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FDA Delays Final DSCSA Mandate
Rules for Electronic Drug Distribution Security Pushed Back to November 2024
► Read/Download the FDA's New DSCSA Guidance
The FDA today issued a one-year delay in implementation of the final enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA) that were set to take effect on November 27. The new date, which was announced in an FDA guidance document, will be November 27, 2024.
The decision to delay the DSCSA requirements was made after multiple pharmacy organizations warned the federal agency that all elements of the drug supply chain are not prepared to comply with the final FDA provisions. The one-year extension gives all retail pharmacies additional time to develop the systems and reporting/compliance processes necessary for efficient transactions.
The delay means that the FDA does not intend to enforce the requirements (until November 2024) for electronic drug distribution security (EDDS), which include:
- The exchange of transaction information and transaction statements in a secure, interoperable, electronic manner; and
- The systems and processes for verification of products at the package level, including the standardized numerical identifier.
All retail pharmacies are still required to comply with the existing DSCSA requirements, including:
- Validating your Authorized Trading Partners;
- Accepting products that possess the Product Identifier (NDC, Serial Number, Lot Number and Expiration Date) in human and machine-readable formats (2D Barcode);
- Receiving and verifying the transaction data (transaction information, transaction Statement, and transaction History (collectively known as the 3Ts) for all DSCSA Covered Products; and
- Continuing due diligence to identify suspect products and incorrect transaction data, conduct investigations, respond to information requests, and notify the FDA when you identify Illegitimate products.
PRS Pharmacy Services has partnered with Advasur to develop DSCSA 360, a comprehensive DSCSA compliance platform. To learn more, click here. PRS/Advasur is a preferred vendor of FPN -- the Federation of Pharmacy Networks -- of which American Pharmacies is a member.
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