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H.B. 109





Chief Sponsor: Dean Sanpei

Senate Sponsor: ____________

             7      LONG TITLE
             8      General Description:
             9          This bill modifies the Utah Controlled Substances Act regarding licenses to conduct
             10      research.
             11      Highlighted Provisions:
             12          This bill:
             13          .    specifies that the Division of Occupational and Professional Licensing may grant
             14      licenses, under specified terms, to conduct research concerning Schedule 1
             15      controlled substances.
             16      Money Appropriated in this Bill:
             17          None
             18      Other Special Clauses:
             19          None
             20      Utah Code Sections Affected:
             21      AMENDS:
             22          58-37-6, as last amended by Laws of Utah 2011, Chapters 12 and 214
             24      Be it enacted by the Legislature of the state of Utah:
             25          Section 11. Section 58-37-6 is amended to read:
             26           58-37-6. License to manufacture, produce, distribute, dispense, administer, or
             27      conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records

             28      required -- Prescriptions.
             29          (1) (a) The division may adopt rules relating to the licensing and control of the
             30      manufacture, distribution, production, prescription, administration, dispensing, conducting of
             31      research with, and performing of laboratory analysis upon controlled substances within this
             32      state.
             33          (b) The division may assess reasonable fees to defray the cost of issuing original and
             34      renewal licenses under this chapter pursuant to Section 63J-1-504 .
             35          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
             36      administers, conducts research with, or performs laboratory analysis upon any controlled
             37      substance in Schedules [II] I through V within this state, or who proposes to engage in
             38      manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
             39      research with, or performing laboratory analysis upon controlled substances included in
             40      Schedules [II] I through V within this state shall obtain a license issued by the division.
             41          (ii) The division shall issue each license under this chapter in accordance with a
             42      two-year renewal cycle established by rule. The division may by rule extend or shorten a
             43      renewal period by as much as one year to stagger the renewal cycles it administers.
             44          (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
             45      administer, conduct research with, or perform laboratory analysis upon controlled substances in
             46      Schedules [II] I through V within this state may possess, manufacture, produce, distribute,
             47      prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
             48      those substances to the extent authorized by their license and in conformity with this chapter.
             49          (c) The following persons are not required to obtain a license and may lawfully possess
             50      controlled substances included in Schedules II through V under this section:
             51          (i) an agent or employee, except a sales representative, of any registered manufacturer,
             52      distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
             53      usual course of the person's business or employment; however, nothing in this subsection shall
             54      be interpreted to permit an agent, employee, sales representative, or detail man to maintain an
             55      inventory of controlled substances separate from the location of the person's employer's
             56      registered and licensed place of business;
             57          (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
             58      warehouseman, who possesses any controlled substance in the usual course of the person's

             59      business or employment; and
             60          (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
             61      a lawful order of a practitioner.
             62          (d) The division may enact rules waiving the license requirement for certain
             63      manufacturers, producers, distributors, prescribers, dispensers, administrators, research
             64      practitioners, or laboratories performing analysis if consistent with the public health and safety.
             65          (e) A separate license is required at each principal place of business or professional
             66      practice where the applicant manufactures, produces, distributes, dispenses, conducts research
             67      with, or performs laboratory analysis upon controlled substances.
             68          (f) The division may enact rules providing for the inspection of a licensee or applicant's
             69      establishment, and may inspect the establishment according to those rules.
             70          (3) (a) (i) Upon proper application, the division shall license a qualified applicant to
             71      manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
             72      controlled substances included in Schedules I through V, unless it determines that issuance of a
             73      license is inconsistent with the public interest.
             74          (ii) The division [shall] may not issue a license to any person to prescribe, dispense, or
             75      administer a Schedule I controlled substance except under Subsection (3)(a)(i).
             76          (iii) In determining public interest under this Subsection (3)(a), the division shall
             77      consider whether or not the applicant has:
             78          [(i)] (A) maintained effective controls against diversion of controlled substances and
             79      any Schedule I or II substance compounded from any controlled substance into other than
             80      legitimate medical, scientific, or industrial channels;
             81          [(ii)] (B) complied with applicable state and local law;
             82          [(iii)] (C) been convicted under federal or state laws relating to the manufacture,
             83      distribution, or dispensing of substances;
             84          [(iv)] (D) past experience in the manufacture of controlled dangerous substances;
             85          [(v)] (E) established effective controls against diversion; and
             86          [(vi)] (F) complied with any other factors that the division establishes that promote the
             87      public health and safety.
             88          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
             89      produce, distribute, conduct research with, or perform laboratory analysis upon controlled

             90      substances in Schedule I other than those specified in the license.
             91          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
             92      substances in Schedules II through V if they are authorized to administer, dispense, or conduct
             93      research under the laws of this state.
             94          (ii) The division need not require a separate license for practitioners engaging in
             95      research with nonnarcotic controlled substances in Schedules II through V where the licensee is
             96      already licensed under this chapter in another capacity.
             97          (iii) With respect to research involving narcotic substances in Schedules II through V,
             98      or where the division by rule requires a separate license for research of nonnarcotic substances
             99      in Schedules II through V, a practitioner shall apply to the division prior to conducting
             100      research.
             101          (iv) Licensing for purposes of bona fide research with controlled substances by a
             102      practitioner considered qualified may be denied only on a ground specified in Subsection (4),
             103      or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
             104      adequately the practitioner's supply of substances against diversion from medical or scientific
             105      use.
             106          (v) Practitioners registered under federal law to conduct research in Schedule I
             107      substances may conduct research in Schedule I substances within this state upon furnishing the
             108      division evidence of federal registration.
             109          (d) Compliance by manufacturers, producers, and distributors with the provisions of
             110      federal law respecting registration, excluding fees, entitles them to be licensed under this
             111      chapter.
             112          (e) The division shall initially license those persons who own or operate an
             113      establishment engaged in the manufacture, production, distribution, dispensation, or
             114      administration of controlled substances prior to April 3, 1980, and who are licensed by the
             115      state.
             116          (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
             117      on probation, or revoked by the division upon finding that the applicant or licensee has:
             118          (i) materially falsified any application filed or required pursuant to this chapter;
             119          (ii) been convicted of an offense under this chapter or any law of the United States, or
             120      any state, relating to any substance defined as a controlled substance;

             121          (iii) been convicted of a felony under any other law of the United States or any state
             122      within five years of the date of the issuance of the license;
             123          (iv) had a federal registration or license denied, suspended, or revoked by competent
             124      federal authority and is no longer authorized to manufacture, distribute, prescribe, or dispense
             125      controlled substances;
             126          (v) had the licensee's license suspended or revoked by competent authority of another
             127      state for violation of laws or regulations comparable to those of this state relating to the
             128      manufacture, distribution, or dispensing of controlled substances;
             129          (vi) violated any division rule that reflects adversely on the licensee's reliability and
             130      integrity with respect to controlled substances;
             131          (vii) refused inspection of records required to be maintained under this chapter by a
             132      person authorized to inspect them; or
             133          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
             134      purpose of manipulating human hormonal structure so as to:
             135          (A) increase muscle mass, strength, or weight without medical necessity and without a
             136      written prescription by any practitioner in the course of the practitioner's professional practice;
             137      or
             138          (B) improve performance in any form of human exercise, sport, or game.
             139          (b) The division may limit revocation or suspension of a license to a particular
             140      controlled substance with respect to which grounds for revocation or suspension exist.
             141          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
             142      this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
             143      Occupational and Professional Licensing Act, and conducted in conjunction with the
             144      appropriate representative committee designated by the director of the department.
             145          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
             146      Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
             147      except where the division is designated by law to perform those functions, or, when not
             148      designated by law, is designated by the executive director of the Department of Commerce to
             149      conduct the proceedings.
             150          (d) (i) The division may suspend any license simultaneously with the institution of
             151      proceedings under this section if it finds there is an imminent danger to the public health or

             152      safety.
             153          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
             154      judicial review, unless withdrawn by the division or dissolved by a court of competent
             155      jurisdiction.
             156          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
             157      substances owned or possessed by the licensee may be placed under seal in the discretion of the
             158      division.
             159          (ii) Disposition may not be made of substances under seal until the time for taking an
             160      appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
             161      orders the sale of perishable substances and the proceeds deposited with the court.
             162          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
             163          (f) The division shall notify promptly the Drug Enforcement Administration of all
             164      orders suspending or revoking a license and all forfeitures of controlled substances.
             165          (g) If an individual's Drug Enforcement Administration registration is denied, revoked,
             166      surrendered, or suspended, the division shall immediately suspend the individual's controlled
             167      substance license, which shall only be reinstated by the division upon reinstatement of the
             168      federal registration, unless the division has taken further administrative action under
             169      Subsection (4)(a)(iv), which would be grounds for the continued denial of the controlled
             170      substance license.
             171          (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
             172      inventories in conformance with the record keeping and inventory requirements of federal and
             173      state law and any additional rules issued by the division.
             174          (b) (i) Every physician, dentist, naturopathic physician, veterinarian, practitioner, or
             175      other person who is authorized to administer or professionally use a controlled substance shall
             176      keep a record of the drugs received by him and a record of all drugs administered, dispensed, or
             177      professionally used by him otherwise than by a prescription.
             178          (ii) A person using small quantities or solutions or other preparations of those drugs for
             179      local application has complied with this Subsection (5)(b) if the person keeps a record of the
             180      quantity, character, and potency of those solutions or preparations purchased or prepared by
             181      him, and of the dates when purchased or prepared.
             182          (6) Controlled substances in Schedules I through V may be distributed only by a

             183      licensee and pursuant to an order form prepared in compliance with division rules or a lawful
             184      order under the rules and regulations of the United States.
             185          (7) (a) A person may not write or authorize a prescription for a controlled substance
             186      unless the person is:
             187          (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
             188      or under the laws of another state having similar standards; and
             189          (ii) licensed under this chapter or under the laws of another state having similar
             190      standards.
             191          (b) A person other than a pharmacist licensed under the laws of this state, or the
             192      pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304 , may not
             193      dispense a controlled substance.
             194          (c) (i) A controlled substance may not be dispensed without the written prescription of
             195      a practitioner, if the written prescription is required by the federal Controlled Substances Act.
             196          (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
             197      conformity with Subsection (7)(d).
             198          (iii) In emergency situations, as defined by division rule, controlled substances may be
             199      dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
             200      designated by the division and filed by the pharmacy.
             201          (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
             202      Subsection (7)(d).
             203          (d) Except for emergency situations designated by the division, a person may not issue,
             204      fill, compound, or dispense a prescription for a controlled substance unless the prescription is
             205      signed by the prescriber in ink or indelible pencil or is signed with an electronic signature of
             206      the prescriber as authorized by division rule, and contains the following information:
             207          (i) the name, address, and registry number of the prescriber;
             208          (ii) the name, address, and age of the person to whom or for whom the prescription is
             209      issued;
             210          (iii) the date of issuance of the prescription; and
             211          (iv) the name, quantity, and specific directions for use by the ultimate user of the
             212      controlled substance.
             213          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I

             214      controlled substance[.] unless:
             215          (i) the person to whom the prescription is issued is licensed under Subsection (2); and
             216          (ii) the prescribed controlled substance is to be used in research.
             217          (f) Except when administered directly to an ultimate user by a licensed practitioner,
             218      controlled substances are subject to the following restrictions:
             219          (i) (A) A prescription for a Schedule II substance may not be refilled.
             220          (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
             221      one-month's supply, as directed on the daily dosage rate of the prescriptions.
             222          (ii) A Schedule III or IV controlled substance may be filled only within six months of
             223      issuance, and may not be refilled more than six months after the date of its original issuance or
             224      be refilled more than five times after the date of the prescription unless renewed by the
             225      practitioner.
             226          (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
             227      prescription directs, but they may not be refilled one year after the date the prescription was
             228      issued unless renewed by the practitioner.
             229          (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
             230      presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
             231      after the date the prescription was issued, or 30 days after the dispensing date, if that date is
             232      specified separately from the date of issue.
             233          (v) A practitioner may issue more than one prescription at the same time for the same
             234      Schedule II controlled substance, but only under the following conditions:
             235          (A) no more than three prescriptions for the same Schedule II controlled substance may
             236      be issued at the same time;
             237          (B) no one prescription may exceed a 30-day supply;
             238          (C) a second or third prescription shall include the date of issuance and the date for
             239      dispensing; and
             240          (D) unless the practitioner determines there is a valid medical reason to the contrary,
             241      the date for dispensing a second or third prescription may not be fewer than 30 days from the
             242      dispensing date of the previous prescription.
             243          (vi) Each prescription for a controlled substance may contain only one controlled
             244      substance per prescription form and may not contain any other legend drug or prescription

             245      item.
             246          (g) An order for a controlled substance in Schedules II through V for use by an
             247      inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
             248      Subsection (7) if the order is:
             249          (i) issued or made by a prescribing practitioner who holds an unrestricted registration
             250      with the federal Drug Enforcement Administration, and an active Utah controlled substance
             251      license in good standing issued by the division under this section, or a medical resident who is
             252      exempted from licensure under Subsection 58-1-307 (1)(c);
             253          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
             254      practitioner designates the quantity ordered;
             255          (iii) entered upon the record of the patient, the record is signed by the prescriber
             256      affirming the prescriber's authorization of the order within 48 hours after filling or
             257      administering the order, and the patient's record reflects the quantity actually administered; and
             258          (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
             259      the physical structure of the hospital, or the order is taken from a supply lawfully maintained by
             260      the hospital and the amount taken from the supply is administered directly to the patient
             261      authorized to receive it.
             262          (h) A practitioner licensed under this chapter may not prescribe, administer, or
             263      dispense a controlled substance to a child, without first obtaining the consent required in
             264      Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child except
             265      in cases of an emergency. For purposes of this Subsection (7)(h), "child" has the same
             266      meaning as defined in Section 78A-6-105 , and "emergency" means any physical condition
             267      requiring the administration of a controlled substance for immediate relief of pain or suffering.
             268          (i) A practitioner licensed under this chapter may not prescribe or administer dosages
             269      of a controlled substance in excess of medically recognized quantities necessary to treat the
             270      ailment, malady, or condition of the ultimate user.
             271          (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             272      any controlled substance to another person knowing that the other person is using a false name,
             273      address, or other personal information for the purpose of securing the controlled substance.
             274          (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
             275      a controlled substance may not manufacture, distribute, or dispense a controlled substance to

             276      another licensee or any other authorized person not authorized by this license.
             277          (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
             278      symbol required by this chapter or by a rule issued under this chapter.
             279          (m) A person licensed under this chapter may not refuse or fail to make, keep, or
             280      furnish any record notification, order form, statement, invoice, or information required under
             281      this chapter.
             282          (n) A person licensed under this chapter may not refuse entry into any premises for
             283      inspection as authorized by this chapter.
             284          (o) A person licensed under this chapter may not furnish false or fraudulent material
             285      information in any application, report, or other document required to be kept by this chapter or
             286      willfully make any false statement in any prescription, order, report, or record required by this
             287      chapter.
             288          (8) (a) (i) Any person licensed under this chapter who is found by the division to have
             289      violated any of the provisions of Subsections (7)(k) through (o) or Subsection (10) is subject to
             290      a penalty not to exceed $5,000. The division shall determine the procedure for adjudication of
             291      any violations in accordance with Sections 58-1-106 and 58-1-108 .
             292          (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
             293      General Fund as a dedicated credit to be used by the division under Subsection 58-37f-502 (1).
             294          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (j)
             295      or Subsection (10) is:
             296          (i) upon first conviction, guilty of a class B misdemeanor;
             297          (ii) upon second conviction, guilty of a class A misdemeanor; and
             298          (iii) on third or subsequent conviction, guilty of a third degree felony.
             299          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
             300      (o) shall upon conviction be guilty of a third degree felony.
             301          (9) Any information communicated to any licensed practitioner in an attempt to
             302      unlawfully procure, or to procure the administration of, a controlled substance is not considered
             303      to be a privileged communication.
             304          (10) A person holding a valid license under this chapter who is engaged in medical
             305      research may produce, possess, or administer, but may not prescribe or dispense, a controlled
             306      substance listed in Section 58-37-4.2 .

Legislative Review Note
    as of 1-30-12 11:57 AM

Office of Legislative Research and General Counsel

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