Recently, the US Pharmacopeial Convention (USP) proposed a new General Chapter 800: “Hazardous Drugs: Handling in the Healthcare Settings.” There has been mixed reaction to this proposal across the profession. We will see what the compounding expert committee recommends, but the controversy provides an opportunity to reflect on the role of USP in pharmacy practice.
USP’s The Pharmacopoeia of the United States was first published in 1820. In 1975, USP acquired the National Formulary from the American Pharmaceutical Association, and merged it and Pharmacopoeia into a single publication containing official substances and preparation monographs. USP’s activities have changed greatly since then, but the importance of USP to pharmacy practice is still significant.
Setting preparation standards and providing reference material continue to be important, as reflected in the USP mission statement. USP has attempted a number of ventures that help demonstrate its value to pharmacy practice, including medication error prevention, providing drug information, and setting pharmacy practice standards.
Although USP has an impressive headquarters building and staff in the Washington, DC area, much of its accomplishments are due to its volunteers, who serve as delegates to the USP convention. As with medical organizations, all state pharmacy associations and schools of pharmacy are eligible to send a convention delegate, providing a unique forum for medicine and pharmacy to interact—the value of which many pharmacists may not appreciate. The expert panels primarily use volunteers to accomplish their work, too.
USP publishes general chapters, and the ones under 1000 contain standards that can be enforced. Because of this enforcement potential, some pharmacy organizations have proposed that Chapter 800 be renamed Chapter 1000. The USP expert panel will decide.
It was the promulgation of Chapter 795: “Pharmaceutical Compounding Nonsterile Preparations” and Chapter 797: “Pharmaceutical Compounding Sterile Preparations” that brought attention to the important role that USP can have in protecting patients and improving pharmacy practice. Chapter 800, if promulgated, will also help protect health care workers. In implementing or proposing these chapters, USP is simply taking the best science available and the existing standards, if available, to provide a regulatory framework for enforcement. It would be nice if everyone did what is right, but unfortunately that is not always the case, as several recent compounding catastrophes have reminded us.
Why does USP have so many volunteers to help accomplish its activities? To find out, I asked a member of the compounding expert committee that is proposing the new Chapter 800 why he volunteered to be on this committee. He is a pharmacy faculty member who teaches compounding, so part of his involvement allowed him to explore a new focus for his career.
But more important for him was a realization that compounding was being looked at differently from a federal perspective. He felt that scientific advancements occurring on the drug manufacturing side had applications to compounding practice. When he realized that many state boards of pharmacy did not even require the elements of Chapters 795/797, he recognized the need to get involved in USP because there was the potential to set standards that can be enforced.
I also talked to a delegate to the USP convention from a state pharmacy association. He got involved because he used and liked some USP products and services and wanted to learn more about USP’s role. As a hospital pharmacist, he saw the contribution that Chapters 795 and 797 had made in changing practice in hospitals. He also supported implementing Chapter 800 because the data are pretty compelling that employees handling hazardous substances are at risk, but many hospital leaders do not appreciate the problem; so Chapter 800 may be an important vehicle for getting organizations to change.
Both of these volunteers felt that serving as a USP volunteer was another way to give back to the profession they love—and both felt they were better practitioners because of their USP service.
In USP’s almost 200-year history, its important role in pharmacy practice has not always been appreciated by the average pharmacist because, like pharmacists, USP often played a behind-the-scenes role. The promulgation of Chapters 795 and 797 and potentially Chapter 800 has moved USP into a more visible role in advancing pharmacy practice.
Mr. Eckel is a professor emeritus at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He is emeritus executive director of the North Carolina Association of Pharmacists. A lifelong advocate for the profession of pharmacy, Mr. Eckel has lectured on pharmacy issues and trends in all 50 states and has traveled to 6 continents to promote, and educate audiences on, the role of the pharmacist.