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.
[Pre-1993 Recodification Citation: 16-1-30-8 part.]
As added by P.L.2-1993, SEC.25.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 3. Uniform Food, Drug, and Cosmetic Act: Adulteration and Misbranding of Drugs or Devices
16-42-3-1. Antibiotic Drug Defined
16-42-3-2. Established Name Defined
16-42-3-2.5. Duties of State Veterinarian and State Board of Animal Health
16-42-3-3. Adulterated Drug or Device
16-42-3-4. Misbranded Drug or Device
16-42-3-5. Exemption of Drugs or Devices in Transit for Further Processing, Labeling, or Repackaging
16-42-3-6. Drugs Dispensed on Prescription
16-42-3-7. New Drugs; Federal Qualification; Testing; Application to Introduce Drug
16-42-3-8. New Drugs; Time for Application to Take Effect
16-42-3-9. New Drugs; Exemption