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 Become familiar with the law

The Drug Supply Chain Security Act (DSCSA) outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements began at various stages in 2015. The requirements, development of standards, and the system for product tracing will continue to be phased in until 2023. FDA will continue working with trading partners and other stakeholders to effectively implement the requirements.

 Work with your trading partners to ensure they are familiar with the law

It is important that all trading partners understand their responsibilities and work together to help facilitate efficient distribution and availability of drug products in the United States.  

  Provide product tracing information (manufacturers, repackagers, wholesale distributors, and dispensers)

To assist manufacturers, repackagers, wholesale distributors, and dispensers to comply with the new product tracing requirements, FDA has published a draft guidance for industry, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs:  How to exchange product tracing information.

• Accept ownership of product with applicable transaction information, transaction history, and transaction statements.
  • If your trading partner does not provide the proper transaction documentation, work with your trading partner to promptly get the proper documentation and to minimize disruption in the supply chain.

  Know how to handle suspect and illegitimate product (manufacturers, repackagers, wholesale distributors, and dispensers)

To assist manufacturers, repackagers, wholesale distributors, and dispensers to comply with the new verification requirements, FDA published the draft guidance for industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.

• Establish systems to:
  • Quarantine and investigate suspect product to determine if it is illegitimate.
  • Notify FDA and immediate trading partners, if illegitimate product is found.

  Confirm authorized trading partners (manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers)

• Check with your trading partner directly to confirm they are authorized, or
  • For manufacturers and repackagers, check FDA’s drug establishment registration database for registration;
  • For wholesale distributors, third-party logistics providers and dispensers, you can check with your respective state authority to confirm licensure.

Note, third-party logistics providers are considered to be licensed under the DSCSA until the effective date of the third-party logistics provider licensing regulations issued by FDA, unless the third-party logistics provider is licensed by a state having a specific third-party logistics provider licensing program.

  Report licensure (third-party logistics providers and wholesale distributors)

To assist third-party logistics providers and wholesale distributors to comply with the new reporting requirements, FDA published a draft guidance, Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers. The draft guidance outlines the information that should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting using FDA’s CDER Direct Electronic Submissions Portal. FDA posted a webinar that provides an overview of annual reporting requirements.