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S.B. 160

             1     

CONTROLLED SUBSTANCES ACT

             2     
AMENDMENTS

             3     
2004 GENERAL SESSION

             4     
STATE OF UTAH

             5     
Sponsor: Paula F. Julander

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill repeals the requirement for practitioners to have a separate controlled
             10      substance license at each principal place of business, and amends prescription labeling
             11      requirements.
             12      Highlighted Provisions:
             13          This bill:
             14          .    repeals the requirement for those licensed to prescribe and administer controlled
             15      substances listed in Schedules I through V to have a separate license at each
             16      principal place of business or professional practice; and
             17          .    removes the prescription label provision that required the pharmacist's personal
             18      name to be on the label.
             19      Monies Appropriated in this Bill:
             20          None
             21      Other Special Clauses:
             22          None
             23      Utah Code Sections Affected:
             24      AMENDS:
             25          58-37-2, as last amended by Chapter 131, Laws of Utah 2003
             26          58-37-6, as last amended by Chapter 33, Laws of Utah 2003
             27          58-37-7, as last amended by Chapter 210, Laws of Utah 1997


             28     
             29      Be it enacted by the Legislature of the state of Utah:
             30          Section 1. Section 58-37-2 is amended to read:
             31           58-37-2. Definitions.
             32          (1) As used in this chapter:
             33          (a) "Administer" means the direct application of a controlled substance, whether by
             34      injection, inhalation, ingestion, or any other means, to the body of a patient or research subject
             35      by:
             36          (i) a practitioner or, in his presence, by his authorized agent; or
             37          (ii) the patient or research subject at the direction and in the presence of the
             38      practitioner.
             39          (b) "Agent" means an authorized person who acts on behalf of or at the direction of a
             40      manufacturer, distributor, or practitioner but does not include a motor carrier, public
             41      warehouseman, or employee of any of them.
             42          (c) "Continuing criminal enterprise" means any individual, sole proprietorship,
             43      partnership, corporation, business trust, association, or other legal entity, and any union or
             44      groups of individuals associated in fact although not a legal entity, and includes illicit as well
             45      as licit entities created or maintained for the purpose of engaging in conduct which constitutes
             46      the commission of episodes of activity made unlawful by Title 58, Chapters 37, 37a, 37b, 37c,
             47      or 37d, which episodes are not isolated, but have the same or similar purposes, results,
             48      participants, victims, methods of commission, or otherwise are interrelated by distinguishing
             49      characteristics. Taken together, the episodes shall demonstrate continuing unlawful conduct
             50      and be related either to each other or to the enterprise.
             51          (d) "Control" means to add, remove, or change the placement of a drug, substance, or
             52      immediate precursor under Section 58-37-3 .
             53          (e) (i) "Controlled substance" means a drug or substance included in Schedules I, II, III,
             54      IV, or V of Section 58-37-4 , and also includes a drug or substance included in Schedules I, II,
             55      III, IV, or V of the federal Controlled Substances Act, Title II, P.L. 91-513, or any controlled
             56      substance analog.
             57          (ii) "Controlled substance" does not include:
             58          (A) distilled spirits, wine, or malt beverages, as those terms are defined or used in Title


             59      32A, regarding tobacco or food;
             60          (B) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment, or
             61      prevention of disease in man or other animals, which contains ephedrine, pseudoephedrine,
             62      norpseudoephedrine, or phenylpropanolamine if the drug is lawfully purchased, sold,
             63      transferred, or furnished as an over-the-counter medication without prescription; or
             64          (C) dietary supplements, vitamins, minerals, herbs, or other similar substances
             65      including concentrates or extracts, which are not otherwise regulated by law, which may
             66      contain naturally occurring amounts of chemical or substances listed in this chapter, or in rules
             67      adopted pursuant to Title 63, Chapter 46a, Utah Administrative Rulemaking Act.
             68          (f) (i) "Controlled substance analog" means a substance the chemical structure of
             69      which is substantially similar to the chemical structure of a controlled substance listed in
             70      Schedules I and II of Section 58-37-4 , or in Schedules I and II of the federal Controlled
             71      Substances Act, Title II, P.L. 91-513:
             72          (A) which has a stimulant, depressant, or hallucinogenic effect on the central nervous
             73      system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central
             74      nervous system of controlled substances in the schedules set forth in this subsection; or
             75          (B) which, with respect to a particular individual, is represented or intended to have a
             76      stimulant, depressant, or hallucinogenic effect on the central nervous system substantially
             77      similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of
             78      controlled substances in the schedules set forth in this Subsection (1).
             79          (ii) "Controlled substance analog" does not include:
             80          (A) a controlled substance currently scheduled in Schedules I through V of Section
             81      58-37-4 ;
             82          (B) a substance for which there is an approved new drug application;
             83          (C) a substance with respect to which an exemption is in effect for investigational use
             84      by a particular person under Section 505 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 366,
             85      to the extent the conduct with respect to the substance is permitted by the exemption; [or]
             86          (D) any substance to the extent not intended for human consumption before an
             87      exemption takes effect with respect to the substance[.];
             88          (E) [Any] any drug intended for lawful use in the diagnosis, cure, mitigation, treatment,
             89      or prevention of disease in man or other animals, which contains ephedrine, pseudoephedrine,


             90      norpseudoephedrine, or phenylpropanolamine if the drug is lawfully purchased, sold,
             91      transferred, or furnished as an over-the-counter medication without prescription[.]; or
             92          (F) [Dietary] dietary supplements, vitamins, minerals, herbs, or other similar
             93      substances including concentrates or extracts, which are not otherwise regulated by law, which
             94      may contain naturally occurring amounts of chemical or substances listed in this chapter, or in
             95      rules adopted pursuant to Title 63, Chapter 46a, Utah Administrative Rulemaking Act.
             96          (g) "Conviction" means a determination of guilt by verdict, whether jury or bench, or
             97      plea, whether guilty or no contest, for any offense proscribed by Title 58, Chapters 37, 37a,
             98      37b, 37c, or 37d, or for any offense under the laws of the United States and any other state
             99      which, if committed in this state, would be an offense under Title 58, Chapters 37, 37a, 37b,
             100      37c, or 37d.
             101          (h) "Counterfeit substance" means:
             102          (i) any substance or container or labeling of any substance that without authorization
             103      bears the trademark, trade name, or other identifying mark, imprint, number, device, or any
             104      likeness of them, of a manufacturer, distributor, or dispenser other than the person or persons
             105      who in fact manufactured, distributed, or dispensed the substance which falsely purports to be a
             106      controlled substance distributed by, any other manufacturer, distributor, or dispenser; or
             107          (ii) any substance that is represented to be a controlled substance.
             108          (i) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a
             109      controlled substance or a listed chemical, whether or not an agency relationship exists.
             110          (j) "Department" means the Department of Commerce.
             111          (k) "Depressant or stimulant substance" means:
             112          (i) a drug which contains any quantity of barbituric acid or any of the salts of barbituric
             113      acid;
             114          (ii) a drug which contains any quantity of:
             115          (A) amphetamine or any of its optical isomers;
             116          (B) any salt of amphetamine or any salt of an optical isomer of amphetamine; or
             117          (C) any substance which the Secretary of Health and Human Services or the Attorney
             118      General of the United States after investigation has found and by regulation designated
             119      habit-forming because of its stimulant effect on the central nervous system; or
             120          (iii) lysergic acid diethylamide; or


             121          (iv) any drug which contains any quantity of a substance which the Secretary of Health
             122      and Human Services or the Attorney General of the United States after investigation has found
             123      to have, and by regulation designated as having, a potential for abuse because of its depressant
             124      or stimulant effect on the central nervous system or its hallucinogenic effect.
             125          (l) "Dispense" means the delivery of a controlled substance by a pharmacist to an
             126      ultimate user pursuant to the lawful order or prescription of a practitioner, and includes
             127      distributing to, leaving with, giving away, or disposing of that substance as well as the
             128      packaging, labeling, or compounding necessary to prepare the substance for delivery.
             129          (m) "Dispenser" means a pharmacist who dispenses a controlled substance.
             130          (n) "Distribute" means to deliver other than by administering or dispensing a controlled
             131      substance or a listed chemical.
             132          (o) "Distributor" means a person who distributes controlled substances.
             133          (p) "Division" means the Division of Occupational and Professional Licensing created
             134      in Section 58-1-103 .
             135          [(p)] (q) "Drug" means:
             136          (i) articles recognized in the official United States Pharmacopoeia, Official
             137      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             138      supplement to any of them;
             139          (ii) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
             140      of disease in man or other animals;
             141          (iii) articles, other than food, intended to affect the structure or function of man or
             142      other animals; and
             143          (iv) articles intended for use as a component of any articles specified in Subsection
             144      (1)[(p)](q)(i), (ii), or (iii); but does not include devices or their components, parts, or
             145      accessories.
             146          [(q)] (r) "Drug dependent person" means any individual who unlawfully and habitually
             147      uses any controlled substance to endanger the public morals, health, safety, or welfare, or who
             148      is so dependent upon the use of controlled substances as to have lost the power of self-control
             149      with reference to his dependency.
             150          [(r)] (s) "Food" means:
             151          (i) any nutrient or substance of plant, mineral, or animal origin other than a drug as


             152      specified in this chapter, and normally ingested by human beings; and
             153          (ii) foods for special dietary uses as exist by reason of a physical, physiological,
             154      pathological, or other condition including but not limited to the conditions of disease,
             155      convalescence, pregnancy, lactation, allergy, hypersensitivity to food, underweight, and
             156      overweight; uses for supplying a particular dietary need which exist by reason of age including
             157      but not limited to the ages of infancy and childbirth, and also uses for supplementing and for
             158      fortifying the ordinary or unusual diet with any vitamin, mineral, or other dietary property for
             159      use of a food. Any particular use of a food is a special dietary use regardless of the nutritional
             160      purposes.
             161          [(s)] (t) "Immediate precursor" means a substance which the Attorney General of the
             162      United States has found to be, and by regulation designated as being, the principal compound
             163      used or produced primarily for use in the manufacture of a controlled substance, or which is an
             164      immediate chemical intermediary used or likely to be used in the manufacture of a controlled
             165      substance, the control of which is necessary to prevent, curtail, or limit the manufacture of the
             166      controlled substance.
             167          [(t)] (u) "Manufacture" means the production, preparation, propagation, compounding,
             168      or processing of a controlled substance, either directly or indirectly by extraction from
             169      substances of natural origin, or independently by means of chemical synthesis or by a
             170      combination of extraction and chemical synthesis.
             171          [(u)] (v) "Manufacturer" includes any person who packages, repackages, or labels any
             172      container of any controlled substance, except pharmacists who dispense or compound
             173      prescription orders for delivery to the ultimate consumer.
             174          [(v)] (w) "Marijuana" means all species of the genus cannabis and all parts of the
             175      genus, whether growing or not; the seeds of it; the resin extracted from any part of the plant;
             176      and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its
             177      seeds, or resin. The term does not include the mature stalks of the plant, fiber produced from
             178      the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt,
             179      derivative, mixture, or preparation of the mature stalks, except the resin extracted from them,
             180      fiber, oil or cake, or the sterilized seed of the plant which is incapable of germination. Any
             181      synthetic equivalents of the substances contained in the plant cannabis sativa or any other
             182      species of the genus cannabis which are chemically indistinguishable and pharmacologically


             183      active are also included.
             184          [(w)] (x) "Money" means officially issued coin and currency of the United States or
             185      any foreign country.
             186          [(x)] (y) "Narcotic drug" means any of the following, whether produced directly or
             187      indirectly by extraction from substances of vegetable origin, or independently by means of
             188      chemical synthesis, or by a combination of extraction and chemical synthesis:
             189          (i) opium, coca leaves, and opiates;
             190          (ii) a compound, manufacture, salt, derivative, or preparation of opium, coca leaves, or
             191      opiates;
             192          (iii) opium poppy and poppy straw; or
             193          (iv) a substance, and any compound, manufacture, salt, derivative, or preparation of the
             194      substance, which is chemically identical with any of the substances referred to in Subsection
             195      (1)[(x)](y)(i), (ii), or (iii), except narcotic drug does not include decocainized coca leaves or
             196      extracts of coca leaves which do not contain cocaine or ecgonine.
             197          [(y)] (z) "Negotiable instrument" means documents, containing an unconditional
             198      promise to pay a sum of money, which are legally transferable to another party by endorsement
             199      or delivery.
             200          [(z)] (aa) "Opiate" means any drug or other substance having an addiction-forming or
             201      addiction-sustaining liability similar to morphine or being capable of conversion into a drug
             202      having addiction-forming or addiction-sustaining liability.
             203          [(aa)] (bb) "Opium poppy" means the plant of the species papaver somniferum L.,
             204      except the seeds of the plant.
             205          [(bb)] (cc) "Person" means any corporation, association, partnership, trust, other
             206      institution or entity or one or more individuals.
             207          [(cc)] (dd) "Poppy straw" means all parts, except the seeds, of the opium poppy, after
             208      mowing.
             209          [(dd)] (ee) "Possession" or "use" means the joint or individual ownership, control,
             210      occupancy, holding, retaining, belonging, maintaining, or the application, inhalation,
             211      swallowing, injection, or consumption, as distinguished from distribution, of controlled
             212      substances and includes individual, joint, or group possession or use of controlled substances.
             213      For a person to be a possessor or user of a controlled substance, it is not required that he be


             214      shown to have individually possessed, used, or controlled the substance, but it is sufficient if it
             215      is shown that the person jointly participated with one or more persons in the use, possession, or
             216      control of any substances with knowledge that the activity was occurring, or the controlled
             217      substance is found in a place or under circumstances indicating that the person had the ability
             218      and the intent to exercise dominion and control over it.
             219          [(ee)] (ff) "Practitioner" means a physician, dentist, veterinarian, pharmacist, scientific
             220      investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted to
             221      distribute, dispense, conduct research with respect to, administer, or use in teaching or
             222      chemical analysis a controlled substance in the course of professional practice or research in
             223      this state.
             224          [(ff)] (gg) "Prescribe" means to issue a prescription orally or in writing.
             225          [(gg)] (hh) "Prescription" means an order issued by a licensed practitioner, in the
             226      course of that practitioner's professional practice, for a controlled substance, other drug, or
             227      device which it dispenses or administers for use by a patient or an animal. The order may be
             228      issued by word of mouth, written document, telephone, facsimile transmission, computer, or
             229      other electronic means of communication as defined by rule.
             230          [(hh)] (ii) "Production" means the manufacture, planting, cultivation, growing, or
             231      harvesting of a controlled substance.
             232          [(ii)] (jj) "Securities" means any stocks, bonds, notes, or other evidences of debt or of
             233      property.
             234          [(jj)] (kk) "State" means the state of Utah.
             235          [(kk)] (ll) "Ultimate user" means any person who lawfully possesses a controlled
             236      substance for his own use, for the use of a member of his household, or for administration to an
             237      animal owned by him or a member of his household.
             238          (2) If a term used in this chapter is not defined, the definition and terms of Title 76,
             239      Utah Criminal Code, shall apply.
             240          Section 2. Section 58-37-6 is amended to read:
             241           58-37-6. License to manufacture, produce, distribute, dispense, administer, or
             242      conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
             243      required -- Prescriptions.
             244          (1) (a) The [department] division may adopt rules relating to the licensing and control


             245      of the manufacture, distribution, production, prescription, administration, dispensing,
             246      conducting of research with, and performing of laboratory analysis upon controlled substances
             247      within this state.
             248          (b) The [department] division may assess reasonable fees to defray the cost of issuing
             249      original and renewal licenses under this chapter pursuant to Section 63-38-3.2 .
             250          [(c) The director of the department may delegate to any division or agency within the
             251      department, authority to perform the responsibilities and functions prescribed to the department
             252      under this chapter if the delegated authority is consistent with the function of the division or
             253      agency provided by law.]
             254          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
             255      administers, conducts research with, or performs laboratory analysis upon any controlled
             256      substance in Schedules II through V within this state, or who proposes to engage in
             257      manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
             258      research with, or performing laboratory analysis upon controlled substances included in
             259      Schedules II through V within this state shall obtain a license issued by the [department]
             260      division.
             261          (ii) The division shall issue each license under this chapter in accordance with a
             262      two-year renewal cycle established by rule. The division may by rule extend or shorten a
             263      renewal period by as much as one year to stagger the renewal cycles it administers.
             264          (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
             265      administer, conduct research with, or perform laboratory analysis upon controlled substances in
             266      Schedules II through V within this state may possess, manufacture, produce, distribute,
             267      prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
             268      those substances to the extent authorized by their license and in conformity with this chapter.
             269          (c) The following persons are not required to obtain a license and may lawfully possess
             270      controlled substances under this section:
             271          (i) an agent or employee, except a sales representative, of any registered manufacturer,
             272      distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
             273      usual course of his business or employment; however, nothing in this subsection shall be
             274      interpreted to permit an agent, employee, sales representative, or detail man to maintain an
             275      inventory of controlled substances separate from the location of his employer's registered and


             276      licensed place of business;
             277          (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
             278      warehouseman, who possesses any controlled substance in the usual course of his business or
             279      employment; and
             280          (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
             281      a lawful order of a practitioner.
             282          (d) The [department] division may enact rules waiving the license requirement for
             283      certain manufacturers, producers, distributors, prescribers, dispensers, administrators, research
             284      practitioners, or laboratories performing analysis if consistent with the public health and safety.
             285          (e) A separate license is required at each principal place of business or professional
             286      practice where the applicant manufactures, produces, distributes, [prescribes,] dispenses,
             287      [administers,] conducts research with, or performs laboratory analysis upon controlled
             288      substances.
             289          (f) The [department] division may enact rules providing for the inspection of a licensee
             290      or applicant's establishment, and may inspect the establishment according to those rules.
             291          (3) (a) Upon proper application, the [department] division shall license a qualified
             292      applicant to manufacture, produce, distribute, conduct research with, or perform laboratory
             293      analysis upon controlled substances included in Schedules I through V, unless it determines
             294      that issuance of a license is inconsistent with the public interest. The [department] division
             295      shall not issue a license to any person to prescribe, dispense, or administer a Schedule I
             296      controlled substance. In determining public interest, the [department] division shall consider
             297      whether or not the applicant has:
             298          (i) maintained effective controls against diversion of controlled substances and any
             299      Schedule I or II substance compounded from any controlled substance into other than
             300      legitimate medical, scientific, or industrial channels;
             301          (ii) complied with applicable state and local law;
             302          (iii) been convicted under federal or state laws relating to the manufacture, distribution,
             303      or dispensing of substances;
             304          (iv) past experience in the manufacture of controlled dangerous substances;
             305          (v) established effective controls against diversion; and
             306          (vi) complied with any other factors that the [department] division establishes that


             307      promote the public health and safety.
             308          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
             309      produce, distribute, conduct research with, or perform laboratory analysis upon controlled
             310      substances in Schedule I other than those specified in the license.
             311          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
             312      substances in Schedules II through V if they are authorized to administer, dispense, or conduct
             313      research under the laws of this state.
             314          (ii) The [department] division need not require a separate license for practitioners
             315      engaging in research with nonnarcotic controlled substances in Schedules II through V where
             316      the licensee is already licensed under this act in another capacity.
             317          (iii) With respect to research involving narcotic substances in Schedules II through V,
             318      or where the [department] division by rule requires a separate license for research of
             319      nonnarcotic substances in Schedules II through V, a practitioner shall apply to the [department]
             320      division prior to conducting research.
             321          (iv) Licensing for purposes of bona fide research with controlled substances by a
             322      practitioner considered qualified may be denied only on a ground specified in Subsection (4),
             323      or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
             324      adequately his supply of substances against diversion from medical or scientific use.
             325          (v) Practitioners registered under federal law to conduct research in Schedule I
             326      substances may conduct research in Schedule I substances within this state upon furnishing the
             327      [department] division evidence of federal registration.
             328          (d) Compliance by manufacturers, producers, and distributors with the provisions of
             329      federal law respecting registration, excluding fees, entitles them to be licensed under this
             330      chapter.
             331          (e) The [department] division shall initially license those persons who own or operate
             332      an establishment engaged in the manufacture, production, distribution, dispensation, or
             333      administration of controlled substances prior to April 3, 1980, and who are licensed by the
             334      state.
             335          (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
             336      on probation, or revoked by the [department] division upon finding that the applicant or
             337      licensee has:


             338          (i) materially falsified any application filed or required pursuant to this chapter;
             339          (ii) been convicted of an offense under this chapter or any law of the United States, or
             340      any state, relating to any substance defined as a controlled substance;
             341          (iii) been convicted of a felony under any other law of the United States or any state
             342      within five years of the date of the issuance of the license;
             343          (iv) had a federal license denied, suspended, or revoked by competent federal authority
             344      and is no longer authorized to engage in the manufacturing, distribution, or dispensing of
             345      controlled substances;
             346          (v) had his license suspended or revoked by competent authority of another state for
             347      violation of laws or regulations comparable to those of this state relating to the manufacture,
             348      distribution, or dispensing of controlled substances;
             349          (vi) violated any [department] division rule that reflects adversely on the licensee's
             350      reliability and integrity with respect to controlled substances;
             351          (vii) refused inspection of records required to be maintained under this chapter by a
             352      person authorized to inspect them; or
             353          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
             354      purpose of manipulating human hormonal structure so as to:
             355          (A) increase muscle mass, strength, or weight without medical necessity and without a
             356      written prescription by any practitioner in the course of his professional practice; or
             357          (B) improve performance in any form of human exercise, sport, or game.
             358          (b) The [department] division may limit revocation or suspension of a license to a
             359      particular controlled substance with respect to which grounds for revocation or suspension
             360      exist.
             361          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
             362      this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
             363      Occupational and Professional Licensing Act, and conducted in conjunction with the
             364      appropriate representative committee designated by the director of the department.
             365          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
             366      Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
             367      except where the [department] division is designated by law to perform those functions, or,
             368      when not designated by law, is designated by the executive director of the Department of


             369      Commerce to conduct the proceedings.
             370          (d) (i) The [department] division may suspend any license simultaneously with the
             371      institution of proceedings under this section if it finds there is an imminent danger to the public
             372      health or safety.
             373          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
             374      judicial review, unless withdrawn by the [department] division or dissolved by a court of
             375      competent jurisdiction.
             376          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
             377      substances owned or possessed by the licensee may be placed under seal in the discretion of the
             378      [department] division.
             379          (ii) Disposition may not be made of substances under seal until the time for taking an
             380      appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
             381      orders the sale of perishable substances and the proceeds deposited with the court.
             382          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
             383          (f) The [department] division shall notify promptly the Drug Enforcement
             384      Administration of all orders suspending or revoking a license and all forfeitures of controlled
             385      substances.
             386          (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
             387      inventories in conformance with the record keeping and inventory requirements of federal and
             388      state law and any additional rules issued by the [department] division.
             389          (b) (i) Every physician, dentist, veterinarian, practitioner, or other person who is
             390      authorized to administer or professionally use a controlled substance shall keep a record of the
             391      drugs received by him and a record of all drugs administered, dispensed, or professionally used
             392      by him otherwise than by a prescription.
             393          (ii) A person using small quantities or solutions or other preparations of those drugs for
             394      local application has complied with this Subsection (5)(b) if he keeps a record of the quantity,
             395      character, and potency of those solutions or preparations purchased or prepared by him, and of
             396      the dates when purchased or prepared.
             397          (6) Controlled substances in Schedules I through V may be distributed only by a
             398      licensee and pursuant to an order form prepared in compliance with [department] division rules
             399      or a lawful order under the rules and regulations of the United States.


             400          (7) (a) A person may not write or authorize a prescription for a controlled substance
             401      unless he is:
             402          (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
             403      or under the laws of another state having similar standards; and
             404          (ii) licensed under this chapter or under the laws of another state having similar
             405      standards.
             406          (b) A person other than a pharmacist licensed under the laws of this state, or his
             407      licensed intern, as required by Section 58-17a-302 , may not dispense a controlled substance.
             408          (c) (i) A controlled substance may not be dispensed without the written prescription of
             409      a practitioner, if the written prescription is required by the federal Controlled Substances Act.
             410          (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
             411      conformity with Subsection (7)(d).
             412          (iii) In emergency situations, as defined by [department] division rule, controlled
             413      substances may be dispensed upon oral prescription of a practitioner, if reduced promptly to
             414      writing on forms designated by the [department] division and filed by the pharmacy.
             415          (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
             416      Subsection (7)(d).
             417          (d) Except for emergency situations designated by the [department] division, a person
             418      may not issue, fill, compound, or dispense a prescription for a controlled substance unless the
             419      prescription is signed in ink or indelible pencil by the prescriber and contains the following
             420      information:
             421          (i) the name, address, and registry number of the prescriber;
             422          (ii) the name, address, and age of the person to whom or for whom the prescription is
             423      issued;
             424          (iii) the date of issuance of the prescription; and
             425          (iv) the name, quantity, and specific directions for use by the ultimate user of the
             426      controlled substance.
             427          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
             428      controlled substance.
             429          (f) Except when administered directly to an ultimate user by a licensed practitioner,
             430      controlled substances are subject to the following restrictions:


             431          (i) (A) A prescription for a Schedule II substance may not be refilled.
             432          (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
             433      one-month's supply, as directed on the daily dosage rate of the prescriptions.
             434          (ii) A Schedule III or IV controlled substance may be filled only within six months of
             435      issuance, and may not be refilled more than six months after the date of its original issuance or
             436      be refilled more than five times after the date of the prescription unless renewed by the
             437      practitioner.
             438          (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
             439      prescription directs, but they may not be refilled one year after the date the prescription was
             440      issued unless renewed by the practitioner.
             441          (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
             442      presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
             443      after the date the prescription was issued, or 30 days after the dispensing date, if that date is
             444      specified separately from the date of issue.
             445          (v) A practitioner may issue more than one prescription at the same time for the same
             446      Schedule II controlled substance, but only under the following conditions:
             447          (A) no more than three prescriptions for the same Schedule II controlled substance may
             448      be issued at the same time;
             449          (B) no one prescription may exceed a 30-day supply;
             450          (C) a second or third prescription shall include the date of issuance and the date for
             451      dispensing; and
             452          (D) unless the practitioner determines there is a valid medical reason to the contrary,
             453      the date for dispensing a second or third prescription may not be fewer than 30 days from the
             454      dispensing date of the previous prescription.
             455          (vi) Each prescription for a controlled substance may contain only one controlled
             456      substance per prescription form and may not contain any other legend drug or prescription
             457      item.
             458          (g) An order for a controlled substance in Schedules II through V for use by an
             459      inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
             460      Subsection (7) if the order is:
             461          (i) issued or made by a prescribing practitioner who holds an unrestricted registration


             462      with the federal Drug Enforcement Administration, and an active Utah controlled substance
             463      license in good standing issued by the division under this section, or a medical resident who is
             464      exempted from licensure under Subsection 58-1-307 (1)(c);
             465          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
             466      practitioner designates the quantity ordered;
             467          (iii) entered upon the record of the patient, the record is signed by the prescriber
             468      affirming his authorization of the order within 48 hours after filling or administering the order,
             469      and the patient's record reflects the quantity actually administered; and
             470          (iv) filled and dispensed by a pharmacist practicing his profession within the physical
             471      structure of the hospital, or the order is taken from a supply lawfully maintained by the hospital
             472      and the amount taken from the supply is administered directly to the patient authorized to
             473      receive it.
             474          (h) A practitioner licensed under this chapter may not prescribe, administer, or
             475      dispense a controlled substance to a minor, without first obtaining the consent required in
             476      Section 78-14-5 of a parent, guardian, or person standing in loco parentis of the minor except
             477      in cases of an emergency. For purposes of this Subsection (7)(h), "minor" has the same
             478      meaning as defined in Section 78-3a-103 , and "emergency" means any physical condition
             479      requiring the administration of a controlled substance for immediate relief of pain or suffering.
             480          (i) A practitioner licensed under this chapter may not prescribe or administer dosages
             481      of a controlled substance in excess of medically recognized quantities necessary to treat the
             482      ailment, malady, or condition of the ultimate user.
             483          (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             484      any controlled substance to another person knowing that the other person is using a false name,
             485      address, or other personal information for the purpose of securing the controlled substance.
             486          (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
             487      a controlled substance may not manufacture, distribute, or dispense a controlled substance to
             488      another licensee or any other authorized person not authorized by this license.
             489          (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
             490      symbol required by this chapter or by a rule issued under this chapter.
             491          (m) A person licensed under this chapter may not refuse or fail to make, keep, or
             492      furnish any record notification, order form, statement, invoice, or information required under


             493      this chapter.
             494          (n) A person licensed under this chapter may not refuse entry into any premises for
             495      inspection as authorized by this chapter.
             496          (o) A person licensed under this chapter may not furnish false or fraudulent material
             497      information in any application, report, or other document required to be kept by this chapter or
             498      willfully make any false statement in any prescription, order, report, or record required by this
             499      chapter.
             500          (8) (a) (i) Any person licensed under this chapter who is found by the [department]
             501      division to have violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to
             502      a penalty not to exceed $5,000. The [department] division shall determine the procedure for
             503      adjudication of any violations in accordance with Sections 58-1-106 and 58-1-108 .
             504          (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
             505      General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             506          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through
             507      (7)(j) is:
             508          (i) upon first conviction, guilty of a class B misdemeanor;
             509          (ii) upon second conviction, guilty of a class A misdemeanor; and
             510          (iii) on third or subsequent conviction, guilty of a third degree felony.
             511          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
             512      (7)(o) shall upon conviction be guilty of a third degree felony.
             513          (9) Any information communicated to any licensed practitioner in an attempt to
             514      unlawfully procure, or to procure the administration of, a controlled substance is not considered
             515      to be a privileged communication.
             516          Section 3. Section 58-37-7 is amended to read:
             517           58-37-7. Labeling and packaging controlled substance.
             518          (1) A person licensed pursuant to this act may not distribute a controlled substance
             519      unless it is packaged and labeled in compliance with the requirements of Section 305 of the
             520      Federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
             521          (2) No person except a pharmacist for the purpose of filling a prescription shall alter,
             522      deface, or remove any label affixed by the manufacturer.
             523          (3) Whenever a pharmacist sells or dispenses any controlled substance on a


             524      prescription issued by a practitioner, he shall affix to the container in which the substance is
             525      sold or dispensed:
             526          (a) a label showing [his own name, address, and registry number, or the name, address,
             527      and registry number of the pharmacist or pharmacy owner for whom he is lawfully acting;] the:
             528          (i) pharmacy name and address;
             529          (ii) serial number; and
             530          (iii) date of initial filling;
             531          (b) the prescription number, the name of the patient, or if the patient is an animal, the
             532      name of the owner of the animal and the species of the animal;
             533          (c) the name of the practitioner by whom the prescription was written;
             534          (d) any directions stated on the prescription; and
             535          (e) any directions required by rules and regulations promulgated by the department.
             536          (4) A person may not alter the face or remove any label so long as any of the original
             537      contents remain.
             538          (5) (a) An individual to whom or for whose use any controlled substance has been
             539      prescribed, sold, or dispensed by a practitioner and the owner of any animal for which any
             540      controlled substance has been prescribed, sold, or dispensed by a veterinarian may lawfully
             541      possess it only in the container in which it was delivered to him by the person selling or
             542      dispensing it.
             543          (b) It is a defense to a prosecution under this subsection that the person being
             544      prosecuted produces in court a valid prescription for the controlled substance or the original
             545      container with the label attached.




Legislative Review Note
    as of 1-19-04 2:50 PM


A limited legal review of this legislation raises no obvious constitutional or statutory concerns.

Office of Legislative Research and General Counsel


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