Regulations, liability, safety, and economics related to compounding

J Am Acad Dermatol. 2020 Jul;83(1):184-188. doi: 10.1016/j.jaad.2019.11.061. Epub 2019 Dec 9.

Abstract

Extemporaneous compounding is a means to tailor a medication to an individual patient's needs and may be required when no commercial product exists to meet that need. Compounded products range from buffered lidocaine to topical creams and ointments. Recent heightened regulations have made compounding more challenging for dermatologists and prompted this review of regulations, liability, and safety related to compounding. With this information, providers may minimize liability and maximize safety while caring for their patients.

Keywords: botulinum toxin; compounding; cost; economics; financial; formulation; levigation; lidocaine; regulations; regulatory requirements; safety.

Publication types

  • Review

MeSH terms

  • Drug Compounding* / economics
  • Drug Compounding* / standards
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Technology, Pharmaceutical / legislation & jurisprudence
  • United States
  • United States Food and Drug Administration