Compounding Pharmacies' Lawsuit Against FDA Will Continue

The US District Court for the Western District of Texas (Midland, TX) has ruled that a lawsuit against the US Food and Drug Administration will proceed, despite a request from FDA to drop the case.

A coalition of 10 compounding pharmacies hit FDA with a lawsuit for engaging in “unlawful” inspections of state-regulated pharmacies. At the center of the lawsuit is FDA’s 2003 compliance policy guideline (CPG 7125.40), which prohibits the compounding of drugs from bulk ingredients.  The agency has since inspected several compounding pharmacies to enforce the guidelines.

The pharmacies petitioned the court to allow them to continue using compounding methods without FDA considering them a manufacturer or requiring them to meet the agency’s manufacturing guidelines. The coalition alleges that federal law prohibits FDA from inspecting state-regulated pharmacies and that the agency is exercising jurisdiction without the authority to do so.