AN ACT relating to pharmaceutical drug safety and declaring an emergency.

UNOFFICIAL COPY 26 RS BR 1786
Page 1 of 46
XXXX 2/17/2026 9:36 AM Jacketed
AN ACT relating to pharmaceutical drug safety and declaring an emergency. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
Section 1. KRS 315.010 is amended to read as follows: 3
As used in this chapter, unless the context requires otherwise: 4
(1) "Active pharmaceutical ingredient" or "API" means any substance that is 5
intended: 6
(a) For incorporation into a finished drug product; and 7
(b) 1. To furnish pharmacological activity or other direct effect in the 8
diagnosis, cure, mitigation, treatment, or prevention of disease; or 9
2. To affect the structure or any function of the body; 10
(2) "Administer" means the direct application of a drug to a pati ent or research subject 11
by injection, inhalation, or ingestion, whether topically or by any other means; 12
(3)[(2)] "Administrative activities of a pharmacy" means the following functions 13
performed by a pharmacy adhering to all local, state, and federal pati ent privacy 14
laws: 15
(a) Investigating and researching a patient's insurance benefits and updating the 16
patient profile regarding insurance coverage; 17
(b) Billing and collections activities, including: 18
1. Contacting patients for copayments and coinsurance payments; and 19
2. Communicating with insurance companies; 20
(c) Performing patient financial assistance activities and updating patient records 21
accordingly; 22
(d) Opening faxes and accessing electronic prescriptions for the purposes of 23
setting up patient demographic and insurance profiles, excluding height, 24
weight, and allergy information, so long as the activity does not involve the 25
entering of a prescription order into the dispensing or medication management 26
system; 27
UNOFFICIAL COPY 26 RS BR 1786
Page 2 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(e) Initiating insurance prior authorizations for submission to the licensed 1
pharmacy, including communications with the prescribing physician to 2
collect, record, and transmit information to insurance companies, so long as 3
the activity does not include the authorization or receipt of new or refill 4
prescription orders; 5
(f) Answering and transferring telephone calls, whether or not such calls require 6
accessing a patient record, so long as the call does not involve the 7
interpretation, evaluation, or implementation of a drug order; and 8
(g) Communicating with patients via telephone or electronically regarding refill 9
reminders, so long as the communication does not involve the interpretation, 10
evaluation, or implementation of a drug order and a pharmacist is readily 11
available for patient consultation; 12
(4)[(3)] "Adulterated" has the same meaning as in 21 U.S.C. sec. 351 and KRS 13
217.055; 14
(5) "Adverse event" means any untoward medical occurrence associated with the use 15
of a drug product in humans, whether or not it is considered related to the drug 16
product; 17
(6) "Association" means the Kentucky Pharmacists Association; 18
(7)[(4)] "Board" means the Kentucky Board of Pharmacy; 19
(8)[(5)] "Chemical" means any substance not otherwise defined in this chapter that 20
is a biologically active substance intended to produce a therapeu tic effect in the 21
body to diagnose, cure, mitigate, treat, or prevent disease; 22
(9) "Collaborative care agreement" means a written agreement between a pharmacist or 23
pharmacists and a practitioner or practitioners that outlines a plan of cooperative 24
management of patients' drug-related health care needs where: 25
(a) Patients' drug -related health care needs fall within the practitioner's or 26
practitioners' statutory scope of practice; 27
UNOFFICIAL COPY 26 RS BR 1786
Page 3 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(b) Patients are referred by the practitioner or practitioners to the pharmacis t or 1
pharmacists; and 2
(c) The agreement: 3
1. Identifies the practitioner or practitioners and the pharmacist or 4
pharmacists who are parties to the agreement; 5
2. Specifies the drug-related regimen to be provided, and how drug therapy 6
is to be monitored; and 7
3. Stipulates the conditions for initiating, continuing, or discontinuing drug 8
therapy and conditions which warrant modifications to dose, dosage 9
regimen, dosage form, or route of administration; 10
(10)[(6)] "Compound" or "compounding": 11
(a) Means the preparation , combining, admixing, diluting, pooling, or 12
reconstituting of one (1) or more drugs, APIs, or chemicals; and 13
(b) Shall not include mixing, reconstituting, or other such acts that are 14
performed in accordance with directions contained i n approved labeling 15
provided by the product's manufacturer and other manufacturer directions 16
consistent with that labeling [or labeling of a drug pursuant to or in 17
anticipation of a valid prescription drug order, including but not limited to 18
packaging, intr avenous admixture, or manual combination of drug 19
ingredients. "Compounding," as used in this chapter, shall not preclude simple 20
reconstitution, mixing, or modification of drug products prior to 21
administration by nonpharmacists]; 22
(11)[(7)] "Confidential inf ormation" means information which is accessed or 23
maintained by a pharmacist in a patient's record, or communicated to a patient as 24
part of patient counseling, whether it is preserved on paper, microfilm, magnetic 25
media, electronic media, or any other form; 26
(12)[(8)] "Continuing education unit" means ten (10) contact hours of board approved 27
UNOFFICIAL COPY 26 RS BR 1786
Page 4 of 46
XXXX 2/17/2026 9:36 AM Jacketed
continuing pharmacy education. A "contact hour" means fifty (50) continuous 1
minutes without a break period; 2
(13)[(9)] "Controlled substance" has the same meaning as in KRS 218A.010; 3
(14) "Dispense" or "dispensing" means the interpretation, evaluation, and 4
implementation of a prescription drug order, including the preparation, final 5
verification, and delivery of a drug or device to a patient or patient's agent in a 6
suitable container appropriately labeled for subsequent administration to, or use 7
by, a patient [to deliver one (1) or more doses of a prescription drug in a suitable 8
container, appropriately labeled for subsequent administration to or use by a patient 9
or other individual entitled to receive the prescription drug]; 10
(15)[(10)] "Drug" means any of the following: 11
(a) Articles recognized as drugs or drug products in any official compendium or 12
supplement thereto; 13
(b) Articles, other than food, intended to affect the stru cture or function of the 14
body of man or other animals; 15
(c) Articles, including radioactive substances, intended for use in the diagnosis, 16
cure, mitigation, treatment or prevention of disease in man or other animals; 17
or 18
(d) Articles intended for use as a co mponent of any articles specified in 19
paragraphs (a) to (c) of this subsection; 20
(16)[(11)] "Drug regimen review" means retrospective, concurrent, and prospective 21
review by a pharmacist of a patient's drug -related history, including but not limited 22
to the following areas: 23
(a) Evaluation of prescription drug orders and patient records for: 24
1. Known allergies; 25
2. Rational therapy contraindications; 26
3. Appropriate dose and route of administration; 27
UNOFFICIAL COPY 26 RS BR 1786
Page 5 of 46
XXXX 2/17/2026 9:36 AM Jacketed
4. Appropriate directions for use; or 1
5. Duplicative therapies; 2
(b) Evaluation of prescription drug orders and patient records for drug -drug, 3
drug-food, drug-disease, and drug-clinical laboratory interactions; 4
(c) Evaluation of prescription drug orders and patient records for adverse drug 5
reactions; or 6
(d) Evaluation of prescription drug orders and patient records for proper 7
utilization and optimal therapeutic outcomes; 8
(17)[(12)] "Immediate supervision" means under the physical and visual supervision of a 9
pharmacist; 10
(18)[(13)] "Investigational drug" means a new drug or biologic that meets the criteria 11
for investigational use as set forth in KRS 217.075 and has not been approved for 12
general use by the United States Food and Drug Administration; 13
(19) "Manufacturer" or "virtual manufacturer" of a product means: 14
(a) A person that holds an application approved under 21 U.S.C. sec. 355 or a 15
license issued under 42 U.S.C. sec. 262 for such product, or if such product is 16
not the subject of an approved application or license, the person who 17
manufactured the product; 18
(b) A co -licensed partner of the person described in paragraph (a) of this 19
subsection that obtains the product directly from a person described in this 20
paragraph or paragraph (a) of this subsection; 21
(c) An affiliate of a person described in paragraph (a) or (b) of this subsection 22
who receives the product directly from a person described in this paragraph or 23
in paragraph (a) or (b) of this subsection; or 24
(d) [Any person, ] Except a practitioner[pharmacist] compounding in the normal 25
course of professional practice , any person within the Commonwealth 26
engaged in the production, preparation, propagation, compounding, 27
UNOFFICIAL COPY 26 RS BR 1786
Page 6 of 46
XXXX 2/17/2026 9:36 AM Jacketed
conversion, or processing of a drug, either directly or indirectly, by 1
extraction from substanc es of natural origin or independently by means of 2
chemical synthesis, or both, and includes any packaging or repackaging of 3
a drug or the labeling or relabeling of its container; 4
(20)[(14)] "Medical order" means a lawful order of a specifically identified practitioner 5
for a specifically identified patient for the patient's health care needs. "Medical 6
order" may or may not include a prescription drug order; 7
(21)[(15)] "Misbranded" has the same meaning as in 21 U.S.C. sec. 352 and KRS 8
217.065; 9
(22) "Nonprescription drugs" means nonnarcotic medicines or drugs which may be sold 10
without a prescription and are prepackaged and labeled for use by the consumer in 11
accordance with the requirements of the statutes and regulations of this state and the 12
federal government; 13
(23)[(16)] "Outsourcing facility" means a facility at one (1) geographic location or 14
address that: 15
(a) Is engaged in the compounding of human sterile drugs without a patient -16
specific prescription; 17
(b) Has registered as an outsourcing facility with the se cretary of the United 18
States Department of Health and Human Services, Food and Drug 19
Administration; and 20
(c) Complies with all applicable state and federal requirements; 21
(24)[(17)] "Person" has the same meaning as in KRS 217.015; 22
(25) "Pharmacist" means a natural person licensed by this state to engage in the practice 23
of the profession of pharmacy; 24
(26)[(18)] "Pharmacist intern" means a natural person who is: 25
(a) Currently certified by the board to engage in the practice of pharmacy under 26
the direction of a licensed pharmacist and who satisfactorily progresses 27
UNOFFICIAL COPY 26 RS BR 1786
Page 7 of 46
XXXX 2/17/2026 9:36 AM Jacketed
toward meeting the requirements for licensure as a pharmacist; 1
(b) A graduate of an approved college or school of pharmacy or a graduate who 2
has established educational equivalency by obtaining a Foreig n Pharmacy 3
Graduate Examination Committee (FPGEC) certificate, who is currently 4
licensed by the board for the purpose of obtaining practical experience as a 5
requirement for licensure as a pharmacist; 6
(c) A qualified applicant awaiting examination for licen sure as a pharmacist or 7
the results of an examination for licensure as a pharmacist; or 8
(d) An individual participating in a residency or fellowship program approved by 9
the board for internship credit; 10
(27)[(19)] "Pharmacy" means every place where: 11
(a) Drugs are dispensed under the direction of a pharmacist; 12
(b) Prescription drug orders are compounded under the direction of a pharmacist; 13
or 14
(c) A registered pharmacist maintains patient records and other information for 15
the purpose of engaging in the practic e of pharmacy, whether or not 16
prescription drug orders are being dispensed; 17
(28)[(20)] "Pharmacy-related primary care" means the pharmacists' activities in patient 18
education, health promotion, and assistance in the selection and use of over -the-19
counter drugs and appliances for the treatment of common diseases and injuries, as 20
well as those other activities falling within their statutory scope of practice; 21
(29)[(21)] "Pharmacy technician" means a natural person who works under the 22
immediate supervision, or g eneral supervision if otherwise provided for by statute 23
or administrative regulation, of a pharmacist for the purpose of assisting a 24
pharmacist with the practice of pharmacy; 25
(30)[(22)] "Practice of pharmacy" means interpretation, evaluation, and implement ation 26
of medical orders and prescription drug orders; responsibility for dispensing 27
UNOFFICIAL COPY 26 RS BR 1786
Page 8 of 46
XXXX 2/17/2026 9:36 AM Jacketed
prescription drug orders, including radioactive substances; participation in drug and 1
drug-related device selection; administration of medications or biologics in the 2
course of dispensing or maintaining a prescription drug order; the administration of 3
adult immunizations pursuant to prescriber -approved protocols; the administration 4
of immunizations to individuals five (5) to seventeen (17) years of age pursuant to 5
prescriber-approved protocols with the consent of a parent or guardian; the 6
administration of immunizations to a child as defined in KRS 214.032, pursuant to 7
protocols as authorized by KRS 315.500; drug evaluation, utilization, or regimen 8
review; maintenance of pati ent pharmacy records; and provision of patient 9
counseling and those professional acts, professional decisions, or professional 10
services necessary to maintain and manage all areas of a patient's pharmacy -related 11
care, including pharmacy-related primary care as defined in this section; 12
(31)[(23)] "Practitioner" has the same meaning as in KRS 217.015 and 218A.010, and 13
includes a pharmacist[given in KRS 217.015(35)]; 14
(32)[(24)] "Prescription drug" means a drug which: 15
(a) Under federal law is required to be labe led with either of the following 16
statements: 17
1. "Caution: Federal law prohibits dispensing without prescription"; 18
2. "Caution: Federal law restricts this drug to use by, or on the order of, a 19
licensed veterinarian"; 20
3. "Rx Only"; or 21
4. "Rx";[ or] 22
(b) Is required by any applicable federal or state law or administrative regulation 23
to be dispensed only pursuant to a prescription drug order or is restricted to 24
use by practitioners; 25
(c) Is intended for administration by injection into the human body other t han 26
through a natural orifice of the human body; 27
UNOFFICIAL COPY 26 RS BR 1786
Page 9 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(d) Is a biological product as defined in 42 U.S.C. sec. 262; 1
(e) Is an API; or 2
(f) Is an investigational drug; 3
(33)[(25)] "Prescription drug order" means an original or new order from a practitioner 4
for drugs, drug-related devices or treatment for a human or animal, including orders 5
issued through collaborative care agreements or protocols authorized by the board. 6
Lawful prescriptions result from a valid practitioner -patient relationship, are 7
intended to add ress a legitimate medical need, and fall within the prescribing 8
practitioner's scope of professional practice; 9
(34)[(26)] "Responsible practitioner" means a licensed practitioner: 10
(a) With the independent authority to procure, prescribe, dispense, or 11
administer prescription drugs and devices; and 12
(b) Who is responsible for supervising the operations of a terminal distributor 13
of prescription drugs; 14
(35) "Sale" or "sell" includes any transaction or offer made by any person, as 15
principal proprietor, agent, or employee to: 16
(a) Deliver; 17
(b) Distribute; 18
(c) Broker; 19
(d) Exchange; 20
(e) Gift or otherwise give away; or 21
(f) Transfer by passage of title, physical movement, or both; 22
(36) "Serious adverse event" means an adverse event that results in one (1) or more of 23
the following: 24
(a) Death; 25
(b) A life-threatening adverse event; 26
(c) Inpatient hospitalization or prolongation of existing hospitalization; 27
UNOFFICIAL COPY 26 RS BR 1786
Page 10 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(d) A persistent or significant incapacity or substantial disruption of the ability 1
to conduct normal life functions; or 2
(e) A congenital anomaly or birth defect; 3
(37) "Society" means the Kentucky Society of Health-Systems Pharmacists; 4
(38)[(27)] "Supervision" means the presence of a pharmacist on the premises to which a 5
pharmacy permit is issued, who is responsible, in who le or in part, for the 6
professional activities occurring in the pharmacy;[ and] 7
(39)[(28)] "Terminal distributor of prescription drugs" or "terminal distributor": 8
(a) Means a person that: 9
1. Has possession, custody, or control of prescription drugs for any 10
purpose other than for personal use and consumption; and 11
2. Procures prescription drugs for sale, administration, compounding, or 12
dispensing by or under the supervision of a pharmacist or li censed 13
practitioner authorized to prescribe drugs; and 14
(b) Shall not include a manufacturer, repackager, outsourcing facility, third -15
party logistics provider, wholesale distributor, pharmacy, or pharmacist; 16
(40) "United States Pharmacopeia" or "USP" means the independent, nonprofit, 17
scientific organization that establishes public standards for the quality, purity, 18
strength, and consistency of medicines, food ingredients, and dietary 19
supplements; and 20
(41) "Wholesaler" means any person who legally buys drugs for resale or distribution to 21
persons other than patients or consumers. 22
Section 2. KRS 315.020 is amended to read as follows: 23
(1) An[No] owner of a pharmacy who is not a pharmacist shall [fail to ] place a 24
pharmacist in charge of his or her pharmacy and[or] shall not permit any person to 25
compound or dispense prescription drugs, medicines, or pharmaceuticals in his or 26
her place of business except in the presence and under the immediate supervision of 27
UNOFFICIAL COPY 26 RS BR 1786
Page 11 of 46
XXXX 2/17/2026 9:36 AM Jacketed
a pharmacist. 1
(2) A terminal distributor shall designate a responsible practitioner to serve for each 2
permitted location who shall along with the terminal distributor, accept 3
responsibility for a nd supervision of the operation of the permitted location in 4
accordance with all applicable state and federal laws. The board shall promulgate 5
administrative regulations in accordance with KRS Chapter 13A to establish 6
criteria for a responsible practitioner. 7
(3) A[No] manufacturer of pharmaceuticals who is not a pharmacist shall [fail to ]place 8
a pharmacist in charge of his or her place of business and[or] shall not permit any 9
person to compound prescription drugs, medicines, or pharmaceuticals in his or he r 10
place of business, except as provided by the board through the promulgation of 11
administrative regulations in accordance with[pursuant to] KRS Chapter 13A. 12
(4)[(3)] Except as provided in subsection (5)[(4)] of this section, a[no] person shall 13
not engage i n the practice of pharmacy unless licensed to practice under the 14
provisions of KRS Chapter 315. 15
(5)[(4)] The provisions of subsection (4)[(3)] of this section shall not apply to: 16
(a) Pharmacist interns performing professional practice activities under the 17
immediate supervision of a licensed pharmacist. The nature and scope of the 18
activities referred to in this paragraph shall be determined by the board 19
through administrative regulation promulgated pursuant to KRS Chapter 13A; 20
(b) Pharmacist interns and phar macy technicians performing specifically 21
identified pharmacy practice activities while under the supervision of a 22
pharmacist. The nature and scope of the activities referred to in this paragraph 23
shall be determined by the board through administrative regul ation 24
promulgated in accordance with[pursuant to] KRS Chapter 13A; 25
(c) Other licensed health care professionals practicing within the statutory scope 26
of their professional practices; or 27
UNOFFICIAL COPY 26 RS BR 1786
Page 12 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(d) Volunteer health practitioners providing services under KRS 39A.35 0 to 1
39A.366. 2
(6)[(5)] (a) As used in this subsection: 3
1. "Order entry" means the process by which pharmacy personnel validate 4
prescription data and enter that data into a pharmacy's dispensing or 5
medication management system. Prescription data includes bu t is not 6
limited to patient demographics, prescriber demographics, drug name, 7
strength, dosage form, quantity, the directions for use, refill 8
authorization, or any clarifications of the same; and 9
2. "Order entry verification" means the process by which a p harmacist 10
verifies prescription data entered in a pharmacy's dispensing or 11
medication management system after order entry has been completed. 12
(b) Nothing in this chapter shall prohibit a pharmacist licensed in Kentucky, or a 13
pharmacy technician registered in Kentucky or a pharmacy intern certified in 14
Kentucky who is working under the supervision of the pharmacist, from 15
accessing the electronic database of the pharmacy, from inside or outside of 16
the pharmacy, to perform order entry, order entry verification, or drug 17
regimen review as defined in KRS 315.010, if: 18
1. The pharmacy has established controls to protect the confidentiality and 19
integrity of protected health information; 20
2. No part of the pharmacy's database is duplicated, downloaded, or 21
removed from the electronic database; and 22
3. The pharmacy is located in Kentucky and is permitted by the board. 23
(c) Supervision required by paragraph (b) of this subsection may include 24
electronic supervision. 25
(d) This subsection shall only apply to: 26
1. Pharmacies that are not open to the public and do not dispense to walk -27
UNOFFICIAL COPY 26 RS BR 1786
Page 13 of 46
XXXX 2/17/2026 9:36 AM Jacketed
in patients in a retail setting; or 1
2. Hospitals licensed under KRS Chapter 216B. 2
(e) Nothing in this subsection shall be construed to authorize final product 3
verification and dispensing of a prescription from a location outside of or 4
other than a pharmacy. 5
(f) Nothing in this subsection permits pharmacists, pharmacy technicians, or 6
pharmacy interns to receive hard copy prescriptions outside of the premises of 7
a permitted pharmacy. 8
(7)[(6)] [Effective April 1, 2009, ] An owner of a pharmacy shall not employ a person 9
to assist in the practice of pharmacy unless the person is registered as a ph armacy 10
technician by the board or exempt under KRS 315.135. 11
(8) The board may enter into agreements with other states, federal agencies, and 12
other entities to exchange information concerning the permitting and inspection 13
of pharmacies and terminal distribu tors located within or outside of Kentucky 14
and to investigate alleged violations of the laws governing the distribution of 15
drugs. Any information received pursuant to the agreements is subject to the 16
same confidentiality requirements applicable to the agency or entity from which it 17
was received and shall not be released without prior authorization from that 18
agency or entity. 19
Section 3. KRS 315.035 is amended to read as follows: 20
(1) A[No] person shall not operate a pharmacy within this Commonwealth, physically 21
or by means of the internet, facsimile, phone, mail, or any other means, without 22
having first obtained a permit as provided for in KRS Chapter 315. An application 23
for a permit to operate a pharmacy s hall be made to the board upon forms provided 24
by it and shall contain such information as the board requires, which may include 25
affirmative evidence of ability to comply with such reasonable standards and rules 26
and regulations as may be prescribed by the b oard. Each application shall be 27
UNOFFICIAL COPY 26 RS BR 1786
Page 14 of 46
XXXX 2/17/2026 9:36 AM Jacketed
accompanied by a reasonable permit fee to be set by administrative regulation 1
promulgated by the board in accordance with [pursuant] to KRS Chapter 13A, not 2
to exceed two hundred fifty dollars ($250). 3
(2) (a) Upon receipt of an application of a permit to operate a pharmacy, 4
accompanied by the permit fee not to exceed two hundred fifty dollars ($250), 5
the board shall issue a permit if the pharmacy meets the standards and 6
requirements of KRS Chapter 315 and the rules and administrative 7
regulations of the board. 8
(b) The board shall refuse to renew any permit to operate unless the pharmacy 9
meets the standards and requirements of KRS Chapter 315 and administrative 10
regulations promulgated by the board in accordance with KRS Chapter 11
13A[the rules and regulations of the board]. 12
(c) The board shall act upon an application for a permit to operate within thirty 13
(30) days after the receipt thereof; provided, however, that the board may 14
issue a temporary permit to operate in any instance whe re it considers 15
additional time necessary for investigation and consideration before taking 16
final action upon the application. In such event, the temporary permit shall be 17
valid for a period of thirty (30) days, unless extended. 18
(3) In the review of an app lication for a permit for a pharmacy, the board may 19
consider any previous: 20
(a) Compliance of the applicant and any affiliated persons or entities, including 21
any entity under common ownership or control with the applicant; and 22
(b) Permit violations committe d by any entity under common ownership or 23
control with the applicant, or by any person who substantially participates 24
in the ownership, management, or control of the applicant. 25
(4) A separate permit to operate shall be required for each pharmacy. 26
(5)[(4)] Each permit to operate a pharmacy, unless sooner suspended or revoked, shall 27
UNOFFICIAL COPY 26 RS BR 1786
Page 15 of 46
XXXX 2/17/2026 9:36 AM Jacketed
expire on June 30 following its date of issuance and be renewable annually 1
thereafter upon proper application accompanied by such reasonable renewal fee as 2
may be set by administr ative regulation of the board, not to exceed two hundred 3
fifty dollars ($250) nor to increase more than twenty -five dollars ($25) per year. An 4
additional fee not to exceed the annual renewal fee may be assessed and set by 5
administrative regulation as a del inquent renewal penalty for failure to renew by 6
June 30 of each year. 7
(6)[(5)] Permits to operate shall be issued only for the premises and persons named in 8
the application and shall not be transferable; provided however, that a buyer may 9
operate the pharmacy under the permit of the seller pending a decision by the board 10
of an application which shall be filed by the buyer with the board at least five (5) 11
days prior to the date of sale. 12
(7)[(6)] The board may promulgate administrative[rules and] regulations in 13
accordance with KRS Chapter 13A to ensure[assure] that proper equipment and 14
reference material is on hand considering the nature of the pharmaceutical practice 15
conducted at the particular pharmacy and to ensure[assure] reasonable health and 16
sanitation standards for areas within pharmacies which are not subject to health and 17
sanitation standards of[promulgated by] the Kentucky Cabinet for Health and 18
Family Services or a local health department. 19
(8)[(7)] Each pharmacy shall comply with KRS 218A.202. 20
(9)[(8)] Any pharmacy within the Commonwealth that dispenses more than twenty -21
five percent (25%) of its total prescription volume as a result of an original 22
prescription order received or solicited by use of the internet, including but not 23
limited to electronic mail, shall, prior to obtaining a permit, obtain[receive and 24
display in every medium in which it advertises itself a seal of] approval for the 25
National Association of Boards of Pharmacy (NABP) Digital Pharmacy 26
Accreditation Program [certifying that it is a Verified Internet Pharmacy Practice 27
UNOFFICIAL COPY 26 RS BR 1786
Page 16 of 46
XXXX 2/17/2026 9:36 AM Jacketed
Site (VIPPS)] or [a seal certifying approval of ] a substantially similar program 1
approved by the Kentucky Board of Pharmacy. The NABP Digital Pharmacy 2
Accreditation Program [VIPPS], or any other substantially similar prog ram 3
approved by the Kentucky Board of Pharmacy, accreditation shall be maintained 4
and remain current. 5
(10)[(9)] Any pharmacy within the Commonwealth doing business by use of the 6
internet shall certify the percentage of its annual business conducted via the internet 7
and submit such supporting documentation as requested by the board, and in a form 8
or application required by the board, when it applies for permit or renewal. 9
(11)[(10)] A pharmacist may temporarily operate a pharmacy in an area not designated 10
on the permit as authorized in KRS 315.500. 11
Section 4. KRS 315.0351 is amended to read as follows: 12
(1) Except as provided in subsection (2) of this section: 13
(a) Every person or pharmacy located outside this Commonwealth which does 14
business, physically or by means of the internet, facsimile, phone, mail, or any 15
other means, inside this Commonwealth within the meaning of KRS Chapter 16
315, shall hold a current pharmacy permit as provided in KRS 315.035(1) and 17
(5)[(4)] issued by the Kentucky Board of Pharmacy. The pharmacy shall be 18
designated an "out -of-state pharmacy" and the permit shall be designated an 19
"out-of-state pharmacy permit." The fee for the permit shall not exceed the 20
current in-state pharmacy permit fee as provided under KRS 315.035; 21
(b) Every out-of-state pharmacy granted an out -of-state pharmacy permit by the 22
board shall disclose to the board the location, names, and titles of all principal 23
corporate officers and all pharmacists who are dispensing prescription drugs 24
to residents of the Commonwealth. A report containing this information shall 25
be made to the board on an annual basis and within thirty (30) days after any 26
change of office, corporate officer, or pharmacist; 27
UNOFFICIAL COPY 26 RS BR 1786
Page 17 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(c) Every out -of-state pharmacy granted an out -of-state pharmacy permit shall 1
comply with all statutorily -authorized directions and requests for information 2
from any regulatory agency of the Commonwealth and from the board in 3
accordance with the provisions of this section. The out -of-state pharmacy 4
shall maintain at all times a valid unexpired permit, license, or registration to 5
conduct the pharmacy in compliance with the laws of the jurisdiction in which 6
it is a resident. As a prerequisite to seeking a permit from the Kentucky Board 7
of Pharmacy, the out-of-state pharmacy shall submit a copy of the most recent 8
inspection report resulting from an inspection conducted by the regulatory or 9
licensing agency of the jurisdiction in which it is located. Thereafter, the out-10
of-state pharmacy granted a permit shall submit to the Kentucky Board of 11
Pharmacy a copy of any subsequent inspection report on the pharmacy 12
conducted by the regulatory or licensing body of the jurisdiction in which it is 13
located; 14
(d) Every out-of-state pharmacy granted an out -of-state pharmacy permit by the 15
board shall maintain records of any controlled substances or dangerous drugs 16
or devices dispensed to patients in the Commonwealth so that the records are 17
readily retrievable from the records of other drugs dispensed; 18
(e) Records for all prescriptions delivered into Kentucky shall be readily 19
retrievable from the other prescription records of the out-of-state pharmacy; 20
(f) Each out -of-state pharmacy shall, during its regular hours of operation, but 21
not less than six (6) days per week and for a minimum of forty (40) hours per 22
week, provide a toll-free telephone service directly to the pharmacist in charge 23
of the out -of-state pharmacy and available to both the patient and each 24
licensed and practicing in -state pharmacist for the purpose of facilitating 25
communication between the patient and the Kentucky pharmacist with access 26
to the patient's prescription records. A toll -free number shall be placed on a 27
UNOFFICIAL COPY 26 RS BR 1786
Page 18 of 46
XXXX 2/17/2026 9:36 AM Jacketed
label affixed to each container of drugs dispensed to patients within the 1
Commonwealth; 2
(g) Each out-of-state pharmacy shall have a pharmacist in charge who is licensed 3
to engage in the practice of pharmacy by the Commonwealth that shall be 4
responsible for compliance by the pharmacy with the provisions of thi s 5
section and for the distribution and sale of dialysate solutions and devices 6
pursuant to subsection (2) of this section; 7
(h) Each out-of-state pharmacy shall comply with KRS 218A.202; 8
(i) Any out -of-state pharmacy that dispenses more than twenty -five per cent 9
(25%) of its total prescription volume as a result of an original prescription 10
order received or solicited by use of the internet, including but not limited to 11
electronic mail, shall obtain[receive and display in every medium in which it 12
advertises itself a seal of] approval for the National Association of Boards of 13
Pharmacy (NABP) Digital Pharmacy Accreditation Program [certifying that 14
it is a Verified Internet Pharmacy Practice Site (VIPPS)] or [a seal certifying 15
approval of ]a substantially similar program approved by the Kentucky Board 16
of Pharmacy. The NABP Digital Pharmacy Accreditation [VIPPS], or any 17
other substantially similar accreditation, shall be maintained and remain 18
current; 19
(j) Any out-of-state pharmacy doing business in the Commonwealth of Kentucky 20
shall certify the percentage of its annual business conducted via the internet 21
and electronic mail and submit such supporting documentation as requested 22
by the board, and in a form or application required by the board, when it 23
applies for permit or renewal; 24
(k) Any pharmacy doing business within the Commonwealth of Kentucky shall 25
use the address on file with the Kentucky Board of Pharmacy as the return 26
address on the labels of any package shipped into or within the 27
UNOFFICIAL COPY 26 RS BR 1786
Page 19 of 46
XXXX 2/17/2026 9:36 AM Jacketed
Commonwealth. The return address shall be placed on the package in a clear 1
and prominent manner;[ and] 2
(l) The Kentucky Board of Pharmacy may waive the permit requirements of this 3
chapter for an out -of-state pharmacy that only does business within the 4
Commonwealth of Kentucky in limited transactions; and 5
(m) In the review of an application for a permit for an out -of-state pharmacy, 6
the board may consider any previous permit: 7
1. Compliance of the applicant and any affiliated persons or entities, 8
including any entity under common ownership or control with the 9
applicant; and 10
2. Violations committed by any entity under common ownership or 11
control with the applicant, or by any person who substantially 12
participates in the ownership, management, or control of the 13
applicant. 14
(2) (a) Only subsection (1)(g) of this section shall apply to the sale or distribution of 15
dialysate solutions or devices necessary to perform home peritoneal kidney 16
dialysis to patients with end-stage renal disease, if: 17
1. The dialysate solutions or devices are approved or clea red by the federal 18
Food and Drug Administration, as required by federal law; 19
2. The dialysate solutions or devices are lawfully held by a manufacturer 20
or manufacturer's agent that is properly registered with or licensed by 21
the board as a manufacturer, whol esale distributer, or third -party 22
logistics provider under this chapter; 23
3. The dialysate solutions or devices are held and delivered in their 24
original, sealed packaging from a Food and Drug Administration -25
approved manufacturing facility; 26
4. The dialysate solutions or devices are only delivered upon receipt of a 27
UNOFFICIAL COPY 26 RS BR 1786
Page 20 of 46
XXXX 2/17/2026 9:36 AM Jacketed
physician's prescription by a Kentucky licensed pharmacy and the 1
transmittal of an order from the Kentucky licensed pharmacy to the 2
manufacturer or manufacturer's agent; and 3
5. The manufacturer or m anufacturer's agent delivers the dialysate 4
solutions or devices directly to: 5
a. A patient with end-stage renal disease or the patient's designee for 6
the patient's self-administration of dialysis therapy; or 7
b. A health-care provider or institution for admi nistration or delivery 8
of dialysis therapy to a patient with end-stage renal disease. 9
(b) 1. A manufacturer or manufacturer's agent who sells or distributes 10
dialysate solutions or devices under this subsection shall employ or 11
contract with a pharmacist who is licensed to engage in the practice of 12
pharmacy by the Commonwealth to conduct a retrospective audit on ten 13
percent (10%) of the orders processed by that manufacturer or 14
manufacturer's agent each month. 15
2. On or before February 1 of each year, an annual summary of the 16
monthly audits shall be prepared and submitted to the board, in the form 17
prescribed by the board. 18
3. On or before June 1 of each year, the board shall compile the summaries 19
of monthly audits into a single report and submit that report to th e 20
Interim Joint Committee on Health Services. 21
(c) Prescriptions and records of delivery for dialysate solutions or devices sold or 22
distributed under this subsection shall be maintained by the manufacturer or 23
manufacturer's agent for a minimum of two (2) ye ars and shall be made 24
available to the board upon request. 25
(d) As used in this subsection, "dialysate solutions" means dextrose or icodextrin 26
when used to perform home peritoneal kidney dialysis. 27
UNOFFICIAL COPY 26 RS BR 1786
Page 21 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(e) The Kentucky Board of Pharmacy will retain oversight of the distribution of 1
dialysate solutions and devices under this section. 2
Section 5. KRS 315.121 is amended to read as follows: 3
(1) The board may refuse to issue or renew a license, permit, or certificate to, or may 4
suspend, temporarily suspend, revoke, fine, place on probation, repri mand, 5
reasonably restrict, or take any combination of these actions against any licensee, 6
permit holder, or certificate holder for the following reasons: 7
(a) Unprofessional or unethical conduct; 8
(b) Mental or physical incapacity that prevents the licensee, permit holder, or 9
certificate holder from engaging or assisting in the practice of pharmacy or the 10
wholesale distribution or manufacturing of drugs with reasonable skill, 11
competence, and safety to the public; 12
(c) Being convicted of, or entering an "Alford" plea or plea of nolo contendere to, 13
irrespective of an order granting probation or suspending imposition of any 14
sentence imposed following the conviction or entry of such plea, one (1) or 15
more or the following, if in accordance with KRS Chapter 335B: 16
1. A crime as defined in KRS 335B.010; or 17
2. A violation of the pharmacy or drug laws, rules, or administrative 18
regulations of this state, any other state, or the federal government; 19
(d) Knowing or having reason to know that a pharmacist, pharmacist intern, o r 20
pharmacy technician is incapable of engaging or assisting in the practice of 21
pharmacy with reasonable skill, competence, and safety to the public and 22
failing to report any relevant information to the board; 23
(e) Knowingly making or causing to be made any false, fraudulent, or forged 24
statement or misrepresentation of a material fact in securing issuance or 25
renewal of a license, permit, or certificate; 26
(f) Engaging in fraud in connection with the practice of pharmacy or the 27
UNOFFICIAL COPY 26 RS BR 1786
Page 22 of 46
XXXX 2/17/2026 9:36 AM Jacketed
wholesale distribution or manufacturing of drugs; 1
(g) Engaging in or aiding and abetting an individual to engage or assist in the 2
practice of pharmacy without a license or falsely using the title of 3
"pharmacist," "pharmacist intern," "pharmacy technician," or other term 4
which might imply t hat the individual is a pharmacist, pharmacist intern, or 5
pharmacy technician; 6
(h) Being found by the board to be in violation of any provision of this chapter, 7
KRS Chapter 217, KRS Chapter 218A, or the administrative regulations 8
promulgated pursuant to these chapters; 9
(i) Violation of any order issued by the board to comply with any applicable law 10
or administrative regulation; 11
(j) Knowing or having reason to know that a person, pharmacist, pharmacist 12
intern, or pharmacy technician has engaged in or aided a nd abetted the 13
unlawful distribution of legend medications, and failing to report any relevant 14
information to the board; 15
(k) Failure to notify the board within fourteen (14) days of a change in one's 16
home address; or 17
(l) As provided in KRS 311.824(2), bein g convicted of a violation of KRS 18
311.823(2). 19
(2) Unprofessional or unethical conduct includes but is not limited to the following acts 20
of a pharmacist, pharmacist intern, or pharmacy technician: 21
(a) Publication or circulation of false, misleading, or dece ptive statements 22
concerning the practice of pharmacy; 23
(b) Divulging or revealing to unauthorized persons patient information or the 24
nature of professional services rendered without the patient's express consent 25
or without order or direction of a court. In addition to members, inspectors, or 26
agents of the board, the following are considered authorized persons: 27
UNOFFICIAL COPY 26 RS BR 1786
Page 23 of 46
XXXX 2/17/2026 9:36 AM Jacketed
1. The patient, patient's agent, or another pharmacist acting on behalf of 1
the patient; 2
2. Certified or licensed health -care personnel who are respons ible for care 3
of the patient; 4
3. Designated agents of the Cabinet for Health and Family Services for the 5
purposes of enforcing the provisions of KRS Chapter 218A; 6
4. Any federal, state, or municipal officer whose duty is to enforce the laws 7
of this state or the United States relating to drugs and who is engaged in 8
a specific investigation involving a designated person; or 9
5. An agency of government charged with the responsibility of providing 10
medical care for the patient, upon written request by an authoriz ed 11
representative of the agency requesting such information; 12
(c) Selling, transferring, or otherwise dis posing of accessories, chemicals, drugs, 13
or devices found in illegal traffic when the pharmacist, pharmacy intern, or 14
pharmacy technician knows or should have known of their intended use in 15
illegal activities; 16
(d) Engaging in conduct likely to deceive, def raud, or harm the public, 17
demonstrating a willful or careless disregard for the health, welfare, or safety 18
of a patient, or engaging in conduct which substantially departs from accepted 19
standards of pharmacy practice ordinarily exercised by a pharmacist or 20
pharmacy intern, with or without established proof of actual injury; 21
(e) Engaging in grossly negligent professional conduct, with or without 22
established proof of actual injury; 23
(f) Except as provided in KRS 315.500, selling, transferring, dispensing, 24
ingesting, or administering a drug for which a prescription drug order is 25
required, without having first received a prescription drug order for the drug; 26
(g) Willfully or knowingly failing to maintain complete and accurate records of 27
UNOFFICIAL COPY 26 RS BR 1786
Page 24 of 46
XXXX 2/17/2026 9:36 AM Jacketed
all drugs received, dispen sed, or disposed of in compliance with federal and 1
state laws, rules, or administrative regulations; 2
(h) Obtaining any remuneration by fraud, misrepresentation, or deception; 3
(i) Accessing or attempting to access confidential patient information for person s 4
other than those with whom a pharmacist has a current pharmacist -patient 5
relationship and where such information is necessary to the pharmacist to 6
provide pharmacy care; 7
(j) Failing to exercise appropriate professional judgment in determining whether 8
a prescription drug order is lawful; 9
(k) Violating KRS 304.39-215; or 10
(l) Engaging in conduct that is subject to the penalties under KRS 304.99 -060(4) 11
or (5). 12
(3) Any licensee, permit holder, or certificate holder entering an "Alford" plea, 13
pleading nolo cont endere, or who is found guilty of a violation prescribed in 14
subsection (1)(c) of this section shall within thirty (30) days notify the board of that 15
plea or conviction. Failure to do so shall be grounds for suspension or revocation of 16
the license, certificate, or permit. 17
(4) Any person whose license, permit, or certificate has been revoked in accordance 18
with the provisions of this section, may petition the board for reinstatement. The 19
petition shall be made in writing and in a form prescribed by the board. The board 20
shall investigate all reinstatement petitions, and the board may reinstate a license, 21
permit, or certificate upon showing that the former holder has been rehabilitated 22
and is again able to engage in the practice of pharmacy with reasonable skill, 23
competency, and safety to the public. Reinstatement may be on the terms and 24
conditions that the board, based on competent evidence, reasonably believes 25
necessary to protect the health and welfare of the citizens of the Commonwealth. 26
(5) Upon exercising th e power of revocation provided for in subsection (1) of this 27
UNOFFICIAL COPY 26 RS BR 1786
Page 25 of 46
XXXX 2/17/2026 9:36 AM Jacketed
section, the board may reasonably prohibit any petition for reinstatement for a 1
period up to and including five (5) years. 2
(6) Any licensee, permit holder, or certificate holder who is discipline d under this 3
section for a minor violation may request in writing that the board expunge the 4
minor violation from the licensee's, permit holder's, or certificate holder's 5
permanent record. 6
(a) The request for expungement may be filed no sooner than three ( 3) years after 7
the date on which the licensee, permit holder, or certificate holder has 8
completed disciplinary sanctions imposed and if the licensee, permit holder, 9
or certificate holder has not been disciplined for any subsequent violation of 10
the same nature within this period of time. 11
(b) No person may have his or her record expunged under this section more than 12
once. 13
The board shall promulgate administrative regulations under KRS Chapter 13A to 14
establish violations which are minor violations under this subsection. A violation 15
shall be deemed a minor violation if it does not demonstrate a serious inability to 16
practice the profession; assist in the practice of pharmacy; provide home medical 17
equipment and services; adversely affect the public health, safety , or welfare; or 18
result in economic or physical harm to a person; or create a significant threat of 19
such harm. 20
(7) The board shall retain jurisdiction to investigate and to take disciplinary action 21
for acts or omissions committed while a person was license d, permitted, or 22
certified by the board, notwithstanding the surrender, expiration, lapse, or 23
nonrenewal of the person's license, permit, or certification. Surrender, 24
expiration, lapse, or nonrenewal of a license, permit, or certification shall not 25
deprive the board of authority to enter findings of fact and conclusions of law, 26
impose discipline relating to the prior license, permit, or certification, or deny, 27
UNOFFICIAL COPY 26 RS BR 1786
Page 26 of 46
XXXX 2/17/2026 9:36 AM Jacketed
condition, restrict, or limit any future application for licensure, permitting, or 1
certification. 2
Section 6. KRS 315.131 is amended to read as follows: 3
(1) Every proceeding imposing a fine or for probation, suspension, or revocation of a 4
license, permit, or certificate issued pursuant to this chapter shall be conduct ed in 5
accordance with KRS Chapter 13B. Upon failure of the licensee, permit holder, or 6
certificate holder to respond to the complaint at or before the time of the hearing, 7
the allegations set forth in the complaint shall be taken by the board as confessed. 8
(2) All decisions revoking or suspending a license, permit, or certificate or placing a 9
licensee, permit holder, or certificate holder on probation or imposing a fine shall 10
be made by the board. 11
(3) The board may when in its opinion the continued practice of the licensee or 12
certificate holder or the continued operation of the permit holder would be 13
dangerous to the health, welfare, and safety of the general public, issue an 14
emergency order as provided in KRS 13B.125. 15
(4) A licensee, permit holder, or certi ficate holder aggrieved by a final order of the 16
board may within ten (10) days after notice thereof move the board to reconsider 17
this order. A motion to reconsider based on newly -discovered material evidence 18
must be made within one (1) year of the entry of the order. 19
(5) A licensee, permit holder, or certificate holder aggrieved by a final order of the 20
board may appeal to the Franklin Circuit Court in accordance with KRS Chapter 21
13B. 22
(6) (a) The board may, without benefit of a hearing, temporarily suspend a license, 23
certificate, or permit for not more than sixty (60) days if the president of the 24
board finds on the basis of reasonable evidence that a licensee, certificate 25
holder, or permit holder: 26
1.[(a)] Has violated a statute or administrative regulation the board is 27
UNOFFICIAL COPY 26 RS BR 1786
Page 27 of 46
XXXX 2/17/2026 9:36 AM Jacketed
empowered to enforce, and continued practice or operation by the 1
licensee, certificate holder, or permit holder would create imminent risk 2
of harm to the public; or 3
2.[(b)] Suffers a mental o r physical condition that through continued 4
practice or operation could create an imminent risk of harm to the 5
public. 6
(b) The emergency suspension shall take effect upon receipt by the licensee, 7
certificate holder, or permit holder of written notice, deli vered by certified 8
mail or in person, specifying the statute or administrative regulation violated. 9
At the time the emergency suspension order issues, the board shall schedule a 10
disciplinary hearing to be held in accordance with the provisions of KRS 11
Chapter 13B within sixty (60) days thereafter. 12
(c) The board may extend the temporary emergency suspension for one (1) or 13
more additional periods not to exceed sixty (60) days provided that the: 14
1. Board has initiated proceedings under KRS Chapter 13B; 15
2. Board finds in writing that the immediate danger continues to exist; 16
and 17
3. Extension is not attributable to actions of the board. 18
(d) A temporary suspension shall not exceed more than one hundred eighty 19
(180) days absent a final order. 20
Section 7. KRS 315.191 is amended to read as follows: 21
(1) The board is authorized to: 22
(a) Promulgate administrative regulations pursuant to KRS Chapter 13A 23
necessary to regulate and control all matters set forth in this chapter relating to 24
pharmacists, pharmacist interns, pharmacy technicians, pharmacies, terminal 25
distributors, wholesale distributors, and manufacturers, to the extent that 26
regulation and control of same have not been delegated to some other agency 27
UNOFFICIAL COPY 26 RS BR 1786
Page 28 of 46
XXXX 2/17/2026 9:36 AM Jacketed
of the Commonwealth, but admini strative regulations relating to drugs shall 1
be limited to the regulation and control of drugs procured, dispensed, 2
compounded, or administered by licensed practitioners [sold pursuant to a 3
prescription drug order]. This chapter shall not be construed to authorize the 4
board to promulgate administrative regulations relating to: 5
1. The practice of medicine, nursing, or any other profession or 6
occupation licensed or regulated by another board or agency of the 7
Commonwealth; or 8
2. [However, ]Except as provided in KRS 315.038 and Section 9 of this 9
Act, [nothing contained in this chapter shall be construed as authorizing 10
the board to promulgate any administrative regulations relating to 11
]prices or fees or to advertising or the promotion of the sales or use of 12
commodities or services; 13
(b) Issue subpoenas, schedule and conduct hearings, or appoint hearing officers to 14
schedule and conduct hearings on behalf of the board on any matter under the 15
jurisdiction of the board; 16
(c) Prescribe the time, place, method, manner, sco pe, and subjects of 17
examinations, with at least two (2) examinations to be held annually; 18
(d) Issue and renew all licenses, certificates, and permits for all pharmacists, 19
pharmacist interns, pharmacies, pharmacy technicians, terminal distributors, 20
wholesale distributors, and manufacturers engaged in the manufacture, 21
distribution, or dispensation of drugs; 22
(e) Investigate all complaints or violations of the state pharmacy and drug laws 23
and the administrative regulations promulgated by the board, and bring all 24
these cases to the notice of the proper law enforcement authorities; 25
(f) Promulgate administrative regulations in accordance with[, pursuant to] KRS 26
Chapter 13A [,] that are necessary and to control the storage, retrieval, 27
UNOFFICIAL COPY 26 RS BR 1786
Page 29 of 46
XXXX 2/17/2026 9:36 AM Jacketed
dispensing, refilling, and transfer of prescription drug orders within and 1
between pharmacists and pharmacies licensed or issued a permit by it; 2
(g) Perform all other functions necessary to carry out the provisions of law and 3
the administrative regulations promulgated by the boa rd relating to 4
pharmacists, pharmacist interns, pharmacy technicians, pharmacies, terminal 5
distributors, wholesale distributors, and manufacturers; 6
(h) Establish or approve programs for training, qualifications, and registration of 7
pharmacist interns; 8
(i) Assess reasonable fees, in addition to the fees specifically provided for in this 9
chapter and consistent with KRS 61.870 to 61.884, for services rendered to 10
perform its duties and responsibilities, including, but not limited to, the 11
following: 12
1. Issuance of duplicate certificates; 13
2. Mailing lists or reports of data maintained by the board; 14
3. Copies of documents; or 15
4. Notices of meetings; 16
(j) Seize any drugs, chemicals, or devices [drug or device] found by the board to 17
constitute an imminent danger to public health and welfare; 18
(k) 1. Establish an advisory council to advise the board on statutes, 19
administrative regulations, and other matters within the discretion of the 20
board pertinent to the pract ice of pharmacy and regulation of 21
pharmacists, pharmacist interns, pharmacy technicians, pharmacies, 22
terminal distributors, wholesale distributors, and manufacturers [drug 23
distribution, and drug manufacturing] . The council shall provide 24
recommendations for updating policies and procedures, including 25
administrative regulations relating to the practice of pharmacy. 26
2. The council shall consist of nine (9) pharmacists broadly representative 27
UNOFFICIAL COPY 26 RS BR 1786
Page 30 of 46
XXXX 2/17/2026 9:36 AM Jacketed
of the profession of pharmacy. For purposes of this subparagraph, 1
"broadly representative" means the following: 2
a. Two (2) pharmacists appointed by the Kentucky Pharmacists 3
Association; 4
b. Two (2) pharmacists appointed by the Kentucky Independent 5
Pharmacy Alliance; 6
c. One (1) pharmacist who practices or specializes primarily in a mail 7
order pharmacy appointed by the Kentucky Pharmacists 8
Association; 9
d. One (1) pharmacist who practices or specializes primarily in a 10
long-term care pharmacy appointed by Kentucky Association of 11
Health Care Facilities; 12
e. One (1) pharmacist who pra ctices or specializes primarily in a 13
veterinary pharmacy appointed by the Kentucky Pharmacists 14
Association; 15
f. One (1) pharmacist who practices or specializes primarily in a 16
hospital pharmacy appointed by the Kentucky Society of Health -17
System Pharmacists; and 18
g. One (1) pharmacist who practices in a specialized pharmacy that 19
solely or mostly provides medication to persons living with serious 20
health conditions requiring complex therapies, appointed by the 21
Kentucky Pharmacists Association. 22
3. Each pharmacist member shall be licensed by the board, a resident of 23
Kentucky, and employed for at least two (2) consecutive years in the 24
practice area he or she represents. 25
4. Members shall serve terms of up to four (4) years and may serve two (2) 26
consecutive terms, but shall not serve on the council for more than two 27
UNOFFICIAL COPY 26 RS BR 1786
Page 31 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(2) consecutive terms. Members may continue to serve until their 1
successors are appointed. 2
5. Members shall be confirmed by roll call vote of the board at a meeting 3
conducted in accordance with the Open Meet ings Act, KRS 61.805 to 4
61.850; and 5
(l) Promulgate administrative regulations in accordance with KRS Chapter 13A 6
establishing the qualifications that pharmacy technicians are required to attain 7
prior to engaging in pharmacy practice activities outside the immediate 8
supervision of a pharmacist. 9
(2) The board shall have other authority as may be necessary to enforce pharmacy laws 10
and administrative regulations of the board including, but not limited to: 11
(a) Joining or participating in professional organizatio ns and associations 12
organized exclusively to promote improvement of the standards of practice of 13
pharmacy for the protection of public health and welfare or facilitate the 14
activities of the board; and 15
(b) Receiving and expending funds, in addition to its b iennial appropriation, 16
received from parties other than the state, if: 17
1. The funds are awarded for the pursuit of a specific objective which the 18
board is authorized to enforce through this chapter, or which the board is 19
qualified to pursue by reason of its jurisdiction or professional expertise; 20
2. The funds are expended for the objective for which they were awarded; 21
3. The activities connected with or occasioned by the expenditure of the 22
funds do not interfere with the performance of the board's 23
responsibilities and do not conflict with the exercise of its statutory 24
powers; 25
4. The funds are kept in a separate account and not commingled with funds 26
received from the state; and 27
UNOFFICIAL COPY 26 RS BR 1786
Page 32 of 46
XXXX 2/17/2026 9:36 AM Jacketed
5. Periodic accountings of the funds are maintained at the board office for 1
inspection or review. 2
(3) In addition to the sanctions provided in KRS 315.121, the board or its hearing 3
officer may direct any licensee, permit holder, or certificate holder found guilty of a 4
charge involving pharmacy or drug laws, rules, or administrative regu lations of the 5
state, any other state, or federal government, to pay to the board a sum not to 6
exceed the reasonable costs of investigation and prosecution of the case, not to 7
exceed twenty-five thousand dollars ($25,000). 8
(4) In an action for recovery of costs, proof of the board's order shall be conclusive 9
proof of the validity of the order of payment and any terms for payment. 10
Section 8. KRS 315.220 is amended to read as follows: 11
(1) For the purpose of enforcing the provisions of this chapter, officers, agents, and 12
inspectors of the board shall have the power and authority to: 13
(a) Administer oaths; 14
(b) Enter the[upon] premises of all facilities issued a permit or license by the 15
board and any facility suspected of operating as a pharmacy, terminal 16
distributor, wholesaler, or manufacturer , at all reasonable times for the 17
purpose of: 18
1. Making inspections and carrying out the provisions of this chapter . 19
Inspections: 20
a. Shall include areas of the facility where drugs or any other 21
chemicals are received, stored, compounded, or prepared for 22
dispensing or administration; 23
b. May include a review of records, including but not limited to 24
ownership information, invoices, purchase orders, certificat es of 25
analysis, transaction information, compounding logs, medical 26
charts, prescription orders, or dispensing and administration 27
UNOFFICIAL COPY 26 RS BR 1786
Page 33 of 46
XXXX 2/17/2026 9:36 AM Jacketed
information; and 1
c. If the pharmacy, terminal distributor, or manufacturer is 2
engaged in compounding, shall evaluate compliance with the 3
most current published version of the USP; 4
2. Conducting investigations; 5
3. Requiring production of books, papers, documents, records, or other 6
evidence for inspection or copying; 7
4. Seizing evidence;[ or] 8
5. Seizing and quarantining drugs or any other chemicals if there is 9
probable cause to believe that the drug or chemical is: 10
a. An unapproved new drug; 11
b. Adulterated, misbranded, or counterfeit or otherwise 12
unauthorized for human or animal use; 13
c. Labeled in a manner that indicates the substanc e is for research 14
use only; or 15
d. Not compounded in accordance with USP or otherwise in 16
violation of this chapter; or 17
6. Securing oral or written statements; 18
(c) Employ special investigators; 19
(d) Expend funds for the purpose of obtaining evidence; and 20
(e) Issue subpoenas. 21
(2) As used in subsection (1) of this section, "records" includes [,] but is not limited 22
to[,] patient records. 23
(3) Any decision to inspect, copy, or seize books, papers, documents, records, or other 24
evidence shall be at the discretion of the officer, agent, or inspector of the board. 25
(4) Inspection, copying, or seizure of books, papers, documents, records, or other 26
evidence does not affect the confidential nature of those records, and the board shall 27
UNOFFICIAL COPY 26 RS BR 1786
Page 34 of 46
XXXX 2/17/2026 9:36 AM Jacketed
maintain the records so as to protect the confidentiality of the records. 1
(5) The board or its authorized representatives may investigate any location that the 2
board has reasonable cause to suspect is in violation of Section 9, 10, or 11 of this 3
Act. 4
(6) A pharmacist, pharmacy intern, pharmacy t echnician, terminal distributor, 5
manufacturer, outsourcing facility, third -party logistics provider, or wholesale 6
distributor shall: 7
(a) Cooperate with federal, state, and local government investigations; and 8
(b) Divulge all relevant information when reque sted by a government agency, 9
except when divulging the information is otherwise prohibited by state or 10
federal law, including the Kentucky Rules of Evidence. 11
SECTION 9. A NEW SECTION OF KRS CHAPTER 315 IS CREATED TO 12
READ AS FOLLOWS: 13
(1) On or after January 1, 2027, a person shall not operate or engage in activities as 14
a terminal distributor of prescription drugs, including any prescription drugs that 15
are distributed, delivered, shipped, or offered for sale, administration, 16
compounding, or dispensing within or into this Commonwealth, without first 17
obtaining a permit from the board. An application for a permit to operate a 18
terminal distributor shall be made to the board upon forms provided by the board. 19
Each application shall be accompanied by a reasonable permit fee to be set by 20
administrative regulations promulgated by the board in accordance with KRS 21
Chapter 13A. 22
(2) (a) Upon receipt of an application for a permit to o perate a terminal distributor 23
and the permit fee, the board shall issue a permit if the terminal distributor 24
meets the requirements of this chapter and administrative regulations 25
promulgated by the board in accordance with KRS Chapter 13A. 26
(b) The board sh all refuse to renew any permit to operate unless the terminal 27
UNOFFICIAL COPY 26 RS BR 1786
Page 35 of 46
XXXX 2/17/2026 9:36 AM Jacketed
distributor meets the requirements of this chapter and administrative 1
regulations promulgated by the board in accordance with KRS Chapter 2
13A. 3
(c) The board shall act upon an application for a permit to operate within thirty 4
(30) days after the receipt of the application. 5
(d) The board may issue a temporary permit to operate if additional time is 6
necessary for investigation and consideration of the application before 7
taking final action. The temp orary permit shall be valid for thirty (30) days, 8
unless extended by the board. 9
(3) In the review of an application for a permit for a terminal distributor, the board 10
may consider any previous permit: 11
(a) Compliance of the applicant and of any affiliated p ersons or entities 12
including any entity under common ownership or control with the 13
applicant; and 14
(b) Violations committed by any entity under common ownership or control 15
with the applicant, or by any person who substantially participates in the 16
ownership, management, or control of the applicant. 17
(4) The board shall: 18
(a) Require a separate permit for each location operated by a terminal 19
distributor; 20
(b) Require a permit to be issued to the physical address on the application; 21
(c) Require the primary busine ss address or authorized service location for a 22
mobile or temporary facility authorized by the board be an authorized 23
location for procuring prescription drugs; and 24
(d) Prohibit a permit for a terminal distributor located in or operated from a 25
personal res idence or any portion of a building used for residential 26
purposes. 27
UNOFFICIAL COPY 26 RS BR 1786
Page 36 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(5) Each permit to operate as a terminal distributor, unless previously suspended or 1
revoked, shall expire on June 30 following its date of issuance and shall be 2
renewable annually thereaft er upon proper application accompanied by the 3
renewal fee required by the board. An additional fee not to exceed the annual 4
renewal fee may be assessed as a delinquent renewal penalty for failure to renew 5
the permit by June 30 of each year. 6
(6) The board may deny, refuse to issue, refuse to renew, suspend, revoke, restrict, or 7
place conditions or limitations upon any permit issued to a terminal distributor if 8
the applicant, or any officer, owner, partner, member, manager, responsible 9
practitioner, agent, or employee of the applicant, has been found to have violated 10
any provision of this chapter, KRS Chapter 217 or 218A, or any administrative 11
regulation promulgated by the board, unless the applicant affirmatively 12
demonstrates to the satisfaction of the board that adequate safeguards have been 13
implemented to prevent recurrence of the violation. 14
(7) A permit to operate a terminal distributor shall not be transferable, except that a 15
buyer may operate the terminal distributor under the permit of the seller pending 16
a decision by the board of an application if the buyer has submitted a completed 17
application to the board at least five (5) days prior to the date of purchase of the 18
terminal distributor. 19
(8) Each terminal distributor shall comply with the provisions of K RS 218A.202 20
relating to the electronic system for monitoring controlled substances. 21
(9) A terminal distributor located in Kentucky doing business by use of the internet 22
shall: 23
(a) Certify the percentage of its annual business conducted via the internet an d 24
submit supporting documentation as requested by the board; 25
(b) Obtain approval for the National Association of Boards of Pharmacy 26
(NABP) Digital Pharmacy Accreditation Program or a substantially similar 27
UNOFFICIAL COPY 26 RS BR 1786
Page 37 of 46
XXXX 2/17/2026 9:36 AM Jacketed
program approved by the board; and 1
(c) Maintain and keep current accreditation form the NABP Digital Pharmacy 2
Accreditation Program, or any other substantially similar program 3
approved by the Kentucky Board of Pharmacy. 4
(10) The following shall not be required to obtain a permit to operate as a terminal 5
distributor: 6
(a) A licensed practitioner prescribing drugs in their usual course of 7
professional practice unless the licensed practitioner also possesses, has 8
custody or control of, administers, or dispenses a prescription drug; 9
(b) A person possessing medic ations for asthma or anaphylaxis as permitted 10
under KRS 158.836; 11
(c) A person possessing medications for diabetes or seizure disorders as 12
permitted under KRS 158.838; 13
(d) A person possessing medications for health services in schools as permitted 14
under KRS 156.502; 15
(e) A person possessing overdose reversal drugs as permitted for the purposes 16
described in KRS 217.186; 17
(f) A person possessing nitrous oxide for use as a direct ingredient in food 18
pursuant to 21 C.F.R. 184.1545 or for testing or maintaining a plumbing or 19
heating, ventilation, and air conditioning system; 20
(g) A person possessing medical gases, sterile water, or sterile saline for direct 21
administration to patients or for the purpose of installation or maintenance 22
of home medical equipment as defined in KRS 309.402; or 23
(h) A facility that is owned and operated by the United States Department of 24
Defense, the United States Department of Veterans Affairs, or any other 25
federal agency. 26
(11) The board may promulgate administrative regulations in accordance with KRS 27
UNOFFICIAL COPY 26 RS BR 1786
Page 38 of 46
XXXX 2/17/2026 9:36 AM Jacketed
Chapter 13A to: 1
(a) Ensure reasonable health and sanitation standards for areas in the physical 2
location a terminal distributor that are not subject to health an d sanitation 3
standards of the Cabinet for Health and Family Services or a local health 4
department; and 5
(b) Implement this section. 6
SECTION 10. A NEW SECTION OF KRS CHAPTER 315 IS CREATED TO 7
READ AS FOLLOWS: 8
(1) Prescription drugs shall only be sold, distributed, administered, or possessed in 9
accordance with KRS Chapters 217 and 218A. 10
(2) Except for a transfer of prescription drugs exempted in KRS 315.400(19), a 11
pharmacy, terminal distributor, or person that is exempt fro m a permit under this 12
chapter shall not purchase prescription drugs from any person other than a 13
licensed manufacturer, outsourcing facility, third -party logistics provider, or 14
wholesale distributor. 15
(3) A pharmacy or terminal distributor shall not engage in the sale or transfer of, or 16
maintain possession, custody, or control of, prescription drugs at any 17
establishment or place other than the physical address listed on the permit issued 18
by the board unless the board has authorized a mobile or temporary location. 19
(4) This section shall not be construed to interfere with the performance of official 20
duties by any law enforcement official authorized by municipal, county, state, or 21
federal law to collect samples of any drug, regardless of its nature or who 22
possesses it. 23
SECTION 11. A NEW SECTION OF KRS CHAPTER 315 IS CREATED TO 24
READ AS FOLLOWS: 25
(1) A pharmacy, terminal distributor, or any person shall not dispense any 26
compounded preparation for human use unless compounded in anticipation of or 27
UNOFFICIAL COPY 26 RS BR 1786
Page 39 of 46
XXXX 2/17/2026 9:36 AM Jacketed
pursuant to a valid prescription drug order. 1
(2) A pharmacy, terminal distributor, or any person shall not procure, administer, 2
compound, or dispense drugs or any other chemicals that are intended for 3
research-use only, unless the permitted pharmacy or terminal distributor is 4
engaged in a systematic research program and has obtained the necessary 5
approvals in accordance with KRS 217.075. 6
(3) A pharmacy, terminal distributor, or any other person shall not procure, 7
administer, compound, or dispense drugs or any other chemicals intended for 8
dispensing or administration to humans that are labeled not for use in humans. 9
(4) A pharmacy or terminal distributor engaged in compounding under the 10
supervision and direction of the pharmacist or responsible practitioner shall 11
compound in accordance with applicable chapters of the most current version of 12
USP for sterile and nonsterile compounding and shall only procure APIs from an 13
establishment registered with the United States Food and Drug Administration 14
and licensed by the board. 15
(5) A pharmacy or terminal distributor engaged in compounding under the 16
supervision and directio n of a pharmacist or responsible practitioner shall 17
compound in compliance with the requirements of state and federal law, 18
including all applicable guidance documents published by the United States Food 19
and Drug Administration. 20
SECTION 12. A NEW SECTION OF KRS CHAPTER 315 IS CREATED TO 21
READ AS FOLLOWS: 22
(1) A pharmacy or terminal distributor that becomes aware or receives a report of a 23
serious adverse event associated with a drug product procured, administered, 24
compounded, or dispensed by the pharmacy or terminal distributor shall report 25
the serious adverse event to the board in a manner and form prescribed by the 26
board within five (5) business days of becoming aware of or receiving the report. 27
UNOFFICIAL COPY 26 RS BR 1786
Page 40 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(2) The board shall provide t he professional licensing board that issued a 1
professional license to the responsible practitioner the following: 2
(a) Notification of any refusal of entry into the terminal distributor's permitted 3
location for inspection and investigation purposes; 4
(b) Inspection reports that identify any violations of this chapter; 5
(c) 1. Investigative material, including the original complaint. 6
2. If the investigation reveals the culpability of other professionally 7
licensed individuals, the board shall share the investig ative material 8
and the original complaints with the relevant licensing boards; 9
(d) Any fines levied against the responsible practitioner; and 10
(e) Any unpaid fines levied against the responsible practitioner. 11
(3) The board shall advise the professional licensing board whether additional action 12
is needed to protect public health and safety. Any public disciplinary action taken 13
by professional licensing boards shall be shared with the board. 14
(4) No later than August 1, 2027, and each August 1 thereafter, the board shall 15
submit a comprehensive report to the Legislative Research Commission for 16
referral to the Interim Joint Committee on Health Services on its inspection and 17
investigation findings in the preceding year. The report shall include but is not 18
limited to: 19
(a) The total number of pharmacy and terminal distributor compounding 20
inspections conducted; 21
(b) The total number of consumer compounding comp laints received against 22
pharmacies and terminal distributors; 23
(c) A summary of the most significant findings related to violations of 24
compounding and procurement of drugs; 25
(d) The identity and amount of any drugs or any other chemicals seized by the 26
board; 27
UNOFFICIAL COPY 26 RS BR 1786
Page 41 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(e) A summary of serious adverse events reported to the board; 1
(f) A summary of public disciplinary action taken by professional licensing 2
boards against responsible practitioners or other licensed professionals; 3
(g) An estimated cost to the board for in spections and investigations conducted 4
pursuant to Section 8 of this Act; 5
(h) The total amount of penalties levied and collected for violations of this 6
chapter; and 7
(i) Specific recommendations for legislative or regulatory changes, including 8
any requests for additional enforcement powers or oversight. 9
(5) This section shall not preclude the reporting of adverse events by outsourcing 10
facilities as required under 21 U.S.C. sec. 353b(b)(5). 11
SECTION 13. A NEW SECTION OF KR S CHAPTER 315 IS CREATED TO 12
READ AS FOLLOWS: 13
Notwithstanding the existence or pursuit of any other civil or criminal remedy, the 14
board may maintain, in its own name, an action to restrain or enjoin any violation of 15
this chapter, regardless of whether there exists an adequate remedy at law. 16
Section 14. KRS 315.990 is amended to read as follows: 17
(1) Except for the provisions of KRS 315.320, any person violating any provision of 18
KRS Chapter 315 shall be fined for each offens e not less than one hundred dollars 19
($100) nor more than one thousand dollars ($1,000) or imprisoned in the county jail 20
for not more than six (6) months, or both. Each week that any provision of KRS 21
315.020, 315.030, or 315.035 is violated shall also constitute a separate offense. 22
(2) Any person convicted of willfully resisting, preventing, impeding, obstructing, 23
threatening, or interfering with the officers, agents, or inspectors of the board in the 24
administration of the provisions of this chapter shall be guilty of a Class A 25
misdemeanor. 26
(3) The board may levy an administrative fine not to exceed five thousand dollars 27
UNOFFICIAL COPY 26 RS BR 1786
Page 42 of 46
XXXX 2/17/2026 9:36 AM Jacketed
($5,000) for each offense, for any violation of KRS 315.121. All such fines shall be 1
deposited to the credit of the licensing board to be us ed by the board in carrying out 2
the provisions of this chapter. 3
(4) The board may refuse to issue or renew a permit, or may suspend, temporarily 4
suspend, revoke, fine, or reasonably restrict any permit holder for any violation of 5
KRS 315.0351. Any administ rative fine levied by the board shall not exceed five 6
thousand dollars ($5,000) for any violation of KRS 315.0351. All such fines shall 7
be deposited to the credit of the licensing board to be used by the Board of 8
Pharmacy in carrying out the provisions of this chapter. 9
(5) For a violation of KRS 315.320, the Board of Pharmacy may, in addition to any 10
other civil or criminal penalty, levy an administrative fine not exceeding one 11
hundred thousand dollars ($100,000). All such fines shall be deposited to the cre dit 12
of the Board of Pharmacy in carrying out the provisions of this chapter. 13
(6) (a) Any person who intentionally, knowingly, or recklessly violates KRS 14
216B.200 to 216B.210 is guilty of a Class D felony. 15
(b) Any person who violates KRS 216B.200 to 216B.21 0 shall be fined not more 16
than one million dollars ($1,000,000). 17
(c) Notwithstanding KRS 440.200, the Attorney General may demand from the 18
Governor of any other state the surrender of any person found in the other 19
state who is charged in Kentucky with the crime of violating KRS 216B.200 20
to 216B.210. The provisions for extradition under this subsection shall apply 21
to any such demand even if the person whose surrender is demanded was not 22
in Kentucky at the time of the commission of the crime. Neither the dema nd, 23
the oath, nor any proceedings for extradition pursuant to this section need 24
state or show that the person whose surrender is demanded has fled from 25
justice, or at the time of the commission of the crime was in Kentucky or the 26
other state. 27
UNOFFICIAL COPY 26 RS BR 1786
Page 43 of 46
XXXX 2/17/2026 9:36 AM Jacketed
(7) Any person in violation of subsection (1), (2), or (3) of Section 10 of this Act shall 1
be guilty of a Class A misdemeanor for the first offense and a Class D felony for 2
each subsequent offense. 3
(8) Unless another specific penalty is provided in this sectio n, any person who 4
violates any provision of subsection (1), (2), or (3) of Section 11 of this Act shall 5
be guilty of a Class A misdemeanor for the first offense and a Class D felony for 6
each subsequent offense. 7
Section 15. KRS 194A.800 is amended to read as follows: 8
(1) For the purposes of this section, "pilot program" means a program in a county or set 9
of counties, or a subset or subsets of the population, as designated by the Cabinet 10
for Health and Family Services and t he Department for Behavioral Health, 11
Developmental and Intellectual Disabilities. 12
(2) A pilot program is established to analyze the outcomes and effectiveness of a 13
community pharmacy care delivery model for medication -assisted therapy for 14
treatment of substance abuse in order to ensure that the Commonwealth is: 15
(a) Using approaches that have been shown to be effective; 16
(b) Intervening early at important stages and transitions; and 17
(c) Intervening in appropriate settings and domains. 18
(3) Sources of data for the pilot program shall include, at a minimum, claims data from 19
the Department for Medicaid Services, including claims data from Medicaid 20
managed care organizations submitted to the Department for Medicaid Services. 21
(4) As funds are available, the Cabinet for Health and Family Services shall initiate a 22
pilot program to determine, collect, and analyze performance measurement data for 23
a community pharmacy care delivery model for noncontrolled medication -assisted 24
therapy as part of substance abuse treatment se rvices to determine practices that 25
increase access to treatment, reduce frequency of relapse, provide better outcomes 26
for patients, and control health costs related to substance abuse treatment. Program 27
UNOFFICIAL COPY 26 RS BR 1786
Page 44 of 46
XXXX 2/17/2026 9:36 AM Jacketed
components shall: 1
(a) Use a community pharmacy care d elivery model for noncontrolled 2
medication-assisted therapy for the treatment of substance abuse, as 3
authorized by the Kentucky Board of Pharmacy pursuant to a prescription 4
drug order as defined in KRS 315.010[(25)]; 5
(b) Include a wraparound services model that engages psychological and social 6
support for the patient; 7
(c) Establish collaborative relationships between detention facilities, drug courts, 8
community pharmacists, and practitioners who provide psychosocial 9
interventions to evaluate individuals' e ligibility for participation in a 10
community pharmacy care delivery model for noncontrolled medication -11
assisted therapy; and 12
(d) Include pilot program data collection designed to inform the outcomes and 13
effectiveness of a community pharmacy care delivery mo del for medication -14
assisted therapy for treatment of substance abuse. 15
(5) By December 31, 2019, the Cabinet for Health and Family Services shall provide a 16
joint report to the Legislative Research Commission and the Office of the Governor 17
that: 18
(a) Details the findings of the pilot program; and 19
(b) Includes recommendations based on the pilot program's results for optimizing 20
substance abuse treatment services provided in community pharmacies. 21
Section 16. KRS 217.215 is amended to read as follows: 22
(1) The Board of Pharmacy, its agents and inspectors shall have the same powers of 23
inspection and enforcement as the cabinet under KRS 217.005 to 217.215 [, insofar 24
as it relates to drugs in licensed pharmacies]. 25
(2) The Board of Pha rmacy may establish regulations relating to the storage and 26
retrieval of prescription records in licensed pharmacies, including regulations 27
UNOFFICIAL COPY 26 RS BR 1786
Page 45 of 46
XXXX 2/17/2026 9:36 AM Jacketed
regarding computerized recordkeeping systems. 1
(3) (a) No prescription for any drug may be refilled by a pharmacist u nless 2
authorized by the prescribing practitioner, except that, in emergency situations 3
in which such authorization may not be readily or easily obtained from the 4
practitioner, a pharmacist may: 5
1. Dispense up to a seventy -two (72) hour supply of maintenanc e 6
medication; 7
2. Dispense greater than a seventy -two (72) hour supply of maintenance 8
medication if: 9
a. The standard unit of dispensing for the drug exceeds a seventy-two 10
(72) hour supply; 11
b. The pharmacist dispenses a supply of the drug that is equal to th e 12
standard unit of dispensing for the drug; and 13
c. The drug is used for insulin therapy or the treatment of chronic 14
respiratory diseases; and 15
3. Dispense up to a thirty (30) day supply of ma intenance medication in 16
emergency situations as authorized by KRS 315.500. 17
(b) Emergency refills dispensed under this subsection shall not be authorized for 18
any controlled substance or for any drug which is not essential to maintenance 19
of life or continuation of therapy in chronic disease conditions. 20
(c) The Board of Pharmacy shall promulgate administrative regulations to carry 21
out the provisions of this subsection. 22
Section 17. KRS 217.913 is amended to read as follows: 23
The provisions of KRS 217.907 to 217.917 shall not apply to drug products compounded 24
by a pharmacist licensed pursuant to KRS Chapter 315, in a pharmacy or terminal 25
distributor's permitted location operating under a permit authorized by the board [as 26
required by KRS 315.035]. 27
UNOFFICIAL COPY 26 RS BR 1786
Page 46 of 46
XXXX 2/17/2026 9:36 AM Jacketed
Section 18. KRS 315.205 is amended to read as follows: 1
Upon the request of an individual or his or her parent or guardian, a pharmacist who 2
administers an immunization to an individual who is five (5) to seventeen (17) years of 3
age, as authorized in the practice of pharmacy as defined in KRS 315.010[(22)], shall 4
provide notification of the immunization to the individual's primary care provider. 5
Section 19. This Act may be cited as Jimmie's Law. 6
Section 20. Whereas it is critical that the Kentucky Board of Pharmacy have the 7
authority to ensure the safety of the pharmaceutical drug supply for the health and well -8
being of the citizens of the Commonwealth, an emergency is declared to exist, and this 9
Act takes effect upon its passage and approval by the Governor or upon its otherwise 10
becoming a law. 11