Improving and enforcing compounding pharmacy practices to protect patients

Clinical Infectious Diseases

Volumn 43, Issue 7, 2006, Pages 838-840

  Pegues, David A ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETAMETHASONE;

BACTERIAL MENINGITIS; DRUG CONTAMINATION; DRUG FORMULATION; EPIDEMIC; NOTE; PHARMACY; PRIORITY JOURNAL; SERRATIA MARCESCENS; FOOD AND DRUG ADMINISTRATION; HOSPITAL PHARMACY; HUMAN; LAW; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; UNITED STATES;

DRUG COMPOUNDING; HUMANS; LEGISLATION, PHARMACY; PHARMACEUTICAL SERVICES; PHARMACIES; PHARMACY SERVICE, HOSPITAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33748639251     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/507341     Document Type: Note

References (16)

1. Smith I.K. Regulatory and operational issues of founding a compounding pharmacy. Int J Pharmaceutical Compounding 2002; 6:434-7.
2. US Food and Drug Administration. Compliance policy guidance for Food and Drug Administration staff and industry. Section 460-200, pharmacy compounding. Available at: http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html. Accessed 22 June 2006.
3. Santell JP, Kamalich RF. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities, 1995. Am J Health Syst Pharm 1996; 53:2591-605.
4. Myers CE. Needed: serious attention to sterile products. Am J Health Syst Pharm 1996; 53: 2582.
5. Morris AM, Schneider PJ, Pedersen CA, et al. National survey of quality assurance activities for pharmacy-compounded sterile preparations. Am J Health Syst Pharm 2003; 60: 2567-76.
6. US Food and Drug Administration. Report: limited FDA survey of compounded drug products. Available at: http://www.fda.gov/cder/pharmcomp/survey.htm. Accessed 22 June 2006.
7. Civens R, Vugia DJ, Alexander R, et al. Outbreak of Serratia marcescens infection following injections of betamethasone compounded at a community pharmacy. Clin Infect Dis 2005; 43:831-7 (in this issue).
8. Mattner F, Gastmeier P. Bacterial contamination of multiple-dose vials: a prevalence study. Am J Infect Control 2004; 32:12-6.
9. Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular catheter-related infections. MMWR Recomm Rep 2002;51(RR-10):1-32.
10. Centers for Disease Control and Prevention. Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy. MMWR Morb Mortal Wkly Rep 2002; 51:1109-12.
11. Centers for Disease Control and Prevention. Pseudomonas bloodstream infections associated with a heparin/saline flush-Missouri, New York, Texas, and Michigan, 2004-2005. MMWR Morb Mortal Wkly Rep 2005; 54: 269-72.
12. US Pharmacopeial Convention. Pharmaceutical compounding: sterile preparations. In: U.S. pharmacopeia 27-national formulary 22. Rockville, MD: U.S. Pharmacopeial Convention, 2004:2461-77.
13. Thompson CA. USP chapter 797: enforceable but not often enforced. AJHP News. 1 June 2006. Available at: http://www.ashp.org/news/ShowArticle.cfm?cfid = 16023873 = 37972883 = 15317.
14. Proposed revision to general chapter 797, pharmaceutical compounding-sterile preparations. Available at: http://www.usp.org/pdf/EN/USPNF/ PF797.pdf. Accessed 22 June 2006.
15. American Society of Health-System Pharmacists. ASHP technical assistance bulletin on quality assurance for pharmacy-prepared sterile products. Am J Hosp Pharm 1993; 50: 2286-98.
16. US Food and Drug Administration. Current good manufacturing practice for finished pharmaceuticals. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, 1996. Available at http://www.fda.gov/ cder/dmpq/cgmpregs .htm. Accessed 22 June 2006.