Less than 40% of hospital pharmacies reported that they met or exceeded the requirements of USP Chapter 797 in a recent national survey; another 46% said they met most requirements.1 Those that are not fully in compliance, as well as the 15% that have yet to implement programs to bring them up to USP 797 standards may want to focus more attention to the areas where they fall short. In recent years, the number of states requiring direct compliance with USP 797 has risen to 27 and an additional 21 have instituted their own similar regulations. Following the deaths 64 people from contaminated compounded parenteral drugs in 2012, many state boards of pharmacy have begun aggressively inspecting pharmacies for compliance with USP 797 standards.
What are the most commonly missed requirements of USP 797? Errors may occur in training, product storage or processes, but about half of the most frequently cited gaps in compliance have to do with the physical environment.2,3
These include the following five areas:
- Facility design issues: In the last five years, 40% of all hospital pharmacies surveyed and nearly half of pharmacies in hospitals with more than 200 beds have renovated their clean rooms and other areas. “Notably, those facilities that have recently renovated their pharmacy are more likely to report having achieved full compliance with 797,” according to the State of Pharmacy Compounding survey published in the April 2015 issues of Pharmacy Purchasing & Products.1 Still, renovations completed by vendors without a thorough understanding of 797 standards can create some problematic issues, particularly in building a negative pressure ISO Class 7 buffer area with a positive pressure ISO Class 7 ante area. Contractors may overlook details like the need for seamless vinyl floor covering in buffer and ante areas, so someone knowledgeable about the details and proper execution of the USP 797 standards must be involved in the renovation process.
- Lack of environmental testing and certification: If a facility has been renovated, a qualified individual must test the engineering controls and certify the levels of air cleanliness in a sterile compounding facility upon completion. The testing must include particle sampling as well as biological air sampling. Every facility must be tested every six months (renovated or not) and pharmacy leadership must maintain a record of the testing and certification results, along with any remedial action taken of abnormal test data that is warranted.
- Inadequate monitoring and documentation of storage temperatures: All compounded sterile products (CSPs) and ingredients must be stored at appropriate temperatures and conditions, whether in the pharmacy or on the patient care unit, to protect their integrity. The temperature of every storage area or device must be recorded daily. Wireless temperature monitoring systems and electronic documentation systems can simplify this process.
Un-caulked ceiling tiles & floors: Contaminants can be introduced from the anywhere--including from unfiltered air coming through shifted ceiling tiles. Make sure your ceiling tiles and floors cannot move or be damaged in the cleaning & disinfection process, by caulking tiles in place as stated in USP Chapter 797.
Environmental Cleaning & Disinfection: Even if the compounding area does not appear to be physically soiled, and even if it has not been used recently, USP 797 stipulates that personnel shall clean & disinfect the floors in the compounding area daily. Cleaning & disinfection should start in the buffer area and work outwards to the ante room. All other surfaces, including walls, ceilings, shelves and containers, shall be cleaned and disinfected at least monthly.
- Halvorsen D. State of Pharmacy Compounding. Pharmacy Purchasing & Products. April 2015;12(4):S6-S17.
- Kastango, E. The Top Ten Things You Need to Know About USP 797. Infusion. May/June 2009.
- Kastango, E. The Top 10 Gaps in USP Chapter <797> Compliance. Pharmacy Purchasing & Products. Sept 2009.