Compounding: How Does FDA Expand Oversight Without Legislation?
After House Republicans indicate legislation expanding agency’s oversight of compounding is unlikely, FDA could consider other regulatory options, like changing internal policies or hoping a court clarifies its regulatory authority.
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FDA calls North Carolina compounder’s products misbranded and adulterated after the company did not receive valid prescriptions for a number of products it made and agency found several GMP violations.
Rep. Griffith circulates a discussion draft with new procedures for states to tell FDA when they have found problems at a compounder, but only then could the agency inspect the facility.
Compounding manufacturers would have to report adverse events and quality problems much like traditional drug and biologic makers as a Senate committee moves toward mark up of legislation.