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Why Pharmacists are Being Held Accountable for USP 797 Compliance

In today’s increasingly regulated healthcare environment, pharmacy management must adopt and adapt to the standards set by U.S. Pharmacopeia (USP) Chapter 797. It describes the process, procedures and compliance requirements for pharmacies involved in compounding sterile preparations (CSPs). USP 797 has an impact on nearly every process in sterile compounding, including facility design, environmental controls and monitoring processes, staff training and evaluation, and documentation.

Historically, the pharmacy profession has been governed within a state by the professional practice acts of each state, which are enacted by the state legislature. State boards of pharmacy govern pharmacies by developing and enforcing legislation that affects the delivery of pharmacy products, and by disciplining pharmacists who don’t comply with the laws and regulations of that state.

In addition to state laws and regulations, pharmacists must comply with the standards found in USP 797. This is particularly important when USP 797 standards are part of the requirements by the state board of pharmacy. But even in states where there is not a specific written requirement to adhere to USP 797, pharmacists will be held accountable to those compliance requirements. There are several reasons for this situation.

USP 797 spells out accountability

The standards in USP 797 are intended to apply to all persons who prepare CSPs and all places where they are prepared. USP 797 requirements affect all disciplines involved in sterile compounding, including physicians, nurses, pharmacists and pharmacy technicians. As the trained experts in sterile compounding, the highest levels of accountability fall upon the pharmacist.

USP 797 and compounding risk level assignment

USP Chapter 797 delineates that the pharmacist is responsible for ensuring that CSPs are properly prepared, labeled, stored, dispensed, and delivered. Furthermore, it is written such that the determination of the compounding risk level is the responsibility of the compounder. This means that assigning the compounding risk level is ultimately the job of the pharmacist.

Historical relationships

In the U.S. health care system, there is a longstanding relationship between the compounding pharmacies and the healthcare organizations that provide them to patients. Customized CSPs such as individual chemotherapy agents, allergy-free preparations and doses not commercially available have long been the responsibility of the pharmacist.

Recent fatalities

One of the primary reasons that compounding pharmacists are being held more accountable to USP 797 standards relates to an incident in 2012 with the New England Compounding Center’s (NECC) role in the deaths of 64 patients and the more than 750 who were injured due to compounded sterile injections that caused fungal meningitis. Following this tragic incident, state boards of pharmacy and the FDA took a closer look at sterile compounding compliance levels and decided that more stringent oversight was required.

Many pharmacies have turned to a software solution that streamlines USP 797 compliance. What is your organization doing?

Understanding USP 71-Sterility Testing and Extending Beyond-Use Dating. Watch the webinar.

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