902 KAR 55:010. Licensing of manufacturers and wholesalers

Link to law: http://www.lrc.ky.gov/kar/902/055/010.htm
Published: 2015

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      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.)