FDA Proposes Criteria For Allowing Bulk Compounding To Address Unmet Clinical Need
FDA’s draft guidance spells out criteria for which bulk drug substances outsourcing facilities can use to address unmet clinical needs, yet uncertainty lingers as to whether the draft guidance resolves a pending lawsuit.
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By siding with the FDA against bulk compounding of vasopressin, is court encouraging more limits to Section 503B outsourcing facilities?
FDA has taken its first action on the 503B bulks list since DQSA was enacted five years ago by banning two bulk drug substances – vasopressin and nicardipine hydrochloride – from the list of bulk drug substances that outsourcing facilities can use to compound drugs. The agency also issued final guidance addressing its polices for developing the 503B bulks list. Legal observers say that these actions should prompt outsourcing facilities to be wary of using bulk drug substances not approved by FDA.
FDA’s proposal would, if finalized, protect pharmaceutical manufacturers like Endo, maker of Vasostrict, from competition by outsourcing facilities regulated under Section 503B of the Food, Drug and Cosmetic Act, at least for vasopressin and two other drugs.