Drug Supply Chain Security Act (DSCSA)

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The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain. This helps prevent harmful drugs from entering the U.S. drug supply chain, detect harmful drugs if they do enter the supply chain and enable rapid response to remove harmful drugs from the supply chain to protect patients.

Visit FDA’s implementation of DSCSA requirements and product tracing for more information.

Latest Activity

• FDA reopened a request for information to better understand the status of trading partners’ interoperable systems and processes for enhanced drug distribution security (June 12, 2024).
• DSCSA waivers and exemptions beyond the stabilization period, June 12, 2024

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DSCSA Portal

Use the DSCSA portal to exchange information with FDA and other trading partners.

Waiver, Exceptions and Exemptions

Request a waiver, exception and exemption from certain DSCSA requirements.

Illegitimate Product Notification

Notify FDA within 24-hours after determining a product is illegitimate.

Annual Reports for Licensure

Wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA.