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Article | December 31, 1997
OTC drug uniformity
Provisions of the newly passed FDA modernization law guarantee one national system of regulation for OTC drugs, including labeling requirements. The law prohibits states from imposing different or additional requirements from those of FDA.
The one exception is California's Proposition 65 which requires warnings on labels of products containing carcinogens. Prop 65 was "grandfathered" meaning it remains fully in effect. The bill requires OTC medicine labels to disclose the name and quantity of all active ingredients and the name of all inactive ingredients (currently voluntary).
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