US: FDA’s DSCSA Exemptions, Waiver, & Exception

FDA’S Exemptions Granted to Trading Partners

The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the Drug Supply Chain Security Act (DSCSA) to ease the compliance burden for eligible trading partners within the pharmaceutical supply chain. Eligible trading partners were referred to those who have completed or made documented efforts to complete data connections with their immediate trading partners but still face challenges exchanging data.

The key purposes of the exemption are to ensure patient access to medicines without disruptions and to offer a bridge for smooth progress toward full DSCSA implementation.

Important dates to note for trading partners who qualify for the exemption:

• Manufacturers and Repackagers: Exemption lasts until 27 May 2025

• Wholesale Distributors: Exemption lasts until 27 August 2025

• Dispensers with 26 or more full-time employees: Exemption lasts until 27 November 2025

  
  

Impact on the Supply Chain

This exemption reflects the FDA’s understanding of the complexities that trading partners face in achieving full compliance with the DSCSA requirements. With extra periods for partners to establish seamless data exchanges, the FDA ensures that patient access to critical medications is not disrupted. This flexibility was also vital for maintaining the security and efficiency of the pharmaceutical supply chain as trading partners work toward full compliance.

FDA’s Exemptions to Small Dispensers for DSCSA Compliance

These exemptions will be in effect until 27 November 2026 giving small dispensers additional time to fully comply with the enhanced drug distribution security requirements outlined in the DSCSA.

For these exemptions, a dispenser is classified as a small dispenser, if, by 27 November 2024, the company that owns the dispenser employs 25 or fewer full-time staff licensed as pharmacists or qualified pharmacy technicians. The responsibility lies with the pharmacies to ensure they correctly classify their operations as small dispensers.

Any small dispensers and their trading partners who utilize these exemptions do not need to notify the FDA or submit any documentation to utilize this additional period.

How to Request a Waiver, Exception, or Exemption

Trade partners should be aware that 27 November 2024 is the deadline for compliance with the enhanced drug distribution security requirements under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). If any trading partners are unable to meet the DSCSA requirements, they may request a waiver, exception, or exemption from the FDA.

It is important to note that submitting a request does not automatically grant relief, pause, or extended period from compliance. While waiting for the FDA’s response, trading partners are expected to continue making every effort to meet the enhanced security requirements.

Overall, pharmacies and trade partners were advised to take this time to assess their readiness and make any necessary adjustments to their procedures to meet these important security standards by the revised deadline. Hence, the pharmaceutical industry can continue making strides toward a secure and efficient drug supply chain, ensuring that patients receive their medications without disruption.

Source: US Food Drug and Administration (US FDA)