Ill. Admin. Code tit. 77 § 3100.50

Current through Register Vol. 48, No. 45, November 8, 2024

Section 3100.50 - Separate Licensure 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;

4) Conducting instructional activities with controlled substances listed in Schedules II through V;

5) Conducting instructional activities with controlled substances listed in Schedule I;

6) 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 license for each group of activities, except as provided in this subsection. Any person, when licensed to engage in the group of activities described in subsections (b)(1) through (6), shall be authorized to engage in the coincident activities described in the specific subsection without obtaining a registration to engage in those coincident activities, provided that, unless specifically exempted, he or she complies with all requirements and duties prescribed by law for persons licensed to engage in those coincident activities:

1) A person licensed to manufacture any controlled substance shall be authorized to distribute that substance, but no other substances that he or she is not licensed to manufacture;

2) A person licensed to manufacture any controlled substance listed in Schedules II through V 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 or she is authorized to manufacture;

3) A person authorized by the appropriate agencies of the State of Illinois and the federal government to conduct research with a controlled substance shall be authorized to manufacture that substance if and to the extent that the manufacture is set forth in the research protocol filed with the application and to distribute that substance to other persons authorized to conduct research with that substance or to conduct chemical analysis;

4) A person licensed to conduct chemical analysis with controlled substances shall be authorized:

A) to manufacture and import those substances for analytical purposes, and distribute those substances to persons licensed or authorized to conduct chemical analysis, instructional activities or research with those substances or persons who are exempted from licensure pursuant to law; and

B) to export those substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries;

5) A person authorized by the appropriate agencies of the State of Illinois or the federal government to conduct research 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 or she is authorized to conduct research, to manufacture those substances if and to the extent that the manufacture is authorized by the appropriate agency, and to distribute those substances to other persons licensed or authorized to conduct chemical analysis or research with those substances and to persons exempted from licensure pursuant to law;

6) A person licensed to dispense controlled substances in Schedules II through V shall be authorized to conduct instructional activities with those substances.

c) A single license 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.

Ill. Admin. Code tit. 77, § 3100.50

Amended at 39 Ill. Reg. 3656, effective 2/27/2015