Section 19
SEC. 19. A drug or device shall be deemed to be misbranded:— (a) If its labeling is false or misleading in any particular. (b) If in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary. (c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, cabromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulfonmethane; or any chemical derivative of such substance, which derivative has been recommended by the Secretary, after investigation and by regulations, designated as, habit forming; unless its label bears the name, and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning"May be habit forming." (e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not the name and quantity of proportion of any bromides ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides mercury, ouabain, strophanthin strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, That where compliance with this paragraph is impracticable, exemptions shall, upon recommendation of the Food and Drug Administrator, be established by regulations promulgated by the Secretary. (f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users: Provided, That where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall, upon recommendation of the Food and Drug Administrator, promulgate regulations exempting such drug or device from such requirement. (g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is package and labeled as prescribed therein: Provided, That the method of packing may be modified with the consent of Secretary. (h) If it has been found by the Secretary to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health. (i) (1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug. (j) If it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof. (k) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other anti-biotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a), and (2) such certificate of release is in effect with respect to such drug: Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under Section twenty-one (a), (b) and (c). EXEMPTION IN CASE OF DRUGS AND DEVICES