GDP in the US: Drug Supply Chain Security Act (DSCSA) - Recent Updates

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

In the US, there has been a lot going on in the area of Good Distribution Practice (GDP) in the recent weeks and months.

The United States Pharmacopeia (USP) is continuing its efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices. The U.S. Food and Drug Administration (FDA) has published several new documents related to the Drug Supply Chain Security Act (DSCSA).

Background

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013. It outlines steps to achieve electronic tracing of products at the package level to identify and trace certain prescription drugs. The DSCSA also directs the FDA to establish national licensure standards for wholesale distributors and third-party logistics providers.

Track and Trace

The DSCSA distribution security requirements will come into effect in November next year. In July 2022, the FDA announced the availability of revised versions of two previously published draft guidances to help trading partners comply with the DSCSA:

• DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, Revised Draft Guidance
• Identifying Trading Partners Under the Drug Supply Chain Security Act, Revised Draft Guidance

According to the FDA, "these documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on November 27, 2023." Comments can be submitted until September 5, 2022.

Overview of Drug Supply Chain Security Act Law and Policies

Since the DSCSA was enacted in 2013, the FDA has issued a couple of guidance and policy documents - as the overview "Drug Supply Chain Security Act Law and Policies" shows.