HIDA Regulatory Insights

2023 Fully Interoperable And Electronic Pharmaceutical Traceability Requirements – Are You Ready?

The second phase of the Drug Supply Chain Security Act (DSCSA) will go into effect November 27, 2023 and requires the interoperable, electronic tracing of pharmaceutical products at the package level. (Currently, the DSCSA generally requires products to be traceable at the lot level.) The 2023 requirements, which apply to any wholesale distributor that sells pharmaceutical products, are comprised of three specific, but highly interrelated statutory components:

  1. Interoperable Exchange. Trading partners must exchange required transaction information (TI) and transaction statements (TS) in a secure, electronic, interoperable manner, and the TI must include the product identifier at the package level.
  2. Interoperable Verification. Trading partners must be able to verify the product identifier on a package or sealed homogenous case in a secure, electronic, interoperable manner.
  3. Interoperable Tracing. Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.

As the second phase of the DSCSA is self-effectuating (meaning there will not be a final implementation regulation from FDA), a group of industry stakeholders has worked together through the Partnership for DSCSA Governance to provide a blueprint for the 2023 interoperable and electronic system. This resource can be accessed here.

DSCSA 2023 Checklist

1. Familiarize yourself with the law

The DSCSA outlines requirements for manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). The requirements, development of standards, and the system for product tracing will continue to be phased in until 2023.

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

All trading partners need to understand their responsibilities and work together to help facilitate efficient distribution and availability of drug products in the United States.

3. Provide product tracing information (this applies to manufacturers, re-packagers, wholesale distributors, and dispensers). Do you have processes in place to trace the product?

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.

4. Know how to handle suspect and illegitimate product (this applies to manufacturers, re- packagers, wholesale distributors, and dispensers). Do you have standard operating procedures in place to identify as suspect or illegitimate product at your pharmacy?

Establish systems to quarantine and investigate suspect product to determine if it is illegitimate and notify FDA and immediate trading partners if illegitimate product is found.

Consider the following:

  • Do you quarantine and investigate suspect prescription drugs to determine if illegitimate?
  • If the product is illegitimate, do you work with manufacture to take steps to prevent it from reaching patients?
  • Do you store records of the investigation of suspect product for at least 6 years?

5. Confirm authorized trading partners (this applies to manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics providers)

Check with your trading partner directly to confirm they are authorized. Or:

  • For manufacturers and re-packagers, check FDA’s drug establishment registration database for registration;
  • For wholesale distributors, third-party logistics providers, and dispensers, check with your respective state authority to confirm licensure.

6. Report licensure (this applies to 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. It 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.

Additional Background and Resources

Enacted November 27, 2013, the DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The DSCSA helps protect consumers from exposure to drugs that may be counterfeit, stolen, or contaminated and improves detection and removal of potentially dangerous drugs from the drug supply chain.

By 2023, the DSCSA aims to implement interoperable, electronic tracing of pharmaceutical products that will:

  • Enable secure tracing of product at the package level
  • Use product identifiers to verify product at the package level
  • Enable prompt response to suspect and illegitimate products when found
  • Improve efficiency of recalls

Additionally, the DSCSA’s goal is to establish national standards for licensure for wholesale distributors and third-party logistics providers (3PLs).

For more information, please refer to the following:

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