Page:United States Statutes at Large Volume 111 Part 3.djvu/234

 Ill STAT. 2322 PUBLIC LAW 105-115—NOV. 21, 1997 (2) A notice entitled "Draft Guideline on the Manufacture of Positron Emission Tomography Radiopharmaceutical Drug Products; Availability", published in the Federal Register on February 27, 1995, 60 Fed. Reg. 10593. (3) A final rule entitled "Current Good Manufacturing Practice for Finished Pharmaceuticals; Positron Emission Tomography, published in the Federal Register on April 22, 1997, 62 Fed. Reg. 19493 (codified at part 211 of title 21, Code of Federal Regulations). 21 USC 355 note. (e) DEFINITION. —As used in this section, the term "compounded positron emission tomography drug" has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 21 USC 355 note. SEC. 122. REQUIREMENTS FOR RADIOPHARMACEUTICALS. (a) REQUIREMENTS.— (1) REGULATIONS.— (A) PROPOSED REGULATIONS.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services, after consultation with patient advocacy groups, associations, physicians licensed to use radiopharmaceuticals, and the regulated industry, shall issue proposed regulations governing the approval of radiopharmaceuticals. The regulations shall provide that the determination of the safety and effectiveness of such a radiopharmaceutical under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) shall include consideration of the proposed use of the radiopharmaceutical in the practice of medicine, the pharmacological and toxicological activity of the radiopharmaceutical (including any carrier or ligand component of the radiopharmaceutical), and the estimated absorbed radiation dose of the radiopharmaceutical. (B) FINAL REGULATIONS.—Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate final regulations governing the approval of the radiopharmaceuticals. (2) SPECIAL RULE.— In the case of a radiopharmaceutical, the indications for which such radiopharmaceutical is approved for marketing may, in appropriate cases, refer to manifestations of disease (such as biochemical, physiological, anatomic, or pathological processes) common to, or present in, one or more disease states. (b) DEFINITION.— In this section, the term "radiopharmaceutical" means— (1) an article— (A) that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans; and (B) that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or (2) any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of any such article.

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