High Importance! Must Read Story-Jul 21, 2014 Compounded Medicines: FDA Spars with Recalcitrant Compounding Pharmacy, Again by Ed Silverman

       

FDA Spars With Recalcitrant Compounding Pharmacy, Again

 

For the third time in 15 months, the FDA is warning health care providers and consumers not to use drugs that were made by a Dallas compounder because the medicines may be contaminated. And the ongoing struggle between the agency and NuVision Pharmacy underscores the difficulties that beset the pharmaceutical supply chain despite a recently passed law designed to bolster safety.
In an alert issued late last week, the FDA took the unusual step of including a link to a 15-page inspection report that was completed July 16, showing numerous instances in which NuVision failed to investigate batches of various medicines after finding sterility problems. The FDA noted in its alert that these medicines had been marketed to the public as ‘sterile.’

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