![]() The airflow, air quality, pressurization, temperature and humidity requirements in USP 800 make it risky to assume the existing infrastructure is adequate to comply with the guideline. It is important that construction phasing be evaluated during the planning process and that the quantity of phases be balanced between limiting staff disruption and construction cost.Īnother item that can greatly impact construction cost and schedule is the condition and capacity of the existing HVAC system. Some locations have the luxury of soft space that allows for smoother construction with the establishment of a temporary pharmacy that can be utilized during construction, but this is not always the case. One of the biggest challenges for a pharmacy renovation is keeping the existing pharmacy operational while the spaces are being renovated. Many factors can impact the overall renovation cost for compliance. Planning and budgetingĪs pharmacies look to modify their current operations to ensure compliance with USP 800, it is recommended traditional dollar per square foot values are not utilized for initial budgeting until the entire scope of construction is understood. USP 800 was developed for this reason and to provide guidance on protecting any individual who may have exposure to HDs. What USP 797 did not cover was the handling of HDs and the associated risk of exposure of patients and health care workers. Standards for preparing sterile drugs to reduce the risk for contamination, infection or incorrect dosing are defined throughout USP 797. In simplistic terms, the main intent of USP 797 was to protect hazardous and nonhazardous drugs from contamination. Prior to the development of USP 800, the main guidance related to the handling of HDs was covered in USP General Chapter 797, Pharmaceutical Compounding - Sterile Preparations. ![]() Health care providers are required to develop and keep a list of HDs utilized at their facility on file and available for surveyors. Drugs are classified as hazardous if they possess characteristics such as genotoxicity, organ toxicity, teratogenicity or development toxicity, reproductive toxicity and carcinogenicity. USP 800 utilizes the list of HDs identified by the National Institute for Occupational Safety and Health.
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