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14 January 20255 minute read

Certain DSCSA deadline extensions set to eclipse in 2025

Overview of the DSCSA

The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion incidents, including the 2008 case of adulterated heparin.

Enacted on November 27, 2013, the DSCSA is designed to safeguard the US drug supply chain against counterfeit products by tracking and tracing certain prescription drugs at the package level through a valid chain of custody as they move through the supply chain.

The DSCSA applies to trading partners in the drug distribution system, which includes manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies), and third-party logistics providers. This “track-and-trace” system aims to prevent counterfeit, contaminated, stolen, or otherwise harmful prescription drugs from entering the US drug supply chain; detect such drugs if they do enter the supply chain; and enable trade partners to quickly respond and remove such drugs from the supply chain.

The DSCSA was implemented through the following phased-in approach:

  • Lot/batch-level tracing phase: Beginning in 2015, trading partners were required to provide and receive transaction documents at the lot level.

  • Serialization phase: Beginning on November 27, 2017, manufacturers and repackagers were required to encode product identifiers on the smallest salable units of prescription drugs and pharmaceutical products.

  • Enhanced drug distribution security phase: Beginning on November 27, 2023, trading partners were expected to implement an enhanced level of security, featured by an electronic, interoperable system that identifies and traces certain prescription drugs at the package level as they are distributed in the US.

Recent developments

One-year stabilization period ended November 2024

The enhanced drug distribution security requirements went into effect on November 27, 2023. After the industry raised overwhelming concerns, the Food and Drug Administration (FDA) issued two guidance documents, establishing a one-year stabilization period to provide trading partners in the drug supply chain additional time to implement, troubleshoot, and mature their electronic interoperable systems required by the DSCSA. During this stabilization period, no enforcement action was implemented for the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. This stabilization period ended on November 27, 2024.

On October 9, 2024, upon receiving continued concerns from stakeholders, the FDA issued broad exemptions to meet enhanced drug distribution security requirements for certain trading partners. These temporary exemptions are not meant to enable intentional delays in compliance, but to provide additional time to troubleshoot and ensure uninterrupted product distribution. As noted in the October 9 exemption notice, the exemptions only apply to “trading partners who have initiated their systems and processes, including electronic DSCSA data connections, to strengthen capabilities to address challenges with data exchange, quality and reliability.” Similar to the implementation of the DSCSA, the exemptions will be phased in. The specific compliance deadlines depend on the role of the entity, as listed below:

  • Manufacturers and repackagers: May 27, 2025

  • Wholesale distributors: August 27, 2025

  • Dispensers with 26 or more full-time employees: November 27, 2025

These exemptions are limited to the enhanced drug distribution security requirements, and trading partners are expected to meet other obligations and requirements under the DSCSA, such as interoperability requirements. In addition, the FDA exempts small dispensers – defined as any entity with 25 or fewer full-time employees – and certain small business dispensers’ trading partners from certain requirements in section 582 of the FD&C Act until November 27, 2026. This exemption allows additional time needed by small business dispensers to fully transition to interoperable, electronic product tracing at the package level under the DSCSA.

Entities impacted by these exemptions

The FDA offered these exemptions to support the continued implementation of the DSCSA without disrupting patient access to their medications. Trading partners throughout the supply chain, including manufacturers and repackagers, wholesale distributors, and dispensers, could be impacted by this exemption if eligible. Importantly, eligible entities who rely on the temporary exemptions do not need to submit a notification or request for a waiver or exemption to the FDA. Trading partners that are not eligible for any of the exemptions and are facing difficulties with complying with DSCSA requirements may apply for a waiver, exception, or exemption as provided in the DSCSA and in FDA guidance.

Looking ahead

The DSCSA is a comprehensive statutory system designed to improve the safety of the pharmaceutical supply chain by tracking, tracing, and verifying prescription drugs distributed in the US. Congress initially projected that it would take ten years to fully implement all the statutory requirements. Yet, the implementation was delayed multiple times due to various issues faced by both the agency and trading partners. Stakeholders are encouraged to monitor the relevant FDA agency actions, including DSCSA policies and guidances, public hearing, and webinars to navigate the complicated statutory obligations and enforcement policies. If trading partners and other relevant entities have other challenges meeting the new deadlines, early communication with the FDA is highly recommended. For example, the FDA had previously indicated a firm stance that the November 2024 stabilization period would not be extended. However, during the PDG-FDA Joint Public Meeting in June 2024, the FDA learned the challenges that stakeholders face and eventually granted certain extensions to accommodate the industry’s concerns.

If you have any questions about the DSCSA, please contact the authors or your DLA Piper relationship partner.

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