At the end of last year, a horrific meningitis outbreak prompted the U.S. Food and Drug Administration to begin investigating compounding pharmacies, facilities at which batches of pharmaceuticals are prepared. On Thursday, a report showed that the FDA had found nearly all of the facilities it inspected were in violation of safety standards:
The FDA said Thursday it issued inspection reports to all but one of the pharmacies citing unsanitary conditions and quality control problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation, and employees wearing non-sterile lab coats.
The agency generally issues such reports before taking formal action against companies. Inspectors visited pharmacies in 18 states, including Florida, Arizona, Colorado, Tennessee and New Jersey.[…]
In a blog post to the FDA’s website Thursday, FDA Commissioner Margaret Hamburg noted that four pharmacies initially refused to admit the agency’s inspectors. In two cases the agency had to return with search warrants and U.S. marshals to complete the inspections.
The more than 28,000 compounding pharmacies in the United States are outside the jurisdiction of the FDA because what they do — combining different drugs and medications together — is technically categorized as pharmacy work, not drug manufacturing. But some compounding pharmacies, like the New England Compounding Center where the meningitis outbreak originated, produce thousands of drug combinations. The FDA is able to step in during extenuating circumstances regarding public health.
In the wake of the meningitis outbreak, the FDA called on Congress to clarify and strengthen regulations for compounding industries, but the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act was not adopted before the end of the last legislative season, and has not yet been re-introduced. Its original co-sponsor, Rep. Rosa DeLauro (D-CT) plans to introduce it again.