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The first dose is usually 1000 mcg (1 mg)

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FDA routinely conducts similar, web-based inspections, which are well suited to reveal a products intended use often the determining factor in whether a product is a drug. See 21 CFR 201.128 (intended use can be derived from a broad array of objective factors, including labeling claims, advertising matter, or oral or written statements.) See also 21 USC 321(g) (defining drug based on, inter alia, its intended use)