Washington, D.C. Partner David Rosen was quoted in an Inside Health Reform article on July 17, 2013 titled, “FDA Legal Action Holds N.J. Compounder to Manufacturing Standards.” The article discusses a recent consent decree of permanent injunction against a drug compounder that FDA previously flagged mandates the pharmacy follow drug manufacturer standards. Mr. Rosen was quoted saying, “They’re holding them to drug manufacturer-style GMPs.” He also noted that drug companies involved in consent decrees sometimes enter a plan to rehab some of their products, whether it be active pharmaceutical ingredients or ingredients in process, but this must be approved by FDA and there is often a bond to ensure it is carried out.
