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Compounding Pharmacies: Who is in Charge?
MedLine Citation:
PMID:  23350709     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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 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.
Authors:
Joseph V Pergolizzi; Sumedha Labhsetwar; Jo Ann Lequang
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-28
Journal Detail:
Title:  Pain practice : the official journal of World Institute of Pain     Volume:  -     ISSN:  1533-2500     ISO Abbreviation:  Pain Pract     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101130835     Medline TA:  Pain Pract     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 The Authors Pain Practice © 2013 World Institute of Pain.
Affiliation:
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.
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