Page:United States Statutes at Large Volume 76.djvu/829

 76

STAT.]

PUBLIC LAW 87-781-OCT. 10, 1962

781

operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess;". EFFECTIVE N E S S A N D SAFETY OF N E W DRUGS

SEC. 102. (a)(1) Section 201(p)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (p)(1)), defining the term "new drug", is amended by (A) inserting therein, immediately after the words "to evaluate the safety", the words "and effectiveness", and (B) inserting therein, immediately after the words "as safe", the words "and

52 Stat. i04i.

(2) Section 201(p)(2) of such Act (21 U.S.C. 321 (p)(2)) is amended by inserting therein, immediately after the word "safety", the words and effectiveness". (b) Section 505(b) of such Act (21 U.S.C. 355(b)) is amended by S2 Stat. 1052. inserting therein, immediately after the words "is safe for use", the words "and whether such drug is effective in use". (c) Section 505(d) of such Act (21 U.S.C. 355(d)) is amended to read as follows: " (d) If the Secretary finds, after due notice to the applicant in Grounds for reaccordance with subsection (c) and giving him an opportunity for a ^i^«^"s appiicahearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug wdll have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. If, after such notice and opportunity Approval of apfor hearing, the Secretary finds that clauses (1) through (6) do not pii*=«'io"apply, he shall issue an order approving the application. As used in this subsection and subsection (e), the term 'substantial evidence' means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof." (d) Section 505(e) of such Act (21 U.S.C. 355(e)) is amended to 52 Stat. 1052. read as follows:

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