21 CFR 212, Current Good Manufacturing Practice (CGMP) for PET Radiopharmaceuticals

Background

21 CFR 212 requires manufacturers of PET drugs for clinical use to be compliant with the rule. Any facility that produces PET drugs for clinical use is required to submit either a New Drug Application or an Abbreviated New Drug Application for each of its clinical PET drugs, whether or not the drugs are produced for commercial distribution.

Current Status

On December 10, 2009, the FDA published the final rule for 21 CFR 212, Current Good Manufacturing Practice (CGMP) for PET Radiopharmaceuticals. Through the work of the Coalition for PET Drug Approval and FDA Task Force, SNMMI remains committed to ensuring that patients receive safe advanced medical imaging procedures and therapies.