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First Substitute H.B. 487

Representative Christopher N. Herrod proposes the following substitute bill:

             1      HOSPICE PHARMACY DISPENSING OF MEDICATION
             2      2012 GENERAL SESSION
             3      STATE OF UTAH
             4      Chief Sponsor: Christopher N. Herrod
             5      Senate Sponsor: Wayne L. Niederhauser
             6     
             7      LONG TITLE
             8      General Description:
             9          This bill modifies Title 58, Chapter 37, Utah Controlled Substances Act, by amending
             10      the procedure for dispensing and filling a verbal prescription for a terminally ill patient
             11      in a licensed hospice.
             12      Highlighted Provisions:
             13          This bill:
             14          .    permits a prescribing practitioner to give a verbal prescription for a Schedule II
             15      controlled substance for use by a terminally ill patient in a licensed hospice, not to
             16      exceed a seven day supply;
             17          .    permits a pharmacy to fill a verbal prescription for a Schedule II controlled
             18      substance in certain circumstances for use by a terminally ill patient in a licensed
             19      hospice, not to exceed a seven day supply; and
             20          .    makes technical changes.
             21      Money Appropriated in this Bill:
             22          None
             23      Other Special Clauses:
             24          None
             25      Utah Code Sections Affected:

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             26      AMENDS:
             27          58-37-6, as last amended by Laws of Utah 2011, Chapters 12 and 214
             28          58-37f-502, as last amended by Laws of Utah 2010, Chapter 391 and renumbered and
             29      amended by Laws of Utah 2010, Chapter 287
             30     
             31      Be it enacted by the Legislature of the state of Utah:
             32          Section 1. Section 58-37-6 is amended to read:
             33           58-37-6. License to manufacture, produce, distribute, dispense, administer, or
             34      conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
             35      required -- Prescriptions.
             36          (1) (a) The division may adopt rules relating to the licensing and control of the
             37      manufacture, distribution, production, prescription, administration, dispensing, conducting of
             38      research with, and performing of laboratory analysis upon controlled substances within this
             39      state.
             40          (b) The division may assess reasonable fees to defray the cost of issuing original and
             41      renewal licenses under this chapter pursuant to Section 63J-1-504 .
             42          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
             43      administers, conducts research with, or performs laboratory analysis upon any controlled
             44      substance in Schedules II through V within this state, or who proposes to engage in
             45      manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
             46      research with, or performing laboratory analysis upon controlled substances included in
             47      Schedules II through V within this state shall obtain a license issued by the division.
             48          (ii) The division shall issue each license under this chapter in accordance with a
             49      two-year renewal cycle established by rule. The division may by rule extend or shorten a
             50      renewal period by as much as one year to stagger the renewal cycles it administers.
             51          (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
             52      administer, conduct research with, or perform laboratory analysis upon controlled substances in
             53      Schedules II through V within this state may possess, manufacture, produce, distribute,
             54      prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
             55      those substances to the extent authorized by their license and in conformity with this chapter.
             56          (c) The following persons are not required to obtain a license and may lawfully possess

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             57      controlled substances under this section:
             58          (i) an agent or employee, except a sales representative, of any registered manufacturer,
             59      distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
             60      usual course of the person's business or employment; however, nothing in this subsection shall
             61      be interpreted to permit an agent, employee, sales representative, or detail man to maintain an
             62      inventory of controlled substances separate from the location of the person's employer's
             63      registered and licensed place of business;
             64          (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
             65      warehouseman, who possesses any controlled substance in the usual course of the person's
             66      business or employment; and
             67          (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
             68      a lawful order of a practitioner.
             69          (d) The division may enact rules waiving the license requirement for certain
             70      manufacturers, producers, distributors, prescribers, dispensers, administrators, research
             71      practitioners, or laboratories performing analysis if consistent with the public health and safety.
             72          (e) A separate license is required at each principal place of business or professional
             73      practice where the applicant manufactures, produces, distributes, dispenses, conducts research
             74      with, or performs laboratory analysis upon controlled substances.
             75          (f) The division may enact rules providing for the inspection of a licensee or applicant's
             76      establishment, and may inspect the establishment according to those rules.
             77          (3) (a) Upon proper application, the division shall license a qualified applicant to
             78      manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
             79      controlled substances included in Schedules I through V, unless it determines that issuance of a
             80      license is inconsistent with the public interest. The division shall not issue a license to any
             81      person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
             82      public interest, the division shall consider whether or not the applicant has:
             83          (i) maintained effective controls against diversion of controlled substances and any
             84      Schedule I or II substance compounded from any controlled substance into other than
             85      legitimate medical, scientific, or industrial channels;
             86          (ii) complied with applicable state and local law;
             87          (iii) been convicted under federal or state laws relating to the manufacture, distribution,

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             88      or dispensing of substances;
             89          (iv) past experience in the manufacture of controlled dangerous substances;
             90          (v) established effective controls against diversion; and
             91          (vi) complied with any other factors that the division establishes that promote the
             92      public health and safety.
             93          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
             94      produce, distribute, conduct research with, or perform laboratory analysis upon controlled
             95      substances in Schedule I other than those specified in the license.
             96          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
             97      substances in Schedules II through V if they are authorized to administer, dispense, or conduct
             98      research under the laws of this state.
             99          (ii) The division need not require a separate license for practitioners engaging in
             100      research with nonnarcotic controlled substances in Schedules II through V where the licensee is
             101      already licensed under this chapter in another capacity.
             102          (iii) With respect to research involving narcotic substances in Schedules II through V,
             103      or where the division by rule requires a separate license for research of nonnarcotic substances
             104      in Schedules II through V, a practitioner shall apply to the division prior to conducting
             105      research.
             106          (iv) Licensing for purposes of bona fide research with controlled substances by a
             107      practitioner considered qualified may be denied only on a ground specified in Subsection (4),
             108      or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
             109      adequately the practitioner's supply of substances against diversion from medical or scientific
             110      use.
             111          (v) Practitioners registered under federal law to conduct research in Schedule I
             112      substances may conduct research in Schedule I substances within this state upon furnishing the
             113      division evidence of federal registration.
             114          (d) Compliance by manufacturers, producers, and distributors with the provisions of
             115      federal law respecting registration, excluding fees, entitles them to be licensed under this
             116      chapter.
             117          (e) The division shall initially license those persons who own or operate an
             118      establishment engaged in the manufacture, production, distribution, dispensation, or

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             119      administration of controlled substances prior to April 3, 1980, and who are licensed by the
             120      state.
             121          (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
             122      on probation, or revoked by the division upon finding that the applicant or licensee has:
             123          (i) materially falsified any application filed or required pursuant to this chapter;
             124          (ii) been convicted of an offense under this chapter or any law of the United States, or
             125      any state, relating to any substance defined as a controlled substance;
             126          (iii) been convicted of a felony under any other law of the United States or any state
             127      within five years of the date of the issuance of the license;
             128          (iv) had a federal registration or license denied, suspended, or revoked by competent
             129      federal authority and is no longer authorized to manufacture, distribute, prescribe, or dispense
             130      controlled substances;
             131          (v) had the licensee's license suspended or revoked by competent authority of another
             132      state for violation of laws or regulations comparable to those of this state relating to the
             133      manufacture, distribution, or dispensing of controlled substances;
             134          (vi) violated any division rule that reflects adversely on the licensee's reliability and
             135      integrity with respect to controlled substances;
             136          (vii) refused inspection of records required to be maintained under this chapter by a
             137      person authorized to inspect them; or
             138          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
             139      purpose of manipulating human hormonal structure so as to:
             140          (A) increase muscle mass, strength, or weight without medical necessity and without a
             141      written prescription by any practitioner in the course of the practitioner's professional practice;
             142      or
             143          (B) improve performance in any form of human exercise, sport, or game.
             144          (b) The division may limit revocation or suspension of a license to a particular
             145      controlled substance with respect to which grounds for revocation or suspension exist.
             146          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
             147      this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
             148      Occupational and Professional Licensing Act, and conducted in conjunction with the
             149      appropriate representative committee designated by the director of the department.

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             150          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
             151      Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
             152      except where the division is designated by law to perform those functions, or, when not
             153      designated by law, is designated by the executive director of the Department of Commerce to
             154      conduct the proceedings.
             155          (d) (i) The division may suspend any license simultaneously with the institution of
             156      proceedings under this section if it finds there is an imminent danger to the public health or
             157      safety.
             158          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
             159      judicial review, unless withdrawn by the division or dissolved by a court of competent
             160      jurisdiction.
             161          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
             162      substances owned or possessed by the licensee may be placed under seal in the discretion of the
             163      division.
             164          (ii) Disposition may not be made of substances under seal until the time for taking an
             165      appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
             166      orders the sale of perishable substances and the proceeds deposited with the court.
             167          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
             168          (f) The division shall notify promptly the Drug Enforcement Administration of all
             169      orders suspending or revoking a license and all forfeitures of controlled substances.
             170          (g) If an individual's Drug Enforcement Administration registration is denied, revoked,
             171      surrendered, or suspended, the division shall immediately suspend the individual's controlled
             172      substance license, which shall only be reinstated by the division upon reinstatement of the
             173      federal registration, unless the division has taken further administrative action under
             174      Subsection (4)(a)(iv), which would be grounds for the continued denial of the controlled
             175      substance license.
             176          (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
             177      inventories in conformance with the record keeping and inventory requirements of federal and
             178      state law and any additional rules issued by the division.
             179          (b) (i) Every physician, dentist, naturopathic physician, veterinarian, practitioner, or
             180      other person who is authorized to administer or professionally use a controlled substance shall

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             181      keep a record of the drugs received by him and a record of all drugs administered, dispensed, or
             182      professionally used by him otherwise than by a prescription.
             183          (ii) A person using small quantities or solutions or other preparations of those drugs for
             184      local application has complied with this Subsection (5)(b) if the person keeps a record of the
             185      quantity, character, and potency of those solutions or preparations purchased or prepared by
             186      him, and of the dates when purchased or prepared.
             187          (6) Controlled substances in Schedules I through V may be distributed only by a
             188      licensee and pursuant to an order form prepared in compliance with division rules or a lawful
             189      order under the rules and regulations of the United States.
             190          (7) (a) A person may not write or authorize a prescription for a controlled substance
             191      unless the person is:
             192          (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
             193      or under the laws of another state having similar standards; and
             194          (ii) licensed under this chapter or under the laws of another state having similar
             195      standards.
             196          (b) A person other than a pharmacist licensed under the laws of this state, or the
             197      pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304 , may not
             198      dispense a controlled substance.
             199          (c) (i) A controlled substance may not be dispensed without the written prescription of
             200      a practitioner, if the written prescription is required by the federal Controlled Substances Act.
             201          (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
             202      conformity with Subsection (7)(d).
             203          (iii) In emergency situations, as defined by division rule, controlled substances may be
             204      dispensed upon oral prescription of a practitioner, if:
             205          (A) reduced promptly to writing on forms designated by the division and filed by the
             206      pharmacy[.]; or
             207          (B) the requirements of Subsection (8) are met.
             208          (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
             209      Subsection (7)(d).
             210          (d) Except for emergency situations designated by the division, a person may not issue,
             211      fill, compound, or dispense a prescription for a controlled substance unless the prescription is

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             212      signed by the prescriber in ink or indelible pencil or is signed with an electronic signature of
             213      the prescriber as authorized by division rule, and contains the following information:
             214          (i) the name, address, and registry number of the prescriber;
             215          (ii) the name, address, and age of the person to whom or for whom the prescription is
             216      issued;
             217          (iii) the date of issuance of the prescription; and
             218          (iv) the name, quantity, and specific directions for use by the ultimate user of the
             219      controlled substance.
             220          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
             221      controlled substance.
             222          (f) Except when administered directly to an ultimate user by a licensed practitioner,
             223      controlled substances are subject to the following restrictions:
             224          (i) (A) A prescription for a Schedule II substance may not be refilled.
             225          (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
             226      one-month's supply, as directed on the daily dosage rate of the prescriptions.
             227          (ii) A Schedule III or IV controlled substance may be filled only within six months of
             228      issuance, and may not be refilled more than six months after the date of its original issuance or
             229      be refilled more than five times after the date of the prescription unless renewed by the
             230      practitioner.
             231          (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
             232      prescription directs, but they may not be refilled one year after the date the prescription was
             233      issued unless renewed by the practitioner.
             234          (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
             235      presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
             236      after the date the prescription was issued, or 30 days after the dispensing date, if that date is
             237      specified separately from the date of issue.
             238          (v) A practitioner may issue more than one prescription at the same time for the same
             239      Schedule II controlled substance, but only under the following conditions:
             240          (A) no more than three prescriptions for the same Schedule II controlled substance may
             241      be issued at the same time;
             242          (B) no one prescription may exceed a 30-day supply;

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             243          (C) a second or third prescription shall include the date of issuance and the date for
             244      dispensing; and
             245          (D) unless the practitioner determines there is a valid medical reason to the contrary,
             246      the date for dispensing a second or third prescription may not be fewer than 30 days from the
             247      dispensing date of the previous prescription.
             248          (vi) Each prescription for a controlled substance may contain only one controlled
             249      substance per prescription form and may not contain any other legend drug or prescription
             250      item.
             251          (g) An order for a controlled substance in Schedules II through V for use by an
             252      inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
             253      Subsection (7) if the order is:
             254          (i) issued or made by a prescribing practitioner who holds an unrestricted registration
             255      with the federal Drug Enforcement Administration, and an active Utah controlled substance
             256      license in good standing issued by the division under this section, or a medical resident who is
             257      exempted from licensure under Subsection 58-1-307 (1)(c);
             258          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
             259      practitioner designates the quantity ordered;
             260          (iii) entered upon the record of the patient, the record is signed by the prescriber
             261      affirming the prescriber's authorization of the order within 48 hours after filling or
             262      administering the order, and the patient's record reflects the quantity actually administered; and
             263          (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
             264      the physical structure of the hospital, or the order is taken from a supply lawfully maintained by
             265      the hospital and the amount taken from the supply is administered directly to the patient
             266      authorized to receive it.
             267          (h) A practitioner licensed under this chapter may not prescribe, administer, or
             268      dispense a controlled substance to a child, without first obtaining the consent required in
             269      Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child except
             270      in cases of an emergency. For purposes of this Subsection (7)(h), "child" has the same
             271      meaning as defined in Section 78A-6-105 , and "emergency" means any physical condition
             272      requiring the administration of a controlled substance for immediate relief of pain or suffering.
             273          (i) A practitioner licensed under this chapter may not prescribe or administer dosages

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             274      of a controlled substance in excess of medically recognized quantities necessary to treat the
             275      ailment, malady, or condition of the ultimate user.
             276          (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             277      any controlled substance to another person knowing that the other person is using a false name,
             278      address, or other personal information for the purpose of securing the controlled substance.
             279          (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
             280      a controlled substance may not manufacture, distribute, or dispense a controlled substance to
             281      another licensee or any other authorized person not authorized by this license.
             282          (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
             283      symbol required by this chapter or by a rule issued under this chapter.
             284          (m) A person licensed under this chapter may not refuse or fail to make, keep, or
             285      furnish any record notification, order form, statement, invoice, or information required under
             286      this chapter.
             287          (n) A person licensed under this chapter may not refuse entry into any premises for
             288      inspection as authorized by this chapter.
             289          (o) A person licensed under this chapter may not furnish false or fraudulent material
             290      information in any application, report, or other document required to be kept by this chapter or
             291      willfully make any false statement in any prescription, order, report, or record required by this
             292      chapter.
             293          (8) A practitioner may dispense a Schedule II controlled substance for use by a
             294      terminally ill patient in a licensed hospice by oral prescription if:
             295          (a) an emergency situation exists;
             296          (b) the practitioner or pharmacy who receives the prescription promptly reduces the
             297      prescription to writing on forms designated by the division and filed by the pharmacy;
             298          (c) the quantity dispensed is only sufficient to cover the patient for the emergency
             299      situation described in Subsection (8)(a), not to exceed seven days; and
             300          (d) a valid prescription is delivered to the pharmacist within seven working days after
             301      the day on which the oral prescription is made, in a format designated by the division by rule.
             302          [(8)] (9) (a) (i) Any person licensed under this chapter who is found by the division to
             303      have violated any of the provisions of Subsections (7)(k) through (o) or Subsection [(10)] (11)
             304      is subject to a penalty not to exceed $5,000. The division shall determine the procedure for

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             305      adjudication of any violations in accordance with Sections 58-1-106 and 58-1-108 .
             306          (ii) The division shall deposit all penalties collected under Subsection [(8)] (9)(a)(i) in
             307      the General Fund as a dedicated credit to be used by the division under Subsection
             308      58-37f-502 (1).
             309          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (j)
             310      or Subsection [(10)] (11) is:
             311          (i) upon first conviction, guilty of a class B misdemeanor;
             312          (ii) upon second conviction, guilty of a class A misdemeanor; and
             313          (iii) on third or subsequent conviction, guilty of a third degree felony.
             314          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
             315      (o) shall upon conviction be guilty of a third degree felony.
             316          [(9)] (10) Any information communicated to any licensed practitioner in an attempt to
             317      unlawfully procure, or to procure the administration of, a controlled substance is not considered
             318      to be a privileged communication.
             319          [(10)] (11) A person holding a valid license under this chapter who is engaged in
             320      medical research may produce, possess, or administer, but may not prescribe or dispense, a
             321      controlled substance listed in Section 58-37-4.2 .
             322          Section 2. Section 58-37f-502 is amended to read:
             323           58-37f-502. Use of dedicated credits -- Controlled Substance Database --
             324      Collection of penalties.
             325          (1) The director may use the money deposited in the General Fund as a dedicated credit
             326      under Subsections 58-37-6 [(8)](9)(a), 58-37f-601 (3)(d), and 58-37f-602 (2) for the following
             327      purposes:
             328          (a) maintenance and replacement of the database equipment, including hardware and
             329      software;
             330          (b) training of staff; and
             331          (c) pursuit of external grants and matching funds.
             332          (2) The director of the division may collect any penalty imposed under Subsections
             333      58-37-6 [(8)](9)(a), 58-37f-601 (3)(d), and 58-37f-602 (2) and which is not paid by:
             334          (a) referring the matter to the Office of State Debt Collection or a collection agency; or
             335          (b) bringing an action in the district court of the county in which the person owing the

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             336      debt resides or in the county where the office of the director is located.
             337          (3) The director may seek legal assistance from the attorney general or the county or
             338      district attorney of the district in which the action is brought to collect the fine.
             339          (4) The court shall award reasonable attorney fees and costs to the division for
             340      successful collection actions under Subsection (2)(b).

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