Indiana Code 25-26-14-8.3. “Misbranded”
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Sec. 8.3. As used in this chapter, “misbranded” means that a legend drug‘s label:
(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;
(1) is false or misleading;
Terms Used In Indiana Code 25-26-14-8.3
- label: means a display of written, printed, or graphic matter on the immediate container of a legend drug. See Indiana Code 25-26-14-6.5
- legend drug: has the meaning set forth in IC 16-18-2-199. See Indiana Code 25-26-14-7
- manufacturer: means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a legend drug. See Indiana Code 25-26-14-8
(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.
As added by P.L.212-2005, SEC.38.