The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists openaccess articles

July 2018 | Volume 17 | Issue 7 | Supplement | s17 | Copyright © 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

Abstract

Medication compounding gained national attention in the fall of 2012 after contaminated compounded medications produced in the New England Compounding Center infected 800 people with fungal meningitis and led to several fatalities. This prompted Congress to pass regulations on compounding through the Drug Quality and Security Act (DQSA) in 2013. The act increased oversight of patient-specific drug compounding taking place in compounding pharmacies, created 503(b) outsourcing facilities to obtain compounded drugs, and added regulations for obtaining compounded drugs from traditional 503(a) pharmacies. These regulations also had a broader overall impact by triggering federal and state-specific policies, which have ultimately limited a physician’s ability to perform low-risk, in-office compounding. This article provides an overview of the different types of compounding restrictions, reviews the current federal and state regulations and/or guidelines, discusses how newly proposed policies may affect the practice of dermatology, and presents an algorithm on how the practicing dermatologist should approach compounding. J Drugs Dermatol. 2018;17(7 Suppl):s17-22

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INTRODUCTION

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. The United States (U.S.) Food and Drug Administration (FDA) has released several non-binding draft guidance documents on clinical compounding. Meanwhile, the United States Pharmacopeia (USP) General Chapter <797> Pharmaceutical Compounding - Sterile Preparations is currently undergoing revisions to set standards that prioritize patient safety and assure quality of all compounded medications. These changes have significant implications on the practice of medicine in certain specialties and they may profoundly impact the ability of dermatologists to provide care to their patients. Amid such flux in regulations and guidelines, it is imperative for dermatologists to be abreast of new information, incorporate established standards into their practice, and understand the risks associated with compounding. This article provides an overview of the different types of compounding, reviews the current regulations and guidelines, and discusses how the practice of dermatology may be affected by new proposed policies.Definition of CompoundingThe FDA defines compounding as combining, mixing, or altering the ingredients of a drug to create a distinct medication tailored to a patient. Compounding must be performed by a licensed pharmacist, a licensed physician, or a person under the direct supervision of a licensed pharmacist in an outsourcing facility. Importantly, compounded medications are not FDA-approved and have not undergone FDA pre-market review for safety, effectiveness, and quality.1BackgroundIn September 2012, tainted steroid injections compounded by the New England Compounding Center caused a multi-state fungal meningitis outbreak that led to several fatalities. Prior to this, the regulations surrounding compounding were more lenient. In

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