The product Bee-Shield Hand Sanitizer with Aloe Vera (10 fl. oz. or 1 gallon bottles) is an unapproved new drug and in violation of federal law.
该产品含有芦荟(10盎司或1加仑瓶装规格)未经批准，违反了联邦法律。
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Thus, this product is an unapproved new drug and violates federal law,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.
因此,该产品是一种未经批准的新药，违反了联邦法律。
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One is a law intended to encourage generics that grants the first copy of a patented drug to win regulatory approval in America a six-month monopoly.