FDA Really Wants Dallas' NuVision Pharmacy to Quit Making Drugs Contaminated by Endotoxins

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If you more than glance at the website for NuVision Pharmacy, you might start having second thoughts about having the Dallas-based company compound your pharmaceuticals. Why, you might wonder by looking at the home page, did quality testing have to be expanded to check for endotoxins? Why is the "about us" section so keen to point out that the company "is not recalling all sterile injectables." And this "FDA response letter" certainly should give one pause:

There is no evidence to support the FDA's claim that our products lack sterility assurance. ...The FDA did not receive reports about fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product. This is information we voluntarily provided to the FDA. The FDA inspectors had no knowledge of this incident prior to our disclosure. ...Neither the FDA nor our pharmacy uncovered any evidence that the symptoms were caused by our product and were not due to an unknown alternative source.

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There are reasons for these less-than-inspiring assurances of safety, and they're found on the FDA's website. The first, a recall announcement issued by the FDA in April 2013, says that some of NuVision's supposedly sterile drugs were "produced under conditions that could create a high potential for contamination" and "should not be administered to patients." The next month, the FDA expanded the recall after investigators "observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company's sterile drug products" during an inspection and received reports of fever and flu-like symptoms in patients after some of its products were injected. In August, the federal agency issued yet another alert because "NuVision Pharmacy has repeatedly declined to recall its sterile products."

A third warning came on Friday and included the results of an inspection completed two days earlier. The inspection lists more than a dozen problems with NuVision's sterility procedures and found several drugs that failed its test for endotoxins, a byproduct of bacteria.

NuVision president and pharmacist in charge Kristi Kubosh says the FDA's most recent alert is overblown.

"What's not mentioned in there is all the things we improved," she says, adding that "the inspection went pretty well compared to last time." This time, most of the FDA's complaints centered on paperwork and record-keeping. The endotoxins that were found were in substances that were under a 14-day quarantine. None of the contaminated product had been shipped to customers.

More broadly, Kubosh critiques the agency for evaluating her business on the rules governing manufacturing pharmacies, not the more lenient ones being formulated for compounding pharmacies.

"Everything in this gray area as far as laws and regulations go," Kubosh says.

The Wall Street Journal reports that NuVision's response has been cited by the FDA as it attempts to persuade Congress to expand its regulatory authority over compounding pharmacies.

In 2012, in the wake of an outbreak of fungal-meningitis spread by a compounding pharmacies, President Obama signed the Drug Quality and Security Act, which allowed the custom drug-makers to voluntarily register with the FDA. NuVision did not, though the agency argues that many of the same regulations still apply.

This post has been updated with a response from NuVision president and pharmacist in charge Kristi Kubosh.

Send your story tips to the author, Eric Nicholson.

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