What must Connecticut hospitals with pharmacies that do sterile compounding adhere to?

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Connecticut hospitals with pharmacies that are involved in sterile compounding are required to adhere to the standards set forth by the United States Pharmacopeia (USP). Specifically, USP standards, particularly USP <797>, outline the guidelines and requirements for compounding sterile preparations to ensure patient safety, quality control, and proper environmental conditions.

These standards address critical aspects such as the design of the compounding area, proper garbing, the use of suitable equipment, and the need for environmental monitoring to minimize the risk of contamination. By following USP standards, hospitals ensure that they are not only compliant with national best practices but also maintaining the integrity of sterile products being administered to patients.

While federal regulations and state laws play important roles in the broader context of pharmacy operations, the USP standards are specifically tailored for compounding practices and are thus essential for hospitals that engage in sterile compounding. Internal policies may further refine these practices but must at a minimum comply with the USP standards to ensure patient safety and effective compounding.

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