Compounders Hint At Legal Action Over FDA's Clinical Need Guidance

Lawyers representing outsourcing compounders are signaling they may sue FDA should it finalize guidance outlining its plans to evaluate whether there is a clinical need to compound a drug using bulk active pharmaceutical ingredients. The compounders throw a number of legal arguments at FDA, including that the guidance is effectively a rule and must go through notice-and-comment rulemaking, that making such determinations would allow FDA to practice medicine, and that treating 503A and 503B compounders differently is arbitrary and capricious...