FDA: PET Drugs — Current Good Manufacturing Practice (CGMP)

This guidance is intended to help small businesses better understand and comply with the regulations issued by FDA concerning current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The guidance addresses resources, procedures, and documentation for all PET drug production facilities. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.