What 21 CFR Part 205 - FDA Guidelines for State Licensing of Wholesale Prescription Drug Distributors requires
21 CFR Part 205 sets the minimum standards and guidelines for the state licensing of wholesale prescription drug distributors implementing the Prescription Drug Marketing Act. A wholesale distributor of prescription drugs must be licensed in accordance with these requirements, and must provide the minimum information required for licensure and meet the minimum qualifications for the conduct of wholesale distribution. The distributor must ensure that personnel meet the applicable requirements and must satisfy the minimum requirements for the storage and handling of prescription drugs, including appropriate facilities, security against diversion and theft, and proper temperature and conditions. The distributor must establish and maintain the required prescription drug distribution records and make them available for inspection, and must avoid the violations for which penalties are provided. These standards protect the integrity of the U.S. prescription drug distribution chain.
Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-205
SHA-256 integrity: c6f9b5a235aa26c212d7ffcc35ec05a75b270cd67f796e154ad4d4710731bc23
Primary Citations — 7 traced to source
- Prescription Drug Marketing Act of 1987 and Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq. - statutory authority
- 21 CFR Part 205, § 205.4 - wholesale drug distributor licensing requirement
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