MANY HOSPITAL AND ALTERNATE SITE PHARMACIES ARE MAKING SWEEPING

changes to comply with the requirements of USP Chapter <797>. Even without a physical plant that meets the requirements of USP <797>, many worthwhile processes can be changed or put in place to reduce the risk of contamination to compounded sterile preparations (CSPs), thereby improving patient safety. Some of these practices include personnel hand-washing and garbing guidelines, cleaning and sanitization procedures, and an environmental monitoring program. There is no valid rationale for waiting, and it may be more important to implement these elements immediately, especially in inferior physical plants. In pharmacy compounding complexes that are not engineered to reduce particles through appropriate secondary engineering controls, proper materials handling, personnel garbing, routine cleaning, and environmental monitoring are the only mechanisms that the pharmacy can implement immediately to reduce the risk of contamination. Eventually, however, for many organizations, physical plant improvements are required and must be made. Once the pharmacy determines the best course of action, successfully communicating this complicated and high-dollar request to individuals with approval authority may be difficult and time-consuming. This article will briefly review the factors influencing pharmacy design and detail suggested elements of a white paper, based on one that has been used to successfully obtain approval for major expenditures, such as pharmacy compounding complexes.

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