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

James Quertermous, Seemal Desai, Julie Harper, Mark Lebwohl, Abel Torres, Leon H. Kircik

Research output: Contribution to journalReview article

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.

Original languageEnglish (US)
Pages (from-to)s17-s22
JournalJournal of drugs in dermatology : JDD
Volume17
Issue number7
StatePublished - Jul 1 2018

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Drug Compounding
Pharmacies
Fungal Meningitis
Outsourced Services
New England
Drug and Narcotic Control
Dermatology
Pharmaceutical Preparations
Guidelines
Physicians
Dermatologists

ASJC Scopus subject areas

  • Dermatology

Cite this

Quertermous, J., Desai, S., Harper, J., Lebwohl, M., Torres, A., & Kircik, L. H. (2018). The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists. Journal of drugs in dermatology : JDD, 17(7), s17-s22.

The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists. / Quertermous, James; Desai, Seemal; Harper, Julie; Lebwohl, Mark; Torres, Abel; Kircik, Leon H.

In: Journal of drugs in dermatology : JDD, Vol. 17, No. 7, 01.07.2018, p. s17-s22.

Research output: Contribution to journalReview article

Quertermous, J, Desai, S, Harper, J, Lebwohl, M, Torres, A & Kircik, LH 2018, 'The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists', Journal of drugs in dermatology : JDD, vol. 17, no. 7, pp. s17-s22.
Quertermous, James ; Desai, Seemal ; Harper, Julie ; Lebwohl, Mark ; Torres, Abel ; Kircik, Leon H. / The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists. In: Journal of drugs in dermatology : JDD. 2018 ; Vol. 17, No. 7. pp. s17-s22.
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