2022-01929: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

Summary

The Food and Drug Administration (FDA, the Agency, or we) is proposing national standards for the licensing of prescription drug wholesale distributors ("wholesale distributors" or "wholesale drug distributors") and third-party logistics providers ("3PLs"), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.

The agency’s own summary, as published.

What this changes

Amends 4 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 10 Administrative Practices and Procedures
• 21 CFR 12 Formal Evidentiary Public Hearing
• 21 CFR 16 Regulatory Hearing Before the Food and Drug Administration
• 21 CFR 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors