Part 212 — Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 355, 371, 374; Sec. 121, Pub. L. 105-115, 111 Stat. 2296.
Source: 74 FR 65431, Dec. 10, 2009, unless otherwise noted.
Sections
- § 212.1 What are the meanings of the technical terms used in these regulations?
- § 212.2 What is current good manufacturing practice for PET drugs?
- § 212.5 To what drugs do the regulations in this part apply?
- § 212.10 What personnel and resources must I have?
- § 212.20 What activities must I perform to ensure drug quality?
- § 212.30 What requirements must my facilities and equipment meet?
- § 212.40 How must I control the components I use to produce PET drugs and the containers and closures I package them in?
- § 212.50 What production and process controls must I have?
- § 212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
- § 212.61 What must I do to ensure the stability of my PET drug products through expiry?
- § 212.70 What controls and acceptance criteria must I have for my finished PET drug products?
- § 212.71 What actions must I take if a batch of PET drug product does not conform to specifications?
- § 212.80 What are the requirements associated with labeling and packaging PET drug products?
- § 212.90 What actions must I take to control the distribution of PET drug products?
- § 212.100 What do I do if I receive a complaint about a PET drug product produced at my facility?
- § 212.110 How must I maintain records of my production of PET drugs?