§ 16-42-3-2 — Established name defined

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.
[Pre-1993 Recodification Citation: 16-1-30-8 part.]

Legislative History

As added by P.L.2-1993, SEC.25.