Last week, FDA announced final current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs. The regulation establishes minimum standards for the production and testing of PET drug products, and is intended to ensure that PET drug products meet the requirements of the federal Food, Drug and Cosmetic Act as to safety, identity, strength, quality and purity. In conjunction with issuance of the regulations, FDA announced the availability of a guidance entitled "PET Drugs - Current Good Manufacturing Practice (CGMP)." The CGMP regulations for PET drugs will go into effect and become mandatory for PET drug production two years after the publication of the final rule. At that time, FDA will also require the submission of a new drug application (NDA) or abbreviated new drug application (ANDA) for any PET drug product marketed for clinical use in the United States. Despite industry concerns, FDA believes that the PET final rule does not conflict with the practice of medicine or pharmacy, or with the current regulation of drug compounding. Section 121 of the 1997 Food and Drug Administration Modernization Act (Public Law 105-115) directed FDA to establish appropriate approval procedures and CGMP requirements for PET drugs. FDA had published a proposed rule to establish CGMP requirements for PET drugs in 2005.