POSITRON EMISSION TOMOGRAPHY.

SEC. 121. POSITRON EMISSION TOMOGRAPHY. (a) Regulation of Compounded Positron Emission Tomography Drugs.—Section 201 (21 U.S.C. 321) is amended by adding at the end the following: “(ii) The term ‘compounded positron emission tomography drug’— “(1) means a drug that— “(A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for the purpose of providing dual photon positron emission tomographic diagnostic images; and “(B) has been compounded by or on the order of a practitioner who is licensed by a State to compound or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that State’s law, for a patient or for research, teaching, or quality control; and “(2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic synthesizer, or other apparatus or computer program to be used in the preparation of such a drug.”. (b) Adulteration.— (1) In general.—Section 501(a) (21 U.S.C. 351(a)) is amended by striking “; or (3)” and inserting the following: “; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3)”. (2) Sunset.—Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B), whichever is later. 111 STAT. 2321 (c) Requirements for Review of Approval Procedures and Current Good Manufacturing Practices for Positron Emission 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 abbreviated 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 compounded 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.—Within 30 days after the date of enactment of this Act, the Secretary of Health and Human 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. 111 STAT. 2322 (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). (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).