059-3 Wyo. Code R. § 3-5

Current through April 27, 2019
Section 3-5 - Separate Registration for Independent Activities

(a) The following six groups of activities are deemed to be independent of each other:

  • (i) Manufacturing controlled substances;
  • (ii) Distributing controlled substances;
  • (iii) Dispensing, conducting research with (other than research described in subparagraph (4) of this paragraph), and conducting instructional activities with controlled substances listed in Schedules II through V;
  • (iv) Conducting research with narcotic drugs listed in Schedules II through V for the purpose of continuing the dependence on such drugs of a narcotic drug dependent person in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program pursuant to a Notice of Claimed Investigational Exemption for a New Drug approved by the Food and Drug Administration;
  • (v) Conducting research and instructional activities with controlled substances listed in Schedule I; and
  • (vi) Conducting chemical analysis with controlled substances listed in any schedule.

(b) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph.

  • (i) A person registered to manufacture any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class which he is not registered to manufacture;
  • (ii) A person registered to manufacture any controlled substance listed in Schedules II through V shall be authorized to conduct chemical analysis and preclinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;
  • (iii) A person registered to conduct research with a basic class of controlled substance listed in Schedule I shall be authorized to manufacture such class if and to the extent that such manufacture is set forth in the research protocol filed with the application for registration and to distribute such class to other persons registered to conduct research with such class or to conduct chemical analysis;
  • (iv) A person registered to conduct chemical analysis with controlled substance shall be authorized to manufacture such substances for analytical or instructional purposes, to distribute such substances to other persons registered to conduct chemical analysis or instructional activities, to persons registered or authorized to conduct research with such substances, and to conduct instructional activities with controlled substances;
  • (v) A person registered or authorized to conduct research (other than research described in paragraph (a) (4) of this section) with controlled substances listed in Schedules II through V shall be authorized to conduct chemical analysis with controlled substances listed in those schedules in which he is authorized to conduct research to manufacture is set forth in a statement filed with the application for registration, and to distribute such substances to other persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances, and to conduct instructional activities with controlled substances;
  • (vi) A person registered to dispense, or to conduct research (other than research described in paragraph (a) (4) of this section) with controlled substances listed in Schedules II through V shall be authorized to dispense and to conduct such research and to conduct instructional research with those substances.

(c) A single registration to engage in any group of independent activities may include one or more controlled substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I may conduct research with any substance listed in Schedule I for which he has filed and had approved a research protocol.

059-3 Wyo. Code R. § 3-5