17 MISBRANDED DRUGS AND DEVICES 1 2 SEO. 402. A drug or device shall be deemed to be 3 misbranded 4 (a) If its labeling is false or misleading in any particular. Any representation concerning any effect of a 6 drug or device shall be deemed to be false under this 5 7 paragraph if such representation is not supported by demonstrable scientific facts or substantial and reliable medical or scientific opinion. 8 9 10 11 (b) If it is dangerous to health under the conditions of use prescribed when used in the dosage, or with the 12 frequency or duration, prescribed or recommended in the labeling or advertising advertisement thereof. 13 14 15 16 17 18 (c) If in package form it fails to bear unless it bears a label containing (1) the name and place of business of the manufacturer, and of the packer, seller, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under 19 subdivision (2) of this paragraph reasonable variations shall 20 be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. 21 22 (d) If any word, statement, or other information 23 required on the label under any provision of this Act is 24 not prominently placed thereon in such a manner as to be 25 easily seen and in such terms as to be readily understood by J. 62545-2 18 1 purchasers and users of such articles under customary con 2 3 4 ditions of purchase and use, due consideration being given to the size of the package. (e) If it is for use by man and contains any quantity 5 of any of the following narcotic or hypnotic substances: 6 Alpha eucaine, barbituric acid, beta, eucaine, bromal, can7 nabis, carbromal, chloral, coca, cocaine, codeine, heroin, 8 marihuana, morphine, opium, paraldehyde, peyote, sulphon9 methane, or any substance chemically derived therefrom, 10 therefrom or any other narcotic or hypnotic substance, which 11 derivative or other narcotic or hypnotic substance has been designated as habit forming by regulations as provided by sections 701 and 703 unless the derivative is clearly not 12 13 14 habit forming prescribed by the Secretary, and, except when 15 dispensed on the written order of a member of the medical 16 profession, its label fails to bear the name and quantity or 17 proportion of such substance or derivative and in juxtaposi18 tion therewith the statement "Warning-May be habit 19 forming". 20 (f) If it is a drug and is not designated solely by a 21 name recognized in an official compendium and its label 22 fails to bear (1) a common or usual name of the drug, if such there be; and or (2), in case it is fabricated from two or more ingredients, the name of each active ingredient, 23 24 25 including the quantity, kind, and proportion of any alcohol: 19 1 Provided, That, to the extent that compliance with the 2 requirements of subdivision (2) of this paragraph is imprac3 ticable, exemptions shall be established by regulations 4 promulgated by the Secretary. Such subdivision (2) shall not (except the requirements as to alcohol) apply to any 6 drug the ingredients of which are fully and correctly disclosed to the Secretary. 5 7 8 10 13 14 (g) If its labeling fails to bear plainly and conspicu 9 ously (1) complete and adequate directions for use, and or (2) such warnings, in such manner and form, as may be 11 adequate are required by regulations prescribed by the 12 Secretary, against use in such 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: Provided, That where any requirement of subdivision (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the 18 public health, the Secretary shall promulgate regulations, as 19 provided by sections 701 and 703, exempting such drug or device from such requirement. 15 16 17 20 21 22 (h) If its name is recognized in an official compendium, or if it purports to be a drug the name of which is so recog23 nized, and it is not packaged and labeled as prescribed there24 in-unless exempted under (!) of this section. Whenever 25 a drug is recognized in both the United States Pharmacopoeia 20 1 and the Homœopathic Pharmacopoeia of the United States it 2 shall be subject to the requirements of the United States Phar3 macopoeia with respect to packaging and labeling unless it is 4 labeled and offered for sale as a homeopathic drug, in which 5 case it shall be subject to the provisions of the Homœopathic 6 Pharmacopoeia of the United States, and not to those of the 7 United States Pharmacopoeia. 8 9 10 11 12 13 14 15 (i) If it has been designated by regulations, as provided by sections 701 and 703, prescribed by the Secretary as a drug liable to deterioration, and is not packaged in such form er and manner, or its label fails to bear a statement of such precautions, as such regulations require for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the Secretary shall have informed the appropriate body 16 charged with the revision of such compendium of the need for such packaging or labeling requirements and such body 18 shall have failed within a reasonable time to prescribe such 17 19 requirements. 20 (j) (1) If it is a drug and its container is so made, 21 formed, or filled as to mislead the purchaser; or (2) if it 22 23 is an imitation of another drug; or (3) if it is offered for sale under the name of another drug. 21 1 MEANING OF "ANTISEPTIC"; REGULATIONS MAKING 2 3 EXEMPTIONS, SEC. 403. (a) When construing and enforcing 4 the provisions of this Act with respect to labeling and 5 advertisements, the term "antiseptic" shall be deemed to 6 have the same meaning as the word "germicide", except, 7 however, in the case of a drug purporting to be, or repre 8 sented as, an antiseptic for inhibitory use as a wet dressing, 9 ointment, dusting powder, or such other use as involves 10 prolonged contact with the body. 11 (b) The Secretary is hereby directed to promul 12 gate regulations exempting from any labeling or packaging 13 requirement of this Act drugs and devices which are, in accordance with the practice of the trade, to be processed, 15 labeled, or repacked in substantial quantities at establish16 ments other than those where originally processed or packed, 14 17 on condition that such drugs and devices are in conformity 18 with not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or 20 repacking establishment. 19 21 CERTIFICATION OF COAL-TAR COLORS FOR DRUGS 22 23 SEC. 403 404. The Secretary is hereby authorized to promulgate regulations, as provided by sections 701 and |