According to Ocala Star Banner, staff writer Fred Hiers has been investigating thousands of compounding pharmacies that are becoming significant players in the nation’s drug market. His series, “Compound Fractures”, reveals that the public is at risk from unsafe drugs made at those pharmacies.
Despite the risk to the public, the state and federal response to the issue has been generally voluntary, leaving the public with little confidence that compounding pharmacies are receiving adequate oversight. Outdated laws allow compounding pharmacies to manufacture drugs in larger quantities than intended while lacking the equipment, testing, and quality control of major drug manufacturers.
EMSL will be hosting a free webinar, “USP 797 Analytical Testing and cGMP – What Compounding Pharmacies and Their Consultants Should Expect from Their Testing Labs”. This webinar is timely in view of the flurry of product recalls since the recall of sterile injectables from many compounding pharmacies nationwide in August and September of 2013.
In 2012, New England Compounding Pharmacy was responsible for the worst drug disaster in decades. They sold contaminated injectables that resulted in over 700 illnesses and 64 deaths. This prompted FDA inspections of the testing laboratories that support compounding pharmacies in making sure these products are sterile. This webinar will include an overview of the FDA 483 violations, the USP 797 guidelines in terms of design principles of sterile compounding spaces, cGMP practices within these spaces, and the requirements labs must reach to analyze these samples.
“In addition to New England Compounding Pharmacy, drugs manufactured in compounding pharmacies in Alabama, Maryland, South Carolina and Texas have previously been linked to deaths due to issues such as drug contamination, improper sterilization practices and potency levels much higher than drug labels indicated,” states Diane Miskowski, MPH, Business Development Manager at EMSL Analytical, Inc. “EMSL Analytical, the nation’s leading environmental testing laboratory, has FDA registered, DEA licensed, and ISO 17025 compliant laboratories located throughout the United States that provide advanced testing on pharmaceutical samples.”