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Sterility Testing for Compounded Sterile Preparations

The process of sterility testing for compounded sterile preparations, including the use of USP Sterility Tests and related lot-testing expectations.

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Jan 31, 2026

What quality control, sterility, and testing standards (USP <797>, <71>, lot testing) apply to pharmacies compounding injectable tirzepatide?

Pharmacies compounding injectable tirzepatide must follow General Chapter for sterile preparations, which sets requirements for personnel, facilities, environmental monitoring, storage, and testing of...