{"data":{"id":"us-ky/krs-315.0351","jurisdiction":"us-ky","citation":"KRS 315.0351","heading":"315.0351   Out -of-state pharmacy -- Permit -- Requests for information --","body":"Records -- Toll-free telephone service -- Pharmacist on duty -- Requirements\nfor out-of-state pharmacy doing business through the Internet -- Application\nto sale or distribution of dialysate solution or devices.\n(1) Except as provided in subsection (2) of this section:\n(a) Every person or pharmacy located outside this Commonwealth which does\nbusiness, physically or by means of the Internet, facsimile, phone, mail, or\nany other mea ns, inside this Commonwealth within the meaning of KRS\nChapter 315, shall hold a current pharmacy permit as provided in KRS\n315.035(1) and (4) issued by the Kentucky Board of Pharmacy. The pharmacy\nshall be designated an \"out -of-state pharmacy\" and the per mit shall be\ndesignated an \"out-of-state pharmacy permit.\" The fee for the permit shall not\nexceed the current in -state pharmacy permit fee as provided under KRS\n315.035;\n(b) Every out-of-state pharmacy granted an out -of-state pharmacy permit by the\nboard shall disclose to the board the location, names, and titles of all principal\ncorporate officers and all pharmacists who are dispensing prescription drugs\nto residents of the Commonwealth. A report containing this information shall\nbe made to the board on a n annual basis and within thirty (30) days after any\nchange of office, corporate officer, or pharmacist;\n(c) Every out -of-state pharmacy granted an out -of-state pharmacy permit shall\ncomply with all statutorily -authorized directions and requests for inform ation\nfrom any regulatory agency of the Commonwealth and from the board in\naccordance with the provisions of this section. The out -of-state pharmacy\nshall maintain at all times a valid unexpired permit, license, or registration to\nconduct the pharmacy in compliance with the laws of the jurisdiction in which\nit is a resident. As a prerequisite to seeking a permit from the Kentucky Board\nof Pharmacy, the out-of-state pharmacy shall submit a copy of the most recent\ninspection report resulting from an inspectio n conducted by the regulatory or\nlicensing agency of the jurisdiction in which it is located. Thereafter, the out -\nof-state pharmacy granted a permit shall submit to the Kentucky Board of\nPharmacy a copy of any subsequent inspection report on the pharmacy\nconducted by the regulatory or licensing body of the jurisdiction in which it is\nlocated;\n(d) Every out-of-state pharmacy granted an out -of-state pharmacy permit by the\nboard shall maintain records of any controlled substances or dangerous drugs\nor devices dispensed to patients in the Commonwealth so that the records are\nreadily retrievable from the records of other drugs dispensed;\n(e) Records for all prescriptions delivered into Kentucky shall be readily\nretrievable from the other prescription records of the out-of-state pharmacy;\n(f) Each out -of-state pharmacy shall, during its regular hours of operation, but\nnot less than six (6) days per week and for a minimum of forty (40) hours per\nweek, provide a toll-free telephone service directly to the pharmacist in charge\nof the out -of-state pharmacy and available to both the patient and each\nlicensed and practicing in -state pharmacist for the purpose of facilitating\ncommunication between the patient and the Kentucky pharmacist with access\nto the patient's prescri ption records. A toll -free number shall be placed on a\nlabel affixed to each container of drugs dispensed to patients within the\nCommonwealth;\n(g) Each out-of-state pharmacy shall have a pharmacist in charge who is licensed\nto engage in the practice of pha rmacy by the Commonwealth that shall be\nresponsible for compliance by the pharmacy with the provisions of this\nsection and for the distribution and sale of dialysate solutions and devices\npursuant to subsection (2) of this section;\n(h) Each out-of-state pharmacy shall comply with KRS 218A.202;\n(i) Any out -of-state pharmacy that dispenses more than twenty -five percent\n(25%) of its total prescription volume as a result of an original prescription\norder received or solicited by use of the Internet, including b ut not limited to\nelectronic mail, shall receive and display in every medium in which it\nadvertises itself a seal of approval for the National Association of Boards of\nPharmacy certifying that it is a Verified Internet Pharmacy Practice Site\n(VIPPS) or a s eal certifying approval of a substantially similar program\napproved by the Kentucky Board of Pharmacy. VIPPS, or any other\nsubstantially similar accreditation, shall be maintained and remain current;\n(j) Any out-of-state pharmacy doing business in the Commonwealth of Kentucky\nshall certify the percentage of its annual business conducted via the Internet\nand electronic mail and submit such supporting documentation as requested\nby the board, and in a form or  application required by the board, when it\napplies for permit or renewal;\n(k) Any pharmacy doing business within the Commonwealth of Kentucky shall\nuse the address on file with the Kentucky Board of Pharmacy as the return\naddress on the labels of any pack age shipped into or within the\nCommonwealth. The return address shall be placed on the package in a clear\nand prominent manner; and\n(l) The Kentucky Board of Pharmacy may waive the permit requirements of this\nchapter for an out -of-state pharmacy that only does business within the\nCommonwealth of Kentucky in limited transactions.\n(2) (a) Only subsection (1)(g) of this section shall apply to the sale or distribution of\ndialysate solutions or devices necessary to perform home peritoneal kidney\ndialysis to patients with end-stage renal disease, if:\n1. The dialysate solutions or devices are approved or cleared by the federal\nFood and Drug Administration, as required by federal law;\n2. The dialysate solutions or devices are lawfully held by a manufacturer\nor manuf acturer's agent that is properly registered with or licensed by\nthe board as a manufacturer, wholesale distributer, or third -party\nlogistics provider under this chapter;\n3. The dialysate solutions or devices are held and delivered in their\noriginal, sealed  packaging from a Food and Drug Administration -\napproved manufacturing facility;\n4. The dialysate solutions or devices are only delivered upon receipt of a\nphysician's prescription by a Kentucky licensed pharmacy and the\ntransmittal of an order from the Ken tucky licensed pharmacy to the\nmanufacturer or manufacturer's agent; and\n5. The manufacturer or manufacturer's agent delivers the dialysate\nsolutions or devices directly to:\na. A patient with end-stage renal disease or the patient's designee for\nthe patient's self-administration of dialysis therapy; or\nb. A health-care provider or institution for administration or delivery\nof dialysis therapy to a patient with end-stage renal disease.\n(b) 1. A manufacturer or manufacturer's agent who sells or distributes\ndialysate solutions or devices under this subsection shall employ or\ncontract with a pharmacist who is licensed to engage in the practice of\npharmacy by the Commonwealth to conduct a retrospective audit on ten\npercent (10%) of the orders processed by that ma nufacturer or\nmanufacturer's agent each month.\n2. On or before February 1 of each year, an annual summary of the\nmonthly audits shall be prepared and submitted to the board, in the form\nprescribed by the board.\n3. On or before June 1 of each year, the board shall compile the summaries\nof monthly audits into a single report and submit that report to the\nInterim Joint Committee on Health Services.\n(c) Prescriptions and records of delivery for dialysate solutions or devices sold or\ndistributed under this subse ction shall be maintained by the manufacturer or\nmanufacturer's agent for a minimum of two (2) years and shall be made\navailable to the board upon request.\n(d) As used in this subsection, \"dialysate solutions\" means dextrose or icodextrin\nwhen used to perform home peritoneal kidney dialysis.\n(e) The Kentucky Board of Pharmacy will retain oversight of the distribution of\ndialysate solutions and devices under this section.","path":["KRS Chapter 315"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=53707","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:58:11Z","sha256":"9d03dbb029ab47ecd37374b10736bf6ff891c1960cb019836a0e4265688466c2","source_id":"us-ky","stale":false,"prev":"us-ky/krs-315.0350","next":"us-ky/krs-315.036"},"notice":"GroundRules: Original legal text. Not legal advice."}