FDA grants small dispensers two-year delay for DSCSA tracking rules, opens door for exemption requests

The US Food and Drug Administration (FDA) on Wednesday announced it will grant small dispensers a two-year extension for complying with the enhanced tracking requirements for drugs under the Drug Supply Chain Security Act (DSCSA). These systems were supposed to go live on 27 November 2024 after a one-year stabilization period and will now go into effect on 27 November 2026 for applicable entities.

FDA also announced it will consider waiver or exemption requests from other trading partners that are not ready to implement these systems by November. All waiver requests should be submitted by 1 August 2024 to be considered. The agency notes that it “cannot guarantee it will grant or deny the waiver or exemption by November 27, 2024, but will make every effort to do so.”

FDA’s final guidance on granting, or denying waiver, exceptions and exemption (WEE) allows trading partners to request a WEE if they are not ready to meet the DSCSA tracking requirements; the final guidance was issued in August 2023. (RELATED: FDA finalizes guidance on DSCSA waivers, exceptions and exemptions, Regulatory Focus 7 August 2023)

The announcement explicitly states that all trading partners, not just small dispensers, may request a waiver or exemption if they are unable to meet the enhanced tracking requirements. “Trading partners that do not qualify for the small dispenser exemptions and are unable to meet the enhanced drug distribution security requirements of section 582 of the FD&C Act by November 27, 2024, may request a waiver or exemption from those requirements.”

FDA received feedback from small dispensers who expressed a lack of readiness in implementing track and trace systems and cited challenges related to the time and costs related to developing the technologies to enable data exchange and establishing business relationships with trading partners.

The additional time will allow small dispensers with less than 25 employees to “focus resources and efforts on refining systems and technological infrastructures” to comply with these requirements.

There were earlier signs that dispensers were having problems implementing electronic systems with their trading partners. A 2021 industry survey found that trading partners were lagging in exchanging electronic information with each other; while half of manufacturers and distributors said they were exchanging Electronic Product Code Information Services (EPCIS) data with each other, this data was not being exchanged at all between distributors and dispensers. (RELATED: Pharmaceutical trading partners lagging in exchanging product information, Regulatory Focus 24 September 2021)

FDA’s Michael Levy, deputy director of the Office of Compliance (OC) in the Center or Drug Evaluation and Research (CDER) said the exemption is “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by small dispensers to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act.”

Instead, the agency “strongly urges small dispensers to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”

Dispensers will still have to verify that the product has a product identifier, and that the product is not suspect or illegitimate; that the transaction information and the transaction statements have been exchanged in a secure, interoperable manner; and promptly respond to requests for transaction information and transaction statements.

The Healthcare Distribution Alliance (HDA) said it supports FDA’s action granting more time to dispensers. “HDA appreciates the FDA’s efforts to support the small dispenser community. We will continue to analyze the announcement and engage with the FDA on further considerations soon.”

FDA announcement; Policy for small dispensers

FDA grants small dispensers two-year delay for DSCSA tracking rules, opens door for exemption requests

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