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 and the Partnership for DSCSA Governance (PDG) will host three town halls on DSCSA implementation efforts in 2025. Interested parties are invited to attend any or all town halls. The town halls will be virtual from 1 to 3 p.m. ET on the following dates:
  • March 26, 2025: Progress toward end of manufacturer exemption
  • June 25, 2025: Progress toward end of wholesale distributor exemption
  • September 24, 2025: Progress toward end of dispenser exemption

Review DSCSA and FDA policies

Find information for pharmacists

Learn about our private-public partnership

Engage with FDA

Submit Information to FDA

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.