58-17b-102 - Definitions.
58-17b-102. Definitions.
In addition to the definitions in Section 58-1-102, as used in this chapter:
(1) "Administering" means:
(a) the direct application of a prescription drug or device, whether by injection,inhalation, ingestion, or by any other means, to the body of a human patient or research subjectby another person; or
(b) the placement by a veterinarian with the owner or caretaker of an animal or group ofanimals of a prescription drug for the purpose of injection, inhalation, ingestion, or any othermeans directed to the body of the animal by the owner or caretaker in accordance with written orverbal directions of the veterinarian.
(2) "Adulterated drug or device" means a drug or device considered adulterated under 21U.S.C.S. Sec. 351 (2003).
(3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for thepurpose of analysis.
(b) "Analytical laboratory" does not include a laboratory possessing prescription drugsused as standards and controls in performing drug monitoring or drug screening analysis if theprescription drugs are prediluted in a human or animal body fluid, human or animal body fluidcomponents, organic solvents, or inorganic buffers at a concentration not exceeding onemilligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic use.
(4) "Animal euthanasia agency" means an agency performing euthanasia on animals bythe use of prescription drugs.
(5) "Automated pharmacy systems" includes mechanical systems which performoperations or activities, other than compounding or administration, relative to the storage,packaging, dispensing, or distribution of medications, and which collect, control, and maintainall transaction information.
(6) "Beyond use date" means the date determined by a pharmacist and placed on aprescription label at the time of dispensing that indicates to the patient or caregiver a time beyondwhich the contents of the prescription are not recommended to be used.
(7) "Branch pharmacy" means a pharmacy or other facility in a rural or medicallyunderserved area, used for the storage and dispensing of prescription drugs, which is dependentupon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated andapproved by the division as the parent pharmacy.
(8) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created inSection 58-17b-201.
(9) "Centralized prescription processing" means the processing by a pharmacy of arequest from another pharmacy to fill or refill a prescription drug order or to perform processingfunctions such as dispensing, drug utilization review, claims adjudication, refill authorizations,and therapeutic interventions.
(10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a retailpharmacy to compound or dispense a drug or dispense a device to the public under a prescriptionorder.
(11) "Class B pharmacy":
(a) means a pharmacy located in Utah:
(i) that is authorized to provide pharmaceutical care for patients in an institutionalsetting; and
(ii) whose primary purpose is to provide a physical environment for patients to obtainhealth care services; and
(b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
(ii) pharmaceutical administration and sterile product preparation facilities.
(12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to engagein the manufacture, production, wholesale, or distribution of drugs or devices.
(13) "Class D pharmacy" means a nonresident pharmacy.
(14) "Class E pharmacy" means all other pharmacies.
(15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to adefined and exclusive group of patients who have access to the services of the pharmacy becausethey are treated by or have an affiliation with a specific entity, including a health maintenanceorganization or an infusion company, but not including a hospital pharmacy, a retailer of goodsto the general public, or the office of a practitioner.
(16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one ormore pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one ormore practitioners under protocol whereby the pharmacist may perform certain pharmaceuticalcare functions authorized by the practitioner or practitioners under certain specified conditions orlimitations.
(17) "Collaborative pharmacy practice agreement" means a written and signed agreementbetween one or more pharmacists and one or more practitioners that provides for collaborativepharmacy practice for the purpose of drug therapy management of patients and prevention ofdisease of human subjects.
(18) (a) "Compounding" means the preparation, mixing, assembling, packaging, orlabeling of a limited quantity drug, sterile product, or device:
(i) as the result of a practitioner's prescription order or initiative based on the practitioner,patient, or pharmacist relationship in the course of professional practice;
(ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis andnot for sale or dispensing; or
(iii) in anticipation of prescription drug orders based on routine, regularly observedprescribing patterns.
(b) "Compounding" does not include:
(i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale toanother pharmacist or pharmaceutical facility;
(ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in adosage form which is regularly and commonly available from a manufacturer in quantities andstrengths prescribed by a practitioner; or
(iii) the preparation of a prescription drug, sterile product, or device which has beenwithdrawn from the market for safety reasons.
(19) "Confidential information" has the same meaning as "protected health information"under the Standards for Privacy of Individually Identifiable Health Information, 45 C.F.R. Parts160 and 164.
(20) "Controlled substance" has the same definition as in Section 58-37-2.
(21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter 417,Sec. 3a(ff) which is incorporated by reference.
(22) "Dispense" means the interpretation, evaluation, and implementation of a
prescription drug order or device or nonprescription drug or device under a lawful order of apractitioner in a suitable container appropriately labeled for subsequent administration to or useby a patient, research subject, or an animal.
(23) "Distribute" means to deliver a drug or device other than by administering ordispensing.
(24) (a) "Drug" means:
(i) a substance recognized in the official United States Pharmacopoeia, OfficialHomeopathic Pharmacopoeia of the United States, or Official National Formulary, or anysupplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease in humans or animals;
(ii) a substance that is required by any applicable federal or state law or rule to bedispensed by prescription only or is restricted to administration by practitioners only;
(iii) a substance other than food intended to affect the structure or any function of thebody of humans or other animals; and
(iv) substances intended for use as a component of any substance specified inSubsections (24)(a)(i), (ii), (iii), and (iv).
(b) "Drug" does not include dietary supplements.
(25) "Drug product equivalent" means a drug product that is designated as the therapeuticequivalent of another drug product in the Approved Drug Products with Therapeutic EquivalenceEvaluations prepared by the Center for Drug Evaluation and Research of the Federal Food andDrug Administration.
(26) "Drug regimen review" includes the following activities:
(a) evaluation of the prescription drug order and patient record for:
(i) known allergies;
(ii) rational therapy-contraindications;
(iii) reasonable dose and route of administration; and
(iv) reasonable directions for use;
(b) evaluation of the prescription drug order and patient record for duplication of therapy;
(c) evaluation of the prescription drug order and patient record for the followinginteractions:
(i) drug-drug;
(ii) drug-food;
(iii) drug-disease; and
(iv) adverse drug reactions; and
(d) evaluation of the prescription drug order and patient record for proper utilization,including over- or under-utilization, and optimum therapeutic outcomes.
(27) "Drug sample" means a prescription drug packaged in small quantities consistentwith limited dosage therapy of the particular drug, which is marked "sample", is not intended tobe sold, and is intended to be provided to practitioners for the immediate needs of patients fortrial purposes or to provide the drug to the patient until a prescription can be filled by the patient.
(28) "Electronic signature" means a trusted, verifiable, and secure electronic sound,symbol, or process attached to or logically associated with a record and executed or adopted by aperson with the intent to sign the record.
(29) "Electronic transmission" means transmission of information in electronic form orthe transmission of the exact visual image of a document by way of electronic equipment.
(30) "Extern" means a college of pharmacy student enrolled in a college coordinatedpractical experience program in a health care setting under the supervision of a preceptor, asdefined in this act, and approved by a college of pharmacy.
(31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to inpatientsof a general acute hospital or specialty hospital licensed by the Department of Health under Title26, Chapter 21, Health Care Facility Licensing and Inspection Act.
(32) "Legend drug" has the same meaning as prescription drug.
(33) "Licensed pharmacy technician" means an individual licensed with the division, thatmay, under the supervision of a pharmacist, perform the activities involved in the technicianpractice of pharmacy.
(34) "Manufacturer" means a person or business physically located in Utah licensed to beengaged in the manufacturing of drugs or devices.
(35) (a) "Manufacturing" means:
(i) the production, preparation, propagation, conversion, or processing of a drug ordevice, either directly or indirectly, by extraction from substances of natural origin orindependently by means of chemical or biological synthesis, or by a combination of extractionand chemical synthesis, and includes any packaging or repackaging of the substance or labelingor relabeling of its container; and
(ii) the promotion and marketing of such drugs or devices.
(b) "Manufacturing" includes the preparation and promotion of commercially availableproducts from bulk compounds for resale by pharmacies, practitioners, or other persons.
(c) "Manufacturing" does not include the preparation or compounding of a drug by apharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,compounding, packaging, labeling of a drug, or incident to research, teaching, or chemicalanalysis.
(36) "Medical order" means a lawful order of a practitioner which may include aprescription drug order.
(37) "Medication profile" or "profile" means a record system maintained as to drugs ordevices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyzethe profile to provide pharmaceutical care.
(38) "Misbranded drug or device" means a drug or device considered misbranded under21 U.S.C.S. Sec. 352 (2003).
(39) (a) "Nonprescription drug" means a drug which:
(i) may be sold without a prescription; and
(ii) is labeled for use by the consumer in accordance with federal law.
(b) "Nonprescription drug" includes homeopathic remedies.
(40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to aperson in Utah.
(41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
(42) "Out-of-state mail service pharmacy" means a pharmaceutical facility locatedoutside the state that is licensed and in good standing in another state, that:
(a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient inthis state pursuant to a lawfully issued prescription;
(b) provides information to a patient in this state on drugs or devices which may include,but is not limited to, advice relating to therapeutic values, potential hazards, and uses; or
(c) counsels pharmacy patients residing in this state concerning adverse and therapeuticeffects of drugs.
(43) "Patient counseling" means the written and oral communication by the pharmacistor pharmacy intern of information, to the patient or caregiver, in order to ensure proper use ofdrugs, devices, and dietary supplements.
(44) "Pharmaceutical administration facility" means a facility, agency, or institution inwhich:
(a) prescription drugs or devices are held, stored, or are otherwise under the control ofthe facility or agency for administration to patients of that facility or agency;
(b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist orpharmacy intern with whom the facility has established a prescription drug supervisingrelationship under which the pharmacist or pharmacy intern provides counseling to the facility oragency staff as required, and oversees drug control, accounting, and destruction; and
(c) prescription drugs are professionally administered in accordance with the order of apractitioner by an employee or agent of the facility or agency.
(45) (a) "Pharmaceutical care" means carrying out the following in collaboration with aprescribing practitioner, and in accordance with division rule:
(i) designing, implementing, and monitoring a therapeutic drug plan intended to achievefavorable outcomes related to a specific patient for the purpose of curing or preventing thepatient's disease;
(ii) eliminating or reducing a patient's symptoms; or
(iii) arresting or slowing a disease process.
(b) "Pharmaceutical care" does not include prescribing of drugs without consent of aprescribing practitioner.
(46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,distributing, manufacturing, or wholesaling of prescription drugs or devices within or into thisstate.
(47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facilityengaged in the business of wholesale vending or selling of any prescription drug or device toother than the consumer or user of the prescription drug or device, which the pharmaceuticalfacility has not produced, manufactured, compounded, or dispensed.
(b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical facilitycarrying out the following business activities:
(i) intracompany sales;
(ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell, purchaseor trade a prescription drug or device between hospitals or other health care facilities that areunder common ownership or control of the management and operation of the facilities;
(iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell, purchase,or trade a prescription drug or device for emergency medical reasons, or to supply anotherpharmaceutical facility to alleviate a temporary shortage; or
(iv) the distribution of a prescription drug or device as a sample by representatives of amanufacturer.
(48) "Pharmacist" means an individual licensed by this state to engage in the practice ofpharmacy.
(49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing who
accepts responsibility for the operation of a pharmacy in conformance with all laws and rulespertinent to the practice of pharmacy and the distribution of drugs, and who is personally in fulland actual charge of the pharmacy and all personnel.
(50) "Pharmacist preceptor" means a licensed pharmacist in good standing with two ormore years of licensed experience. The preceptor serves as a teacher, example of professionalconduct, and supervisor of interns in the professional practice of pharmacy.
(51) "Pharmacy" means any place where:
(a) drugs are dispensed;
(b) pharmaceutical care is provided;
(c) drugs are processed or handled for eventual use by a patient; or
(d) drugs are used for the purpose of analysis or research.
(52) "Pharmacy benefits manager or coordinator" means a person or entity thatadministers the prescription drug or device portion of a health insurance plan on behalf of aself-insured employer, insurance company, health maintenance organization, or other plansponsor, as defined by rule.
(53) "Pharmacy intern" means an individual licensed by this state to engage in practice asa pharmacy intern.
(54) "Pharmacy technician training program" means an approved technician trainingprogram providing education for pharmacy technicians.
(55) (a) "Practice as a licensed pharmacy technician" means engaging in practice as apharmacy technician under the general supervision of a licensed pharmacist and in accordancewith a scope of practice defined by division rule made in collaboration with the board.
(b) "Practice as a licensed pharmacy technician" does not include:
(i) performing a drug utilization review, prescription drug order clarification from aprescriber, final review of the prescription and prescribed drug prepared for dispensing,dispensing of the drug, or counseling a patient with respect to a prescription drug;
(ii) counseling regarding nonprescription drugs and dietary supplements unless delegatedby the supervising pharmacist; or
(iii) receiving new prescription drug orders when communicating telephonically orelectronically unless the original information is recorded so the pharmacist may review theprescription drug order as transmitted.
(56) "Practice of pharmacy" includes the following:
(a) providing pharmaceutical care;
(b) collaborative pharmacy practice in accordance with a collaborative pharmacy practiceagreement;
(c) compounding, packaging, labeling, dispensing, administering, and the coincidentdistribution of prescription drugs or devices, provided that the administration of a prescriptiondrug or device is:
(i) pursuant to a lawful order of a practitioner when one is required by law; and
(ii) in accordance with written guidelines or protocols:
(A) established by the licensed facility in which the prescription drug or device is to beadministered on an inpatient basis; or
(B) approved by the division, in collaboration with the board and the PhysiciansLicensing Board, created in Section 58-67-201, if the prescription drug or device is to beadministered on an outpatient basis solely by a licensed pharmacist;
(d) participating in drug utilization review;
(e) ensuring proper and safe storage of drugs and devices;
(f) maintaining records of drugs and devices in accordance with state and federal law andthe standards and ethics of the profession;
(g) providing information on drugs or devices, which may include advice relating totherapeutic values, potential hazards, and uses;
(h) providing drug product equivalents;
(i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacytechnicians;
(j) providing patient counseling, including adverse and therapeutic effects of drugs;
(k) providing emergency refills as defined by rule;
(l) telepharmacy; and
(m) formulary management intervention.
(57) "Practice of telepharmacy" means the practice of pharmacy through the use oftelecommunications and information technologies.
(58) "Practice of telepharmacy across state lines" means the practice of pharmacythrough the use of telecommunications and information technologies that occurs when the patientis physically located within one jurisdiction and the pharmacist is located in another jurisdiction.
(59) "Practitioner" means an individual currently licensed, registered, or otherwiseauthorized by the appropriate jurisdiction to prescribe and administer drugs in the course ofprofessional practice.
(60) "Prescribe" means to issue a prescription:
(a) orally or in writing; or
(b) by telephone, facsimile transmission, computer, or other electronic means ofcommunication as defined by division rule.
(61) "Prescription" means an order issued:
(a) by a licensed practitioner in the course of that practitioner's professional practice orby collaborative pharmacy practice agreement; and
(b) for a controlled substance or other prescription drug or device for use by a patient oran animal.
(62) "Prescription device" means an instrument, apparatus, implement, machine,contrivance, implant, in vitro reagent, or other similar or related article, and any component partor accessory, which is required under federal or state law to be prescribed by a practitioner anddispensed by or through a person or entity licensed under this chapter or exempt from licensureunder this chapter.
(63) "Prescription drug" means a drug that is required by federal or state law or rule to bedispensed only by prescription or is restricted to administration only by practitioners.
(64) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugsand devices to the general public.
(65) "Self-audit" means an internal evaluation of a pharmacy to determine compliancewith this chapter.
(66) "Supervising pharmacist" means a pharmacist who is overseeing the operation of thepharmacy during a given day or shift.
(67) "Supportive personnel" means unlicensed individuals who:
(a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed pharmacy
technician in nonjudgmental duties not included in the definition of the practice of pharmacy,practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as those dutiesmay be further defined by division rule adopted in collaboration with the board; and
(b) are supervised by a pharmacist in accordance with rules adopted by the division incollaboration with the board.
(68) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501.
(69) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-17b-502 andmay be further defined by rule.
(70) "Veterinary pharmaceutical facility" means a pharmaceutical facility that dispensesdrugs intended for use by animals or for sale to veterinarians for the administration for animals.
Amended by Chapter 101, 2010 General Session