But some unimpressed by FDA's approach . . .

New Bulk Substance Compounding Guidance Coming In 2018

January 25, 2018 at 1:27 PM
In the wake of a controversial policy that ended up getting the agency sued, FDA announced it will release new guidance in March on determining the clinical need to warrant compounding using bulk substances, which one source familiar with the drafting and negotiations around the compounding law says could “right the ship” on bulk compounding. But FDA also finalized, without any substantive changes, two controversial guidances outlining when compounders can copy FDA-approved drugs, which some have argued has negative implications...


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