Monday, April 8, 2013

More failures uncovered at US compounding centres


he US Food and Drug Administration (FDA) has discovered failures at several drug compounding centres after a series of inspections, prompted by a meningitis outbreak last year that killed 51 people.
A review of 30 reports, which cover inspections from January to March, highlight several short-comings, such as failures in following set procedures to prevent contamination, in appropriate protection worn by people working in sanitary areas, and inadequate testing to determine expiration dates, Bloomberg news reports.
It is thought that the FDA will use the reports, known as 483s, which they do not normally publish, to gain more authority over the industry.
The new focus on the drug compounding centres - where drugs are mixed on site at a supposedly small scale - occurred after New England Compounding Pharmacy Inc was shut down in October last year after a contaminated steroid shot mixed and developed by the pharmacy was linked to a meningitis outbreak that killed 57 people.
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