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Pharmaceuticals / Regulatory Affairs

Gottlieb Hears From Lawmakers on Drug Compounding

June 2, 2017

FDA Commissioner Scott Gottlieb is getting pressure from Capitol Hill to change official FDA guidance for compounders.

A bipartisan group of 65 lawmakers sent a letter pressing him to rescind a late 2016 agency decision restricting state-licensed pharmacies from compounding prescription drugs for healthcare providers to use in their offices without an individual prescription.

Instead, the letter calls on the agency to draft a proposed rule allowing office-use compounding where authorized by state law.

Led by Reps. Chris Stewart (R-Utah) and Earl L. “Buddy” Carter (R-Ga.), the coalition is arguing that the FDA guidance goes against Congressional intent.

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