Current through Register Vol. 48, No. 9, September 27, 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 paragraph (a) (6) of this section) with controlled substances
listed in schedules II through V;
(5) Conducting instructional activities with
controlled substances listed in schedule II through V;
(6) Conducting a narcotic treatment program
using any drug listed in Schedules II through V: however, pursuant to §
109, employees, agents or
affiliated practitioners, in programs, need not register separately. Each
program site located away from the principal location and at which place
narcotic drugs are stored or dispensed shall be separately registered and
obtain narcotic drugs by use of order forms pursuant to §§901 and
902;
(7) Conducting research and
instructional activities with controlled substances listed in schedule
I;
(8) Conducting chemical analysis
with controlled substances listed in any schedules;
(9) Importing controlled
substances;
(10) Exporting
controlled substances listed in schedules I through IV;
(11) A compounder as defined by §
102(g);
and
(12) Automated storage machines
at long term care facilities.
(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 or
import 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 or import;
(2) A person registered 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 is authorized to manufacture;
(3) A person registered to conduct research
with a basic class of controlled substance listed in schedule I shall be
authorized to manufacture or import such class if and to the extent that such
manufacture and importation is set forth in the research protocol filed with
the application for registration which shall conform with the provisions of 21
CFR §1301.33, 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 to conduct chemical
analysis with controlled substances shall be authorized to manufacture and
import such substances for analytical or instructional purposes, to distribute
such substances to other persons registered to conduct chemical analysis or
instructional activities and to persons exempted from registration pursuant to
§
111, to export such substances to
persons in other countries performing chemical analysis or enforcing laws
relating to controlled substances or drugs in those countries, 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
section) with controlled substances listed in those schedules in which he or
she 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 import such substances for research purposes,
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 §
111, and to conduct instructional
activities with controlled substances; and
(6) A person registered to dispense
controlled substances listed in Schedules II through V may conduct research
(other than research described in paragraph (a) (6) of this section) in
conformity with the provisions of S.C. Code Ann. §
44-53-300(c)
and conduct instructional activities with those substances.
(c) A single registration to
engage in any group of independent activities may include one or more
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 or she has filed and had approved a research
protocol.
