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by dermatologists or any physician should not be held to the same burdensome requirements proposed in the FDA’s draft guidance pharmacy compounding and insanitary conditions.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.


  1. Research C for DE and Compounding - Compounding and the FDA: Questions and Answers [Internet]. [cited 2017 Nov 25]. Available from:
  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:
  3. Bell A. What the Letters “USP” Mean on the Label of Your Medicine [Internet]. Quality Matters. 2015 [cited 2017 Dec 13]. Available from:
  4. | USP [Internet]. [cited 2017 Dec 10]. Available from:
  5. Feb_2017_State_Compounding_Regulations.pdf [Internet]. [cited 2017 Dec 14]. Available from:
  6. Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act [Internet]. [cited 2017 Dec 2]. Available from:
  7. Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act [Internet]. [cited 2017 Nov 30]. Available from:
  8. Compounding - FDA Implementation of the Compounding Quality Act [Internet]. [cited 2017 Dec 14]. Available from:
  9. Research C for DE and. CDER Small Business and Industry Assistance - The Complexities of Compounding - CDER SBIA Chronicles and Audio Podcast [Internet]. [cited 2017 Dec 2]. Available from:
  10. UCM469120.pdf [Internet]. [cited 2017 Dec 21]. Available from:
  11. UCM469122.pdf [Internet]. [cited 2017 Dec 21]. Available from:
  12. Office USGA. Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges. 2016 Nov 17 [cited 2018 Feb 2];(GAO-17-64). Available from:
  13. Associate SBTPCTS. National Assessment of State Oversight of Sterile Drug Compounding [Internet]. [cited 2017 Dec 3]. Available from:
  14. usp-gc-797-proposed-revisions-sep-2015.pdf [Internet]. [cited 2017 Dec 14]. Available from:
  15. Standards for Compounding Sterile Preparations Go Under Major Revision | USP [Internet]. [cited 2017 Dec 11]. Available from:
  16. 21 U.S.C. 333 - Penalties [Internet]. [cited 2017 Dec 2]. Available from:
  17. Stewart JH, Chinn SE, Cole GW, Klein JA. Neutralized lidocaine with epinephrine for local anesthesia - II. J Dermatol Surg Oncol. 1990 Sep 1;16(9):842–845.
  18. Pate DA, Shimizu I, Akin R, Snodgrass K, Emrick A. Safety of prefilled buffered lidocaine syringes with and without epinephrine. Dermatol Surg Off Publ Am Soc Dermatol Surg Al. 2016 Mar;42(3):361–365.
  19. Schmidt RM, Rosenkranz HS. Antimicrobial activity of local anesthetics: lidocaine and procaine. J Infect Dis. 1970 Jun;121(6):597–607.
  20. Helms S, Brodell, Robert. Shortage of Xylocaine®/Lidocaine with Epinephrine: Causes and Solutions. Pending acceptance;
  21. ucm514666.pdf [Internet]. [cited 2018 Feb 13]. Available from:
  22. State of Ohio Board of Pharmacy [Internet]. [cited 2017 Dec 26]. Available from:
  23. Laws and Regulations - California State Board of Pharmacy [Internet]. [cited 2017 Dec 26]. Available from:
  24. Verbal Communication with a New York State Board of Pharmacy Pharmacist. 2017.
  25. Isedeh P, Forrest ML, Liu D, Aires D. Ensuring that injectable bicarbonate-buffered lidocaine-epinephrine complies with 2015 United States Pharmacopeia (USP) compounding provisions. J Am Acad Dermatol. 2016 Aug;75(2):454–5.


Leon H. Kircik MD