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.

The answer to FDA’s legal problems with regulating compounding may come through a designation of responsibility rather than a formal expansion of authority.

Commissioner Margaret Hamburg labored through hours of criticism from House and Senate committees during two days of hearings to defend...