New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › General Provisions › Section 80.5 - Licenses

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Licenses for
					 controlled substances privileges shall be issued by the department in the
					 following classifications:
Class Issued
								  to:
Manufacturers and
								  distributors
1
Manufacturer
1a
Manufacturer out-of-state
2
Distributor
2a
Distributor out-of-state
Institutional
								  dispenser
3
Institutional dispenser
3a
Institutional dispenser, limited
Research and
								  instructional
4
Researcher-II to V
4a
Researcher-special industrial II to V
5
Instructional activities-II to V
6
Treatment programs, methadone
6a
Treatment programs, methadone and other
								  substances
6b
Hospital pharmacies-detoxification, temporary
								  treatment
7
Research and instructional activities-I
8
Analytical laboratories
Importers and
								  exporters
9
Importer
9a
Importer broker
10
Exporter
10a
Exporter broker
Registered community
								  pharmacy
11
Registered community pharmacy-automated dispensing
								  system
(1) A
					 person licensed to manufacture or import any controlled substance shall be
					 authorized to distribute that substance, but no other substance which he is not
					 licensed to manufacture or import;
(2) A person licensed 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;
(3) A person licensed to conduct research
					 with a 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 license and to
					 distribute such class to other persons licensed or authorized to conduct
					 research with such class or licensed or authorized to conduct chemical analysis
					 with controlled substances;
(4) A
					 person licensed or authorized 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 licensed or authorized to conduct chemical analysis or instructional
					 activities or research with such substances and to persons exempted from
					 license pursuant to section 3305  of Public Health Law, 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;
					 and
(5) A person licensed or
					 authorized 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 is authorized to conduct
					 research to manufacturer such substances if, and to the extent that, such
					 manufacture is set forth in a statement filed with the application for license,
					 and to distribute such substances to other persons licensed or authorized to
					 conduct chemical analysis, instructional activities, or research with, such
					 substances and to persons exempted from licensing under section 3305  of the
					 Public Health Law, and to conduct instructional activities with controlled
					 substances;
(6) A person licensed
					 to dispense controlled substances listed in schedules II through V shall be
					 authorized to conduct research and to conduct instructional activities with
					 those substances.
(7) 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.
(8) A
					 separate license is required for each principal place of business or
					 professional practice at one general physical location where controlled
					 substances are manufactured, distributed or dispensed by a person.
(9) The following locations shall be deemed
					 not to be places where controlled substances are manufactured, distributed or
					 dispensed:
(i) a warehouse where controlled
					 substances are stored by or on behalf of a licensed person, unless such
					 substances are distributed directly from such warehouse other than the licensed
					 location from which the substances were delivered or to persons not required to
					 be licensed in accordance with section 3305  of the Public Health Law;
(ii) an office used by agents of a licensee
					 where sales of controlled substances are solicited, made or supervised, but
					 which neither contains such substances nor serves as a distribution point for
					 filling sales orders; and
(iii) an
					 office used by a practitioner (who is registered at another location) where
					 controlled substances are prescribed but neither administered nor otherwise
					 dispensed as a regular part of the professional practice of the practitioner at
					 such office, and where no supplies of controlled substances are
					 maintained.