201 KAR 2 — Board of Pharmacy

201 KAR 2:030.License transfer. RELATES TO: KRS 315.050, 315.191(1)(c), (d), 315.210 STATUTORY AUTHORITY: KRS 218A.205(8), 315.191(1)(a), (c), (d), 315.210 NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.210 authorizes the board to establish conditions for licensure by reciprocity. …

201 KAR 2:040.Registration of pharmacist interns. RELATES TO: KRS 315.010(18), 315.020(3), (4), 315.050(4), (5), 315.191(1)(h) STATUTORY AUTHORITY: KRS 315.050(4), (5), 315.191(1)(a), (h) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.050(4) requires the Kentucky Board of Pharmacy …

201 KAR 2:045.Technicians. RELATES TO: KRS 142.301, 315.010, 315.020, 315.136, 315.191(1) STATUTORY AUTHORITY: KRS 315.010(21), 315.020(4)(b), 315.191(1)(a), (g), (l) CERTIFICATION STATEMENT: NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgat…

201 KAR 2:050.Licenses and permits; fees. 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 STATUTORY AUTHORITY: KRS 218A.205(3)(g), 315.035(1), (2), (4), 315.036(1), 315.050(5), 315.060, 315.110…

201 KAR 2:061.Procedures followed by the Kentucky Board of Pharmacy in the investigation and hearing of complaints. RELATES TO: KRS 218A.205, 315.121, 315.131, 315.191, 21 C.F.R. 310.305(b) STATUTORY AUTHORITY: KRS 218A.205(3)(e), (f), (5), 315.191(1), (2), (3), (4) NECESSITY, FU…

201 KAR 2:070.Prescription intermediary services restricted. RELATES TO: KRS Chapter 315 STATUTORY AUTHORITY: KRS 315.020(2), 315.121(1), 315.191(2), (8) CERTIFICATION STATEMENT: NECESSITY, FUNCTION, AND CONFORMITY: By the authority of KRS 315.191(2) the Board of Pharmacy is resp…

201 KAR 2:074.Pharmacy services in hospitals. RELATES TO: KRS 315.010, 315.020, 315.030, 315.121 STATUTORY AUTHORITY: 315.002, 315.005, KRS 315.191(1) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1) authorizes the Kentucky Board of Pharmacy to establish requirements to regula…

201 KAR 2:076.Compounding. 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 STATUTORY AUTHORITY: KRS 315.020(1), 315.035(6), 315.0351, 315.191(1)(a), (g) NECESSITY, FUNCTION, AND CONFORMITY: KR…

201 KAR 2:090.Reference material and prescription equipment. RELATES TO: KRS Chapter 315 STATUTORY AUTHORITY: KRS 315.035(6), 315.191 CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with the requirements of 2025 RS HB 6, Section 8. NECESSI…

201 KAR 2:095.Pharmacist interns. RELATES TO: KRS 315.010(12), (18), (27), 315.020, 315.050 STATUTORY AUTHORITY: KRS 315.020(4), 315.191(1)(a) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgate administrative regulations necessary to regulat…

201 KAR 2:100.Security and control of drugs and prescriptions. RELATES TO: KRS Chapter 315 STATUTORY AUTHORITY: KRS 315.035, 315.191(1) CERTIFICATION STATEMENT: NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1) authorizes the Kentucky Board of Pharmacy to promulgate administrat…

201 KAR 2:105.Requirements for wholesalers, medical gas wholesalers, wholesale distributors, and virtual wholesale distributors. 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 STA…

201 KAR 2:106.Licensed or permitted facility closures. RELATES TO: KRS 315.035, 315.0351, 315.036, 315.121, 315.340, 315.342, 315.350, 315.402, 315.4102 STATUTORY AUTHORITY: KRS 315.191(1)(a) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgat…

Title 201 | Chapter 002 | Regulation 110REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:110.Drug products for which there is insufficient data.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCE…

Title 201 | Chapter 002 | Regulation 111EINACTIVEThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:111E.Repeal of 201 KAR 2:110RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableNECESSITY, FUNCTION, AND C…

Title 201 | Chapter 002 | Regulation 115EXPIREDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:115.Controlled release tablets, capsules and injectablesRELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCE…

201 KAR 2:116.Substitution of drugs, biologics, and biosimilar products. RELATES TO: KRS 217.819, 217.822 STATUTORY AUTHORITY: KRS 217.814(5), (6), (7), (8), 217.819(1), 315.191 CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with the requ…

Title 201 | Chapter 002 | Regulation 120REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:120.Enteric coated oral dosage forms.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCERTIFICATION STATEM…

Title 201 | Chapter 002 | Regulation 121INACTIVEThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:121.Repeal of 201 KAR 2:120, 125, 135, 140, 145, 150, and 155RELATES TO:Not availableSTATUTORY AUTHORITY:Not ava…

Title 201 | Chapter 002 | Regulation 125REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:125.Drug products in aerosol-nebulizer delivery systems.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableC…

Title 201 | Chapter 002 | Regulation 130REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:130.Schedule I and II controlled substances.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCERTIFICATION…

Title 201 | Chapter 002 | Regulation 131INACTIVEThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:131.Repeal of 201 KAR 2:130RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableNECESSITY, FUNCTION, AND CON…

Title 201 | Chapter 002 | Regulation 135REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:135.Drug products with bioinequivalence problems.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCERTIFIC…

Title 201 | Chapter 002 | Regulation 140REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:140.Drug products having drug standard deficiencies.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCERTI…

Title 201 | Chapter 002 | Regulation 145REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:145.Drug products with potential bioequivalence issues.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCE…

Title 201 | Chapter 002 | Regulation 150REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:150.Topical products.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCERTIFICATION STATEMENT: NECESSITY, …

Title 201 | Chapter 002 | Regulation 155REPEALEDThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 2:155.Suppositories and enemas for systemic use.RELATES TO:Not availableSTATUTORY AUTHORITY:Not availableCERTIFICATI…

201 KAR 2:160.Licensees; inactive status. RELATES TO: KRS Chapter 315 STATUTORY AUTHORITY: KRS 315.065, 315.110, 315.120, 315.191(1) CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with the requirements of 2025 RS HB 6, Section 8. NECESSIT…

201 KAR 2:165.Transfer of prescription information. RELATES TO: KRS 217.215, 315.121, 315.191, 21 C.F.R. 1306.08, 1306.25 STATUTORY AUTHORITY: KRS 217.215(2), 315.191(1)(a), (f) CERTIFICATION STATEMENT: NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(f) authorizes the Board of P…

Title 201 | Chapter 002 | Regulation 167WITHDRAWNThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:167.Facsimile prescription ordersRELATES TO:Not availableSTATUTORY AUTHORITY:Not availableNECESSITY, FUNCTION, …

Title 201 | Chapter 002 | Regulation 170INACTIVEThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:170.Computerized recordkeepingRELATES TO:Not availableSTATUTORY AUTHORITY:Not availableNECESSITY, FUNCTION, AND …

201 KAR 2:171.Computerized recordkeeping. RELATES TO: KRS 217.215, 217.216, 315.191 STATUTORY AUTHORITY: KRS 217.215(2), 315.191(1), (a), (f) NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.215(2) authorizes the board to establish administrative regulations relating to the storage a…

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. RELATES TO: KRS Chapters 217, 315 STATUTORY AUTHORITY: KRS 217.215(3), 315.191 NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.215(3) requires the Boa…

201 KAR 2:180.Pharmacy sanitation. RELATES TO: KRS Chapter 315 STATUTORY AUTHORITY: KRS 315.035(6), 315.191(1) CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with the requirements of 2025 RS HB 6, Section 8. NECESSITY, FUNCTION, AND CONFO…

201 KAR 2:185.Noncontrolled substance prescription drug refills. RELATES TO: KRS 315.191(1)(f) STATUTORY AUTHORITY: KRS 217.215, 315.191(1)(f) CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with the requirements of 2025 RS HB6, Section 8.…

201 KAR 2:190.Return of prescription drugs RELATES TO: KRS Chapters 217 and 315 STATUTORY AUTHORITY: KRS 217.055, 217.215, 315.191(1), 315.404(4) CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with the requirements of 2025 RS HB 6, Sectio…

Title 201 | Chapter 002 | Regulation 195WITHDRAWNThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:195.Impaired pharmacistsRELATES TO:Not availableSTATUTORY AUTHORITY:Not availableNECESSITY, FUNCTION, AND CONFO…

Title 201 | Chapter 002 | Regulation 200WITHDRAWNThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:200.Nuclear pharmacy servicesRELATES TO:Not availableSTATUTORY AUTHORITY:Not availableNECESSITY, FUNCTION, AND …

201 KAR 2:205.Pharmacist-in-charge. RELATES TO: KRS 315.020, 315.035, 315.0351, 315.191, 315.300, 315.335, 21 C.F.R. 1301.76(b) STATUTORY AUTHORITY: KRS 315.020(1), 315.0351, 315.191(1) CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with …

201 KAR 2:210.Patient records, drug regimen review, patient counseling, and final product verification. RELATES TO: KRS 217.015(9), 218A.010(11), 218A.185, 315.010(7), (9), (14), (24), (25), 315.020(5)(e), 315.191(1), 42 C.F.R. Part 456 STATUTORY AUTHORITY: KRS 217.215(2), 315.19…

201 KAR 2:215.Nuclear pharmacy services. RELATES TO: KRS Chapter 315 STATUTORY AUTHORITY: KRS 315.191(1) CERTIFICATION STATEMENT: NECESSITY, FUNCTION, AND CONFORMITY: The Kentucky Board of Pharmacy shall be responsible for imposing minimum standards in all settings where drug pro…

201 KAR 2:220.Collaborative care agreements. RELATES TO: KRS 315.010(5), 315.121, 315.040(3), 315.191(1)(a) STATUTORY AUTHORITY: KRS 315.191(1)(a) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the Board of Pharmacy to promulgate administrative regulations to r…

201 KAR 2:225.Special limited pharmacy permit – Medical gas. RELATES TO: KRS 217.015(11), 315.010(9), 315.020, 315.035, 315.191(1)(a) STATUTORY AUTHORITY: KRS 315.020, 315.035, 315.191(1)(a) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgate…

201 KAR 2:230.Special limited pharmacy permit – Central Fill. RELATES TO: KRS 315.010(9), 315.020, 315.035, 315.191(1)(a) STATUTORY AUTHORITY: KRS 315.020, 315.035, 315.0351, 315.191(1)(a) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgate a…

201 KAR 2:240.Special limited pharmacy permit – Charitable. RELATES TO: KRS 315.035 STATUTORY AUTHORITY: KRS 315.020, 315.030, 315.035, 315.191(1)(a) NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgate administrative regulations to prescribe …

Title 201 | Chapter 002 | Regulation 025WITHDRAWNThis document is no longer current.ALTERNATE VIEWThis is how this document appeared before it was engrossed.201 KAR 002:025.License reinstatementRELATES TO:Not availableSTATUTORY AUTHORITY:Not availableNECESSITY, FUNCTION, AND CONF…

201 KAR 2:250.Pharmacist Recovery Network Committee. RELATES TO: KRS 315.121(1)(d) STATUTORY AUTHORITY: KRS 61.810(k), 315.126(3), (6) ,(7), 315.191(1)(a) CERTIFICATION STATEMENT: This is to certify that this administrative regulation complies with the requirements of 2025 RS HB …