Exposure to pharmaceuticals in compounding environments can lead to a number of health risks for pharmaceutical employees and patients. These health risks can range from contact with hazardous waste materials, harmful particulates during pressure changes or even transmissible disease. The U.S. Pharmacopoeia (USP) drug standards are used in over 140 countries and are enforceable by the Food and Drug Administration (FDA) in the United States to protect pharmacy staff and reduce the number of transmitted infections. According to IACP statistics there are currently over 30 states that are compliant with USP 797 and new states are being added every year. The strategy governs a range of policies and procedures for any facility that prepares, stores or dispenses Compounded Sterile Preparations (CSPs).
For health care institutions, pharmacies and facilities that handle CSPs, the design and construction of clean rooms has focused specifically on applications that require USP 797 compliance. In the near future, a supplement to the USP 797 standards will be issued in the USP 800 publication, which will provide a wider scope to address garb, cleaning, administering and facility design. The supplement gives more attention to the design of the facilities and the manner in which hazardous drugs are stored. Storage will be required in negative or neutral pressure, and compounding must be completed in a separate room with negative pressure. The new regulations may require a remodel where an intermediary room will be necessary between common areas in order to remain compliant.
In addition, USP 800 will necessitate new monitoring in clean rooms for worker safety. A monthly particle count will be required at these facilities, as well as immediate alert capabilities for any pressure changes. To help you meet these new regulations, Mesa Labs offers an array of pressure monitoring devices in our AmegaView and CheckPoint lines that meet or exceed the new alarm requirements.
Please contact your Mesa representative today to discuss how we can work together to maintain compliance.
For more information on USP 797, please visit the USP website. You can also visit the USP website for their FAQ on the new USP 800.
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