Freshwater-reared salmonids: for the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicida

Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

(iii) 182 to 2,724

Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare

Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish for freshwater-reared warmwater finfish and other freshwater-reared finfish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

(iv) 273 to 2,724

Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae

Feed as a sole ration for 10 consecutive days to deliver 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

§ 558.265 Halofuginone.

(a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.308 of this chapter.

(d) Conditions of use. It is used in feed as follows:

(1) Chickens —

Halofuginone in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 2.72

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter

016592

(ii) 2.72

Bacitracin methylenedisalicylate, 10 to 50

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for improved feed efficiency

Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter

016592

(iii) 2.72

Bambermycins, 1 to 2

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E, acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter

016592

(iv) 2.72

Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati / E. mitis, and E. brunetti

Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter

016592

(2) Turkeys —

Halofuginone in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 1.36 to 2.72

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis

Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl

016592

(ii) 1.36 to 2.72

Bacitracin methylenedisalicylate, 10 to 50

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain

Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl

016592

(iii) 1.36 to 2.72

Bambermycins, 2

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain

Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl

016592

(3) Halofuginone may also be used in combination with:

(i) Lincomycin as in § 558.325.

(ii) [Reserved]

§ 558.274 Hygromycin B.

(a) Specifications. Type A medicated articles containing 2.4 or 8 grams hygromycin B per pound (g/lb).

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter for as follows:

(c) Related tolerances. See § 556.330 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled.

(e) Conditions of use. It is used in feed as follows:

(1) Chickens —

Hygromycin B grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 8 to 12

Chickens: For control of infections of large roundworms ( Ascaris galli ), cecal worms ( Heterakis gallinae ), and capillary worms ( Capillaria obsignata )

Use in complete feed. Withdraw 3 days before slaughter

058198

(ii) [Reserved]

(2) Swine —

Hygromycin B grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 12

Swine: For control of infections of large roundworms ( A. suis ), nodular worms ( O. dentatum ), and whipworms ( Trichuris suis )

In market hogs, use in complete feed for 8 weeks during the growing period. Withdraw 15 days before slaughter

058198

(ii) [Reserved]

§ 558.295 Iodinated casein.

(a) Specifications. Type A medicated article containing iodinated casein.

(b) Sponsor. See No. 017762 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Ducks —

Amount in grams/ton

Indications for use

Limitations

Sponsor

(i) 100 to 200

Growing ducks: For increased rate of weight gain

017762

(ii) [Reserved]

(2) Dairy cows —

Amount in grams/pound

Indications for use

Limitations

Sponsor

(1) 0.5 to 1.5 per 100 lb of body weight

Dairy cows: For increased milk production

This drug is effective for limited periods of time, and the effectiveness is limited to the declining phase of lactation. Administration must be accompanied with increased feed intake. Administration may increase heat sensitivity of the animal

017762

(2) [Reserved]

§ 558.300 Ivermectin.

(a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb).

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.344 of this chapter.

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use in swine. It is used in feed as follows:

Ivermectin in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(1) 1.8

Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms ( Stephanurus dentatus, adults and fourth-stage larvae); lungworms ( Metastrongylus spp., adults); threadworms ( Strongyloides ransomi, adults and somatic larvae); lice ( Haematopinus suis ); and mange mites ( Sarcoptes scabiei var. suis )

Feed as the only feed for 7 consecutive days to provide 0.1 milligrams per kilograms (mg/kg) of body weight per day. Withdraw 5 days before slaughter

000010

(2) 1.8

Bacitracin methylenedisalicylate, 10 to 30

Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms ( Stephanurus dentatus, adults and fourth-stage larvae); lungworms ( Metastrongylus spp., adults); threadworms ( Strongyloides ransomi, adults and somatic larvae); lice ( Haematopinus suis ); and mange mites ( Sarcoptes scabiei var. suis ); and for increased rate of weight gain and improved feed efficiency

Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter

000010

(3) 1.8

Bacitracin methylenedisalicylate, 250

Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms ( Stephanurus dentatus, adults and fourth-stage larvae); lungworms ( Metastrongylus spp., adults); threadworms ( Strongyloides ransomi, adults and somatic larvae); lice ( Haematopinus suis ); and mange mites ( Sarcoptes scabiei var. suis ); and for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where symptoms have not yet occurred, or following an approved treatment of disease condition

Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter

000010

(4) 1.8 to 11.8

Adult and breeding swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms ( Stephanurus dentatus, adults and fourth-stage larvae); lungworms ( Metastrongylus spp., adults); threadworms ( Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice ( Haematopinus suis ); and mange mites ( Sarcoptes scabiei var. suis )

Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter

000010

(5) 1.8 to 11.8

Bacitracin methylenedisalicylate, 250

Pregnant sows: For treatment and control of gastrointestinal roundworms ( Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms ( Stephanurus dentatus, adults and fourth-stage larvae); lungworms ( Metastrongylus spp., adults); threadworms ( Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice ( Haematopinus suis ); and mange mites ( Sarcoptes scabiei var. suis ); and for control of clostridial enteritis caused by Clostridium perfringens in suckling piglets

Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. Feed bacitracin methylenedisalicylate Type C medicated feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours

000010

(6) 18.2 to 120

Adult and breeding swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms ( Stephanurus dentatus, adults and fourth-stage larvae); lungworms ( Metastrongylus spp., adults); threadworms ( Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice ( Haematopinus suis ); and mange mites ( Sarcoptes scabiei var. suis )

Top dress on daily ration for individual treatment for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter

000010

§ 558.305 Laidlomycin.

(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Tolerances. See § 556.346 of this chapter.

(d) Special considerations. (1) Laidlomycin liquid Type B feeds may be manufactured from dry laidlomycin Type A articles. The liquid Type B feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) The expiration date for the liquid Type B feed is 21 days after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 7 days after date of manufacture.

(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements:

(i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.

(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.

(iii) Not for use in animals intended for breeding.

(e) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:

Laidlomycin in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(1) 5

For improved feed efficiency and increased rate of weight gain.

Feed continuously in a Type C feed at a rate of 30 to 75 mg/head/day.

054771

(2) 5 to 10

For improved feed efficiency.

Feed continuously in a Type C feed at a rate of 30 to 150 milligrams/head/day.

054771

(f) Laidlomycin may also be used in combination with chlortetracycline as in § 558.128.

§ 558.311 Lasalocid.

(a) Specifications. Each pound of Type A medicated article contains 68 grams (15 percent), 90.7 grams (20 percent), or 150 grams (33.1 percent) lasalocid as lasalocid sodium activity. A minimum of 90 percent of lasalocid activity is derived from lasalocid A.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerance. See § 556.347 of this chapter.

(d) Special considerations. (1) Type C cattle and sheep feeds may be manufactured from lasalocid liquid Type B feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) A physically stable lasalocid liquid feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.

(3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid feed by:

(i) Either filing a new animal drug application for the product or establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental new animal drug application to establish physical stability; and

(iii) Requesting the sponsor of an approved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing directions different from the standard directions established in paragraph (d)(1) of this section may also follow this procedure.

(4) If adequate information is submitted to show that a particular liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of this section may be waived.

(5) Required label statements:

(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.

(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(3)(vi) through (e)(3)(viii) of this section must be the subject of an approved NADA or supplemental NADA as provided in § 510.455 of this chapter.

(e) Conditions of use. It is used as follows:

(1) The conditions of use for chickens are:

Lasalocid in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 68 to 113

Broiler or fryer chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima.

Feed continuously as the sole ration.

054771

(ii) 68

Bacitracin methylenedisalicylate, 10 to 50

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increased rate of weight gain and improved feed efficiency.

Feed continuously as the sole ration. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter.

054771

(iii) 68 to 113

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for improved feed efficiency.

Feed continuously as the sole ration. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter.

054771

(iv) 68 to 113

Bacitracin zinc, 4 to 50

Broiler chickens. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increased rate of weight gain and improved feed efficiency.

Feed continuously as the sole ration. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter.

054771

(v) 68 to 113

Bambermycins, 1 to 2

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increased rate of weight gain and improved feed efficiency.

Feed continuously as sole ration. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter.

016592

(2) The conditions of use for turkeys are:

Lasalocid in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 68 to 113

Growing turkeys; For prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides.

Feed continuously as sole ration.

054771

(ii) 68 to 113

Bacitracin methylenedisalicylate, 4 to 50

Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides; and for increased rate of weight gain and improved feed efficiency.

Feed continuously as the sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter.

054771

(iii) 68 to 113

Bacitracin zinc, 4 to 50

Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides; and for increased rate of weight gain and improved feed efficiency.

Feed continuously as the sole ration. Bacitracin zinc as provided by No. 054771 in § 510.600(c) in this chapter.

054771

(3) The conditions of use for cattle are—

Lasalocid amount

Indications for use

Limitations

Sponsor

(i) 10 to 30 grams/ton of feed

Cattle fed in confinement for slaughter: For improved feed efficiency.

Feed continuously in complete feed to provide not less than 100 milligrams (mg) nor more than 360 mg of lasalocid sodium activity per head per day.

054771

(ii) 25 to 30 grams/ton of feed

Cattle fed in confinement for slaughter: For improved feed efficiency and increased rate of weight gain.

Feed continuously in complete feed to provide not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day.

054771

(iii) Not less than 60 mg or more than 300 mg of lasalocid per head per day

Pasture cattle (slaughter, stocker, feeder cattle, and beef replacement heifers): For increased rate of weight gain

Feed continuously at a rate of not less than 60 mg or more than 300 mg of lasalocid per head per day when on pasture. The drug must be contained in at least 1 pound of feed. Daily intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day

054771

(iv) 1 mg lasalocid per 2.2 pounds (lb) body weight per day

Cattle up to 800 lb: For control of coccidiosis caused by Eimeria bovis and E. zuernii.

Hand feed continuously at a rate of 1 mg of lasalocid per 2.2 lb body weight per day to provide not more than 360 mg of lasalocid per head per day.

054771

(v) 1 mg lasalocid per 2.2 lb body weight per day

Replacement calves: For control of coccidiosis caused by E. bovis and E. zuernii.

In milk replacer powder, hand feed at a rate of 1 mg of lasalocid per 2.2 lb body weight per day. A withdrawal period has not been established for lasalocid in pre-ruminating calves. Do not use in calves to be processed for veal.

054771

(vi) 1,440 grams/ton

Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain.

As a free-choice Type C medicated loose mineral, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.

012286

(vii) 1,440 grams/ton

Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain.

As a free-choice Type C medicated mineral block, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.

017800

(viii) 300 grams/ton

Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain.

As a free-choice Type C medicated protein block, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.

067949

(ix) 60 to 300 mg of lasalocid per head per day

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replacement beef and dairy heifers on pasture: For increased rate of weight gain

Feed continuously as a Type C free-choice medicated feed at a rate of 60 to 300 mg of lasalocid per head per day. Daily intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day

054771

(4) The conditions of use for minor species are:

Lasalocid in grams/ton

Indications for use

Limitations

Sponsor

(i) 20 to 30

Sheep maintained in confinement: For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, and E. intricata.

Feed continuously in complete feed to provide not less than 15 milligrams (mg) nor more than 70 mg of lasalocid sodium activity per head per day depending on body weight.

054771

(ii) 113

Chukar partridges: For prevention of coccidiosis caused by E. legionensis.

Feed continuously as sole ration up to 8 weeks of age.

054771

(iii) 113

Rabbits: For prevention of coccidiosis caused by E. stiedae.

Feed continuously as sole ration up to 6 1/2 weeks of age

054771

(5) It is used as a free-choice mineral Type C feed as follows:

(i) Specifications.

Ingredient

Percent

International feed No.

Defluorinated phosphate (20.5% Ca, 18.5% P)

35.9

6-01-080

Sodium chloride (salt)

20.0

6-04-152

Calcium carbonate (38% Ca)

18.0

6-01-069

Cottonseed meal

10.0

5-01-621

Potassium chloride

3.0

6-03-755

Selenium premix (0.02 percent Se) 1

3.0

Dried cane molasses (46% sugars)

2.5

4-04-695

Magnesium sulfate

1.7

6-02-758

Vitamin premix 1

1.4

Magnesium oxide (58% Mg)

1.2

6-02-756

Potassium sulfate

1.2

6-06-098

Trace mineral premix 1

1.04

Lasalocid Type A medicated article (68 g/lb) 2

1.06

1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

2 To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs per ton (0.794%), adding molasses.

(ii) Amount. 1,440 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers); feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(6) It is used as a ruminant free-choice liquid Type C feed as follows:

(i) Specifications.

Ingredient

Percent

International feed No.

Cane molasses

55.167

4-13-241

Condensed molasses fermentation solubles

24.0

50% Urea Solution (23% N)

12.0

Ammonium polyphosphate solution

1.0

6-08-42

Phosphoric acid (54%)

3.0

6-03-707

Xanthan gum

0.05

8-15-818

Water

4.0

Trace mineral premix 1

0.5

Vitamin premix 1

0.2

Lasalocid liquid Type A medicated article (90.7 g/lb) 2

0.083

1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

2 To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a lasalocid liquid Type A medicated article containing 90.7 g/lb. If using a dry lasalocid Type A medicated article containing 68 g/lb, use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652 lbs per ton (0.083%), adding molasses.

(ii) Amount. 150 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(7) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

Ingredient

Percent

International feed No.

Monocalcium phosphate (21% P)

57.70

6-01-082

Salt

17.55

6-04-152

Distillers dried grains w/ solubles

5.40

5-28-236

Dried cane molasses (46% Sugars)

5.20

4-04-695

Potassium chloride

4.90

6-03-755

Trace mineral/vitamin premix 1

3.35

Calcium carbonate (38% Ca)

2.95

6-01-069

Mineral oil

1.05

8-03-123

Magnesium oxide (58% Mg)

1.00

6-02-756

Iron oxide (52% Fe)

0.10

6-02-431

Lasalocid Type A medicated article (68 g/lb) 2

0.80

1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

2 To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs per ton (0.6%), adding molasses.

(ii) Amount. 1,088 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day.

(v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(8) Lasalocid may also be used in combination with:

(i) Chlortetracycline as in § 558.128.

(ii) Chlortetracycline and sulfamethazine as in § 558.140.

(iii) Lincomycin as in § 558.325.

(iv) Melengestrol as in § 558.342.

(v) Oxytetracycline as in § 558.450.

(vi) Tylosin alone or in combination with melengestrol acetate as in § 558.625.

(vii) Virginiamycin as in § 558.635.

§ 558.325 Lincomycin.

(a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.360 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled.

(3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following:

(i) “CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”

(ii) [Reserved]

(4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following:

(i) “CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”

(ii) “CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.”

(e) Conditions of use —(1) Chickens —

Lincomycin grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsors

(i) 2

Broilers: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin

Feed as the sole ration. Not for use in layers, breeders, or turkeys

054771

(ii) [Reserved]

(iii) 2

Clopidol, 113.5

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the prevention of cecal and intestinal coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati

Feed as the sole ration to broiler chickens. Do not feed to chickens over 16 weeks of age. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Clopidol as provided by No. 016592 in § 510.600 of this chapter

054771

(iv) 2

Decoquinate, 27.2

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed as the sole ration. Do not use in feeds containing bentonite. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Decoquinate as provided by No. 054771 in § 510.600 of this chapter

054771

(v) 2

Halofuginone 2.72

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed continuously as sole ration. Withdraw 4 days before slaughter. Do not feed to laying chickens or waterfowl. Halofuginone hydrobromide as provided by No. 016592 in § 510.600 of this chapter

016592

(vi) 2

Lasalocid, 68 to 113

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E maxima

Feed as the sole ration. Type C feed must be used within 4 weeks of manufacture. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Lasalocid as provided by No. 054771 in § 510.600 of this chapter

054771

(vii) 2

Monensin, 90 to 110

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed as the sole ration. Must be thoroughly mixed in feeds before use. Do not feed undiluted. Not for use in laying hens, breeding chickens, or turkeys. Do not allow horses, or other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Monensin as provided by No. 058198 in § 510.600 of this chapter

054771

(viii) 2

Robenidine hydrochloride, 30

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix

Feed as the sole ration. Do not use in feeds containing bentonite. Do not feed to laying hens producing eggs for human consumption. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Withdraw 5 days prior to slaughter. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Robenidine hydrochloride as provided by No. 054771 in § 510.600 of this chapter

054771

(ix) 2

Salinomycin, 40 to 60

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E maxima, E. brunetti, and E. mivati

Feed as the sole ration to broiler chickens. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Salinomycin as provided by No. 054771 in § 510.600 of this chapter

05477

(x) 2

Zoalene, 113.5

Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention and control of coccidiosis

Feed as the sole ration from the time chicks are placed in floor pens until slaughtered for meat. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Zoalene as provided by No. 054771 in § 510.600 of this chapter

054771

(2) Swine —

Lincomycin grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsors

(i) 40

For control of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis

Feed as sole ration. For use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis)

054771

(ii) [Reserved]

(iii) 40

Pyrantel, 96

For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; and as an aid in the prevention of establishment of nodular worm ( Oesophagostomum spp.) infections

Feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

066104

(iv) 40

Pyrantel, 96

For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum ) infections

Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

066104

(v) 40 or 100

Pyrantel, 96

For the treatment and/or control of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; and as an aid in the prevention of establishment of nodular worm ( Oesophagostomum spp.) infections

For treatment of swine dysentery, feed 100 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed for 3 weeks or until clinical signs of the disease disappear, following with 40 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

066104

(vi) 40

Pyrantel, 800

For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum ) and nodular worm ( Oesophagostomum spp.) infections

Feed as a single therapeutic treatment at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb and 5 lb of feed per head for animals over 200 lb. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. See paragraph (d) of this section. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

066104

(vii) 100

For treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis

Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear

054771

(viii) [Reserved]

(ix) 100

Pyrantel, 96

For the treatment of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; and as an aid in the prevention of establishment of nodular worm ( Oesophagostomum spp.) infections

Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

066104

(x) 100

Pyrantel, 96

For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum ) infections

Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

066104

(xi) 100

Pyrantel, 800

For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum ) and nodular worm ( Oesophagostomum spp.) infections

Feed as a single therapeutic treatment. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

066104

(xii) 100 to 200

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae

Feed as sole ration for 21 days

054771

(xiii) [Reserved]

(xiv) 200

Pyrantel, 96

For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; aid in the prevention of establishment of nodular worm ( Oesophagostomum spp.) infections

Feed as the sole ration for 21 days. Not for use in swine that weigh more than 250 pounds. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter

054771

§ 558.330 Lubabegron.

(a) Specifications. Each pound of Type A medicated article contains 4.54 grams (10 grams per kilogram) or 22.7 grams (50 grams per kilogram) of lubabegron as lubabegron fumarate.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.370 of this chapter.

(d) Special considerations. Labeling shall bear the following caution statements:

(1) Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals.

(2) Do not allow horses or other equines access to feed containing lubabegron.

(3) A decrease in dry matter intake may be noticed in some animals receiving lubabegron.

(e) Conditions of use. (1) It is used in cattle feed as follows:

Lubabegron (as lubabegron fumarate) in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsors

(i) 1.25 to 4.54

Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight during the last 14 to 91 days on feed

Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section.

058198

(ii) 1.25 to 4.54

Melengestrol acetate, 0.25 to 2 g/ton

Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and for reduction of ammonia gas emissions per pound of live weight and hot carcass weight during the last 14 to 91 days on feed

Melengestrol acetate Type C top-dress medicated feed (0.5 to 2 lb(s) per head per day) must be top dressed onto or mixed at feeding with a Type C medicated feed containing 1.25 to 4.54 g/ton lubabegron to provide 0.25 to 0.5 mg melengestrol acetate and 13 to 90 mg lubabegron per head per day. Feed as the sole ration during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section and in § 558.342(d). Lubabegron fumarate as provided by No. 058198; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter.

058198

(iii) 1.25 to 4.54

Monensin, 5 to 40

Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and for improved feed efficiency during the last 14 to 91 days on feed

Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day and 50 to 480 mg monensin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). See special labeling considerations in paragraph (d) of this section and in § 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter.

016592, 058198

(iv) 1.25 to 4.54

Monensin, 10 to 40

Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 14 to 91 days on feed

Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day and 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section and in § 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter.

016592, 058198

(v) 1.25 to 4.54

Monensin, 10 to 40 and melengestrol acetate, 0.25 to 2

Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii during the last 14 to 91 days on feed

Melengestrol acetate Type C top-dress medicated feed (0.5 to 2 lb(s) per head per day) must be top dressed onto or mixed at feeding with a Type C medicated feed containing 1.25 to 4.54 g/ton lubabegron and 10 to 40 g/ton monensin, to provide 0.25 to 0.5 mg melengestrol acetate and 13 to 90 mg lubabegron per head per day, and 0.14 to 0.42 mg monensin per pound of body weight per day, depending upon severity of challenge, up to a maximum of 480 mg monensin per head per day. Feed as the sole ration during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section, and in §§ 558.342(d) and 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 058198 or 016592; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter

058198, 016592

(2) Lubabegron may also be used in combination with:

(i) [Reserved]

(ii) Tylosin as in § 558.625.

§ 558.340 Maduramicin.

(a) Specifications. Type A medicated articles containing 4.54 grams maduramicin per pound.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Tolerances. See § 556.375 of this chapter.

(d) Conditions of use in chickens —

Amount in grams/ton

Indications for use

Limitations

Sponsor

(1) 4.54 to 5.45

Broiler chickens: For prevention of coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, and E. mivati

Feed continuously as sole ration. For broiler chickens only. Do not feed to laying hens. Withdraw 5 days before slaughter

054771

(2) [Reserved]

§ 558.342 Melengestrol.

(a) Specifications. (1) Dry Type A medicated articles containing 100 or 200 milligrams (mg) melengestrol acetate per pound.

(2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound.

(b) Sponsor. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 054771 for use of products described in paragraph (a)(1) of this section:

(2) Nos. 016592, 051311, 054771, and 058198 for use of product described in paragraph (a)(2) of this section.

(c) Related tolerances. See § 556.380 of this chapter.

(d) Special considerations. (1) Type B or C medicated feeds may be manufactured from melengestrol acetate liquid Type A articles or Type B or C medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) A physically stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.

(3) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be labeled in accordance with § 558.311(d).

(4) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and monensin must be labeled in accordance with § 558.355(d).

(5) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with § 558.625(d).

(6) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement.

(e) Conditions of use —(1) Cattle.

Melengestrol acetate in mg/head/day

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 0.25 to 0.5

Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat).

Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to 0.5 mg melengestrol acetate/head/day.

016592, 051311, 054771, 058198

(ii) 0.5

Heifers intended for breeding: For suppression of estrus (heat)

Administer 0.5 to 2.0 lb/head/day of Type C feed containing 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/day. Do not exceed 24 days of feeding

016592, 051311, 054771, 058198

(iii) 0.25 to 0.5

Lasalocid, 10 to 30

Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for control of coccidiosis caused by Eimeria bovis and Eimeria zuernii

Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 30 g of lasalocid per ton to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 milligrams of lasalocid per head/day. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771, 058198

(iv) 0.25 to 0.5

Monensin, 10 to 40

Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii

Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/day. See § 558.355(d) of this chapter. Monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016952, 054771, or 058198 in § 510.600(c) of this chapter

016592 045771 058198

(2) Melengestrol may also be used in combination with:

(i) Oxytetracycline as in § 558.450.

(ii) Ractopamine as in § 558.500.

(iii) Tylosin as in § 558.625.

(iv) Zilpaterol as in § 558.665.

§ 558.348 Mibolerone.

(a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms (µg) of mibolerone.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. 30 µg for animals weighing up to 25 pounds; 60 µg for animals weighing 26 to 50 pounds; 120 µg for animals weighing 51 to 100 pounds; 180 µg for animals weighing over 100 pounds, or German Shepherds or German Shepherd mix weighing 30 to 80 pounds. Administer daily at least 30 days before expected initiation of heat and continue as long as desired, but for not more than 12 months.

(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.

(3) Limitations. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington terriers. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 558.355 Monensin.

(a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 058198 for use as in paragraph (e) of this section.

(2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(vii), (e)(1)(xiv), (e)(2), (e)(3), (e)(4)(v), and (e)(5) of this section.

(c) Related tolerances. See § 556.420 of this chapter.

(d) Special considerations. (1) Type C chicken feed containing monensin as the mycelial cake shall bear an expiration date of 90 days after its date of manufacture.

(2)-(3) [Reserved]

(4) Liquid Type B feeds shall bear an expiration date of 8 weeks after its date of manufacture.

(5) All Type A medicated articles containing monensin shall bear the following warning statement: When mixing and handling monensin Type A medicated articles, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water.

(6) All formulations containing monensin shall bear the following caution statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.

(7) Type A medicated articles containing monensin intended for use in cattle and goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following statements:

(i) Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions.

(ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats.

(iii) Must be thoroughly mixed in feeds before use.

(iv) Do not feed undiluted.

(v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result.

(vi) Do not feed to lactating goats.

(vii) If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section).

(viii) A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(ix) You may notice the following: Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Increased incidence of cystic ovaries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin. Have a comprehensive and ongoing nutritional, reproductive, and herd health program in place when feeding monensin to dairy cows.

(x) Inadequate mixing (recirculation or agitation) of monensin liquid Type B or Type C medicated feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats.

(8) Type A medicated articles containing monensin intended for use in chickens, turkeys, and quail shall bear the following statements:

(i) Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

(ii) Must be thoroughly mixed in feeds before use.

(iii) Do not feed undiluted.

(iv) Do not feed to laying chickens.

(v) Do not feed to chickens over 16 weeks of age.

(vi) Not for broiler breeder replacement chickens.

(vii) Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis.

(viii) In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain.

(9) Type B feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). See paragraphs (d)(6) and (d)(7)(i) through (v), (vii), and (viii) of this section.

(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). See paragraphs (d)(6) and (d)(7)(i) through (iv), (vii), (viii), and (ix) of this section.

(iii) Goats : See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi) of this section.

(iv) Chickens : See paragraphs (d)(8)(i) through (d)(8)(vi), and (d)(8)(viii) of this section.

(v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of this section.

(vi) Quail : See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii) of this section.

(10) Type C feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). See paragraphs (d)(6) and (d)(7)(i), (v), (vii), and (viii) of this section. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chapter.

(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). See paragraphs (d)(6) and (d)(7)(i), (vii), (viii), and (ix) of this section. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chapter.

(iii) Goats : See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this section.

(iv) Chickens : See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and (d)(8)(viii) of this section.

(v) Turkeys : See paragraphs (d)(8)(i) and (d)(8)(vii) of this section.

(vi) Quail : See paragraph (d)(8)(i) of this section.

(11) Type B and Type C liquid feeds requiring recirculation or agitation that contain monensin and are intended for use in cattle (including dairy cows) and goats shall bear the caution statement specified in paragraph (d)(7)(x) of this section.

(12) Mixing directions for liquid feeds requiring recirculation or agitation:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(e) Conditions of use. It is used as follows:

(1) Chickens —

Monensin in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 90 to 110

Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

016592

058198

(ii) 90 to 110

Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima

Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

016592

058198

(iii) 90 to 110

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency

Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter

054771

(iv) 90 to 110

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

Feed as the sole ration throughout the feeding period. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter

069254

(v) 90 to 110

Bacitracin methylenedisalicylate, 4 to 50

Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

Feed as the sole ration throughout the feeding period. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter

069254

(vi) 90 to 110

Bacitracin methylenedisalicylate, 4 to 50

Layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter

054771

(vii) 90 to 110

Bacitracin methylenedisalicylate, 5 to 25

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increase in rate of weight gain and improved feed efficiency

Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section.

016592

058198

(viii) 90 to 110

Bacitracin methylenedisalicylate, 50

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens

Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter

069254

(ix) 90 to 110

Bacitracin methylenedisalicylate, 50

Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens

Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter

069254

(x) 90 to 110

Bacitracin methylenedisalicylate, 50

Broiler and layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin

Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter

054771

(xi) 90 to 110

Bacitracin zinc, 4 to 50

Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter

054771

(xii) 90 to 110

Bacitracin zinc, 10

Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter

058198

(xiii) 90 to 110

Bacitracin zinc, 10 to 30

Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency

Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter

058198

(xiv) 90 to 110

Bambermycins, 1 to 2

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increase in rate of weight gain and improved feed efficiency

Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section.

016592

058198

(2) Turkeys —

Monensin in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 54 to 90

Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E.gallopavonis

For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Not for broiler breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 16 weeks of age. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

016592

058198

(ii) 54 to 90

Bacitracin methylenedisalicylate, 4 to 50

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration. The optimum level depends upon the severity of coccidiosis exposure. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by Nos. 066104 or 069254 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section

016592

058198

069254

(iii) 54 to 90

Bacitracin methylenedisalicycate, 200

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate

Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section

016592

058198

(iv) 54 to 90

Bambermycins, 1 to 2

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for improved feed efficiency

Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section

016592

058198

(v) 54 to 90

Bambermycins, 2

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section

016592

058198

(3) Cattle —

Monensin in grams/ton

Indications for use

Limitations

Sponsor

(i) 5 to 40

Growing beef steers and heifers fed in confinement for slaughter: For improved feed efficiency

Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). See special labeling considerations in paragraph (d) of this section

016592 058198

(ii) 10 to 40

Growing beef steers and heifers fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii

Feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day. See special labeling considerations in paragraph (d) of this section

016592 058198

(iii) 10 to 200

Calves excluding veal calves: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii

Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day. See special labeling considerations in paragraph (d) of this section

016592 058198

(iv) 11 to 22

Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake)

Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See special labeling considerations in paragraph (d) of this section

016592 058198

(v) 11 to 400

Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake)

Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. See special labeling considerations in paragraph (d) of this section

016592 058198

(vi) 15 to 400

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii

For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed. See special labeling considerations in paragraph (d) of this section

016592 058198

(vii) 25 to 400

Beef cows: For improved feed efficiency when receiving supplemental feed, and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii

Feed as supplemental feed, either hand-fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day in not less than 1 pound of feed. See special labeling considerations in paragraph (d) of this section

016592 058198

(4) Free-choice cattle feeds —

Monensin amount

Indications for use

Limitations

Sponsor

(i) 150 milligrams per pound of protein-mineral block (0.033%)

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replacement beef heifers on pasture: For increased rate of weight gain, and for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii in pasture cattle which may require supplemental feed

Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. See paragraph (d)(10)(i) of this section

012286

(ii) 175 milligrams per pound of protein-mineral block (0.038%)

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter): For increased rate of weight gain

Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day, at least 1 block per 4 head of cattle. Do not allow cattle access to salt or mineral while being fed this product. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. See paragraph (d)(10)(i) of this section

017800

(iii) 400 milligrams per pound of protein-mineral block (0.088%)

Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain

Provide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or minerals containing salt. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section

067949

(iv) 400 mg per pound of block

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and beef replacement heifers): for increased rate of weight gain

Provide 50 to 200 mg of monensin (2 to 8 ounces of block) per head per day, in at least one block per five head of cattle. Feed blocks continuously. Do not feed salt of mineral supplements in addition to this block. Discontinue feeding if block consumption falls below 2 ounces or rises above 8 ounces daily. See paragraph (d)(10)(i) of this section.

086113

(v) 1,620 grams per ton of mineral granules as specified in paragraph (f)(4)(v)(A) of this section

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii

Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement

016592 058198

(A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:

Ingredient

Percent

International feed No.

Monocalcium phosphate (21% phosphorus, 15% calcium)

29.49

6-01-082

Sodium chloride (salt)

24.37

6-04-152

Dried cane molasses

20.0

4-04-695

Ground limestone (33% calcium) or calcium carbonate (38% calcium)

13.75

6-02-632

Cane molasses

3.0

4-04-696

Processed grain by-products (as approved by AAFCO)

5.0

Vitamin/trace mineral premix 1

2.5

Monensin Type A article, 90.7 grams per pound

0.89

Antidusting oil

1.0

1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18).

(B) [Reserved]

(5) Minor species —

Monensin in

grams/ton

Indications for use

Limitations

Sponsor

(i) 73

Growing bobwhite quail: For the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae

Feed continuously as sole ration. Not for broiler breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

016592

058198

(ii) 20

Goats maintained in confinement: For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae

Feed continuously. Do not feed to lactating goats. See paragraph (d)(11) of this section for provisions for monensin liquid Type C goat feeds.

016592

058198

(6) Monensin may also be used in combination with:

(i) Avilamycin as in § 558.68.

(ii) Chlortetracycline as in § 558.128.

(iii) Decoquinate as in § 558.195.

(iv) Lubabegron as in § 558.330.

(v) Lincomycin as in § 558.325.

(vi) Melengestrol acetate as in § 558.342.

(vii) Oxytetracycline as in § 558.450.

(viii) Ractopamine as in § 558.500.

(ix) Tilmicosin as in § 558.618.

(x) Tylosin as in § 558.625.

(xi) Virginiamycin as in § 558.635.

(xii) Zilpaterol alone or in combination as in § 558.665.

§ 558.360 Morantel.

(a) Specifications. Each pound of Type A medicated article contains 88 grams morantel tartrate.

(b) Sponsor. See No. 066104 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.425 of this chapter.

(d) Special considerations. (1) Do not use in Type B or Type C medicated feeds containing bentonite.

(2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(e) Conditions of use. It is used in feed as follows:

Morantel tartrate in grams/ton

Indications for use

Limitations

Sponsor

(1) 0.44 to 4.4 grams of morantel tartrate per pound of feed

Cattle: For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms ( Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine ( Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine ( Oesophagostomum radiatum )

Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle within 14 days of slaughter

066104

(2) 0.44 to 4.4 grams of morantel tartrate per pound of feed

Goats: For removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylus axei

Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat goats within 30 days of slaughter

066104

§ 558.363 Narasin.

(a) Specifications. Type A medicated articles containing 36, 45, 54, 72, or 90 grams narasin per pound.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Tolerances. See § 556.428 of this chapter.

(d) Special considerations. An expiration date of 2 months (8 weeks) is required for narasin Type C medicated swine feeds.

(e) Conditions of use. It is used as follows:

(1) Chickens —

Narasin grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 54 to 90

Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima

For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal

058198

(ii) 54 to 72

Bacitracin methylenedisalicylate, 10 to 50

Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(iii) 54 to 72

Bacitracin zinc, 4 to 50

Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter

054771

(iv) 54 to 72

Bambermycins, 1 to 2

Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

016592

(2) Swine —

Narasin grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 13.6 to 27.2

Growing-finishing swine: For increased rate of weight gain when fed for at least 4 weeks

Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins ( e.g. , tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use

058198

(ii) 18.1 to 27.2

Growing-finishing swine: For increased rate of weight gain and improved feed efficiency when fed for at least 4 weeks

Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins ( e.g. , tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use

058198

(3) Narasin single-ingredient Type A medicated articles may also be used in combination with:

(i) Avilamycin as in § 558.68.

(ii) [Reserved]

§ 558.364 Narasin and nicarbazin.

(a) Specifications. A fixed-ratio, combination drug Type A medicated article containing 36 grams narasin and 36 grams nicarbazin per pound.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Tolerances. See §§ 556.428 and 556.445 of this chapter.

(d) Conditions of use. It is used as follows:

(1) Chickens —

Narasin and nicarbazin grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 27 to 45 of each drug

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati

Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. The two drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter may be used in the combination

058198

(ii) 27 to 45 of each drug

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Withdraw 5 days before slaughter. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

058198

(iii) 27 to 45 of each drug

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency

Feed as the sole ration throughout the feeding period. For broiler chickens only. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter

069254

(iv) 27 to 45 of each drug

Bacitracin methylenedisalicylate, 50

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin

Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Withdraw 5 days before slaughter. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(v) 27 to 45 of each drug

Bacitracin methylenedisalicylate, 50

Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens

Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. For broiler chickens only. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter

069254

(vi) 27 to 45 of each drug

Bacitracin methylenedisalicylate, 100 to 200

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin

To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(vii) 27 to 45 of each drug

Bambermycins, 1 to 2

Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

058198

(2) Narasin and nicarbazin fixed-ratio, combination drug Type A medicated articles may also be used in combination with:

(i) Avilamycin as in § 558.68.

(ii) Virginiamycin as in § 558.635.

§ 558.365 Neomycin sulfate.

(a) Specifications. Type A medicated article containing 325 grams neomycin sulfate per pound.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.430 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled.

(e) Conditions of use. Neomycin sulfate is used as follows:

Neomycin Sulfate

Combination

Indications for Use

Limitations

Sponsor

(1) 250 to 2,250 grams per ton (g/t) of dry type C feed.

Cattle, swine, sheep, and goats. For treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin.

To provide 10 milligrams (mg) of neomycin sulfate per pound of body weight per day for a maximum of 14 days. The concentration of neomycin sulfate required in medicated feed must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects feed consumption. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in dry feeds only. Not for use in liquid feed supplements.

054771

(2) 400 to 2,000 g/t of type C milk replacer.

Do.

To provide 10 mg of neomycin sulfate per pound of body weight per day for a maximum of 14 days. Amount consumed will vary depending on animal's consumption and weight. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in milk replacers only.

054771

§ 558.366 Nicarbazin.

(a) Specifications. Type A medicated articles containing 25 percent nicarbazin.

(b) Sponsors. See Nos. 060728, 066104, and 069254 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.445 of this chapter.

(d) Conditions of use. It is used as follows:

(1) Chickens —

Nicarbazin in grams per ton

Combination in grams per ton

Indications for use

Limitations

Sponsor

(i) 90.8 to 181.6

Chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton

066104

(ii) 90.8 to 181.6

Bacitracin methylenedisalicylate, 4 to 50

Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(iii) 90.8 to 181.6

Bacitracin methylenedisalicylate, 30

Broiler chickens; As an aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

066104

(iv) 90.8 to 181.6

Bacitracin methylenedisalicylate 50

Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

054771

(v) 113.5

Chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter

060728

069254

(vi) 113.5

Bacitracin methylenedisalicylate, 30

Broiler chickens; aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter

060728

(vii) 113.5

Bacitracin zinc, 4 to 50

Broiler chickens; aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis, and for increased rate of weight gain and improved feed efficiency

For broiler chickens only. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104, bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter

054771 066104

(viii) 113.5

Bambermycins, 1 to 2

Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella ) and intestinal ( E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis, and for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter

016592

(2) Nicarbazin single-ingredient Type A medicated articles may also be used in combination with:

(i) [Reserved]

(ii) Virginiamycin as in § 558.635.

§ 558.415 Novobiocin.

(a) Specifications. Type A medicated article containing 25 grams of novobiocin activity per pound.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.460 of this chapter.

(d) Conditions of use. It is used in animal feeds as follows:

(1) Chickens —

Novobiocin amount

Indications for use

Limitations

Sponsor

(i) To provide 6 to 7 milligrams per pound (mg/lb) of body weight per day.

Chickens: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.

Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter.

054771

(ii) To provide 10 to 14 mg/lb of body weight per day.

Chickens: For the treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin.

Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter.

054771

(2) Turkeys —

Novobiocin amount

Indications for use

Limitations

Sponsor

(i) To provide 4 to 5 mg/lb of body weight per day.

Turkeys: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.

Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter.

054771

(ii) To provide 5 to 8 mg/lb of body weight per day.

Turkeys: As an aid in the control of recurring outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin following initial treatment with 7 to 8 mg/lb of body weight per day.

Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter.

054771

(iii) To provide 7 to 8 mg/lb of body weight per day.

Turkeys: For the treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin; and treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin.

Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter.

054771

(3) Minor species —

Novobiocin amount

Indications for use

Limitations

Sponsor

(i) 350 grams per ton.

Ducks: For the control of infectious serositis and fowl cholera in ducks caused by Pasteurella anatipestifer and P. multocida, susceptible to novobiocin.

Administer as the sole ration for 5 to 7 days. Continue medication for 14 days if necessary. Repeat if reinfection occurs. Discontinue use at least 3 days before slaughter. Not for use in laying ducks.

054771

(ii) To provide 20 mg/lb of body weight per day.

Mink: For the treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms.

Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 7 days.

054771

§ 558.430 Nystatin.

(a) Specifications. Type A medicated article containing 20 grams of nystatin activity per pound.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.470 of this chapter.

(d) Conditions of use —

Amount in grams/ton

Indications for use

Limitations

Sponsor

(1) 50

Growing and laying chickens and growing turkeys: As an aid in the control of crop mycosis and mycotic diarrhea ( Candida albicans )

054771

(2) 100

Growing and laying chickens and growing turkeys: For the treatment of crop mycosis and mycotic diarrhea ( Candida albicans )

To be fed for 7 to 10 days

054771

§ 558.450 Oxytetracycline.

(a) Specifications. Each pound of Type A medicated article contains:

(1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride.

(2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 066104: Type A medicated articles as in paragraph (a)(1) of this section.

(2) No. 069254: Type A medicated articles as in paragraph (a)(2) of this section.

(c) Related tolerances. See § 556.500 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.

(3) In accordance with § 558.5, labeling shall bear the statement: “For use in dry animal feed only. Not for use in liquid feed supplements.”

(e) Conditions of use —(1) Chickens —

Oxytetracycline amount

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 100 to 200 g/ton

Chickens: For control of infectious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline

Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period

066104 069254

(ii) 200 g/ton

Monensin, 90 to 110

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air sac infection) caused by Mycoplasma gallisepticum and Escherichia coli

Feed continuously as the sole ration. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter

066104

(iii) 400 g/ton

Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline

Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period

066104 069254

(iv) 400 g/ton

Robenidine, 30

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline

Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 5 days before slaughter. Oxytetracycline as provided by No. 066104; robenidine as provided by No. 054771 in § 510.600(c) of this chapter

066104

(v) 500 g/ton

Chickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline

Feed continuously for 5 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter

066104 069254

(vi) 500 g/ton

Monensin, 90 to 100

Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline

Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter

066104

(vii) 500 g/ton

Salinomycin, 40 to 60

Chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by E. coli sensitive to oxytetracycline

Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter

066104 016592

(2) Turkeys —

Oxytetracycline amount

Indications for use

Limitations

Sponsor

(i) 100 g/ton

Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline

Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period

066104 069254

(ii) 200 g/ton

Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline

Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period

066104 069254

(iii) 25 mg/lb of body weight daily

Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline

Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period

066104 069254

(3) Swine —

Oxytetracycline amount

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 10 mg/lb of body weight daily

Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline

Feed continuously for 7 to 14 days

066104

069254

(ii) 10 mg/lb of body weight daily

Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline

Feed continuously for not more than 14 days

066104

069254

(iii) 10 mg/lb of body weight daily

Carbadox, 10 to 25

Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency

Feed continuously as the sole ration for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not mix in feeds containing bentonite. Do not feed to swine within 42 days of slaughter. Oxytetracycline and carbadox as provided by No. 066104 in § 510.600(c) of this chapter

066104

(4) Cattle —

Oxytetracycline amount

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 10 mg/lb of body weight daily

Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline

Feed continuously for 7 to 14 days. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period

066104

069254

(ii) 10 mg/lb of body weight daily

Calves: For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline

Feed continuously for 7 to 14 days in milk replacer or starter feed. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period

066104

069254

(iii) 75 mg/head/day

Growing cattle (over 400 lb): For reduction of incidence of liver abscesses

Feed continuously. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows

066104

069254

(iv) 75 mg/head/day

Lasalocid 25 to 30

Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain and improved feed efficiency

Feed continuously to provide 250 to 360 mg lasalocid and 75 mg of oxytetracycline per head per day. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter

054771

(v) 75 mg/head/day

Melengestrol acetate, 0.25 to 2.0

Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)

Feed continuously to provide 0.25 to 0.5 mg of melengestrol acetate and 75 mg of oxytetracycline per head per day. Melengestrol as provided by No. 054771 in § 510.600(c) of this chapter

054771

(vi) 0.5 to 2.0 g/head/day

Cattle: For prevention and treatment of the early stages of shipping fever complex

Feed 3 to 5 days before and after arrival in feedlots. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows

066104

069254

(5) Minor species —

Oxytetracycline amount

Indications for use

Limitations

Sponsor

(i) 10 mg/lb of body weight daily

Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline

Feed continuously for 7 to 14 days; withdraw 5 days before slaughter

066104 069254

(ii) 200 mg/colony as a dust (200 mg/oz) or syrup (200 mg/5 lb)

Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline

Apply every 4 to 5 days for a total of three applications. Remove at least 6 weeks prior to main honey flow

066104 069254

(iii) 800 mg/colony as an extender patty (800 mg/patty)

Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline

Use as a single application. Remove at least 6 weeks prior to main honey flow

066104 069254

(iv) 333 to 7,500 g/ton to provide 2.5 to 3.75 g/100 lb of fish/day

1. Freshwater-reared salmonids: for control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. hydrophila, and pseudomonas disease

Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed

066104

2. Catfish: for control of bacterial hemorrhagic septicemia caused by A. hydrophila and pseudomonas disease

Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water temperature is below 16.7 °C (62 °F)

066104

(v) 500 to 7,500 g/ton to provide 3.75 g/100 lb of fish/day

1. Freshwater-reared salmonids: for control of mortality due to coldwater disease associated with Flavobacterium psychrophilum or for control of mortality due to columnaris disease associated with Flavobacterium columnare

Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed

066104

2. Freshwater-reared salmonids weighing up to 55 grams: for marking of the skeletal tissue

Feed for 10 days. Immediate release is permitted following last feeding of medicated feed

066104

3. Catfish: for control of mortality due to columnaris disease associated with Flavobacterium columnare

Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water temperature is below 16.7 °C (62 °F)

066104

(vi) 1.25 to 25 g/kg to provide 11.35 g/100 lb of fish/day

Pacific salmon not over 30 grams body weight: for marking of the skeletal tissue

Administer medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed

066104

(vii) 1 g/lb of medicated feed

Lobsters: For control of gaffkemia caused by Aerococcus viridans

Administer as sole ration for 5 consecutive days; withdraw medicated feed 30 days before harvesting lobsters

066104

§ 558.455 Oxytetracycline and neomycin.

(a) Specifications. Type A medicated articles containing oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate.

(b) Sponsors. See Nos. 066104 and 069254 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.430 and 556.500 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for oxytetracycline and neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline and neomycin shall not be refilled.

(3) Cattle feeds shall bear the following warning statement: “Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.”

(e) Indications for use —(1) Chickens. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount in grams per ton of feed

Indications for use

Limitations

Sponsors

(i) 100 to 200

Chickens: For control of infectious synovitis caused by Mycoplasma synoviae ; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.

Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feed, withdraw 3 d before slaughter.

066104 069254

(ii) 400

Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to oxytetracycline.

Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter.

066104 069254

(iii) 500

Chickens: For reduction of mortality due to air sacculitis (air-sac- infection) caused by E. coli susceptible to oxytetracycline.

Feed continuously for 5 d; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter.

066104 069254

(2) Turkeys. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount

Indications for use

Limitations

Sponsors

(i) 100 g/ton of feed

Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.

Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.

066104 069254

(ii) 200 g/ton of feed

Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline.

Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.

066104 069254

(iii) To provide 25 milligrams per pound (mg/lb) of body weight daily.

Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline.

Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.

066104 069254

(3) Swine. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount

Limitations

Sponsors

(i) To provide 10 mg/lb of body weight daily

Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin

Feed continuously for 7 to 14 d; withdraw 5 d before slaughter

066104

069254

(ii) To provide 10 mg/lb of body weight daily

Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline

Feed continuously for not more than 14 d; withdraw 5 d before slaughter

066104

069254

(4) Cattle. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount

Indications for use

Limitations

Sponsors

(i) To provide 10 mg/lb of body weight daily

Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin

Feed continuously for 7 to 14 d; in feed or milk replacers. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter

066104

069254

(ii) To provide 10 mg/lb of body weight daily

Calves (up to 250 lb): For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin

Feed continuously for 7 to 14 d; in milk replacers or starter feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter

066104

069254

(iii) To provide 75 mg/head/day

Growing cattle (over 400 lb): For the reduction of the incidence of liver abscesses

Feed continuously

066104

069254

(iv) To provide 0.5 to 2.0 g/head/ day

Cattle: For prevention and treatment of the early stages of shipping fever complex

Feed 3 to 5 d before and after arrival in feedlots. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older

066104

069254

(5) Sheep. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount

Indications for use

Limitations

Sponsors

(i) To provide 10 mg/lb of body weight daily

Sheep: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin

Feed continuously for 7 to 14 days. Treatment should continue 24 to 48 hours beyond remission of clinical signs of disease. Withdraw 5 days before slaughter

066104

069254

(ii) [Reserved]

§ 558.464 Poloxalene.

(a) Specifications. Dry Type A medicated articles containing 53 percent poloxalene or liquid Type A medicated articles containing 99.5 percent poloxalene.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.517 of this chapter.

(d) Conditions of use. (1) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle.

(2) Poloxalene dry Type A article and liquid Type A article must be thoroughly blended and evenly distributed in feed prior to use. This may be accomplished by adding the Type A article to a small quantity of feed, mixing thoroughly, then adding this mixture to the remaining feed and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily and continued during exposure to bloat producing conditions. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat dosage if animals are exposed to bloat-producing conditions more than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period.

§ 558.470 Polyoxyethylene.

(a) Specifications. Each molasses-based block contains 2.2 percent polyoxyethylene (23) lauryl ether.

(b) Sponsor. See No. 067949 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use —(1) Amount. 2 grams of polyoxyethylene (23) lauryl ether per 100 kilograms of body weight per day (1 pound of block per 500 kilogram (1,100 pound) animal per day). Initially, provide one block per five head of cattle. Start treatment 10 to 14 days before exposure to bloat-producing pastures.

(2) Indications for use. For reduction of the incidence of bloat (alfalfa and clover) in pastured cattle.

(3) Limitations. Administer free-choice to beef cattle and nonlactating dairy cattle only. Do not allow cattle access to other sources of salt while being fed this product. Do not feed this product to animals without adequate forage/roughage consumption.

§ 558.485 Pyrantel.

(a) Specifications. Type A medicated articles containing 48 or 80 grams per pound pyrantel tartrate.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as follows:

(1) No. 066104: 48 and 80 grams per pound for use as in paragraph (e)(1) of this section.

(2) Nos. 017135 and 054771: 48 grams per pound for use as in paragraph (e)(2) of this section.

(c) Related tolerances. See § 556.560 of this chapter.

(d) Special considerations. (1) See § 500.25 of this chapter. Consult a veterinarian before using in severely debilitated animals.

(2) Do not mix in Type B or Type C medicated feeds containing bentonite.

(e) Conditions of use —(1) Swine —

Pyrantel grams/ton

Indications for use

Limitations

Sponsor

(i) 96

Swine: As an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; aid in the prevention of establishment of nodular worm ( Oesophagostomum ) infections

Feed continuously as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter

066104

(ii) 96

Swine: For the removal and control of large roundworm ( Ascaris suum ) infections

Feed for 3 days as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter

066104

(iii) 800

Swine: For the removal and control of large roundworm ( Ascaris suum ) and nodular worm ( Oesophagostomum ) infections

Feed as the sole ration for a single therapeutic treatment in Type C feed at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over. Withdraw 24 hours prior to slaughter

066104

(2) Horses —

Pyrantel tartrate

g/ton

Indications for use

Limitation

Sponsor

(i) 120 to 1,200 to provide 1.2 mg/lb body weight

For prevention of Strongylus vulgaris larval infections; control of adult large strongyles ( S. vulgaris, and S. edentatus ), adult and 4th stage larvae small strongyles ( Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms ( Oxyuris equi ), and adult and 4th stage larvae ascarids ( Parascaris equorum )

Feed continuously as the horse's daily grain ration during the time that the animal is at risk of exposure to internal parasites. Do not use in horses intended for human consumption. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism

017135

054771

(ii) Top dress medicated feed —(A) Proprietary Formulas. The following feed can be manufactured only per an approved proprietary formula and specifications:

Pyrantel tartrate amount

Indications for use

Limitations

Sponsor

( 1 ) 9.6 g/lb to provide 1.2 mg/lb body weight

Prevention of Strongylus vulgaris larval infections; control of adult large strongyles ( S. vulgaris, and S. edentatus ), adult and 4th stage larvae small strongyles ( Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms ( Oxyuris equi ), and adult and 4th stage larvae ascarids ( Parascaris equorum )

Feed continuously as a top dress during the time that the animal is at risk of exposure to internal parasites. Do not use in horses intended for human consumption. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism

017135

054771

( 2 ) [Reserved].

(B) [Reserved]

(3) Pyrantel may also be used in combination with:

(i) Carbadox as in § 558.115.

(ii) Lincomycin as in § 558.325.

(iii) Tylosin as in § 558.625.

§ 558.500 Ractopamine.

(a) Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

(1) Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride.

(2) Nos. 051311 and 054771: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride.

(c) Related tolerances. See § 556.570 of this chapter.

(d) Special considerations. (1) Labeling of Type B and Type C feeds shall bear the following: “Not for animals intended for breeding.”

(2) Labeling of Type B and Type C swine feeds shall bear the following:

(i) “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton.”

(ii) “Ractopamine may increase the number of injured and/or fatigued pigs during marketing.”

(3) Labeling of Type B and Type C tom turkey feeds shall bear the following: “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.6 g/ton.”

(4) Tylosin in combinations as tylosin phosphate.

(5) Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(e) Conditions of use —(1) Swine —

Ractopamine in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 4.5 to 9.0

For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine, weighing not less than 150 lb, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter

Feed continuously as sole ration

016592

054771

058198

(ii) [Reserved]

(2) Cattle.

Ractopamine in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 8.2 to 24.6

Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed

Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding

016592 051311 054771 058198

(ii) 8.2 to 24.6 to provide 70 to 430 mg/head/day

Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day

Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed

Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter

016592 054771 058198

(iii) 9.8 to 24.6

Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed

Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding

016592 051311 054771 058198

(iv) 9.8 to 24.6 to provide 90 to 430 mg/head/day

Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day

Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed

Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter

016592 054771 058198

(v) 9.8 to 24.6 to provide 90 to 430 mg/head/day

Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day

Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) during the last 28 to 42 days on feed

Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in §§ 558.342(d) and 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016592, 054771 or 058198 in § 510.600(c) of this chapter

016592 054771 058198

(vi) Not to exceed 800; to provide 70 to 400 mg/head/day

Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed

Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continuously during the last 28 to 42 days on feed. Not for animals intended for breeding

016592 051311 054771 058198

(vii) Not to exceed 800; to provide 70 to 400 mg/head/day

Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day

Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed

Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continuously during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter

016592 054771 058198

(3) Turkeys —

Ractopamine in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

(i) 4.6 to 11.8 (5 to 13 ppm)

Finishing hen turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 7 to 14 days prior to slaughter.

Feed continuously as sole ration during the last 7 to 14 days prior to slaughter.

058198

(ii) 4.6 to 11.8 (5 to 13 ppm)

Finishing tom turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 14 days prior to slaughter.

Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.

058198

(iii) 4.6 to 11.8 (5 to 13 ppm)

Monensin 54 to 90

Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides , E. meleagrimitis and E. gallopavonis.

Feed continuously as sole ration during the last 7 to 14 days prior to slaughter. See § 558.355(d).

058198

(iv) 4.6 to 11.8 (5 to 13 ppm)

Monensin 54 to 90

Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides , E. meleagrimitis and E. gallopavonis.

Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality. See § 558.355(d).

058198

(4) Ractopamine may also be used in combination with tylosin in as in § 558.625.

§ 558.515 Robenidine.

(a) Specifications. Type A medicated articles containing 30 grams per pound.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.580 of this chapter.

(d) Special considerations. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use in Type B or Type C medicated feeds containing bentonite.

(e) Conditions of use. It is used in feed for chickens as follows:

Robenidine hydrochloride in grams/ton

Combination in grams/ton

Indications for use

Limitations

Sponsor

30 (0.0033 pct)

Broiler chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix.

Feed continuously as sole ration. Do not feed to chickens producing eggs for food. Withdraw 5 days prior to slaughter.

054771

Bacitracin (as bacitracin methylenedisalicylate) 4 to 30

For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.

Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.

054771

Bacitracin (as bacitracin methylenedisalicylate) 27 to 50

For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.

Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.

054771

Bacitracin (as bacitracin methylenedisalicylate) 50

For broiler and fryer chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter.

054771

Bacitracin (as bacitracin methylenedisalicylate) 100 to 200

For broiler and fryer chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

To control a necrotic enteritis outbreak, start medication at first clinical signs of disease; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin methylenedisalicylate to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter.

054771

Bacitracin (as bacitracin zinc) 4 to 30

For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.

Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.

054771 054771

Bacitracin (as bacitracin zinc) 27 to 50

For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.

Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.

054771 054771

(f) Robenidine may also be used in combination with:

(1) Chlortetracycline as in § 558.128.

(2) Lincomycin as in § 558.325.

(3) Oxytetracycline as in § 558.450.