0910-AB63 200104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Positron Emission Tomography Drugs; Current Good Manufacturing Practices Positron emission tomography (PET) is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug. PET drugs are usually injected intravenously into patients for diagnostic purposes. Most PET drugs are produced using cyclotrons at locations that are in close proximity to the patients to whom the drugs are administered (e.g., in hospitals or academic institutions). Each PET drug is compounded under a physician's prescription and, due to the short half-lives of PET drugs, is administered to the patient within a few minutes or hours. Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice (CGMP) to assure that the drug meets the requirements of the 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. FDA's CGMP requirements for drug products are set forth in 21 CFR parts 210 and 211. On November 21, 1997, the President signed into law the Food and Drug Administration Modernization Act (Modernization Act) (Pub. L. 105-115). Section 121 of the Modernization Act contains several provisions affecting the regulation of PET drugs. Section 121(c)(1)(A) of the Modernization Act directs FDA to establish, within two years after enactment, appropriate approval procedures and CGMP requirements for PET drugs. Section 121(c)(1)(B) requires FDA to consult with patient advocacy groups, professional associations, manufacturers, and other interested persons as the agency develops PET drug CGMP requirements and approval procedures. FDA's proposed rule on PET drug CGMP's will be designed to reflect the unique nature of PET drug products. Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined 21 CFR 220 PL 105-115, sec 121 Statutory Final 11/21/1999 Yes Congress directed FDA to establish appropriate CGMP requirements for PET drugs. FDA's proposed rule on PET drug CGMP's will be designed to reflect the unique nature of PET drug products. Conformance with these CGMP's should ensure that each PET drug meets the requirements of the 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, in accordance with section 501(a)(2)(B) of the Act. As noted above, section 121(c)(1)(A) of the Modernization Act directs FDA to establish appropriate CGMP requirements for PET drugs. FDA interprets this as a directive to establish CGMP regulations for PET drugs. FDA has considered several different approaches to establishing CGMP's for PET drugs. In addition, the agency has held public meetings on this matter and has received extensive input from the PET community and other interested persons on what CGMP requirements would be appropriate for PET drugs. FDA has not yet quantified the costs and benefits of any regulatory approach. The agency has been working with the PET community to develop CGMP's that are appropriately suited to the production of PET drugs while still being consistent with statutory requirements for current good manufacturing practice for drug products. Responses to the proposed rule likely will provide more information on the potential costs and benefits of the proposed CGMP's. None. NPRM 09/00/2001 Undetermined Undetermined NA Not Collected Brian Pendleton L. 0910 Food and Drug Administration FDA 301 796-4614 301 847-8616 brian.pendleton@fda.hhs.gov Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002 Not Procurement Related No