Compounding The Problem: Congress, FDA Argue Over Regulatory Responsibility
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.
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FDA says traditional compounding pharmacies cannot produce office stock, but some states specifically allow the practice, and the International Academy of Compounding Pharmacists wants help from Congress.
When the agency finds a traditional compounder during an inspection, it asks state boards of pharmacy to ensure corrections are made.
As bill heads to President, voluntary registration system for compounders likely means not all large-scale operations will subject themselves to FDA oversight.