USP 797 is a chapter for sterile compounding requirements produced and published by United States Pharmacopeia and National Formulary (USP-NF) aimed to “help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength, and potency”.¹ Since a nationwide meningitis outbreak in 2012, many state pharmacy practice laws have adopted USP 797 to require pharmacies be compliant in all settings.² The new revisions for USP 797 will impact the preparation of compounded sterile products in a large way, ultimately increasing sterility and safety of products by increasing the requirements needed for personnel and facilities involved in the preparation of compounded sterile products (CSPs). The new revisions of USP 797 were originally planned to be implemented December 1st, 2019, but have been postponed until a later date due to appeals by individual pharmacies and potential revisions of the material.1 Many hospital systems have been continuing to adhere to the proposed revisions since the original December deadline in preparation for when they become finalized.

However, the updates have come at a cost. The financial and planning burdens of implementing the new standards have been challenging for some hospital-systems that do not have preexisting clean rooms. The new revision of USP 797 requires a clean room with sufficient air exchanges for extended beyond use dates (BUDs) on sterile products which are past 24 hours, a very important feature for maximizing medication usage and decreasing pharmaceutical waste.¹

Our local ICHP chapter reached out to Eva Morrison, PharmD, Inpatient Pharmacy Manager at SwedishAmerican Hospital, a Division of UW Health, to comment on the changes and challenges of implementing the USP 797 revision. Dr. Morrison states that the SwedishAmerican pharmacy department has been working on implementing the USP 797 revision since the beginning of 2018 and the challenges presented to the hospital on implementation have been multifactorial.

The largest and most time-consuming challenge for the hospital was determining the location of the clean room. Dr. Morrison states that the main hospital was not a feasible option for the clean room because of “the high cost of the air handling system that would be required to meet the 797 requirements for air exchanges”. The hospital decided to build the clean room in a nearby facility, the Home Infusion Pharmacy which is one mile away from the parent hospital location.

Implementation difficulties have affected other departments as well. The financial aspect of building a clean room is apparent but Dr. Morrison shared that the changes have affected workflow, too. The new 24-hour BUDs on products produced at the hospital have required new workflow strategies for recurrent continuous medications such as patient controlled analgesics or epidural bags for the labor and delivery floor. The Swedish American Hospital Belvidere campus has had to use some creative solutions “since they can only give CSPs 24-hour BUDs and there isn’t pharmacy staff there on the weekends” says Dr. Morrison.

Overall, Dr. Morrison says that while implementation is difficult and has required problem solving to meet the requirements set forth by USP, the changes are worth while and are a step forward for better patient care. Dr. Morrison states, “I think the stricter requirements are essential to ensure the highest quality environment for sterile product preparation, ultimately improving patient safety and quality care.”

Our chapter mirrors Dr. Morrison’s thoughts towards the new regulation of USP 797. We think that it is important for pharmacies to move forward and provide safer medications to our patients. Our chapter’s P1 liaison, Evan Fetten, has been setting up hospital tours for student pharmacists, particularly those in their first year, to become accustomed to the world of health-system pharmacy. We believe that it is important for students to see how advances in health care impact pharmacies daily and learn how to implement changes so that we can continue to provide quality care. We have tours with SwedishAmerican Hospital as well as Van Matre Encompass Health Rehabilitation Hospital so that students can see how their course work dovetails with clinical practice.

1. Compounding Standards, 2020. https://www.usp.org/compounding (accessed 8 March 2020)
2. What is USP 797 and How to Stay Compliant, 2019. https://www.pharmacyonesource.com/what-is-usp-797-and-how-to-stay-compliant/ (accessed 8 March 2020)