Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA

This FAQ guide was prepared by GS1 US® and the GS1 Healthcare US® Secure Supply Chain Workgroup to assist the U.S. pharmaceutical industry in implementing GS1 Standards to support the requirements of the U.S. Drug Supply Chain Security Act (DSCSA). It was developed using information obtained from a wide variety of members of the U.S. pharmaceutical supply chain from manufacturers to providers.*

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*For information about the act, see the 2013 Drug Supply Chain Security Act

For information on the delay enforcement, see the FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. June 30, 2017

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.