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In practice, the SAFE Drugs Act: Reduces tolerance for informal workarounds Strengthens the FDAs enforcement posture Signals congressional intent to limit unauthorized distribution of approved drugs As a result, arguments that once relied on disclaimers alone are far weaker under the SAFE Drugs Act

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First described by Gustav Simon in 1864, this procedure attached flaps from the lateral lip segments to the prolabium to reshape the lip and underlying alveolus before definitive lip repair