Section 80.5 - Licenses

80.5 Licenses. (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 manufacture 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.

(b) Holders of licenses shall register with the appropriate Federal agency or agencies in the comparable controlled substances schedule and license class provided for under Federal regulations.

(c) A controlled substances license shall be permanently displayed in the place to which it applies.

(d) No controlled substances license shall be considered valid and in good standing unless the indicated activity is conducted at the address stated therein and by the person in whose name the license has been issued and unless the license has been renewed as required.

(e) A controlled substances license shall be promptly returned to the department upon revocation or suspension, or when the activity for which the applicant is licensed has been discontinued.

(f) A registered community pharmacy licensed in class 11 and maintaining a separate registration with the Drug Enforcement Administration may install and operate automated dispensing systems in a Residential Health Care Facility (“RHCF”) which is licensed or approved by the Department.

(g) A registered community pharmacy operating an automated dispensing system as provided in paragraph (f) of this section shall provide to such system only those controlled substances obtained under the Drug Enforcement Administration registration of the registered community pharmacy and not the Drug Enforcement Administration registration of the automated dispensing system.

Effective Date: 
Wednesday, November 26, 2008
Doc Status: 
Complete