The Hatch-Waxman Act of 1984 created the legal pathway for generic drugs in the U.S., balancing innovation and competition. It cut approval costs, spurred generic entry, and saved over $1.7 trillion in healthcare spending.
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Pharmacists use the FDA's Orange Book to legally verify generic drug equivalence, ensuring safe substitutions based on pharmaceutical and bioequivalence standards. This process protects patient safety and reduces costs across the U.S. healthcare system.
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