Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

New England Compounding Center Indictment

Author(s):  Cabaleiro Joe

Issue:  Mar/Apr 2015 - Volume 19, Number 2
View All Articles in Issue

Page(s):  94-102

Note:  Electronic version includes supplemental material.

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

Download in electronic PDF format for $75

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: Joe Cabaleiro, RPh, 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

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
New England Compounding Center Indictment
Cabaleiro Joe
Mar/Apr 2015
Pg. 94-102

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations
Allen Loyd V Jr
Nov/Dec 2021
Pg. 491-496

Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
Mar/Apr 2021
Pg. 115-124

Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R
, Newton Gail D
May/Jun 2004
Pg. 181-185

Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations
Okeke Claudia C
Jul/Aug 2007
Pg. 302-305

Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2007
Pg. 404-410

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 9: Immediate-Use Compounded Sterile Preparations
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2008
Pg. 440-443

Misinterpretation of United States Pharmacopeia Chapter <797>
McElhiney Linda F
Jan/Feb 2012
Pg. 6-10

United States Pharmacopeia Chapter <797> Timeline: 1989 to 2013
Newton David W
Jul/Aug 2013
Pg. 283-288

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 7: Microbial Contamination Risk Levels, 12-Hour Use, and Immediate Use
Allen Loyd V Jr
, Okeke Claudia C
May/Jun 2008
Pg. 252-257

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 6: 2008 Revisions to Chapter <797>
Allen Loyd V Jr
, Okeke Claudia C
Mar/Apr 2008
Pg. 136-144

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 13: Environmental Quality and Control
Allen Loyd V Jr
, Okeke Claudia C
May/Jun 2009
Pg. 234-238

Basics of Compounding for Fungal Sinusitis
Allen Loyd V Jr
Jul/Aug 2004
Pg. 289-291

Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards
Kastango Eric S
May/Jun 2008
Pg. 216-229

Basics of Compounding: The Responsibilities of Compounding Personnel in Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 2
Allen Loyd V Jr
, Okeke Claudia C
Jul/Aug 2007
Pg. 314-323

Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
Martin Matt
Sep/Oct 2018
Pg. 401-404

Basics of Sterile Compounding. Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 2
Martin Matt
Nov/Dec 2018
Pg. 475-478

Establishing a Structured Pharmacy Training Program in Sterile Compounding
Dirbas Muhannad
, AbuSara Aseel K, Whiyabi Shatha, Harb Rema, Telfah Shorouq
Nov/Dec 2020
Pg. 460-465

Return to Top