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Compounded Drugs May Return To Supreme Court After 5th Circuit Backs FDAMA

Executive Summary

The Supreme Court could once again be asked to consider FDA's authority over compounded drugs following an appeals court ruling that found the products are considered "new drugs" but are entitled to safe harbor protections under the FDA Modernization Act

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Wyeth will probably be satisfied by FDA's response to its citizen petition appealing for regulatory action against pharmacies distributing compounded hormone replacement therapy products. Although the agency denied the bulk of Wyeth's petition, FDA took action against compounding pharmacies for several related violations

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