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From Health Law Daily, March 12, 2013

FDA inspects 29 compounding pharmacies, continues to find violations

By Sarah E. Baumann, JD

In light of the 2012 meningitis outbreak stemming from contaminated sterile drug products produced at the New England Compounding Center (NECC), the FDA is continuing to investigate threats to public health posed by compounding pharmacies that fail to maintain appropriate sterile drug production practices. The agency recently completed inspection of 29 firms identified for priority inspections on the basis of either reports of death or two of the following: serious adverse event reports, historical inspection data, or reports of product quality problems. The FDA has posted FDA Forms 483, lists of inspectional observations, for 28 of those firms on its website. The remaining firm no longer produces sterile drugs.

Findings. Commissioner Margaret Hamburg, in a blog recent blog post, noted that, in certain instances, investigators observed rust and mold in “clean rooms” where medications were produced, unidentified black particles floating in allegedly sterile medicine, and employees failing to wear sterile lab coats or handling sterile products without gloves. Several firms have voluntarily recalled or temporarily suspended production of products, in part due to the FDA’s investigations.

Delay. The investigations were delayed and hampered by the lack of cooperation on behalf of some of the firms. In four instances, firms initially refused to permit the FDA access to review records or observe sterile processing activities. Eventually, investigators were allowed in, although sometimes not until the agency engaged in discussions with the firms’ legal counsel. In two notable instances, the FDA was only able to access records and/or conduct investigations of Lowlite Investments, d/b/a/ Olympia Compounding Pharmacy in Orlando, Florida and Wedgewood Pharmacy in Swedesboro, New Jersey, after obtaining administrative warrants and being escorted by U.S. Marshals.

Future FDA involvement. The FDA plans to “take aggressive action” against firms operating outside the bounds of traditional pharmacy compounding and exhibiting serious sterile production issues. However, the agency emphasized that it may be unable to take action against pharmacies acting within traditional compounding boundaries, unless they have violated a specific law. Hamburg has previously suggested that the FDA be granted the authority to oversee compliance, registration, and adverse event reporting of high-risk sterile compounding facilities and authority to both examine a pharmacy’s records in response to an outbreak or legal violation and prohibit compounding of the highest risk products by all compounding facilities.

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