CFR section
21 CFR 212.61(b): What must I do to ensure the stability of my PET drug products through expiry?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart G-Laboratory Controls
Key facts
| Citation | 21 CFR 212.61(b) |
|---|---|
| Section | What must I do to ensure the stability of my PET drug products through expiry? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart G-Laboratory Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (b) Storage conditions and expiration dates. The results of such stability testing must be documented and used in determining appropriate storage conditions and expiration dates and times for each PET drug product you produce. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.