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H.B. 258

             1     

PRESCRIPTION FOR CONTROLLED

             2     
SUBSTANCES

             3     
2000 GENERAL SESSION

             4     
STATE OF UTAH

             5     
Sponsor: Eli H. Anderson

             6      AN ACT RELATING TO CONTROLLED SUBSTANCES; EXTENDING THE TIME WITHIN
             7      WHICH A PRESCRIPTION FOR A CONTROLLED SUBSTANCE MAY BE FILLED.
             8      This act affects sections of Utah Code Annotated 1953 as follows:
             9      AMENDS:
             10          58-37-6, as last amended by Chapter 13, Laws of Utah 1998
             11      Be it enacted by the Legislature of the state of Utah:
             12          Section 1. Section 58-37-6 is amended to read:
             13           58-37-6. License to manufacture, produce, distribute, dispense, administer, or
             14      conduct research -- Issuance by department -- Denial, suspension, or revocation -- Records
             15      required -- Prescriptions.
             16          (1) (a) The department may adopt rules relating to the licensing and control of the
             17      manufacture, distribution, production, prescription, administration, dispensing, conducting of
             18      research with, and performing of laboratory analysis upon controlled substances within this state.
             19          (b) The department may assess reasonable fees to defray the cost of issuing original and
             20      renewal licenses under this chapter pursuant to Section 63-38-3.2 .
             21          (c) The director of the department may delegate to any division or agency within the
             22      department, authority to perform the responsibilities and functions prescribed to the department
             23      under this chapter if the delegated authority is consistent with the function of the division or
             24      agency provided by law.
             25          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
             26      administers, conducts research with, or performs laboratory analysis upon any controlled substance
             27      in Schedules II through V within this state, or who proposes to engage in manufacturing,


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


             59          (3) (a) Upon proper application, the department shall license a qualified applicant to
             60      manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
             61      controlled substances included in Schedules I through V, unless it determines that issuance of a
             62      license is inconsistent with the public interest. The department shall not issue a license to any
             63      person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
             64      public interest, the department shall consider whether or not the applicant has:
             65          (i) maintained effective controls against diversion of controlled substances and any
             66      Schedule I or II substance compounded from any controlled substance into other than legitimate
             67      medical, scientific, or industrial channels;
             68          (ii) complied with applicable state and local law;
             69          (iii) been convicted under federal or state laws relating to the manufacture, distribution,
             70      or dispensing of substances;
             71          (iv) past experience in the manufacture of controlled dangerous substances;
             72          (v) established effective controls against diversion; and
             73          (vi) complied with any other factors that the department establishes that promote the public
             74      health and safety.
             75          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
             76      produce, distribute, conduct research with, or perform laboratory analysis upon controlled
             77      substances in Schedule I other than those specified in the license.
             78          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
             79      substances in Schedules II through V if they are authorized to administer, dispense, or conduct
             80      research under the laws of this state.
             81          (ii) The department need not require a separate license for practitioners engaging in
             82      research with nonnarcotic controlled substances in Schedules II through V where the licensee is
             83      already licensed under this act in another capacity.
             84          (iii) With respect to research involving narcotic substances in Schedules II through V, or
             85      where the department by rule requires a separate license for research of nonnarcotic substances in
             86      Schedules II through V, a practitioner shall apply to the department prior to conducting research.
             87          (iv) Licensing for purposes of bona fide research with controlled substances by a
             88      practitioner considered qualified may be denied only on a ground specified in Subsection (4), or
             89      upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard adequately


             90      his supply of substances against diversion from medical or scientific use.
             91          (v) Practitioners registered under federal law to conduct research in Schedule I substances
             92      may conduct research in Schedule I substances within this state upon furnishing the department
             93      evidence of federal registration.
             94          (d) Compliance by manufacturers, producers, and distributors with the provisions of
             95      federal law respecting registration, excluding fees, entitles them to be licensed under this chapter.
             96          (e) The department shall initially license those persons who own or operate an
             97      establishment engaged in the manufacture, production, distribution, dispensation, or administration
             98      of controlled substances prior to April 3, 1980, and who are licensed by the state.
             99          (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed on
             100      probation, or revoked by the department upon finding that the applicant or licensee has:
             101          (i) materially falsified any application filed or required pursuant to this chapter;
             102          (ii) been convicted of an offense under this chapter or any law of the United States, or any
             103      state, relating to any substance defined as a controlled substance;
             104          (iii) been convicted of a felony under any other law of the United States or any state within
             105      five years of the date of the issuance of the license;
             106          (iv) had a federal license denied, suspended, or revoked by competent federal authority and
             107      is no longer authorized to engage in the manufacturing, distribution, or dispensing of controlled
             108      substances;
             109          (v) had his license suspended or revoked by competent authority of another state for
             110      violation of laws or regulations comparable to those of this state relating to the manufacture,
             111      distribution, or dispensing of controlled substances;
             112          (vi) violated any department rule that reflects adversely on the licensee's reliability and
             113      integrity with respect to controlled substances;
             114          (vii) refused inspection of records required to be maintained under this chapter by a person
             115      authorized to inspect them; or
             116          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the purpose
             117      of manipulating human hormonal structure so as to:
             118          (A) increase muscle mass, strength, or weight without medical necessity and without a
             119      written prescription by any practitioner in the course of his professional practice; or
             120          (B) improve performance in any form of human exercise, sport, or game.


             121          (b) The department may limit revocation or suspension of a license to a particular
             122      controlled substance with respect to which grounds for revocation or suspension exist.
             123          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to this
             124      section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
             125      Occupational and Professional Licensing Act, and conducted in conjunction with the appropriate
             126      representative committee designated by the director of the department.
             127          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and Professional
             128      Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses, except where
             129      the department is designated by law to perform those functions, or, when not designated by law,
             130      is designated by the executive director of the Department of Commerce to conduct the
             131      proceedings.
             132          (d) (i) The department may suspend any license simultaneously with the institution of
             133      proceedings under this section if it finds there is an imminent danger to the public health or safety.
             134          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
             135      judicial review, unless withdrawn by the department or dissolved by a court of competent
             136      jurisdiction.
             137          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
             138      substances owned or possessed by the licensee may be placed under seal in the discretion of the
             139      department.
             140          (ii) Disposition may not be made of substances under seal until the time for taking an
             141      appeal has lapsed, or until all appeals have been concluded, unless a court, upon application, orders
             142      the sale of perishable substances and the proceeds deposited with the court.
             143          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
             144          (f) The department shall notify promptly the Drug Enforcement Administration of all
             145      orders suspending or revoking a license and all forfeitures of controlled substances.
             146          (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and inventories
             147      in conformance with the record keeping and inventory requirements of federal and state law and
             148      any additional rules issued by the department.
             149          (b) (i) Every physician, dentist, veterinarian, practitioner, or other person who is authorized
             150      to administer or professionally use a controlled substance shall keep a record of the drugs received
             151      by him and a record of all drugs administered, dispensed, or professionally used by him otherwise


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


             183          (iv) the name, quantity, and specific directions for use by the ultimate user of the
             184      controlled substance.
             185          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
             186      controlled substance.
             187          (f) Except when administered directly to an ultimate user by a licensed practitioner,
             188      controlled substances are subject to the following restrictions:
             189          (i) A prescription for a Schedule II substance may be refilled only upon the written
             190      prescription of an authorized practitioner, and a prescription for a Schedule II controlled substance
             191      may not be filled in a quantity to exceed a one-month's supply, as directed on the daily dosage rate
             192      of the prescriptions.
             193          (ii) A Schedule III or IV controlled substance may not be refilled more than six months
             194      after the date of its original issuance or be refilled more than five times after the date of the
             195      prescription unless renewed by the practitioner.
             196          (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
             197      prescription directs, but they may not be refilled one year after the date the prescription was issued
             198      unless renewed by the practitioner.
             199          (iv) Any prescription for a Schedule II, III, and IV substance that is not presented to a
             200      pharmacist for dispensing by a pharmacist, or, if an oral prescription, that is not obtained within
             201      [ten days of the date the prescription was written or authorized,] the time periods established by
             202      federal law may not be filled or dispensed.
             203          (g) An order for a controlled substance in Schedules II through V for use by an inpatient
             204      or an outpatient of a licensed hospital is exempt from all requirements of Subsection (7) if the
             205      order is:
             206          (i) issued or made by a prescribing practitioner who holds an unrestricted registration with
             207      the federal Drug Enforcement Administration, and an active Utah controlled substance license in
             208      good standing issued by the division under this section, or a medical resident who is exempted
             209      from licensure under Subsection 58-1-307 (1)(c);
             210          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
             211      practitioner designates the quantity ordered;
             212          (iii) entered upon the record of the patient, the record is signed by the prescriber affirming
             213      his authorization of the order within 48 hours after filling or administering the order, and the


             214      patient's record reflects the quantity actually administered; and
             215          (iv) filled and dispensed by a pharmacist practicing his profession within the physical
             216      structure of the hospital, or the order is taken from a supply lawfully maintained by the hospital
             217      and the amount taken from the supply is administered directly to the patient authorized to receive
             218      it.
             219          (h) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             220      a controlled substance to a minor, without first obtaining the consent required in Section 78-14-5
             221      of a parent, guardian, or person standing in loco parentis of the minor except in cases of an
             222      emergency. For purposes of this Subsection (7)(h), "minor" has the same meaning as defined in
             223      Section 78-3a-103 , and "emergency" means any physical condition requiring the administration
             224      of a controlled substance for immediate relief of pain or suffering.
             225          (i) A practitioner licensed under this chapter may not prescribe or administer dosages of
             226      a controlled substance in excess of medically recognized quantities necessary to treat the ailment,
             227      malady, or condition of the ultimate user.
             228          (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             229      any controlled substance to another person knowing that the other person is using a false name,
             230      address, or other personal information for the purpose of securing the controlled substance.
             231          (k) A person who is licensed under this chapter to manufacture, distribute, or dispense a
             232      controlled substance may not manufacture, distribute, or dispense a controlled substance to another
             233      licensee or any other authorized person not authorized by this license.
             234          (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a symbol
             235      required by this chapter or by a rule issued under this chapter.
             236          (m) A person licensed under this chapter may not refuse or fail to make, keep, or furnish
             237      any record notification, order form, statement, invoice, or information required under this chapter.
             238          (n) A person licensed under this chapter may not refuse entry into any premises for
             239      inspection as authorized by this chapter.
             240          (o) A person licensed under this chapter may not furnish false or fraudulent material
             241      information in any application, report, or other document required to be kept by this chapter or
             242      willfully make any false statement in any prescription, order, report, or record required by this
             243      chapter.
             244          (8) (a) Any person licensed under this chapter who is found by the department to have


             245      violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a fine not to exceed
             246      $5,000. The department shall determine the procedure for adjudication of any violations in
             247      accordance with Sections 58-1-106 and 58-1-108 .
             248          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (7)(j)
             249      is:
             250          (i) upon first conviction, guilty of a class B misdemeanor;
             251          (ii) upon second conviction, guilty of a class A misdemeanor; and
             252          (iii) on third or subsequent conviction, guilty of a third degree felony.
             253          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through (7)(o)
             254      shall upon conviction be guilty of a third degree felony.
             255          (9) Any information communicated to any licensed practitioner in an attempt to unlawfully
             256      procure, or to procure the administration of, a controlled substance is not considered to be a
             257      privileged communication.




Legislative Review Note
    as of 1-24-00 12:10 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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