Finished Drug Product Controls and Acceptance

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs: General
  6. Current Good Manufacturing Practice for Positron Emission Tomography Drugs
  7. Finished Drug Product Controls and Acceptance

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Section
212.70

What controls and acceptance criteria must I have for my finished PET drug products?

Section
212.71

What actions must I take if a batch of PET drug product does not conform to specifications?