NHIA's Sterile Compounding Clinic
NHIA’s Sterile Compounding ACT is the definitive training program for Sterile Compounding competency, including what you need to know about the revised USP General Chapter <797> and is a must-have resource for <797> designated persons. The training is a must-have resources for all clean rooms and especially for <797> designated persons.
The preparation of compounded sterile preparations (CSPs) in compliance with federal, state, and industry standards is a core function of home infusion pharmacy practice. Patients rely on the expertise of home infusion providers to ensure medications are prepared in a sterile, accurate, and safe manner.
Home infusion providers must be aware of changing standards and regulations related to the professional practice of sterile compounding in order to remain in good standing with regulating bodies, and to ensure operating procedures are adequate to protect patients and employees.
NHIA strives to ensure all stakeholders are informed of the latest trends in sterile compounding regulatory and standard-setting activities, and regularly posts updated information on this site.
Oversight for sterile compounding practice falls primarily to the states and is typically governed by the individual state’s board of pharmacy, however the Food and Drug Administration (FDA) also maintains authority to inspect pharmacies for insanitary conditions. In some states, the Board of Medicine (or similar entity) regulates sterile compounding that occurs in physician offices. Most pharmacies maintain active accreditation from an agency that performs rigorous inspections for compliance with state laws and internal policies. Majority of state laws and accreditation standards are based on the principles outlined in the U.S. Pharmacopeial Chapter <797> Pharmaceutical Compounding – Sterile Preparations.
On November 1, 2022, USP published the final version of USP General Chapter <797>. This long-awaited chapter is the core the drives the home infusion industry in setting the standard for sterile compounding practices. The implementation date for the new chapter is November 1, 2023.
Complying with the 2022 Version of USP General Chapter <797>
Abby Roth of Pure Microbiology highlights the major changes to USP General Chapter <797>, focusing on beyond-use dating, personnel training and competencies, viable sampling, and quality management. Nuance changes that significantly impact sterile compounding operations will also be discussed.