During the ASHP 2018 Midyear Meeting, experts in compounding compliance offered ways to attain regulatory success while complying with USP standards. Jami S. Earnest, PharmD, MS-HQS, BCPP, director, healthcare quality & safety, United States Pharmacopeis (USP), Rockville, Maryland, delineated the organization’s mandate.
“The quality of medicine and how it’s delivered to patients is fundamental to treating illness and maintaining health," he said. "We help build the safety net across the drug industry and healthcare system, establishing standards to help ensure medicine is of the highest quality from the time it’s manufactured until the moment someone takes it.”
Earnest added, “We not only provide standards for what goes into a medicine and how it’s named and labeled, but also to help ensure that once it’s in the hands of a healthcare team, it’s prepared and handled safely.”
Summarizing USP compounding standards, Jeanne Sun, PharmD, manager, compounding, USP, described the three primary forms that are utilized: monographs for ingredients used in compounded preparations; monographs for compounded preparations; and practice standards.
The most relevant standards to hospital pharmacists, according to Sun, are Pharmaceutical Compounding–Nonsterile Preparations <795>; Pharmaceutical Compounding–Sterile Preparations <797>; and Hazardous Drugs <800>.
Offering insights into attaining successful accreditation, Robert Campbell, PharmD, director, clinical standards interpretation, hospital/ambulatory programs, USP, recommended that healthcare organizations understand what the certifier is “doing at their site and read their report.” He also suggested that organizations develop expertise in their team for reading and interpreting certification reports.
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