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 June 1, 2019, USP published revisions to general Chapters <795> for non-sterile compounding and <797> for sterile compounding. General Chapter <825> was introduced for radiopharmaceutical compounding. USP received four (4) appeals from stakeholders who requested further review of the chapters. USP conducted hearings on January 21st and 22nd, 2020, and the results were made public on March 12, 2020.
The appeal to General Chapters <795> and <797> has been granted and the chapters are being remanded back to the Compounding Expert Committee (CMP EC) for more engagement regarding beyond-use dates. The appeal to General Chapter <825> has been denied and asks the appellant to submit a more focused request to the Chemical Medicines Monograph 4 Expert Committee (CHM4 EC). As a result, the current official chapters of <795> (revised in 2014) and <797> (revised in 2008) remain official until further notice.
For more information on this NITR please click here.
For more information please click on this link: USP website.
USP releases finalized <795> and <797> revisions with enforcement date of December 1st, 2019 alongside <800>. The organization also released a newly created standard <825> for Radiopharmaceuticals.
Board of Pharmacy Specialties (BPS) registration for Spring testing was to close on March 20th, 2020. Due to COVID-19 situation please click on this link to stay up-to-date. Registration for Fall testing is scheduled to open May 15th, 2020 and close August 3rd, 2020. For more information please click here. (3/25/2020)
PTCB has announced that all Pearson VUE has suspended test delivery at its US and Canada based center until April 16th, 2020, at the earliest. For all COVID-19 information pertaining to PTCB, please select click here. (3/25/2020)
NHIA is now a PTCB-Recognized Education/Training program for CSPT Certification.