FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA keeps asking it to recall all of its sterile products, and NuVision Pharmacy keeps ignoring the request as it tests the limits of the FDA's authority over drug compounders. The FDA then warns healthcare providers they shouldn't use any drugs NuVision compounded, and NuVision tells customers that all is well.

The scenario is again playing out this week. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them. Included in the warning was a link to its letter to Dallas-based Downing Labs, which operates as NuVision, again asking the company to voluntarily recall its products and laying out a list of problems it said it discovered at the facility during an inspection that ran over 5 weeks in June and July.

The FDA said the inspection determined that 19 lots that were purportedly sterile drugs "tested positive for microbial contamination. In addition, three lots failed endotoxin testing." The FDA said that may be the result of poor aseptic filling processes and because APIs coming into the facility were contaminated with endotoxins.

But in a response on its website, NuVision said the 19 lots were never released. "We want to assure the public that the compounded lots with failed sterility and endotoxin test results were never released by our pharmacy. It is our policy to hold all compounded sterile products for a quarantine period of at least 14 days in order to wait for test results from a third party lab. Any products that fail sterility or endotoxin testing are investigated and destroyed by our pharmacy. These products are never dispensed to patients--we would be happy to provide all sterility results by our third party testing, as well as destruction logs of incineration, from our accredited third party for any lots in question."

The response goes on to outline a long list of changes it has made in response to FDA concerns. It has switched to an FDA-approved testing lab, changed gowning procedures and relocated and added HEPA filters in clean rooms. It said it is making changes that are outside the requirements of compounders to better serve its customers.

NuVision was among dozens of large-scale compounders caught up in a sweep by the FDA that began in 2012 after a fungal meningitis outbreak that killed 64 people was tracked back to a Massachusetts compounder. FDA Commissioner Margaret Hamburg was called on the carpet by Congress for not having a better fix on the situation. Because the compounding industry had fought federal oversight, the agency asked Congress for explicit authority to regulate the largest operators. Last year, Congress granted it some expanded powers: the authority to require certain standards and regularly inspect those companies which voluntarily sign up for oversight. Congress said then the market would punish bad players by giving business to those that are FDA approved.

So far, 56 sites out of more than 3,000 compounders have been registered. NuVision is not among them.

- read the notice to providers
- and the letter to NuVision (PDF)
- here's NuVision's response