21 CFR Part 212 - Current Good Manufacturing Practice for PET Drugs

What it says

Positron emission tomography drugs have their own CGMP regulation, tailored to the realities of producing short-lived radiopharmaceuticals, covering personnel, facilities, equipment, production and process controls, laboratory controls, labeling, and records, in place of the general drug CGMP requirements in 21 CFR Parts 210 and 211.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Part 212 exists because the very short half-lives of PET isotopes make some conventional CGMP expectations, such as completing every test before release, impractical, so the regulation defines requirements suited to that reality.
• A PET production site must still demonstrate control through validated processes, qualified equipment and documented batch records, even though product is often released within a very short window.
• The USP chapters on PET and radiopharmaceutical preparation sit alongside this regulation, but Part 212 is the binding CGMP framework for PET drug producers.

What FDA inspectors look for

• Whether production and process controls are validated and consistently followed for each PET drug batch.
• Whether release decisions rely on testing and controls the site has actually validated for its compressed timeline.
• Whether sterility assurance and aseptic practices are maintained even where post-release sterility testing results arrive after the product has been used.

Related regulations