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FDA Proposes Criteria For Allowing Bulk Compounding To Address Unmet Clinical Need

 
• By Joanne S. Eglovitch

FDA’s draft guidance spells out criteria for which bulk drug substances outsourcing facilities can use to address unmet clinical needs, yet uncertainty lingers as to whether the draft guidance resolves a pending lawsuit.

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A US FDA draft guidance document that outlines the agency's criteria for deciding which bulk drug substances can be used by outsourcing facilities for compounding even if FDA-approved drugs are available could mean a lawsuit filed against the agency over its interim policy on authorizing bulk compounding is now moot.

FDA Commissioner Scott Gottlieb acknowledged on March 23 in announcing the draft guidance that using compounded drugs when an...

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