The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists
July 2018 | Volume 17 | Issue 7 | Supplement Individual Articles | 17 | Copyright © July 2018
James Quertermous MD,a Seemal Desai MD,b Julie Harper MD,c Mark Lebwohl MD,d Abel Torres MD,e Leon H. Kircik MDd,f
aLoma Linda University School of Medicine, Loma Linda, CA bInnovative Dermatology, Plano, TX; The University of Texas Southwestern Medical Center, Department of Dermatology, Dallas, TX cDermatology and Skin Care Center of Birmingham, Birmingham, AL dIcahn School of Medicine at Mount Sinai, NY eLoma Linda University School of Medicine, Loma Linda, CA fIndiana School of Medicine, Indianapolis, IN Physicians Skin Care, PLLC, Louisville, KY DermResearch, PLLC, Louisville, KY Skin Sciences, PLLC, Louisville, KY
be considered an insanitary environment unfit for in-office compounding.25 This would limit dermatologists’ ability to provide care for many of their patients due to the inability to compound certain low-risk medications.To assist dermatologists with compounding, we propose the following algorithm as a guideline to comply with scrutiny by State and/or Federal agencies. See Figure 1.
Compounding serves an important role in the field of medicine and quality assurance is paramount to ensure patient safety. 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by dermatologists or any physician should not be held to the same burdensome requirements proposed in the FDA’s draft guidance pharmacy compounding and insanitary conditions. Such requirements have the potential to delay treatments, raise health care costs and negatively affect patient satisfaction. Physicians, pharmacists and policymakers should work together to formulate a risk stratification scheme for compounded drugs in various healthcare settings based on reproducible data. In the meantime, physicians can use the algorithm proposed, to minimize their risk of exposure while trying to help their patients.
Dr. Desai serves on the US Food & Drug Administration Pharmacy Compounding Advisory Committee (PCAC). His views and opinions are his own and do not represent his role at the FDA. In addition, this manuscript was drafted on a scientific basis without any governmental affiliation.Dr. Harper is a speaker and advisor for Aclaris, LaRoche Posay, and Ortho, a speaker, consultant, and advisor for Allergan and Galderma, a consultant for Aqua, BioPharmX, and Sun, and a speaker, consultant, and investigator for Bayer.Mark Lebwohl is an employee of Mount Sinai, which receives research funds from: Abbvie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, Leo Pharmaceutucals, Medimmune/Astra Zeneca, Novartis, Pfizer, Sciderm, UCB, Valeant, and ViDac. Dr. Lebwohl is also a consultant for Allergan, Aqua, Boehringer-Ingelheim, LEO Pharma, Menlo, and Promius.Dr. Kircik has received compensation for his editorial support from JDD and is the president of International Dermatology Education Foundation.Drs. Torres and Quartermous have no conflicts of interest to declare.
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Leon H. Kircik MD firstname.lastname@example.org