Bipartisan Senate health committee leaders have released draft legislation that would give the Food and Drug Administration (FDA) greater oversight of compounding pharmacies, in response to last year’s fatal meningitis outbreak allegedly caused by a contaminated compounded drug. The proposal would subject large compounding operations to direct federal oversight by FDA, rather than the state pharmacy boards that have traditionally overseen them.

According to a Senate Committee on Health, Education, Labor, and Pensions one-pager on the discussion draft, the legislation (i) “establishes a clear boundary between traditional compounders and compounding manufacturers”; (ii) “clarifies that compounded drugs are new drugs subject to the Federal Food, Drug, and Cosmetic Act, and specifies which provisions of the law will apply to traditional compounders, and which will apply to compounding manufacturers”; (iii) defines FDA’s role in the oversight of compounding manufacturers; (iv) “enhances bulk chemical requirements for the used in all compounded products”; and (v) “encourages communication among states and increases communication between states and the FDA.”