New England Compounding Center Indictment

Author(s):  Cabaleiro Joe

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