CHA News Article

New Proposed Sterile Compounding Regulations Could Significantly Impact Hospitals

The Board of Pharmacy has proposed a new set of regulations that would require a physically separate room for hazardous sterile compounding, along with specific ventilation requirements. The modified text, along with corresponding U.S. Pharmacopeial Convention (USP) 800 requirements of the Food and Drug Administration, are attached. Because the amendments were newly introduced last week, hospital pharmacists in charge (PICs) may not be aware of the proposed regulations. CHA urges hospital executives to consult with their PIC immediately.

The Board of Pharmacy has stated that it is committed to following USP 800 guidelines as a way of ensuring maximum protection and safety standards for hospital staff, but that it will offer program flexibility to hospitals that do not meet the proposed hazardous sterile compounding requirements, allowing them to address their deficiencies and formulate a plan of correction. CHA will soon offer a member webinar to review the updated regulations and provide supportive solutions as hospitals work to address the changes.

Many issues that CHA has raised over the past year have been addressed by the Board of Pharmacy, but the hazardous sterile compounding requirements were re-introduced last week. CHA and its medication safety pharmacy experts are reviewing the modified regulations and composing a response.