Yes to Appropriate Compounding, No to Illegal Compounding

July 2018 | Volume 17 | Issue 7 | Supplement Individual Articles | 15 | Copyright © July 2018


Leon H. Kircik MD

Icahn School of Medicine at Mount Sinai, NY Indiana School of Medicine, Indianapolis, IN Physicians Skin Care, PLLC, Louisville, KY DermResearch, PLLC, Louisville, KY Skin Sciences, PLLC, Louisville, KY

differences between legal and illegal compounding so that we can fight to preserve the appropriate and safe patient care and stop the illegal compounding. If we do not fight the fight ourselves then someone else will do it for us, which will not be the best outcome as we have seen in the past. As importantly, we must then respond to regulatory concerns with a reasonable argument to protect our practices. We must advocate for ourselves and for our patients to protect access. No one else has a vested interest in protecting our access to compounding.We can only save appropriate compounding by preventing inappropriate and illegal compounding!!Leon H. Kircik MDIcahn School of Medicine at Mount Sinai, NYIndiana School of Medicine, Indianapolis, INPhysicians Skin Care, PLLC, Louisville, KYDermResearch, PLLC, Louisville, KYSkin Sciences, PLLC, Louisville, KYDisclosureDr. Kircik has received compensation for his editorial support from JDD and is the president of International DermatologyEducation Foundation.This supplement is supported by International Dermatology Education Foundation via grants from Allergan, Aqua, Bayer, Dermira,LEO Pharma, and Valeant.REFERENCES1. Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act [Internet]. [cited 2017 Dec 2]. Available from:https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469119.pdf2. 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/PharmacyCompounding/UCM536549.pdf3. Compounding - FDA Implementation of the Compounding Quality Act [Internet]. [cited 2017 Dec 14]. Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm375804.htm4. 21 U.S.C. 333 - Penalties [Internet]. [cited 2017 Dec 2]. Available from: https://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapIII-sec333