Navigating the Implementation Challenges of USP <797> Regulations in Pharmacy Practice

Not too long ago, the responsibility of mixing pharmacy preparations rested with the RNs on the unit. However, with a heightened emphasis on safety nationwide, this task was transitioned to the pharmacy. Subsequently, new regulations were proposed and established to ensure patient safety, leading to the inception of USP <797> regulations. These regulations have evolved over time to align with industry standards and a heightened focus on quality assurance, with the most recent revision becoming official in November 2023.

The implementation of these new regulations has posed numerous challenges for pharmacies, including increased costs, heightened workload for staff, and the necessity for additional training.

The costs associated with implementation are multifaceted. The new regulations mandate increased surface sampling, with any identified growth requiring identification down to the genus level. This necessitates either outsourcing services, which can be expensive, or establishing an internal process. Internal processes require additional full-time equivalents (FTEs), training for surface sampling, equipment for incubation, and the presence of an internal microbiologist. Addressing any growth discovered during testing necessitates corrective actions and resampling, consuming both time and resources. Additionally, redesigning facilities to meet regulatory requirements, including HVAC systems and design to support specified air changes per hour (ACPH), pressures, ISO classification, and airflow from cleanest to dirtiest, incurs additional costs.

The escalating shortage of pharmacy technicians exacerbates implementation challenges. While larger sites may outsource additional workload, smaller institutions lack this flexibility. 

Disparities in pay and increased workload contribute to burnout among technicians, highlighting the urgent need to address compensation within the industry.

The severity of the shortage has prompted some sites to involve pharmacists in technician workflows, albeit at an added cost and dissatisfaction among pharmacists who are compelled to perform tasks below their skill level. Traditionally, training for medium-risk compounding pharmacies has primarily targeted technicians. However, the new requirements now encompass pharmacists as well. All individuals involved in compounding must undergo fingertip and media fill testing every six months, with those overseeing the process required to undergo yearly testing. Additionally, annual didactic training is mandatory. While this additional training enhances quality assurance, its implementation presents challenges. Qualified personnel must administer and undergo tests, supplies are costly, and the time required for testing varies based on skill level. Pharmacists, in particular, face prolonged testing periods due to their infrequent compounding practice.

In conclusion, while the new USP <797> regulations aim to bolster patient safety and quality assurance, their implementation is fraught with challenges, including increased costs, workforce strain, and training demands. Addressing these challenges requires a concerted effort from stakeholders across the pharmacy industry.