U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. Drug Supply Chain Integrity
  5. Drug Supply Chain Security Act (DSCSA)
  1. Drug Supply Chain Integrity

Drug Supply Chain Security Act (DSCSA)

Notify FDA of Illegitimate Products

Manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA within 24-hours after determining a product is illegitimate.

Submit Annual Report for Licensure

The law requires wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA.

Sign up for email updates on the Drug Supply Chain Security Act.

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 achieve interoperable, electronic tracing of products at the package level 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. These requirements 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.

Latest Activity

Resources

Contact FDA

If you have questions related to wholesale distributor and third-party logistics provider requirements, email us WDD3PLRequirements@fda.hhs.gov.

If you have other DSCSA-related questions, such as those related to product tracing information, waivers, exceptions and exemptions, and trading partner requirements, email us at drugtrackandtrace@fda.hhs.gov.



Back to Top