reglab/statecodes huggingface dataset:
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 1 - Board of Accountancy › Section 201 KAR 1:180 - Safe harbor language for nonlicensees to use in connection with a compilation of financial information

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				325.380(4)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				325.380(4) requires Kentucky
				State Board of Accountancy to issue an administrative regulation that contains
				language that a nonlicensee may use in preparing a compilation of financial
				information.
Section 1. Definitions.
			 "Compilation of financial information" means a presentation of financial data,
			 including accompanying notes, derived from accounting records and intended to
			 communicate an entity's economic resources and obligations at a point in time
			 or the changes therein for a period of time and does not contain any reference
			 to or language found in generally-accepted accounting standards and
			 generally-accepted accounting principles.
Section 2. Pursuant to
			 KRS
			 320.380(4), nonlicensees may
			 use the following language in connection with a compilation of financial
			 information and not be in violation of the provisions of KRS Chapter 325 and
			 the accompanying administrative regulations: "The accompanying balance sheet
			 (or _________ ) of XYZ Company as of 20__ and the related statements of income,
			 (or retained earnings, or cash flows) for the year then ended have been
			 prepared by me (us). The information presented in these financial statements is
			 the representation of management (owners)."
STATUTORY AUTHORITY:
				  KRS
				  325.240,
				  325.380(4)
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 1 - Board of Accountancy › Section 201 KAR 1:300 - Rules of professional conduct

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				325.240,
				325.340
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				325.240(2) authorizes the
				Kentucky State Board of Accountancy to promulgate administrative regulations
				for the administration of KRS Chapter 325, and to establish and maintain a high
				standard of integrity and dignity in the profession of public accounting. This
				administrative regulation establishes the Kentucky State Board of Accountancy
				Rules of Professional Conduct that incorporate by reference the AICPA Code of
				Professional Conduct.
Section 1.
			 Definitions.
(1) "AICPA" means the American
			 Institute of Certified Public Accountants.
(2) "Board" is defined by
			 KRS
			 325.220(1).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 1 - Board of Accountancy › Section 201 KAR 1:310 - Expungement of minor violation

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				325.240(2)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				325.240(2) authorizes the
				Kentucky State Board of Accountancy to promulgate administrative regulations to
				administer KRS Chapter 325.
				KRS
				325.340(5) requires the
				board to promulgate an administrative regulation to establish procedures to
				expunge a minor violation. This administrative regulation establishes those
				expungement procedures.
Section 1.
			 Definition. "Expungement" means all affected records are sealed and the
			 proceedings to which the records refer never occurred.
Section 2. A licensee whose record has been
			 expunged may properly reply, upon inquiry, that disciplinary records do not
			 exist.
Section 3. Any licensee
			 seeking expungement of a minor violation from the licensee's record shall
			 submit to the board a written request that specifically demonstrates
			 satisfaction of each of the elements for expungement identified in
			 KRS
			 325.340(4).
Section 4.
(1) Upon receipt of the written request, the
			 board shall:
(a) Review the request for
			 expungement; and
(b) Provide the
			 licensee with a written response granting or denying the request.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:010 - Schools approved by the board

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.050
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1) authorizes the
				board to promulgate administrative regulations to regulate and control all
				matters set forth in KRS Chapter 315 relating to pharmacists.
				KRS
				315.050(1) requires the
				board to approve the schools or colleges of pharmacy whose curricula or course
				of studies are acceptable. This administrative regulation establishes the
				educational standards for an applicant for licensure as a pharmacist in
				Kentucky and identifies the acceptable and approved colleges or schools of
				pharmacy from which an applicant shall graduate.
Section 1. An applicant for licensure as a
			 pharmacist, shall have graduated and received a degree in an accredited
			 pharmacy degree program, which has been approved by the Board of Pharmacy. A
			 program shall be considered approved if the program's standards are equivalent
			 to the minimum standards for accreditation for a similar program established
			 by:
(1) The Accreditation Council on
			 Pharmaceutical Education, Accreditation Standards and Key Elements for the
			 Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree;
			 or
(2) The Canadian Council for
			 Accreditation of Pharmacy Programs, Accreditation Standards for Canadian First
			 Professional Degree in Pharmacy Programs.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:015 - Continuing education

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010,
				315.065,
				315.120,
				315.121
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.065(2) and (3) require
				the Board of Pharmacy to establish continuing education requirements for
				pharmacists. This administrative regulation establishes requirements for the
				continuing pharmacy education of registered pharmacists and requires all
				registered pharmacists holding a license issued by the board to participate in
				continuing pharmacy education as a means of renewal of their licenses.
Section 1. Definitions.
(1) "Continuing education unit" or "CEU" is
			 defined by KRS
			 315.010(8).
(2) "Sponsor" means a person, school,
			 association, company, corporation, or group who wishes to develop a continuing
			 education program.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:020 - Examination

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				218A.205(7),
				315.050
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.050(2) and
				315.191(1)(c)
				authorize the board to promulgate administrative regulations to prescribe the
				time, place, method, manner, scope, and subjects of examinations.
				KRS
				218A.205(8) requires the
				board to establish requirements for background checks for licensees. This
				administrative regulation establishes the examination and application
				requirements for obtaining a license to practice pharmacy in Kentucky.
Section 1. The examination for licensure
			 shall include:
(1) The North American
			 Pharmacist Licensure Examination (NAPLEX); and
(2) The Multistate Pharmacy Jurisprudence
			 Examination (MPJE).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:030 - License transfer

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.191(1)(c), (d),
				315.210
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS 315.210
				authorizes the board to establish conditions for licensure by reciprocity.
				KRS
				218A.205(8) requires the
				board to establish requirements for background checks for licensees. This
				administrative regulation establishes conditions, forms, and examination
				requirements for licensure by reciprocity.
Section
			 1. Definitions.
(1) "Board" is
			 defined by
			 KRS
			 315.010(4).
(2) "License transfer" means a license to
			 practice pharmacy in Kentucky issued by the board to a pharmacist licensed in
			 another jurisdiction.
(3) "NABP"
			 means the National Association of Boards of Pharmacy.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:040 - Registration of pharmacist interns

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010(18),
				315.020(3),
				(4),
				315.050(4),
				(5),
				315.191(1)(h)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.050(4) requires the
				Kentucky Board of Pharmacy to establish standards for pharmacy intern
				certification. KRS
				315.191(1)(h) authorizes the
				board to establish an internship program for training, qualifications, and
				registration of applicants for registration of pharmacist interns. This
				administrative regulation establishes the standards for training,
				qualifications, and registration of pharmacist interns
Section 1. Definitions.
(1) "Academic experience program" means a
			 course or series of courses taken by a pharmacist intern at a school or college
			 of pharmacy approved by the board that involves actual practice of pharmacy
			 experiences.
(2) "Pharmacist
			 intern" is defined by
			 KRS
			 315.010(18).
(3) "Preceptor" means the pharmacist who is
			 responsible to the board for the practice of pharmacy experiences of a
			 pharmacist intern.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:045 - Technicians

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS 315.010(12), (20),
				(26),
				315.020(4)(b),
				315.191(1)(a),
				(g), (l)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations governing pharmacy technicians.
				KRS
				315.020(4)(b) authorizes the
				board to establish the scope of practice for pharmacy technicians.
				KRS
				315.010(20) and
				315.191(1)(l)
				authorize the board to promulgate administrative regulations establishing when
				a pharmacy technician can practice under the general, rather than immediate,
				supervision of a pharmacist. This administrative regulation establishes the
				qualifications required for a pharmacy technician to practice under the general
				supervision of a pharmacist, and establishes the scope of practice for a
				pharmacy technician.
Section 1. A
			 person shall be recognized by the board as a certified pharmacy technician, if:
(1)
(a) The
			 person has successfully completed the Pharmacy Technician Certification Exam
			 (PTCE) administered by the Pharmacy Technician Certification Board (PTCB) or
			 the Examination for the Certification of Pharmacy Technicians (ExCPT) by the
			 National Healthcareer Association (NHA); and
(b) The certificate issued by the PTCB or NHA
			 is current; or
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:045 - Technicians

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010(12), (20), (26),
				315.020(4)(b),
				315.191(1)(a), (g),
				(l)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations governing pharmacy technicians.
				KRS
				315.020(4)(b) authorizes the
				board to establish the scope of practice for pharmacy technicians.
				KRS
				315.010(20) and
				315.191(1)(l)
				authorize the board to promulgate administrative regulations establishing when
				a pharmacy technician can practice under the general, rather than immediate,
				supervision of a pharmacist. This administrative regulation establishes the
				qualifications required for a pharmacy technician to practice under the general
				supervision of a pharmacist, and establishes the scope of practice for a
				pharmacy technician.
Section 1. A
			 person shall be recognized by the board as a certified pharmacy technician, if:
(1)
(a) The
			 person has successfully completed the Pharmacy Technician Certification Exam
			 (PTCE) administered by the Pharmacy Technician Certification Board (PTCB) or
			 the Examination for the Certification of Pharmacy Technicians (ExCPT) by the
			 National Healthcareer Association (NHA); and
(b) The certificate issued by the PTCB or NHA
			 is current; or
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:050 - Licenses and permits; fees

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				218A.205(3)(g),
				315.035(1), (2),
				(4),
				315.0351(1),
				315.036(1),
				315.050(5),
				315.060,
				315.110,
				315.120,
				315.191,
				315.402
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(i) authorizes the
				board to assess reasonable fees for services rendered to perform its duties and
				responsibilities. This administrative regulation establishes reasonable fees
				for the board to perform all the functions for which it is responsible.
Section 1. The following fees shall be paid
			 in connection with pharmacist examinations and licenses, pharmacy permits,
			 intern certificates, and the issuance and renewal of licenses and permits:
(1) Application for initial pharmacist
			 license - $150;
(2) Application and
			 initial license for a pharmacist license by license transfer - $250;
(3) Annual renewal of a pharmacist license -
			 ninety-five (95) dollars;
(4)
			 Delinquent renewal penalty for a pharmacist license - ninety-five (95)
			 dollars;
(5) Annual renewal of an
			 inactive pharmacist license - ten (10) dollars;
(6) Pharmacy intern certificate valid six (6)
			 years - twenty-five (25) dollars;
(7) Duplicate of original pharmacist license
			 wall certificate - seventy-five (75) dollars;
(8) Application for a permit to operate a
			 pharmacy - $150;
(9) Renewal of a
			 permit to operate a pharmacy - $150;
(10) Delinquent renewal penalty for a permit
			 to operate a pharmacy - $150 dollars;
(11) Change of location or change of
			 ownership of a pharmacy or manufacturer permit - $150;
(12) Application for a permit to operate as a
			 manufacturer - $150;
(13) Renewal
			 of a permit to operate as a manufacturer - $150;
(14) Delinquent renewal penalty for a permit
			 to operate as a manufacturer - $150;
(15) Change of location or change of
			 ownership of a wholesale distributor license - $150;
(16) Application for a license to operate as
			 a wholesale distributor -$150;
(17)
			 Renewal of a license to operate as a wholesale distributor -$150;
(18) Delinquent renewal penalty for a license
			 to operate as a wholesale distributor -$150; and
(19) Query to the National Practitioner Data
			 Bank of the United States Department of Health and Human Services - twenty-five
			 (25) dollars.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:061 - Procedures followed by the Kentucky Board of Pharmacy in the investigation and hearing of complaints

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				218A.205,
				315.121,
				315.131,
				315.191,
				21
				C.F.R. 310.305(b)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations relating to the practice of
				pharmacy, including a process for complaints and hearings.
				KRS
				315.191(2) authorizes the
				board to enforce pharmacy laws and administrative regulations.
				KRS
				218A.205(3)(e), (f) and (5)
				require the board to promulgate administrative regulations relating to
				complaints, licensure standards, and disciplinary actions. The administrative
				regulation establishes board procedure for investigations, the administrative
				hearings process, and the penalties for violations.
Section 1. Definitions.
(1) "Adverse drug experience" means any
			 adverse event associated with the use of a drug in humans, whether or not
			 considered drug related, including the following:
(a) An adverse event occurring in the course
			 of the use of a drug product in professional practice;
(b) An adverse event occurring from drug
			 overdose, whether accidental or intentional;
(c) An adverse event occurring from drug
			 abuse;
(d) An adverse event
			 occurring from drug withdrawal; and
(e) Any failure of expected pharmacological
			 action.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:070 - Prescription intermediary services restricted

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 315
NECESSITY, FUNCTION, AND CONFORMITY: By the authority of
				KRS
				315.191(2) the Board of
				Pharmacy is responsible to control all matters relating to pharmacies and
				pharmacists with respect to drugs sold by prescriptions only. This
				administrative regulation assures the public that a registered pharmacist is
				present and that prescription drugs distribution is curtailed.
Section 1. No pharmacist shall fill and
			 dispense prescriptions obtained from an establishment or place which offers to
			 the public, in any manner, its services as a "pickup station" or "intermediary"
			 for the purpose of having prescriptions filled or delivered unless such
			 establishment or place has a registered pharmacist in full charge of such
			 services.
STATUTORY AUTHORITY:
				  KRS
				  315.020(2),
				  315.121(1),
				  315.191(2),
				  (8)
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:074 - Pharmacy services in hospitals

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
				requires the board to ensure the safety of all drug products provided to the
				citizens of Kentucky. This administrative regulation establishes requirements
				for pharmacy services in hospitals.
Section
			 1. Definitions.
(1) "Automated
			 pharmacy system" 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 and shall be
			 either:
(a) A decentralized automated
			 pharmacy system that is located outside the pharmacy department, but within the
			 same institution, and under the supervision of a pharmacist; or
(b) A centralized automated pharmacy system
			 from which medications are prepared for final distribution that require the
			 approval of a pharmacist.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:076 - Compounding

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.055(1),
				217.065(7),
				315.020(1),
				315.035(6),
				315.0351,
				315.121,
				315.191(1)(a),
				(g),
				21 U.S.C.
				353A,
				21 C.F.R.
				216.23
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.020(1) requires the
				owner of a pharmacy who is not a pharmacist to place a pharmacist in charge of
				the owner's pharmacy.
				KRS
				315.035(6) authorizes the
				board to promulgate administrative regulations to assure that proper equipment
				and reference material is on hand considering the nature of the pharmacy
				practice conducted at the particular pharmacy and to assure reasonable health
				and safety standards for areas within the pharmacies, which are not subject to
				these standards under CHFS.
				KRS
				315.191(1) authorizes the
				board to promulgate administrative regulations necessary to regulate and
				control all matters relating to pharmacists, pharmacist interns, pharmacy
				technicians, pharmacies, wholesale distributors, and manufacturers. This
				administrative regulation establishes the requirements for compounding
				non-sterile and sterile preparations, and the preparation, compounding,
				dispensing, and repackaging of radiopharmaceuticals in accordance with
				21 U.S.C.
				353A.
Section
			 1. Definitions.
(1) "API" means
			 active pharmaceutical ingredient.
(2) "Designated person" means one (1) or more
			 individuals assigned to be responsible and accountable for the performance and
			 operation of the facility and personnel as related to the preparation of
			 compounded non-sterile or sterile preparations or the preparation, compounding,
			 dispensing, and repackaging of radiopharmaceuticals.
(3) "Essential copy of a commercially
			 available drug product" is a compounded preparation in which:
(a) The compounded preparation has the same
			 API as the commercially available drug product;
(b) The APIs have the same, similar, or an
			 easily substitutable dosage strength; and
(c) The commercially available drug product
			 can be used by the same route of administration as prescribed for the
			 compounded preparations, unless a prescriber determines that there is a change,
			 made for an identified individual patient, which produces, for that patient, a
			 significant difference from the commercially available drug product.
(4) "Hazardous Drug" means any
			 drug identified by the National Institute for Occupational Safety and Health
			 with at least one (1) of the following criteria:
(a) Carcinogenicity, teratogenicity, or
			 developmental toxicity;
(b)
			 Reproductive toxicity in humans;
(c) Organ toxicity at low dose in humans or
			 animals;
(d) Genotoxicity;
			 or
(e) New drugs that mimic
			 existing hazardous drugs in structure or toxicity.
(5) "USP" means United States
			 Pharmacopeia.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:090 - Reference material and prescription equipment

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 315
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.035(6) authorizes the
				Board of Pharmacy to promulgate administrative regulations regarding reference
				material and equipment suitable for pharmaceutical practice. This
				administrative regulation establishes the reference material and equipment
				required for pharmaceutical practice.
Section
			 1.
(1) The pharmacy shall have
			 appropriate reference material and equipment as dictated by experience to meet
			 the needs of the particular pharmacy, and necessary to practice pharmacy in a
			 safe manner.
(a) Appropriate reference
			 material includes references such as those from the following categories:
1. Category I - Pharmacology;
2. Category II - Drug Interactions;
3. Category III - Drug Product Composition;
			 and
4. Category IV - State and
			 Federal Laws and Regulations.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:095 - Pharmacist Interns

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS 315.010(12), (18),
				(27),
				315.020,
				315.050
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 the practice of
				pharmacists and pharmacist interns. This administrative regulation establishes
				the professional responsibilities of a pharmacist and a pharmacist intern under
				supervision.
Section 1. A pharmacist
			 intern, under the supervision and direction of a licensed pharmacist, shall
			 practice pharmacy pursuant to
			 KRS
			 315.010(22) with the
			 exception that prior to dispensing, a pharmacist shall verify the accuracy and
			 appropriateness to include drug utilization review (DUR) and final product
			 verification of the prescription or product dispensed.
Section 2. A pharmacist shall be responsible
			 for all the actions of a pharmacist intern.
STATUTORY AUTHORITY:
				  KRS
				  315.020(4),
				  315.191(1)(a)
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:100 - Security and control of drugs and prescriptions

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 315
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1) authorizes the
				Kentucky Board of Pharmacy to promulgate administrative regulations necessary
				to regulate and control pharmacists and pharmacies. This administrative
				regulation establishes requirements for adequate security and control of drugs
				and prescriptions.
Section 1.
(1) A pharmacy shall:
(a) Provide adequate security and control of
			 its controlled substances and prescription legend drugs; and
(b) Be closed in the absence of a
			 pharmacist.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:105 - Requirements for wholesalers, medical gas wholesalers, wholesale distributors, and virtual wholesale distributors

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.182,
				315.010,
				315.0351,
				315.121,
				315.350,
				315.400,
				315.402,
				315.404,
				315.406,
				315.408,
				315.410,
				315.412,
				21 U.S.C.
				360eee -eee-4
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations to regulate and control all
				matters set forth in KRS Chapter 315.
				KRS
				315.350,
				315.402 and
				315.406 require the board to
				promulgate administrative regulations to regulate wholesalers, medical gas
				wholesalers, wholesale distributors, and virtual wholesale distributors of
				prescription drugs and drug-related devices. This administrative regulation
				establishes the requirements for the regulation of wholesalers, medical gas
				wholesalers, wholesale distributors, and virtual wholesale distributors.
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)
			 "Distribution" or "distribute" is defined by
			 KRS
			 315.400(5).
(3) "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.
(4)
			 "Illegitimate Product" is defined by
			 KRS
			 315.400(11).
(5) "Medical gas wholesaler" is defined by
			 KRS
			 315.400(13).
(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 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) "Wholesale distribution" is defined by
			 KRS
			 315.400(20).
(9) "Wholesale distributor" is defined by
			 KRS
			 315.400(21).
(10) "Wholesaler" is defined by
			 KRS
			 315.010(28), and includes
			 medical gas wholesalers, wholesale distributors, and virtual wholesale
			 distributors.
(11) "Virtual
			 wholesale distributor" has the same meaning given in
			 KRS
			 315.400(21).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:106 - Licensed or permitted facility closures

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.035,
				315.0351,
				315.036,
				315.121,
				315.340,
				315.342,
				315.350,
				315.402,
				315.4102
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. This administrative regulation establishes
				requirements relating to closure of business by licensees and permit
				holders.
Section 1. Definitions.
(1) "Involuntary closure" means an
			 interruption of formal business activity resulting from:
(a) Acute illness or
			 incapacitation;
(b)
			 Death;
(c) Fire, flood, or other
			 natural disaster;
(d) Bankruptcy
			 proceedings; or
(e) Court,
			 government, or Board of Pharmacy action.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:116 - Substitution of drugs, biologics and biosimilar products

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.819
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				217.819(1) requires the
				Kentucky Board of Pharmacy to prepare by administrative regulation a drug
				product formulary of drugs which should not be interchanged by pharmacists.
				This administrative regulation references drug products with active ingredients
				or dosage forms that are interchangeable. All other products not referenced as
				interchangeable are non-interchangeable.
Section
			 1. The following have been determined by the board to be
			 interchangeable:
(1) Drugs, drug products, or
			 dosage formulations considered by the United States Food and Drug
			 Administration to be therapeutically equivalent as published in the Approved
			 Drug Products with Therapeutic Equivalence Evaluations (Orange Book);
			 and
(2) Biologics drugs, biologics
			 drug products, or biologics dosage formulations considered by the United States
			 Food and Drug Administration to be therapeutically equivalent as published in
			 the Lists of Licensed Biological Products with Reference Product Exclusivity
			 and Biosimilarity or Interchangeability Evaluations (Purple Book).
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:160 - Licensees; inactive status

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 315
NECESSITY, FUNCTION, AND CONFORMITY: Senate Bill 241 of the
				General Assembly, Commonwealth of Kentucky, Regular Session 1982, provided for
				changes in KRS Chapter 315. This necessitated requirements for licensees to be
				issued inactive status and for those who desire to apply for renewal of a
				license to return to active practice.
Section
			 1. A pharmacist may apply for inactive status by:
(1) Completing annual renewal application;
			 and
(2) Paying annual fee for
			 inactive status.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:165 - Transfer of prescription information

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.215(2),
				315.191(1)(f),
				21 C.F.R.
				1306.08,
				1306.25
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(f) authorizes the
				Board of Pharmacy to promulgate administrative regulations to control the
				transfer of prescription drug orders between pharmacists and pharmacies. This
				administrative regulation establishes the procedures by which a prescription
				may be transferred between pharmacies in the Commonwealth or between a pharmacy
				and an establishment located in a state or United States Territory or District
				outside the Commonwealth and similarly credentialed as a pharmacy by that state
				or U.S. Territory or District for the purpose of dispensing.
Section 1.
(1) The transfer of prescription information
			 for any noncontrolled substance prescription for the purpose of new or refill
			 dispensing may occur if:
(a) It is orally
			 communicated directly between two (2) pharmacists or pharmacist interns in the
			 Commonwealth or between a pharmacist and an individual located in a state or
			 U.S. Territory or District outside the Commonwealth and similarly credentialed
			 as a pharmacist by that state or U.S. Territory or District;
(b) It is made through an online real-time
			 computer system that provides documentation of the presence of a pharmacist or
			 an individual located in a state or U.S. Territory or District outside the
			 Commonwealth and similarly credentialed as a pharmacist by that state or U.S.
			 Territory or District when the information is transferred;
(c) It is made through the use of a facsimile
			 machine and all the information required by this administrative regulation is
			 provided to the sending and receiving pharmacist or an individual located in a
			 state or U.S. Territory or District outside the Commonwealth and similarly
			 credentialed as a pharmacist by that state or U.S. Territory or District;
			 or
(d) It is made through the use
			 of voice recording technology and all information required by this
			 administrative regulation is provided to the sending and receiving pharmacist
			 or an individual located in a state or U.S. Territory or District outside the
			 Commonwealth and similarly credentialed as a pharmacist by that state or U.S.
			 Territory or District.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:171 - Computerized recordkeeping

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.215,
				217.216,
				315.191
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				217.215(2) authorizes the
				board to establish administrative regulations relating to the storage and
				retrieval of prescription records in licensed pharmacies, including
				administrative regulations regarding computerized record-keeping. This
				administrative regulation provides standards for licensed pharmacies using
				computerized recordkeeping.
Section 1.
			 The following information shall be entered into the system:
(1) All information pertinent to a
			 prescription shall be entered into the system, including items such as each of
			 the following:
(a) The prescription
			 number;
(b) The patient's name and
			 address;
(c) The prescriber's name
			 and address;
(d) The prescriber's
			 Federal Drug Enforcement Administration number, if appropriate;
(e) Refill authorization;
(f) Any prescriber's instructions or
			 patient's preference permitted by KRS Chapters 217, 218A, and 315, or 201 KAR
			 Chapter 2;
(g) The name, strength,
			 dosage form, and quantity of the drug dispensed originally and upon each
			 refill; and
(h) The date of
			 dispensing of the prescription and the identifying designation of the
			 dispensing pharmacist for the original filling and each refill.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:175 - Emergency prescription refills of up to a seventy-two (72) hour supply or greater than a seventy-two (72) hour supply

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapters 217, 315
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				217.215(3) requires the
				Board of Pharmacy to promulgate administrative regulations to carry out the
				provisions for emergency refills by a pharmacist in emergency situations when
				authorization may not be readily or easily obtained from the prescribing
				practitioner.
				KRS
				315.191 authorizes the board to promulgate
				administrative regulations necessary to regulate and control all matters set
				forth in KRS Chapter 315 relating to pharmacists. This administrative
				regulation establishes the conditions for when a prescription may be refilled
				in an emergency situation and the prescriber is unavailable.
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:
(1) Dispense a one (1) time
			 emergency refill of up to a seventy-two (72) hour supply of the maintenance
			 medication when:
(a) The prescription refill
			 is not for a controlled substance;
(b) The medication is essential to the
			 maintenance of life or to the continuation of therapy in chronic
			 conditions;
(c) In the pharmacist's
			 professional judgment, the interruption of therapy may reasonably produce
			 undesirable health consequences or may be detrimental to the patient's welfare
			 and cause physical or mental discomfort;
(d) The pharmacist notes on the prescription
			 record the date, the quantity dispensed, and the pharmacist's name or initials;
			 and
(e) In all situations an
			 emergency refill shall be followed by authorization from the prescriber for
			 continued therapy.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:180 - Pharmacies sanitation

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 315
NECESSITY, FUNCTION, AND CONFORMITY: There is no existing
				uniform administrative regulation for which the Kentucky Board of Pharmacy can
				monitor a pharmacy for cleanliness. Existing administrative regulations pertain
				only to food handling facilities. The purpose of this administrative regulation
				is to provide the board with the authority to require standards for
				compliance.
Section 1. The designated
			 pharmacy area(s) shall be used exclusively for the compounding and dispensing
			 of drugs and other usual procedures incidental to compounding and dispensing of
			 drugs. This area shall be maintained in a clean and sanitary condition,
			 adequately lighted and ventilated.
Section
			 2. No compounding or dispensing of drugs shall be carried on in
			 any room used as a dwelling or for usual household purposes.
Section 3. Hot and cold water shall be
			 readily accessible. Adequate facilities, separate and distinct from toilets and
			 washrooms, shall be provided for maintaining clean and sanitary
			 conditions.
Section 4. All
			 equipment used in the storage, compounding, and dispensing of drugs or
			 medicines shall be kept in a clean and sanitary manner.
Section 5. Proper temperatures shall be
			 maintained for compounding and dispensing of drugs and medicines. Controlled
			 room temperatures shall be fifteen (15) to thirty (30) degrees Centigrade,
			 fifty-nine (59) to eighty-six (86) degrees Fahrenheit. Refrigeration
			 temperatures shall be two (2) to eight (8) degrees Centigrade, thirty-six (36)
			 to forty-six (46) degrees Fahrenheit. Freezer temperatures shall be minus
			 twenty (-20) to minus ten (-10) degrees Centigrade, minus four (-4) to fourteen
			 (14) degrees Fahrenheit. Under nonspecific conditions, it is to be understood
			 that the storage conditions include protection from moisture, freezing, and
			 excessive heat.
Section 6.
			 Violation of any provision of this administrative regulation constitutes
			 unethical or unprofessional conduct in accordance with
			 KRS
			 315.121.
STATUTORY AUTHORITY:
				  KRS
				  315.035(6),
				  315.191(1),
				  (5)
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:185 - Noncontrolled substance prescription drug refills

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS 215.191(f), (g),
				315.191(1)(f)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.010,
				315.191
				and
				217.215(2)
				require the Board of Pharmacy to promulgate administrative regulations
				necessary to regulate the practice of pharmacists and the recordkeeping systems
				associated with prescriptions. This administrative regulation establishes the
				responsibilities of pharmacists and practitioners relating to prescription drug
				refills.
Section 1.
(1) A pharmacist shall not refill a
			 prescription for a noncontrolled substance prescription drug unless authorized
			 by the prescribing practitioner.
(2) A pharmacist shall record all refills by
			 writing the date of the refill together with his name or initials on the
			 original prescription.
(3) If an
			 alternate approved automated data processing system is used, refills and
			 records shall be maintained in compliance with
			 201 KAR
			 2:170.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:190 - Return of prescription drugs prohibited

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapters 217 and 315
NECESSITY, FUNCTION, AND CONFORMITY: To prevent the dispensing
				of drugs that have been adulterated, contaminated or misbranded.
Section 1. No pharmacy, pharmacist, or agent
			 thereof shall accept for reuse or resale a prescription drug. This
			 administrative regulation shall not apply to sealed/unopened unit dose, unit of
			 use or tamper resistant drug packaging.
Section
			 2. Violation of any provision of this administrative regulation
			 constitutes unethical or unprofessional conduct in accordance with
			 KRS
			 315.121.
STATUTORY AUTHORITY:
				  KRS
				  315.010(5),
				  315.191(1),
				  (5)
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:210 - Patient records and patient counseling

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.191(1), (5), (6), 42
				C.F.R. Part 456
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1), (56), 42 CFR
				Part 456 mandates that pharmacists implement drug utilization reviews and
				provide patient counseling to those recipients of health-care benefits for
				which federal funds are allocated. This administrative regulation provides for
				this mechanism and broadens its magnitude by rendering this valuable service
				available to all Kentucky's citizenry, equitably.
Section 1. Patient Records.
(1)
(a) A
			 patient record system shall, with the exercise of professional judgment, be
			 maintained by a pharmacy for patients for whom prescriptive drug orders are
			 dispensed at that pharmacy location.
(b) A pharmacist, with the exercise of
			 professional judgment, shall establish a procedure for obtaining, recording,
			 and maintaining information required for a patient record.
(c) A pharmacist, or his designee, shall
			 obtain, record, and maintain the information for a patient record.
(d) A patient record shall:
1. Be readily retrievable by manual or
			 electronic means;
2. Enable the
			 pharmacist to identify previously dispensed drugs and known disease
			 conditions;
3. Enable the
			 pharmacist to determine the impact of previously dispensed drugs and known
			 disease conditions upon the newly submitted prescriptive drug order;
			 and
4. Be maintained for not less
			 than 180 days from the date of the last entry.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:220 - Collaborative care agreements

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.010(4),
				315.121,
				315.040(4),
				315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				Board of Pharmacy to promulgate administrative regulations to regulate and
				control matters relating to pharmacists, pharmacist interns, pharmacy
				technicians, pharmacies, wholesale distributors, and manufacturers. This
				administrative regulation establishes minimum requirements for the development
				and maintenance of collaborative care agreements between pharmacist and
				practitioner.
Section 1. A
			 collaborative care agreement shall:
(1) Be in
			 writing;
(2) Be signed and dated
			 by:
(a) Each practitioner; and
(b) Each pharmacist who is a party to the
			 agreement;
(3) Provide
			 the method for referral of patients to be managed under the agreement;
			 and
(4) State the method for
			 termination of the agreement.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:225 - Special limited pharmacy permit - Medical gas

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.015(11),
				315.010(9),
				315.020,
				315.035,
				315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1)(a) authorizes the
				board to promulgate administrative regulations to regulate and control all
				matters set forth in KRS Chapter 315 relating to pharmacists and pharmacies.
				This administrative regulation establishes, consistent with the requirements of
				KRS
				315.191(1)(a), minimum
				requirements for the permitting of those entities that distribute medical
				gases.
Section 1. Definitions.
(1) "Medical gases" means gases (including
			 liquefied gases) classified by FDA as drugs or devices that are used for
			 medical applications and which may be stored and administered through the use
			 of Medical Gas Related Equipment, which may or may not be required under
			 Federal or State law for the immediate container to bear the label, "Rx only"
			 or "Caution: Federal or State law prohibits dispensing without a
			 prescription."
(2) "Special limited
			 pharmacy permit" means a permit issued to a pharmacy that provides
			 miscellaneous specialized pharmacy service and functions.
Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:230 - Special limited pharmacy permit - Central Fill

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
				315.191(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.
				KRS
				315.020 requires that prescription drugs,
				medicines, and pharmaceuticals be dispensed or manufactured by a licensed
				pharmacist.
				KRS
				315.035 and
				315.0351
				require that all pharmacies hold a permit issued by the board. This
				administrative regulation establishes, consistent with the requirements of
				KRS
				315.191(1)(a), minimum
				requirements for the permitting of those pharmacies that package, label, and
				distribute central fill prescriptions to pharmacies in the Commonwealth.
Section 1. Definition. "Central fill
			 pharmacy" means a pharmacy that provides packaging, labeling, and delivery of a
			 prescription product to another pharmacy for the purpose of the dispensing of a
			 valid prescription.
Section 2. The
			 central fill pharmacy shall:
(1) Either:
(a) Have a written contract with the pharmacy
			 which has custody of the original prescription authorization for dispensing;
			 or
(b) Be under common ownership
			 with that pharmacy;