Page:United States Statutes at Large Volume 59 Part 1.djvu/482

 PUBLIC LAWS-CH. 281-JULY 6, 1945 as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. Regulitions for "(b) Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this sec- tion, including provisions prescribing (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) administration and procedure; and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection within the shortest time consistent with the purposes of this section. Exemptions; regula- "(C) Whenever in the judgment of the Administrator, the require- Ante, p. 63. ments of this section and of section 502 (1) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use, the Administrator shall promulgate regulations exempting such drug or class of drugs from such requirements. "(d) The Administrator shall promulgate regulations exempting from any requirement of this section and of section 502 (1), (1) drugs which are to be stored, processed, labeled, or repacked at establish- ments other than those where manufactured, on condition that such drugs comply with all such requirements upon removal from such establishments; (2) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended for use in manufacturing other drugs; and (3) drugs which are intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs. 52 Stat. 1052 "(e) No drug which is subject to section 507 shall be deemed to be 21U.s.. i 3a. subject to any provision of section 505. Compliance of any drug sub- 52Sat. 049, 1051. ject to section 502 (1) or 507 with sections 501 (b) and 502 (g) shall 1(3 . S . C If 351 be determined by the application of the standards of strength, quality and purity, the tests and methods of assay, and the requirements of packaging and labeling, respectively, prescribed by regulations pro- mulgated under section 507. isftclannet.tc., ofregu "(f) Any interested person may file with the Administrator a peti- lations. tion proposing the issuance, amendment, or repeal of any regulation contemplated by this section. The petition shall set forth the proposal No. in general terms and shall state reasonable grounds therefor. The Administrator shall give public notice of the proposal and an oppor- tunity for all interested persons to present their views thereon, orally or in writing, and as soon as practicable thereafter shall make public Time limitation. his action upon such proposal. At any time prior to the thirtieth day after such action is made public any interested person may file objec- tions to such action, specifying with particularity the changes desired, stating reasonable grounds therefor, and requesting a public hearing Hearing upon such objections. The Administrator shall thereupon, after due notice, hold such public hearing. As soon as practicable after com- pletion of the hearing, the Administrator shall by order make public rder; basis. his action on such objections. The Administiator shall base his order only on substantial evidence of record at the hearing and shall set forth as part of the order detailed findings of fact on which the order 21 U. S. C. 371 is based. The order shall be subject to the provisions of section 701 (0), . (f) and (g)." Approved July 6, 1945. 464 [59 STAT.

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