title: Regulatory Requirements for PET Drug Production.
abstract: The Food and Drug Administration (FDA) issued the final rule for title 21 of Code of Federal Regulations part 212 regarding the regulations on current good manufacturing practice for PET drugs. The regulations are intended to ensure that PET drugs meet the safety and quality assurance requirements of the Federal Food, Drug, and Cosmetic Act. The new regulation became effective December 12, 2011, but the FDA used regulatory discretion to allow new drug applications and abbreviated new drug applications to be filed until June 12, 2012, without interruption of the existing PET drug production for human use. The production of PET drugs for both clinical use and clinical research use are outlined in this continuing education module, including an overview of specific requirements for compliance. Additionally, FDA preapproval inspections and postapproval reporting requirements are reviewed.
authors.affiliation: Department of Radiology, Washington University School of Medicine, St. Louis, Missouri schwarzs@mir.wustl.edu.
authors.forename: Sally W
authors.initials: SW
authors.lastname: Schwarz
authors.affiliation: Department of Radiology, University of Iowa, Iowa City, Iowa.
authors.forename: David
authors.initials: D
authors.lastname: Dick
authors.affiliation: Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California; and.
authors.forename: Henry F
authors.initials: HF
authors.lastname: VanBrocklin
authors.affiliation: Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, University of Utah, and Department of Radiology, University of Utah School of Medicine, Salt Lake City, Utah.
authors.forename: John M
authors.initials: JM
authors.lastname: Hoffman
mesh_terms: D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004355:Drug Stability; D005249:Fees and Charges; D033161:Government Regulation; D049268:Positron-Emission Tomography; D011786:Quality Control; D019275:Radiopharmaceuticals; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D019275:Radiopharmaceuticals
keywords: FDA inspections; FDA part 212; NDA/ANDA; USP chapter <823>; annual reporting