! The Capitol Complex is closed to the public due to COVID-19. All meetings will be held virtually online. View procedures and guidelines for remote public comment

Download Zipped Enrolled WordPerfect SB0078.ZIP
[Introduced][Amended][Status][Bill Documents][Fiscal Note][Bills Directory]

S.B. 78 Enrolled

             1     

PHARMACY ACT AMENDMENTS

             2     
2013 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: J. Stuart Adams

             5     
House Sponsor: Stewart Barlow

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill amends the Pharmacy Practice Act to allow the substitution of interchangeable
             10      biosimilar products in the place of prescribed biological products.
             11      Highlighted Provisions:
             12          This bill:
             13          .    allows a pharmacist or pharmacy intern dispensing a prescription to substitute a
             14      biosimilar product in the place of a prescribed biological product if:
             15              .    the United States Food and Drug Administration (FDA) has determined that the
             16      biosimilar product is interchangeable with the prescribed product;
             17              .    the interchangeable biosimilar product is approved to move through interstate
             18      commerce;
             19              .    the prescribing practitioner has not prohibited the substitution; and
             20              .    the substitution is not prohibited by law;
             21          .    requires out-of-state mail pharmacies substituting interchangeable biosimilar
             22      products in the place of prescribed biological products to notify the patient and to
             23      keep records of the substitution;
             24          .    prohibits the substitution of a biosimilar product for the prescribed biological
             25      product without the prescriber's authorization unless the FDA has determined the
             26      biosimilar product to be interchangeable with the prescribed biological product;
             27          .    assigns no greater liability to a pharmacist or pharmacy intern who substitutes an
             28      interchangeable biosimilar product in the place of a prescribed biological product
             29      than would be incurred without the substitution;


             30          .    sets forth that a prescriber can prohibit the substitution of a biological product with
             31      an interchangeable biosimilar product orally or in writing;
             32          .    establishes requirements for the substitution of a biological product with an
             33      interchangeable biosimilar product relating to:
             34              .    labeling;
             35              .    patient notification; and
             36              .    record keeping; and
             37          .     makes technical changes.
             38      Money Appropriated in this Bill:
             39          None
             40      Other Special Clauses:
             41          None
             42      Utah Code Sections Affected:
             43      AMENDS:
             44          58-17b-102, as last amended by Laws of Utah 2012, Chapters 265 and 320
             45          58-17b-605, as last amended by Laws of Utah 2008, Chapter 205
             46          63I-2-258, as last amended by Laws of Utah 2012, Chapters 88 and 369
             47      ENACTS:
             48          58-17b-605.5, Utah Code Annotated 1953
             49     
             50      Be it enacted by the Legislature of the state of Utah:
             51          Section 1. Section 58-17b-102 is amended to read:
             52           58-17b-102. Definitions.
             53          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             54          (1) "Administering" means:
             55          (a) the direct application of a prescription drug or device, whether by injection,
             56      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             57      by another person; or


             58          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             59      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             60      means directed to the body of the animal by the owner or caretaker in accordance with written
             61      or verbal directions of the veterinarian.
             62          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             63      21 U.S.C.S. Sec. 351 (2003).
             64          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             65      the purpose of analysis.
             66          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             67      used as standards and controls in performing drug monitoring or drug screening analysis if the
             68      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
             69      components, organic solvents, or inorganic buffers at a concentration not exceeding one
             70      milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
             71      use.
             72          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
             73      the use of prescription drugs.
             74          (5) "Automated pharmacy systems" includes mechanical systems which perform
             75      operations or activities, other than compounding or administration, relative to the storage,
             76      packaging, dispensing, or distribution of medications, and which collect, control, and maintain
             77      all transaction information.
             78          (6) "Beyond use date" means the date determined by a pharmacist and placed on a
             79      prescription label at the time of dispensing that indicates to the patient or caregiver a time
             80      beyond which the contents of the prescription are not recommended to be used.
             81          (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
             82      in Section 58-17b-201 .
             83          (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
             84      underserved area, used for the storage and dispensing of prescription drugs, which is dependent
             85      upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and


             86      approved by the division as the parent pharmacy.
             87          (9) "Centralized prescription processing" means the processing by a pharmacy of a
             88      request from another pharmacy to fill or refill a prescription drug order or to perform
             89      processing functions such as dispensing, drug utilization review, claims adjudication, refill
             90      authorizations, and therapeutic interventions.
             91          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
             92      retail pharmacy to compound or dispense a drug or dispense a device to the public under a
             93      prescription order.
             94          (11) "Class B pharmacy":
             95          (a) means a pharmacy located in Utah:
             96          (i) that is authorized to provide pharmaceutical care for patients in an institutional
             97      setting; and
             98          (ii) whose primary purpose is to provide a physical environment for patients to obtain
             99      health care services; and
             100          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
             101          (ii) pharmaceutical administration and sterile product preparation facilities.
             102          (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
             103      engage in the manufacture, production, wholesale, or distribution of drugs or devices.
             104          (13) "Class D pharmacy" means a nonresident pharmacy.
             105          (14) "Class E pharmacy" means all other pharmacies.
             106          (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
             107      defined and exclusive group of patients who have access to the services of the pharmacy
             108      because they are treated by or have an affiliation with a specific entity, including a health
             109      maintenance organization or an infusion company, but not including a hospital pharmacy, a
             110      retailer of goods to the general public, or the office of a practitioner.
             111          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
             112      more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
             113      more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical


             114      care functions authorized by the practitioner or practitioners under certain specified conditions
             115      or limitations.
             116          (17) "Collaborative pharmacy practice agreement" means a written and signed
             117      agreement between one or more pharmacists and one or more practitioners that provides for
             118      collaborative pharmacy practice for the purpose of drug therapy management of patients and
             119      prevention of disease of human subjects.
             120          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
             121      labeling of a limited quantity drug, sterile product, or device:
             122          (i) as the result of a practitioner's prescription order or initiative based on the
             123      practitioner, patient, or pharmacist relationship in the course of professional practice;
             124          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
             125      not for sale or dispensing; or
             126          (iii) in anticipation of prescription drug orders based on routine, regularly observed
             127      prescribing patterns.
             128          (b) "Compounding" does not include:
             129          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
             130      another pharmacist or pharmaceutical facility;
             131          (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
             132      dosage form which is regularly and commonly available from a manufacturer in quantities and
             133      strengths prescribed by a practitioner; or
             134          (iii) the preparation of a prescription drug, sterile product, or device which has been
             135      withdrawn from the market for safety reasons.
             136          (19) "Confidential information" has the same meaning as "protected health
             137      information" under the Standards for Privacy of Individually Identifiable Health Information,
             138      45 C.F.R. Parts 160 and 164.
             139          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             140          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
             141      417, Sec. 3a(ff) which is incorporated by reference.


             142          (22) "Dispense" means the interpretation, evaluation, and implementation of a
             143      prescription drug order or device or nonprescription drug or device under a lawful order of a
             144      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             145      by a patient, research subject, or an animal.
             146          (23) "Distribute" means to deliver a drug or device other than by administering or
             147      dispensing.
             148          (24) (a) "Drug" means:
             149          (i) a substance recognized in the official United States Pharmacopoeia, Official
             150      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             151      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
             152      prevention of disease in humans or animals;
             153          (ii) a substance that is required by any applicable federal or state law or rule to be
             154      dispensed by prescription only or is restricted to administration by practitioners only;
             155          (iii) a substance other than food intended to affect the structure or any function of the
             156      body of humans or other animals; and
             157          (iv) substances intended for use as a component of any substance specified in
             158      Subsections (24)(a)(i), (ii), (iii), and (iv).
             159          (b) "Drug" does not include dietary supplements.
             160          [(25) "Drug product equivalent" means a drug product that is designated as the
             161      therapeutic equivalent of another drug product in the Approved Drug Products with
             162      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             163      of the Federal Food and Drug Administration.]
             164          [(26)] (25) "Drug regimen review" includes the following activities:
             165          (a) evaluation of the prescription drug order and patient record for:
             166          (i) known allergies;
             167          (ii) rational therapy-contraindications;
             168          (iii) reasonable dose and route of administration; and
             169          (iv) reasonable directions for use;


             170          (b) evaluation of the prescription drug order and patient record for duplication of
             171      therapy;
             172          (c) evaluation of the prescription drug order and patient record for the following
             173      interactions:
             174          (i) drug-drug;
             175          (ii) drug-food;
             176          (iii) drug-disease; and
             177          (iv) adverse drug reactions; and
             178          (d) evaluation of the prescription drug order and patient record for proper utilization,
             179      including over- or under-utilization, and optimum therapeutic outcomes.
             180          [(27)] (26) "Drug sample" means a prescription drug packaged in small quantities
             181      consistent with limited dosage therapy of the particular drug, which is marked "sample", is not
             182      intended to be sold, and is intended to be provided to practitioners for the immediate needs of
             183      patients for trial purposes or to provide the drug to the patient until a prescription can be filled
             184      by the patient.
             185          [(28)] (27) "Electronic signature" means a trusted, verifiable, and secure electronic
             186      sound, symbol, or process attached to or logically associated with a record and executed or
             187      adopted by a person with the intent to sign the record.
             188          [(29)] (28) "Electronic transmission" means transmission of information in electronic
             189      form or the transmission of the exact visual image of a document by way of electronic
             190      equipment.
             191          [(30)] (29) "Extern" means a college of pharmacy student enrolled in a college
             192      coordinated practical experience program in a health care setting under the supervision of a
             193      preceptor, as defined in this act, and approved by a college of pharmacy.
             194          [(31)] (30) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
             195      inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             196      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             197          [(32)] (31) "Legend drug" has the same meaning as prescription drug.


             198          [(33)] (32) "Licensed pharmacy technician" means an individual licensed with the
             199      division, that may, under the supervision of a pharmacist, perform the activities involved in the
             200      technician practice of pharmacy.
             201          [(34)] (33) "Manufacturer" means a person or business physically located in Utah
             202      licensed to be engaged in the manufacturing of drugs or devices.
             203          [(35)] (34) (a) "Manufacturing" means:
             204          (i) the production, preparation, propagation, conversion, or processing of a drug or
             205      device, either directly or indirectly, by extraction from substances of natural origin or
             206      independently by means of chemical or biological synthesis, or by a combination of extraction
             207      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             208      or relabeling of its container; and
             209          (ii) the promotion and marketing of such drugs or devices.
             210          (b) "Manufacturing" includes the preparation and promotion of commercially available
             211      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             212          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             213      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             214      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
             215      analysis.
             216          [(36)] (35) "Medical order" means a lawful order of a practitioner which may include a
             217      prescription drug order.
             218          [(37)] (36) "Medication profile" or "profile" means a record system maintained as to
             219      drugs or devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
             220      analyze the profile to provide pharmaceutical care.
             221          [(38)] (37) "Misbranded drug or device" means a drug or device considered
             222      misbranded under 21 U.S.C.S. Sec. 352 (2003).
             223          [(39)] (38) (a) "Nonprescription drug" means a drug which:
             224          (i) may be sold without a prescription; and
             225          (ii) is labeled for use by the consumer in accordance with federal law.


             226          (b) "Nonprescription drug" includes homeopathic remedies.
             227          [(40)] (39) "Nonresident pharmacy" means a pharmacy located outside of Utah that
             228      sells to a person in Utah.
             229          [(41)] (40) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical
             230      service.
             231          [(42)] (41) "Out-of-state mail service pharmacy" means a pharmaceutical facility
             232      located outside the state that is licensed and in good standing in another state, that:
             233          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
             234      this state pursuant to a lawfully issued prescription;
             235          (b) provides information to a patient in this state on drugs or devices which may
             236      include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
             237      or
             238          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             239      effects of drugs.
             240          [(43)] (42) "Patient counseling" means the written and oral communication by the
             241      pharmacist or pharmacy intern of information, to the patient or caregiver, in order to ensure
             242      proper use of drugs, devices, and dietary supplements.
             243          [(44)] (43) "Pharmaceutical administration facility" means a facility, agency, or
             244      institution in which:
             245          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
             246      the facility or agency for administration to patients of that facility or agency;
             247          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             248      or pharmacy intern with whom the facility has established a prescription drug supervising
             249      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             250      or agency staff as required, and oversees drug control, accounting, and destruction; and
             251          (c) prescription drugs are professionally administered in accordance with the order of a
             252      practitioner by an employee or agent of the facility or agency.
             253          [(45)] (44) (a) "Pharmaceutical care" means carrying out the following in collaboration


             254      with a prescribing practitioner, and in accordance with division rule:
             255          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             256      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
             257      the patient's disease;
             258          (ii) eliminating or reducing a patient's symptoms; or
             259          (iii) arresting or slowing a disease process.
             260          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
             261      prescribing practitioner.
             262          [(46)] (45) "Pharmaceutical facility" means a business engaged in the dispensing,
             263      delivering, distributing, manufacturing, or wholesaling of prescription drugs or devices within
             264      or into this state.
             265          [(47)] (46) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical
             266      facility engaged in the business of wholesale vending or selling of any prescription drug or
             267      device to other than the consumer or user of the prescription drug or device, which the
             268      pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
             269          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             270      facility carrying out the following business activities:
             271          (i) intracompany sales;
             272          (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             273      purchase or trade a prescription drug or device between hospitals or other health care facilities
             274      that are under common ownership or control of the management and operation of the facilities;
             275          (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             276      purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
             277      another pharmaceutical facility to alleviate a temporary shortage; or
             278          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             279      manufacturer.
             280          [(48)] (47) "Pharmacist" means an individual licensed by this state to engage in the
             281      practice of pharmacy.


             282          [(49)] (48) "Pharmacist-in-charge" means a pharmacist currently licensed in good
             283      standing who accepts responsibility for the operation of a pharmacy in conformance with all
             284      laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
             285      personally in full and actual charge of the pharmacy and all personnel.
             286          [(50)] (49) "Pharmacist preceptor" means a licensed pharmacist in good standing with
             287      one or more years of licensed experience. The preceptor serves as a teacher, example of
             288      professional conduct, and supervisor of interns in the professional practice of pharmacy.
             289          [(51)] (50) "Pharmacy" means any place where:
             290          (a) drugs are dispensed;
             291          (b) pharmaceutical care is provided;
             292          (c) drugs are processed or handled for eventual use by a patient; or
             293          (d) drugs are used for the purpose of analysis or research.
             294          [(52)] (51) "Pharmacy benefits manager or coordinator" means a person or entity that
             295      provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
             296      self-insured employer, insurance company, health maintenance organization, or other plan
             297      sponsor, as defined by rule.
             298          [(53)] (52) "Pharmacy intern" means an individual licensed by this state to engage in
             299      practice as a pharmacy intern.
             300          [(54)] (53) "Pharmacy technician training program" means an approved technician
             301      training program providing education for pharmacy technicians.
             302          [(55)] (54) (a) "Practice as a licensed pharmacy technician" means engaging in practice
             303      as a pharmacy technician under the general supervision of a licensed pharmacist and in
             304      accordance with a scope of practice defined by division rule made in collaboration with the
             305      board.
             306          (b) "Practice as a licensed pharmacy technician" does not include:
             307          (i) performing a drug utilization review, prescription drug order clarification from a
             308      prescriber, final review of the prescription and prescribed drug prepared for dispensing,
             309      dispensing of the drug, or counseling a patient with respect to a prescription drug;


             310          (ii) counseling regarding nonprescription drugs and dietary supplements unless
             311      delegated by the supervising pharmacist; or
             312          (iii) receiving new prescription drug orders when communicating telephonically or
             313      electronically unless the original information is recorded so the pharmacist may review the
             314      prescription drug order as transmitted.
             315          [(56)] (55) "Practice of pharmacy" includes the following:
             316          (a) providing pharmaceutical care;
             317          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             318      practice agreement;
             319          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             320      distribution of prescription drugs or devices, provided that the administration of a prescription
             321      drug or device is:
             322          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             323          (ii) in accordance with written guidelines or protocols:
             324          (A) established by the licensed facility in which the prescription drug or device is to be
             325      administered on an inpatient basis; or
             326          (B) approved by the division, in collaboration with the board and the Physicians
             327      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             328      administered on an outpatient basis solely by a licensed pharmacist;
             329          (d) participating in drug utilization review;
             330          (e) ensuring proper and safe storage of drugs and devices;
             331          (f) maintaining records of drugs and devices in accordance with state and federal law
             332      and the standards and ethics of the profession;
             333          (g) providing information on drugs or devices, which may include advice relating to
             334      therapeutic values, potential hazards, and uses;
             335          (h) providing drug product equivalents;
             336          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             337      technicians;


             338          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
             339          (k) providing emergency refills as defined by rule;
             340          (l) telepharmacy; and
             341          (m) formulary management intervention.
             342          [(57)] (56) "Practice of telepharmacy" means the practice of pharmacy through the use
             343      of telecommunications and information technologies.
             344          [(58)] (57) "Practice of telepharmacy across state lines" means the practice of
             345      pharmacy through the use of telecommunications and information technologies that occurs
             346      when the patient is physically located within one jurisdiction and the pharmacist is located in
             347      another jurisdiction.
             348          [(59)] (58) "Practitioner" means an individual currently licensed, registered, or
             349      otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
             350      course of professional practice.
             351          [(60)] (59) "Prescribe" means to issue a prescription:
             352          (a) orally or in writing; or
             353          (b) by telephone, facsimile transmission, computer, or other electronic means of
             354      communication as defined by division rule.
             355          [(61)] (60) "Prescription" means an order issued:
             356          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             357      by collaborative pharmacy practice agreement; and
             358          (b) for a controlled substance or other prescription drug or device for use by a patient
             359      or an animal.
             360          [(62)] (61) "Prescription device" means an instrument, apparatus, implement, machine,
             361      contrivance, implant, in vitro reagent, or other similar or related article, and any component
             362      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             363      and dispensed by or through a person or entity licensed under this chapter or exempt from
             364      licensure under this chapter.
             365          [(63)] (62) "Prescription drug" means a drug that is required by federal or state law or


             366      rule to be dispensed only by prescription or is restricted to administration only by practitioners.
             367          [(64)] (63) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
             368      drugs and devices to the general public.
             369          [(65)] (64) "Self-audit" means an internal evaluation of a pharmacy to determine
             370      compliance with this chapter.
             371          [(66)] (65) "Supervising pharmacist" means a pharmacist who is overseeing the
             372      operation of the pharmacy during a given day or shift.
             373          [(67)] (66) "Supportive personnel" means unlicensed individuals who:
             374          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             375      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             376      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             377      those duties may be further defined by division rule adopted in collaboration with the board;
             378      and
             379          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             380      collaboration with the board.
             381          [(68)] (67) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             382          [(69)] (68) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             383      58-17b-502 and may be further defined by rule.
             384          [(70)] (69) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             385      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             386      for animals.
             387          Section 2. Section 58-17b-605 is amended to read:
             388           58-17b-605. Drug product equivalents.
             389          (1) For the purposes of this section:
             390          (a) (i) "Drug" is as defined in Section 58-17b-102 .
             391          (ii) "Drug" does not mean a "biological product" as defined in Section 58-17b-605.5.
             392          (b) "Drug product equivalent" means a drug product that is designated as the
             393      therapeutic equivalent of another drug product in the Approved Drug Products with


             394      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             395      of the United States Food and Drug Administration.
             396          [(1)] (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific
             397      drug by brand or proprietary name may substitute a drug product equivalent[, as defined in
             398      Section 58-17b-102 ,] for the prescribed drug only if:
             399          (a) the purchaser specifically requests or consents to the substitution of a drug product
             400      equivalent;
             401          (b) the drug product equivalent is of the same generic type and is designated the
             402      therapeutic equivalent in the approved drug products with therapeutic equivalence evaluations
             403      prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug
             404      Administration;
             405          (c) the drug product equivalent is permitted to move in interstate commerce;
             406          (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
             407      response to the prescribed drug, whether a substitute or not, and the substitution is not
             408      otherwise prohibited by this chapter;
             409          (e) the prescribing practitioner has not indicated that a drug product equivalent may not
             410      be substituted for the drug, as provided in Subsection [(5)] (6); and
             411          (f) the substitution is not otherwise prohibited by law.
             412          [(2)] (3) (a) Each out-of-state mail service pharmacy dispensing a drug product
             413      equivalent as a substitute for another drug into this state shall notify the patient of the
             414      substitution either by telephone or in writing.
             415          (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
             416      chapter with respect to a drug product equivalent substituted for another drug, including
             417      labeling and record keeping.
             418          [(3)] (4) Pharmacists or pharmacy interns may not substitute without the prescriber's
             419      authorization on trade name drug product prescriptions unless the product is currently
             420      categorized in the approved drug products with therapeutic equivalence evaluations prepared
             421      by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration


             422      as a drug product considered to be therapeutically equivalent to another drug product.
             423          [(4)] (5) A pharmacist or pharmacy intern who dispenses a prescription with a drug
             424      product equivalent under this section assumes no greater liability than would be incurred had
             425      the pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
             426          [(5)] (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of
             427      the patient that a drug product equivalent not be substituted for a prescribed drug, the
             428      practitioner may indicate a prohibition on substitution either by writing "dispense as written" or
             429      signing in the appropriate space where two lines have been preprinted on a prescription order
             430      and captioned "dispense as written" or "substitution permitted".
             431          (b) If the prescription is communicated orally by the prescribing practitioner to the
             432      pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
             433      and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
             434      name of the practitioner and the words "orally by" and the initials of the pharmacist or
             435      pharmacy intern written after it.
             436          [(6)] (7) A pharmacist or pharmacy intern who substitutes a drug product equivalent
             437      for a prescribed drug shall communicate the substitution to the purchaser. The drug product
             438      equivalent container shall be labeled with the name of the drug dispensed, and the pharmacist,
             439      pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
             440      the name of the prescribed drug and the name of the drug product equivalent dispensed in its
             441      place.
             442          [(7)] (8) (a) For purposes of this Subsection [(7)] (8), "substitutes" means to substitute:
             443          (i) a generic drug for another generic drug;
             444          (ii) a generic drug for a nongeneric drug;
             445          (iii) a nongeneric drug for another nongeneric drug; or
             446          (iv) a nongeneric drug for a generic drug.
             447          (b) A prescribing practitioner who makes a finding under Subsection [(5)] (6)(a) for a
             448      patient with a seizure disorder shall indicate a prohibition on substitution of a drug product
             449      equivalent in the manner provided in Subsection [(5)] (6)(a) or (b).


             450          (c) Except as provided in Subsection [(7)] (8)(d), a pharmacist or pharmacy intern who
             451      cannot dispense the prescribed drug as written, and who needs to substitute a drug product
             452      equivalent for the drug prescribed to the patient to treat or prevent seizures shall notify the
             453      prescribing practitioner prior to the substitution.
             454          (d) Notification under Subsection [(7)] (8)(c) is not required if the drug product
             455      equivalent is paid for in whole or in part by Medicaid.
             456          [(8)] (9) Failure of a licensed medical practitioner to specify that no substitution is
             457      authorized does not constitute evidence of negligence.
             458          Section 3. Section 58-17b-605.5 is enacted to read:
             459          58-17b-605.5. Interchangeable biosimilar products.
             460          (1) For the purposes of this section:
             461          (a) "biological product" is as defined in 21 U.S.C. Sec. 262;
             462          (b) "biosimilar" is as defined in 21 U.S.C. Sec. 262; and
             463          (c) "interchangeable" is as defined in 21 U.S.C. Sec. 262.
             464          (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific
             465      biological product by brand or proprietary name may substitute a biosimilar product for the
             466      prescribed biological product only if:
             467          (a) the purchaser specifically requests or consents to the substitute of an
             468      interchangeable biosimilar product;
             469          (b) the biosimilar product has been determined by the United States Food and Drug
             470      Administration to be interchangeable with the prescribed biological product;
             471          (c) the interchangeable biosimilar product is permitted to move in interstate commerce;
             472          (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
             473      response to the prescribed biological product, whether a substitute or not, and the substitution
             474      is not otherwise prohibited by this chapter;
             475          (e) the prescribing practitioner has not prohibited the substitution of an interchangeable
             476      biosimilar product for the prescribed biological product, as provided in Subsection (6); and
             477          (f) the substitution is not otherwise prohibited by law.


             478          (3) (a) Each out-of-state mail service pharmacy dispensing an interchangeable
             479      biosimilar product as a substitute for another biological product into this state shall notify the
             480      patient of the substitution either by telephone or in writing.
             481          (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
             482      chapter with respect to an interchangeable biosimilar product substituted for another biological
             483      product, including labeling and record keeping.
             484          (4) Pharmacists or pharmacy interns may not substitute without the prescriber's
             485      authorization biological product prescriptions unless the product has been determined by the
             486      United States Food and Drug Administration to be interchangeable with the prescribed
             487      biological product.
             488          (5) A pharmacist or pharmacy intern who dispenses a prescription with an
             489      interchangeable biosimilar product under this section assumes no greater liability than would
             490      be incurred had the pharmacist or pharmacy intern dispensed the prescription with the
             491      biological product prescribed.
             492          (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
             493      patient that an interchangeable biosimilar product not be substituted for a prescribed biological
             494      product, the practitioner may prohibit a substitution either by writing "dispense as written" or
             495      by signing in the appropriate space where two lines have been preprinted on a prescription
             496      order and captioned "dispense as written" or "substitution permitted."
             497          (b) (i) If the prescription is communicated orally by the prescribing practitioner to the
             498      pharmacist or pharmacy intern, the practitioner shall direct the prohibition or substitution.
             499          (ii) The pharmacist or pharmacy intern shall make a written note of the practioner's
             500      direction by writing the name of the practitioner and the words "orally by" and the initials of
             501      the pharmacist or pharmacy intern written after it.
             502          (7) A pharmacist or pharmacy intern who substitutes an interchangeable biosimilar
             503      product for a prescribed biological product shall communicate the substitution to the purchaser.
             504      The interchangeable biosimilar product container shall be labeled with the name of the
             505      interchangeable biosimilar product dispensed, and the pharmacist, pharmacy intern, or


             506      pharmacy technician shall indicate on the file copy of the prescription both the name of the
             507      prescribed biological product and the name of the interchangeable biosimilar product dispensed
             508      in its place.
             509          (8) (a) A pharmacist or pharmacy intern who substitutes an interchangeable biosimilar
             510      product for a prescribed biological product shall:
             511          (i) notify the prescriber in writing, by fax, telephone, or electronic transmission of the
             512      substitution, as soon as practicable, but not later than three business days after dispensing the
             513      interchangeable biosimilar product in place of the prescribed biological product; and
             514          (ii) include the name and manufacturer of the interchangeable biosimilar product
             515      substituted.
             516          (b) This subsection is repealed on May 15, 2015.
             517          Section 4. Section 63I-2-258 is amended to read:
             518           63I-2-258. Repeal dates -- Title 58.
             519          (1) Subsection 58-72-201 (1)(b) is repealed July 1, 2014.
             520          (2) Subsection 58-17b-605.5 (8) is repealed on May 15, 2015.


[Bill Documents][Bills Directory]