FDA released the following Guidance Document, effective April 2012: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.
This guidance is intended to help manufacturers of positron emission tomography (PET) drugs meet the requirements for the Agency’s current good manufacturing practice (CGMP) regulations for PET drugs (21 CFR part 212). Most PET drugs are designed for parenteral administration and are produced by aseptic processing.
Additionally, until June 12, 2012, FDA does not intend to take enforcement action against a PET facility currently producing PET drugs for clinical use for a failure to submit a new drug application by December 12, 2011, provided that the facility complies with all other FDA requirements, including current good manufacturing practices (CGMPs). FDA will not exercise enforcement discretion after June 12, 2012. Therefore, if a facility wishes to continue to produce PET drugs for clinical use after June 12, 2012, they must have submitted a new drug application (NDA) or an abbreviated new drug application (ANDA) by that date, or be producing the drugs under an investigational new drug application (IND).