The United States Pharmacopeia (USP) and The National Formulary (NF) publish USP-NF, a book of standards for many areas of pharmaceuticals, medicine, and other therapeutics. Chapter 797 (USP 797), applicable to any U.S. institution that prepares, stores, or dispenses compounded sterile preparations, recommends standards for the sterile compounding environment, process and personnel. Enforcement of USP 797 lies largely in the hands of state boards of pharmacy, but state policies regarding the standard vary greatly. States have chosen to cite USP 797 as standards that are to be followed directly, indirectly, or not at all.
Numerous incidents resulting in adverse events at sterile compounding facilities continue to occur, even after the 2004 introduction and the 2008 revision of USP 797. After over 600 cases of fungal meningitis and 45 deaths were recently linked to contaminated steroids produced at the New England Compounding Center (NECC) in Massachusetts, authorities began looking at ways to further regulate pharmacies that perform sterile compounding. A lack of adherence to and enforcement of USP 797, particularly standards for environmental quality, control and evaluation as they relate to potential microbiological contamination of compounded sterile preparations, is a major obstacle to reducing the risk of preventable incidents that result in infections or that could cause death.
Legislation has been introduced in Massachusetts that seeks to give more enforcement power to the state Board of Pharmacy including the ability to impose monetary fines for those violating state laws, regulations, or Board of Pharmacy policies. If enacted, the legislation would also require pharmacies to obtain a special license that would help track sterile compounding operations in the state, establish accountability, provide protection for whistle-blowers, reorganize the Board of Pharmacy, and more fully integrate a public health presence. Other states are likely to follow suit with legislation similar to that proposed in Massachusetts.
Compliance Extends Beyond Patient Safety
Health care institutions that perform sterile compounding are audited by the Joint Commission to ensure they comply with requirements for accreditation and certification. Future Joint Commission audits may require strict compliance with USP 797 and if an organization is determined to be out of compliance, certifications could be at risk.
Maintaining and evaluating a sterile compounding environment has always been a critical component of protecting patient and worker safety. Experts such as industrial hygienists and other public health professionals who specialize in evaluating sterile compounding environments and who provide guidance and recommendations for environmental quality and aseptic practice have played a key role in assisting health care organizations meet and maintain compliance. Stricter adherence to USP797 through enhanced oversight and enforcement by states is likely to result in an increased demand for such experts in order to help manage the risk of incidents or events that could lead to civil or criminal litigation.