Title 201 | Chapter 002 | Regulation 040
PREVIOUS VERSION
The previous document that this document is based upon is available.
201 KAR 2:040.Registration of pharmacist interns.
Section 1.
Definitions.(1)
"Academic experience program" means a course or series of courses taken by a pharmacist intern at a school or college of pharmacy approved by the board that involves actual practice of pharmacy experiences.(2)
"Pharmacist intern" is defined by KRS 315.010(18).(3)
"Preceptor" means the pharmacist who is responsible to the board for the practice of pharmacy experiences of a pharmacist intern.Section 2.
An applicant for registration as a pharmacist intern shall:(1)
File an Application for Registration as a Pharmacist Intern, Form I, with the board; and(2)
Submit proof of acceptance or graduation by a college or school of pharmacy approved by the board.Section 3.
An applicant for initial licensure as a pharmacist shall:(1)
Complete 1,500 hours of internship;(2)
Be awarded credit for internship for hours worked in a pharmacy or in related research during the time the pharmacist intern is enrolled in an approved school or college of pharmacy;(3)
Not be awarded credit for hours worked in a pharmacy or in related research during the period the pharmacist intern is completing the academic experience program;(4)
Be limited to internship credit:(a)
Of forty-eight (48) hours per week during non-academic sessions if the pharmacist intern is in good standing with a college or school of pharmacy and the board; and(b)
Of twenty (20) hours per week during academic sessions in a college or school of pharmacy. The maximum credit allowed for this enrolled time shall be 500 hours;(5)
Be given credit for the following forms of internship:(a)
Completion of an academic experience program;(b)
Work performed in a pharmacy under the supervision of a preceptor;(c)
Work or research related to the practice of pharmacy that was performed under the supervision of a preceptor for a government body, college or university, pharmacy business, or other entity if the pharmacist intern has received prior approval by the board. The maximum credit allowed for this time shall be 400 hours, and the pharmacist intern shall file an essay of at least 500 words describing the work or research experience and the relation of the work or research to the practice of pharmacy, which shall be approved by the board president; or(d)
An internship performed outside of Kentucky if the:1.
Requirements for internship in that state are at least equivalent to the requirements established in this administrative regulation; and2.
Board of licensure in that state has certified that the preceptor, pharmacy, government body, college or university, pharmaceutical business, or other entity is in good standing; and(6)
Not be awarded credit for an internship completed prior to registration with the board.Section 4.
A pharmacist intern shall:(1)
Be issued a Registration Identification Card;(2)
Carry the Registration Identification Card when on duty;(3)
Show it upon request to a member of the board or its authorized agent; and(4)
Notify the board within thirty (30) days of any charge of:(a)
A felony;(b)
A violation of drug laws; or(c)
A violation of alcohol laws.Section 5.
The registration of a pharmacist intern shall not be revoked if the intern is not currently enrolled in a college or school of pharmacy approved by the board if the board finds that:(1)
The intern is on a semester break; or(2)
Personal or family health concerns or other reasons beyond the control of the pharmacist intern necessitate a temporary absence from enrollment and the absence is approved by the board.Section 6.
A person who is not registered as a pharmacist intern shall not:(1)
Hold himself or herself out as a pharmacist intern; or(2)
Perform the duties of a pharmacist intern.Section 7.
(1)
A preceptor shall be a pharmacist who:(a)
Has a license in good standing;(b)
Has been licensed by the board for at least one (1) year; and(c)
Has requested in writing to be designated as a preceptor.(2)
A preceptor shall be actively engaged in the practice of pharmacy in the location where the pharmacist intern performs his or her internship.(3)
The preceptor shall supervise only one (1) pharmacist intern at a time for the purpose of the intern obtaining credit for the practice of pharmacy experience unless the pharmacist is supervising interns as a faculty member at a school or college pharmacy approved by the board during an academic experience program.Section 8.
Credit for Non-Academic Experience Programs.(1)
Within ten (10) days of beginning an internship credit for non-academic experience program, a pharmacist intern shall submit a Pharmacist Preceptor's Affidavit, Form II.(2)
On or before graduation from a college or school of pharmacy, a pharmacist intern shall submit an Internship Report, Form III.Section 9.
Credit for Academic Experience Programs.(1)
For a Doctor of Pharmacy degree, credit shall be awarded for each hour of successful completion of an academic experience program at a college or school of pharmacy approved by the board.(2)
An academic experience program shall be reported on an Academic Experience Affidavit, Form IV, which shall be filed with the board upon completion of the academic experience program or prior to certification for examination.Section 10.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Registration as a Pharmacist Intern", Form I, 08/2023;(b)
"Pharmacist Preceptor's Affidavit", Form II, 08/2023;(c)
"Internship Report", Form III, 08/2023; and(d)
"Academic Experience Affidavit", Form IV, 08/2023.(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 Web site at https://pharmacy.ky.gov/professionals/Pages/Pharmacist-Interns.aspx.HISTORY: (Rx-6; 1 Ky.R. 9; eff. 9-11-74; Am. 9 Ky.R. 247; eff. 9-8-82; 11 Ky.R. 1125; eff. 3-12-85; 16 Ky.R. 795; eff. 1-12-90; 25 Ky.R. 2187; 2832; eff. 6-16-99; 26 Ky.R. 1023; 1404; eff. 1-12-2000; 34 Ky.R. 1095; 1703; eff. 2-1-2008; 39 Ky.R. 1051; 1372; eff. 2-1-2013; 41 Ky.R. 300; 739; eff. 10-15-2014; 47 Ky.R. 2029; 48 Ky.R. 22; eff. 7-21-2021; 50 Ky.R. 719; eff. 12-13-2023.)
CHRISTOPHER HARLOW, Executive Director
APPROVED BY AGENCY: August 14, 2023
FILED WITH LRC: August 14, 2023 at 3:00 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on October 24th, at 9:00 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 October 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 professional responsibilities of a pharmacist supervising a pharmacist intern and a pharmacist intern.
(b) The necessity of this administrative regulation:
KRS 315.191(1)(a) requires the board to promulgate administrative regulations necessary to regulate and control the practice of pharmacists. This administrative regulation establishes the professional responsibilities of a pharmacist and a pharmacist intern under supervision.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 315.050 requires the Board to promulgate regulations to ensure appropriate oversight of pharmacist interns.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures pharmacist interns are appropriately credentialed and supervised, as the statutory provisions require.
(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:
This amendment removes language that conflicts with KRS 315.050 and removes the section five which prevented a pharmacist licensed in another state from applying to be an intern if they are no longer in school.
(b) The necessity of the amendment to this administrative regulation:
This amendment was necessary to ensure congruence with KRS 315.050.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment ensures the regulation is congruent with statutory language.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment ensures the regulation is congruent with statutory language.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
The Board anticipates pharmacy students to be most impacted by this regulation.
(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:
Pharmacy students or those awaiting full licensure will need to familiarize themselves with the language of the regulation.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There are no expected costs to comply with this regulation.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Pharmacist students and those awaiting licensure will benefit from compliance with this regulation.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
no costs incurred.
(b) On a continuing basis:
no costs incurred.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Board revenues from pre-existing 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:
No increase in fees or funding will be required.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not establish fees or directly or indirectly increase any fees.
(9) TIERING: Is tiering applied?
Tiering is not applied because the regulation is applicable to all pharmacy students or pharmacists from another state applying to be a pharmacist intern.
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 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)(a).
(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?
This administrative regulation will not generate revenue for the board in the first year.
(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?
This administrative regulation will not generate revenue for the board in subsequent years.
(c) How much will it cost to administer this program for the first year?
No costs are required to administer this program the first year.
(d) How much will it cost to administer this program for subsequent years?
No costs are required to administer this program for subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
0
Expenditures (+/-):
0
Other Explanation:
not applicable.
(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?
There will be no cost savings for the regulated entity during the first year.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
There will be no cost savings for the regulated entity for subsequent years.
(c) How much will it cost the regulated entities for the first year?
There should be no costs for the regulated entities during the first year.
(d) How much will it cost the regulated entities for subsequent years?
There should be no costs for the regulated entities for subsequent years.
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 (+/-):
0
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.
201 KAR 2:040.Registration of pharmacist interns.
Section 1.
Definitions.(1)
"Academic experience program" means a course or series of courses taken by a pharmacist intern at a school or college of pharmacy approved by the board that involves actual practice of pharmacy experiences.(2)
"Pharmacist intern" is defined by KRS 315.010(18).(3)
"Preceptor" means the pharmacist who is responsible to the board for the practice of pharmacy experiences of a pharmacist intern.Section 2.
An applicant for registration as a pharmacist intern shall:(1)
File an Application for Registration as a Pharmacist Intern, Form I, with the board; and(2)
Submit proof of acceptance or graduation by a college or school of pharmacy approved by the board.Section 3.
An applicant for initial(1)
Complete 1,500 hours of internship;(2)
Be awarded credit for internship for hours worked in a pharmacy or in related research during the time the pharmacist intern is enrolled in an approved school or college of pharmacy;(3)
Not be awarded credit for hours worked in a pharmacy or in related research during the period the pharmacist intern is completing the academic experience program;(4)
Be limited to internship credit:(a)
Of forty-eight (48) hours per week during non-academic sessions if the pharmacist intern is in good standing with a college or school of pharmacy and the board; and(b)
Of twenty (20) hours per week during academic sessions in a college or school of pharmacy. The maximum credit allowed for this enrolled time shall be 500 hours;(5)
Be given credit for the following forms of internship:(a)
Completion of an academic experience program;(b)
Work performed in a pharmacy under the supervision of a preceptor;(c)
Work or research related to the practice of pharmacy that was performed under the supervision of a preceptor for a government body, college or university, pharmacy business, or other entity if the pharmacist intern has received prior approval by the board. The maximum credit allowed for this time shall be 400 hours, and the pharmacist intern shall file an essay of at least 500 words describing the work or research experience and the relation of the work or research to the practice of pharmacy, which shall be approved by the board president; or(d)
An internship performed outside of Kentucky if the:1.
Requirements for internship in that state are at least equivalent to the requirements established in this administrative regulation; and2.
Board of licensure in that state has certified that the preceptor, pharmacy, government body, college or university, pharmaceutical business, or other entity is in good standing; and(6)
Not be awarded credit for an internship completed prior to registration with the board.Section 4.
A pharmacist intern shall:(1)
Be issued a Registration Identification Card;(2)
Carry the Registration Identification Card when on duty;(3)
Show it upon request to a member of the board or its authorized agent; and(4)
Notify the board within thirty (30) days of any charge of:(a)
A felony;(b)
A violation of drug laws; or(c)
A violation of alcohol laws.Section 5.
(1)
(a)
(b)
(2)
(3)
Section 6.
The registration of a pharmacist intern shall not be revoked if the intern is not currently enrolled in a college or school of pharmacy approved by the board if the board finds that:(1)
The intern is on a semester break; or(2)
Personal or family health concerns or other reasons beyond the control of the pharmacist intern necessitate a temporary absence from enrollment and the absence is approved by the board.Section 6.Section 7.
A person who is not registered as a pharmacist intern shall not:(1)
Hold himself or herself out as a pharmacist intern; or(2)
Perform the duties of a pharmacist intern.Section 7.Section 8.
(1)
A preceptor shall be a pharmacist who:(a)
Has a license in good standing;(b)
Has been licensed by the board for at least one (1) year; and(c)
Has requested in writing to be designated as a preceptor.(2)
A preceptor shall be actively engaged in the practice of pharmacy in the location where the pharmacist intern performs his or her internship.(3)
The preceptor shall supervise only one (1) pharmacist intern at a time for the purpose of the intern obtaining credit for the practice of pharmacy experienceSection 8.Section 9.
Credit for Non-Academic Experience Programs.(1)
Within ten (10) days of beginning an internship credit for non-academic experience program, a pharmacist intern shall submit a Pharmacist Preceptor's Affidavit, Form II.(2)
On or before graduation from a college or school of pharmacy, a pharmacist intern shall submit an Internship Report, Form III.Section 9.Section 10.
Credit for Academic Experience Programs.(1)
For a Doctor of Pharmacy degree, credit shall be awarded for each hour of successful completion of an academic experience program at a college or school of pharmacy approved by the board.(2)
An academic experience program shall be reported on an Academic Experience Affidavit, Form IV, which shall be filed with the board upon completion of the academic experience program or prior to certification for examination.Section 10.Section 11.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Registration as a Pharmacist Intern", Form I, 08/2023(b)
"Pharmacist Preceptor's Affidavit", Form II, 08/2023(c)
"Internship Report", Form III, 08/2023(d)
"Academic Experience Affidavit", Form IV, 08/2023(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 Web site at https://pharmacy.ky.gov/professionals/Pages/Pharmacist-Interns.aspx.HISTORY: (Rx-6; 1 Ky.R. 9; eff. 9-11-74; Am. 9 Ky.R. 247; eff. 9-8-82; 11 Ky.R. 1125; eff. 3-12-85; 16 Ky.R. 795; eff. 1-12-90; 25 Ky.R. 2187; 2832; eff. 6-16-99; 26 Ky.R. 1023; 1404; eff. 1-12-2000; 34 Ky.R. 1095; 1703; eff. 2-1-2008; 39 Ky.R. 1051; 1372; eff. 2-1-2013; 41 Ky.R. 300; 739; eff. 10-15-2014; 47 Ky.R. 2029; 48 Ky.R. 22; eff. 7-21-2021; 50 Ky.R. 719; eff. 12-13-2023.)
CHRISTOPHER HARLOW, Executive Director
APPROVED BY AGENCY: August 14, 2023
FILED WITH LRC: August 14, 2023 at 3:00 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on October 24th, at 9:00 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 October 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 professional responsibilities of a pharmacist supervising a pharmacist intern and a pharmacist intern.
(b) The necessity of this administrative regulation:
KRS 315.191(1)(a) requires the board to promulgate administrative regulations necessary to regulate and control the practice of pharmacists. This administrative regulation establishes the professional responsibilities of a pharmacist and a pharmacist intern under supervision.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 315.050 requires the Board to promulgate regulations to ensure appropriate oversight of pharmacist interns.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures pharmacist interns are appropriately credentialed and supervised, as the statutory provisions require.
(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:
This amendment removes language that conflicts with KRS 315.050 and removes the section five which prevented a pharmacist licensed in another state from applying to be an intern if they are no longer in school.
(b) The necessity of the amendment to this administrative regulation:
This amendment was necessary to ensure congruence with KRS 315.050.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment ensures the regulation is congruent with statutory language.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment ensures the regulation is congruent with statutory language.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
The Board anticipates pharmacy students to be most impacted by this regulation.
(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:
Pharmacy students or those awaiting full licensure will need to familiarize themselves with the language of the regulation.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There are no expected costs to comply with this regulation.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Pharmacist students and those awaiting licensure will benefit from compliance with this regulation.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
no costs incurred.
(b) On a continuing basis:
no costs incurred.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Board revenues from pre-existing 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:
No increase in fees or funding will be required.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not establish fees or directly or indirectly increase any fees.
(9) TIERING: Is tiering applied?
Tiering is not applied because the regulation is applicable to all pharmacy students or pharmacists from another state applying to be a pharmacist intern.
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 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)(a).
(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?
This administrative regulation will not generate revenue for the board in the first year.
(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?
This administrative regulation will not generate revenue for the board in subsequent years.
(c) How much will it cost to administer this program for the first year?
No costs are required to administer this program the first year.
(d) How much will it cost to administer this program for subsequent years?
No costs are required to administer this program for subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
0
Expenditures (+/-):
0
Other Explanation:
not applicable.
(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?
There will be no cost savings for the regulated entity during the first year.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
There will be no cost savings for the regulated entity for subsequent years.
(c) How much will it cost the regulated entities for the first year?
There should be no costs for the regulated entities during the first year.
(d) How much will it cost the regulated entities for subsequent years?
There should be no costs for the regulated entities for subsequent years.
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 (+/-):
0
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.