Sec. 8.3. As used in this chapter, "misbranded" means that a legend drug's label: (1) is false or misleading; (2) does not bear the name and address of the manufacturer, packer, or distributor or does not contain an accurate statement of the quantities of active ingredients of the legend drug; (3) does not show an accurate monograph for the legend drug; or (4) does not comply with any other requirements of the federal Food, Drug, and Cosmetic Act.
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