Title 201 | Chapter 002 | Regulation 050
SUPERSEDED
This document is no longer current.
PREVIOUS VERSION
The previous document that this document is based upon is available.
BOARDS AND COMMISSIONS
Board of Pharmacy
(Amendment)
201 KAR 2:050.Licenses and permits; fees.
Section 1.
The following fees shall be paid in connection with pharmacist examinations and licenses, pharmacy permits, intern certificates, and the issuance and renewal of licenses and permits:(1)
Application for initial pharmacist license - $150;(2)
Application and initial license for a pharmacist license by license transfer - $250;(3)
Annual renewal of a pharmacist license - ninety-five (95) dollars;(4)
Delinquent renewal penalty for a pharmacist license - ninety-five (95) dollars;(5)
Annual renewal of an inactive pharmacist license - ten (10) dollars;(6)
Pharmacy intern certificate valid six (6) years - twenty-five (25) dollars;(7)
Duplicate of original pharmacist license wall certificate - seventy-five (75) dollars;(8)
Application for a permit to operate a pharmacy - $150(9)
Renewal of a permit to operate a pharmacy - $150(10)
Delinquent renewal penalty for a permit to operate a pharmacy - $150(11)
Change of location or change of ownership of a pharmacy or manufacturer permit - $150(12)
Application for a permit to operate as a manufacturer - $150(13)
Renewal of a permit to operate as a manufacturer - $150(14)
Delinquent renewal penalty for a permit to operate as a manufacturer - $150(15)
Change of location or change of ownership of a wholesale distributor license - $150(16)
Application for a license to operate as a wholesale distributor -$150(17)
Renewal of a license to operate as a wholesale distributor -$150(18)
Delinquent renewal penalty for a license to operate as a wholesale distributor -$150(19)
Query to the National Practitioner Data Bank of the United States Department of Health and Human Services - twenty-five (25) dollars;Section 2.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Non-Resident Pharmacy Permit, Form 3, 6/2023(b)
Application for Non-Resident Pharmacy Permit Renewal, Form 4, 6/2023(c)
Application for Permit to Operate a Pharmacy in Kentucky, Form 1, 6/2023(d)
Application for Resident Pharmacy Permit Renewal, Form 2, 6/2023(2)
This material may be inspected, copied, or obtained subject to applicable copyright law, at the Kentucky Board of Pharmacy, State Office Building Annex, Suite 300, 125 Holmes Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. This material is also available on the board's website at https://pharmacy.ky.gov/Businesses/Pages/Pharmacy.aspx.CHRISTOPHER HARLOW, Executive Director
APPROVED BY AGENCY: June 7, 2023
FILED WITH LRC: June 7, 2023 at 1:45 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on August 30, 2023, at 10:00 a.m. Eastern Time via zoom teleconference. Individuals interested in being heard at this hearing shall notify this agency in writing by five workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through August 31, 2023. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Christopher Harlow
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the fees associated with Board of Pharmacy licensure.
(b) The necessity of this administrative regulation:
KRS 315.191(1)(i) authorizes the Board of Pharmacy to assess reasonable fees for services rendered to perform its duties and responsibilities. This administrative regulation establishes reasonable fees for the board to perform all the functions for which it is responsible.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation establishes reasonable fees for the board to perform all the functions for which it is reasonable.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This regulation allows for the funding to support Board administration.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
The amendment increases fees for facilities permitted by the Board.
(b) The necessity of the amendment to this administrative regulation:
This administrative regulation is necessary to ensure the Board is appropriately funded to cover personnel costs and comply with the administrative functions required for pharmacies, wholesale distributors, and manufacturers.
(c) How the amendment conforms to the content of the authorizing statutes:
The KRS 315.191(1)(i) authorizes the Board of Pharmacy to assess reasonable fees for services rendered to perform its duties and responsibilities.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment will further promote, preserve, and protect public health through effective regulation of permitted entities.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
The board anticipates pharmacists will be affected minimally by this regulation amendment. Pharmacies, manufacturers and wholesale distributors will have increased fees of twenty-five dollars (25) for a new or a renewal license or permit. The application for change in location or change in ownership will have the same fee as the new and renewal applications because they require completion of a new application.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
During renewal, the identified entities will have an increased permitting fee to pay.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
Cost of compliance for pharmacies, wholesale distributors, and manufacturers will be $150.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
These entities will have the benefit of ensured compliance with federal law due to the state adoption of the federal licensing standards.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
No costs will be incurred.
(b) On a continuing basis:
No costs will be incurred. Other explanation: n/a
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Board revenues from fees provide the funding to enforce the regulation.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
Yes, this regulation assesses an increase in fees. The increase in fees are necessary to properly fund the Board for the administrative activities related to licensing and inspection to ensure the Board is achieving its mission of public and patient safety.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
Yes, fees for pharmacies, manufacturers, and wholesale distributors.
(9) TIERING: Is tiering applied?
No. Tiering is not applied because the regulation is applicable to all pharmacies, wholesale distributors, and manufacturers.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
The Kentucky Board of Pharmacy will be the only entity impacted by this administrative regulation.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 315.191(1)(i); 315.035(4); 315.036(1); 315.110(1).
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
The proposed amendment will increase revenue by $91,925.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
The proposed amendment will increase revenue by $91,925.
(c) How much will it cost to administer this program for the first year?
The Board of Pharmacy does not anticipate any additional cost to administer this regulation for the first year.
(d) How much will it cost to administer this program for subsequent years?
The Board of Pharmacy does not anticipate any additional cost to administer this regulation for the first year.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Amendment will provide an annual $91,925 in revenue.
Expenditures (+/-):
0
Other Explanation:
n/a
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
None.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
None.
(c) How much will it cost the regulated entities for the first year?
$150 per permit.
(d) How much will it cost the regulated entities for subsequent years?
$150 annually.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
0
Expenditures (+/-):
-$150
Other Explanation:
n/a
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This regulation does not have major economic impact.
BOARDS AND COMMISSIONS
Board of Pharmacy
(Amendment)
201 KAR 2:050.Licenses and permits; fees.
Section 1.
The following fees shall be paid in connection with pharmacist examinations and licenses, pharmacy permits, intern certificates, and the issuance and renewal of licenses and permits:(1)
Application for initial pharmacist license - $150;(2)
Application and initial license for a pharmacist license by license transfer - $250;(3)
Annual renewal of a pharmacist license - ninety-five (95) dollars;(4)
Delinquent renewal penalty for a pharmacist license - ninety-five (95) dollars;(5)
Annual renewal of an inactive pharmacist license - ten (10) dollars;(6)
Pharmacy intern certificate valid six (6) years - twenty-five (25) dollars;(7)
Duplicate of original pharmacist license wall certificate - seventy-five (75) dollars;(8)
Application for a permit to operate a pharmacy - $150;(9)
Renewal of a permit to operate a pharmacy - $150;(10)
Delinquent renewal penalty for a permit to operate a pharmacy - $150 dollars;(11)
Change of location or change of ownership of a pharmacy or manufacturer permit - $150;(12)
Application for a permit to operate as a manufacturer - $150;(13)
Renewal of a permit to operate as a manufacturer - $150;(14)
Delinquent renewal penalty for a permit to operate as a manufacturer - $150;(15)
Change of location or change of ownership of a wholesale distributor license - $150;(16)
Application for a license to operate as a wholesale distributor -$150;(17)
Renewal of a license to operate as a wholesale distributor -$150;(18)
Delinquent renewal penalty for a license to operate as a wholesale distributor -$150; and(19)
Query to the National Practitioner Data Bank of the United States Department of Health and Human Services - twenty-five (25) dollars;Section 2.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Non-Resident Pharmacy Permit, Form 3, 6/2023(b)
Application for Non-Resident Pharmacy Permit Renewal, Form 4, 6/2023(c)
Application for Permit to Operate a Pharmacy in Kentucky, Form 1, 6/2023(d)
Application for Resident Pharmacy Permit Renewal, Form 2, 6/2023(2)
This material may be inspected, copied, or obtained subject to applicable copyright law, at the Kentucky Board of Pharmacy, State Office Building Annex, Suite 300, 125 Holmes Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. This material is also available on the board's website at https://pharmacy.ky.gov/Businesses/Pages/Pharmacy.aspx.CHRISTOPHER HARLOW, Executive Director
APPROVED BY AGENCY: June 7, 2023
FILED WITH LRC: June 7, 2023 at 1:45 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on August 30, 2023, at 10:00 a.m. Eastern Time via zoom teleconference. Individuals interested in being heard at this hearing shall notify this agency in writing by five workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through August 31, 2023. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Christopher Harlow
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the fees associated with Board of Pharmacy licensure.
(b) The necessity of this administrative regulation:
KRS 315.191(1)(i) authorizes the Board of Pharmacy to assess reasonable fees for services rendered to perform its duties and responsibilities. This administrative regulation establishes reasonable fees for the board to perform all the functions for which it is responsible.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation establishes reasonable fees for the board to perform all the functions for which it is reasonable.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This regulation allows for the funding to support Board administration.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
The amendment increases fees for facilities permitted by the Board.
(b) The necessity of the amendment to this administrative regulation:
This administrative regulation is necessary to ensure the Board is appropriately funded to cover personnel costs and comply with the administrative functions required for pharmacies, wholesale distributors, and manufacturers.
(c) How the amendment conforms to the content of the authorizing statutes:
The KRS 315.191(1)(i) authorizes the Board of Pharmacy to assess reasonable fees for services rendered to perform its duties and responsibilities.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment will further promote, preserve, and protect public health through effective regulation of permitted entities.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
The board anticipates pharmacists will be affected minimally by this regulation amendment. Pharmacies, manufacturers and wholesale distributors will have increased fees of twenty-five dollars (25) for a new or a renewal license or permit. The application for change in location or change in ownership will have the same fee as the new and renewal applications because they require completion of a new application.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
During renewal, the identified entities will have an increased permitting fee to pay.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
Cost of compliance for pharmacies, wholesale distributors, and manufacturers will be $150.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
These entities will have the benefit of ensured compliance with federal law due to the state adoption of the federal licensing standards.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
No costs will be incurred.
(b) On a continuing basis:
No costs will be incurred. Other explanation: n/a
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Board revenues from fees provide the funding to enforce the regulation.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
Yes, this regulation assesses an increase in fees. The increase in fees are necessary to properly fund the Board for the administrative activities related to licensing and inspection to ensure the Board is achieving its mission of public and patient safety.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
Yes, fees for pharmacies, manufacturers, and wholesale distributors.
(9) TIERING: Is tiering applied?
No. Tiering is not applied because the regulation is applicable to all pharmacies, wholesale distributors, and manufacturers.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
The Kentucky Board of Pharmacy will be the only entity impacted by this administrative regulation.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 315.191(1)(i); 315.035(4); 315.036(1); 315.110(1).
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
The proposed amendment will increase revenue by $91,925.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
The proposed amendment will increase revenue by $91,925.
(c) How much will it cost to administer this program for the first year?
The Board of Pharmacy does not anticipate any additional cost to administer this regulation for the first year.
(d) How much will it cost to administer this program for subsequent years?
The Board of Pharmacy does not anticipate any additional cost to administer this regulation for the first year.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Amendment will provide an annual $91,925 in revenue.
Expenditures (+/-):
0
Other Explanation:
n/a
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
None.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
None.
(c) How much will it cost the regulated entities for the first year?
$150 per permit.
(d) How much will it cost the regulated entities for subsequent years?
$150 annually.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
0
Expenditures (+/-):
-$150
Other Explanation:
n/a
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This regulation does not have major economic impact.