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# Enforcement Deferred on Drug Security Needs
- URL: https://www.fdaweb.com/enforcement-deferred-on-drug-security-needs/
- Published: 2023-08-25T12:00:00.000Z
- Updated: 2026-09-14T18:52:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155179

FDA has released a new [guidance](https://www.fda.gov/media/171592/download?ref=fdaweb.com) entitled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies” that spells out the agency’s intention to not take enforcement actions pursuant to the security requirements until after 11/27/2024\. The requirements were to take effect 11/27/2023.

Under the guidance, the deferred enforcement applies to:

- Section 582(g)(1)(B) of the FD&C Act that requires transaction information to be exchanged, including the product identifier (i.e., the standardized numerical identifier consisting of the NDC and serial number, lot number, and expiration date) at the package level for each package included in the transaction.
- The requirement under section 582(g)(1)(A) that the transaction information and the transaction statements be exchanged in a secure, interoperable, electronic manner in accordance with the standards established.
- The requirement under section 582(g)(1)(C) that systems and processes for verification of products at the package level, including the standardized numerical identifier, be in accordance with the standards established.
- The requirement under section 582(g)(1)(D) for systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the secretary, or other appropriate federal official.
- The requirement under section 582(g)(1)(E) for systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable (i) in the event of a request by the secretary, or other appropriate federal official.
- The requirement under section 582(g)(1)(F) that each person accepting a saleable return have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement for the product.