75TH CONGRESS 3D SESSION S. 3073 IN THE HOUSE OF REPRESENTATIVES MAY 7, 1938 Referred to the Committee on Interstate and Foreign Commerce AN ACT To safeguard the public health. 1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 3 That (a) in order to safeguard the public health against the 4 distribution of drugs which have not become generally recog5 nized as safe for use, no person shall introduce or deliver 6 for introduction into interstate commerce any drug com7 posed, in whole or in part, of any substance or combination 8 of substances, which substance or combination is not gener9 ally recognized as safe for use in the dosage and with the 10 frequency and duration prescribed, recommended, or sug11 gested in the labeling thereof, unless the packer of such drug 1 2 holds a notice of a finding by the Secretary that such drug 2 is not unsafe for use. 3 (b) To enable the Secretary to make a finding on any 4 such drug the packer thereof shall submit to the Secretary 5 (1) full reports of investigations which have been made to 6 show whether or not such drug is safe for use; (2) a full list 7 of the articles used as components of such drug; (3) a full 8 description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing 10 of such drug; (4) a full statement of the composition of such 11 drug; (5) such samples of such drug and of the articles used as components thereof as the Secretary may require; and (6) 13 specimens of all proposed labeling for such drug. 9 12 14 (c) To aid and advise him in making such finding the 15 Secretary is hereby authorized to create a board consisting 16 of one representative from each of the following organiza17 tions: The Public Health Service of the United States Treas18 ury Department, the American Institute of Homeopathy, 19 the American Medical Association, the United States Phar20 macopoeial Convention, the American Pharmaceutical Association, and the Food and Drug Administration of the Depart22 ment. No person who has a financial interest in the manu23 facture or distribution of any drug shall serve on such board. The Secretary is authorized to pay to each member of 'the board who is not a representative of a Federal department $25 21 24 25 8 1 per day for each day he is engaged in the work of the board. 2 The appropriation for the enforcement of the Food and Drugs 3 Act is hereby specifically made available for such purpose, 4 and for travel and other expenses of all members of the board 5 in accordance with the fiscal regulations of the Department. 6 (d) If the Secretary, after having received the aid and 7 advice of such board, finds that (1) such investigations 8 include tests by all existing methods reasonably applicable 9 to such drug; (2) the results of such tests do not show that 10 such drug is unsafe for use as prescribed, recommended, or 11 suggested in the labeling thereof; (3) the methods used in, 12 and the facilities and controls used for, the manufacture, 13 processing, and packing of such drug are adequate to preserve the identity, strength, quality, and purity thereof; and 15 (4) that such drug otherwise complies with the other pro16 visions of the Food and Drugs Act, he shall issue to such 14 17 packer a notice of finding that such drug is not unsafe for 18 use. In case the Secretary refuses to issue such notice he 19 shall notify the packer of his reasons for such refusal. 20 225 21 (e) The Secretary shall promulgate regulations for exempting from the operation of this section drugs intended 22 solely for investigational use by persons qualified by scientific 23 training and experience to make investigations as contem24 plated by this section. |