You may have seen last week that FDA determined that pharmacies and other small dispensers (a corporate entity that owns the dispenser has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians) are exempt from certain DSCSA interoperable system requirements until Nov. 27, 2026. This follows NCPA’s continued and consistent advocacy efforts on this issue, spanning more than 10 years. For FDA’s full announcement, see here, but we’ll break it down for you.
NCPA members who meet the small dispenser definition with 25 or fewer full-time employees licensed as pharmacists or qualified as technicians will be exempt from the requirements to use systems for interoperable exchange of tracing data, the requirement to receive package-level tracing data, the requirement to verify the product identifier on suspect or illegitimate product in your control, and a few other requirements related to having interoperable systems for exchanging tracing data, but only until November 2026.
FDA stated that these exemptions are not intended to provide and should not be viewed as providing a justification for delaying efforts by small dispensers to requirements under the DSCSA. NCPA has resources for members to ensure they comply with the other aspects of DSCSA that are enforceable today and for use in preparing for the end of this small dispenser exemption in November 2026. Download the DSCSA Checklist and learn about DSCSA360.
For those who meet the small dispenser exemptions, no further action is needed. Additionally, FDA is reminding trading partners, including pharmacies, that the DSCSA one-year stabilization period ends on Nov. 27, 2024. The agency is not extending the stabilization period beyond this date.
Trading partners including pharmacies who 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 Nov. 27, 2024, may request a waiver or exemption from those requirements. Although requests can be submitted at any time, the FDA recommends trading partners submit a waiver or an exemption request by Aug. 1, 2024. The agency cannot guarantee it will grant or deny the waiver or exemption by Nov. 27, 2024, but will make every effort to do so. For details, click here.
