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- 21 CFR 203.33 · Drug sample forms.
- 21 CFR 203.34 · Policies and procedures; administrative systems.
- 21 CFR 203.35 · Standing requests.
- 21 CFR 203.36 · Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.
- 21 CFR 203.37 · Investigation and notification requirements.
- 21 CFR 203.38 · Sample lot or control numbers; labeling of sample units.
- 21 CFR 203.39 · Donation of drug samples to charitable institutions.
- 21 CFR 203.50 · Requirements for wholesale distribution of prescription drugs.
- 21 CFR 203.60 · Request and receipt forms, reports, and records.
- 21 CFR 203.70 · Application for a reward.
- 21 CFR 205.1 · Scope.
- 21 CFR 205.2 · Purpose.
- 21 CFR 205.3 · Definitions.
- 21 CFR 205.4 · Wholesale drug distributor licensing requirement.
- 21 CFR 205.5 · Minimum required information for licensure.
- 21 CFR 205.6 · Minimum qualifications.
- 21 CFR 205.7 · Personnel.
- 21 CFR 205.8 · Violations and penalties.
- 21 CFR 205.50 · Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
- 21 CFR 206.1 · Scope.
- 21 CFR 206.3 · Definitions.
- 21 CFR 206.7 · Exemptions.
- 21 CFR 206.10 · Code imprint required.
- 21 CFR 207.1 · What definitions and interpretations of terms apply to this part?
- 21 CFR 207.3 · Bulk drug substance.
- 21 CFR 207.5 · What is the purpose of this part?
- 21 CFR 207.9 · Who does this part cover?
- 21 CFR 207.13 · Who is exempt from the registration and listing requirements?
- 21 CFR 207.17 · Who must register?
- 21 CFR 207.21 · When must initial registration information be provided?
- 21 CFR 207.25 · What information is required for registration?
- 21 CFR 207.29 · What are the requirements for reviewing and updating registration information?
- 21 CFR 207.33 · What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
- 21 CFR 207.35 · What changes require a new NDC?
- 21 CFR 207.37 · What restrictions pertain to the use of the NDC?
- 21 CFR 207.41 · Who must list drugs and what drugs must they list?
- 21 CFR 207.45 · When, after initial registration of an establishment, must drug listing information be submitted?
- 21 CFR 207.49 · What listing information must a registrant submit for a drug it manufactures?
- 21 CFR 207.53 · What listing information must a registrant submit for a drug that it repacks or relabels?
- 21 CFR 207.54 · What listing information must a registrant submit for a drug that it salvages?
- 21 CFR 207.55 · What additional drug listing information may FDA require?
- 21 CFR 207.57 · What information must registrants submit when updating listing information and when?
- 21 CFR 207.61 · How is registration and listing information provided to FDA?
- 21 CFR 207.65 · How can a waiver of the electronic submission requirement be obtained?
- 21 CFR 207.69 · What are the requirements for an official contact and a United States agent?
- 21 CFR 207.77 · What legal status is conferred by registration and listing?
- 21 CFR 207.81 · What registration and listing information will FDA make available for public disclosure?
- 21 CFR 208.1 · Scope and purpose.
- 21 CFR 208.3 · Definitions.
- 21 CFR 208.20 · Content and format of a Medication Guide.
- 21 CFR 208.24 · Distributing and dispensing a Medication Guide.
- 21 CFR 208.26 · Exemptions and deferrals.
- 21 CFR 209.1 · Scope and purpose.
- 21 CFR 209.2 · Definitions.
- 21 CFR 209.10 · Content and format of the side effects statement.
- 21 CFR 209.11 · Dispensing and distributing the side effects statement.
- 21 CFR 210.1 · Status of current good manufacturing practice regulations.
- 21 CFR 210.2 · Applicability of current good manufacturing practice regulations.
- 21 CFR 210.3 · Definitions.
- 21 CFR 211.1 · Scope.
- 21 CFR 211.3 · Definitions.
- 21 CFR 211.22 · Responsibilities of quality control unit.
- 21 CFR 211.25 · Personnel qualifications.
- 21 CFR 211.28 · Personnel responsibilities.
- 21 CFR 211.34 · Consultants.
- 21 CFR 211.42 · Design and construction features.
- 21 CFR 211.44 · Lighting.
- 21 CFR 211.46 · Ventilation, air filtration, air heating and cooling.
- 21 CFR 211.48 · Plumbing.
- 21 CFR 211.50 · Sewage and refuse.
- 21 CFR 211.52 · Washing and toilet facilities.
- 21 CFR 211.56 · Sanitation.
- 21 CFR 211.58 · Maintenance.
- 21 CFR 211.63 · Equipment design, size, and location.
- 21 CFR 211.65 · Equipment construction.
- 21 CFR 211.67 · Equipment cleaning and maintenance.
- 21 CFR 211.68 · Automatic, mechanical, and electronic equipment.
- 21 CFR 211.72 · Filters.
- 21 CFR 211.80 · General requirements.
- 21 CFR 211.82 · Receipt and storage of untested components, drug product containers, and closures.
- 21 CFR 211.84 · Testing and approval or rejection of components, drug product containers, and closures.
- 21 CFR 211.86 · Use of approved components, drug product containers, and closures.
- 21 CFR 211.87 · Retesting of approved components, drug product containers, and closures.
- 21 CFR 211.89 · Rejected components, drug product containers, and closures.
- 21 CFR 211.94 · Drug product containers and closures.
- 21 CFR 211.100 · Written procedures; deviations.
- 21 CFR 211.101 · Charge-in of components.
- 21 CFR 211.103 · Calculation of yield.
- 21 CFR 211.105 · Equipment identification.
- 21 CFR 211.110 · Sampling and testing of in-process materials and drug products.
- 21 CFR 211.111 · Time limitations on production.
- 21 CFR 211.113 · Control of microbiological contamination.
- 21 CFR 211.115 · Reprocessing.
- 21 CFR 211.122 · Materials examination and usage criteria.
- 21 CFR 211.125 · Labeling issuance.
- 21 CFR 211.130 · Packaging and labeling operations.
- 21 CFR 211.132 · Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
- 21 CFR 211.134 · Drug product inspection.
- 21 CFR 211.137 · Expiration dating.
- 21 CFR 211.142 · Warehousing procedures.