Compounding Pharmacies: Who is in Charge?

Joseph V. Pergolizzi, Sumedha Labhsetwar, Jo Ann Lequang

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Compounding pharmacies play an increasing and increasingly important role in our healthcare system, but recent media attention has exposed limited regulatory control over these organizations at the same time their role is expanding. Compounding pharmacies are not regulated in the same manner as pharmaceutical companies and are governed largely by Chapter , a monograph on the pharmaceutical compounding of sterile products, issued but not enforced by the U.S. Pharmacopeial Convention. Not all states require adherence to Chapter , and those that do may choose not to enforce it stringently. Furthermore, Chapter is not a strong standard-for example, it does not require documentation of drug lot numbers or cross-references for patient identification. Thus, there have long been many potential quality issues associated with compounding pharmacies. As these compounding pharmacies provide important products and services, better regulation is urgently needed. Moreover, clinicians should be better aware that some injectable products they use may have been prepared by a compounding pharmacy. Pain Practice

Original languageEnglish (US)
Pages (from-to)253-257
Number of pages5
JournalPain Practice
Issue number3
StatePublished - Mar 2013


  • Analgesia
  • Compounding pharmacies
  • Contamination
  • Epidural steroids
  • Fungal meningitis
  • Regulation

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine


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