FDA Commissioner Margaret Hamburg, MD, testified at a House Energy and Commerce subcommittee hearing on last year’s fungal meningitis outbreak due to contaminated products from a compounding pharmacy. To date, the tainted drugs have caused 51 deaths and sickened more than 730 people, according to Dr. Hamburg’s testimony.
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Dr. Hamburg presented a risk-based framework for improving the safety of compounded drugs. Under the framework, the FDA would categorize compounding practices as either traditional — such as combining ingredients to develop a prescribed and medically necessary medication — or non-traditional, such as compounding that is for a medical need but poses higher risks.
Oversight of traditional compounding would be the purview of state regulation, whereas non-traditional compounding would have to meet federal standards, according to the testimony.
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