Current Good Manufacturing Practice for Finished Pharmaceuticals; Positron Emission Tomography

The Food and Drug Administration (FDA) is amending its regulations to permit FDA to approve requests from manufacturers of positron emission tomography (PET) radiopharmaceutical drug products for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. This action is intended to relieve manufacturers of PET radiopharmaceutical drug products from regulations that might result in unsafe handling of these products or that are inapplicable or inappropriate, and that do not enhance safety or quality in the manufacture of PET radiopharmaceutical drug products. Elsewhere in this issue of the Federal Register, FDA is amending its regulations to authorize the Director, Center for Drug Evaluation and Research (CDER) and CDER's Director of the Office of Compliance to grant or deny citizen petitions under FDA regulations requesting an exception or alternative to any requirement pertaining to CGMP.