Compounding The Problem: Congress, FDA Argue Over Regulatory Responsibility
Executive Summary
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.
You may also be interested in...
FDA Power v. State Laws: Compounders Want Clarity On Office Use
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.
Compounding: FDA Refining Post-Inspection Hand-off To States
When the agency finds a traditional compounder during an inspection, it asks state boards of pharmacy to ensure corrections are made.
Compounding Law: How Many “Outsourcing Facilities” Will Emerge?
As bill heads to President, voluntary registration system for compounders likely means not all large-scale operations will subject themselves to FDA oversight.