What is DSCSA?

The DSCSA sets rules for trading partners in the drug supply chain. It started in 2014 and will be fully implemented by 2023. FDA collaborates with partners for effective implementation.

All trading partners must comprehend their responsibilities and collaborate to ensure efficient distribution and availability of drug products in the United States.

Take responsibility for products along with relevant transaction information, history, and statements. If a trading partner fails to provide necessary transaction documentation, collaborate promptly to obtain the required documentation and minimize disruptions in the supply chain.

Implement systems to:

• Isolate and investigate suspicious products to verify it's legitimacy.
• Inform the FDA and immediate trading partners promptly upon identification of illegitimate products.

Directly confirm the authorization of your trading partner.

Wholesale distributors and third-party logistics providers (3PLs) must report their licensing information to FDA on an annual basis.