Comment from Eton Pharmaceuticals

Summary: Eton Pharmaceuticals, Inc. opposes the inclusion of phenylephrine hydrochloride in the 503B Bulks List for use in compounding injectable drug products at concentrations of 0.1 mg/mL or below. The company argues that because they have an FDA-approved product (BIORPHEN®) for this indication, there is no clinical need for compounded versions and that such compounding undermines the new drug approval process.