{"data":{"id":"us-ky/krs-315.400","jurisdiction":"us-ky","citation":"KRS 315.400","heading":"Definitions for KRS 315.400 to 315.412.","body":"As used in KRS 315.400 to 315.412:\n(1) \"Authorized distributor of record\" means a wholesale distributor that:\n(a) Has established an ongoing relationship with a manufacturer to distribute the\nmanufacturer's prescription drug. An ongoing relationship exists  between a\nwholesale distributor and a manufacturer if the wholesale distributor,\nincluding any affiliated group of the wholesale distributor as defined in\nSection 1504 of the Internal Revenue Code, has a written agreement for\ndistribution in effect; and\n(b) Is listed on the manufacturer's current list of authorized distributors of record;\n(2) \"Co-licensed product\" means a prescription drug manufactured by two (2) or more\nco-licensed partners;\n(3) \"Counterfeit prescription drug\" means a drug which, or the c ontainer or labeling of\nwhich, without authorization, bears the trademark, trade name, or other identifying\nmark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor,\npacker, or distributor other than the person or persons who in  fact manufactured,\nprocessed, packed, or distributed the drug and which thereby falsely purports or is\nrepresented to be the product of, or to have been packed or distributed by, the other\ndrug manufacturer, processor, packer, or distributor;\n(4) \"Dispenser\" means:\n(a) A retail pharmacy, hospital pharmacy, a group of chain pharmacies under\ncommon ownership and control that do not act as a wholesale distributor, or\nany other person authorized by law to dispense or administer prescription\ndrugs, and the affi liated warehouse distribution centers of such entities under\ncommon ownership and control that do not act as a wholesale distributor; but\n(b) Does not include a person who dispenses only products to be used in animals\nin accordance with 21 U.S.C. sec. 360b(a)(4) and (5);\n(5) \"Distribution\" or \"distribute\" means the sale, purchase, trade, delivery, handling,\nstorage, or receipt of a product, and does not include the dispensing of a product\npursuant to a prescription executed in accordance with Section 503(b) (1) of the\nfederal Drug Quality and Security Act or the dispensing of a product approved\nunder Section 512(b) of the federal Drug Quality and Security Act;\n(6) \"Drop shipment\" means a product not physically handled or stored by a wholesale\ndistributor and that is exempt from Section 582 of the federal Drug Quality and\nSecurity Act, except the notification requirements under clauses (ii), (iii), and (iv) of\nsubsection (c)(4)(B) of Section 582 of the federal Drug Quality and Security Act,\nprovided that the ma nufacturer, repackager, or other wholesale distributor that\ndistributes the product to the dispenser by means of a drop shipment for the\nwholesale distributor includes on the transaction information and transaction history\nto the dispenser the contact info rmation of the wholesale distributor and provides\nthe transaction information, transaction history, and transaction statement directly to\nthe dispenser. Providing administrative services, including the processing of orders\nand payments, shall not by itself  be construed as being involved in the handling,\ndistribution, or storage of a product;\n(7) \"Emergency medical reasons\" includes but is not limited to:\n(a) Transfers of a prescription drug between health -care entities or between a\nhealth-care entity and a retail pharmacy to alleviate a temporary shortage of a\nprescription drug arising from delays in or interruptions of the regular\ndistribution schedules;\n(b) Sales of drugs for use in the treatment of acutely ill or injured persons to\nnearby emergency medical services providers, firefighting organizations, or\nlicensed health-care practitioners in the same marketing or service area;\n(c) The provision of emergency supplies of drugs to nearby nursing homes, home\nhealth agencies, or hospice organizations for emergency use when necessary\ndrugs cannot be obtained; or\n(d) Transfers of prescription drugs by a retail pharmacy to another retail pharmacy\nto alleviate a temporary shortage;\n(8) \"End user\" means a patient or consumer that uses a prescription drug as prescribed\nby an authorized health-care professional;\n(9) \"Exclusive distributor\" means the wholesale distributor that directly purchased the\nproduct from the manu facturer and is the sole distributor of that manufacturer's\nproduct to a subsequent repackager, wholesale distributor, or dispenser;\n(10) \"FDA\" means the United States Food and Drug Administration and any successor\nagency;\n(11) \"Illegitimate product\" means  a product for which credible evidence shows that the\nproduct:\n(a) Is counterfeit, diverted, or stolen;\n(b) Is intentionally adulterated so that the product would result in serious adverse\nhealth consequences or death to humans;\n(c) Is the subject of a fraudulent transaction; or\n(d) Appears otherwise unfit for distribution so that the product would be\nreasonably likely to result in serious adverse health consequences or death to\nhumans;\n(12) \"Manufacturer\" means the same as defined in KRS 315.010;\n(13) \"Medical gas wholesaler\" means a person licensed to distribute, transfer, wholesale,\ndeliver, or sell medical gases on drug orders to suppliers or other entities licensed to\nuse, administer, or distribute medical gas;\n(14) \"Pharmacy warehouse\" means a physical location for prescription drugs that acts as\na central warehouse and performs intracompany sales or transfers of prescription\ndrugs to a group of pharmacies under common ownership and control;\n(15) \"Prescription drug\" means the same as defined in KRS 315.010;\n(16) \"Repackager\" means a person who owns or operates an establishment that repacks\nand relabels a product or package for further sale, or distribution without a further\ntransaction;\n(17) \"Reverse distributor\" means every person who acts as an agent for pharmacies, drug\nwholesalers, manufacturers, or other entities by receiving, taking inventory, and\nmanaging the disposition of outdated or nonsalable drugs;\n(18) \"Third-party logistics provider\" means an entity that contracts with a manufacturer,\nwholesale distributor, repackager, or dispenser to provide and coordinate\nwarehousing or other logistics services on behalf of a manufacturer, wholesale\ndistributor, repackager, or dispenser, but does not take title to the drug or have\nresponsibility to direct the sale of the drug. A third -party logistics provider shall be\nconsidered as part of the normal distribution channel;\n(19) \"Transaction\" means the transfer of product between persons in which a change of\nownership occurs, with the following exemptions:\n(a) Intracompany distribution of any product between members of an affiliate or\nwithin a manufacturer;\n(b) The distribution of a product among hospitals or other health care entities that\nare under common control;\n(c) The distribution of a product for emergen cy medical reasons, including a\npublic health emergency declaration pursuant to Section 319 of the federal\nPublic Health Service Act, except that a drug shortage not caused by a public\nhealth emergency shall not constitute an emergency medical reason;\n(d) The dispensing of a product pursuant to a prescription executed in accordance\nwith Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act;\n(e) The distribution of product samples by a manufacturer or a licensed wholesale\ndistributor in accordance wi th Section 503(d) of the Federal Food, Drug, and\nCosmetic Act;\n(f) The distribution of blood or blood components intended for transfusion;\n(g) The distribution of minimal quantities of product by a licensed retail\npharmacy to a licensed practitioner for office use;\n(h) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a\ndrug by a charitable organization described in Section 501(c)(3) of the Internal\nRevenue Code of 1986 to a nonprofit affiliate of the organization to the extent\notherwise permitted by law;\n(i) The distribution of a product pursuant to the sale or merger of a pharmacy or\npharmacies or a wholesale distributor or wholesale distributors, except that\nany records required to be maintained for the product shall be transf erred to\nthe new owner of the pharmacy or pharmacies or wholesale distributor or\nwholesale distributors;\n(j) The dispensing of a product approved under Section 512(c) of the Federal\nFood, Drug, and Cosmetic Act;\n(k) Products transferred to or from any facility that is licensed by the Nuclear\nRegulatory Commission or by the state pursuant to an agreement with the\ncommission under Section 274 of the federal Atomic Energy Act, 42 U.S.C.\nsec. 2021;\n(l) A combination product that is not subject to approval under Section 505 of the\nfederal Drug Quality and Security Act or licensure under Section 351 of the\nfederal Public Health Service Act, and that is:\n1. A product composed of a device and one (1) or more other regulated\ncomponents such as a drug or drug device, a biologic or biologic device,\nor a drug and biologic or drug and biologic device that are physically,\nchemically, or otherwise combined or mixed and produced as a single\nentity;\n2. Two (2) or more separate products packaged together in a single\npackage or as a unit and composed of a drug and device or device and\nbiological product; or\n3. Two (2) or more finished medical devices plus one (1) or more drug or\nbiological products that are packaged together in what is ref erred to as a\nmedical convenience kit as described in paragraph (m) of this\nsubsection;\n(m) The distribution of a medical convenience kit or collection of finished medical\ndevices which may include a product or biological product, assembled in kit\nform strictly for the convenience of the purchaser or user, if:\n1. The medical convenience kit is assembled in an establishment that is\nregistered with the federal Food and Drug Administration as a device\nmanufacturer in accordance with Section 510(b)(2) of the Fe deral Food,\nDrug, and Cosmetic Act;\n2. The medical convenience kit does not contain a controlled substance\nthat appears in a schedule contained in the federal Comprehensive Drug\nAbuse Prevention and Control Act of 1970;\n3. In the case of a medical convenie nce kit that includes a product, the\nperson that manufacturers the kit:\na. Purchased the product directly from the pharmaceutical\nmanufacturer or from a wholesale distributor that purchased the\nproduct directly from the pharmaceutical manufacturer; and\nb. Does not alter the primary container or label of the product as\npurchased from the manufacturer or wholesale distributor; and\n4. In the case of a medical convenience kit that includes a product, the\nproduct is:\na. An intravenous solution intended for the r eplenishment of fluids\nand electrolytes;\nb. A product intended to maintain the equilibrium of water and\nminerals in the body;\nc. A product intended for irrigation or reconstitution;\nd. An anesthetic;\ne. An anticoagulant;\nf. A vasopressor; or\ng. A sympathomimetic;\n(n) The distribution of an intravenous product that, by its formulation, is intended\nfor the replenishment of fluids and electrolytes such as sodium, chloride, and\npotassium, or calories such as dextrose and amino acids;\n(o) The distribution of an intravenous product used to maintain the equilibrium of\nwater and minerals in the body, such as dialysis solutions;\n(p) The distribution of a product that is intended for irrigation, or sterile water,\nwhether intended for such purposes or for injection;\n(q) The distribution of a medical gas as defined in Section 575 of the Federal\nFood, Drug, and Cosmetic Act; or\n(r) The distribution or sale of any licensed product under Section 351 of the\nfederal Public Health Service Act that meets the definition of a dev ice under\nSection 201(h) of the Federal Food, Drug, and Cosmetic Act;\n(20) \"Wholesale distribution\" means the distribution of a prescription drug to persons\nother than an end user or to the end user pursuant to KRS 315.0351(2), but does not\ninclude:\n(a) Intracompany sales or transfers;\n(b) The sale, purchase, distribution, trade, or transfer of a prescription drug for\nemergency medical reasons;\n(c) The distribution of prescription drug samples by a manufacturer or authorized\ndistributor;\n(d) Drug returns or transfers to the original manufacturer, original wholesale\ndistributor, or transfers to a reverse distributor or third-party returns processor;\n(e) The sale, purchase, or trade of a drug pursuant to a prescription;\n(f) The delivery of a prescription drug by a common carrier;\n(g) The purchase or acquisition by a health -care entity or pharmacy that is a\nmember of a group purchasing organization of a drug for its own use from the\ngroup purchasing organization, or health -care entities or pharmacies that are\nmembers of the group organization;\n(h) The sale, purchase, distribution, trade, or transfer of a drug by a charitable\nhealth-care entity to a nonprofit affiliate of the organization as otherwise\npermitted by law;\n(i) The sale, transfer, merger, or consolid ation of all or part of the business of a\npharmacy with another pharmacy or pharmacies; or\n(j) The distribution of a prescription drug to a health -care practitioner or to\nanother pharmacy if the total number of units transferred during a twelve (12)\nmonth period does not exceed five percent (5%) of the total number of all\nunits dispensed by the pharmacy during the immediate twelve (12) month\nperiod; and\n(21) \"Wholesale distributor\" or \"virtual wholesale distributer\" means a person other than\na manufacturer,  a manufacturer's co -licensed partner, a third -party logistics\nprovider, or repackager engaged in wholesale distribution as defined by 21 U.S.C.\nsec. 353(e)(4) as amended by the federal Drug Supply Chain Security Act.","path":["KRS Chapter 315"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=49250","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:58:12Z","sha256":"b4298fa5f7d7f32a0ffa158d87feb676c170d094bc1ef3ec2f238deafcd5b9d4","source_id":"us-ky","stale":false,"prev":"us-ky/krs-315.350","next":"us-ky/krs-315.402"},"notice":"GroundRules: Original legal text. Not legal advice."}