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This chapter provides procedures and requirements for compounding sterile preparations These standards apply to all pharmacy professionals in all practice settings that engage in sterile compounding in any capacity and are an important way to ensure patient safety and protect pharmacy personnel. Sterile compounding differs from nonsterile compounding (see pharmaceutical compounding—nonsterile preparations 795 and good compounding practices 1075) primarily by requiring a test for sterility.
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Here’s what to know about sterility testing when performing usp 797 sterile compounding, including a look at the us fda regulations in 21 cfr 211. Our pharmacy has created policies and procedures for our pharmacy staff that meet federal health canada requirements, provincial requirements, and sterile compounding standards. Understanding the role of sterility testing in compounding a prescribed dilution scheme, and a defined incubation time
Shortly thereafter, the usp also adopted a sterility test
The first version, which appeared in 1935, included one medium, a ilution scheme, and a retest provision to evaluate failures
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