As appropriators weigh in on bulk compounding . . .

FDA Lays Out Test For Showing Clinical Need For Compounding From Bulks

March 23, 2018 at 7:13 PM
In long-awaited guidance released Friday (March 23), FDA laid out a two-part test on how the agency will determine whether there is a clinical need for 503B compounders to make drugs with bulk substances, rather than FDA-approved drugs. FDA will consider a number of factors that go beyond whether using an FDA-approved drug as a base would cause complications for patients, including the physical and chemical structure of the substance and its history of use. In a document accompanying the...


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