IC 16-42-3-2: Established name defined

Sec. 2. As used in this chapter, "established name", with respect to a drug or ingredient of a drug, means:

(1) the applicable official name designated under Section 508 of the Federal Act;

(2) if there is no official name and the drug or the ingredient is an article recognized in an official compendium, the official title of the drug or ingredient in the compendium; or

(3) if neither subdivision (1) nor (2) applies, the common or usual name, if any, of the drug or the ingredient.

However, when subdivision (2) applies to an article recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia applies unless the article is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia applies.