Microbial Monitoring in the Pharmacy

In 2007, the United States Pharmacopeia finalized a program to ensure that compounded sterile products prepared for individual patients by physician order were indeed prepared aseptically. The program name became the chapter number in the national formulary, i.e., 〈797〉. Accredited clinical or environmental laboratories are required to support microbial testing of (i) the air in the i.v. area and hoods, (ii) the sterility of the compounded product itself, (iii) the reliability of surface decontamination, and (iv) the determination of whether the pharmacist or pharmacy technician can compound a surrogate product aseptically. This article reviews those quality metrics for pharmacies that involve microbial testing.