(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.