Laboratory Controls

  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. Laboratory Controls

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Section
212.60

What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?

Section
212.61

What must I do to ensure the stability of my PET drug products through expiry?