R156-17b-617e. Class E Pharmacy Operating Standards - Human Clinical Investigational Drug Research Facility

(1) Under Section 58-17b-302 and Subsection 58-17b-601(1), a human clinical investigational drug research facility licensed as a Class E pharmacy shall, in addition to the requirements in Section R156-17b-617a, conduct operations in accordance with the operating standards set forth in 21 CFR Part 312, April 1, 2012 edition, which is incorporated by reference. (2) Under Subsections 58-37-6(2)(b) and (3)(a)(i), persons licensed to conduct research in Utah with controlled substances in Schedules I-V may possess, manufacture, produce, distribute, prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon those substances to the extent authorized by their license. (3) Under Subsection 58-37-6(2), the following persons are not required to obtain a license and may lawfully possess controlled substances in Schedules II-V: (a) an agent or employee acting in the usual course of the person's business or employment, and (b) an ultimate user, or a person who possesses a controlled substance pursuant to a lawful order of a practitioner. (4) A separate license is required at each principal place of business or professional practice where the applicant manufactures, produces, distributes, dispenses, conducts research with, or performs laboratory analysis upon controlled substances.