- National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
The Drug Supply Chain Security Act (DSCSA) outlines requirements to develop and enhance drug supply chain security by 2023. This includes product tracing requirements that went into effect in 2015 for manufacturers, repackagers, wholesale distributors and dispensers (primarily pharmacies).
The DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.
FDA has developed materials for state officials, including overviews of the requirements and standards for licensure, a summary of the 2015 Intergovernmental Meeting, and two Long-Term Information-Sharing Agreements to facilitate the exchange of information about DSCSA between FDA and the states.
- Webinar: Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
- FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
- Overview of Product Tracing Requirements
- Overview of Wholesale Distributor and Third-party Logistics Provider Requirements and Standards for Licensure (PDF - 338KB)
- FDA’s Guidance on Uniform National Policy (Section 585 of the FDCA) (PDF - 155KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting
- Intergovernmental Working Meeting on the DSCSA, November 17, 2015: Summary and Action Items (PDF - 98KB)
- DSCSA Long-Term 21 CFR §20.88 Information-Sharing Agreement Template: DSCSA only (PDF - 166KB)
- DSCSA Long-Term 21 CFR §20.88 Information-Sharing Agreement Template: Combined DSCSA and Compounding Agreement (PDF - 165KB)
This webpage will be updated as new information becomes available. FDA encourages state officials to explore this webpage and the DSCSA to learn more about the law.
How to Submit Inquiries
- State officials can send questions to FDA’s Intergovernmental Affairs Staff at IGA@fda.hhs.gov.