Now, don’t get too excited as this likely will not apply to you (see below for more detail for non-small dispensers)! The FDA expects all entities to be fully compliant with the Drug Supply Chain Security Act (DSCSA) by November 27, 2024; however, there are certain exemptions for what the Agency describes as “small dispensers” that may be available to ensure sufficient time to comply with the Act. This is outlined in a newly published document titled Drug Supply Chain Security Act Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Small Dispensers Until November 27, 2026 (here).
Although the majority of participants in the DSCSA are required to be in full compliance with the provisions of the Act and meet the November 27, 2024 deadline as outlined in two compliance guidances that were published in 2023, the “FDA has continued to receive comments and feedback from stakeholders and trading partners, particularly small dispensers, expressing concern with readiness to implement requirements under section 582(g)(1) of the FD&C Act at the conclusion of the stabilization period on November 27, 2024. Specifically, small dispensers have described challenges related to the time, costs, and resources needed to further develop the robust technologies and processes to enable data exchange, establish business relationships with their trading partners, and operationalize business practices.”
So what is a “small dispenser”? According to the FDA, “a dispenser is considered a ‘small dispenser’ if the corporate entity that owns the dispenser has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.” The exemption (if granted) will permit an extension for full compliance until November 27, 2026.
The FDA notes that “[T]he exemptions described in this notification are not intended to provide, and should not be viewed as providing, a justification for delaying efforts by small dispensers to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges small dispensers to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”
Waiver Provisions
“Trading partners that do not qualify for the small dispenser exemptions and are unable to meet the enhanced drug distribution security requirements of section 582 of the FD&C Act by November 27, 2024, may request a waiver or exemption from those requirements” (emphasis added). However, the FDA also notes that the waiver for non-small dispensers should be submitted as soon as possible but not later than August 1, 2024. The FDA further notes that it cannot guarantee that the waiver will be denied or granted prior to the November 27, 2024 deadline for implementation. Don’t expect the FDA to grant many waivers.
So, readers, pay particular attention to which pot you fall into for exemptions or waivers, and understand all of the implications for which you are applying. Additional information on the current provisions and requirements can be found here, and remember that the November 27, 2024 will be here before you know it! Don’t ruin your Thanksgiving celebration by not having all of the requirements of the DSCSA in place or the appropriate exemption or waiver granted by the FDA by then.
