From Johns Hopkins: Compounding Pharmacies: Who is in Charge?

http://www.ncbi.nlm.nih.gov/pubmed/23350709

Pain Pract. 2013 Jan 28. doi: 10.1111/papr.12033. [Epub ahead of print]

Compounding Pharmacies: Who is in Charge?

Pergolizzi JV Jr, Labhsetwar S, Lequang JA.

Source

Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, U.S.A; Department of Pharmacology, Temple University School of Medicine, Philadelphia, Pennsylvania, U.S.A.

Abstract

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 <797>, 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 <797>, and those that do may choose not to enforce it stringently. Furthermore, Chapter <797> 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 compoundingpharmacies. 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.