Section 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.Utah Admin. Code R156-17b-617e
Amended by Utah State Bulletin Number 2023-02, effective 1/5/2023