Page:United States Statutes at Large Volume 76.djvu/834

 786 59 Stat. 464. E»««"p"°"' '**enn a ons.

PUBLIC LAW 87-781-OCT. 10, 1962

[76 STAT.

(d) Section 507(c) of such Act (21 U.S.C. 357(c)) is amended by adding at the end thereof the following: " I n deciding whether an antibiotic drug, or class of antibiotic drugs, is to be exempted from the requirement of certification the Secretary shall give consideration, among other relevant factors, to— " (1) whether such drug or class of drugs is manufactured by a person who has, or hereafter shall have, produced fifty consecu,.., rtive batches of such drug or class of drugs in compliance with the regulations for the certification thereof within a period of not more than eighteen calendar months, upon the application by such person to the Secretary; or "(2) whether such drug or class of drugs is manufactured by any person who has otherwise demonstrated such consistency in the production of such drug or class of drugs, in compliance with the regulations for the certification thereof, as in the judgment of the Secretary is adequate to insure the safety and efficacy of use thereof. When an antibiotic drug or a drug manufacturer has been exempted from the requirement of certification, the manufacturer may still obtain certification of a batch or batches of that drug if he applies for and meets the requirements for certification. Nothing in this Act shall be deemed to prevent a manufacturer or distributor of an antibiotic drug from making a truthful statement in labeling or advertising of the product as to whether it has been certified or exempted from the requirement of certification." (e) The first sentence of section 507^e) of such Act (21 U.S.C. 59 Stat. 464. 357(e)) is amended to read as follows: No drug which is subject to section 507 shall be deemed to be subject to any provision of section 21 USC 355. 505 except a new drug exempted from the requirements of this section and of section 502(1) pursuant to regulations promulgated by the Secretary: Provided., That, for purposes of section 505, the initial request for certification, as thereafter duly amended, pursuant to section 507, of a new drug so exempted shall be considered a part of the application filed pursuant to section 505(b) with respect to the person filing such request and to such drug as of the date of the exemption." 59 Stat. 463; (f) Section 507 of such Act (21 U.S.C. 357) is further amended by Post, p. 787. adding at the end of such section the following new subsection: " (h) In the case of a drug for which, on the d a j immediately preceding the effective date of this subsection, a prior approval of an 21 USC 355. application under section 505 had not been withdrawn under section 505(e), the initial issuance of regulations providing for certification or exemption of such drug under this section 507 shall, with respect to the conditions of use prescribed, recommended, or suggested in the labeling covered by such application, not be conditioned upon an affirmative finding of the efficacy of such drug. Any subsequent amendment or repeal of such regulations so as no longer to provide for such certification or exemption on the ground of a lack of efficacy of such drug for use under such conditions of use may be effected only on or after that effective date of clause (3) of the first sentence of section 505(e) which would be applicable to such drug under such conditions of use if such drug were subject to section 505(e), and then only if (1) such amendment or repeal is made in accordance with the procedure specified in subsection (f) of this section (except that such amendment or repeal may be initiated either by a proposal of the Secretary or by a petition of any interested person) and (2) the Secretary finds, on the basis of new information with respect to such drug evaluated together with the information before him when the application under section 505 became effective or was approved, that

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