Although the USP 797 guidelines only recommend sterility testing if the beyond use date (BUD) extends beyond nine days in medium risk level CSPs, the batch in question was sterility tested anyway and given exactly nine days as a BUD. The syringes had been released for use prior to receipt ...
USP 800 合规性指南：评估风险说明书
Category 1 includes drugs compounded in a non-classified area with a BUD of 12 hours or less at room temperature of 24 hours when cold. Category 2 includes longer BUDs, but it has to be compounded in a clean room setup, such as a hazardous negative buffer room. Category 3 drugs have s...