Definitions

PURPOSE: This rule defines the term “drug” as utilized in Chapter 338, RSMo, and the rules of the board. (1) “Drug,” “prescription drug,” or “legend drug” means any drug or biological product— (A) Subject to section 503(b) of the Federal Food, Drug and Cosmetic Act, including finished dosage forms and active ingredients subject to section 503(b); (B) Required by federal law to be labeled with one (1) of the following statements, prior to being dispensed or delivered: 1. “Caution: Federal law prohibits dispensing without prescription”; 2. “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”; or 3. “Rx Only”; and (C) Required by any applicable federal or state law or regulation to be dispensed by prescription only or that is restricted to use by practitioners only. (2) For purposes of sections 338.300 to 338.370, RSMo, the term “drug,” “prescription drug,” or “legend drug” shall not include: (A) An investigational new drug or biological product, as defined by 21 CFR 312.3(b), that is being utilized for the purposes of conducting a clinical trial/investigation of that drug or product if such clinical trial/investigation is governed by, and being conducted pursuant to, 21 CFR 312, et seq.; (B) A legend drug or biological product being utilized for the purposes of a clinical trial/investigation that is governed by, and being conducted pursuant to, 21 CFR 312, et seq.; or (C) A legend drug or biological product being utilized for the purposes of a clinical trial/investigation that is governed or approved by an institutional review board subject to 21 CFR 56 or 45 CFR Part 46. AUTHORITY: section 338.010, RSMo Supp. 2010 and sections 338.140, 338.280, and 338.350, RSMo 2000.* Emergency rule filed Sept. 3, 2010, effective Sept. 13, 2010, expired March 11, 2011. Original rule filed March 7, 2011, effective Aug. 30, 2011. *Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009; 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.280, RSMo 1951, amended 1971, 1981; and 338.350, RSMo 1989, amended 1993, 1995.