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Home » FDA Issues Draft Guidance on ‘Clinical Need’ Test for Bulk Substances Used in Compounding
FDA Issues Draft Guidance on ‘Clinical Need’ Test for Bulk Substances Used in Compounding
In what Commissioner Scott Gottlieb called “a significant milestone” in the FDA’s new policy for oversight of drug compounding , the agency released draft guidance Friday on how it will develop a list of bulk drug substances, known as the 503B list, that outsourcing facilities can use in compounded drugs.