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1 of such articles under custoinary conditions of purchase and
3 (d) If it is for internal use by man and contains any 4 quantity of any of the following narcotic or hypnotic sub5 stances: Alpha eucaine, barbital, beta eucaine, bromal, can6 nabis, carbromal, chloral, coca, cocaine, codeine, heroin, 7 marihuana, morphine, opium, paraldehyde, peyote, sulphon8 methane, or any narcotic or hypnotic substance chemically 9 derived therefrom, or any other narcotic or hypnotic sub9
stance which has been designated as habit forming by regula
11 tions as provided by sections 701 and 703, and its label
fails to bear the name and quantity or proportion of such
13 substance or derivative and in juxtaposition therewith the 14 statement “Warning—May be habit forming ". 15 (e) If it is not designated solely by a name recognized 16 in an official compendium and its label fails to bear (1) a 17 common or usual name of the drug, if such there be; and (2) 18 in case it is fabricated from two or more ingredients the 19 names and quantity or proportion of each active ingredient: 20 Provided, That exemption to compliance with subdivision 21 (2) of this paragraph is given in such cases where the 22 name, quantity, and proportion of each active ingredient is 23 filed with the Secretary in accordance with regulations 24 promulgated by him.
(f) If its labeling fails to bear plainly and conspicuously (1) complete and explicit directions for use, and (2) such 3 warnings in such manner and form as may be prescribed by 4 regulations, as provided by sections 701 and 703, against use 5 in such pathological conditions or by children where its use is 6 contraindicated and may be dangerous to health, or against
unsafe dosage or methods or duration of administration or 8 application: Provided, That where any requirement of sub9 division (1) of this paragraph, as applied to any drug, is 10 not necessary for the protection of the public health, the 11 Secretary shall promulgate regulations, as provided by 12 sections 701 and 703, exempting such drug from such 13 requirement. 14 (g) If its name is the same as, or simulates, a name 15 recognized in an official compendium and it is not packaged 16 and labeled as prescribed therein. Whenever a drug is 17 recognized in both the United States Pharmacopæia and 18 the Homeopathic Pharmacopæia of the United States it shall 19 be subject to the requirements of the United States Pharma20 copæia with respect to packaging and labeling unless it is 21 labeled and offered for sale as a homeopathic drug, in which 22 case it shall be subject to the provisions of the Homeopathic 23 Pharmacopæia of the United States, and not to those of the 24 United States Pharmacopæia.
1 (b) If it has been designated by regulations, as pro2 vided by sections 701 and 703, as a drug liable to deteriora3 tion, and is not packaged in such form or manner, or its label 4 fails to bear a statement of such precautions, as such regu
5 lations require for the protection of public health. No such 6 regulation shall be established for any drug recognized in an 7 official compendium until the Secretary shall have informed 8 the appropriate body charged with the revision of such com9 pendium of the need for such packaging or labeling require10 ments and such body shall have failed within a reasonable 11 time to prescribe such requirements. 12 (i) (1) If its container is so made, formed, or filled 13 as to mislead the purchaser; or (2) if it is an imitation of 14 another drug; or (3) if it is offered for sale under the name
16 (j) If it purports to be or is represented as a germi17 cide, bactericide, disinfectant, or antiseptic for any use on 18 or within the body and its labeling fails to bear a plain and 19 conspicuous statement of such use, including the strength or 20 dilution, manner, and duration of application, and when 21 tested by a standard method, it does not have the germi22 cidal effect within the duration so prescribed of a one 23 to eighty dilution of phenol used by a standard testing 24 method for ten minutes at thirty-seven degrees centigrade. 25 All testing methods for the purposes of this paragraph shall
be prescribed by regulations as provided by sections 701 and 703: Provided, That no drug shall be deemed to be mio
branded under this paragraph by reason of failure of its + labeling to bear a statement of any advertised use if sugh
advertising is disseminated only to members of the medical
and pharmaceutical professions, or appears only in scientific i publications of these professions.
T 8 (k) If it purports to be or is represented as an inhib 9 itory antiseptic for any use as a wet dressing, ointment, 10 dusting powder, or such other use as involves prolonged 11 contact with the body, and its labeling fails to bear a plain 12 and conspicuous statement of such use, including strength 13 or dilution and manner of application, and when tested by
a standard method, it fails to prevent the growth of micm 15 organisms within the entire time of such duration. U 16 testing methods for the purposes of this paragraph shall 17 be prescribed by regulations as provided by sections 791 18 and 703: Provided, That no drug shall be deemed to bę 19 misbranded under this paragraph by reason of failure of 20 its labeling to bear a statement of any advertised use is 21 such advertising is disseminated only to members of tho 22 medical and pharmaceutical profession, or appears only in 23 scientific publications of these professions.
:::: :: 24 (1) The Secretary is hereby authorized to promulgato 25 regulations exempting from any labeling or packaging
i requirement of this Act drugs which are, in accordance 2 with the practice of the trade, processed, labeled, or repacked 3 in substantial quantities at establishments other than those 4 where originally processed or packed, on condition that such 5 drugs are in conformity with the provisions of this Act 6 upon removal from such processing, labeling, or repacking
(a) If it bears or contains any poisonous or dele13 terious substance which may render it injurious to the user 14 under the conditions of use prescribed in the labeling 15 thereof, or under such conditions of use as are customary
(b) If it bears or contains any poisonous or deleterious substance prohibited, or in excess of the limits of tolerance prescribed, by regulations as provided by sections
503, 701, and 703.
(a) If its labeling is false or misleading in any par