NuVision Pharmacy Recall Resistance Results in FDA Warning Over Sterility

Federal drug regulators have gone on the offensive against a Texas compounding pharmacy, which has refused to recall drugs that may not be safe.  

On August 16, the FDA issued a warning to health care providers informing them not to use sterile products from NuVision Pharmacy in Dallas, Texas because the compounding pharmacy’s drugs are not guaranteed to be sterile. FDA investigators say NuVision has substandard sterility practices that could put patients in danger.

The warning went out after the FDA sent a letter to NuVision (PDF) on July 26, asking it to voluntarily recall all of its sterile products. The pharmacy refused, rejecting the FDA’s authority. The FDA says it has no power at this time to force the company to recall its drugs.

The FDA inspectors found a laundry list of problems at NuVision during their inspection. According to investigators, NuVision “did not perform any activity that would reliably remove microbial spores from the aseptic processing area.” The facility only had HEPA filters that covered less than half of the area where sterile drugs were aseptically manipulated, used products labeled “for laboratory use only and not for direct patient contact” in drugs going to patients, and did not have proper safeguards that would limit air from the dirtiest part of the facility from flowing into the clean area where sterile drugs are manipulated.

NuVision, along with Apothecure, Inc., issued a methylcobalamin injection and lyophilized injection products recall due to sterility problems in April. However, NuVision refused to remove all of its drugs from the market and is continuing to try to sell them to hospitals.

The conflict appears to give credence to recent claims made by FDA officials that the agency needs stronger authority over compounding pharmacies in the wake of a fungal meningitis outbreak that started about a year ago, killing more than 60 people and sickening more than 700 others nationwide.

The fungal meningitis outbreak was traced back to thousands of contaminated epidural steroid injections distributed by the New England Compounding Center (NECC) in Massachusetts.

In the wake of the outbreak, NECC has filed for bankruptcy and faces a number of fungal meningitis lawsuits. However, reports have suggested that the FDA knew about problems at NECC for years, but did not take action to remove its drugs from the market until after the outbreak had begun, earning criticism from some lawmakers and groups who say it should have taken action.

The FDA has argued that it does not have the authority it needs over compounding pharmacies and is calling for legislation that would give the agency that power in the face of defiant compounding pharmacies that may be distributing unsafe drugs to patients, like NuVision.

Several pieces of legislation are currently under consideration in both the Senate and the House of Representatives.