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# 2 Draft DSCSA Guidances Out
- URL: https://www.fdaweb.com/2-draft-dscsa-guidances-out/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152230

FDA has published two draft guidances covering portions of the Drug Supply Chain Security Act (DSCSA). The first guidance, *DSCSA Standard for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs,* identifies 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/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs?ref=fdaweb.com) also clarifies the trading partners, products, and transactions subject to such standards.

The guidance revises an 11/2014 draft to update the policy articulated in that draft to reflect enhanced drug distribution security requirements that take effect 11/27/23.

The second [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/identifying-trading-partners-under-drug-supply-chain-security-act?ref=fdaweb.com), *Identifying Trading Partners Under the Drug Supply Chain Security Act*, is to assist industry and state and local governments in understanding how to categorize the entities in the drug supply chain under the act. The document revises an 8/2017 guidance to address the status of some entities as trading partners, provide clarification on certain drug distribution scenarios, and address the interpretation of a section of the law that discusses third-party logistics providers’ licensure status before the effective date of forthcoming regulations establishing licensure standards.