USP Compliance Remains a Focus Of TJC Surveyors L ike most things in 2021, this year’s r’s Jo Joint oint veys w ill Commission compounding pharmacy surveys will tiice c ce take a different tack, based in part on the pract practice nts ar re a re pressures of COVID-19. The main developments are pdatess tto o continued delay in enforcement of recent updates ous dr rug USP’s chapters on compounding and hazardous drug dancee ffor or or handling and a pandemic-related interim guidance compounding pharmacies. For pharmacies that scrambled to obtain funding to build cleanrooms and update existing segregated compounding areas (SCAs) to meet requirements for the 2019 revision of USP General Chapter <797> guidance on sterile compounding, USP’s decision to consider stakeholder appeals for more expert deliberation on the new revision was reassuring. “The organizations that were not able to get the funding for such significant projects can breathe a sigh of relief that their current setup is adequate to keep them in compliance with USP <797>,” said Susan Reed, RPh, a pharmacy consultant at Steve Hirsch and Associates, in Fountain Valley, Calif. In contrast, organizations that had upgraded their facilities to comply with the 2019 revision will likely meet or exceed the 2008 version from a structural perspective, Ms. Reed noted during the virtual ASHP 2020 Midyear Clinical Meeting and Exhibition, while in her former role as a consultant at Joint Commission Resources Inc. One of the more stringent rules in the 2019 USP <797> revision is a requirement that anterooms and buffer rooms be supplied with HEPA-filtered air through outlets located at the ceiling level, with returns placed low on the walls, Ms. Reed noted. In addition, unlike the 2008 revision of USP <797>, which only permits low-risk nonhazardous compounding in SCAs, the latest revision allows hazardous drug compounding in SCAs, assuming facilities are upgraded, she said. “The two revisions address sterile product compounding differently,” Ms. Reed explained. Whereas the 2008 revision categorized sterile products by the number and type of ingredients used in the preparation, the 2019 revision still under expert review categorizes compounded sterile products by the location in which products are prepared.
USP Chapter <800> Organizations that have geared up to comply with USP <800> can continue with early adoption and ask
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Technicians at Massachusetts General Hospital prepare daily compounded sterile preparations.
surveyors to assess their adherence to this chapter, according to Ms. Reed. She stressed, however, that they should expect scrutiny of everything from staff training and competencies to receipt of product, through to compounding preparation and appropriate use of personal protective equipment (PPE). One detail that surveyors will want to see in place for organizations requesting assessment for USP <800> compliance is that an individual has been designated to oversee hazardous medication compounding, Ms. Reed noted. “This individual needs to ensure that staff that handle and prepare hazardous medications receive appropriate training, including [on] the appropriate use of PPE for their role,” she said. “The individual needs to work with a multidisciplinary team to perform an assessment of risk for hazardous medications and to determine proper handling, including PPE for receipt and storage, product preparation, disposal, and decontamination and cleaning requirements,” Ms. Reed added.
USP Interim Guidance During Pandemic USP has made exceptions to some rules during the COVID-19 pandemic. For example, to help with management of drug shortages, pharmacies may perform mediumrisk compounding in SCAs until the public health emergency is declared over, Ms. Reed noted. “However, if you’re
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see TJC SURVEYORS, page 8
