Another compounder recalls drugs because of lapse in outside testing

A third compounding pharmacy is recalling sterile injectable drugs nationwide because it can't rely on the results of an outside laboratory that tested them for sterility. The recall comes as the FDA is applying more heat to this niche of the drugmaking market despite the lack of its clear authority to do so. The agency filed a warning letter against another compounder this week, but in it acknowledged there are questions about its powers to take action.

Birmingham, AL-based Medaus Pharmacy today said it is is voluntarily recalling 11 products, including lipo injections with lidocaine, because it was unable to confirm testing "was conducted in a manner consistent with the highest standards of excellence we demand from ourselves and on behalf of our patients." The compounder did not name the outside lab.

Two other compounders, Birmingham, AL-based Wellness Pharmacy and JCB Laboratories of Wichita, KS, both recalled 6 lots of products last week because of concerns about testing by Front Range Laboratories of Loveland, CO. Questions about outside lab testing may become more important as the FDA skirmishes with yet another Texas compounding pharmacy that claims the FDA has no real authority to ask it to recall products.

The FDA last month updated a notice to healthcare providers to remind them not to use products produced by NuVision Pharmacy of Dallas, TX. The FDA said questions of sterility were raised during an inspection of the facility. But that compounder is contesting the FDA's authority and findings. In a notice on its own website, NuVision says the FDA is judging compounders using manufacturing standards and that is not a manufacturer. It claims all of its products are sterile, tested by an outside lab, and customers with concerns can have the results of those tests sent to them as proof.

While compounders are traditionally overseen by state authorities, the FDA began conducting inspections of the largest compounding pharmacies following last year's outbreak of fungal meningitis that infected hundreds of people, dozens fatally. The patients fell ill after they were injected with pain drugs from the now defunct New England Compounding Center (NECC) of Framingham, MA.

This week the agency filed a warning letter against Stewart Compounding Pharmacy in Fayetteville, NC, after inspectors found problems with sterile manufacturing there. But in the letter, the FDA acknowledged, "there are conflicting judicial decisions regarding the applicability" of federal law as it applies to compounding pharmacies. It said it believes it has the authority to enforce certain standards. At the same time, the FDA has been urging Congress to pass legislation that would specifically grant it powers over the largest compounders, limit the drugs they could manufacture and require them to meet certain minimum requirements. In testimony before Congress, FDA Commissioner Margaret Hamburg has said that the agency's authority is not clear, making it difficult to take actions against compounders.

http://www.fiercepharma.com/story/another-compounder-recalls-drugs-because-lapse-outside-testing/2013-09-06