Clinical Microbiology Newsletter
Volume 30, Issue 14 , Pages 105-108 , 15 July 2008

USP Chapter 〈797〉 and Environmental Monitoring

  • Eric S. Kastango, MBA, RPh, FASHP

      Affiliations

    • Corresponding Author InformationMailing Address: Eric S. Kastango, MBA, RPh, FASHP, Clinical IQ, 184 Columbia Turnpike, #282, Florham Park, NJ 07932. Tel.: 973-765-9393. Fax: 973-966-8720.

References 

  1. U.S. Pharmacopeial Convention . Pharmaceutical compounding: sterile preparations . In: U.S. pharmacopeia 27 — national formulary 22 . Rockville, MD: U.S. Pharmacopeial Convention; 2004;p. 2461–2477
  2. Myers CE . Needed: serious attention to sterile products . Am. J. Health Syst. Pharm. . 1996;53:2582
  3. Patel R , et al.   Hepatitis C virus infections from a contaminated radiopharmaceutical used in myocardial perfusion studies . JAMA . 2006;296:2005–2011
  4. Civens R , et al.   Outbreak of Serratia marcescens infection following injections of betamethasone compounded at a community pharmacy . Clin. Infect. Dis. . 2005;43:831–837
  5. Mattner F , Gastmeier P . Bacterial contamination of multiple-dose vials: a prevalence study . Am. J. Infect. Control . 2004;32:12–16
  6. Centers for Disease Control and Prevention . Guidelines for the prevention of intravascular catheter-related infections . MMWR Recomm. Rep. . 2002;51(RR-10):1–32
  7. Centers for Disease Control and Prevention . Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy . MMWR Morb. Mortal. Wkly. Rep. . 2002;51:1109–1112
  8. 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;54:269–272
  9. Kastango ES , Douglass K . Quality assurance for sterile products . Int. J. Pharm. Compd. . 2001;5:246–253
  10. U.S. Pharmacopeial Convention . Revision bulletin, December 2007. Chapter 〈797〉 pharmaceutical compounding — sterile preparations . http://www.usp.org/pdf/EN/USPNF/generalchapter797.pdf 2007;
  11. U.S. Food and Drug Administration . Guideline on sterile drug products produced by aseptic processing . Rockville, MD: FDA; 2004; http://www.fda.gov/Cder/guidance/5882fnl.pdf
  12. CDC website . http://www.cdc.gov/ncidod/dhqp/gl_environinfection.html

PII: S0196-4399(08)00033-0

doi: 10.1016/j.clinmicnews.2008.06.003

Clinical Microbiology Newsletter
Volume 30, Issue 14 , Pages 105-108 , 15 July 2008

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