The FDA recently released a statement1 regarding the upcoming enforcement of section 582 of the FD&C act regarding trading partners.
Section 582 of the FD&C act is FDA’s guidance regarding DSCSA requirements for electronic drug tracing.
Deadline
At this time, the FDA has no plans to extend the stabilization period beyond the previously provided date of November 27, 2024. The FDA will allow small dispensers, and, if applicable, their trading partners, to request an exemption.
Small Dispensers
The FDA defines small dispensers in the case of exemptions as a “company that owns the dispenser [and] has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.”
Exemption Request Deadline
The guidance from the FDA suggests requests for exemption should be submitted prior to August 1, 2024 in order for the FDA to review and grant exemptions by the November deadline, however, those needing an exemption should submit a request as soon as possible to avoid delays.
Trading Partners
Trading partners that do not qualify for this exemption will be required to comply with section 582 of the FD&C act as of November 27, 2024.
For further information regarding section 582 of the FD&C act, please review the complete document found here.
To review the guidance for submitting a request for exemption, please refer to this document.
