Philadelphia partner Scott Coffina wrote an article for BNA’s Pharmaceutical Law & Industry Report titled, “Coming Soon: Increased Scrutiny of Compounding Pharmacies.”
Scott predicts that the toll of sick and dead from the outbreak of meningitis associated with contaminated steroids from a pharmacy in Massachusetts will result in increased regulatory oversight and DOJ enforcement activity against these businesses.
Compounding pharmacies can expect “exacting scrutiny from Congress, the Food and Drug Administration and law enforcement authorities” in the near future. The Justice Department will also, surely, be looking for cases to bring under the FDCA and the False Claims Act, particularly given the serious safety issues involved.
Scott outlines the nature and regulation of compounding pharmacies to date, as well as applicable case law. He says that “compounding pharmacies, particularly those with large-scale operations, now face a precarious enforcement landscape.”
He adds that large-scale compounding operations “may have to re-think their business models entirely” and should “prepare for the increased scrutiny by making sure their manufacturing processes are in full compliance with state law and Good Manufacturing Practices.”