1. Introduction We comment to request a reconsideration and extension of the current deadline for compliance with the revised USP Chapters <795> and <797> for 503A compounding pharmacies to November 1st, 2024.
2. Reason for Request Due to ongoing and significant challenges faced by the pharmaceutical industry, including extended delays from laboratories in performing stability studies and terminal sterilization, as well as persistent supply chain disruptions, we propose the Board discuss an extension of the deadline to November 1, 2024. These challenges have created a complex operating environment, hindering our ability to comply within the current timeline and will ultimately lead to a negative impact on patient care.
3. Impact of Delays The delays in laboratory services are not only affecting the timely compliance with the new standards but also impacting the overall quality and safety measures that these revisions aim to uphold. Furthermore, supply chain issues have led to a scarcity of critical materials and equipment (agar plates, air samplers, non-viable particle samplers, biological/chemical indicators) necessary for adherence to the revised chapters.
4. Importance of Compliance While we fully support the intent and importance of the USP revisions in ensuring the highest standards of quality and safety in compounding practices, the current timeline imposes considerable strain on our resources and operational capabilities, and ultimately on patient care.
5. Proposed Solution An extension of the compliance deadline to November 1, 2024, would provide the necessary time for compounding pharmacies to adapt effectively to these changes, ensuring that compliance is achieved without compromising on quality or safety standards.
6. Conclusion In light of these challenges, we respectfully request the Board to consider this extension, which we believe is in the best interest of both the pharmaceutical industry and the patients we serve. We appreciate the Board’s understanding and support in these unprecedented times.