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Compounding in Dermatology – How to Navigate the Regulatory and Legal Landscape

Compounding has been a cornerstone of the practice of dermatology since its inception. Often it is the best way to provide effective treatment for patients with skin disease. Nevertheless, current events have resulted in a regulatory climate that threatens the survival of this time-honored practice by dermatologists and consequently access to effective therapies by our patients.

Medication compounding gained national attention in 2012 after contaminated compounded medications produced in the New England Compounding Center caused an infectious outbreak that led to several fatalities. In addition, rising costs and national shortages of medications have sparked new interest in the practice of compounding. Regulations and guidelines related to sterile and non-sterile compounding by physicians and pharmacists, however, have never been more complex. It is imperative for dermatologists to be abreast of new information, incorporate established standards into their practice, and understand the risks associated with compounding.

In the field of dermatology, compounding takes many forms:

  • It can take the form of “in office” compounding such as combining injectable lidocaine with sodium bicarbonate to minimize the pain of injection
  • Preparing topical antigens for use in patch testing a patient for allergies
  • Compounding use can be “office use” of medications prepared by a local pharmacy to treat skinconditions for which there are no approved medications or for whom approved medications may not be as effective

Thus, compounding serves an important role in the field of medicine, yet there is no denying that quality assurance is paramount to ensure patient safety. Nevertheless, while some forms of compounding require strict adherence to FDA requirements, low-risk in-office compounding by dermatologists or any physician should not be held to the same burdensome requirements proposed in the FDA’s draft guidance for pharmacy compounding and insanitary conditions. Similarly, office use compounding should not be so restricted so as to minimize access to effective medications by patients.

Navigating this myriad of regulations can be very confusing and legally treacherous. This regulatory and legal landscape is continuously changing and physicians are too busy trying to keep up with patient care to adequately comprehend all the ramifications of their actions. Thus, there is a need to help dermatologists keep abreast of the changes and guide them to make the best decisions. Towards that end my presentation at the Generational DermatologyTM Palm Spring Symposium, I will provide an overview of the different types of compounding, review the current regulations and guidelines, and discuss how the practice of dermatology may be affected by new proposed policies and just as importantly will provide a paradigm for approaching compounding.

To learn more about the upcoming Generational DermatologyTM Palm Springs Symposium (March 22-25), click here.

1. Research C for DE and. Compounding – Compounding and the FDA: Questions and Answers [Internet]. [cited 2017 Nov 25]. Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm3 39764.htm#what

2. FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017) [Internet]. [cited 2017 Nov 24]. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompou nding/UCM536549.pdf

About Abel Torres, M.D. JD, M.B.A.

Abel Torres, MD
Abel Torres, MD

Abel Torres completed his medical education at The Mount Sinai School of Medicine graduating from a 6 year BS-MD program. He subsequently completed a residency in Internal Medicine at Loma Linda University, a residency in Dermatology at New York University and a fellowship in Dermatologic Mohs/Surgery at the University of California, San Francisco. Recently he served as the Professor and Chairman of the Case Western Reserve University (CWRU) Metro Health Systems Department of Dermatology, and is now full time at Loma Linda University as Professor and Chairman of the Department of Dermatology. He has also served on the Board of Directors for the American Society of Dermatologic Surgery, The American College of Mohs Surgery and the American Academy of Dermatology. He attended the Loyola of Los Angeles Law School, graduating and passing the Bar exam in 1991 and recently completed his executive MBA at CWRU. He has published multiple articles and chapters on medico-legal issues, served part time as an attorney and frequently lectures on medico- legal issues.