“Small Dispensers” Receive 2-Year Exemption from Key DSCSA Requirements
Pharmacies received some welcome news in June 2024 when the Food and Drug Administration (FDA) announced “small dispenser exemptions” from certain provisions of the Drug Supply Chain Security Act (DSCSA). The announcement, which only applies to qualified pharmacies, affects provisions of the law that were scheduled to take effect on November 27, 2024. Compliance with those provisions has now been delayed until November 27, 2026.
Pharmacies not eligible for the small dispenser exemption are expected to be in full compliance as scheduled in November 2024.
About The Drug Supply Chain Security Act (DSCSA)
The DSCSA, which was signed into law in 2013, is designed to ensure the safety and integrity of the nation’s pharmaceutical supply chain. The law establishes a national “track and trace” system as a way to validate the legitimacy of prescription drugs and prevent counterfeits and other illicit products from making their way to pharmacy shelves. The law mandates compliance by all stakeholders – manufacturers, wholesalers, distributors, prescribers, and dispensers – to ensure comprehensive accountability throughout the entire supply chain.
The DSCSA was to be implemented over 10 years, with different milestones set to take effect at various intervals. However, as the enormity of the project became apparent, many deadlines were extended. Important to note is that no stakeholder was exempted from any of the law’s provisions. Instead, parties have been given additional time to adapt to the law’s requirements and make adjustments necessary for full compliance.
“Small Dispenser” Qualifications Under The FDA
This includes the June announcement pertaining to small dispensers. That announcement, which was hailed as a “win” by the National Community Pharmacists Association (NCPA) applies to pharmacies with “25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.”
According to an analysis by the National Association of Boards of Pharmacy (NABP), qualified pharmacies are exempt “from using electronic and interoperable methods” for several DSCSA provisions that include:
- Exchanging transaction information and transaction statements with trading partners.
- Conducting product verifications for suspect and illegitimate products.
- Gathering transaction information for recalls at the package level.
- Gathering information to respond to a regulator in circumstances when they identify a suspect or illegitimate product.
“Ultimately,” the NABP analysis notes, “dispensers are still required to do all these things, but they can simply rely on manual or existing methods for the above.”
Exemption Notifications
Pharmacies that qualify under the FDA’s guidance as “small dispensers” must notify all trading partners of their exemption status. The FDA also allowed pharmacies that do not qualify, but that would not be ready in time to meet the November 2024 start date, to apply for a waiver. The application for submitting a waiver request was August 1. All other pharmacies are expected to be in full compliance.
The June announcement follows a decision last year to delay the start date, originally scheduled for November 27, 2023, to November 27, 2024. That postponement, referred to as a “stabilization period,” affected all stakeholders. The FDA will not extend the stabilization period beyond November 2024. The agency’s most recent decision only applies to qualified “small dispensers,” and pharmacies that were granted a waiver.
The FDA’s latest decision reflects what NCPA CEO B. Douglas Hoey has described as the “many complexities associated with implementing DSCA,” and the importance of ensuring pharmacies are given the time needed to ensure accurate and complete compliance.
Conclusion
PrimeRx has produced a white paper, “The Drug Supply Chain Security Act (DSCSA) – Ensuring Full Pharmacy Compliance”, which provides a detailed overview of the legislation, including all pharmacist-related compliance requirements. The discussion also discusses how technology-based solutions, including the PrimeRx pharmacy management system, can help facilitate compliance.
