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# Interoperable Info Exchange Guidance
- URL: https://www.fdaweb.com/interoperable-info-exchange-guidance/
- Published: 2023-09-05T12:00:00.000Z
- Updated: 2026-09-14T18:54:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155246

FDA has published a guidance, *DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs*, to identify the standards necessary to facilitate the adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain. The [document](https://www.fda.gov/media/171796/download?ref=fdaweb.com) also clarifies the trading partners, products, and transactions subject to the standards.

The guidance finalizes policies in a 7/2022 revision of an 11/2014 draft guidance to reflect the enhanced drug distribution security requirements that take effect under the Drug Supply Chain Security Act on 11/27/2023, including that only electronic methods of product tracing will be permitted and verification of product at the package level will be required, unless a waiver, exception, or exemption applies. It also makes changes to improve clarity.