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In-office preparations


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The current state of in-office compounding

By Allison Evans, assistant managing editor

For many years, dermatologists and their clinical staff have safely performed low-risk, low-volume in-office preparations for biopsies, skin cancer excisions, and other dermatologic procedures. Preparing medications in the clinical setting allows physicians to cater to the individual needs of patients. Since the New England fungal meningitis tragedy and the subsequent passage of the Drug Quality and Security Act (DQSA) in 2013, various federal and state policymakers and standard-setting organizations have increased oversight and regulation of medication preparation by not only pharmacists but also physicians. Congressional intent for the DQSA was presumably to regulate large-scale, high-risk compounding operations — but the unintended consequences of the regulations may jeopardize physicians’ ability to produce in-office preparations, and ultimately patient care.

What is the USP?

For many years, dermatologists and their clinical staff have safely performed low-risk, low-volume in-office preparations for biopsies, skin cancer excisions, and other dermatologic procedures. Preparing medications in the clinical setting allows physicians to cater to the individual needs of patients. Since the New England fungal meningitis tragedy and the subsequent passage of the Drug Quality and Security Act (DQSA) in 2013, various federal and state policymakers and standard-setting organizations have increased oversight and regulation of medication preparation by not only pharmacists but also physicians. Congressional intent for the DQSA was presumably to regulate large-scale, high-risk compounding operations — but the unintended consequences of the regulations may jeopardize physicians’ ability to produce in-office preparations, and ultimately patient care.

State oversight

Traditional compounders have been under state jurisdiction since 1997. According to a February 2018 report by the Pew Charitable Trusts and National Association of Boards of Pharmacy, in 2015, only 26 states required Chapter 797 or equivalent quality standards for sterile compounding. Currently, about 32 state boards of pharmacy require full compliance with USP’s Chapter 797 standards, according to Lisa Albany, JD, the AADA’s director of state policy. You also need to closely review the state board of pharmacy rules to determine if physicians are subject to their laws. For example, the Ohio Board of Pharmacy requires many physicians who compound dangerous drugs to obtain a Terminal Distributor of Dangerous Drugs license.

“The state laws vary in which version of the chapter they follow as well as whether states will incorporate any updates,” she said. “We have been weighing in with a number of states explaining why they should refrain from adopting USP’s current standards. We’re in an area of uncertainty, and USP standards are not yet finalized,” Albany said. Despite this uncertainty, Albany believes it will be tough to convince states not to adopt a recognized standard. “There will be a continued push [for pharmacy boards] to adopt the final revisions of Chapter 797, as I think state boards may seek to adopt uniform standards.”

Because state pharmacy boards regulate the preparation and administration of drugs, in-office compounding by physicians falls with the realm of pharmacy regulation, Albany said. In 2005 the Virginia legislature carved out compounding in physician offices from the board of pharmacy, and placed the responsibility for oversight with the medical board. This was a positive move since the AADA wants state medical boards to view physician compounding as the practice of medicine, she said. “But in Virginia, even though inspections were under the jurisdiction of the medical board, they hired pharmacists to inspect physician offices. This was something we hadn’t seen before.”

In addition to seeking a preparation-specific exemption, the AADA Compounding Workgroup is also monitoring individual state legislative and regulatory activity, asking states to hold off on adopting or updating any standards until Chapter 797 and hopefully the preparation-specific exemption is finalized. The AADA is seeking to work with the rest of the house of medicine to monitor and respond to state policymaking affecting the practice of medicine.

USP Chapter 797 revisions

Allison Vidimos, MD, RPh, chairman of the department of dermatology and program director of the micrographic surgery and dermatologic oncology fellowship at the Cleveland Clinic, was nominated by the American College of Mohs Surgery to serve as an Expert Consultant to the USP’s Compounding Expert Committee in 2018. While obtaining an appointment to this committee was no easy feat, now that she has a seat at the table, she has seen just how critical and helpful it is to have physician consultants on board. An anesthesiologist (also a pharmacist), allergist, pulmonologist, and Dr. Vidimos serve as non-voting Expert Consultants to this USP committee.

“Being in the room with the USP pharmacists and representatives from the FDA and CDC to educate them about daily dermatology practice and the safety and practicalities of in-office compounding has been a huge help. My experiences as a pharmacist have helped me better understand their practices and standards as well,” she said. “Addressing the pertinent issues with the 797 revisions has been a significant team effort by other Academy members and staff. I am very grateful dermatology has a voice at the table and a willingness on the part of the USP and FDA to work together toward a resolution.”

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Allison Vidimos, MD, RPh, chairman of the department of dermatology and program director of the micrographic surgery and dermatologic oncology fellowship at the Cleveland Clinic, was nominated by the American College of Mohs Surgery to serve as an Expert Consultant to the USP’s Compounding Expert Committee in 2018. While obtaining an appointment to this committee was no easy feat, now that she has a seat at the table, she has seen just how critical and helpful it is to have physician consultants on board. An anesthesiologist (also a pharmacist), allergist, pulmonologist, and Dr. Vidimos serve as non-voting Expert Consultants to this USP committee.

“Being in the room with the USP pharmacists and representatives from the FDA and CDC to educate them about daily dermatology practice and the safety and practicalities of in-office compounding has been a huge help. My experiences as a pharmacist have helped me better understand their practices and standards as well,” she said. “Addressing the pertinent issues with the 797 revisions has been a significant team effort by other Academy members and staff. I am very grateful dermatology has a voice at the table and a willingness on the part of the USP and FDA to work together toward a resolution.”

Additional Dermatology World Resources

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