DSCSA and FDA

The Drug Supply Chain Security Act (DSCSA) and the FDA

The DSCSA has ramifications for companies in the pharmaceutical supply chain. This includes, and is not limited to, manufacturers, repackagers, drug wholesalers, third-party logistics providers (3PL), and others.

According to the FDA:

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.

Source: Drug Supply Chain Security Act (DSCSA) webpage on the FDA website

Additional Resources:

• Drug Supply Chain Security Act (PDF)
• Are you ready for the Drug Supply Chain Security Act? (an FDA webpage)
• Implementation Guideline - Applying the GS1 Lightweight Messaging Standard for - DSCSA Verification of Returned Product Identifiers - by GS1 Healthcare US (PDF)