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Title 21

Displaying title 21, up to date as of 6/04/2026. Title 21 was last amended 6/03/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter CDrugs: General200 – 299
Part 212Current Good Manufacturing Practice for Positron Emission Tomography Drugs212.1 – 212.110
Subpart AGeneral Provisions212.1 – 212.5
Subpart BPersonnel and Resources212.10
§ 212.10What personnel and resources must I have?
Subpart CQuality Assurance212.20
§ 212.20What activities must I perform to ensure drug quality?
Subpart DFacilities and Equipment212.30
§ 212.30What requirements must my facilities and equipment meet?
Subpart EControl of Components, Containers, and Closures212.40
§ 212.40How must I control the components I use to produce PET drugs and the containers and closures I package them in?
Subpart FProduction and Process Controls212.50
§ 212.50What production and process controls must I have?
Subpart GLaboratory Controls212.60 – 212.61
§ 212.60What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
§ 212.61What must I do to ensure the stability of my PET drug products through expiry?
Subpart HFinished Drug Product Controls and Acceptance212.70 – 212.71
§ 212.70What controls and acceptance criteria must I have for my finished PET drug products?
§ 212.71What actions must I take if a batch of PET drug product does not conform to specifications?
Subpart IPackaging and Labeling212.80
§ 212.80What are the requirements associated with labeling and packaging PET drug products?
Subpart JDistribution212.90
§ 212.90What actions must I take to control the distribution of PET drug products?
Subpart KComplaint Handling212.100
§ 212.100What do I do if I receive a complaint about a PET drug product produced at my facility?
Subpart LRecords212.110
§ 212.110How must I maintain records of my production of PET drugs?