Video
In this webisode, Scott Mooney discusses McKesson’s response to the FDA compliance policy announcement and the actions you should take to prepare for DSCSA implementation.
Statement as of October 2024
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, which is available at https://www.fda.gov/media/182584/download?attachment, 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:
- For manufacturers and repackagers, May 27, 2025.
- For wholesale distributors, Aug. 27, 2025,
- For dispensers with 26 or more pharmacists and technicians, Nov. 27, 2025.
- Dispensers with 25 or fewer pharmacists and technicians were previously exempted until November 2026. Here is the link to the full FDA exemption announcement for small dispensers.