USP 797 Pharmaceutical Compounding - Sterile Preparations outlines the minimum standards for preparing compounded sterile preparations (CSPs) for human and animal medications. These standards are designed to ensure the quality of CSPs and to minimize potential harm to patients.
CSPs are distinguished into three categories (1, 2, and 3) based on the following criteria:
· Compounding environment in which the CSP is prepared
· Likelihood of microbial growth
· Time period for use (beyond use date)
Category 2 CSPs:
· Must be prepared in a cleanroom suite
· May be assigned a beyond use date (BUD) of >12 hours at controlled room temperature or >24 hours, if refrigerated, not to exceed the longest permitted BUDs in Table 13
· Requires stability data to support BUD
Personnel Qualification and Environmental Monitoring
Maintaining control of environmental conditions is crucial in a compounding pharmacy. USP requires all personnel who compound or supervise compounding personnel to complete initial competency assessments, followed by ongoing assessments to maintain quality assurance and quality control. Click here to download ARL's Handout on personnel qualification and environmental control requirements.
Release Inspections and Testing
Ensuring the quality characteristics of a sterile compounded preparation is essential for patient safety. USP requires documentation, visual inspections, and release testing to maintain sterility assurance and verify that the preparation meets quality standards before CSPs are released for patient use. Click here to download ARL's Handout on Category 2 Testing requirements.
Release Inspections and Testing | Category 2 USP Testing Requirements |
Antimicrobial Effectiveness Testing | For preservative aqueous multiple-dose CSPs, antimicrobial effectiveness testing must meet USP 51 requirements |
Bacterial Endotoxin Testing | Required for injectable CSPs compounded from one or more nonsterile component(s) and assigned a BUD that requires sterility testing; and, Should be tested for injectable CSPs compounded from one or more nonsterile component(s) and assigned a BUD that does not require sterility testing |
Container Closure Integrity Testing | Required for multidose containers and must pass the container-closure integrity test once for each formulation |
Sterility Testing | Required for CSPs assigned a BUD that requires sterility testing |
Visual Inspection | Must be performed at the completion of compounding and before release and dispensing |
ARL Bio Pharma supports your commitment to patient safety and meeting USP standards. Contact ARL at 800-393-1595 or info@arlok.com to learn more about our testing services and how we can assist with your quality testing requirements.