52 STAT.] 75TH CONG. , 3D SESS.-CH. 675-JUNE 25, 1938 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 propor- tion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloro- form, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mer- cury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, That to the extent that compliance with the requirements of clause (2) of this paragraph is impracticable, exemptions shall 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 con- ditions 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 protec- tion 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 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 packaged and labeled as pre- scribed therein: Provided, That the method of packing may be modi- fied with the consent of the Secretary. Whenever a drug is recog- nized in both the United States Pharmacopoeia and the Homceopathic Pharmacopoeia of the United States, it shall be subject to the require- ments of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeo- pathic Pharmacopoeia of the United States, and not to those of the United States Pharmacopoeia. (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. No such regulation shall be established for any drug recog- nized in an official compendium until the Secretary shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements. (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 or duration prescribed, recommended, or suggested in the labeling thereof. EXEMPTIONS IN CASE OF DRUGS AND DEVICES SEC. 503. (a) The Secretary is hereby directed to promulgate regu- lations exempting from any labeling or packaging requirement of this Act drugs and devices which are, in accordance with the prac- tice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally proc- essed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment. Exemptions in case of drugs and devices. Processing, repack- ing, etc. , at other than original establish- ment. 1051 Provio. Exemptions. Directions for use; warnings, etc. Proviso. Exemptions. Purported to be recognized drug. Proviso. Modification in method of packing. Drug liable to dete- rioration. Drug and container misleading, etc. Daogeroustohealth.
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