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H.B. 128






Sponsor: Eli H. Anderson

             6      This act modifies the Controlled Substances Act by specifying that up to three prescriptions
             7      for the same Schedule II controlled substance medication may be issued at the same time.
             8      The act sets forth specific procedures for issuing more than one prescription for a Schedule
             9      II medication at the same time, including requiring specified dispensing dates on the
             10      prescriptions. The act also provides that all prescriptions for Schedule II medications may
             11      only be filled within 30 days after prescription issue date or dispensing date.
             12      This act affects sections of Utah Code Annotated 1953 as follows:
             13      AMENDS:
             14          58-37-6, as last amended by Chapter 145, Laws of Utah 2000
             15      Be it enacted by the Legislature of the state of Utah:
             16          Section 1. Section 58-37-6 is amended to read:
             17           58-37-6. License to manufacture, produce, distribute, dispense, administer, or
             18      conduct research -- Issuance by department -- Denial, suspension, or revocation -- Records
             19      required -- Prescriptions.
             20          (1) (a) The department may adopt rules relating to the licensing and control of the
             21      manufacture, distribution, production, prescription, administration, dispensing, conducting of
             22      research with, and performing of laboratory analysis upon controlled substances within this state.
             23          (b) The department may assess reasonable fees to defray the cost of issuing original and
             24      renewal licenses under this chapter pursuant to Section 63-38-3.2 .
             25          (c) The director of the department may delegate to any division or agency within the
             26      department, authority to perform the responsibilities and functions prescribed to the department
             27      under this chapter if the delegated authority is consistent with the function of the division or

             28      agency provided by law.
             29          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
             30      administers, conducts research with, or performs laboratory analysis upon any controlled substance
             31      in Schedules II through V within this state, or who proposes to engage in manufacturing,
             32      producing, distributing, prescribing, dispensing, administering, conducting research with, or
             33      performing laboratory analysis upon controlled substances included in Schedules II through V
             34      within this state shall obtain a license issued by the department.
             35          (ii) The division shall issue each license under this chapter in accordance with a two-year
             36      renewal cycle established by rule. The division may by rule extend or shorten a renewal period
             37      by as much as one year to stagger the renewal cycles it administers.
             38          (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense, administer,
             39      conduct research with, or perform laboratory analysis upon controlled substances in Schedules II
             40      through V within this state may possess, manufacture, produce, distribute, prescribe, dispense,
             41      administer, conduct research with, or perform laboratory analysis upon those substances to the
             42      extent authorized by their license and in conformity with this chapter.
             43          (c) The following persons are not required to obtain a license and may lawfully possess
             44      controlled substances under this section:
             45          (i) an agent or employee, except a sales representative, of any registered manufacturer,
             46      distributor, or dispenser of any controlled substance, if the agent or employee is acting in the usual
             47      course of his business or employment; however, nothing in this subsection shall be interpreted to
             48      permit an agent, employee, sales representative, or detail man to maintain an inventory of
             49      controlled substances separate from the location of his employer's registered and licensed place
             50      of business;
             51          (ii) a motor carrier or warehouseman, or an employee of a motor carrier or warehouseman,
             52      who possesses any controlled substance in the usual course of his business or employment; and
             53          (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
             54      a lawful order of a practitioner.
             55          (d) The department may enact rules waiving the license requirement for certain
             56      manufacturers, producers, distributors, prescribers, dispensers, administrators, research
             57      practitioners, or laboratories performing analysis if consistent with the public health and safety.
             58          (e) A separate license is required at each principal place of business or professional

             59      practice where the applicant manufactures, produces, distributes, prescribes, dispenses,
             60      administers, conducts research with, or performs laboratory analysis upon controlled substances.
             61          (f) The department may enact rules providing for the inspection of a licensee or applicant's
             62      establishment, and may inspect the establishment according to those rules.
             63          (3) (a) Upon proper application, the department shall license a qualified applicant to
             64      manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
             65      controlled substances included in Schedules I through V, unless it determines that issuance of a
             66      license is inconsistent with the public interest. The department shall not issue a license to any
             67      person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
             68      public interest, the department shall consider whether or not the applicant has:
             69          (i) maintained effective controls against diversion of controlled substances and any
             70      Schedule I or II substance compounded from any controlled substance into other than legitimate
             71      medical, scientific, or industrial channels;
             72          (ii) complied with applicable state and local law;
             73          (iii) been convicted under federal or state laws relating to the manufacture, distribution,
             74      or dispensing of substances;
             75          (iv) past experience in the manufacture of controlled dangerous substances;
             76          (v) established effective controls against diversion; and
             77          (vi) complied with any other factors that the department establishes that promote the public
             78      health and safety.
             79          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
             80      produce, distribute, conduct research with, or perform laboratory analysis upon controlled
             81      substances in Schedule I other than those specified in the license.
             82          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
             83      substances in Schedules II through V if they are authorized to administer, dispense, or conduct
             84      research under the laws of this state.
             85          (ii) The department need not require a separate license for practitioners engaging in
             86      research with nonnarcotic controlled substances in Schedules II through V where the licensee is
             87      already licensed under this act in another capacity.
             88          (iii) With respect to research involving narcotic substances in Schedules II through V, or
             89      where the department by rule requires a separate license for research of nonnarcotic substances in

             90      Schedules II through V, a practitioner shall apply to the department prior to conducting research.
             91          (iv) Licensing for purposes of bona fide research with controlled substances by a
             92      practitioner considered qualified may be denied only on a ground specified in Subsection (4), or
             93      upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard adequately
             94      his supply of substances against diversion from medical or scientific use.
             95          (v) Practitioners registered under federal law to conduct research in Schedule I substances
             96      may conduct research in Schedule I substances within this state upon furnishing the department
             97      evidence of federal registration.
             98          (d) Compliance by manufacturers, producers, and distributors with the provisions of
             99      federal law respecting registration, excluding fees, entitles them to be licensed under this chapter.
             100          (e) The department shall initially license those persons who own or operate an
             101      establishment engaged in the manufacture, production, distribution, dispensation, or administration
             102      of controlled substances prior to April 3, 1980, and who are licensed by the state.
             103          (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed on
             104      probation, or revoked by the department upon finding that the applicant or licensee has:
             105          (i) materially falsified any application filed or required pursuant to this chapter;
             106          (ii) been convicted of an offense under this chapter or any law of the United States, or any
             107      state, relating to any substance defined as a controlled substance;
             108          (iii) been convicted of a felony under any other law of the United States or any state within
             109      five years of the date of the issuance of the license;
             110          (iv) had a federal license denied, suspended, or revoked by competent federal authority and
             111      is no longer authorized to engage in the manufacturing, distribution, or dispensing of controlled
             112      substances;
             113          (v) had his license suspended or revoked by competent authority of another state for
             114      violation of laws or regulations comparable to those of this state relating to the manufacture,
             115      distribution, or dispensing of controlled substances;
             116          (vi) violated any department rule that reflects adversely on the licensee's reliability and
             117      integrity with respect to controlled substances;
             118          (vii) refused inspection of records required to be maintained under this chapter by a person
             119      authorized to inspect them; or
             120          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the purpose

             121      of manipulating human hormonal structure so as to:
             122          (A) increase muscle mass, strength, or weight without medical necessity and without a
             123      written prescription by any practitioner in the course of his professional practice; or
             124          (B) improve performance in any form of human exercise, sport, or game.
             125          (b) The department may limit revocation or suspension of a license to a particular
             126      controlled substance with respect to which grounds for revocation or suspension exist.
             127          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to this
             128      section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
             129      Occupational and Professional Licensing Act, and conducted in conjunction with the appropriate
             130      representative committee designated by the director of the department.
             131          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and Professional
             132      Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses, except where
             133      the department is designated by law to perform those functions, or, when not designated by law,
             134      is designated by the executive director of the Department of Commerce to conduct the
             135      proceedings.
             136          (d) (i) The department may suspend any license simultaneously with the institution of
             137      proceedings under this section if it finds there is an imminent danger to the public health or safety.
             138          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
             139      judicial review, unless withdrawn by the department or dissolved by a court of competent
             140      jurisdiction.
             141          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
             142      substances owned or possessed by the licensee may be placed under seal in the discretion of the
             143      department.
             144          (ii) Disposition may not be made of substances under seal until the time for taking an
             145      appeal has lapsed, or until all appeals have been concluded, unless a court, upon application, orders
             146      the sale of perishable substances and the proceeds deposited with the court.
             147          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
             148          (f) The department shall notify promptly the Drug Enforcement Administration of all
             149      orders suspending or revoking a license and all forfeitures of controlled substances.
             150          (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and inventories
             151      in conformance with the record keeping and inventory requirements of federal and state law and

             152      any additional rules issued by the department.
             153          (b) (i) Every physician, dentist, veterinarian, practitioner, or other person who is authorized
             154      to administer or professionally use a controlled substance shall keep a record of the drugs received
             155      by him and a record of all drugs administered, dispensed, or professionally used by him otherwise
             156      than by a prescription.
             157          (ii) A person using small quantities or solutions or other preparations of those drugs for
             158      local application has complied with Subsection (5)(b) if he keeps a record of the quantity,
             159      character, and potency of those solutions or preparations purchased or prepared by him, and of the
             160      dates when purchased or prepared.
             161          (6) Controlled substances in Schedules I through V may be distributed only by a licensee
             162      and pursuant to an order form prepared in compliance with department rules or a lawful order
             163      under the rules and regulations of the United States.
             164          (7) (a) A person may not write or authorize a prescription for a controlled substance unless
             165      he is:
             166          (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
             167      or under the laws of another state having similar standards; and
             168          (ii) licensed under this chapter or under the laws of another state having similar standards.
             169          (b) A person other than a pharmacist licensed under the laws of this state, or his licensed
             170      intern, as required by Section 58-17a-302 , may not dispense a controlled substance.
             171          (c) (i) A controlled substance may not be dispensed without the written prescription of a
             172      practitioner, if the written prescription is required by the federal Controlled Substances Act.
             173          (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
             174      conformity with Subsection (7)(d).
             175          (iii) In emergency situations, as defined by department rule, controlled substances may be
             176      dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
             177      designated by the department and filed by the pharmacy.
             178          (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
             179      Subsection (7)(d).
             180          (d) Except for emergency situations designated by the department, a person may not issue,
             181      fill, compound, or dispense a prescription for a controlled substance unless the prescription is
             182      signed in ink or indelible pencil by the prescriber and contains the following information:

             183          (i) the name, address, and registry number of the prescriber;
             184          (ii) the name, address, and age of the person to whom or for whom the prescription is
             185      issued;
             186          (iii) the date of issuance of the prescription; and
             187          (iv) the name, quantity, and specific directions for use by the ultimate user of the
             188      controlled substance.
             189          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
             190      controlled substance.
             191          (f) Except when administered directly to an ultimate user by a licensed practitioner,
             192      controlled substances are subject to the following restrictions:
             193          (i) A prescription for a Schedule II substance may be refilled only upon the written
             194      prescription of an authorized practitioner, and a prescription for a Schedule II controlled substance
             195      may not be filled in a quantity to exceed a one-month's supply, as directed on the daily dosage rate
             196      of the prescriptions.
             197          (ii) A Schedule III or IV controlled substance may be filled only within six months of
             198      issuance, and may not be refilled more than six months after the date of its original issuance or be
             199      refilled more than five times after the date of the prescription unless renewed by the practitioner.
             200          (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
             201      prescription directs, but they may not be refilled one year after the date the prescription was issued
             202      unless renewed by the practitioner.
             203          (iv) Any prescription for a Schedule II[, III, and IV] substance [that] may not be dispensed
             204      if it is not presented to a pharmacist for dispensing by a pharmacist[,] or[, if an oral prescription,
             205      that is not obtained] a pharmacy intern within [the time periods established by federal law may not
             206      be filled or dispensed] 30 days after the date the prescription was issued, or 30 days after the
             207      dispensing date, if that date is specified separately from the date of issue.
             208          (v) A practitioner may issue more than one prescription at the same time for the same
             209      Schedule II controlled substance, but only under the following conditions:
             210          (A) no more than three prescriptions for the same Schedule II controlled substance may
             211      be issued at the same time;
             212          (B) no one prescription may exceed a 30-day supply;
             213          (C) a second or third prescription shall include the date of issuance and the date for

             214      dispensing; and
             215          (D) unless the practitioner determines there is a valid medical reason to the contrary, the
             216      date for dispensing a second or third prescription may not be fewer than 30 days from the
             217      dispensing date of the previous prescription.
             218          (vi) Each prescription for a controlled substance may contain only one controlled
             219      substance per prescription form and may not contain any other legend drug or prescription item.
             220          (g) An order for a controlled substance in Schedules II through V for use by an inpatient
             221      or an outpatient of a licensed hospital is exempt from all requirements of this Subsection (7) if the
             222      order is:
             223          (i) issued or made by a prescribing practitioner who holds an unrestricted registration with
             224      the federal Drug Enforcement Administration, and an active Utah controlled substance license in
             225      good standing issued by the division under this section, or a medical resident who is exempted
             226      from licensure under Subsection 58-1-307 (1)(c);
             227          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
             228      practitioner designates the quantity ordered;
             229          (iii) entered upon the record of the patient, the record is signed by the prescriber affirming
             230      his authorization of the order within 48 hours after filling or administering the order, and the
             231      patient's record reflects the quantity actually administered; and
             232          (iv) filled and dispensed by a pharmacist practicing his profession within the physical
             233      structure of the hospital, or the order is taken from a supply lawfully maintained by the hospital
             234      and the amount taken from the supply is administered directly to the patient authorized to receive
             235      it.
             236          (h) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             237      a controlled substance to a minor, without first obtaining the consent required in Section 78-14-5
             238      of a parent, guardian, or person standing in loco parentis of the minor except in cases of an
             239      emergency. For purposes of this Subsection (7)(h), "minor" has the same meaning as defined in
             240      Section 78-3a-103 , and "emergency" means any physical condition requiring the administration
             241      of a controlled substance for immediate relief of pain or suffering.
             242          (i) A practitioner licensed under this chapter may not prescribe or administer dosages of
             243      a controlled substance in excess of medically recognized quantities necessary to treat the ailment,
             244      malady, or condition of the ultimate user.

             245          (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             246      any controlled substance to another person knowing that the other person is using a false name,
             247      address, or other personal information for the purpose of securing the controlled substance.
             248          (k) A person who is licensed under this chapter to manufacture, distribute, or dispense a
             249      controlled substance may not manufacture, distribute, or dispense a controlled substance to another
             250      licensee or any other authorized person not authorized by this license.
             251          (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a symbol
             252      required by this chapter or by a rule issued under this chapter.
             253          (m) A person licensed under this chapter may not refuse or fail to make, keep, or furnish
             254      any record notification, order form, statement, invoice, or information required under this chapter.
             255          (n) A person licensed under this chapter may not refuse entry into any premises for
             256      inspection as authorized by this chapter.
             257          (o) A person licensed under this chapter may not furnish false or fraudulent material
             258      information in any application, report, or other document required to be kept by this chapter or
             259      willfully make any false statement in any prescription, order, report, or record required by this
             260      chapter.
             261          (8) (a) Any person licensed under this chapter who is found by the department to have
             262      violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a fine not to exceed
             263      $5,000. The department shall determine the procedure for adjudication of any violations in
             264      accordance with Sections 58-1-106 and 58-1-108 .
             265          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (7)(j)
             266      is:
             267          (i) upon first conviction, guilty of a class B misdemeanor;
             268          (ii) upon second conviction, guilty of a class A misdemeanor; and
             269          (iii) on third or subsequent conviction, guilty of a third degree felony.
             270          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through (7)(o)
             271      shall upon conviction be guilty of a third degree felony.
             272          (9) Any information communicated to any licensed practitioner in an attempt to unlawfully
             273      procure, or to procure the administration of, a controlled substance is not considered to be a
             274      privileged communication.

Legislative Review Note
    as of 12-20-01 11:50 AM

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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