Abstract

New England Compounding Center Indictment

Author(s): Cabaleiro Joe

Issue: Mar/Apr 2015 - Volume 19, Number 2

Page(s): 94-102

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  • New England Compounding Center Indictment Page 1
  • New England Compounding Center Indictment Page 2
  • New England Compounding Center Indictment Page 3
  • New England Compounding Center Indictment Page 4
  • New England Compounding Center Indictment Page 5
  • New England Compounding Center Indictment Page 6
  • New England Compounding Center Indictment Page 7
  • New England Compounding Center Indictment Page 8
  • New England Compounding Center Indictment Page 9

Note: Electronic version includes supplemental material.

Abstract

This article is a review of the lapses in compliance with United States Pharmacopeia standards and pharmacy law as alleged by the New England Compounding Center indictment. This indictment was a result of an outbreak of fungal meningitis traced to fungal contamination of compounded methylprednisolone suspension for epidural steroid injections. This article is also intended as a gap analysis for compounders to review compliance at their own facility, and, if necessary, take the appropriate steps to implement best practices.

Related Keywords

  • United States Pharmacopeia Chapter <797>
  • New England Compounding Center
  • criminal charges
  • indictment
  • fungal meningitis outbreak
  • microbiological contamination
  • compounded sterile preparations
  • practices and procedures
  • patient-specific prescriptions
  • Drug Quality and Security Act
  • DQSA
  • best practices
  • personnel training
  • state laws
  • state regulations
  • quality standards
  • pharmacy technicians
  • laboratory cleaning
  • disinfection standards
  • surface sampling
  • fingertip testing
  • viable air sampling
  • microorganisms
  • pathogens
  • office use
  • documentation
  • sterilization
  • record retention
  • sterility testing
  • media-fill testing

Related Categories

  • ENVIRONMENTAL
  • LEGAL
  • STERILE PREPARATIONS
  • UNITED STATES PHARMACOPEIA CONVENTIONS

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