Communications

(Oct. 18, 2024) – On Oct. 9, the Food and Drug Administration issued exemptions from the upcoming Nov. 27, 2024, compliance deadline for the U.S. Drug Supply Chain Security Act requirements. The updated exemptions from the FDA do NOT change the following requirements for pharmacies:

• Know your drug suppliers and ensure they are authorized trading partners.
• Know where your product tracing or transaction information (data) is stored and how to access it.
• Know what the suspect product is, how to identify and investigate it and what to do if it is deemed illegitimate.
• Policies and procedures for prescription drug purchasing and investigations for suspect or illegitimate products.

According to the FDA's announcement this week, the FDA continues receiving feedback from trading partners regarding readiness to adequately meet the Food Drug and Cosmetic Act requirements by the Nov. 27, 2024, compliance deadline. The FDA recognizes that trading partners who have initiated their systems and processes and have established electronic DSCSA data connections with their trading partners may need additional time beyond Nov. 27, 2024, when the stabilization period ends, to strengthen capabilities to mitigate data issues associated with electronic DSCSA transaction information and transaction statements and to ensure uninterrupted product distribution. The FDA's notification outlines exemptions for manufacturers, repackagers, wholesale distributors and dispensers with 26 or more full-time employees.

Review the FDA's Oct. 9 notice of exemptions to the DSCSA for detailed information about exemptions. KHA will monitor compliance requirements and exemptions and their impact on hospital pharmacies, communicate with the Board of Pharmacy and continue to provide updates to KHA members.
--Karen Braman