Medication Compounding Certification Fact Sheet
- The Joint Commission began offering Medication Compounding Certification in 2017.
- The program was developed in response to patient safety and quality events related to medication compounding, including a multistate meningitis outbreak in 2012 that stemmed from a contaminated compounded injectable medication.
Serious events involving medication compounding have led many state legislatures and boards of pharmacy to enhance their laws and regulations regarding compounding pharmacies (any physical pharmacy that is licensed to mix or “compound” chemical ingredients into a finished medication).
Medication Compounding Certification is open to all compounding pharmacies operating in or shipping to states with regulations that require compliance with United States Pharmacopeial Convention (USP®) General Chapters 797 (process, testing, and verification of compounded sterile preparations), 795 (nonsterile preparations), and 800 (practice and quality standards for hazardous drugs).
The certification program is awarded for a two-year period and is designed to help organizations:
- Reduce risk and harm.
- Ensure USP standards compliance related to the process, testing and verification of compounded sterile and nonsterile preparations.
- Find and fix gaps in policies and procedures, focusing on:
- People: Training, competency, proper use of personal protective equipment and aseptic technique.
- Product: Sterility of base products, expiration dates and labeling.
- Environment: Airflow, buffer areas, guidelines for cleaning and documentation, and storage.
- Demonstrate excellence through complying with both Joint Commission and USP standards.
The Medication Compounding Certification Program was developed with assistance from technical advisory panels, in-depth environmental assessments and strategic leadership meetings with industry experts within and outside The Joint Commission.