Compounding Hearings Are First Step In Creating Active Legislative Ingredients
This article was originally published in The Pink Sheet Daily
Congress will explore causes and potential policy solutions to the meningitis outbreak at the New England Compounding Center in back-to-back hearings, but any legislation increasing FDA regulatory authority faces a long road.
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State regulators seem to agree with FDA about confusion over regulatory responsibility, saying writing consistent definitions for compounding and manufacturing will help determine future FDA involvement.
After the House and Senate question whether FDA needs more authority to regulate compounders like the New England Compounding Center, Sen. Lamar Alexander suggests clearly designating who has jurisdiction may be the answer.
Commissioner Hamburg asks for more power over non-traditional compounding to better regulate companies like the New England Compounding Center, but several House members say it looks like the agency already has the authority it needs.