Compliance
21 CFR 212
FDA cGMP for PET drugs
FDA cGMP rule for Positron Emission Tomography (PET) drugs — short half-life specific.
21 CFR 212 is the FDA's cGMP rule for PET drugs. Because PET radiopharmaceuticals decay too fast for standard finished-product testing before release, 212.70(d) permits conditional release with verified in-process controls — V5 implements this with a calibration-time-stamped activity check and a documented condition-of-release record.
Industries that live with this
Related terms
Want to see 21 CFR 212 in V5?
Free trial, no credit card, onboard in days, not months.