Utah Legislature SB0078

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S.B. 78

             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 than would
             29      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      ENACTS:
             47          58-17b-605.5, Utah Code Annotated 1953
             48     
             49      Be it enacted by the Legislature of the state of Utah:
             50          Section 1. Section 58-17b-102 is amended to read:
             51           58-17b-102. Definitions.
             52          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             53          (1) "Administering" means:
             54          (a) the direct application of a prescription drug or device, whether by injection,
             55      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             56      by another person; or
             57          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             58      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other


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


             90          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
             91      retail pharmacy to compound or dispense a drug or dispense a device to the public under a
             92      prescription order.
             93          (11) "Class B pharmacy":
             94          (a) means a pharmacy located in Utah:
             95          (i) that is authorized to provide pharmaceutical care for patients in an institutional
             96      setting; and
             97          (ii) whose primary purpose is to provide a physical environment for patients to obtain
             98      health care services; and
             99          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
             100          (ii) pharmaceutical administration and sterile product preparation facilities.
             101          (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
             102      engage in the manufacture, production, wholesale, or distribution of drugs or devices.
             103          (13) "Class D pharmacy" means a nonresident pharmacy.
             104          (14) "Class E pharmacy" means all other pharmacies.
             105          (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
             106      defined and exclusive group of patients who have access to the services of the pharmacy
             107      because they are treated by or have an affiliation with a specific entity, including a health
             108      maintenance organization or an infusion company, but not including a hospital pharmacy, a
             109      retailer of goods to the general public, or the office of a practitioner.
             110          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
             111      more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
             112      more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
             113      care functions authorized by the practitioner or practitioners under certain specified conditions
             114      or limitations.
             115          (17) "Collaborative pharmacy practice agreement" means a written and signed
             116      agreement between one or more pharmacists and one or more practitioners that provides for
             117      collaborative pharmacy practice for the purpose of drug therapy management of patients and
             118      prevention of disease of human subjects.
             119          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
             120      labeling of a limited quantity drug, sterile product, or device:


             121          (i) as the result of a practitioner's prescription order or initiative based on the
             122      practitioner, patient, or pharmacist relationship in the course of professional practice;
             123          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
             124      not for sale or dispensing; or
             125          (iii) in anticipation of prescription drug orders based on routine, regularly observed
             126      prescribing patterns.
             127          (b) "Compounding" does not include:
             128          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
             129      another pharmacist or pharmaceutical facility;
             130          (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
             131      dosage form which is regularly and commonly available from a manufacturer in quantities and
             132      strengths prescribed by a practitioner; or
             133          (iii) the preparation of a prescription drug, sterile product, or device which has been
             134      withdrawn from the market for safety reasons.
             135          (19) "Confidential information" has the same meaning as "protected health
             136      information" under the Standards for Privacy of Individually Identifiable Health Information,
             137      45 C.F.R. Parts 160 and 164.
             138          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             139          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
             140      417, Sec. 3a(ff) which is incorporated by reference.
             141          (22) "Dispense" means the interpretation, evaluation, and implementation of a
             142      prescription drug order or device or nonprescription drug or device under a lawful order of a
             143      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             144      by a patient, research subject, or an animal.
             145          (23) "Distribute" means to deliver a drug or device other than by administering or
             146      dispensing.
             147          (24) (a) "Drug" means:
             148          (i) a substance recognized in the official United States Pharmacopoeia, Official
             149      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             150      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
             151      prevention of disease in humans or animals;


             152          (ii) a substance that is required by any applicable federal or state law or rule to be
             153      dispensed by prescription only or is restricted to administration by practitioners only;
             154          (iii) a substance other than food intended to affect the structure or any function of the
             155      body of humans or other animals; and
             156          (iv) substances intended for use as a component of any substance specified in
             157      Subsections (24)(a)(i), (ii), (iii), and (iv).
             158          (b) "Drug" does not include dietary supplements.
             159          [(25) "Drug product equivalent" means a drug product that is designated as the
             160      therapeutic equivalent of another drug product in the Approved Drug Products with
             161      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             162      of the Federal Food and Drug Administration.]
             163          [(26)] (25) "Drug regimen review" includes the following activities:
             164          (a) evaluation of the prescription drug order and patient record for:
             165          (i) known allergies;
             166          (ii) rational therapy-contraindications;
             167          (iii) reasonable dose and route of administration; and
             168          (iv) reasonable directions for use;
             169          (b) evaluation of the prescription drug order and patient record for duplication of
             170      therapy;
             171          (c) evaluation of the prescription drug order and patient record for the following
             172      interactions:
             173          (i) drug-drug;
             174          (ii) drug-food;
             175          (iii) drug-disease; and
             176          (iv) adverse drug reactions; and
             177          (d) evaluation of the prescription drug order and patient record for proper utilization,
             178      including over- or under-utilization, and optimum therapeutic outcomes.
             179          [(27)] (26) "Drug sample" means a prescription drug packaged in small quantities
             180      consistent with limited dosage therapy of the particular drug, which is marked "sample", is not
             181      intended to be sold, and is intended to be provided to practitioners for the immediate needs of
             182      patients for trial purposes or to provide the drug to the patient until a prescription can be filled


             183      by the patient.
             184          [(28)] (27) "Electronic signature" means a trusted, verifiable, and secure electronic
             185      sound, symbol, or process attached to or logically associated with a record and executed or
             186      adopted by a person with the intent to sign the record.
             187          [(29)] (28) "Electronic transmission" means transmission of information in electronic
             188      form or the transmission of the exact visual image of a document by way of electronic
             189      equipment.
             190          [(30)] (29) "Extern" means a college of pharmacy student enrolled in a college
             191      coordinated practical experience program in a health care setting under the supervision of a
             192      preceptor, as defined in this act, and approved by a college of pharmacy.
             193          [(31)] (30) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
             194      inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             195      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             196          [(32)] (31) "Legend drug" has the same meaning as prescription drug.
             197          [(33)] (32) "Licensed pharmacy technician" means an individual licensed with the
             198      division, that may, under the supervision of a pharmacist, perform the activities involved in the
             199      technician practice of pharmacy.
             200          [(34)] (33) "Manufacturer" means a person or business physically located in Utah
             201      licensed to be engaged in the manufacturing of drugs or devices.
             202          [(35)] (34) (a) "Manufacturing" means:
             203          (i) the production, preparation, propagation, conversion, or processing of a drug or
             204      device, either directly or indirectly, by extraction from substances of natural origin or
             205      independently by means of chemical or biological synthesis, or by a combination of extraction
             206      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             207      or relabeling of its container; and
             208          (ii) the promotion and marketing of such drugs or devices.
             209          (b) "Manufacturing" includes the preparation and promotion of commercially available
             210      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             211          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             212      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             213      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical


             214      analysis.
             215          [(36)] (35) "Medical order" means a lawful order of a practitioner which may include a
             216      prescription drug order.
             217          [(37)] (36) "Medication profile" or "profile" means a record system maintained as to
             218      drugs or devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
             219      analyze the profile to provide pharmaceutical care.
             220          [(38)] (37) "Misbranded drug or device" means a drug or device considered
             221      misbranded under 21 U.S.C.S. Sec. 352 (2003).
             222          [(39)] (38) (a) "Nonprescription drug" means a drug which:
             223          (i) may be sold without a prescription; and
             224          (ii) is labeled for use by the consumer in accordance with federal law.
             225          (b) "Nonprescription drug" includes homeopathic remedies.
             226          [(40)] (39) "Nonresident pharmacy" means a pharmacy located outside of Utah that
             227      sells to a person in Utah.
             228          [(41)] (40) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical
             229      service.
             230          [(42)] (41) "Out-of-state mail service pharmacy" means a pharmaceutical facility
             231      located outside the state that is licensed and in good standing in another state, that:
             232          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
             233      this state pursuant to a lawfully issued prescription;
             234          (b) provides information to a patient in this state on drugs or devices which may
             235      include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
             236      or
             237          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             238      effects of drugs.
             239          [(43)] (42) "Patient counseling" means the written and oral communication by the
             240      pharmacist or pharmacy intern of information, to the patient or caregiver, in order to ensure
             241      proper use of drugs, devices, and dietary supplements.
             242          [(44)] (43) "Pharmaceutical administration facility" means a facility, agency, or
             243      institution in which:
             244          (a) prescription drugs or devices are held, stored, or are otherwise under the control of


             245      the facility or agency for administration to patients of that facility or agency;
             246          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             247      or pharmacy intern with whom the facility has established a prescription drug supervising
             248      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             249      or agency staff as required, and oversees drug control, accounting, and destruction; and
             250          (c) prescription drugs are professionally administered in accordance with the order of a
             251      practitioner by an employee or agent of the facility or agency.
             252          [(45)] (44) (a) "Pharmaceutical care" means carrying out the following in collaboration
             253      with a prescribing practitioner, and in accordance with division rule:
             254          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             255      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
             256      the patient's disease;
             257          (ii) eliminating or reducing a patient's symptoms; or
             258          (iii) arresting or slowing a disease process.
             259          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
             260      prescribing practitioner.
             261          [(46)] (45) "Pharmaceutical facility" means a business engaged in the dispensing,
             262      delivering, distributing, manufacturing, or wholesaling of prescription drugs or devices within
             263      or into this state.
             264          [(47)] (46) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical
             265      facility engaged in the business of wholesale vending or selling of any prescription drug or
             266      device to other than the consumer or user of the prescription drug or device, which the
             267      pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
             268          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             269      facility carrying out the following business activities:
             270          (i) intracompany sales;
             271          (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             272      purchase or trade a prescription drug or device between hospitals or other health care facilities
             273      that are under common ownership or control of the management and operation of the facilities;
             274          (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             275      purchase, or trade a prescription drug or device for emergency medical reasons, or to supply


             276      another pharmaceutical facility to alleviate a temporary shortage; or
             277          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             278      manufacturer.
             279          [(48)] (47) "Pharmacist" means an individual licensed by this state to engage in the
             280      practice of pharmacy.
             281          [(49)] (48) "Pharmacist-in-charge" means a pharmacist currently licensed in good
             282      standing who accepts responsibility for the operation of a pharmacy in conformance with all
             283      laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
             284      personally in full and actual charge of the pharmacy and all personnel.
             285          [(50)] (49) "Pharmacist preceptor" means a licensed pharmacist in good standing with
             286      one or more years of licensed experience. The preceptor serves as a teacher, example of
             287      professional conduct, and supervisor of interns in the professional practice of pharmacy.
             288          [(51)] (50) "Pharmacy" means any place where:
             289          (a) drugs are dispensed;
             290          (b) pharmaceutical care is provided;
             291          (c) drugs are processed or handled for eventual use by a patient; or
             292          (d) drugs are used for the purpose of analysis or research.
             293          [(52)] (51) "Pharmacy benefits manager or coordinator" means a person or entity that
             294      provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
             295      self-insured employer, insurance company, health maintenance organization, or other plan
             296      sponsor, as defined by rule.
             297          [(53)] (52) "Pharmacy intern" means an individual licensed by this state to engage in
             298      practice as a pharmacy intern.
             299          [(54)] (53) "Pharmacy technician training program" means an approved technician
             300      training program providing education for pharmacy technicians.
             301          [(55)] (54) (a) "Practice as a licensed pharmacy technician" means engaging in practice
             302      as a pharmacy technician under the general supervision of a licensed pharmacist and in
             303      accordance with a scope of practice defined by division rule made in collaboration with the
             304      board.
             305          (b) "Practice as a licensed pharmacy technician" does not include:
             306          (i) performing a drug utilization review, prescription drug order clarification from a


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


             338          (k) providing emergency refills as defined by rule;
             339          (l) telepharmacy; and
             340          (m) formulary management intervention.
             341          [(57)] (56) "Practice of telepharmacy" means the practice of pharmacy through the use
             342      of telecommunications and information technologies.
             343          [(58)] (57) "Practice of telepharmacy across state lines" means the practice of
             344      pharmacy through the use of telecommunications and information technologies that occurs
             345      when the patient is physically located within one jurisdiction and the pharmacist is located in
             346      another jurisdiction.
             347          [(59)] (58) "Practitioner" means an individual currently licensed, registered, or
             348      otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
             349      course of professional practice.
             350          [(60)] (59) "Prescribe" means to issue a prescription:
             351          (a) orally or in writing; or
             352          (b) by telephone, facsimile transmission, computer, or other electronic means of
             353      communication as defined by division rule.
             354          [(61)] (60) "Prescription" means an order issued:
             355          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             356      by collaborative pharmacy practice agreement; and
             357          (b) for a controlled substance or other prescription drug or device for use by a patient
             358      or an animal.
             359          [(62)] (61) "Prescription device" means an instrument, apparatus, implement, machine,
             360      contrivance, implant, in vitro reagent, or other similar or related article, and any component
             361      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             362      and dispensed by or through a person or entity licensed under this chapter or exempt from
             363      licensure under this chapter.
             364          [(63)] (62) "Prescription drug" means a drug that is required by federal or state law or
             365      rule to be dispensed only by prescription or is restricted to administration only by practitioners.
             366          [(64)] (63) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
             367      drugs and devices to the general public.
             368          [(65)] (64) "Self-audit" means an internal evaluation of a pharmacy to determine


             369      compliance with this chapter.
             370          [(66)] (65) "Supervising pharmacist" means a pharmacist who is overseeing the
             371      operation of the pharmacy during a given day or shift.
             372          [(67)] (66) "Supportive personnel" means unlicensed individuals who:
             373          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             374      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             375      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             376      those duties may be further defined by division rule adopted in collaboration with the board;
             377      and
             378          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             379      collaboration with the board.
             380          [(68)] (67) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             381          [(69)] (68) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             382      58-17b-502 and may be further defined by rule.
             383          [(70)] (69) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             384      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             385      for animals.
             386          Section 2. Section 58-17b-605 is amended to read:
             387           58-17b-605. Drug product equivalents.
             388          (1) For the purposes of this section:
             389          (a) (i) "Drug" is as defined in Section 58-17b-102 ; and
             390          (ii) "drug" does not mean a "biological product" as defined in Section 58-17b-605.5.
             391          (b) "Drug product equivalent" means a drug product that is designated as the
             392      therapeutic equivalent of another drug product in the Approved Drug Products with
             393      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             394      of the United States Food and Drug Administration.
             395          [(1)] (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific
             396      drug by brand or proprietary name may substitute a drug product equivalent[, as defined in
             397      Section 58-17b-102 ,] for the prescribed drug only if:
             398          (a) the purchaser specifically requests or consents to the substitution of a drug product
             399      equivalent;


             400          (b) the drug product equivalent is of the same generic type and is designated the
             401      therapeutic equivalent in the approved drug products with therapeutic equivalence evaluations
             402      prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug
             403      Administration;
             404          (c) the drug product equivalent is permitted to move in interstate commerce;
             405          (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
             406      response to the prescribed drug, whether a substitute or not, and the substitution is not
             407      otherwise prohibited by this chapter;
             408          (e) the prescribing practitioner has not indicated that a drug product equivalent may not
             409      be substituted for the drug, as provided in Subsection [(5)] (6); and
             410          (f) the substitution is not otherwise prohibited by law.
             411          [(2)] (3) (a) Each out-of-state mail service pharmacy dispensing a drug product
             412      equivalent as a substitute for another drug into this state shall notify the patient of the
             413      substitution either by telephone or in writing.
             414          (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
             415      chapter with respect to a drug product equivalent substituted for another drug, including
             416      labeling and record keeping.
             417          [(3)] (4) Pharmacists or pharmacy interns may not substitute without the prescriber's
             418      authorization on trade name drug product prescriptions unless the product is currently
             419      categorized in the approved drug products with therapeutic equivalence evaluations prepared
             420      by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
             421      as a drug product considered to be therapeutically equivalent to another drug product.
             422          [(4)] (5) A pharmacist or pharmacy intern who dispenses a prescription with a drug
             423      product equivalent under this section assumes no greater liability than would be incurred had
             424      the pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
             425          [(5)] (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of
             426      the patient that a drug product equivalent not be substituted for a prescribed drug, the
             427      practitioner may indicate a prohibition on substitution either by writing "dispense as written" or
             428      signing in the appropriate space where two lines have been preprinted on a prescription order
             429      and captioned "dispense as written" or "substitution permitted".
             430          (b) If the prescription is communicated orally by the prescribing practitioner to the


             431      pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
             432      and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
             433      name of the practitioner and the words "orally by" and the initials of the pharmacist or
             434      pharmacy intern written after it.
             435          [(6)] (7) A pharmacist or pharmacy intern who substitutes a drug product equivalent
             436      for a prescribed drug shall communicate the substitution to the purchaser. The drug product
             437      equivalent container shall be labeled with the name of the drug dispensed, and the pharmacist,
             438      pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
             439      the name of the prescribed drug and the name of the drug product equivalent dispensed in its
             440      place.
             441          [(7)] (8) (a) For purposes of this Subsection [(7)] (8), "substitutes" means to substitute:
             442          (i) a generic drug for another generic drug;
             443          (ii) a generic drug for a nongeneric drug;
             444          (iii) a nongeneric drug for another nongeneric drug; or
             445          (iv) a nongeneric drug for a generic drug.
             446          (b) A prescribing practitioner who makes a finding under Subsection [(5)] (6)(a) for a
             447      patient with a seizure disorder shall indicate a prohibition on substitution of a drug product
             448      equivalent in the manner provided in Subsection [(5)] (6)(a) or (b).
             449          (c) Except as provided in Subsection [(7)] (8)(d), a pharmacist or pharmacy intern who
             450      cannot dispense the prescribed drug as written, and who needs to substitute a drug product
             451      equivalent for the drug prescribed to the patient to treat or prevent seizures shall notify the
             452      prescribing practitioner prior to the substitution.
             453          (d) Notification under Subsection [(7)] (8)(c) is not required if the drug product
             454      equivalent is paid for in whole or in part by Medicaid.
             455          [(8)] (9) Failure of a licensed medical practitioner to specify that no substitution is
             456      authorized does not constitute evidence of negligence.
             457          Section 3. Section 58-17b-605.5 is enacted to read:
             458          58-17b-605.5. Interchangeable biosimilar products.
             459          (1) For the purposes of this section:
             460          (a) "biological product" is as defined in 21 U.S.C. Sec. 262;
             461          (b) "biosimilar" is as defined in 21 U.S.C. Sec. 262; and


             462          (c) "interchangeable" is as defined in 21 U.S.C. Sec. 262.
             463          (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific
             464      biological product by brand or proprietary name may substitute a biosimilar product for the
             465      prescribed biological product only if:
             466          (a) the purchaser specifically requests or consents to the substitute of an
             467      interchangeable biosimilar product;
             468          (b) the biosimilar product has been determined by the United States Food and Drug
             469      Administration to be interchangeable with the prescribed biological product;
             470          (c) the interchangeable biosimilar product is permitted to move in interstate commerce;
             471          (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
             472      response to the prescribed biological product, whether a substitute or not, and the substitution
             473      is not otherwise prohibited by this chapter;
             474          (e) the prescribing practitioner has not prohibited the substitution of an interchangeable
             475      biosimilar product for the prescribed biological product, as provided in Subsection (6); and
             476          (f) the substitution is not otherwise prohibited by law.
             477          (3) (a) Each out-of-state mail service pharmacy dispensing an interchangeable
             478      biosimilar product as a substitute for another biological product into this state shall notify the
             479      patient of the substitution either by telephone or in writing.
             480          (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
             481      chapter with respect to an interchangeable biosimilar product substituted for another biological
             482      product, including labeling and record keeping.
             483          (4) Pharmacists or pharmacy interns may not substitute without the prescriber's
             484      authorization biological product prescriptions unless the product has been determined by the
             485      United States Food and Drug Administration to be interchangeable with the prescribed
             486      biological product.
             487          (5) A pharmacist or pharmacy intern who dispenses a prescription with an
             488      interchangeable biosimilar product under this section assumes no greater liability than would
             489      be incurred had the pharmacist or pharmacy intern dispensed the prescription with the
             490      biological product prescribed.
             491          (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
             492      patient that an interchangeable biosimilar product not be substituted for a prescribed biological


             493      product, the practitioner may prohibit a substitution either by writing "dispense as written" or
             494      by signing in the appropriate space where two lines have been preprinted on a prescription
             495      order and captioned "dispense as written" or "substitution permitted."
             496          (b) (i) If the prescription is communicated orally by the prescribing practitioner to the
             497      pharmacist or pharmacy intern, the practitioner shall direct the prohibition or substitution.
             498          (ii) The pharmacist or pharmacy intern shall make a written note of the practioner's
             499      direction by writing the name of the practitioner and the words "orally by" and the initials of
             500      the pharmacist or pharmacy intern written after it.
             501          (7) A pharmacist or pharmacy intern who substitutes an interchangeable biosimilar
             502      product for a prescribed biological product shall:
             503          (a) communicate the substitution to the purchaser;
             504          (b) ensure that the interchangeable product container is labeled with the name and the
             505      manufacturer of the interchangeable biosimilar product dispensed; and
             506          (c) indicate on the file copy of the prescription:
             507          (i) the name and the manufacturer of the prescribed biological product; and
             508          (ii) the name and the manufacturer of the interchangeable biosimilar product dispensed
             509      in place of the prescribed biological product.
             510          (8) A pharmacist or pharmacy intern who substitutes an interchangeable biosimilar
             511      product for a prescribed biological product shall:
             512          (a) notify the prescriber in writing of the substitution, as soon as practicable, but not
             513      later than three business days after dispensing the interchangeable biosimilar product in place
             514      of the prescribed biological product; and
             515          (b) include the name and manufacturer of the interchangeable biosimilar product
             516      substituted.
             517          (9) The pharmacist or pharmacy intern shall:
             518          (a) retain a written record of the substitution for at least five years; and
             519          (b) include the name and manufacturer of the interchangeable product substituted.
             520          (10) A licensed medical practitioner who fails to specify that no substitution is
             521      authorized does not constitute evidence of negligence.





Legislative Review Note
    as of 2-14-13 1:42 PM


Office of Legislative Research and General Counsel


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