Sterile compounding differs from nonsterile compounding (see pharmaceutical compounding—nonsterile preparations 795 and good compounding practices 1075) primarily by requiring a test for sterility. Our pharmacy has created policies and procedures for our pharmacy staff that meet federal health canada requirements, provincial requirements, and sterile compounding standards. 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.
Alessandra Alves
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
