FDA announces compliance policy guidance for drug distribution security

FDA extended the DCSCA Deadline for 2025

Getting your Trinity Audio player ready...

 

In August FDA issued documents for the official extension of DSCSA in order to support the trading partners in meeting upcoming requirements. Furthermore, in October, the FDA issued an exemption from the enhanced drug distribution security requirements for certain eligible trading partners. Discover the exemptions and their role for the various stakeholders.

 

Exemption Overview

 

The issued exemption applies to any product transacted by eligible trading partners, which are trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.

With the release of the exemption, the FDA aims to avoid any supply chain disruptions and ensure patients will not face delays in receiving the medicines they need.

 

 

 

The duration of the exemption varies depending on the eligible trading partners:

 

  • Manufacturers and Repackagers: May 27, 2025
  • Wholesale Distributors: August 27, 2025
  • Dispensers with 26 or more full-time employees: November 27, 2025

 

Trading partners who utilize these exemptions do not need to notify FDA.

 

Check the detailed document that outlines the DSCSA requirements covered by this exemption, as well as the certain eligible trading partners.

 

 

 

Exemption for Small Dispensers and their Trading Partners

 

To support and stabilize the Small Dispensers` operations to fully implement the enhanced drug distribution security requirements of DSCSA, the FDA issued an exemption until November 27, 2026.

 

*A dispenser is considered a small dispenser if the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. Pharmacies must make their own determination of whether they meet the definition of a small dispenser.

 

 

 

Request for Waiver and Exemption

 

Trading partners that do not qualify for the exemptions above and are unable to meet the enhanced drug distribution security requirements by November 27, 2024, may request a waiver, exception, or exemption from those requirements. The FDA announced that will respond to the waiver, exception, or exemption request by November 27, 2024.

 

If you are interested in requesting a waiver/exemption, you could check the following guidance and be aware of what type of data is recommended to include – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act

 

 

 

SoftGroup states that will support you during the journey of becoming DSCSA compliant – do not hesitate to reach us and receive all answers to your questions >>

 

Book a Free Online Consultation

 


Sources:

https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period

https://www.fda.gov/media/182584/download?attachment