With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing requirements.
On August 28, 2023, the U.S. Food and Drug Administration ("FDA") issued compliance policies regarding the §582(g)(1) enhanced drug distribution security requirements of the Federal Food, Drug, and Cosmetic Act. While trading partners—manufacturers, repackagers, wholesale distributors, and dispensers—and FDA have been preparing for enhanced drug distribution security since the 2013 enactment of the Drug Supply Chain Security Act ("DSCSA"), industry concerns regarding readiness and a stated need for clarity and flexibility to ensure continued product movement through the supply chain prompted agency action. FDA's enforcement discretion is intended to provide additional time to implement, troubleshoot, and mature systems and processes while supporting the continued availability of products to patients.
In summary, until November 27, 2024, FDA does not intend to enforce the §582 requirements that:
- Transaction information and transaction statements be exchanged in a secure, interoperable, electronic manner;
- Systems and processes for verification of product at the package level, including the standardized numerical identifier, be in accordance with the standards established under DSCSA-required guidance;
- Systems and processes are enabled for prompt response regarding transaction information for a product upon a request by the secretary, or other appropriate federal or state official, in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product;
- Companies have the systems and processes necessary to promptly facilitate gathering information necessary to produce transaction information for each transaction going back to the manufacturer in a secure manner that ensures the protection of confidential commercial information and trade secrets in response to certain requests; and
- Each person accepting a saleable return have systems and processes in place to allow acceptance of such product and allowing acceptance only if such person can associate the saleable return product with the transaction information and transaction statement for the product.
FDA advises that the guidance is not intended to justify delaying implementation of enhanced drug distribution security requirements and urges trading partners to continue efforts to satisfy §582(g)(1) requirements.