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FDA Asks Recalcitrant Compounder to Recall Products, Again

File this under ‘enough already.’
FDA officials have asked a compounding pharmacy with which they have repeatedly sparred to recall all of its sterile products over concerns that medicines that are currently circulating may be contaminated and present a risk of illness or injury, according to a letter sent yesterday to Downing Labs, which operates NuVision Pharmacy in Dallas, Texas.
The move comes after the FDA found a host of problems during an inspection earlier this summer and warned health care providers and consumers not to use the medicines made by the compounder. In fact, this was the third such warning in 15 months that the agency issued about NuVision and the safety of its compounded drugs.
“Given the high rate of contamination, there is a high probability that contaminated units from other purportedly sterile drug product lots produced at the Downing Labs facility are currently in distribution,” the FDA wrote in what the agency calls a ‘formal request.’ “Based on the inspectional findings, FDA has serious concerns about the conditions and practices at the facility for the production of sterile drugs, which result in a lack of sterility assurance.”
The letter goes on to cite various manufacturing problems, such as a lack of “sound scientific data” to support explanations for sterility failures and an inability to identify the cause of the sterility failures. The FDA also noted vials containing fibers and particles were culled from 184 lots of supposedly sterile drugs, but only visual exams took place and there was no investigation to determine the cause.
We asked NuVision for comment and will update you accordingly.
As we have written previously, the FDA issued alerts twice last year about sterility problems; NuVision recalled one product. And a year ago, the agency tried unsuccessfully to persuade the compounder to recall still more products and NuVision responded by posting a notice on its website saying it did not qualify as a drug manufacturer and so was not required to follow FDA standards for manufacturing.
Some background from an earlier post: The defiant posture taken by NuVision was cited last year by the FDA as further need for Congress to pass legislation that would allow the agency to bolster its regulatory oversight and legal options when encountering recalcitrant compounders. At the time, the FDA was defending its actions in the wake of an outbreak of fungal meningitis in 2012 that was tied to a compounded and caused dozens of deaths.
In response, the Drug Quality and Security Act was passed to, in part, bolster compounding oversight. The law creates two classes of compounders. One group voluntarily registers with the FDA and must follow so-called good manufacturing standards. The agency hopes added requirements will give hospitals and physicians the confidence to purchase medicines from such compounders (here is the list).
Such an imprimatur is designed to act as an incentive that could boost compounding orders at the expense of those that do not register and lack such a designation. Just the same, those compounders that do not register, such as NuVision, are still subject to warning letters, product seizures, injunctions and, possibly, criminal violations for distributing contaminated products, according to an FDA guidance.
State boards of pharmacy are expected to provide added oversight of this group. We asked the Texas Board of Pharmacy if they took any recent action or planned any against NuVision and will provide you with any response.