Page:United States Statutes at Large Volume 111 Part 3.djvu/233

From Wikisource
Jump to: navigation, search
This page needs to be proofread.


PUBLIC LAW 105-115 —NOV. 21, 1997 111 STAT. 2321 (c) REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND 21 USC 355 note. CURRENT GOOD MANUFACTURING PRACTICES FOR POSITRON EMIS- SION TOMOGRAPHY.— (1) PROCEDURES AND REQUIREMENTS.— (A) IN GENERAL.— In order to take account of the special characteristics of positron emission tomography drugs and the special techniques and processes required to produce these drugs, not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall establish— (i) appropriate procedures for the approval of positron emission tomography drugs pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and (ii) appropriate current good manufacturing practice requirements for such drugs. (B) CONSIDERATIONS AND CONSULTATION. — In establishing the procedures and requirements required by subparagraph (A), the Secretary of Health and Human Services shall take due account of any relevant differences between not-for-profit institutions that compound the drugs for their patients and commercial manufacturers of the drugs. Prior to establishing the procedures and requirements, the Secretary of Health and Human Services shall consult with patient advocacy groups, professional associations, manufacturers, and physicians and scientists licensed to make or use positron emission tomography drugs. (2) SUBMISSION OF NEW DRUG APPLICATIONS AND ABBRE- VIATED NEW DRUG APPLICATIONS. — (A) IN GENERAL.—Except as provided in subparagraph (B), the Secretary of Health and Human Services shall not require the submission of new drug applications or abbreviated new drug applications under subsection (b) or (j) of section 505 (21 U.S.C. 355), for compoimded positron emission tomography drugs that are not adulterated drugs described in section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a period of 4 years after the date of enactment of this Act, or for 2 years after the date on which the Secretary establishes procedures and requirements under paragraph (1), whichever is longer. (B) EXCEPTION.— Nothing in this Act shall prohibit the voluntary submission of such applications or the review of such applications by the Secretary of Health and Human Services. Nothing in this Act shall constitute an exemption for a positron emission tomography drug from the requirements of regulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). (d) REVOCATION OF CERTAIN INCONSISTENT DOCUMENTS. — Federal Register, Within 30 days after the date of enactment of this Act, the Secretary publication. of Health and Humsui Services shall publish in the Federal Register a notice terminating the application of the following notices and rule: (1) A notice entitled "Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public Workshop", published in the Federal Register on February 27, 1995, 60 Fed. Reg. 10594.