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S.B. 50

             1     

CONTROLLED SUBSTANCE AMENDMENTS

             2     
2005 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Sponsor: Patrice M. Arent

             5     
             6      LONG TITLE
             7      General Description:
             8          This bill amends the Pharmacy Practice Act and the Controlled Substances Act to
             9      repeal the Controlled Substance Database Advisory Committee and assign the
             10      committee's duties to the State Board of Pharmacy. This bill allows authorized
             11      employees of the Department of Health access to the controlled substance database for
             12      scientific studies. This bill also allows the division to authorize by rule a prescriber's
             13      use of an electronic or digital signature in issuing prescriptions.
             14      Highlighted Provisions:
             15          This bill:
             16          .    amends the functions of the State Board of Pharmacy to include its duties regarding
             17      the controlled substance database; and
             18          .    requires that Department of Health employees having access to the controlled
             19      substance database maintain the confidentiality of persons and pharmacies in the
             20      database.
             21      Monies Appropriated in this Bill:
             22          None
             23      Other Special Clauses:
             24          None
             25      Utah Code Sections Affected:
             26      AMENDS:
             27          58-17b-201, as enacted by Chapter 280, Laws of Utah 2004


             28          58-37-6, as last amended by Chapters 241 and 280, Laws of Utah 2004
             29          58-37-7.5, as last amended by Chapter 280, Laws of Utah 2004
             30     
             31      Be it enacted by the Legislature of the state of Utah:
             32          Section 1. Section 58-17b-201 is amended to read:
             33           58-17b-201. Board -- Membership -- Qualifications -- Terms.
             34          (1) There is created the Utah State Board of Pharmacy consisting of five pharmacists,
             35      one pharmacy technician, and one member of the general public.
             36          (a) The public member of the board shall be a Utah resident who:
             37          (i) is 21 years of age or older;
             38          (ii) has never been licensed to engage in the practice of pharmacy;
             39          (iii) has never been the spouse of a person licensed to engage in the practice of
             40      pharmacy;
             41          (iv) has never held any material financial interest in pharmacy practice; and
             42          (v) has never engaged in any activity directly related to the practice of pharmacy.
             43          (b) The licensed pharmacist and licensed pharmacy technician members of the board
             44      shall:
             45          (i) have been Utah residents continuously for at least three years;
             46          (ii) have at least five years experience in the practice of pharmacy in good standing
             47      with the division in Utah after licensure; and
             48          (iii) maintain licensure in good standing to engage in the practice of pharmacy or
             49      practice as a pharmacy technician in Utah for the duration of the appointment.
             50          (2) The board shall be appointed and serve in accordance with Section 58-1-201 .
             51          (3) The duties and responsibilities of the board are in accordance with Sections
             52      58-1-202 and 58-1-203 , and as required under Section 58-37-7.5 regarding the controlled
             53      substance database. In addition, the board shall designate an appropriate member on a
             54      permanent or rotating basis to:
             55          (a) assist the division in reviewing complaints concerning the unlawful or
             56      unprofessional conduct of a licensee; and
             57          (b) advise the division in its investigation of these complaints.
             58          (4) A board member who has, under Subsection (3), reviewed a complaint or advised


             59      in its investigation may be disqualified from participating with the board when the board serves
             60      as a presiding officer in an adjudicative proceeding concerning the complaint.
             61          (5) A board member may be removed in accordance with Subsection 58-1-201 (2)(e) or
             62      upon one of the following grounds:
             63          (a) refusal or inability for any reason of a board member to perform his duties as a
             64      member of the Board in an efficient, responsible, and professional manner;
             65          (b) misuse of appointment to obtain personal, pecuniary, or material gain or advantage
             66      for himself or another through such appointment; or
             67          (c) violation of the laws governing the practice of pharmacy or Chapter 37, Utah
             68      Controlled Substances Act.
             69          Section 2. Section 58-37-6 is amended to read:
             70           58-37-6. License to manufacture, produce, distribute, dispense, administer, or
             71      conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
             72      required -- Prescriptions.
             73          (1) (a) The division may adopt rules relating to the licensing and control of the
             74      manufacture, distribution, production, prescription, administration, dispensing, conducting of
             75      research with, and performing of laboratory analysis upon controlled substances within this
             76      state.
             77          (b) The division may assess reasonable fees to defray the cost of issuing original and
             78      renewal licenses under this chapter pursuant to Section 63-38-3.2 .
             79          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
             80      administers, conducts research with, or performs laboratory analysis upon any controlled
             81      substance in Schedules II through V within this state, or who proposes to engage in
             82      manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
             83      research with, or performing laboratory analysis upon controlled substances included in
             84      Schedules II through V within this state shall obtain a license issued by the division.
             85          (ii) The division shall issue each license under this chapter in accordance with a
             86      two-year renewal cycle established by rule. The division may by rule extend or shorten a
             87      renewal period by as much as one year to stagger the renewal cycles it administers.
             88          (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
             89      administer, conduct research with, or perform laboratory analysis upon controlled substances in


             90      Schedules II through V within this state may possess, manufacture, produce, distribute,
             91      prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
             92      those substances to the extent authorized by their license and in conformity with this chapter.
             93          (c) The following persons are not required to obtain a license and may lawfully possess
             94      controlled substances under this section:
             95          (i) an agent or employee, except a sales representative, of any registered manufacturer,
             96      distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
             97      usual course of his business or employment; however, nothing in this subsection shall be
             98      interpreted to permit an agent, employee, sales representative, or detail man to maintain an
             99      inventory of controlled substances separate from the location of his employer's registered and
             100      licensed place of business;
             101          (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
             102      warehouseman, who possesses any controlled substance in the usual course of his business or
             103      employment; and
             104          (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
             105      a lawful order of a practitioner.
             106          (d) The division may enact rules waiving the license requirement for certain
             107      manufacturers, producers, distributors, prescribers, dispensers, administrators, research
             108      practitioners, or laboratories performing analysis if consistent with the public health and safety.
             109          (e) A separate license is required at each principal place of business or professional
             110      practice where the applicant manufactures, produces, distributes, dispenses, conducts research
             111      with, or performs laboratory analysis upon controlled substances.
             112          (f) The division may enact rules providing for the inspection of a licensee or applicant's
             113      establishment, and may inspect the establishment according to those rules.
             114          (3) (a) Upon proper application, the division shall license a qualified applicant to
             115      manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
             116      controlled substances included in Schedules I through V, unless it determines that issuance of a
             117      license is inconsistent with the public interest. The division shall not issue a license to any
             118      person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
             119      public interest, the division shall consider whether or not the applicant has:
             120          (i) maintained effective controls against diversion of controlled substances and any


             121      Schedule I or II substance compounded from any controlled substance into other than
             122      legitimate medical, scientific, or industrial channels;
             123          (ii) complied with applicable state and local law;
             124          (iii) been convicted under federal or state laws relating to the manufacture, distribution,
             125      or dispensing of substances;
             126          (iv) past experience in the manufacture of controlled dangerous substances;
             127          (v) established effective controls against diversion; and
             128          (vi) complied with any other factors that the division establishes that promote the
             129      public health and safety.
             130          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
             131      produce, distribute, conduct research with, or perform laboratory analysis upon controlled
             132      substances in Schedule I other than those specified in the license.
             133          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
             134      substances in Schedules II through V if they are authorized to administer, dispense, or conduct
             135      research under the laws of this state.
             136          (ii) The division need not require a separate license for practitioners engaging in
             137      research with nonnarcotic controlled substances in Schedules II through V where the licensee is
             138      already licensed under this act in another capacity.
             139          (iii) With respect to research involving narcotic substances in Schedules II through V,
             140      or where the division by rule requires a separate license for research of nonnarcotic substances
             141      in Schedules II through V, a practitioner shall apply to the division prior to conducting
             142      research.
             143          (iv) Licensing for purposes of bona fide research with controlled substances by a
             144      practitioner considered qualified may be denied only on a ground specified in Subsection (4),
             145      or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
             146      adequately his supply of substances against diversion from medical or scientific use.
             147          (v) Practitioners registered under federal law to conduct research in Schedule I
             148      substances may conduct research in Schedule I substances within this state upon furnishing the
             149      division evidence of federal registration.
             150          (d) Compliance by manufacturers, producers, and distributors with the provisions of
             151      federal law respecting registration, excluding fees, entitles them to be licensed under this


             152      chapter.
             153          (e) The division shall initially license those persons who own or operate an
             154      establishment engaged in the manufacture, production, distribution, dispensation, or
             155      administration of controlled substances prior to April 3, 1980, and who are licensed by the
             156      state.
             157          (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
             158      on probation, or revoked by the division upon finding that the applicant or licensee has:
             159          (i) materially falsified any application filed or required pursuant to this chapter;
             160          (ii) been convicted of an offense under this chapter or any law of the United States, or
             161      any state, relating to any substance defined as a controlled substance;
             162          (iii) been convicted of a felony under any other law of the United States or any state
             163      within five years of the date of the issuance of the license;
             164          (iv) had a federal license denied, suspended, or revoked by competent federal authority
             165      and is no longer authorized to engage in the manufacturing, distribution, or dispensing of
             166      controlled substances;
             167          (v) had his license suspended or revoked by competent authority of another state for
             168      violation of laws or regulations comparable to those of this state relating to the manufacture,
             169      distribution, or dispensing of controlled substances;
             170          (vi) violated any division rule that reflects adversely on the licensee's reliability and
             171      integrity with respect to controlled substances;
             172          (vii) refused inspection of records required to be maintained under this chapter by a
             173      person authorized to inspect them; or
             174          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
             175      purpose of manipulating human hormonal structure so as to:
             176          (A) increase muscle mass, strength, or weight without medical necessity and without a
             177      written prescription by any practitioner in the course of his professional practice; or
             178          (B) improve performance in any form of human exercise, sport, or game.
             179          (b) The division may limit revocation or suspension of a license to a particular
             180      controlled substance with respect to which grounds for revocation or suspension exist.
             181          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
             182      this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of


             183      Occupational and Professional Licensing Act, and conducted in conjunction with the
             184      appropriate representative committee designated by the director of the department.
             185          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
             186      Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
             187      except where the division is designated by law to perform those functions, or, when not
             188      designated by law, is designated by the executive director of the Department of Commerce to
             189      conduct the proceedings.
             190          (d) (i) The division may suspend any license simultaneously with the institution of
             191      proceedings under this section if it finds there is an imminent danger to the public health or
             192      safety.
             193          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
             194      judicial review, unless withdrawn by the division or dissolved by a court of competent
             195      jurisdiction.
             196          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
             197      substances owned or possessed by the licensee may be placed under seal in the discretion of the
             198      division.
             199          (ii) Disposition may not be made of substances under seal until the time for taking an
             200      appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
             201      orders the sale of perishable substances and the proceeds deposited with the court.
             202          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
             203          (f) The division shall notify promptly the Drug Enforcement Administration of all
             204      orders suspending or revoking a license and all forfeitures of controlled substances.
             205          (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
             206      inventories in conformance with the record keeping and inventory requirements of federal and
             207      state law and any additional rules issued by the division.
             208          (b) (i) Every physician, dentist, veterinarian, practitioner, or other person who is
             209      authorized to administer or professionally use a controlled substance shall keep a record of the
             210      drugs received by him and a record of all drugs administered, dispensed, or professionally used
             211      by him otherwise than by a prescription.
             212          (ii) A person using small quantities or solutions or other preparations of those drugs for
             213      local application has complied with this Subsection (5)(b) if he keeps a record of the quantity,


             214      character, and potency of those solutions or preparations purchased or prepared by him, and of
             215      the dates when purchased or prepared.
             216          (6) Controlled substances in Schedules I through V may be distributed only by a
             217      licensee and pursuant to an order form prepared in compliance with division rules or a lawful
             218      order under the rules and regulations of the United States.
             219          (7) (a) A person may not write or authorize a prescription for a controlled substance
             220      unless he is:
             221          (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
             222      or under the laws of another state having similar standards; and
             223          (ii) licensed under this chapter or under the laws of another state having similar
             224      standards.
             225          (b) A person other than a pharmacist licensed under the laws of this state, or his
             226      licensed intern, as required by Sections 58-17b-303 and 58-17b-304 , may not dispense a
             227      controlled substance.
             228          (c) (i) A controlled substance may not be dispensed without the written prescription of
             229      a practitioner, if the written prescription is required by the federal Controlled Substances Act.
             230          (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
             231      conformity with Subsection (7)(d).
             232          (iii) In emergency situations, as defined by division rule, controlled substances may be
             233      dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
             234      designated by the division and filed by the pharmacy.
             235          (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
             236      Subsection (7)(d).
             237          (d) Except for emergency situations designated by the division, a person may not issue,
             238      fill, compound, or dispense a prescription for a controlled substance unless the prescription is
             239      signed by the prescriber in ink or indelible pencil [by the prescriber] or is signed with an
             240      electronic or digital signature of the prescriber as authorized by division rule, and contains the
             241      following information:
             242          (i) the name, address, and registry number of the prescriber;
             243          (ii) the name, address, and age of the person to whom or for whom the prescription is
             244      issued;


             245          (iii) the date of issuance of the prescription; and
             246          (iv) the name, quantity, and specific directions for use by the ultimate user of the
             247      controlled substance.
             248          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
             249      controlled substance.
             250          (f) Except when administered directly to an ultimate user by a licensed practitioner,
             251      controlled substances are subject to the following restrictions:
             252          (i) (A) A prescription for a Schedule II substance may not be refilled.
             253          (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
             254      one-month's supply, as directed on the daily dosage rate of the prescriptions.
             255          (ii) A Schedule III or IV controlled substance may be filled only within six months of
             256      issuance, and may not be refilled more than six months after the date of its original issuance or
             257      be refilled more than five times after the date of the prescription unless renewed by the
             258      practitioner.
             259          (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
             260      prescription directs, but they may not be refilled one year after the date the prescription was
             261      issued unless renewed by the practitioner.
             262          (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
             263      presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
             264      after the date the prescription was issued, or 30 days after the dispensing date, if that date is
             265      specified separately from the date of issue.
             266          (v) A practitioner may issue more than one prescription at the same time for the same
             267      Schedule II controlled substance, but only under the following conditions:
             268          (A) no more than three prescriptions for the same Schedule II controlled substance may
             269      be issued at the same time;
             270          (B) no one prescription may exceed a 30-day supply;
             271          (C) a second or third prescription shall include the date of issuance and the date for
             272      dispensing; and
             273          (D) unless the practitioner determines there is a valid medical reason to the contrary,
             274      the date for dispensing a second or third prescription may not be fewer than 30 days from the
             275      dispensing date of the previous prescription.


             276          (vi) Each prescription for a controlled substance may contain only one controlled
             277      substance per prescription form and may not contain any other legend drug or prescription
             278      item.
             279          (g) An order for a controlled substance in Schedules II through V for use by an
             280      inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
             281      Subsection (7) if the order is:
             282          (i) issued or made by a prescribing practitioner who holds an unrestricted registration
             283      with the federal Drug Enforcement Administration, and an active Utah controlled substance
             284      license in good standing issued by the division under this section, or a medical resident who is
             285      exempted from licensure under Subsection 58-1-307 (1)(c);
             286          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
             287      practitioner designates the quantity ordered;
             288          (iii) entered upon the record of the patient, the record is signed by the prescriber
             289      affirming his authorization of the order within 48 hours after filling or administering the order,
             290      and the patient's record reflects the quantity actually administered; and
             291          (iv) filled and dispensed by a pharmacist practicing his profession within the physical
             292      structure of the hospital, or the order is taken from a supply lawfully maintained by the hospital
             293      and the amount taken from the supply is administered directly to the patient authorized to
             294      receive it.
             295          (h) A practitioner licensed under this chapter may not prescribe, administer, or
             296      dispense a controlled substance to a minor, without first obtaining the consent required in
             297      Section 78-14-5 of a parent, guardian, or person standing in loco parentis of the minor except
             298      in cases of an emergency. For purposes of this Subsection (7)(h), "minor" has the same
             299      meaning as defined in Section 78-3a-103 , and "emergency" means any physical condition
             300      requiring the administration of a controlled substance for immediate relief of pain or suffering.
             301          (i) A practitioner licensed under this chapter may not prescribe or administer dosages
             302      of a controlled substance in excess of medically recognized quantities necessary to treat the
             303      ailment, malady, or condition of the ultimate user.
             304          (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
             305      any controlled substance to another person knowing that the other person is using a false name,
             306      address, or other personal information for the purpose of securing the controlled substance.


             307          (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
             308      a controlled substance may not manufacture, distribute, or dispense a controlled substance to
             309      another licensee or any other authorized person not authorized by this license.
             310          (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
             311      symbol required by this chapter or by a rule issued under this chapter.
             312          (m) A person licensed under this chapter may not refuse or fail to make, keep, or
             313      furnish any record notification, order form, statement, invoice, or information required under
             314      this chapter.
             315          (n) A person licensed under this chapter may not refuse entry into any premises for
             316      inspection as authorized by this chapter.
             317          (o) A person licensed under this chapter may not furnish false or fraudulent material
             318      information in any application, report, or other document required to be kept by this chapter or
             319      willfully make any false statement in any prescription, order, report, or record required by this
             320      chapter.
             321          (8) (a) (i) Any person licensed under this chapter who is found by the division to have
             322      violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a penalty not to
             323      exceed $5,000. The division shall determine the procedure for adjudication of any violations in
             324      accordance with Sections 58-1-106 and 58-1-108 .
             325          (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
             326      General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             327          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through
             328      (7)(j) is:
             329          (i) upon first conviction, guilty of a class B misdemeanor;
             330          (ii) upon second conviction, guilty of a class A misdemeanor; and
             331          (iii) on third or subsequent conviction, guilty of a third degree felony.
             332          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
             333      (7)(o) shall upon conviction be guilty of a third degree felony.
             334          (9) Any information communicated to any licensed practitioner in an attempt to
             335      unlawfully procure, or to procure the administration of, a controlled substance is not considered
             336      to be a privileged communication.
             337          Section 3. Section 58-37-7.5 is amended to read:


             338           58-37-7.5. Controlled substance database -- Advisory committee -- Pharmacy
             339      reporting requirements -- Access -- Penalties.
             340          (1) As used in this section:
             341          (a) "Committee" means the Controlled Substance Database Advisory Committee
             342      created in this section.
             343          (b) "Database" means the controlled substance database created in this section.
             344          (c) "Database manager" means the person responsible for operating the database, or his
             345      designee.
             346          (d) "Division" means the Division of Occupational and Professional Licensing created
             347      in Section 58-1-103 .
             348          (e) "Health care facility" has the same definition as in Section 26-21-2 .
             349          (f) "Pharmacy or pharmaceutical facility" has the same definition as in Section
             350      58-17b-102 .
             351          (2) (a) There is created within the division a controlled substance database.
             352          (b) The division shall administer and direct the functioning of the database in
             353      accordance with this section. The division may under state procurement laws contract with
             354      another state agency or private entity to establish, operate, or maintain the database. The
             355      division in collaboration with the board shall determine whether to operate the database within
             356      the division or contract with another entity to operate the database, based on an analysis of
             357      costs and benefits.
             358          (c) The purpose of the database is to contain data as described in this section regarding
             359      every prescription for a controlled substance dispensed in the state to any person other than an
             360      inpatient in a licensed health care facility.
             361          (d) Data required by this section shall be submitted in compliance with this section to
             362      the manager of the database by the pharmacist in charge of the drug outlet where the controlled
             363      substance is dispensed.
             364          [(3) (a) There is created the Controlled Substance Database Advisory Committee. The
             365      committee members are:]
             366          [(i) two members representing the Utah Medical Association;]
             367          [(ii) one member representing the Utah Dental Association;]
             368          [(iii) two members representing the Utah Pharmaceutical Association;]


             369          [(iv) one member representing the Department of Public Safety;]
             370          [(v) one member representing the Utah Association of Chiefs of Police;]
             371          [(vi) one member representing the Utah Sheriffs Association;]
             372          [(vii) one member representing the state Office of the Attorney General;]
             373          [(viii) one member representing the Statewide Association of Public Attorneys; and]
             374          [(ix) three members representing the general public, and who are not health care
             375      providers.]
             376          [(b) The committee shall be appointed and serve in accordance with Section 58-1-201 .]
             377          [(c)] (3) The [committee] Utah State Board of Pharmacy created in Section 58-17b-201
             378      shall advise the division regarding:
             379          [(i)] (a) establishing, maintaining, and operating the database;
             380          [(ii)] (b) access to the database and how access is obtained; and
             381          [(iii)] (c) control of information contained in the database.
             382          (4) The pharmacist in charge shall, regarding each controlled substance dispensed by a
             383      pharmacist under his supervision other than those dispensed for an inpatient at a health care
             384      facility, submit to the manager of the database the following information, by a procedure and in
             385      a format established by the division:
             386          (a) name of the prescribing practitioner;
             387          (b) date of the prescription;
             388          (c) date the prescription was filled;
             389          (d) name of the person for whom the prescription was written;
             390          (e) positive identification of the person receiving the prescription, including the type of
             391      identification and any identifying numbers on the identification;
             392          (f) name of the controlled substance;
             393          (g) quantity of controlled substance prescribed;
             394          (h) strength of controlled substance;
             395          (i) quantity of controlled substance dispensed;
             396          (j) dosage quantity and frequency as prescribed;
             397          (k) name of drug outlet dispensing the controlled substance;
             398          (l) name of pharmacist dispensing the controlled substance; and
             399          (m) other relevant information as required by division rule.


             400          (5) The division shall maintain the database in an electronic file or by other means
             401      established by the division to facilitate use of the database for identification of:
             402          (a) prescribing practices and patterns of prescribing and dispensing controlled
             403      substances;
             404          (b) practitioners prescribing controlled substances in an unprofessional or unlawful
             405      manner;
             406          (c) individuals receiving prescriptions for controlled substances from licensed
             407      practitioners, and who subsequently obtain dispensed controlled substances from a drug outlet
             408      in quantities or with a frequency inconsistent with generally recognized standards of dosage for
             409      that controlled substance; and
             410          (d) individuals presenting forged or otherwise false or altered prescriptions for
             411      controlled substances to a pharmacy.
             412          (6) (a) The division shall by rule establish the electronic format in which the
             413      information required under this section shall be submitted to the administrator of the database.
             414          (b) The division shall ensure the database system records and maintains for reference:
             415          (i) identification of each person who requests or receives information from the
             416      database;
             417          (ii) the information provided to each person; and
             418          (iii) the date and time the information is requested or provided.
             419          (7) The division shall make rules in collaboration with the committee to:
             420          (a) effectively enforce the limitations on access to the database as described in
             421      Subsection (8); and
             422          (b) establish standards and procedures to ensure accurate identification of individuals
             423      requesting information or receiving information without request from the database.
             424          (8) The manager of the database shall make information in the database available only
             425      to the following persons, and in accordance with the limitations stated and division rules:
             426          (a) personnel of the division specifically assigned to conduct investigations related to
             427      controlled substances laws under the jurisdiction of the division;
             428          (b) authorized division personnel engaged in analysis of controlled substance
             429      prescription information as a part of the assigned duties and responsibilities of their
             430      employment;


             431          (c) employees of the Department of Health whom the director of the Department of
             432      Health assigns to conduct scientific studies regarding the use or abuse of controlled substances,
             433      provided that the identity of the individuals and pharmacies in the database are confidential and
             434      are not disclosed in any manner to any individual who is not directly involved in the scientific
             435      studies;
             436          [(c)] (d) a licensed practitioner having authority to prescribe controlled substances, to
             437      the extent the information relates specifically to a current patient of the practitioner, to whom
             438      the practitioner is prescribing or considering prescribing any controlled substance;
             439          [(d)] (e) a licensed pharmacist having authority to dispense controlled substances to the
             440      extent the information relates specifically to a current patient to whom that pharmacist is
             441      dispensing or considering dispensing any controlled substance;
             442          [(e)] (f) federal, state, and local law enforcement authorities engaged as a specified
             443      duty of their employment in enforcing laws regulating controlled substances; and
             444          [(f)] (g) an individual who is the recipient of a controlled substance prescription
             445      entered into the database, upon providing evidence satisfactory to the database manager that the
             446      individual requesting the information is in fact the person about whom the data entry was
             447      made.
             448          (9) Any person who knowingly and intentionally releases any information in the
             449      database in violation of the limitations under Subsection (8) is guilty of a third degree felony.
             450          (10) Any person who obtains or attempts to obtain information from the database by
             451      misrepresentation or fraud is guilty of a third degree felony.
             452          (11) (a) A person may not knowingly and intentionally use, release, publish, or
             453      otherwise make available to any other person or entity any information obtained from the
             454      database for any purpose other than those specified in Subsection (8). Each separate violation
             455      of this Subsection (11) is a third degree felony and is also subject to a civil penalty not to
             456      exceed $5,000.
             457          (b) The procedure for determining a civil violation of this Subsection (11) shall be in
             458      accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
             459          (c) Civil penalties assessed under this Subsection (11) shall be deposited in the General
             460      Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             461          (12) (a) The failure of a pharmacist in charge to submit information to the database as


             462      required under this section after the division has submitted a specific written request for the
             463      information or when the division determines the individual has a demonstrable pattern of
             464      failing to submit the information as required is grounds for the division to take the following
             465      actions in accordance with Section 58-1-401 :
             466          (i) refuse to issue a license to the individual;
             467          (ii) refuse to renew the individual's license;
             468          (iii) revoke, suspend, restrict, or place on probation the license;
             469          (iv) issue a public or private reprimand to the individual;
             470          (v) issue a cease and desist order; and
             471          (vi) impose a civil penalty of not more than $1,000 for each dispensed prescription
             472      regarding which the required information is not submitted.
             473          (b) Civil penalties assessed under Subsection (12)(a)(vi) shall be deposited in the
             474      General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             475          (c) The procedure for determining a civil violation of this Subsection (12) shall be in
             476      accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
             477          (13) An individual who has submitted information to the database in accordance with
             478      this section may not be held civilly liable for having submitted the information.
             479          (14) All department and the division costs necessary to establish and operate the
             480      database shall be funded by appropriations from:
             481          (a) the Commerce Service Fund; and
             482          (b) the General Fund.
             483          (15) All costs associated with recording and submitting data as required in this section
             484      shall be assumed by the submitting pharmacy.




Legislative Review Note
    as of 12-29-04 12:31 PM


Based on a limited legal review, this legislation has not been determined to have a high
probability of being held unconstitutional.

Office of Legislative Research and General Counsel


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