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- 21 CFR 211.150 · Distribution procedures.
- 21 CFR 211.160 · General requirements.
- 21 CFR 211.165 · Testing and release for distribution.
- 21 CFR 211.166 · Stability testing.
- 21 CFR 211.167 · Special testing requirements.
- 21 CFR 211.170 · Reserve samples.
- 21 CFR 211.173 · Laboratory animals.
- 21 CFR 211.176 · Penicillin contamination.
- 21 CFR 211.180 · General requirements.
- 21 CFR 211.182 · Equipment cleaning and use log.
- 21 CFR 211.184 · Component, drug product container, closure, and labeling records.
- 21 CFR 211.186 · Master production and control records.
- 21 CFR 211.188 · Batch production and control records.
- 21 CFR 211.192 · Production record review.
- 21 CFR 211.194 · Laboratory records.
- 21 CFR 211.196 · Distribution records.
- 21 CFR 211.198 · Complaint files.
- 21 CFR 211.204 · Returned drug products.
- 21 CFR 211.208 · Drug product salvaging.
- 21 CFR 212.1 · What are the meanings of the technical terms used in these regulations?
- 21 CFR 212.2 · What is current good manufacturing practice for PET drugs?
- 21 CFR 212.5 · To what drugs do the regulations in this part apply?
- 21 CFR 212.10 · What personnel and resources must I have?
- 21 CFR 212.20 · What activities must I perform to ensure drug quality?
- 21 CFR 212.30 · What requirements must my facilities and equipment meet?
- 21 CFR 212.40 · How must I control the components I use to produce PET drugs and the containers and closures I package them in?
- 21 CFR 212.50 · What production and process controls must I have?
- 21 CFR 212.60 · What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
- 21 CFR 212.61 · What must I do to ensure the stability of my PET drug products through expiry?
- 21 CFR 212.70 · What controls and acceptance criteria must I have for my finished PET drug products?
- 21 CFR 212.71 · What actions must I take if a batch of PET drug product does not conform to specifications?
- 21 CFR 212.80 · What are the requirements associated with labeling and packaging PET drug products?
- 21 CFR 212.90 · What actions must I take to control the distribution of PET drug products?
- 21 CFR 212.100 · What do I do if I receive a complaint about a PET drug product produced at my facility?
- 21 CFR 212.110 · How must I maintain records of my production of PET drugs?
- 21 CFR 213.1 · Scope.
- 21 CFR 213.3 · Definitions.
- 21 CFR 213.22 · Responsibilities of quality unit.
- 21 CFR 213.25 · Personnel qualifications and responsibilities.
- 21 CFR 213.34 · Consultants.
- 21 CFR 213.42 · Design and construction features.
- 21 CFR 213.63 · Equipment design, size, and location.
- 21 CFR 213.65 · Equipment construction.
- 21 CFR 213.67 · Equipment maintenance and cleaning.
- 21 CFR 213.68 · Automatic, mechanical, and electronic equipment.
- 21 CFR 213.80 · General requirements.
- 21 CFR 213.82 · Receipt and storage of incoming designated medical gases.
- 21 CFR 213.84 · Testing and approval or rejection of components, containers, and closures.
- 21 CFR 213.89 · Rejected components, incoming designated medical gases, and medical gas containers and closures.
- 21 CFR 213.94 · Medical gas containers and closures.
- 21 CFR 213.100 · Written procedures; deviations.
- 21 CFR 213.101 · Charge-in of components and incoming designated medical gases.
- 21 CFR 213.110 · Sampling and testing of in-process materials.
- 21 CFR 213.122 · Materials examination and usage criteria.
- 21 CFR 213.125 · Labeling issuance.
- 21 CFR 213.130 · Packaging and labeling operations.
- 21 CFR 213.150 · Warehousing and distribution procedures.
- 21 CFR 213.160 · General requirements.
- 21 CFR 213.165 · Testing and release for distribution.
- 21 CFR 213.166 · Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 213.180 · General requirements.
- 21 CFR 213.182 · Equipment cleaning and use log.
- 21 CFR 213.184 · Records for components, medical gas containers and closures, and labeling.
- 21 CFR 213.186 · Master production and control records.
- 21 CFR 213.189 · Batch production and control records.
- 21 CFR 213.192 · Production record review.
- 21 CFR 213.194 · Laboratory records.
- 21 CFR 213.196 · Distribution records.
- 21 CFR 213.198 · Complaint files.
- 21 CFR 213.204 · Returned medical gases.
- 21 CFR 213.208 · Salvaging of medical gases.
- 21 CFR 216.23 · Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 216.24 · Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
- 21 CFR 225.1 · Current good manufacturing practice.
- 21 CFR 225.10 · Personnel.
- 21 CFR 225.20 · Buildings.
- 21 CFR 225.30 · Equipment.
- 21 CFR 225.35 · Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.
- 21 CFR 225.42 · Components.
- 21 CFR 225.58 · Laboratory controls.
- 21 CFR 225.65 · Equipment cleanout procedures.
- 21 CFR 225.80 · Labeling.
- 21 CFR 225.102 · Master record file and production records.
- 21 CFR 225.110 · Distribution records.
- 21 CFR 225.115 · Complaint files.
- 21 CFR 225.120 · Buildings and grounds.
- 21 CFR 225.130 · Equipment.
- 21 CFR 225.135 · Work and storage areas.
- 21 CFR 225.142 · Components.
- 21 CFR 225.158 · Laboratory assays.
- 21 CFR 225.165 · Equipment cleanout procedures.
- 21 CFR 225.180 · Labeling.
- 21 CFR 225.202 · Formula, production, and distribution records.
- 21 CFR 226.1 · Current good manufacturing practice.
- 21 CFR 226.10 · Personnel.
- 21 CFR 226.20 · Buildings.
- 21 CFR 226.30 · Equipment.
- 21 CFR 226.40 · Production and control procedures.
- 21 CFR 226.42 · Components.
- 21 CFR 226.58 · Laboratory controls.