§ 333.17704

333.17704 Definitions; F to I.Sec. 17704. (1) 'Federal act' means the federal food, drug, and cosmetic act, 21 USC 301 to 399h. (2) 'Food and Drug Administration' or 'FDA' means the United States Food and Drug Administration. (3) 'Generic name' means the established or official name of a drug or drug product. (4) 'Harmful drug' means a drug intended for use by human beings that is harmful because of its toxicity, habit-forming nature, or other potential adverse effect; the method of its use; or the collateral measures necessary to its safe and effective use and that is designated as harmful by a rule promulgated under this part. (5) 'Interchangeable biological drug product' means either of the following, as applicable: (a) A biological drug product that is licensed by the FDA and that the FDA has determined meets the standards for interchangeability under 42 USC 262(k)(4). (b) Until March 23, 2021, a biological drug product that the FDA has determined to be therapeutically equivalent as set forth in 'Approved Drug Products with Therapeutic Equivalence Evaluations', an FDA publication that is commonly referred to as the 'Orange Book'.

as determined to be therapeutically equivalent as set forth in 'Approved Drug Products with Therapeutic Equivalence Evaluations', an FDA publication that is commonly referred to as the 'Orange Book'. (6) 'Internship' means an educational program of professional and practical experience for an intern. History: 1978, Act 368, Eff. Sept. 30, 1978 ;-- Am. 2014, Act 280, Eff. Sept. 30, 2014 ;-- Am. 2018, Act 41, Eff. May 29, 2018 Popular Name: Act 368