65-1626. Definitions. [See Revisor's Note]
65-1626
65-1626. Definitions. [See Revisor'sNote]For the purposes of this act:
(a) "Administer" means the direct application of a drug, whether byinjection, inhalation, ingestion or any other means, to the body of apatient or research subject by:
(1) A practitioner or pursuant to the lawful direction of apractitioner;
(2) the patient or research subject at the direction and in thepresence of the practitioner; or
(3) a pharmacist as authorized in K.S.A. 65-1635a andamendments thereto.
(b) "Agent" means an authorized person who acts on behalf of or atthe direction of a manufacturer, distributor or dispenser but shall notinclude a common carrier, public warehouseman or employee ofthe carrier or warehouseman when acting in the usual and lawful courseof the carrier's or warehouseman's business.
(c) "Authorized distributor of record" means a wholesale distributor withwhom a manufacturer has established an ongoing relationship to distribute themanufacturer's prescription drug. An ongoing relationship is deemed to existbetween such wholesale distributor and a manufacturer when the wholesaledistributor, including any affiliated group of the wholesale distributor, asdefined in section 1504 of the internal revenue code, complies with any one ofthe following: (1) The wholesale distributor has a written agreement currentlyin effect with the manufacturer evidencing such ongoing relationship; and (2)the wholesale distributor is listed on the manufacturer's current list ofauthorized distributors of record, which is updated by the manufacturer on noless than a monthly basis.
(d) "Board" means the state board of pharmacy created byK.S.A. 74-1603and amendments thereto.
(e) "Brand exchange" means the dispensing of a differentdrug product ofthe same dosage form and strength and of the same generic name than thebrand name drug product prescribed.
(f) "Brand name" means the registered trademark name givento a drugproduct by its manufacturer, labeler or distributor.
(g) "Chain pharmacy warehouse" means a permanent physical location fordrugs or devices, or both, that act as a central warehouse and performintracompany sales or transfers of prescription drugs or devices to chainpharmaciesthat have the same ownership or control. Chain pharmacy warehouses must beregistered as wholesaledistributors.
(h) "Co-licensee" means a pharmaceutical manufacturer that has entered intoan agreement with another pharmaceutical manufacturer to engage in a businessactivity or occupation related to the manufacture or distribution of aprescription drug and the national drug code on the drug product label shall beused to determine the identity of the drug manufacturer.
(i) "Deliver" or "delivery" means the actual, constructiveor attemptedtransfer from one person to another of any drug whether or not an agencyrelationship exists.
(j) "Direct supervision"means the process by which the responsible pharmacist shall observe and directthe activities of a pharmacy student or pharmacy technician to a sufficientdegree to assure that all such activities are performed accurately, safely andwithout risk or harm to patients, and complete the final check beforedispensing.
(k) "Dispense" means to deliver prescription medication totheultimate user or research subject by or pursuant to the lawful order ofa practitioner or pursuant to the prescription of a mid-levelpractitioner.
(l) "Dispenser" means a practitioner or pharmacist whodispensesprescription medication.
(m) "Distribute" means to deliver, other than byadministering ordispensing, any drug.
(n) "Distributor" means a person who distributes a drug.
(o) "Drop shipment" means the sale, by a manufacturer, that manufacturer'sco-licensee, that manufacturer's third party logistics provider, or thatmanufacturer's exclusive distributor, of the manufacturer's prescription drug,to a wholesale distributor whereby the wholesale distributor takes title butnot possession of such prescription drug and the wholesale distributor invoicesthe pharmacy, the chain pharmacy warehouse, or other designated personauthorized by law to dispense or administer such prescription drug, and thepharmacy, the chain pharmacy warehouse, or other designated person authorizedby law to dispense or administer such prescription drug receives delivery ofthe prescription drug directly from the manufacturer, that manufacturer'sco-licensee, that manufacturer's third party logistics provider, or thatmanufacturer's exclusive distributor, of such prescription drug. Drop shipmentshall be part of the "normal distribution channel".
(p) "Drug" means: (1) Articles recognized in the officialUnitedStates pharmacopoeia, or other such official compendiums of the UnitedStates, or official national formulary, or any supplement of any ofthem; (2) articles intended for use in the diagnosis, cure, mitigation,treatment or prevention of disease in man or other animals; (3)articles, other than food, intended to affect the structure or anyfunction of the body of man or other animals; and (4) articles intendedfor use as a component of any articles specified in clause (1), (2) or(3) of this subsection; but does not include devices or their components,parts or accessories, except that the term "drug" shall not includeamygdalin (laetrile) or any livestock remedy, if such livestock remedyhad been registered inaccordance with the provisions of article 5 of chapter 47 of the KansasStatutes Annotated prior to its repeal.
(q) "Durable medical equipment" means technologically sophisticatedmedical devices that may be used in a residence, including the following: (1)Oxygen and oxygen delivery system; (2) ventilators; (3) respiratory diseasemanagement devices; (4) continuous positive airway pressure (CPAP) devices; (5)electronic and computerized wheelchairs and seating systems; (6) apneamonitors; (7) transcutaneous electrical nerve stimulator (TENS) units; (8) lowair loss cutaneous pressure management devices; (9) sequential compressiondevices; (10) feeding pumps; (11) home phototherapy devices; (12) infusiondelivery devices; (13) distribution of medical gases to end users for humanconsumption; (14) hospital beds; (15) nebulizers; (16) other similar equipmentdetermined by the board in rules and regulations adopted by the board.
(r) "Exclusive distributor" means any entity that: (1) Contracts with amanufacturer to provide or coordinate warehousing, wholesale distribution orother services on behalf of a manufacturer and who takes title to thatmanufacturer's prescription drug, but who does not have general responsibilityto direct the sale or disposition of the manufacturer's prescription drug; (2)is registered as a wholesale distributor under the pharmacy act of the state ofKansas; and (3) to be considered part of the normal distribution channel,must be an authorized distributor of record.
(s) "Electronic transmission" means transmission ofinformation inelectronic form or the transmission of the exact visual image of a document byway of electronic equipment.
(t) "Generic name" means the established chemical name orofficial name of a drug or drug product.
(u) (1) "Institutional drug room" means any locationwhereprescription-only drugs are stored and from which prescription-onlydrugs are administered or dispensed and which is maintained or operatedfor the purpose of providing the drug needs of:
(A) Inmates of a jail or correctional institution or facility;
(B) residents of a juvenile detention facility, as defined by therevised Kansascode for care of children and the revised Kansas juvenile justicecode;
(C) students of a public or private university or college, a communitycollege or any other institution of higher learning which is located in Kansas;
(D) employees of a business or other employer; or
(E) persons receiving inpatient hospice services.
(2) "Institutional drug room" does not include:
(A) Any registered pharmacy;
(B) any office of a practitioner; or
(C) a location where no prescription-only drugs are dispensed and noprescription-only drugs other than individual prescriptions are storedor administered.
(v) "Intracompany transaction" means any transaction or transfer betweenanydivision, subsidiary, parent or affiliated or related company under commonownership or control of a corporate entity, or any transaction or transferbetween co-licensees of a co-licensed product.
(w) "Medical care facility" shall have the meaning providedinK.S.A.65-425 and amendments thereto, except that the term shall also includefacilities licensed under the provisions of K.S.A. 75-3307b and amendmentsthereto except community mental health centers and facilities for the mentallyretarded.
(x) "Manufacture" means the production, preparation,propagation,compounding, conversion or processing of a drug either directly orindirectly by extraction from substances of natural origin, independentlyby means of chemical synthesis or by a combination of extraction andchemical synthesis and includes any packaging or repackaging of the drug orlabeling or relabeling of its container, except that this term shall notinclude the preparation or compounding of a drug by an individual for theindividual's own use or the preparation, compounding, packaging or labelingof a drug by: (1) A practitioner or a practitioner's authorized agentincident to such practitioner's administering or dispensing of a drug inthe course of the practitioner's professional practice; (2) a practitioner,by a practitioner's authorized agent or under a practitioner's supervisionfor the purpose of, or as an incident to, research, teaching or chemicalanalysis and not for sale; or (3) a pharmacist or the pharmacist'sauthorized agent acting under the direct supervision of the pharmacist forthe purpose of, or incident to, the dispensing of a drug by the pharmacist.
(y) "Manufacturer" means a person licensed or approved by the FDA toengage in the manufacture of drugs and devices.
(z) "Normal distribution channel" means a chain of custodyfor aprescription-only drug that goes from a manufacturer of the prescription-onlydrug, from that manufacturer to that manufacturer's co-licensed partner, fromthat manufacturer to that manufacturer's third-party logistics provider, orfrom that manufacturer to that manufacturer's exclusive distributor, directlyor by drop shipment, to:
(1) A pharmacy to a patient or to other designated persons authorized by lawto dispense or administer such drug to a patient;
(2) a wholesale distributor to a pharmacy to a patient or other designatedpersons authorized by law to dispense or administer such drug to a patient;
(3) a wholesale distributor to a chain pharmacy warehouse to that chainpharmacy warehouse's intracompany pharmacy to a patient or other designatedpersons authorized by law to dispense or administer such drug to a patient; or
(4) a chain pharmacy warehouse to the chain pharmacy warehouse's intracompanypharmacy to a patient or other designated persons authorized by law to dispenseor administer such drug to a patient.
(aa) "Person" means individual, corporation, government,governmentalsubdivision or agency, partnership, association or any other legal entity.
(bb) "Pharmacist" means any natural person licensed underthisact to practice pharmacy.
(cc) "Pharmacist in charge" means the pharmacist who isresponsible tothe board for a registered establishment's compliance with the laws andregulations of this state pertaining to the practice of pharmacy,manufacturing of drugs and the distribution of drugs. The pharmacist incharge shall supervise such establishment on a full-time or a part-timebasis and perform such other duties relating to supervision of a registeredestablishment as may be prescribed by the board by rules and regulations.Nothing in this definition shall relieve other pharmacists or persons fromtheir responsibility to comply with state and federal laws and regulations.
(dd) "Pharmacy," "drug store" or "apothecary" meanspremises,laboratory,area or other place: (1) Where drugs are offered for sale where theprofession of pharmacy is practiced and where prescriptions are compoundedand dispensed; or (2) which has displayed upon it or within it the words"pharmacist," "pharmaceutical chemist," "pharmacy," "apothecary,""drugstore," "druggist," "drugs," "drug sundries" or any of these words orcombinations of these words or words of similar import either in English orany sign containing any of these words; or (3) where the characteristicsymbols of pharmacy or the characteristic prescription sign "Rx" may beexhibited. As used in this subsection, premises refers only to the portionof any building or structure leased, used or controlled by the licensee inthe conduct of the business registered by the board at the address forwhich the registration was issued.
(ee) "Pharmacy student" means an individual, registeredwiththe board ofpharmacy, enrolled in an accredited school of pharmacy.
(ff) "Pharmacy technician" means an individual who, underthe directsupervision andcontrol of a pharmacist, may perform packaging,manipulative, repetitive or other nondiscretionary tasks related to theprocessing of a prescription or medication order and who assists the pharmacistin the performance of pharmacy related duties, but who does not perform dutiesrestricted to a pharmacist.
(gg) "Practitioner" means a person licensed to practicemedicine andsurgery, dentist, podiatrist, veterinarian, optometrist licensed under theoptometry law as a therapeutic licensee or diagnostic and therapeutic licensee,or scientific investigator or other person authorized by law to use aprescription-only drug in teaching or chemical analysis or to conduct researchwith respect to a prescription-only drug.
(hh) "Preceptor" means a licensed pharmacist who possessesatleast twoyears' experience as a pharmacist and who supervises students obtaining thepharmaceutical experience required by law as a condition to taking theexamination for licensure as a pharmacist.
(ii) "Prescription" means, according to the context, eitheraprescription order or a prescription medication.
(jj) "Prescription medication" means any drug, includinglabel and containeraccording to context, which is dispensed pursuant to a prescription order.
(kk) "Prescription-only drug" means any drugwhether intended for use by man or animal, required by federal or state law(including 21 United States Code section 353, as amended) to be dispensed onlypursuant to a written or oral prescription or order of a practitioner or isrestricted to use by practitioners only.
(ll) "Prescription order" means: (1) An order to be filledby apharmacist for prescription medication issued and signed by a practitioneror a mid-level practitioner in the authorized course of professionalpractice; or (2) an ordertransmitted to a pharmacist through word of mouth, note, telephone or othermeans of communication directed by such practitioner or mid-levelpractitioner.
(mm) "Probation" means the practice or operation under atemporarylicense, registration or permit or a conditional license, registration orpermit of a business or profession for which a license, registration orpermit is granted by the board under the provisions of the pharmacy act ofthe state of Kansas requiring certain actions to be accomplished or certainactions not to occur before a regular license, registration or permit isissued.
(nn) "Professional incompetency" means:
(1) One or more instances involving failure to adhere to theapplicable standard of pharmaceutical care to a degree which constitutesgross negligence, as determined by the board;
(2) repeated instances involving failure to adhere to the applicablestandard of pharmaceutical care to a degree which constitutes ordinarynegligence, as determined by the board; or
(3) a pattern of pharmacy practice or other behavior whichdemonstrates a manifest incapacity or incompetence to practice pharmacy.
(oo) "Retail dealer" means a person selling at retailnonprescription drugs which are prepackaged, fully prepared by themanufacturer or distributor for use by the consumer and labeled inaccordance with the requirements of the state and federal food, drug andcosmetic acts. Such nonprescription drugs shall not include: (1) Acontrolled substance; (2) aprescription-only drug; or (3) a drug intendedfor human use by hypodermicinjection.
(pp) "Secretary" means the executive secretary of theboard.
(qq) "Third party logistics provider" means an entity that: (1) Providesor coordinates warehousing, distribution or other services on behalf of amanufacturer, but does not take title to the prescription drug or have generalresponsibility to direct the prescription drug's sale or disposition; (2) isregistered as a wholesale distributor under the pharmacy act of the state ofKansas; and (3) to be considered part of the normal distribution channel, mustalso be an authorized distributor of record.
(rr) "Unprofessional conduct" means:
(1) Fraud in securing a registration or permit;
(2) intentional adulteration or mislabeling of any drug, medicine,chemical or poison;
(3) causing any drug, medicine, chemical or poison to be adulteratedor mislabeled, knowing the same to be adulterated or mislabeled;
(4) intentionally falsifying or altering records or prescriptions;
(5) unlawful possession of drugs and unlawful diversion of drugs to others;
(6) willful betrayal of confidential informationunder K.S.A. 65-1654 and amendments thereto;
(7) conduct likely to deceive, defraud or harm the public;
(8) making a false or misleading statement regarding the licensee'sprofessional practice or the efficacy or value of a drug;
(9) commission of any act of sexual abuse, misconduct or exploitationrelated to the licensee's professional practice; or
(10) performing unnecessary tests, examinations or services which haveno legitimate pharmaceutical purpose.
(ss) "Mid-level practitioner" meansan advanced registered nurse practitioner issued a certificate ofqualification pursuant to K.S.A. 65-1131 and amendments theretowhohas authority to prescribe drugs pursuant to a written protocol with aresponsible physician under K.S.A. 65-1130 and amendments thereto or aphysician assistant licensedpursuant to the physician assistant licensure act who has authority toprescribe drugs pursuant to a written protocolwith a responsible physician under K.S.A. 65-28a08 and amendments thereto.
(tt) "Vaccination protocol" means a written protocol,agreed to by apharmacist and a person licensed to practice medicine and surgery by the stateboard of healing arts, which establishes procedures and recordkeeping andreporting requirements for administering a vaccine by the pharmacist for aperiod of time specified therein, not to exceed two years.
(uu) "Veterinary medical teaching hospital pharmacy"meansany locationwhereprescription-only drugs are stored as part of an accredited college ofveterinary medicine and from which prescription-only drugs are distributed foruse in treatment of or administration to anon-human.
(vv) "Wholesale distributor" means any person engaged in wholesaledistribution of prescription drugs or devices in or into the state, including,but not limited to, manufacturers, repackagers, own-label distributors,private-label distributors, jobbers, brokers, warehouses, includingmanufacturers' and distributors' warehouses, co-licensees, exclusivedistributors, third party logistics providers, chain pharmacy warehousesthat conduct wholesale distributions,andwholesale drug warehouses, independent wholesale drug traders and retailpharmacies that conduct wholesale distributions.Wholesale distributor shall not include persons engaged in the sale of durablemedical equipment to consumers or patients.
(ww) "Wholesale distribution" means the distribution ofprescription drugs ordevices by wholesale distributors to persons other than consumers or patients,and includes the transfer of prescription drugs by a pharmacy to anotherpharmacyif the total number of units of transferred drugs during a twelve-month perioddoes not exceed 5% of the total number of all units dispensed by the pharmacyduring the immediately preceding twelve-month period. Wholesale distributiondoes not include: (1) Thesale, purchase or trade of a prescription drug or device, an offer to sell,purchase or trade a prescription drug or device or the dispensing of aprescription drug or device pursuant to a prescription; (2) the sale, purchaseor trade of a prescription drug or device or an offer to sell, purchase ortrade a prescription drug or device for emergency medical reasons; (3)intracompany transactions, as defined in this section, unless in violation ofown use provisions; (4) thesale, purchase or trade of a prescription drug or device or an offer to sell,purchase or trade a prescription drug or device among hospitals, chainpharmacy warehouses, pharmacies or other health care entities that are undercommon control; (5) the sale, purchase or trade of a prescription drug ordevice or the offer to sell, purchase or trade a prescription drug or device bya charitable organization described in 503 (c)(3) of the internal revenue codeof 1954 to a nonprofit affiliate of the organization to the extent otherwisepermitted by law; (6) the purchase or other acquisition by a hospital or othersimilar health care entity that is a member of a group purchasing organizationof a prescription drug or device for its own use from the group purchasingorganization or from other hospitals or similar health care entities that aremembers of these organizations; (7) the transfer of prescription drugs ordevices between pharmacies pursuant to a centralized prescription processingagreement; (8) the sale, purchase or trade of blood and blood componentsintended for transfusion; (9) the return of recalled, expired, damaged orotherwise non-salable prescription drugs, when conducted by a hospital, healthcare entity, pharmacy, chain pharmacy warehouse or charitable institution inaccordance with the board's rules and regulations; (10) the sale, transfer,merger or consolidation of all or part of the business of a retail pharmacy orpharmacies from or with another retail pharmacy or pharmacies, whetheraccomplished as a purchase and sale of stock or business assets, in accordancewith the board's rules and regulations; (11) the distribution of drug samplesby manufacturers' and authorized distributors' representatives; (12) thesale of minimal quantities of drugs by retail pharmacies to licensedpractitioners for office use; or (13) the sale or transfer from a retailpharmacy or chainpharmacy warehouse of expired, damaged, returned or recalled prescription drugsto the original manufacturer, originating wholesale distributor or to a thirdparty returns processor in accordance with the board's rules andregulations.
History: L. 1953, ch. 290, § 3;L. 1975, ch. 319, § 2;L. 1977, ch. 217, § 1;L. 1978, ch. 242, § 1;L. 1978, ch. 243, § 1;L. 1979, ch. 193, § 1;L. 1982, ch. 182, § 138;L. 1986, ch. 235, § 1;L. 1986, ch. 231, § 9;L. 1986, ch. 236, § 1;L. 1987, ch. 235, § 5;L. 1987, ch. 236, § 1;L. 1988, ch. 297, § 2;L. 1989, ch. 193, § 1;L. 1989, ch. 192, § 2;L. 1989, ch. 192, § 3;L. 1991, ch. 272, § 10;L. 1996, ch. 229, § 118;L. 1997, ch. 112, § 1;L. 1999, ch. 38, § 1;L. 1999, ch. 149, § 6;L. 2000, ch. 89, § 1;L. 2000, ch. 159, § 10;L. 2001, ch. 31, § 1;L. 2002, ch. 25, § 2;L. 2003, ch. 124, § 8;L. 2006, ch. 169, § 117;L. 2007, ch. 177, § 30; May 17.