- What to expect for DSCSA going forward
What to expect for DSCSA going forward
7 min read
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:
- 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.
Required as of Nov. 27, 2025
• GLNs (Sold To & Ship To) on file with McKesson for new & existing accounts to receive serialized level transaction data
• Dual electronic DSCSA transaction reporting at current lot level and new serial level. (NOTE: depending on shipping DC, not all customers will see serial level detail on Nov. 27, 2025).
• Enforcement of package-level tracing requirements.
• Written SOP that details your DSCSA processes including identifying and reporting suspect product
Prior to August 27, 2025
• GLNs (Sold To & Ship To) on file for existing accounts specifically for product ordering (NOTE: At this time, McKesson will not hold or cancel orders based on DSCSA requirements.)
• Serialized requirement on saleable returns to McKesson (NOTE: At this time, customers must continue to attest to purchasing product from McKesson on any saleable return)
In Process during Wholesale Distribution Exemption
Serialized electronic records for all McKesson to customer sales
EPCIS records will get closer to 100% as manufacturers provide full data and as all McKesson DCs are able to scan 100% of outbound products. • ATTP will reflect some serialized data for some customers, depending on shipping DC. Some customers may not see any serialized data.
• Existing transaction report (T3) remains available through stabilization period (transaction information, transaction history, & transaction statement)
• McKesson portals (SupplyManagerSM) will populate the serialized data field. Access your portal as you do today for lot level detail.
• If using third-party data connection, complete enrollment process by contacting your Sales representative
• If applicable, establish connection for third-party EPCIS vendors
• Follow existing practices for quarantining lot level product.
• Serialized product quarantine practice delayed until saleable return process is fully outlined and communicated.