DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests.
DSCSA (Drug Supply Chain Security Act): On Wednesday, the US Food and Drug Administration (FDA) announced a two-year extension for small dispensers to comply with the enhanced tracking requirements of the Drug Supply Chain Security Act (DSCSA). Originally set to take effect on November 27, 2024, after a one-year stabilization period, the new compliance date for these entities is now November 27, 2026.
Additionally, the FDA stated it will review requests for waivers or exemptions from other trading partners who are not prepared to implement these systems by November. To be considered, waiver requests must be submitted by August 1, 2024. While the agency aims to decide on these requests by November 27, 2024, it cannot guarantee a decision will be made by that date, but it will make every effort to do so.
In August 2023, the FDA released its final guidance on granting or denying waivers, exceptions, and exemptions (WEE). This guidance permits trading partners to apply for a WEE if they are unable to comply with the DSCSA tracking requirements.
DSCSA
The announcement clearly states that any trading partners, including but not limited to small dispensers, may seek a waiver or exemption if they are unable to comply with the enhanced tracking requirements. It specifies, “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.”
The FDA has received feedback from small dispensers indicating that they are not yet prepared to implement track and trace systems. They have reported difficulties related to the time and costs involved in developing the necessary technologies for data exchange and in establishing business relationships with trading partners.
The additional time will enable small dispensers with fewer than 25 employees to “focus resources and efforts on refining systems and technological infrastructures” to meet these requirements.
Earlier indications suggested that dispensers encountered challenges in implementing electronic systems with their trading partners. According to a 2021 industry survey, it was found that trading partners faced delays in exchanging electronic information. While half of manufacturers and distributors reported exchanging Electronic Product Code Information Services (EPCIS) data, no such exchange occurred between distributors and dispensers (Regulatory Focus, 24 September 2021).
Michael Levy from the FDA’s Office of Compliance in the Center for Drug Evaluation and Research emphasized that the exemption granted should not be seen as a reason for small dispensers to postpone complying with the enhanced drug distribution security requirements outlined in section 582(g)(1) of the FD&C Act. Instead, the FDA encourages small dispensers to continue their efforts to meet these requirements.
Dispensers are still required to confirm that products have a product identifier and are not suspect or illegitimate. They must also ensure that transaction information and statements are exchanged securely and interoperably, and promptly respond to requests for such information.
The Healthcare Distribution Alliance (HDA) expressed support for the FDA’s decision to extend the compliance deadline for dispensers, acknowledging the agency’s efforts to assist the small dispenser community. They indicated their intention to review the announcement further and collaborate with the FDA on future considerations.