On Oct. 9, 2024, the Food and Drug Administration (FDA) announced new deadlines for DSCSA compliance for eligible manufacturers, distributors and pharmacies (FDA Exemption). The FDA Exemption describes criteria and conditions for manufacturers, distributors and pharmacies to be eligible for new deadlines for DSCSA compliance.
The FDA Exemption applies to in-scope products transacted by “eligible trading partners,” as described and subject to the conditions in the FDA Exemption. McKesson intends to utilize the FDA exemption as a wholesale distributor, as permitted by the FDA exemption.
FDA Granted Exemptions
For eligible trading partners that meet the FDA Exemption’s conditions, the FDA granted exemptions from certain DSCSA requirements until the following dates:
Dispensers with 25 or fewer pharmacists and technicians were previously exempted until November 2026.
