902 KAR 55:010.
Licensing of manufacturers and wholesalers.
RELATES TO: KRS
218A.150(1), 218A.160, 218A.170, 218A.200, 21 C.F.R. 210.1-210.3,
211.1-211.208, 1301.01-1301.93, 1304.01-1304.33
STATUTORY
AUTHORITY: KRS 194A.030, 194A.050, 211.090, 218A.150(1), 218A.250
NECESSITY,
FUNCTION, AND CONFORMITY: KRS 218A.150, 218A.160 and 218A.170 authorize the
Cabinet for Health Services to license manufacturers and wholesalers of
controlled substances. This administrative regulation establishes uniform
requirements for the licensing of manufacturers and wholesalers.
Section 1. Definitions. (1)
"Health care entity" means any organization, or business that
provides diagnostic, medical, surgical, dental treatment, or rehabilitative
care.
(2) "Manufacturer" means a
person engaged in the commercial manufacture of a controlled substance.
(3) "Wholesale
distribution" means distribution of a controlled substance to a person
other than a consumer or a patient, and shall not include:
(a) An intracompany sale; or
(b) A distribution by:
1. A charitable organization that
meets the criteria established in 26 USC 501(c)(3) to a nonprofit affiliate of
the organization to the extent permitted by law;
2. A hospital or health care entity
which is a member of a group-purchasing organization to other hospitals or
health care entities that are members of the organization; or
3. A pharmacy that is exempt pursuant
to 902 KAR 55:060.
(4) "Wholesaler" means a
person who is engaged in the wholesale distribution of a controlled substance,
including:
(a) Own-label distributor;
(b) Private-label distributor;
(c) Jobber;
(d) Broker;
(e) Warehouse, including a
manufacturers’ or distributors’ warehouse, chain drug warehouse, or wholesale
drug warehouse;
(f) Independent wholesale drug
trader; and
(g) Pharmacy that conducts wholesale
distributions.
Section 2. License Required and
Exceptions. (1) A separate license shall be required for each location from
which a manufacturer or wholesaler makes a wholesale distribution of a controlled
substance into the Commonwealth.
(2) If a location has more than one
(1) registration with the Drug Enforcement Administration, each registrant that
distributes in the Commonwealth shall obtain a separate license.
(3) A license to distribute controlled
substances shall not be transferred or assigned.
(4) A license shall not be required
for an agent or employee of a licensee if the agent or employee is acting in
the usual course of business or employment.
Section 3. Application for License or
Renewal. (1) An application for a manufacturer’s or wholesaler’s license shall
be submitted to the Cabinet for Health Services on "Application for New
License as Manufacturer or Wholesaler of Controlled Substances", DCB-10
form, and include the following information:
(a) The name, business address and
telephone number of the prospective licensee;
(b) All trade or business names used
by the licensee;
(c) Name, address, and telephone
number of each contact person for controlled substance handling, storage, and
recordkeeping;
(2) An application for a
manufacturer’s or wholesaler’s license shall include the following information
about the ownership of the business:
(a) The type of ownership of
operation;
(b) If an individual or sole
proprietorship, the full name of the individual or proprietor and the name of
the business entity;
(c) If a partnership, the name and
address of each partner and the name of the partnership;
(d) If a limited liability company,
the name and address of each manager and member; and
(e) If a corporation, the name and
title of each corporate officer and director, the corporate names, and the
names of the state of incorporation.
(3) A description of the business,
the physical facilities, and the type security provided.
(4) A change in the information
required by subsection (1), (2), or (3) shall be submitted to the cabinet:
(a) Within thirty (30) days from the
date of the change, or at the time of license renewal, whichever occurs first;
and
(b) On a "License Update
Manufacturer or Wholesaler of Controlled Substances", DCB-11 or an
"Application for Renewal License as Manufacturer or Wholesaler of
Controlled Substances", DCB-12.
Section 4. Qualifications for License
or Renewal. (1) The cabinet shall consider the following factors in reviewing
the qualifications of an applicant to engage in the manufacture or wholesale
distribution of controlled substances:
(a) A conviction of the applicant or
its managing officers under any federal, state, or local law relating to
controlled substances;
(b) A felony conviction of the
applicant or its managing officers;
(c) An applicant’s history with state
or federal regulatory agencies as related to the manufacture or distribution of
controlled substances;
(d) The furnishing of false or
fraudulent information in connection with an application for a license from a
federal, state or local government agency;
(e) Suspension or revocation by
federal, state, or local government of a license currently or previously held
by the applicant for the manufacture or distribution of controlled substances;
(f) Compliance with licensing
requirements under previously granted licenses, if any;
(g) Compliance with requirements to
maintain or make available to the cabinet or to federal, state, or local law
enforcement officials those records required by KRS 218A.200;
(h) The criteria listed in KRS
218A.160; and
(i) Violations of applicable federal
law, rule or regulation or state law, or administrative regulation governing a
controlled substance that relates to Current Good Manufacturing Practice in
Manufacturing, Processing, Packing, or Holding of Drugs in 21 CFR 210.1 to
210.3 or Current Good Manufacturing Practice for Finished Pharmaceuticals in 21
CFR 211.1 to 211.208, adopted by the U.S. Food and Drug Administration.
(2) A license shall be renewed if the
cabinet finds that the applicant:
(a) Qualifies for a license pursuant
to subsection (1) of this section;
(b) Complies with Registration of
Manufacturers, Distributors, and Dispensers of Controlled Substances 21 CFR
1301.01 through 1301.93, adopted by the Drug Enforcement Administration;
(c) Complies with Records and Reports
of Registrants 21 CFR 1304.01 through 1304.33, adopted by the U.S. Drug
Enforcement Administration;
(d) Complies with KRS 315.036 and 201
KAR 2:105; and
(e) Complies with KRS 218A.200.
(3) A manufacturer or wholesaler not
located within the Commonwealth of Kentucky may obtain a license or license
renewal on the basis of reciprocity if:
(a) The out-of-state manufacturer or
wholesaler possesses a valid license granted by another state and the legal
standards for licensure in the other state are no less stringent than the
standards established by this administrative regulation;
(b) The out-of-state manufacturer or
wholesaler is currently registered with the U.S. Drug Enforcement
Administration; and
(c) The state in which it is licensed
extends reciprocity to manufacturers and distributors licensed by Kentucky.
(4) All administrative hearings shall
be conducted in accordance with 902 KAR 1:400.
Section 5.
License Fees; Renewals. (1) An application for a license under the provisions
of this administrative regulation shall be submitted to the Cabinet for Health
Services on an "Application for New License as Manufacturer or Wholesaler
of Controlled Substances" DCB-10 form and shall be accompanied by a
license fee of $240.
(2) An
application to renew a license shall be submitted to the Cabinet for Health
Services on an "Application for Renewal License as Manufacturer or
Wholesaler of Controlled Substances", DCB-12 form, and shall be
accompanied by a renewal fee of $175.
Section 6. Recordkeeping. (1)
Records shall be maintained in accordance with KRS 218A.200 and with 21 CFR
1304.01 to 1304.33, adopted by the U.S. Drug Enforcement Administration.
(2) Records or copies of records that
relate to distributions within the Commonwealth shall be made available to the
cabinet upon request.
Section 7. License Termination, Lapse,
Suspension or Revocation. (1) A license issued pursuant to this administrative
regulation shall be suspended or revoked for cause.
(2) A license shall terminate if the
licensee dies or ceases legal existence.
(3) A license shall lapse if the
renewal application and renewal fee have not been filed with the cabinet prior
to June 30 of each year.
(4) A lapsed license shall be void
and an application for a new license shall be required.
(5) All administrative hearings shall
be conducted in accordance with 902 KAR 1:400.
Section 8. Incorporation by
Reference. (1) The following material is incorporated by reference:
(a) "Application for New License
as Manufacturer or Wholesaler of Controlled Substances (8/98)", DCB-10;
(b) "License Update Manufacturer
or Wholesaler of Controlled Substances (8/98)", DCB-11;
(c) "Application for Renewal
License as Manufacturer or Wholesaler of Controlled Substances (8/98)",
DCB-12.
(2) This material may be inspected,
copied, or obtained at the Cabinet for Health Services, Department for Public
Health, Drug Control and Professional Practices, 275 East Main Street,
Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. - 4:30 p.m. (Recodified from 901 KAR 1:010, 4-14-82; Am. 8
Ky.R. 1181; 1601; eff. 6-25-82; 11 Ky.R. 1673; eff. 6-4-85; 14 Ky.R. 2084; eff.
6-22-88; 17 Ky.R. 136; eff. 9-13-90; 22 Ky.R. 2480; 8-1-96; 25 Ky.R. 625; 1628;
eff. 1-19-99.)
