856 Ind. Admin. Code 2-3-3

Current through December 25, 2024

Section 856 IAC 2-3-3 - Independent activities; separate registration required; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3; IC 35-48-3-4

Sec. 3.

Separate registration for independent activities.

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

(1) Manufacturing controlled substances;

(2) Distributing controlled substances;

(3) Dispensing controlled substances listed in Schedules II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] ;

(4) Conducting research (other than research described in sub-paragraph (6) of this paragraph) with controlled substances listed in Schedules II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] ;

(5) Conducting instructional activities with controlled substances listed in Schedules II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] ;

(6) Conducting research with narcotic drugs listed in Schedules II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] 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;

(7) Conducting research and instructional activities with controlled substances listed in Schedule I [856 IAC 2-2-2] ; and

(8) 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. Any person, when registered to engage in the group of activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described in that subparagraph without obtaining a registration to engage in such coincident activities, provided that, unless specifically exempted, he complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities:

(1) 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;

(2) A person registered to manufacture any controlled substance listed in Schedules II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] shall be authorized to conduct chemical analysis and pre-clinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;

(3) A person registered to conduct research with a basic class of controlled substance listed in Schedule I [856 IAC 2-2-2] shall be authorized to manufacture such class if and to the extent that such manufacture is set forth in a research protocol federally approved by the Drug Enforcement Administration and to distribute such class to other persons registered or authorized to conduct research with such class or registered or authorized to conduct chemical analysis with controlled substances;

(4) A person registered or authorized to conduct chemical analysis with controlled substances shall be authorized to manufacture such substances for analytical or instructional purposes, to distribute such substances to other persons registered or authorized to conduct chemical analysis or instructional activities or research with such substances and to persons exempted from registration pursuant to section 3.16 [856 IAC 2-3-7] , and to conduct instructional activities with controlled substances; and

(5) A person registered or authorized to conduct research (other than research described in paragraph (a)(6) of this section) with controlled substances listed in Schedules II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] shall be authorized to conduct chemical analysis with controlled substances listed in those schedules in which he is authorized to conduct research, to manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration, to distribute such substances to other persons registered or authorized to conduct chemical analysis, exempted from registration pursuant to Section 3.16 [856 IAC 2-3-7] , and to conduct instructional activities with controlled substances;

(6) A person registered to dispense controlled substances listed in Schedules II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] shall be authorized to conduct research (other than research described in paragraph (a) (6) of this section) and to conduct instructional activities with those substances.

(7) A person registered as a manufacturer shall be authorized to conduct one, all or several of the activities and coincident activities enumerated and described in paragraphs (b)(1), (b)(2), (b)(3), (b)(4), and (b)(5) under a single registration if set forth in his application and pertaining to those controlled substances or schedules as set forth in his application. (For example, a manufacturer under a single registration may perform all or any of the following activities, by way of illustration and not limitation; (a) manufacture and distribute any controlled substance or basic class, (b) chemical analysis, (c) Schedule I [856 IAC 2-2-2] research pursuant to a federally approved protocol, (d) Schedule II through V [856 IAC 2-2-3 T 856 IAC 2-2-6] research, and (e) instructional activity if set forth in his application and for those controlled substances or schedules as set forth for each activity.

(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 [856 IAC 2-2-2] may conduct research with any substance listed in Schedule I [856 IAC 2-2-2] for which he has filed and had approved a research protocol, by the Federal Drug Enforcement Administration.

856 IAC 2-3-3

Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.12; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA

Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA