IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

• Citation: 21 CFR Part 522
• Sections: 184

§ 522.23 Acepromazine.

(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) acepromazine maleate.

(b) Sponsors. See Nos. 000010 and 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs, cats, and horses —(1) Amount. Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight; Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100 lbs of body weight.

(2) Indications for use. For use as a tranquilizer and as a preanesthetic agent.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.52 Alfaxalone.

(a) Specifications. Each milliliter contains 10 milligrams (mg) alfaxalone.

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

(c) Conditions of use in cats and dogs —(1) Amount —(i) Cats —(A) Induction of general anesthesia. Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a preanesthetic or 1.0 to 10.8 mg/kg for cats that received a preanesthetic.

(B) Maintenance of general anesthesia following induction. Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes anesthesia in unpreanesthetized cats.

(ii) Dogs —(A) Induction of general anesthesia. Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a preanesthetic.

(B) Maintenance of general anesthesia following induction. Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of anesthesia in unpreanesthetized dogs.

(2) Indications for use. For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in dogs and cats.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Alfaxalone is a Class IV controlled substance.

§ 522.56 Amikacin.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of amikacin as amikacin sulfate.

(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. 5 mg/pound (lb) of body weight twice daily by intramuscular or subcutaneous injection.

(2) Indications for use. For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus spp. and skin and soft tissue infections caused by susceptible strains of Pseudomonas spp. and E. coli.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.62 Aminopentamide.

(a) Specifications. Each milliliter of solution contains 0.5 milligram (mg) aminopentamide hydrogen sulfate.

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

(c) Conditions of use in dogs and cats —(1) Amount. Administer by subcutaneous or intramuscular injection every 8 to 12 hours as follows: For animals weighing up to 10 pounds (lbs): 0.1 mg; For animals weighing 11 to 20 lbs: 0.2 mg; For animals weighing 21 to 50 lbs: 0.3 mg; For animals weighing 51 to 100 lbs: 0.4 mg; For animals weighing over 100 lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five times the suggested dosage. Following parenteral use, dosage may be continued by oral administration of tablets.

(2) Indications for use. For the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.82 Aminopropazine.

(a) Specifications. Each milliliter of solution contains aminopropazine fumarate equivalent to 25 milligrams (mg) aminopropazine base.

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

(c) Conditions of use —(1) Dogs and cats —(i) Amount. 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated, by intramuscular or intravenous injection.

(ii) Indications for use. For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses —(i) Amount. Administer 0.25 mg per pound of body weight, repeated every 12 hours as indicated, by intramuscular or intravenous injection.

(ii) Indications for use. For reducing excessive smooth muscle contractions, such as occur in colic spasms.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.88 Amoxicillin.

(a) Specifications. (1) Each vial contains 3 grams (g) of amoxicillin trihydrate. Each milliliter of constituted suspension contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as in paragraph (d)(1) of this section.

(2) Each vial contains 25 g of amoxicillin trihydrate. Each milliliter of constituted suspension contains 250 mg amoxicillin trihydrate for use as in paragraph (d)(2) of this section.

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

(c) Related tolerance. See § 556.38 of this chapter.

(d) Conditions of use —(1) Dogs and cats —(i) Amount. Administer 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.

(ii) Indications for use —(A) Dogs. For treatment of infections caused by susceptible strains of organisms as follows: Respiratory infections (tonsillitis, tracheobronchitis) due to Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary infections (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal infections (bacterial gastroenteritis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis due to S. aureus, Streptococcus spp., and P. mirabilis; soft tissue infections (abscesses, lacerations, and wounds), due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis.

(B) Cats. For treatment of infections caused by susceptible strains of organisms as follows: Upper respiratory infections due to S. aureus, Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary infections (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal infections due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue infections (abscesses, lacerations, and wounds) due to S. aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cattle —(i) Amount. Administer 3 to 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.

(ii) Indications for use. For treatment of diseases due to amoxicillin-susceptible organisms as follows: Respiratory tract infections (shipping fever, pneumonia) due to P. multocida, P. hemolytica, Haemophilus spp., Staphylococcus spp., and Streptococcus spp. and acute necrotic pododermatitis (foot rot) due to Fusobacterium necrophorum.

(iii) Limitations. Treated animals must not be slaughtered for food during treatment and for 25 days after the last treatment. Milk from treated cows must not be used for human consumption during treatment or for 96 hours (8 milkings) after last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.90a Ampicillin trihydrate suspension.

(a) Specifications. (1) Each milliliter contains ampicillin trihydrate equivalent to 200 milligrams (mg) of ampicillin.

(2) Each milliliter contains ampicillin trihydrate equivalent to 150 mg of ampicillin.

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

(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this section.

(2) No. 054771 for use of product described in paragraph (a)(2) as in paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this section.

(c) Related tolerances. See § 556.40 of this chapter.

(d) Conditions of use —(1) Cattle —(i) Amount. For enteritis: 3 mg per pound of body weight, intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 mg per pound of body weight, intramuscularly, twice daily, for up to 3 days.

(ii) Indications for use. For treatment of bacterial enteritis in calves caused by Escherichia coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.

(iii) Limitations. Treated animals must not be slaughtered for food use during treatment or for 9 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Swine —(i) Amount. 3 mg per pound of body weight by intramuscular injection, once or twice daily, for up to 3 days.

(ii) Indications for use. Treatment of bacterial enteritis (colibacillosis) caused by E. coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.

(iii) Limitations. Treated animals must not be slaughtered for food use during treatment or for 15 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Dogs —(i) Amount. (A) 3 to 6 mg per pound of body weight by intramuscular injection, once or twice daily. Usual treatment is 3 to 5 days.

(B) 3 to 5 mg of ampicillin per pound of body weight, once a day for up to 4 days.

(ii) Indications for use. (A) Treatment of respiratory tract infections due to E. coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and Streptococcus spp.; tonsillitis due to E. coli, Pseudomonas spp., Streptococcus spp., and Staphylococcus spp.; generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to Staphylococcus spp. and Streptococcus spp.

(B) Treatment of bacterial infections of the upper respiratory tract (tonsillitis) due to Streptococcus spp., Staphylococcus spp., E. coli, Proteus spp., and Pasteurella spp., and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., and E. coli, when caused by susceptible organisms.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Cats —(i) Amount. 5 to 10 mg per pound of body weight by intramuscular or subcutaneous injection, once or twice daily. Usual treatment is 3 to 5 days.

(ii) Indications for use. Treatment of generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to Staphylococcus spp., Streptococcus spp., and Pasteurella spp.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.90b Ampicillin trihydrate powder for injection.

(a) Specifications. Each milliliter of aqueous suspension constituted from ampicillin trihydrate powder contains 200, 250, or 400 milligrams (mg) ampicillin equivalents.

(b) Sponsors. See Nos. 000010 and 042791 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.40 of this chapter.

(d) Conditions of use —(1) Dogs and cats —(i) Amount. 3 mg/pound (lb) of body weight twice daily by subcutaneous or intramuscular injection.

(ii) Indications for use. For treatment of strains of organisms susceptible to ampicillin and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cattle —(i) Amount. 2 to 5 mg/lb of body weight once daily by intramuscular injection.

(ii) Indications for use. For treatment of respiratory tract infections caused by organisms susceptible to ampicillin, bacterial pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus spp., Pasteurella multocida, and Escherichia coli.

(iii) Limitations. Do not treat cattle for more than 7 days. Milk from treated cows must not be used for food during treatment and for 48 hours (4 milkings) after the last treatment. Cattle must not be slaughtered for food during treatment and for 144 hours (6 days) after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.90c Ampicillin sodium.

(a) Specifications. Each milliliter of aqueous solution constituted from ampicillin sodium powder contains 300 milligrams (mg) ampicillin equivalents.

(b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in horses —(1) Amount : 3 mg per pound of body weight twice daily by intravenous or intramuscular injection.

(2) Indications for use. For the treatment of respiratory tract infections (pneumonia and strangles) due to Staphylococcus spp., Streptococcus spp. (including S. equi ), Escherichia coli , and Proteus mirabilis , and skin and soft tissue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli , and P. mirabilis , when caused by susceptible organisms.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.144 Arsenamide.

(a) Specifications. Each milliliter of solution contains 10.0 milligrams arsenamide sodium.

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

(c) Conditions of use in dogs —(1) Amount. Administer 0.1 milliliter (mL) per pound of body weight (1.0 mL for every 10 pounds) by intravenous injection twice a day for 2 days.

(2) Indications for use. For the treatment and prevention of canine heartworm disease caused by Dirofilaria immitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.147 Atipamezole.

(a) Specifications. Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride.

(b) Sponsors. See Nos. 015914, 052483, 068504, and 069043 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. Administer 3,750 mcg/m

2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m

2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.

(2) Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.150 Azaperone.

(a) Specifications. Each milliliter of solution contains 40 milligrams (mg) azaperone.

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

(c) Related tolerances. See § 556.68 of this chapter.

(d) Conditions of use —(1) Indications for use. For control of aggressiveness when mixing or regrouping weanling or feeder pigs weighing up to 80 pounds.

(2) Dosage. 2.2 mg per kilogram (1 mg per pound) by deep intramuscular injection.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.158 Bedinvetmab.

(a) Specifications. Each single-use vial contains 5, 10, 15, 20, or 30 milligrams (mg) bedinvetmab in an extractable volume of 1 milliliter.

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

(c) Conditions of use —(1) Amount. Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection.

(2) Indications for use. For the control of pain associated with osteoarthritis in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.161 Betamethasone.

(a) Specifications. Each milliliter of suspension contains:

(1) Betamethasone acetate equivalent to 10.8 milligrams (mg) betamethasone and betamethasone disodium phosphate equivalent to 3 mg of betamethasone.

(2) Betamethasone dipropionate equivalent to 5 mg betamethasone and betamethasone sodium phosphate equivalent to 2 mg of betamethasone.

(b) Sponsor. See sponsor numbers in § 510.600(c) of this chapter:

(1) No. 000061 for product described in paragraph (a)(1) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.

(2) No. 000061 for product described in paragraph (a)(2) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(B), and (c)(2)(iii) of this section.

(c) Conditions of use —(1) Dogs —(i) Amount. Administer by intramuscular injection 0.25 to 0.5 milliliter (mL) per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of four injections.

(ii) Indications for use. As an aid in the control of pruritus associated with dermatoses.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses —(i) Amount. Administer 2.5 to 5 mL by intra-articular injection.

(ii) Indications for use. (A) For the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and fetlock joints.

(B) As an aid in the control of inflammation associated with various arthropathies.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.163 Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension.

(a) Specifications. Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension is a sterile aqueous suspension. Each milliliter of the suspension contains the equivalent of 5 milligrams of betamethasone as betamethasone dipropionate and 2 milligrams of betamethasone as betamethasone sodium phosphate.

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

(c) Conditions of use —(1) Dogs. (i) It is used as an aid in the control of pruritus associated with dermatoses.

(ii) It is administered by intramuscular injection at a dosage of 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of 4 injections.

(2) Horses. (i) It is used as an aid in the control of inflammation associated with various arthropathies.

(ii) It is administered aseptically by intraarticular injection at a dosage of 2.5 to 5 milliliters per joint, depending on the severity of the condition and the joint size. Dosage may be repeated upon recurrence of clinical signs. Injection into the joint cavity should be preceded by withdrawal of synovial fluid.

(iii) Not for use in horses intended for food.

(3) Clinical and experimental data. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(4) Restrictions. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.167 Betamethasone sodium phosphate and betamethasone acetate.

(a) Specifications. Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate).

(b) Sponsor. See No. 010797 in § 510.600(c) of this chapter.

(c) Conditions of use in horses —(1) Amount. Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in horses.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.204 Boldenone.

(a) Specifications. Each milliliter of solution contains 25 or 50 milligrams (mg) boldenone undecylenate.

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

(c) Conditions of use in horses —(1) Amount. 0.5 mg per pound body weight by intramuscular injection. Treatment may be repeated at 3-week intervals.

(2) Indications for use. As an aid for treating debilitated horses when an improvement in weight, hair coat, or general physical condition is desired.

(3) Limitations. Do not administer to horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.224 Bupivacaine.

(a) Specifications. Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.

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

(c) Conditions of use —(1) Dogs —(i) Amount. Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure.

(ii) Indications for use. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery.

(2) Cats —(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve block prior to onychectomy.

(ii) Indications for use. For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy.

§ 522.230 Buprenorphine.

(a) Specifications. Each milliliter of solution contains 1.8 milligrams (mg) buprenorphine.

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

(c) Conditions of use in cats —(1) Amount. Administer 0.24 mg per kilogram (0.11 mg per pound) by subcutaneous injection once daily, for up to 3 days. Administer the first dose approximately 1 hour prior to surgery.

(2) Indications for use. For the control of postoperative pain associated with surgical procedures in cats.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.234 Butamisole.

(a) Specifications. Each milliliter of solution contains 11 milligrams (mg) butamisole hydrochloride.

(b) Sponsors. See Nos. 054771 and 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. Administer 0.1 mg per pound of body weight by subcutaneous injection. In problem cases, retreatment for whipworms may be necessary in approximately 3 months. For hookworms, a second injection should be given 21 days after the initial treatment.

(2) Indications for use. For the treatment of infections with whipworms ( Trichuris vulpis ), and the hookworm ( Ancylostoma caninum ).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.246 Butorphanol.

(a) Specifications. Each milliliter of solution contains butorphanol (as butorphanol tartrate) in the following amounts:

(1) 0.5 milligrams (mg);

(2) 2 mg; or

(3) 10 mg

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

(1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section; for use of the product described in paragraph (a)(2) as in paragraph (d)(2) of this section; and for use of the product described in paragraph (a)(3) as in paragraph (d)(3) of this section.

(2) No. 043264 for use of the product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.

(3) Nos. 000061, 017033, 043264, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use —(1) Dogs —(i) Amount. Administer 0.025 mg per pound of body weight by subcutaneous injection at intervals of 6 to 12 hours, as required. If necessary, increase dose to a maximum of 0.05 mg per pound of body weight. Treatment should not normally be required for longer than 7 days.

(ii) Indications for use. For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.

(2) Cats —(i) Amount. Administer 0.2 mg per pound of body weight by subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days.

(ii) Indications for use. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.

(3) Horses —(i) Amount. Administer 0.05 mg per pound of body weight by intravenous injection. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.

(ii) Indications for use. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.

(iii) Limitations. Do not use in horses intended for human consumption.

§ 522.275 N-Butylscopolammonium.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) N-butylscopolammonium bromide.

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

(c) Conditions of use in horses —(1) Amount. 0.3 mg per kilogram of body weight (0.14 mg per pound) slowly intravenously.

(2) Indications for use. For the control of abdominal pain (colic) associated with spasmodic colic, flatulent colic, and simple impactions.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.304 Carprofen.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) carprofen.

(b) Sponsors. See Nos. 016729, 017033, 054771, 055529, 069043, and 086101 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use in dogs —(1) Amount. 2 mg/lb (4.4 mg/kg) body weight once daily or 1 mg/lb (2.2 mg/kg) twice daily, by subcutaneous injection. For the control of postoperative pain, administer approximately 2 hours before the procedure.

(2) Conditions of use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.311 Cefovecin.

(a) Specifications. Each milliliter of constituted solution contains 80 milligrams (mg) cefovecin as the sodium salt.

(b) Sponsors. See Nos. 054771 and 086163 in § 510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use —(1) Dogs —(i) Amount. Administer 3.6 mg/pound (lb) (8 mg/kilograms (kg)) body weight as a single subcutaneous injection. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response to therapy is not complete.

(ii) Indications for use. For the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of Staphylococcus intermedius and Streptococcus canis (Group G).

(2) Cats —(i) Amount. Administer 3.6 mg/lb (8 mg/kg) body weight as a single, one-time subcutaneous injection.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida.

§ 522.313a Ceftiofur crystalline free acid.

(a) Specifications. The product is a suspension of ceftiofur crystalline free acid.

(1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur equivalents.

(2) Each mL contains 200 mg ceftiofur equivalents.

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

(c) Related tolerances. See § 556.113 of this chapter.

(d) Conditions of use —(1) Swine. The formulation described in paragraph (a)(1) of this section is used as follows:

(i) Amount. 5.0 mg CE per kilogram (kg) of body weight by intramuscular injection in the postauricular region of the neck.

(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Haemophilus parasuis , and Streptococcus suis. For the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.

(iii) Limitations. Following label use as a single treatment, a 14-day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.

(2) Cattle. The formulation described in paragraph (a)(2) of this section is used as follows:

(i) Amount. For subcutaneous (SC) injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle. For SC injection in the middle third of the posterior aspect of the ear or in the base of the ear in beef and non-lactating dairy cattle.

(A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight as a single injection.

(B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight given as two injections in the base of the ear approximately 72 hours apart.

(ii) Indications for use. (A) Single-dose regimen: For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. For the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.

(B) Two-dose regimen: For the treatment of acute metritis (0-to 10-days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.

(iii) Limitations. Following label use as either a single-dose or 2-dose regimen, a 13-day pre-slaughter withdrawal period is required after the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.

(3) Horses. The formulation described in paragraph (a)(2) of this section is used as follows:

(i) Amount. Two intramuscular injections, 4 days apart, at a dose of 3.0 mg/lb (6.6 mg/kg) body weight.

(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.313b Ceftiofur hydrochloride.

(a) Specifications. Each milliliter of suspension contains:

(1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur equivalents in the inactive vehicles phospholipan 90H, sorbitan monooleate, and cottonseed oil;

(2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles polyoxyethylene sorbitan monooleate (polysorbate 80) in a caprylic/capric triglyceride suspension; or

(3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles aluminum monostearate, sorbitan monooleate, and medium chain triglycerides.

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

(1) No. 054771 for products described in paragraphs (a)(1) and (2) of this section; and

(2) No. 055529 for the product described in paragraph (a)(3) of this section.

(c) Related tolerances. See § 556.113 of this chapter.

(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle and swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.

(e) Conditions of use —(1) Swine —(i) Amount. 3 to 5 mg per kilogram (/kg) of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.

(ii) Indications for use. For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Salmonella Choleraesuis, and Streptococcus suis.

(iii) Limitations. For products described in paragraphs (a)(1) and (3) of this section: Treated swine must not be slaughtered for 4 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated swine must not be slaughtered for 6 days following the last treatment when injection site volumes are greater than 5 mL up to the maximum injection site volume of 15 mL. Treated swine must not be slaughtered for 4 days when injection site volumes are less than or equal to 5 mL.

(2) Cattle —(i) Amount. Administer by subcutaneous or intramuscular injection as follows:

(A) For bovine respiratory disease and acute bovine interdigital necrobacillosis: 1.1 to 2.2 mg/kg of body weight at 24-hour intervals for 3 to 5 consecutive days.

(B) For bovine respiratory disease: 2.2 mg/kg of body weight administered twice at a 48 hour interval.

(C) For acute metritis: 2.2 mg/kg of body weight at 24-hour intervals for 5 consecutive days.

(ii) Indications for use. For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida , and Histophilus somni ; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus ; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.

(iii) Limitations. (A) For products described in paragraphs (a)(2) and (3) of this section: Treated cattle must not be slaughtered for 3 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated cattle must not be slaughtered for 4 days following the last treatment.

(B) A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.

§ 522.313c Ceftiofur sodium.

(a) Specifications. Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.

(b) Sponsors. See Nos. 017033 and 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.113 of this chapter.

(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle, swine, chickens, and turkeys for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.

(e) Conditions of use —(1) Swine —(i) Amount. 3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.

(ii) Indications for use. For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Salmonella choleraesuis , and Streptococcus suis.

(iii) Limitations. Treated pigs must not be slaughtered for 4 days following the last treatment.

(2) Cattle —(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

(ii) Indications for use. For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. Also, for the treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

(iii) Limitations. Treated cattle must not be slaughtered for 4 days following the last treatment.

(3) Sheep —(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

(ii) Indications for use. For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.

(4) Goats —(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

(ii) Indications for use. For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.

(5) Chickens —(i) Amount. 0.08 to 0.20 mg as a single subcutaneous injection in the neck.

(ii) Indications for use. For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks.

(6) Turkeys —(i) Amount. 0.17 to 0.5 mg as a single subcutaneous injection in the neck.

(ii) Indications for use. For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults.

(7) Horses —(i) Amount. 2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.

(ii) Indications for use. For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.

(iii) Limitations. Do not use in horses intended for human consumption.

(8) Dogs —(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals for 5 to 14 days.

(ii) Indications for use. For treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis.

§ 522.380 Chloral hydrate, pentobarbital, and magnesium sulfate.

(a) Specifications. Each milliliter of solution contains 42.5 milligrams (mg) of chloral hydrate, 8.86 mg of pentobarbital, and 21.2 mg of magnesium sulfate.

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

(c) Conditions of use —(1) Amount. For general anesthesia: Administer 20 to 50 milliliters per 100 pounds of body weight by intravenous injection until the desired effect is produced. Cattle usually require a lower dosage on the basis of body weight. As a sedative-relaxant: Administer at a level of one-fourth to one-half of the anesthetic dosage level.

(2) Indications for use. For general anesthesia and as a sedative-relaxant in cattle and horses.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.390 Chloramphenicol.

(a) Specifications. Each milliliter of solution contains 100 milligrams of chloramphenicol.

(b) Sponsor. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.

(c) Conditions of use. Dogs —(1) Amount. 5 to 15 milligrams per pound of body weight, intramuscularly or intravenously, every 6 hours. In severe infections, use 4 to 6 hour treatment intervals the first day. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.

(2) Indications for use. Treatment of infections of the respiratory tract, the urinary tract, and enteritis and tonsillitis caused by organisms susceptible to chloramphenicol.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

§ 522.454 Clodronate.

(a) Specifications. Each milliliter of solution contains 60 milligrams (mg) clodronate disodium.

(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(c) Conditions of use in horses —(1) Amount. Administer 1.8 mg per kilogram of body weight by intramuscular injection up to a maximum dose of 900 mg per horse.

(2) Indications for use. For the control of clinical signs associated with navicular syndrome.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.460 Cloprostenol.

(a) Specifications. Each milliliter of solution contains cloprostenol sodium equivalent to:

(1) 125 micrograms (µg) of cloprostenol; or

(2) 250 µg of cloprostenol.

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

(1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section.

(2) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section.

(3) No. 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this section.

(c) Conditions of use in cattle —(1) Amount and indications for use.

(i) Administer 375 µg by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4

1/2 months of gestation.

(ii) Administer 500 µg by intramuscular injection for unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.

(iii) Administer 500 µg by intramuscular injection for treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers.

(iv) Administer 500 µg by intramuscular injection for treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.

(v) Administer 500 µg by intramuscular injection for treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers.

(vi) Administer 500 µg by intramuscular injection for abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers from 1 week after mating until 5 months of gestation. Not for use in heifers placed in feedlots.

(vii) Administer 500 µg by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first injection, for estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers.

(viii) For use with gonadorelin acetate to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows: administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection. Gonadorelin acetate as provided in § 522.1077(a)(1) of this chapter.

(ix) For use with gonadorelin to synchronize estrous cycles to allow for FTAI in lactating dairy cows: administer to each cow by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by gonadorelin by intramuscular injection. Gonadorelin as provided in § 522.1077(a)(1) through (3) of this chapter.

(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.468 Colistimethate sodium powder for injection.

(a) Specifications. Each vial contains colistimethate sodium equivalent to 10 grams colistin activity and mannitol to be reconstituted with 62.5 milliliters sterile saline or sterile water for injection. The resulting solution contains colistimethate sodium equivalent to 133 milligrams per milliliter colistin activity.

(b) Sponsor. See 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.167 of this chapter.

(d) Conditions of use. (1) 1- to 3-day-old chickens.

(i) Dosage. 0.2 milligram colistin activity per chicken.

(ii) Indications for use. Control of early mortality associated with Escherichia coli organisms susceptible to colistin.

(iii) Limitations. For subcutaneous injection in the neck of 1- to 3-day-old chickens. Not for use in laying hens producing eggs for human consumption. Do not use in turkeys. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

§ 522.480 Corticotropin.

(a) Specifications. Each milliliter of aqueous solution contains 40 or 80 U.S.P. (I.U.) units of repository corticotropin.

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

(1) No. 061133 for use as in paragraphs (c)(1) and (2) of this section.

(2) No. 043264 for use as in paragraph (c)(2) and (3) of this section.

(c) Conditions of use —(1) Dogs —(i) Amount. Administer one unit per pound of body weight by intramuscular injection.

(ii) Indications for use. As a diagnostic aid to test for adrenal dysfunction.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dogs and cats —(i) Amount. Administer one unit per pound of body weight by intramuscular or subcutaneous injection, to be repeated as indicated.

(ii) Indications for use. For stimulation of the adrenal cortex where there is a general deficiency of corticotropin (ACTH).

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.500 Cosyntropin injection.

(a) Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(b) Specifications. Each milliliter (mL) contains 0.25 milligrams (mg) cosyntropin, 1 mg glacial acetic acid, 0.82 mg sodium acetate trihydrate, 8.1 mg sodium chloride, and water for injection (to 100%).

(c) Conditions of use —(1) Amount. Administer 0.25 mg (1 mL) per dog weighing 10-110 pounds (4.5-50 kilograms) by intravenous or intramuscular injection.

(2) Indications for use. For the evaluation of adrenal function in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

§ 522.522 Danofloxacin.

(a) Specifications. Each milliliter of solution contains 180 milligrams (mg) danofloxacin as the mesylate salt.

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

(c) Related tolerances. See § 556.169 of this chapter.

(d) Conditions of use in cattle —(1) Amount and indications for use. Administer by subcutaneous injection either:

(i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours, for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida; or

(ii) 8 mg/kg of body weight as a single dose for the treatment of BRD associated with M. haemolytica and P. multocida and for the control of BRD in beef cattle at high risk of developing BRD associated with M. haemolytica and P. multocida.

(2) Limitations. Animals intended for human consumption should not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

§ 522.533 Deslorelin.

(a) Specifications. (1) Each implant contains 2.1 milligrams (mg) deslorelin acetate.

(2) Each milliliter (mL) of suspension contains 1.8 mg deslorelin acetate.

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

(1) No. 051311 for use of product described in paragraph (a)(1) as in paragraph (c)(1) of this section.

(2) No. 043264 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section.

(c) Conditions of use —(1) Horses and ponies —(i) Amount. One implant per mare subcutaneously in the neck.

(ii) Indications for use. For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 millimeters (mm) in diameter.

(iii) Limitations. Do not use in horses or ponies intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses —(i) Amount. Administer 1.8 mg (1 mL) by intramuscular injection in the neck.

(ii) Indications for use. For inducing ovulation within 48 hours in cyclic estrous mares with an ovarian follicle between 30 and 40 mm in diameter.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.535 Desoxycorticosterone.

(a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) of desoxycorticosterone pivalate.

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

(1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and (c)(3) of this section.

(2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section.

(c) Conditions of use —(1) Amount. (i) Administer an initial dose of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection. Subsequent dosages should be individualized according to label instructions based on patient response to therapy.

(ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.

(2) Indications for use —(i) For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's Disease).

(ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.536 Detomidine.

(a) Specification. Each milliliter of solution contains 10 milligrams of detomidine hydrochloride.

(b) Sponsor. See Nos. 015914, 052483, and 059399 in § 510.600(c) of this chapter.

(c) Conditions of use in horses —(1) Amount. For sedation, analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram (0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight, depending on depth and duration required. For sedation, administer by intraveneous (IV) or intramuscular (IM) injection; for analgesia, administer by IV injection; for both sedation and analgesia, administer by IV injection.

(2) Indication for use. As a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.540 Dexamethasone solution.

(a)(1) Specifications. Each milliliter of solution contains 2 milligrams (mg) dexamethasone.

(2) Sponsors. See sponsors in § 510.600(c) of this chapter:

(i) Nos. 000061, 016592, and 061133 for use as in paragraph (a)(3) of this section.

(ii) No. 058005 for use as in paragraphs (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section.

(3) Conditions of use —(i) Amount. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary, as follows:

(A) Dogs. 0.25 to 1 mg.

(B) Cats. 0.125 to 0.5 mg.

(C) Horses. 2.5 to 5 mg.

(D) Cattle. 5 to 20 mg, depending on the severity of the condition.

(ii) Indications for use. The drug is indicated:

(A) For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses;

(B) As an anti-inflammatory agent in dogs and cats.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).

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

(3) Conditions of use —(i) Amount. Administer 0.25 to 1 mg by intravenous injection, repeated for 3 to 5 days or until a response is noted.

(ii) Indications for use. For use in dogs for the treatment of inflammatory conditions, as supportive therapy in canine posterior paresis, as supportive therapy before or after surgery to enhance recovery of poor surgical risks, and as supportive therapy in nonspecific dermatosis.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(c)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).

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

(3) Conditions of use —(i) Amount. Administer 2.5 to 5.0 mg by intravenous injection.

(ii) Indications for use. For use in horses as a rapid adrenal glucocorticoid and/or anti-inflammatory agent.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).

(2) Sponsors. See the following numbers in § 510.600(c) of this chapter:

(i) Nos. 016592 and 051031 for intravenous or intramuscular use of 2.0 milligrams dexamethasone injection.

(ii) No. 054771 for intravenous use of 2.0 milligrams dexamethasone injection.

(3) Conditions of use —(i) Amount. Administer by intravenous or intramuscular injection as follows:

(A) Dogs: 0.25 to 1 mg.

(B) Cats: 0.125 to 0.5 mg.

(C) Horses: 2.5 to 5 mg.

(ii) Indications for use. For use in dogs, cats, and horses as an anti-inflammatory agent.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e)(1) Specifications. Each milliliter of solution contains 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).

(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.

(3) Conditions of use —(i) Amount. Administer by intravenous injection as follows:

(A) Dogs: 0.25 to 1 mg; may be repeated for 3 to 5 days.

(B) Horses: 2.5 to 5 mg.

(ii) Indications for use. For use in dogs and horses for glucocorticoid and anti-inflammatory effect.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.558 Dexmedetomidine.

(a) Specifications. Each milliliter of solution contains:

(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or

(2) 0.5 mg dexmedetomidine hydrochloride.

(b) Sponsors. See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) Nos. 017033, 068504, 069043, 086101, and 086117 for use of product described in paragraph (a)(2) of this section.

(2) No. 052483 for use of products described in paragraph (a) of this section.

(c) Conditions of use —(1) Dogs —(i) Indications for use and amount. (A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m

2 ) of body surface area by intravenous injection or 500 µg/m

2 of body surface area by intramuscular injection.

(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m

2 of body surface area or 375 µg/m

2 of body surface area by intramuscular injection.

(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats —(i) Amount. 40 µg/killogram by intramuscular injection.

(ii) Indications for use. For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.563 Diatrizoate.

(a) Specifications. Each milliliter of solution contains 34.3 percent diatrizoate meglumine and 35 percent diatrizoate sodium, or 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium.

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

(c) Conditions of use in dogs and cats —(1) Amount. For excretion urography, administer 0.5 to 1.0 milliliter (mL) per pound of body weight to a maximum of 30 mL intravenously. For cystography, remove urine, administer 5 to 25 mL directly into the bladder via catheter. For urethrography, administer 1.0 to 5 mL via catheter into the urethra to provide desired contrasts delineation. For angiocardiography (including aortography) rapidly inject 5 to 10 mL directly into the heart via catheter or intraventricular puncture. For cerebral angiography, rapid injection of 3 to 10 mL via carotid artery. For peripheral arteriography and/or venography and selective coronary arteriography, rapidly inject 3 to 10 mL intravascularly into the vascular bed to be delineated. For lymphography, slowly inject 1.0 to 10 mL directly into the lymph vessel to be delineated. For arthrography, slowly inject 1.0 to 5 mL directly into the joint to be delineated. For discography, slowly inject 0.5 to 1.0 mL directly into the disc to be delineated. For sialography, slowly inject 0.5 to 1.0 mL into the duct to be delineated. For delineation of fistulous tracts, slowly inject quantity necessary to fill the tract. For delineation of peritoneal hernias, inject 0.5 to 1.0 mL per pound of body weight directly into the peritoneal cavity.

(2) Indications for use. For visualization in excretion urography, including renal angiography, uretography, cystography, and urethrography; aortography; angiocardiography, peripheral arteriography, and venography; selective coronary arteriography; cerebral angiography; lymphography; arthrography; discography; and sialography; and as an aid in delineating peritoneal hernias and fistulous tracts.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.650 Dihydrostreptomycin sulfate injection.

(a) Specifications. Each milliliter contains dihydrostreptomycin sulfate equivalent to 500 milligrams of dihydrostreptomycin.

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

(c) Related tolerance. See § 556.200 of this chapter.

(d) Conditions of use —(1) Amount. Administer 5 milligrams per pound of body weight by deep intramuscular injection every 12 hours, for 3 to 5 days or until the urine is free of leptospira for at least 72 hours as measured by darkfield microscopic examination.

(2) Indications for use. Treatment of leptospirosis in dogs and horses due to Leptospira canicola, L. icterohemorrhagiae, and L. pomona; in cattle due to L. pomona; and in swine due to L. pomona; and L. grippotyphosa.

(3) Limitations. Discontinue use 30 days before slaughter for food. Not for use in animals producing milk because use of the drug will contaminate the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.690 Dinoprost.

(a) Specifications. Each milliliter (mL) of solution contains dinoprost tromethamine equivalent to:

(1) 5 milligrams (mg) dinoprost; or

(2) 12.5 mg dinoprost.

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

(1) Nos. 054771 and 061133 for use of product described in paragraph (a)(1) as in paragraph (d) of this section.

(2) No. 054771 for use of product described in paragraph (a)(2) as in paragraph (d)(1) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use —(1) Cattle. Administer products described in paragraph (a) of this section as follows:

(i) Amount. 25 mg as an intramuscular injection of the 5 mg/mL product or as an intramuscular or subcutaneous injection of the 12.5 mg/mL product.

(ii) Indications for use. As a luteolytic agent; effective only in those cattle having a corpus luteum, i.e., those which ovulated at least 5 days prior to treatment.

(A) For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.

(B) For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.

(C) For treatment of pyometra (chronic endometritis) in cattle.

(D) For abortion in beef cows, beef heifers and replacement dairy heifers.

(E) For use with gonadorelin injection as in § 522.1077 of this chapter to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

(F) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in lactating dairy cows.

(G) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.

(2) Horses. Administer product described in paragraph (a)(1) of this section as follows:

(i) Amount. 1 mg per 100 pounds of body weight as a single intramuscular injection.

(ii) Indications for use. (A) For controlling the timing of estrus in estrous cycling mares.

(B) For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).

(iii) Limitations. Do not use in horses intended for human consumption.

(3) Swine. Administer product described in paragraph (a)(1) of this section as follows:

(i) Amount. 10 mg as a single intramuscular injection.

(ii) Indications for use. For parturition induction in swine.

§ 522.723 Diprenorphine.

(a) Specifications. Each milliliter of solution contains 2 milligrams of diprenorphine hydrochloride.

(b) Sponsors. See No. 053923 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. It is administered intramuscularly or intravenously at a suitable dosage level depending upon the species.

(2) Indications for use. The drug is used for reversing the effects of etorphine hydrochloride injection, veterinary, the use of which is provided for in § 522.883, in wild and exotic animals.

(3) Limitations. For use in wild or exotic animals only. Do not use in domestic food-producing animals. Do not use 30 days before, or during, the hunting season in free-ranging wild animals that might be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Distribution is restricted to veterinarians engaged in zoo and exotic animal practice, wildlife management programs, and researchers.

§ 522.728 Dipyrone.

(a) Specifications. Each milliliter of solution contains 500 milligrams (mg) dipyrone.

(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(c) Conditions of use in horses —(1) Amount. Administer 30 mg per kilogram of body weight (13.6 mg per pound) by intravenous injection, once or twice daily at a 12-hour interval for up to 3 days.

(2) Indications for use. For control of pyrexia in horses.

(3) Limitations. Do not use in horses intended for human consumption. Do not use in any food-producing animals, including lactating dairy animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.770 Doramectin.

(a) Specifications. Each milliliter of solution contains 10 milligrams of doramectin.

(b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.222 of this chapter.

(d) Conditions of use —(1) Cattle —(i) Amount. 200 micrograms per kilogram (10 milligrams per 110 pounds).

(ii) Indications for use. For treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. To control infections and to protect from reinfection with Cooperia oncophora and Haemonchus placei for 14 days, Ostertagia ostertagi for 21 days, and C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus for 28 days after treatment.

(iii) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single subcutaneous or intramuscular injection. Do not slaughter cattle for human consumption within 35 days of treatment. Not for use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Swine —(i) Amount. 300 micrograms per kilogram (10 milligrams per 75 pounds).

(ii) Indications for use. For treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites.

(iii) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single intramuscular injection. Do not slaughter swine for human consumption within 24 days of treatment.

§ 522.772 Doramectin and levamisole.

(a) Specifications. Each milliliter of solution contains 5 milligrams (mg) of doramectin and 150 mg levamisole hydrochloride.

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

(c) Related tolerances. See §§ 556.222 and 556.350 of this chapter.

(d) Conditions of use —(1) Cattle —(i) Amount. Inject subcutaneously in the neck as a single dose at a dosage of 0.2 mg doramectin (0.91 mg/lb) and 6 mg of levamisole hydrochloride per kg (2.72 mg/lb) of body weight.

(ii) Indications for use. For treatment and control of gastrointestinal roundworms (adults and fourth stage larvae): Ostertagia ostertagi (including inhibited larvae), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. longispicularis (adults only), Cooperia oncophora, C. pectinata (adults only), C. punctata, C. surnabada, Bunostomum phlebotomum (adults only), Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris spp. (adults only) and Nematodirus helvetianus (adults only); lungworms (adults and fourth stage larvae): Dictyocaulus viviparus; eyeworms (adults): Thelazia spp.; grubs (parasitic stages): Hypoderma bovis and H. lineatum; sucking lice: Haematopinus eurysternus, Linognathus vituli, and Solenopotes capillatus; mange mites: Psoroptes bovis and Sarcoptes scabiei in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. Not for use in beef bulls intended for breeding over 1 year of age, dairy calves, and veal calves.

(iii) Limitations. Cattle must not be slaughtered for human consumption within 15 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

§ 522.784 Doxylamine.

(a) Specifications. Each milliliter contains 11.36 milligrams (mg) of doxylamine succinate.

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

(c) Conditions of use —(1) Amount —(i) Horses: Administer 25 mg per hundred pounds of body weight by intramuscular, subcutaneous, or slow intravenous injection.

(ii) Dogs and cats: Administer 0.5 to 1 mg per pound of body weight by intramuscular or subcutaneous injection. Doses may be repeated at 8 to 12 hours, if necessary, to produce desired effect.

(2) Indications for use. For use in conditions in which antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.800 Droperidol and fentanyl.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of droperidol and 0.4 mg of fentanyl citrate.

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

(c) Conditions of use —(1) Amount. (i) For analgesia and tranquilization, administer as follows:

(A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight; or

(B) 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight.

(ii) For general anesthesia, administer as follows:

(A) Administer 1 mL per 40 lbs of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed in 10 minutes by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight; or

(B) Administer 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed within 15 seconds by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight.

(2) Indications for use. As an analgesic and tranquilizer and for general anesthesia.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 522.810 Embutramide, chloroquine, and lidocaine solution.

(a) Specifications. Each milliliter (mL) of solution contains 135 milligrams (mg) embutramide; 45 mg chloroquine phosphate, U.S.P.; and 1.9 mg lidocaine, U.S.P.

(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. One mL per 5 pounds of body weight.

(2) Indications for use. For euthanasia.

(3) Limitations. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.