Injectable pre-mixed drugs in the US

The market for pre-mixed drugs has expanded substantially in recent years due to the value of ready-to-use drugs in bags in the hospital setting. Safety concerns surrounding hospital pharmacy admixture programs has shown that 9% of drugs compounded in hospitals were done in error, according to a recent study. As result of these safety concerns, the new USP 797 guideline increases hospital pharmacy drug compounding requirements to more closely comply with cGMP’s, which has driven more use of pre-mixed bags.

USP 797, a reminder

In the United States Pharmacopoeia (USP), 797 is the title of the chapter “Pharmaceutical Compounding & Sterile Preparations”. The primary objectives of this chapter are ensuring sterility and accuracy of compounded sterile preparation. Physicians, nurses, pharmacists, technicians -anyone who compounds sterile medications or pharmaceutical products- are subject to this guideline. If the chapter 797 deals with the pre-administration manipulations for sterile compounding in specific areas such as the whole arena of compounding, transportation and storage, it is important to note that the IV drug administration itself is not covered.