Once again, the FDA is in dispute with a compounding pharmacy -- the latest case underscoring the difficulties the agency can encounter when trying to oversee a compounder that refuses to comply with enforcement steps.
Late last week, the FDA took the unusual step of issuing a reminder to healthcare providers not to administer any sterile drugs made and distributed by NuVision Pharmacy. The agency issued a similar alert this past May and last month, sending a letter to the Dallas compounder requesting an immediate recall of all sterile products.
However, the compounder responded by issuing a statement on its web site maintaining that it does not qualify as a drug manufacturer and “current state laws do not require compounding pharmacies to follow (FDA) standards for manufacturing.” And NuVision added that it is not issuing a recall for all products, and the FDA maintains it cannot require the compounder to do so.
The FDA is likely to point to this battle as an example of why Congress needs to pass legislation that would clarify and enhance its authority over compounders. FDA officials have ordered inspections of dozens of compounders in recent months, but argue that the lack of legal clarity requires them to go to court to press compounders to comply with certain enforcement actions. Even when successful, though, agency officials say resources are stretched thinner and patient safety is compromised because such maneuvers take time. Read more
