Resources & FAQ
The 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.
FDA Compliance Links
- 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)
The FDA 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