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# DSCSA ‘Enhanced System’ Draft Guidance Explained
- URL: https://www.fdaweb.com/dscsa-enhanced-system-draft-guidance-explained/
- Published: 2021-07-15T12:00:00.000Z
- Updated: 2026-09-14T17:06:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149719

A 6/2021 FDA draft guidance clarifies the enhanced system requirements listed in the Drug Supply Chain Security Act (DSCSA) and gives recommendations on the system attributes necessary for enabling the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation as necessary. A Winston & Strawn [analysis](https://www.winston.com/en/thought-leadership/fda-publishes-guidance-on-the-enhanced-system-under-the-dscsa-going-into-effect-on-november-27-2023.html?utm%5Fsource=Mondaq&utm%5Fmedium=syndication&utm%5Fcampaign=LinkedIn-integration) of the draft says the new requirements take effect 11/27/23 and manufacturers may benefit from planning to engage in internal assessments of current supply chain readiness.

The paper says the DSCSA outlines critical steps for building an electronic, interoperable system by 11/27/23 that will identify and trace certain prescription drug products as they are distributed within the U.S.

System attributes that FDA views as important in promoting drug distribution security are given in the act as: 

- the exchange of transaction information and statements in a secure, interoperable, electronic manner;
- transaction information that includes the data elements of the product identifier at the package level for each package included in the transaction;
- systems and processes for verification of product at the package level;
- systems and processes necessary to promptly respond with the relevant transaction information and transaction statement for a product upon request by FDA or other appropriate federal or state official in the event of a recall or to investigate a suspect product or an illegitimate product;
- systems and processes necessary to promptly facilitate gathering information necessary to produce the transaction information for each transaction going back to the manufacturer on request by FDA or other appropriate federal or state official in the event of a recall or for investigating a suspect or illegitimate product; and
- systems or processes to associate a saleable return product with its applicable transaction information and statement to allow a trading partner to accept the returned product.