reglab/statecodes huggingface dataset:
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:240 - Special limited pharmacy permit - Charitable

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.035
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations to prescribe the criteria for
				obtaining a pharmacy permit to dispense legend drugs and the procedures for the
				safe dispensing of legend drugs to citizens of the Commonwealth. This
				administrative regulation identifies the manner and procedure by which a
				charitable organization may obtain a pharmacy permit and dispense legend drugs
				in the Commonwealth.
Section 1.
			 Definitions.
(1) "Charitable organization"
			 means an organization qualified as a charitable organization pursuant to
			 Section 501(c)(3) of the Internal Revenue Code,
			 26 U.S.C.
			 501(c)(3).
(2) "Legend drug sample" means an unopened
			 package of a manufacturer's legend drug product that has been distributed to
			 either a practitioner or the charitable pharmacy in accordance with the
			 provisions of the Prescription Drug Marketing Act of 1987, 21 C.F.R. Part
			 203.
(3) "Qualified indigent
			 patient" means a patient of the charitable pharmacy that has been screened and
			 approved by the charitable organization as meeting the organization's mission
			 of providing pharmaceutical care to those who are without sufficient funds to
			 obtain needed legend drugs.
(4)
			 "Special limited pharmacy permit" means a permit issued to a pharmacy that
			 provides specialized pharmacy services, such as dispensing legend drugs, and
			 counseling patients.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:250 - Pharmacist Recovery Network Committee

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.121(1)(d),
				315.126
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.126(1) requires the
				Board of Pharmacy to establish a pharmacy recovery network committee (PRNC).
				This administrative regulation establishes minimum requirements for the
				establishment and operation of the PRNC. This administrative regulation
				specifies the manner by which the board's PRNC consultant works with the board
				in intervention, evaluating and treating a pharmacist or intern, and providing
				for continuing care and monitoring by the consultant through a treatment
				provider.
Section 1. The board's
			 Pharmacist Recovery Network Committee (PRNC) consultant shall be a pharmacist
			 licensee of the board. The consultant shall assist the Case Review Committee
			 (CRC) and the PRNC in carrying out their respective responsibilities. This
			 shall include working with the board's inspectors and investigators to
			 determine whether a pharmacist or intern is in fact impaired.
Section 2. If a pharmacist or intern self
			 reports impairment as a result of the misuse or abuse of alcohol or drugs, or
			 both; or if the board receives a legally sufficient complaint alleging that a
			 pharmacist or intern is impaired as a result of the misuse or abuse of alcohol
			 or drugs, or both, and no complaint against the pharmacist or intern other than
			 impairment exists, the reporting of any impairment information to the board
			 shall be forwarded to the consultant and shall not constitute grounds for
			 discipline, if the PRNC finds the pharmacist or intern has:
(1) Acknowledged the impairment
			 problem;
(2) Voluntarily enrolled
			 in an appropriate, approved treatment program;
(3) Voluntarily withdrawn from practice or
			 limited the scope of practice as required by the consultant, in each case,
			 until the PRNC is satisfied the licensee has successfully completed an approved
			 treatment program; and
(4) Executed
			 releases for medical records, authorizing the release of all records of
			 evaluations, diagnoses, and treatment of the licensee, including records of
			 treatment for emotional or mental conditions, to the consultant. The consultant
			 shall not make copies or reports of records that do not regard the issue of the
			 licensee's impairment and his or her participation in a treatment
			 program.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:260 - Automated Pharmacy System in Residential Hospice Facilities

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010(9),
				315.020,
				315.035,
				315.295,
				315.300,
				216B3195
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				335.020(1) requires that
				prescription drugs, medicines, and pharmaceuticals be dispensed or manufactured
				by a licensed pharmacist.
				KRS
				315.295 authorizes the board to regulate an
				automated pharmacy system in a residential hospice facility. This
				administrative regulation establishes the standards for the operation of this
				type of system.
Section 1.
			 Definitions.
(1) "Automated Pharmacy System"
			 is defined by
			 KRS
			 315.295(1)(a).
(2) "Residential Hospice Facility" is defined
			 by
			 KRS
			 315.295(1)(b).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:270 - Expungement

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.121(6),
				315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations relating to subject matters
				governed by KRS Chapter 315.
				KRS
				315.121(6) requires the
				board to promulgate administrative regulations to establish violations that are
				considered minor and subject to expungement. This administrative regulation
				establishes the violations considered minor and the criteria and procedure for
				expungement.
Section 1. Definition.
			 "Expungement" means:
(1) The affected records
			 shall be sealed;
(2) The
			 proceedings to which they refer shall be deemed not to have occurred;
			 and
(3) The affected party may
			 properly represent that no record exists regarding the matter
			 expunged.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:280 - Prescription dispensing for formulary compliance

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.814,
				315.191
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations necessary to regulate and
				control all matters set forth in KRS Chapter 315 relating to pharmacists.
				KRS
				315.191(1)(f) authorizes the
				board to promulgate administrative regulations to control the storage,
				retrieval, dispensing, refilling, and transfer of prescription drug orders
				within and between qualifying pharmacists and pharmacies. This administrative
				regulation establishes procedural and substantive requirements for dispensing
				an equivalent drug product pursuant to a practitioner declaration of formulary
				compliance approval.
Section 1.
			 Dispensing.
(1) A pharmacist may dispense a
			 therapeutic equivalent drug product under the following conditions:
(a) The ordering practitioner has indicated
			 "formulary compliance approval" on the prescription, in one of the following
			 ways:
1. In the practitioner's own
			 handwriting; or
2. By checking a
			 "formulary compliance approval" box on a preprinted form;
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:311 - Compounding drugs for veterinary use

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.191(1)(a),
				321.441
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations necessary to regulate and
				control all matters relating to pharmacists, pharmacist interns, pharmacy
				technicians, and pharmacies. This administrative regulation establishes
				requirements for compounding for veterinary use.
Section 1. The pharmacist shall receive a
			 written, verbal, facsimile, or electronic request for a compounded drug from a
			 practitioner, indicating the formulation, strength, and quantity
			 ordered.
Section 2. A compounded
			 drug containing a controlled substance shall only be compounded for patient
			 specific dispensation from the pharmacy to the ultimate user.
Section 3.
(1) A pharmacist, pharmacist intern, or
			 pharmacy technician may prepare a non-controlled compounded drug to be
			 dispensed for veterinary use or administration that is either institutional or
			 ambulatory, and which does not designate a specific patient for the purpose of
			 direct administration to patients for:
(a)
			 Emergency treatment;
(b) Situations
			 when a time delay would negatively affect a patient outcome; or
(c) Diagnostic purposes.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:320 - Requirements for manufacturers and virtual manufacturers

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.182,
				315.010,
				315.020(2),
				315.036,
				315.191(1)(a),
				315.400,
				315.404,
				21 U.S.C.
				360eee -eee-4
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.020,
				315.036 and
				315.191(1)(a)
				authorize the board to promulgate administrative regulations to regulate the
				manufacturers and virtual manufacturers of drugs and drug-related devices. This
				administrative regulation establishes the requirements for the regulation of
				manufacturers and virtual manufacturers.
Section
			 1. Definitions.
(1) "Component"
			 means any raw material, ingredient, or article intended for use in the
			 manufacture of a drug and drug-related device.
(2) "Drug sample" means a unit of a
			 prescription drug that is not intended to be sold and is intended to promote
			 the sale of the drug.
(3)
			 "Illegitimate Product" is defined by
			 KRS
			 315.400(11).
(4) "Manufacturer or virtual manufacturer" is
			 defined by KRS
			 315.010(13).
(5) "Product" means a prescription drug in a
			 finished dosage form for administration to a patient without substantial
			 further manufacturing, such as capsules, tablets, and lyophilized products
			 before reconstitution.
(6)
			 "Relabeler" means:
(a) Any person who owns or
			 operates an establishment that changes the content of the labeling from that
			 supplied from the original manufacturer for distribution under the
			 establishment's own name; and
(b)
			 Does not include establishments that do not change the original labeling, but
			 merely add their own name.
(7) "Repackager" is defined by
			 KRS
			 315.400(16).
(8) "Suspect product" means a component,
			 prescription drug, or drug-related device for which there is reason to believe
			 that the component, prescription drug, or drug-related device:
(a) Is potentially counterfeit, diverted, or
			 stolen;
(b) Is potentially
			 intentionally adulterated so that the component, prescription drug, or
			 drug-related device may result in serious adverse health consequences or death
			 to humans or animals;
(c) Is
			 potentially the subject of a fraudulent transaction; or
(d) Appears otherwise unfit for distribution
			 so that the component, prescription drug, or drug-related device may result in
			 serious adverse health consequences or death to humans or animals.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:330 - Emergency pharmacy powers

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				39A.100,
				315.500
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.500 establishes the conditions under
				which a pharmacy may operate temporarily in an area not designated on the
				pharmacy permit pursuant to an executive order issued by the Governor pursuant
				to
				KRS
				39A.100. 315.191 authorizes the Board of
				Pharmacy to promulgate administrative regulations governing pharmacists and
				pharmacies. This administrative regulation sets out the conditions whereby a
				prescription may be refilled pursuant to an executive order issued by the
				Governor as authorized by
				KRS
				315.500 when the prescriber is unavailable.
				This administrative regulation sets out the conditions whereby a pharmacy may
				operate temporarily in an area not designated on the pharmacy permit pursuant
				to an executive order issued by the Governor as authorized by
				KRS
				315.500.
Section
			 1. If a pharmacist receives a request for a prescription refill
			 with no refill authorized and the pharmacist is unable to readily obtain refill
			 authorization from the prescriber, the pharmacist may dispense an emergency
			 refill of up to a thirty (30) day supply of the medication if:
(1) The Governor has issued an executive
			 order as authorized by
			 KRS
			 315.500 for the county where the pharmacy is
			 located;
(2) The pharmacist obtains
			 prescription information from:
(a) A
			 prescription label;
(b) A
			 prescription record within the pharmacy;
(c) A prescription record from another
			 pharmacy;
(d) A common
			 database;
(e) The patient;
			 or
(f) Any other healthcare
			 record;
(3) The
			 prescription refill is not for a controlled substance;
(4) The prescription is for a maintenance
			 medication;
(5) In the pharmacist's
			 professional judgment, the interruption of therapy may produce undesirable
			 consequences or may be detrimental to the patient's welfare and cause physical
			 or mental discomfort; and
(6) The
			 pharmacist notes on the prescription record the date, the quantity dispensed,
			 and the pharmacist's name or initials.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:340 - Special limited pharmacy permit - clinical practice

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010(9),
				315.020,
				315.035,
				315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.035 authorizes the Board of Pharmacy
				issue a permit to a pharmacy.
				KRS
				315.191(1)(a) authorizes the
				Board of Pharmacy to promulgate administrative regulations with minimum
				requirements for the permitting of those entities that provide non-dispensing
				pharmacy services. This administrative regulation establishes the requirements
				for the Special limited pharmacy permit - Clinical practice.
Section 1. Definitions.
(1) "Special limited pharmacy permit" means a
			 permit issued to a pharmacy that provides miscellaneous specialized pharmacy
			 service and functions.
(2) "Special
			 limited pharmacy permit - clinical practice" means a permit issued to a
			 pharmacy that maintains patient records and other information for the purpose
			 of engaging in the practice of pharmacy and does not dispense prescription drug
			 orders.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:360 - Opioid antagonist dispensing

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.186
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				217.186(6) requires the
				Board of Pharmacy to promulgate administrative regulations governing dispensing
				of an opioid antagonist by a pharmacist pursuant to a physician-approved
				protocol. This administrative regulation establishes the minimum requirements
				for the pharmacist to be able to dispense an opioid antagonist pursuant to a
				physician-approved protocol; and provides the requirements for a pharmacy to
				stock an opioid antagonist to an emergency department.
Section 1. Certification.
(1) A pharmacist desiring to achieve
			 certification to initiate the dispensing of an opioid antagonist shall complete
			 and submit an Application for Pharmacist Certification for Opioid Antagonist
			 Dispensing, Form 1, with the board and provide the following:
(a) Name;
(b) Address;
(c) Phone number; and
(d) Pharmacist license number.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:370 - Pharmacy services in long-term care facility (LTCF)

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010,
				315.020,
				315.030,
				315.121
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1) authorizes the
				Kentucky Board of Pharmacy to establish requirements to regulate and control
				pharmacies.
				KRS
				315.002 and
				315.005
				require standards of practice in all settings where drugs are handled and
				require the board to ensure safety of all drug products provided to the
				citizens of Kentucky. This administrative regulation establishes requirements
				for pharmacy services in long-term care facilities.
Section 1. Definitions.
(1) "Automated Dispensing System" or "ADS"
			 means a mechanical system that performs operations or activities, other than
			 compounding or administration, relative to the storage, packaging, counting,
			 labeling, and dispensing of medications, and which collects, controls, and
			 maintains all transaction information.
(2) "Emergency Drug" means drugs required to
			 meet the immediate therapeutic needs of patients that are not available from
			 any other authorized source in sufficient time to prevent risk of harm to
			 patients because of delay.
(3)
			 "Emergency Medication Kit" or "EMK" means an onsite manual or automated
			 mechanism for delivering emergency medications.
(4) "Immediate supervision" is defined by
			 KRS
			 315.010(12).
(5) "Individual dose" means smallest unit
			 that is commercially available.
(6)
			 "Long-term care facility" or "LTCF" is defined by
			 KRS
			 216.510(1), excluding
			 family-care homes
(7) "Long Term
			 Care Facility Drug Stock" or "LTCF drug stock" means a dose or doses generated
			 from a prescription order sufficient until the next pharmacy business day or IV
			 fluids that are used for replenishment, which contain no additive drugs, or
			 irrigation solutions.
(8)
			 "Pharmacist-in-charge" or "PIC" means a pharmacist mandated as in charge under
			 KRS
			 315.020 and who meets the requirements of
			 201 KAR
			 2:205.
(9)
			 "Supervision" is defined by
			 KRS
			 315.010(27).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:380 - Board authorized protocols

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010(25),
				315.121(1)(a),
				315.191(1)(a),
				(f)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.010(25) defines a
				prescription drug order, which includes orders issued through protocols
				authorized by the board.
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations necessary to regulate and
				control all matters pertaining to pharmacists, pharmacist interns, pharmacy
				technicians, and pharmacies.
				KRS
				315.191(1)(f) authorizes the
				board to promulgate administrative regulations that are necessary to control
				the dispensing of prescription drug orders. This administrative regulation
				establishes procedures for board authorized protocols by which pharmacists may
				initiate the dispensing of noncontrolled medications or other professional
				services.
Section 1. Definitions.
(1) "Fully executed" means a protocol has
			 been signed and dated by the prescriber and the pharmacist or pharmacists who
			 are the party or parties to the protocol agreement as required by Section 3 of
			 this administrative regulation.
(2)
			 "Prescriber" means any Kentucky licensed physician or advanced practice
			 registered nurse practitioner.
(3)
			 "Protocol" means a written agreement between a pharmacist or pharmacists and a
			 prescriber that outlines the plan to initiate the dispensing of noncontrolled
			 medications, over-the-counter medications, or other professional services
			 within the prescriber's statutory scope of practice.
(4) "Protocol registry" means the records
			 maintained by the board of any fully executed protocol that is being utilized
			 to initiate the dispensing of noncontrolled medications, over-the-counter
			 medications, or other professional services.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:390 - Requirements for third-party logistics providers

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.0351,
				315.121,
				315.191(1)(a),
				315.400,
				315.4102,
				315.4104,
				315.4106,
				315.4108,
				315.4110,
				21 U.S.C.
				360eee -eee-4
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a),
				315.4102,
				315.4104,
				315.4106,
				315.4108, and
				315.4110 authorizes the board to
				promulgate administrative regulations to regulate third-party logistics
				providers. This administrative regulation establishes requirements for the
				regulation of third-party logistics providers
Section 1. Definitions.
(1) "Board" means the Board of
			 Pharmacy.
(2) "Component" means any
			 raw material, ingredient, or article intended for use in the manufacture of a
			 drug and drug-related device.
(3)
			 "Distribution" or "distribute" is defined by
			 KRS
			 315.400(5).
(4) "Drug sample" means a unit of a
			 prescription drug that is not intended to be sold and is intended to promote
			 the sale of the drug.
(5)
			 "Illegitimate product" is defined by
			 KRS
			 315.400(11).
(6) "Product" means a prescription drug in a
			 finished dosage form for administration to a patient without substantial
			 further manufacturing, such as capsules, tablets, and lyophilized products
			 before reconstitution.
(7) "Suspect
			 product" means a component, prescription drug, or drug-related device for which
			 there is a reason to believe that the component, prescription drug, or
			 drug-related device:
(a) Is potentially
			 counterfeit, diverted, or stolen;
(b) Is potentially intentionally adulterated
			 so that the component, prescription drug, or drug-related device may result in
			 serious adverse health consequences or death to humans or animals;
(c) Is potentially the subject of a
			 fraudulent transaction; or
(d)
			 Appears otherwise unfit for distribution so that the component, prescription
			 drug, or drug-related device may result in serious adverse health consequences
			 or death to humans or animals.
(8) "Third-party logistics provider" is
			 defined by KRS
			 315.400(18).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:400 - Outsourcing facility

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.002,
				315.005,
				315.010(16),
				315.191(1)(a),
				315.340,
				315.342
NECESSITY, FUNCTION AND CONFORMITY:
				KRS
				315.340 establishes requirements for in-state
				outsourcing facilities doing business in Kentucky, requires the board to set
				fees, and requires the board to promulgate administrative regulations relating
				to in-state permit applicants for licensure and renewal.
				KRS
				315.342 establishes requirements for
				out-of-state outsourcing facilities doing business in Kentucky, requires the
				board to set fees, and requires the board to promulgate administrative
				regulations relating to in-state permit applicants for licensure and renewal.
				This administrative regulation establishes further licensure, renewal, and
				general requirements for in-state and out-of-state outsourcing
				facilities.
Section 1. Application
			 Requirements for Initial Licensure and Renewal.
(1) An applicant for initial licensure or
			 renewal as an outsourcing facility shall submit:
(a) A nonrefundable initial licensure or
			 renewal fee of $250 by check or money order made payable to the Kentucky State
			 Treasurer;
(b) A complete, sworn,
			 and notarized Application to Operate as an Outsourcer Facility;
(c) Unless previously provided, proof of
			 registration as an outsourcing facility with the secretary of the U. S.
			 Department of Health and Human Services, Food and Drug
			 Administration;
(d)
1. Unless previously provided, a copy of the
			 current inspection report conducted by the United States Food and Drug
			 Administration pursuant to
			 KRS
			 315.340(2)(a) 2. and (b)1.
			 or
			 KRS
			 315.342(2)(a) 2. and (b)1.,
			 if applicable; or
2. If a current
			 inspection report is not available from the United States Food and Drug
			 Administration, the applicant shall submit an inspection report by:
a. The National Association of Boards of
			 Pharmacy (NABP); or
b. The board's
			 authorized agent;
(e) A confirmation statement of the previous
			 owner if ownership changed;
(f)
			 Legal proof of any name change, if applicable;
(g) An explanation if an applicant, owner,
			 officer, or pharmacist-in-charge has ever been convicted of a felony or had a
			 professional license or permit disciplined under federal, state, or local law;
			 and
(h) Ownership information for
			 each owner or officer, including:
1. Name and
			 title;
2. Address;
3. Phone number;
4. Social security number; and
5. Date of birth.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:413E - Ordering and administering vaccinations

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010,
				315.020,
				315.050,
				315.065,
				315.135,
				315.205,
				42 U.S.C.
				247d-6d,
				85 Fed. Reg. 15198, 52136, 79190,
				86 Fed. Reg. 7872, 9516, 10588, 14462 and 41977.
NECESSITY, FUNCTION, AND CONFORMITY: 85 Fed. Reg. 15198, 85
				Fed. Reg. 52136 and 86 Fed. Reg 9516, 10588 and 41977 require the Board of
				Pharmacy to promulgate an administrative regulation to conform state law to
				federal law during the period of this national public health emergency
				resulting from the coronavirus (COVID-19) pandemic.
				KRS
				315.010(22) does not
				authorize pharmacists to order vaccinations nor does
				KRS
				315.010(22) authorize the
				use of prescriber-approved protocols for pharmacists or pharmacist interns to
				administer vaccinations to children under the age of nine (9). 85 Fed. Reg.
				52136, requires that state-licensed pharmacists be authorized to order and to
				administer vaccinations to children between the ages of three (3) and seventeen
				(17) and that state-registered pharmacist interns and pharmacy technicians be
				authorized to administer vaccinations to children between the ages of three (3)
				and seventeen (17). 85 Fed. Reg. 79190 requires that technicians be authorized
				to administer childhood vaccinations and COVID-19 vaccinations and requires
				that state law establish a training requirement for all pharmacists,
				technicians, and interns that will be ordering or administering vaccinations
				pursuant to the declaration. The Prep Act (42 U.S.C.
				247d-6d(8)) preempts any
				state law that would prohibit or effectively prohibit activities authorized by
				the secretary in a PREP Act Declaration. This administrative regulation
				establishes requirements for Kentucky to comply with 85 Fed. Reg. 15198, 52136,
				79190 and 86 Fed. Reg. 7872, 9516, 10588, 14462 and 41977 and ensures a robust
				pool of pharmacist for ordering and administering vaccines.
Section 1. Definitions.
(1) "Administer" is defined by
			 KRS
			 315.010(1).
(2) "Pharmacist" is defined by
			 KRS
			 315.010(17).
(3) "Pharmacist intern" is defined by
			 KRS
			 315.010(18).
(4) "Pharmacy technician" is defined by
			 KRS
			 315.010(21).
(5) "Prescribe" means to issue an original or
			 new order from a pharmacist for an FDA-approved or authorized vaccination or
			 medication, including but not limited to, epinephrine, diphenhydramine and
			 corticosteroids to treat emergency reactions to vaccines.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:414E - Ordering and administering vaccinations

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010,
				315.020,
				315.050,
				315.065,
				315.135,
				315.205,
				42 U.S.C.
				247d-6d,
				85 Fed. Reg. 15198, 52136, 79190,
				86 Fed. Reg. 7872, 9516, 10588, 14462, 41977
NECESSITY, FUNCTION, AND CONFORMITY: 85 Fed. Reg. 15198, 85
				Fed. Reg. 52136 and 6 Fed. Reg. 9516, 10588, and 41977, require the Board of
				Pharmacy to promulgate an administrative regulation to conform state law to
				federal law while the PREP Act declaration remains in effect for COVID-19.
				KRS
				315.010(22) does not
				authorize pharmacists to prescribe vaccinations, nor does
				KRS
				315.010(22) authorize the
				use of prescriber-approved protocols for pharmacists or pharmacist interns to
				administer vaccinations to children under the age of nine (9). 85 Fed. Reg.
				52136 requires that state-licensed pharmacists be authorized to prescribe and
				to administer vaccinations to children between the ages of three (3) and
				seventeen (17). 85 Fed. Reg. 79190 requires that state law establish a training
				requirement for all pharmacists that will be ordering or administering
				vaccinations pursuant to the declaration. The Prep Act (42 U.S.C.
				247d-6d(8)) preempts any
				state law that would prohibit or effectively prohibit activities authorized by
				the secretary in a PREP Act Declaration. This administrative regulation
				establishes requirements for Kentucky to comply with 85 Fed. Reg. 15198, 52136,
				79190 and 86 Fed. Reg. 7872, 9516, 10588, 14462, and 41977 and ensures a robust
				pool of pharmacist for prescribing and administering vaccines.
Section 1. Definitions.
(1) "Administer" is defined by
			 KRS
			 315.010(1).
(2) "Pharmacist" is defined by
			 KRS
			 315.010(17).
(3) "Prescribe" means to issue an original or
			 new order from a pharmacist for an FDA-approved or authorized vaccination or
			 medication, including but not limited to, epinephrine, diphenhydramine, and
			 corticosteroids for the emergency treatment of acute vaccine
			 reactions.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:420 - Administration of vaccines

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010,
				315.050,
				315.136
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations relating to pharmacists,
				pharmacist interns, and pharmacy technicians. This administrative regulation
				authorizes pharmacist interns and pharmacy technicians to administer
				vaccinations pursuant to requirements. This administrative regulation shall not
				change the authorization for pharmacists to administer vaccinations pursuant to
				KRS
				315.010(22).
Section 1. Definitions.
(1) "Administer" is defined by
			 KRS
			 315.010(1).
(2) "Pharmacist" is defined by
			 KRS
			 315.010(17).
(3) "Pharmacist intern" is defined by
			 KRS
			 315.010(18).
(4) "Pharmacy technician" is defined by
			 KRS
			 315.010(21).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:450 - Unprofessional conduct of a pharmacy permit holder

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.030,
				315.035,
				315.0351,
				315.121,
				315.131,
				337.355,
				337.365
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations necessary to regulate and
				control all matters set forth in KRS Chapter 315 relating to pharmacists and
				pharmacies. This administrative regulation establishes the actions that
				constitute unprofessional conduct of a pharmacy permit holder.
Section 1. Definitions.
(1) "Pharmacy permit holder" means any permit
			 maintained by a resident or non-resident pharmacy.
(2) "Provision of pharmacy services" means
			 the services provided to a patient from a licensee, permit holder, or
			 registrant.
(3) "Safe practices"
			 means practices that aim to prevent and reduce risks, errors, and harm, or
			 threat of harm to the public.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:010 - Application for licensure; endorsement

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				218A.205(3)(g),
				320.220,
				320.250,
				320.270
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.220 requires all persons who practice
				optometry in this state to be licensed by the Kentucky Board of Optometric
				Examiners.
				KRS
				320.250 establishes criteria for an applicant
				to apply for a license.
				KRS
				320.270 grants the board the discretion to
				admit to practice in Kentucky persons licensed to practice optometry in other
				states.
				KRS
				218A.205(3)(g) requires
				fingerprint-supported criminal record checks and queries to the National
				Practitioner Data Bank on applicants. This administrative regulation prescribes
				the procedures to be followed in making application to the board for a
				license.
Section 1.
(1) A person wishing to apply for a license
			 to practice optometry shall submit to the board, within fifteen (15) days of
			 board review, the following items:
(a) A
			 completed Application for License to Practice Optometry;
(b) Birth certificate;
(c) A certified copy of college transcripts
			 received directly from the registrar's office;
(d) A certified copy of optometry school
			 transcripts received directly from the registrar's office;
(e) National board results;
(f) Therapeutic Management of Ocular Disease,
			 "TMOD" results;
(g) Two (2) letters
			 of recommendation, one (1) of which shall be from a licensed
			 optometrist;
(h) Proof of
			 successful completion of State Law Exam results;
(i) A passport-sized, recent photograph of
			 head and shoulders, front view;
(j)
			 A money order or cashier's check payable to the Kentucky State Treasurer in the
			 amount of $500; and
(k) A money
			 order or cashier's check in the amount of twenty-five (25) dollars made payable
			 to the Kentucky State Treasurer for the purpose of submitting a query on the
			 applicant to the National Practitioner Data Bank of the United States
			 Department of Health and Human Services.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:030 - Annual courses of study required

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				218A.202,
				218A.205(3)(h),
				320.280
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.280(2) requires all
				licensed optometrists to annually take courses of study in subjects relating to
				the practice of optometry.
				KRS
				218A.205(3)(h) requires
				optometrists to obtain seven and one-half (7.5) percent of their continuing
				education credits in the use of the electronic monitoring system established
				pursuant to
				KRS
				218A.202, pain management, or addiction
				disorders. This administrative regulation establishes the required hours of
				study and prescribes the approved programs and those records that shall be
				maintained and submitted showing proof of attendance at those programs.
Section 1.
(1) The annual course of study shall be
			 completed each calendar year.
(2)
(a) A licensee shall attend a minimum of
			 eight (8) continuing education credit hours.
(b) In addition to the requirements of
			 paragraph (a) of this subsection, an optometrist who is authorized to prescribe
			 therapeutic agents shall attend a minimum of seven (7) credit hours in ocular
			 therapy and pharmacology, for a total of at least fifteen (15) continuing
			 education credits.
(c) In addition
			 to the requirements of paragraph (a) and (b) of this subsection, an optometrist
			 who is credentialed by the board to perform expanded therapeutic procedures
			 shall attend a minimum of five (5) additional credit hours in expanded
			 therapeutic procedures, for a total of at least twenty (20) continuing
			 education credits.
(d) A licensee
			 who is authorized to prescribe controlled substances shall obtain two (2)
			 credit hours that relate to the use of the electronic monitoring system
			 established in accordance with
			 KRS
			 218A.202 known as Kentucky All Schedule
			 Prescription Electronic Reporting (KASPER), pain management, or addiction
			 disorders as part of the licensee's total continuing education
			 credits.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:037 - Advertising

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.295,
				326.060
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.295 prohibits false, misleading, or
				deceptive advertising. This administrative regulation describes what an
				advertisement shall include to avoid being characterized as false, misleading,
				or deceptive.
Section 1.
(1) An advertisement shall state if
			 additional charges may be incurred in an eye examination for related services
			 in individual cases.
(2) An
			 advertisement of price for visual aid glasses, including contact lenses, alone
			 shall clearly state: "does not include eye examination".
(3) Any optometrist who has been subjected to
			 any disciplinary measures for advertising violations may be required by the
			 board to secure prepublication approval of all advertisements by the board for
			 any period of time which the board deems appropriate.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:040 - Unprofessional conduct

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.310(1)(n)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.240(4), (7), and (8)
				that the board shall have the power to promulgate an administrative regulation
				about what acts constitute unprofessional conduct.
				KRS
				320.310(1)(n) authorizes the
				board to discipline a licensee who violates an administrative regulation
				promulgated by the board. This administrative regulation establishes the acts
				that constitute unprofessional conduct.
Section
			 1. An optometrist shall not practice optometry in an office if the
			 instruments and equipment, including office furniture, fixtures and
			 furnishings, contained therein are not maintained in a clean and sanitary
			 manner.
Section 2.
(1) An optometrist shall not give or receive
			 a fee, salary, commission, or other remuneration or thing of value, in any
			 manner, or under any pretext, to or from any person, firm, or corporation:
(a) In return for the referral of optometric
			 patients; or
(b) In order to secure
			 optometric patients.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:050 - Office locations

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.310(2)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.310(2) permits each
				optometrist to maintain branch offices. This administrative regulation requires
				each optometrist to furnish information concerning each office to the
				board.
Section 1. An optometrist shall
			 inform the board of the change in location, mailing address, and telephone
			 number of each office he works in within thirty (30) days of any
			 change.
STATUTORY AUTHORITY:
				  KRS
				  320.240,
				  320.310(2)
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:055 - Telehealth

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				211.332,
				211.334,
				211.335,
				211.336,
				320.210,
				320.300,
				320.390,
				367.680-367.690,
				42 U.S.C. secs.
				1320d to
				1320d-9,
				12101 et. seq.
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.390(2) requires the
				Board of Optometric Examiners to promulgate administrative regulations to
				prevent abuse and fraud through the use of telehealth services, prevent
				fee-splitting through the use of telehealth services, and utilize telehealth in
				the provision of optometric services and in the provision of continuing
				education. KRS
				211.336 establishes requirements for a state
				agency that promulgates administrative regulations relating to telehealth. This
				administrative regulation establishes requirements for the use of telehealth
				services.
Section 1. Definitions.
(1) "Doctor of Optometry" means an individual
			 licensed by the Kentucky Board of Optometric Examiners to engage in the
			 practice of optometry.
(2)
			 "Patient" means the person receiving services or items from a doctor of
			 optometry.
(3) "Practice of
			 optometry" is defined by
			 KRS
			 320.210(2).
(4) "Telehealth" is defined by
			 KRS
			 211.332(5) and
			 320.390(3).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:070 - Board members compensation

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.230
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.230 allows the board members to receive
				per diem compensation to be determined by administrative regulation of the
				board not to exceed $125. This administrative regulation prescribes the board
				member's per diem compensation.
Section
			 1. A board member's per diem compensation shall be $100.
STATUTORY AUTHORITY:
				  KRS
				  320.230,
				  320.240
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:080 - Trade names

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.300(4)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.300(4) prohibits a
				person from practicing optometry under any name other than his own except as
				permitted by the board in its administrative regulations. This administrative
				regulation prescribes the instances where an optometrist may practice under a
				trade name.
Section 1. An optometrist
			 may practice under a trade name if:
(1) It is
			 not the same as his name; and
(2)
			 The name of each optometrist practicing in his office is prominently displayed
			 on:
(a) The exterior of the main entrance to
			 the office; and
(b) Stationery,
			 prescription pads, telephone directory listings, and other items bearing or
			 displaying the trade name.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:090 - Annual renewal fee

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.280
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.280(1) requires the
				Kentucky Board of Optometric Examiners to promulgate an administrative
				regulation to establish the payment of the fee required for an optometrist to
				annually secure a renewal certificate. This administrative regulation
				establishes the amount of the annual renewal fee.
Section 1. The annual renewal fee for an
			 optometrist shall be $250.
STATUTORY AUTHORITY:
				  KRS
				  320.240(4),
				  320.280(1)
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:100 - Expungement

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.310(3)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.310(3) authorizes the
				board to promulgate an administrative regulation to establish minor violations
				that are subject to expungement. This administrative regulation establishes the
				violations considered minor and the criteria and procedure for
				expungement.
Section 1. Definition.
			 "Expungement" means that:
(1) The affected
			 records shall be sealed;
(2) The
			 proceedings to which they refer shall be deemed not to have occurred;
			 and
(3) The affected party may
			 properly represent that no record exists regarding the matter
			 expunged.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:110 - Expanded therapeutic procedures

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				320.210(2),
				320.240(4),
				(5), (7),
				320.310(1)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.240(4) authorizes the
				Kentucky Board of Optometric Examiners to promulgate administrative regulations
				for classification and licensure of optometrists by examination and
				credentials.
				KRS
				320.240(5) requires a
				therapeutically licensed optometrist to meet educational and competence
				criteria set forth by the board in order to perform expanded therapeutic
				procedures, and evidence of proof of continuing competency shall be determined
				by the board. This administrative regulation establishes the educational and
				competence criteria necessary for a therapeutically licensed optometrist to
				perform expanded therapeutic procedures.
Section
			 1. Qualifications for a Kentucky Licensed Optometrist to be
			 Credentialed to Utilize Expanded Therapeutic Procedures. A Kentucky licensed
			 optometrist shall be credentialed to perform expanded therapeutic procedures
			 if:
(1) The applicant provides proof that the
			 applicant:
(a) Holds an active license in good
			 standing by another state;
(b) Is
			 also credentialed by that state to perform expanded therapeutic procedures;
			 and
(c) The requirements in the
			 state of licensure for performing expanded therapeutic procedures meet or
			 exceed the requirements in this section; or
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 5 - Board of Optometric Examiners › Section 201 KAR 5:120 - Practice of optometry outside of regular office for a charitable purpose

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS (7), 320.310(1)(f)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				320.310(1)(f) authorizes the
				board to promulgate administrative regulations to permit the practice of
				optometry outside of the licensee's regular office for a charitable purpose as
				defined by the board. This administrative regulation establishes the standards
				for the practice of optometry outside the licensee's office for a charitable
				purpose.
Section 1. Definitions.
(1) "Charitable organization" means a
			 nonprofit entity accepted by the Internal Revenue Service and organized for
			 benevolent, educational, philanthropic, humane, social welfare, or public
			 health purposes.
(2) "Charitable
			 purpose" means a purpose that holds itself out to be benevolent, educational,
			 philanthropic, humane, or for social welfare or public health.