FDA moves to address disputes between drug makers and compounders

Amid ongoing scrutiny of compounding pharmacies, the Food and Drug Administration has issued new draft guidelines to address a contentious debate: When should compounders use the same raw ingredients that are found in prescription medicines?

Known in industry parlance as bulk substances, these ingredients figure prominently in discussions over the safe use of compounded medicines, as well as rising tensions between drug makers and compounders that are vying for some of the same patients.

And so, the agency is issuing what FDA Commissioner Scott Gottlieb called a “critical policy document” that addresses how bulk substances should be used by certain types of compounders along with an updated list of substances available for compounding.

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