Drugs

Are you ready for the Drug Supply Chain Security Act?

Become familiar with the law

There are new requirements under the Drug Supply Chain Security Act (DSCSA) 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 new 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 new 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)

Start Date

Trading Partner(s)

Requirement

7/1/2015 (DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy Guidance, issued 6/30/2015, announced FDA’s intention not to take action against dispensers under certain circumstances, prior to November 1, 2015. DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised), issued 10/28/2015, announced FDA’s intention to extend the Compliance Policy to 3/1/2016.)

Dispensers (primarily pharmacies)

Lot-level product tracing: provide transaction information, history, and statement

1/1/2015 (DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for Industry, issued 12/2014, announced FDA’s intention not take action against manufacturers, wholesale distributors, or repackagers who did not, prior to May 1, 2015, provide or capture the product tracing information required by sections 582(b)(1), (c)(1), and (e)(1) of the FD&C Act.) 

  • Manufacturers
  • Repackagers
  • Wholesale distributors

Lot-level product tracing: provide transaction information, history, and statement

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wholesale distributors, and dispensers to comply with the new product tracing requirements, FDA has published a draft guidance for industry, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs:  How to exchange product tracing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 (November 2014).

  • 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)

Start Date

Trading Partner(s)

Requirement

1/1/2015

  • Manufacturers
  • Repackagers
  • Wholesale distributors
  • Dispensers (primarily pharmacies)

Establish systems for verification and handling of suspect or illegitimate product.

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 (June 2014). FDA posted a webinar that reviews how to identify suspect product and the process for 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)

Start Date

Trading Partner(s)

Requirement

1/1/2015

  • Manufacturers
  • Repackagers
  • Wholesale distributors
  • Dispensers
  • Third-party logistic providers

Must be authorized, as defined by the FD&C Act

  • 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 logistic providers and dispensers, you can check with your respective state authority to confirm licensure.

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

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

Start Date

Trading Partner(s)

Requirement

1/1/2015

Wholesale distributors

Report licensure and other information to FDA

11/27/2014

Third-party logistics providers

Report licensure and other information to FDA

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 (December 2014). 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.

For more information about DSCSA implementation and new requirements to enhance drug distribution security, please visit FDA’s Drug Supply Chain Security Act web page.

Page Last Updated: 03/01/2016
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