Current through Register Vol. 39, No. 6, September 16, 2024
(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 research [other than research
described in Subparagraph (6) of this Paragraph] with controlled substances
listed in Schedules II through V;
(5) conducting instructional activities with
controlled substances listed in Schedule II through V;
(6) 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 claims investigational exemption
for a new drug approved by the Food and Drug Administration;
(7) conducting research and instructional
activities with controlled substances listed in Schedules I and VI;
(8) conducting chemical analysis with
controlled substances listed in any schedule;
(9) dispensing of controlled substances in
Schedules III-V for opioid treatment; and
(10) possessing or training with controlled
substances for the purpose of providing a commercial detection
service.
(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 activities
described in each Subparagraph of 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, the person complies with all requirements and duties
prescribed by law for persons registered to engage in such coincident
activities as follows:
(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 the person is not registered to
manufacture.
(2) 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 nonnarcotic
controlled substances listed in those Schedules the personauthorized to
manufacture.
(3) A person
registered or authorized to conduct research with a basic class of controlled
substances listed in Schedules I and VI 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 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 Rule
.0111 of this Section and to conduct instructional activities with controlled
substances.
(5) A person registered
or authorized to conduct research [other than research described in Paragraph
(a)(6) of this Rule] 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 the person 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 and to distribute such substances to other persons registered or
authorized to conduct chemical analysis, instructional activities or research
with such substances and to persons exempted from registration pursuant to Rule
.0111of this Section and to conduct instructional activities with controlled
substances.
(6) A person registered
to dispense controlled substances listed in Schedules II through V shall be
authorized to conduct research [other than research described in Paragraph
(a)(6) of this Rule] and to conduct instructional activities 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 Schedules I and VI may conduct research with
any substance listed in Schedules I and VI for which the person has filed and
approved a research protocol from the Drug Enforcement
Administration.
Authority
G.S.
90-100;
90-101;
90-102.1;
143B-210(9);
Eff. June 30, 1978;
Amended Eff. February 1, 2005; July 1,
2004;
Pursuant to
G.S.
150B-21.3A, rule is necessary without
substantive public interest Eff. February 2,
2016.
