FDA announces broad DSCSA exemptions for trading partners

The US Food and Drug Administration (FDA) announced on Wednesday that it will give firms additional time before it begins enforcing its enhanced distribution security requirements under the Drug Supply Chain Security Act (DSCSA), heeding calls from industry and lawmakers to delay certain aspects of the law’s implementation to avoid potential shortages.

FDA said the exemption “applies to any product transacted by eligible trading partners … who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data." The move is the latest in a series of enforcement delays related to DSCSA in more than a decade since its enactment.

While FDA said that trading partners have made “considerable progress with implementing enhanced drug distribution security requirements and initiating their systems and processes,” it continues to hear from stakeholders that more time is needed to fully implement their electronic data exchange systems and to work out the bugs before enforcement begins.

As such, FDA said it is issuing the exemption “to avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need.”

Under the policy, manufacturers and repackagers will have until 27 May 2025 to comply with the enhanced distribution security provisions of the law, while wholesale distributors and dispensers with 26 or more full time employees will have until 27 August 2025 and 27 November 2025, respectively, to comply. The agency also said that firms do not need to notify it that they will use these exemptions.

FDA laid out the specific DSCSA requirements that will fall under the exemption policy in a document accompanying the announcement. For example, FDA will exempt manufacturers and repackagers from the following DSCSA requirements until 27 May 2025:

Transacting information with trading partners in a secure, interoperable, electronic manner under section 582(g)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act);
The requirement for a product identifier at the package level to be included in the transaction information under section 582(g)(1)(B) of the FD&C Act;
The requirement for verification of the product at the package level according to the standards and guidance established by FDA under section 582(g)(1)(C) of the FD&C Act;
The requirement for establishing systems and processes to promptly respond to a request for a from public health officials for the transaction information and transaction statement in the event of a recall or an investigation into a suspect or illegitimate product under section 582(g)(1)(D) of the FD&C Act;
The requirement for establishing systems and processes to facilitate the gathering of information necessary to produce transaction information upon request by public health officials or by authorized trading partners; and
For entities who accept saleable returns, the requirements for having systems and processes in place for accepting such products and associating the products with the relevant transaction information and transaction statement.

The guidance also lays out the specific exemptions applicable to wholesale distributors and dispensers with 26 or more full time employees.

This step-wide approach to implementing DSCSA has been advocated by industry groups, such as the Healthcare Distribution Alliance (HDA). (RELATED: HDA, NACDS call on FDA to grant DSCSA reprieve for distributors and dispensers, Regulatory Focus 20 August 2024)

This action comes on the heels of letter sent this week by members of Congress to FDA, urging the agency to establish a broad category of exemptions for specific products or transactions from complying with the enhanced tracing requirements under the law to allow more time for trading partners to stabilize data exchange and prevent drug shortages once the law takes effect this 27 November. (RELATED: Lawmakers urge FDA to consider broad exemptions from DSCSA to minimize supply chain disruptions, Regulatory Focus 8 October 2024)

FDA, Policy

FDA announces broad DSCSA exemptions for trading partners

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