How often should sterility testing be conducted for compounded sterile preparations?

Sterility testing for compounded sterile preparations is essential to ensure the safety and effectiveness of these medications. Conducting sterility testing based on a predetermined schedule defined in Standard Operating Procedures (SOPs) establishes a regular and systematic approach to quality assurance. This method not only helps in identifying potential contamination before the products are distributed but also ensures compliance with regulatory standards set forth by USP 797.

A predetermined schedule allows for adequate testing of each batch of compounded preparations in a controlled environment. It also enables the compounding facility to maintain a consistent quality assurance process, mitigating risks associated with microbial contamination.

Sterility testing only when a complaint arises does not provide a proactive strategy for ensuring product safety, while once a year testing may not be frequent enough to catch potential issues in a timely manner. Testing after the product reaches its expiration date is ineffective since any contamination would already compromise the safety of the preparation. Regular testing as defined in SOPs is the best practice for maintaining the integrity of compounded sterile preparations.