Page:United States Statutes at Large Volume 111 Part 3.djvu/242

 Ill STAT. 2330 PUBLIC LAW 105-115—NOV. 21, 1997 The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i). "(c) ADVERTISING AND PROMOTION.— ^A drug may be compounded under subsection (a) only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician. "(d) REGULATIONS.— "(1) IN GENERAL.— The Secretary shall issue regulations to implement this section. Before issuing regulations to implement subsections (b)(l)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by the Secretary. "(2) LIMITING COMPOUNDING.—The Secretary, in consultation with the United States Pharmacopoeia Convention, Incorporated, shall promulgate regulations identifying drug substances that may be used in compounding under subsection (b)(l)(A)(i)(III) for which a monograph does not exist or which are not components of drug products approved by the Secretary. The Secretary shall include in the regulation the criteria for such substances, which shall include historical use, reports in peer reviewed medical literature, or other criteria the Secretary may identify. "(e) APPLICATION.—T h is section shall not apply to— "(1) compounded positron emission tomography drugs as defined in section 201(ii); or "(2) radiopharmaceuticals. "(f) DEFINITION. — As used in this section, the term 'compounding' does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.". 21 USC 353a (b) EFFECTIVE DATE. — Section 503A of the Federal Food, Drug, note. and Cosmetic Act, added by subsection (a), shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act. SEC. 128. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PRO- GRAM. Section 2 of Public Law 102-222 (105 Stat. 1677) is amended— (1) in subsection (a), by striking "a grant" and all that follows through "Such grant" and inserting the following: "grants for a pilot program for the training of individuals in clinical pharmacology at appropriate medical schools. Such grants"; and

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