FDA Calls D.C. Court Decision A ‘Victory’ for Compounding Enforcement

The FDA hailed a D.C. court’s decision to uphold the agency’s method for assessing if there’s a clinical need for a bulk drug substance as a “victory for public health” and reiterated its focus on oversight of compounders.

The lawsuit — the first of its kind since the Drug Quality and Security Act was passed in 2013 to give the agency greater authority over compounding — was filed by Athenex, arguing that vasopressin should be fair game for use in compounding.

The company alleged that its vasopressin product fulfilled clinical needs not met by FDA approved Vasostrict (vasopressin) because it was free of chlorobutanol, a preservative that it said causes allergic reactions in some patients.