The Texas drug recall lawyers at Denena Points, PC note that a Dallas-based compounding pharmacy, NuVision Pharmacy, has refused to conduct a recall of its sterile products that was requested by the U.S. FDA in mid-May. So the FDA re-issued its warning regarding the company’s products just a couple of days ago. The FDA letter requesting recall of the NuVision products cited FDA observations of poor sterile production practices discovered by their investigators in an April inspection of the Dallas compounding pharmacy.
Contaminated Sterile Drugs Could be Extremely Dangerous to Your Health
The FDA emphasizes that if a “sterile” medicine becomes contaminated with microbes, patients might be at risk for “serious, potentially life-threatening infections.” That is in fact what occurred last September when “sterile” injectable drugs from NECC compounding pharmacy in Massachusetts became contaminated. Nearly 70 people died and more than 700 became seriously ill with fungal meningitis and related infections.
NuVision Continues to Defy the FDA Based on its Status as a “Compounding Pharmacy” rather than a Drug “Manufacturer”
But NuVision continues to refuse to conduct a recall of its sterile products. The company maintains that it is in compliance with applicable laws. NuVision says that the new FDA inspections of compounding pharmacies since the fungal meningitis outbreak are being conducted under FDA standards 210 and 211, which are only applicable to manufacturers. And that compounding pharmacies are not “manufacturers” under the law. As such, NuVision claims that only the U.S. Pharmacopoeia rules 795 and 797 and state laws governing compounding pharmacies apply to its activities. (Source: Tom Wilemon, The Tennessean, 8/16/13)
Our Texas drug recall lawyers point out that Texas state laws do not require compounding pharmacies to follow manufacturing standards. Technically, NuVision’s claims are all pretty much correct. But the gaping hole in FDA regulatory authority that NuVision’s claims reveal is also the very reason why some lawmakers are pushing for new rules giving the FDA stronger authority over compounding pharmacies.
Many Compounding Pharmacies have in Fact Morphed into Drug Manufacturers and Should be Governed Accordingly
The Texas drug recall lawyers at Denena Points, PC mention that, technicalities of the law aside, many compounding pharmacies have broken away from their former role of mixing individual prescriptions for individual patients with special needs into a new role involving mass production and distribution of drugs much like any other drug manufacturer. And if a compounding pharmacy’s activities have passed into the realm of mass production manufacturing, the company should no longer enjoy the protection of laws designed for a far different and more limited type of activity.
Our Texas drug recall lawyers strongly believe that ALL drug manufacturers should be properly and closely regulated for the sake of everyone’s safety, no matter what functional title they use to describe their business. Click the link to read more about some of the limits on FDA regulatory authority and its implications for your health.