Title 201 | Chapter 002 | Regulation 045REG
PROPOSED
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PREVIOUS VERSION
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BOARDS AND COMMISSIONS
Board of Pharmacy
(Amendment)
201 KAR 2:045.Technicians.
Section 1.
Certified Pharmacy Technician Recognition.(1)
(a)
A person shall be recognized by the board as a certified pharmacy technician, if:(b)(a)
The person has successfully completed the Pharmacy Technician Certification Exam (PTCE) administered by the Pharmacy Technician Certification Board (PTCB) or the Examination for the Certification of Pharmacy Technicians (ExCPT) by the National Healthcareer Association (NHA); and(c)(b)
The certificate issued by the PTCB or NHA is current; or(2)
The person has successfully completed the Nuclear Pharmacy Technician Training Program at the University of Tennessee or other entity approved by the Board of Pharmacy.Section 2.
Registered Technician.(1)
A registered pharmacy technician may, under the immediate supervision of a pharmacist, engage in the following activities at a permitted location to the extent that the activities do not require the exercise of professional judgment:(a)
Initiate or receive telephonic or electronic communication from a practitioner or practitioner's agent concerning refill authorization. If the practitioner or practitioner's agent communicates information that does not relate to the refill authorization:1.
The technician shall immediately inform the pharmacist; and2.
The pharmacist shall receive the communication;(b)
Enter information into and retrieve information from a database or patient profile, including order entry;(c)
Prepare and affix labels;(d)
Stock and retrieve, or return product to or from the pharmacy inventory including the stocking and loading of an automated filling or dispensing system with the use of barcode technology;(e)
Count and pour prescription drugs into patient storage containers;(f)
Obtain, record or maintain information for a patient record;(g)
Make an offer to counsel;(h)
Sell and record the sale of an over-the-counter ephedrine, pseudoephedrine, or phenylpropanolamine product;(i)
Prepare for delivery unit dose mobile transport systems that have been refilled by another technician in an institutional pharmacy;(j)
Receive diagnostic orders within a nuclear pharmacy; and,(k)
Non-sterile and sterile drug compounding.(2)
A registered pharmacy technician may, under electronic supervision, perform order entry from a location outside of the permitted pharmacy pursuant to KRS 315.020(5)(b) and (c).(3)
A registered pharmacy technician may, under general supervision:(a)
Administer a vaccine to an individual if the technician:1.
Completes a minimum of two (2) hours of immunization-related continuing education accredited by the Accreditation Council for Pharmacy Education (ACPE) per each state registration period;2.
Completes, or has completed, a practical training program accredited by ACPE that includes hands-on injection technique and the recognition and treatment of emergency reactions to vaccines; and3.
Possesses a current certificate in basic cardiopulmonary resuscitation.(b)
Stock an automated dispensing system in a residential hospice facility if a pharmacist is on-site; and(c)
Administer point of care tests.Section 3.
Certified Pharmacy Technician. A certified pharmacy technician, under the general supervision of a pharmacist, may be delegated by the supervising pharmacist to perform any function within the practice of pharmacy except the following:(1)
Patient counseling, including clinical advisement necessary to all areas of a patient's health;(2)
Drug evaluation, utilization, and regimen review;(3)
Interpretation of medical orders and prescriptions;(4)
Final product verification;(5)
Receipt of new verbal prescription drug or medical orders; and(6)
Other acts, services, or decisions that require professional judgement.(1)
(2)
(3)
(a)
(b)
1.
2.
Section 4.Section 3.
Directing Pharmacist Responsibility.(1)
(2)
A function performed by a certified pharmacy technician or registered pharmacy technician shall be performed subject to the review of the pharmacist who directed the technician to perform the function.(2)(3)
A pharmacist who directs a certified pharmacy technician or registered pharmacy technician to perform a function shall be responsible for the technician and the performance of the function.Section 5.
Pharmacy Technician Application. An applicant shall provide the following information as part of their initial technician registration application:(1)
Name, maiden, and other names used currently or previously;(2)
telephone number;(3)
address;(4)
social security number;(5)
NABP eprofile number;(6)
email address;(7)
place of employment;(8)
Record of convictions of any felony or misdemeanor offense, other than traffic offenses, and whether or not a sentence was imposed or suspended;(9)
Record of any technician registration revocation, suspension, restriction, termination, or other disciplinary action by any board of pharmacy or other state authority;(10)
Record of licensure, certification or registration as a pharmacy technician in any other state, if applicable;(11)
Record of certification as a pharmacy technician with a national organization, if applicable; and(12)
if they are seeking registration solely as a charitable pharmacy technician.Section 6.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Registration as a Pharmacy Technician", 03/2025; and(b)
"Application for Pharmacy Technician Renewal", 03/2025.(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/statutesandregulations/Documents/Applications%20for%20Individuals%20-%20Incorporated%20By%20Reference.pdf.CHRISTOPHER HARLOW, Pharm.D, Executive Director
APPROVED BY AGENCY: March 6, 2025
FILED WITH LRC: March 6, 2025 at 4:00 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on May 28, 2025, at 10:00 a.m. Eastern Time at 125 Holmes Street, First Floor Conference Room and 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 May 31, 2025. 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 functions that pharmacy technicians are authorized to perform. This regulation also establishes the criteria for registration as a certified pharmacy technician.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to assist pharmacists in the practice of pharmacy. Without this regulation there is no indication as to what a pharmacy technician may or may not do.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 315.191(1)(a) provides the Board with the authority to promulgate administrative regulations necessary to regulate and control all matters set forth in KRS 315 relating to pharmacy technicians.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation provides clarity as to what technicians may or may not do. KRS 315.135 and KRS 315.136 authorize the registration of pharmacy technicians.
(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 provides detailed tasks that pharmacy technicians may perform and it creates delegated tasks that certified pharmacy technicians may perform.
(b) The necessity of the amendment to this administrative regulation:
This amendment was necessary to ensure that pharmacists were assisted in the practice of pharmacy to prevent pharmacies from being overwhelmed with prescription volume. This amendment is also narrowly tailored to ensure public protection.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to KRS 315.191(1)(a) and the authority to promulgate regulations to control and regulate pharmacy technicians.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment provides clarity as to what technicians may or may not do. KRS 315.135 and KRS 315.136 authorize the registration of pharmacy technicians.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
Pharmacies, pharmacists, pharmacy technicians and pharmacist interns will be impacted by this administrative 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:
Pharmacies, pharmacists, pharmacy technicians and pharmacist interns will have to familiarize themselves with the changes in tasks that pharmacy technicians may perform.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
It will not cost regulated entities anything to comply with the amendment.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Pharmacists will have a greater ability to have assistance from technicians, allowing them more time to spend with patients and providing clinical services. (5) Provide an estimate of how much it will cost to implement this administrative Regulation:
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
0
(b) On a continuing basis:
0
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
The Board will enforce this regulation through regular pharmacy inspections which are already funded through the Board’s budget.
(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:
There will be no fee increase with this administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
There are no fees established directly or indirectly by this regulation.
(9) TIERING: Is tiering applied?
Certified technicians are provided with the ability to perform more tasks, as delegated by a supervising pharmacist, because they have attained a level of competency with a national exam. A non-certified technician has no special education or credential.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 315.191(1)(a)
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
The promulgating agency is the Kentucky Board of Pharmacy. We do not anticipate any other state units to be impacted by this regulation.
(a) Estimate the following for the first year:
Expenditures:
0
Revenues:
0
Cost Savings:
0
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
They will still remain 0.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no local affected entities with the exception of the Board.
(a) Estimate the following for the first year:
Expenditures:
n/a
Revenues:
n/a
Cost Savings:
n/a
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
n/a
(4) Identify additional regulated entities not listed in questions (2) or (3):
Regulated entities will include pharmacies, pharmacists, and pharmacy technicians.
(a) Estimate the following for the first year:
Expenditures:
0
Revenues:
0
Cost Savings:
There could be some cost savings because a pharmacy technician may be able to perform a task previously reserved for a pharmacist only.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
They should remain the same.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
This regulation has no fiscal impact.
(b) Methodology and resources used to determine the fiscal impact:
An analysis of the Board’s budget and what it will take regulated entities to comply with this regulation.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
This administrative regulation will not have an overall negative or adverse major economic impact.
(b) The methodology and resources used to reach this conclusion:
The Board reviewed what it would cost permitted entities to comply with this statute.
BOARDS AND COMMISSIONS
Board of Pharmacy
(Amendment)
201 KAR 2:045.Technicians.
Section 1.
Certified Pharmacy Technician Recognition.(1)
(a)
A person shall be recognized by the board as a certified pharmacy technician, if:(b)
The person has successfully completed the Pharmacy Technician Certification Exam (PTCE) administered by the Pharmacy Technician Certification Board (PTCB) or the Examination for the Certification of Pharmacy Technicians (ExCPT) by the National Healthcareer Association (NHA); and(c)
The certificate issued by the PTCB or NHA is current; or(2)
The person has successfully completed the Nuclear Pharmacy Technician Training Program at the University of Tennessee or other entity approved by the Board of Pharmacy.Section 2.
Registered Technician.(1)
A registered pharmacy technician may, under the immediate supervision of a pharmacist, engage in the following activities at a permitted location to the extent that the activities do not require the exercise of professional judgment:(a)
Initiate or receive telephonic or electronic communication from a practitioner or practitioner's agent concerning refill authorization. If the practitioner or practitioner's agent communicates information that does not relate to the refill authorization:1.
The technician shall immediately inform the pharmacist; and2.
The pharmacist shall receive the communication;(b)
Enter information into and retrieve information from a database or patient profile, including order entry;(c)
Prepare and affix labels;(d)
Stock and retrieve, or return product to or from the pharmacy inventory including the stocking and loading of an automated filling or dispensing system with the use of barcode technology;(e)
Count and pour prescription drugs into patient storage containers;(f)
Obtain, record or maintain information for a patient record;(g)
Make an offer to counsel;(h)
Sell and record the sale of an over-the-counter ephedrine, pseudoephedrine, or phenylpropanolamine product;(i)
Prepare for delivery unit dose mobile transport systems that have been refilled by another technician in an institutional pharmacy;(j)
Receive diagnostic orders within a nuclear pharmacy; and,(k)
Non-sterile and sterile drug compounding.(2)
A registered pharmacy technician may, under electronic supervision, perform order entry from a location outside of the permitted pharmacy pursuant to KRS 315.020(5)(b) and (c).(3)
A registered pharmacy technician may, under general supervision:(a)
Administer a vaccine to an individual if the technician:1.
Completes a minimum of two (2) hours of immunization-related continuing education accredited by the Accreditation Council for Pharmacy Education (ACPE) per each state registration period;2.
Completes, or has completed, a practical training program accredited by ACPE that includes hands-on injection technique and the recognition and treatment of emergency reactions to vaccines; and3.
Possesses a current certificate in basic cardiopulmonary resuscitation.(b)
Stock an automated dispensing system in a residential hospice facility if a pharmacist is on-site; and(c)
Administer point of care tests.Section 3.
Certified Pharmacy Technician. A certified pharmacy technician, under the general supervision of a pharmacist, may be delegated by the supervising pharmacist to perform any function within the practice of pharmacy except the following:(1)
Patient counseling, including clinical advisement necessary to all areas of a patient's health;(2)
Drug evaluation, utilization, and regimen review;(3)
Interpretation of medical orders and prescriptions;(4)
Final product verification;(5)
Receipt of new verbal prescription drug or medical orders; and(6)
Other acts, services, or decisions that require professional judgement.Section 4.
Directing Pharmacist Responsibility.(1)
A function performed by a certified pharmacy technician or registered pharmacy technician shall be performed subject to the review of the pharmacist who directed the technician to perform the function.(2)
A pharmacist who directs a certified pharmacy technician or registered pharmacy technician to perform a function shall be responsible for the technician and the performance of the function.Section 5.
Pharmacy Technician Application. An applicant shall provide the following information as part of their initial technician registration application:(1)
Name, maiden, and other names used currently or previously;(2)
telephone number;(3)
address;(4)
social security number;(5)
NABP eprofile number;(6)
email address;(7)
place of employment;(8)
Record of convictions of any felony or misdemeanor offense, other than traffic offenses, and whether or not a sentence was imposed or suspended;(9)
Record of any technician registration revocation, suspension, restriction, termination, or other disciplinary action by any board of pharmacy or other state authority;(10)
Record of licensure, certification or registration as a pharmacy technician in any other state, if applicable;(11)
Record of certification as a pharmacy technician with a national organization, if applicable; and(12)
if they are seeking registration solely as a charitable pharmacy technician.Section 6.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Registration as a Pharmacy Technician", 03/2025; and(b)
"Application for Pharmacy Technician Renewal", 03/2025.(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/statutesandregulations/Documents/Applications%20for%20Individuals%20-%20Incorporated%20By%20Reference.pdf.CHRISTOPHER HARLOW, Pharm.D, Executive Director
APPROVED BY AGENCY: March 6, 2025
FILED WITH LRC: March 6, 2025 at 4:00 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on May 28, 2025, at 10:00 a.m. Eastern Time at 125 Holmes Street, First Floor Conference Room and 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 May 31, 2025. 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 functions that pharmacy technicians are authorized to perform. This regulation also establishes the criteria for registration as a certified pharmacy technician.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to assist pharmacists in the practice of pharmacy. Without this regulation there is no indication as to what a pharmacy technician may or may not do.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 315.191(1)(a) provides the Board with the authority to promulgate administrative regulations necessary to regulate and control all matters set forth in KRS 315 relating to pharmacy technicians.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation provides clarity as to what technicians may or may not do. KRS 315.135 and KRS 315.136 authorize the registration of pharmacy technicians.
(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 provides detailed tasks that pharmacy technicians may perform and it creates delegated tasks that certified pharmacy technicians may perform.
(b) The necessity of the amendment to this administrative regulation:
This amendment was necessary to ensure that pharmacists were assisted in the practice of pharmacy to prevent pharmacies from being overwhelmed with prescription volume. This amendment is also narrowly tailored to ensure public protection.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to KRS 315.191(1)(a) and the authority to promulgate regulations to control and regulate pharmacy technicians.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment provides clarity as to what technicians may or may not do. KRS 315.135 and KRS 315.136 authorize the registration of pharmacy technicians.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
Pharmacies, pharmacists, pharmacy technicians and pharmacist interns will be impacted by this administrative 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:
Pharmacies, pharmacists, pharmacy technicians and pharmacist interns will have to familiarize themselves with the changes in tasks that pharmacy technicians may perform.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
It will not cost regulated entities anything to comply with the amendment.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Pharmacists will have a greater ability to have assistance from technicians, allowing them more time to spend with patients and providing clinical services. (5) Provide an estimate of how much it will cost to implement this administrative Regulation:
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
0
(b) On a continuing basis:
0
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
The Board will enforce this regulation through regular pharmacy inspections which are already funded through the Board’s budget.
(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:
There will be no fee increase with this administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
There are no fees established directly or indirectly by this regulation.
(9) TIERING: Is tiering applied?
Certified technicians are provided with the ability to perform more tasks, as delegated by a supervising pharmacist, because they have attained a level of competency with a national exam. A non-certified technician has no special education or credential.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 315.191(1)(a)
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
The promulgating agency is the Kentucky Board of Pharmacy. We do not anticipate any other state units to be impacted by this regulation.
(a) Estimate the following for the first year:
Expenditures:
0
Revenues:
0
Cost Savings:
0
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
They will still remain 0.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no local affected entities with the exception of the Board.
(a) Estimate the following for the first year:
Expenditures:
n/a
Revenues:
n/a
Cost Savings:
n/a
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
n/a
(4) Identify additional regulated entities not listed in questions (2) or (3):
Regulated entities will include pharmacies, pharmacists, and pharmacy technicians.
(a) Estimate the following for the first year:
Expenditures:
0
Revenues:
0
Cost Savings:
There could be some cost savings because a pharmacy technician may be able to perform a task previously reserved for a pharmacist only.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
They should remain the same.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
This regulation has no fiscal impact.
(b) Methodology and resources used to determine the fiscal impact:
An analysis of the Board’s budget and what it will take regulated entities to comply with this regulation.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
This administrative regulation will not have an overall negative or adverse major economic impact.
(b) The methodology and resources used to reach this conclusion:
The Board reviewed what it would cost permitted entities to comply with this statute.