With the goal of increasing compounding safety, CriticalPoint, LLC, has launched the Qualified Persons Credentialing Program (QPCP) for pharmacists at entities practicing compounding under sections 503A and 503B of the Drug Quality and Security Act (DQSA), Title I – Compounding Quality Act. NABP strongly believes that these pharmacists should be able to demonstrate knowledge, design sound compounding methodology, and develop effective quality systems in order to supervise such operations. The Association is partnering with CriticalPoint to inform its member boards of pharmacy about the QPCP and how the program may assist the boards in establishing a formal and standardized system for evaluating, educating, and credentialing qualified persons for both 503A and 503B entities. The QPCP is detailed below.
- QPCP 503A (for 503A) provides a uniform credentialing program that can be utilized by interested state boards of pharmacy and NABP by building upon CriticalPoint’s existing Sterile Compounding eLearning curriculum, specific live sterile compounding class lectures, and practicum exercises resulting in the acquisition of specific desired demonstrated knowledge and psychomotor skills.
- QPCP 503B (for 503B) provides a uniform credentialing program that can assist state and federal regulatory agencies in cooperation with NABP to provide the necessary oversight by using a combination of CriticalPoint’s existing Sterile Compounding eLearning curriculum and a five-day live training course titled 503B Outsource Providers: Required Elements of Performance. To be eligible for QPCP 503B, individuals would first have to successfully complete the elements of QPCP 503A.
NABP believes that the QPCP can provide additional assurances for the state boards of pharmacy in regard to the safety of sterile compounding pharmacies and ultimately the public health.