{"data":{"id":"us-ky/krs-216b.204","jurisdiction":"us-ky","citation":"KRS 216B.204","heading":"Duties of cabinet -- Eligibility for certification.","body":"(1) The cabinet, shall, at a minimum:\n(a) Require  completion of  the  certification process  for pharmacies,\nmanufacturers, distributors, and abortion facilities;\n(b) Notify certified pharmacies, manufacturers, distributors, and abortion\nfacilities which  physicians are  registered as  nonsurgical abortion\nproviders with the cabinet;\n(c) Prohibit intentionally, knowingly, or recklessly shipping abortion-inducing\ndrugs to physicians who become unregistered;\n(d) Audit newly certified pharmacies, manufacturers, and distributors within\nninety (90) calendar days after certification and annually thereafter, to\nensure that all processes and procedures are in place and functioning to\nsupport the requirements of the Abortion-Inducing Drug Certification\nProgram;\n(e) Suspend  immediately a pharmacist's, manufacturer's, or distributor's\ncertification if found to be  noncompliant until full compliance is\ndemonstrated;\n(f) Enforce compliance and develop a compliance reporting system;\n(g) Prohibit pharmacies  from  intentionally, knowingly, or  recklessly\ndispensing or distributing abortion-inducing drugs directly to a patient in\nthe Commonwealth; and\n(h) Require manufacturers and distributors of abortion-inducing drugs to\nintentionally and knowingly distribute only to certified pharmacies and\nin-person dispensing clinics, medical offices, and hospitals that are in\ncompliance with the United States Federal Drug Administration's outlined\nMifepristone Risk Evaluation and Mitigation Strategy in effect on April 14,\n2022.\n(2) To be eligible for certification, pharmacies, manufacturers, and distributors of\nabortion-inducing drugs shall:\n(a) Have  either obtained a Kentucky license as a distributor, or a Kentucky\npermit as a pharmacy or manufacturer;\n(b) Only distribute to or fulfill prescriptions requested by qualified physicians\nwho  are registered as nonsurgical abortion providers with the cabinet;\n(c) Abide by all applicable standards of the National Association of Boards of\nPharmacy;\n(d) For online sales or orders, hold a current pharmacy or pharma domain\nand abide by all required standards by the National Association of Boards\nof Pharmacy to maintain the domain;\n(e) Follow  all other applicable state or federal laws related to the\ndispensation, distribution, or  delivery of legend  drugs, including\nabortion-inducing drugs; and\n(f) Follow  all acceptable processes  and  procedures to maintain a\ndispensation, distribution, or delivery system that is secure, confidential,\nand  follows all processes and procedures, including those for storage,\nhandling, shipping, tracking packages, serial numbers, National Drug\nCodes,  lot numbers, expiration dates, proof of delivery, and controlled\nreturns of abortion-inducing drugs.\n(3) To be eligible for certification, pharmacies shall:\n(a) Be  certified by the United States Food  and Drug Administration to\ndispense abortion-inducing drugs;\n(b) Submit proof of certification by the abortion-inducing drug manufacturer\nfor the distribution of abortion-inducing drugs; and\n(c) Only fulfill prescriptions that are accompanied by the required patient\nconsent form.","path":["KRS Chapter 216B"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=52228","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:52:23Z","sha256":"23e4724503479c26da7e3ca7793e862db8888fd6ae2e0d188d923c3115ba2163","source_id":"us-ky","stale":false,"prev":"us-ky/krs-216b.202","next":"us-ky/krs-216b.206"},"notice":"GroundRules: Original legal text. Not legal advice."}