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H.B. 128 Enrolled

                 

CONTROLLED SUBSTANCES ACT

                 
AMENDMENTS

                 
2002 GENERAL SESSION

                 
STATE OF UTAH

                 
Sponsor: Eli H. Anderson

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


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

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                  where the applicant manufactures, produces, distributes, prescribes, dispenses, administers, conducts
                  research with, or performs laboratory analysis upon controlled substances.
                      (f) The department may enact rules providing for the inspection of a licensee or applicant's
                  establishment, and may inspect the establishment according to those rules.
                      (3) (a) Upon proper application, the department shall license a qualified applicant to
                  manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
                  controlled substances included in Schedules I through V, unless it determines that issuance of a
                  license is inconsistent with the public interest. The department shall not issue a license to any person
                  to prescribe, dispense, or administer a Schedule I controlled substance. In determining public
                  interest, the department shall consider whether or not the applicant has:
                      (i) maintained effective controls against diversion of controlled substances and any Schedule
                  I or II substance compounded from any controlled substance into other than legitimate medical,
                  scientific, or industrial channels;
                      (ii) complied with applicable state and local law;
                      (iii) been convicted under federal or state laws relating to the manufacture, distribution, or
                  dispensing of substances;
                      (iv) past experience in the manufacture of controlled dangerous substances;
                      (v) established effective controls against diversion; and
                      (vi) complied with any other factors that the department establishes that promote the public
                  health and safety.
                      (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
                  produce, distribute, conduct research with, or perform laboratory analysis upon controlled substances
                  in Schedule I other than those specified in the license.
                      (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
                  substances in Schedules II through V if they are authorized to administer, dispense, or conduct
                  research under the laws of this state.
                      (ii) The department need not require a separate license for practitioners engaging in research
                  with nonnarcotic controlled substances in Schedules II through V where the licensee is already

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                  licensed under this act in another capacity.
                      (iii) With respect to research involving narcotic substances in Schedules II through V, or
                  where the department by rule requires a separate license for research of nonnarcotic substances in
                  Schedules II through V, a practitioner shall apply to the department prior to conducting research.
                      (iv) Licensing for purposes of bona fide research with controlled substances by a practitioner
                  considered qualified may be denied only on a ground specified in Subsection (4), or upon evidence
                  that the applicant will abuse or unlawfully transfer or fail to safeguard adequately his supply of
                  substances against diversion from medical or scientific use.
                      (v) Practitioners registered under federal law to conduct research in Schedule I substances
                  may conduct research in Schedule I substances within this state upon furnishing the department
                  evidence of federal registration.
                      (d) Compliance by manufacturers, producers, and distributors with the provisions of federal
                  law respecting registration, excluding fees, entitles them to be licensed under this chapter.
                      (e) The department shall initially license those persons who own or operate an establishment
                  engaged in the manufacture, production, distribution, dispensation, or administration of controlled
                  substances prior to April 3, 1980, and who are licensed by the state.
                      (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed on
                  probation, or revoked by the department upon finding that the applicant or licensee has:
                      (i) materially falsified any application filed or required pursuant to this chapter;
                      (ii) been convicted of an offense under this chapter or any law of the United States, or any
                  state, relating to any substance defined as a controlled substance;
                      (iii) been convicted of a felony under any other law of the United States or any state within
                  five years of the date of the issuance of the license;
                      (iv) had a federal license denied, suspended, or revoked by competent federal authority and
                  is no longer authorized to engage in the manufacturing, distribution, or dispensing of controlled
                  substances;
                      (v) had his license suspended or revoked by competent authority of another state for
                  violation of laws or regulations comparable to those of this state relating to the manufacture,

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                  distribution, or dispensing of controlled substances;
                      (vi) violated any department rule that reflects adversely on the licensee's reliability and
                  integrity with respect to controlled substances;
                      (vii) refused inspection of records required to be maintained under this chapter by a person
                  authorized to inspect them; or
                      (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the purpose of
                  manipulating human hormonal structure so as to:
                      (A) increase muscle mass, strength, or weight without medical necessity and without a
                  written prescription by any practitioner in the course of his professional practice; or
                      (B) improve performance in any form of human exercise, sport, or game.
                      (b) The department may limit revocation or suspension of a license to a particular controlled
                  substance with respect to which grounds for revocation or suspension exist.
                      (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to this
                  section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
                  Occupational and Professional Licensing Act, and conducted in conjunction with the appropriate
                  representative committee designated by the director of the department.
                      (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and Professional
                  Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses, except where the
                  department is designated by law to perform those functions, or, when not designated by law, is
                  designated by the executive director of the Department of Commerce to conduct the proceedings.
                      (d) (i) The department may suspend any license simultaneously with the institution of
                  proceedings under this section if it finds there is an imminent danger to the public health or safety.
                      (ii) Suspension shall continue in effect until the conclusion of proceedings, including judicial
                  review, unless withdrawn by the department or dissolved by a court of competent jurisdiction.
                      (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
                  substances owned or possessed by the licensee may be placed under seal in the discretion of the
                  department.
                      (ii) Disposition may not be made of substances under seal until the time for taking an appeal

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                  has lapsed, or until all appeals have been concluded, unless a court, upon application, orders the sale
                  of perishable substances and the proceeds deposited with the court.
                      (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
                      (f) The department shall notify promptly the Drug Enforcement Administration of all orders
                  suspending or revoking a license and all forfeitures of controlled substances.
                      (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and inventories
                  in conformance with the record keeping and inventory requirements of federal and state law and any
                  additional rules issued by the department.
                      (b) (i) Every physician, dentist, veterinarian, practitioner, or other person who is authorized
                  to administer or professionally use a controlled substance shall keep a record of the drugs received
                  by him and a record of all drugs administered, dispensed, or professionally used by him otherwise
                  than by a prescription.
                      (ii) A person using small quantities or solutions or other preparations of those drugs for local
                  application has complied with Subsection (5)(b) if he keeps a record of the quantity, character, and
                  potency of those solutions or preparations purchased or prepared by him, and of the dates when
                  purchased or prepared.
                      (6) Controlled substances in Schedules I through V may be distributed only by a licensee and
                  pursuant to an order form prepared in compliance with department rules or a lawful order under the
                  rules and regulations of the United States.
                      (7) (a) A person may not write or authorize a prescription for a controlled substance unless
                  he is:
                      (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state or
                  under the laws of another state having similar standards; and
                      (ii) licensed under this chapter or under the laws of another state having similar standards.
                      (b) A person other than a pharmacist licensed under the laws of this state, or his licensed
                  intern, as required by Section 58-17a-302 , may not dispense a controlled substance.
                      (c) (i) A controlled substance may not be dispensed without the written prescription of a
                  practitioner, if the written prescription is required by the federal Controlled Substances Act.

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                      (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
                  conformity with Subsection (7)(d).
                      (iii) In emergency situations, as defined by department rule, controlled substances may be
                  dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
                  designated by the department and filed by the pharmacy.
                      (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with Subsection
                  (7)(d).
                      (d) Except for emergency situations designated by the department, a person may not issue,
                  fill, compound, or dispense a prescription for a controlled substance unless the prescription is signed
                  in ink or indelible pencil by the prescriber and contains the following information:
                      (i) the name, address, and registry number of the prescriber;
                      (ii) the name, address, and age of the person to whom or for whom the prescription is issued;
                      (iii) the date of issuance of the prescription; and
                      (iv) the name, quantity, and specific directions for use by the ultimate user of the controlled
                  substance.
                      (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I controlled
                  substance.
                      (f) Except when administered directly to an ultimate user by a licensed practitioner,
                  controlled substances are subject to the following restrictions:
                      (i) A prescription for a Schedule II substance may be refilled only upon the written
                  prescription of an authorized practitioner, and a prescription for a Schedule II controlled substance
                  may not be filled in a quantity to exceed a one-month's supply, as directed on the daily dosage rate
                  of the prescriptions.
                      (ii) A Schedule III or IV controlled substance may be filled only within six months of
                  issuance, and may not be refilled more than six months after the date of its original issuance or be
                  refilled more than five times after the date of the prescription unless renewed by the practitioner.
                      (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
                  prescription directs, but they may not be refilled one year after the date the prescription was issued

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                  unless renewed by the practitioner.
                      (iv) Any prescription for a Schedule II[, III, and IV] substance [that] may not be dispensed
                  if it is not presented to a pharmacist for dispensing by a pharmacist[,] or[, if an oral prescription, that
                  is not obtained] a pharmacy intern within [the time periods established by federal law may not be
                  filled or dispensed] 30 days after the date the prescription was issued, or 30 days after the dispensing
                  date, if that date is specified separately from the date of issue.
                      (v) A practitioner may issue more than one prescription at the same time for the same
                  Schedule II controlled substance, but only under the following conditions:
                      (A) no more than three prescriptions for the same Schedule II controlled substance may be
                  issued at the same time;
                      (B) no one prescription may exceed a 30-day supply;
                      (C) a second or third prescription shall include the date of issuance and the date for
                  dispensing; and
                      (D) unless the practitioner determines there is a valid medical reason to the contrary, the date
                  for dispensing a second or third prescription may not be fewer than 30 days from the dispensing date
                  of the previous prescription.
                      (vi) Each prescription for a controlled substance may contain only one controlled substance
                  per prescription form and may not contain any other legend drug or prescription item.
                      (g) An order for a controlled substance in Schedules II through V for use by an inpatient or
                  an outpatient of a licensed hospital is exempt from all requirements of this Subsection (7) if the order
                  is:
                      (i) issued or made by a prescribing practitioner who holds an unrestricted registration with
                  the federal Drug Enforcement Administration, and an active Utah controlled substance license in
                  good standing issued by the division under this section, or a medical resident who is exempted from
                  licensure under Subsection 58-1-307 (1)(c);
                      (ii) authorized by the prescribing practitioner treating the patient and the prescribing
                  practitioner designates the quantity ordered;
                      (iii) entered upon the record of the patient, the record is signed by the prescriber affirming

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                  his authorization of the order within 48 hours after filling or administering the order, and the patient's
                  record reflects the quantity actually administered; and
                      (iv) filled and dispensed by a pharmacist practicing his profession within the physical
                  structure of the hospital, or the order is taken from a supply lawfully maintained by the hospital and
                  the amount taken from the supply is administered directly to the patient authorized to receive it.
                      (h) A practitioner licensed under this chapter may not prescribe, administer, or dispense a
                  controlled substance to a minor, without first obtaining the consent required in Section 78-14-5 of
                  a parent, guardian, or person standing in loco parentis of the minor except in cases of an emergency.
                  For purposes of this Subsection (7)(h), "minor" has the same meaning as defined in Section
                  78-3a-103 , and "emergency" means any physical condition requiring the administration of a
                  controlled substance for immediate relief of pain or suffering.
                      (i) A practitioner licensed under this chapter may not prescribe or administer dosages of a
                  controlled substance in excess of medically recognized quantities necessary to treat the ailment,
                  malady, or condition of the ultimate user.
                      (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense any
                  controlled substance to another person knowing that the other person is using a false name, address,
                  or other personal information for the purpose of securing the controlled substance.
                      (k) A person who is licensed under this chapter to manufacture, distribute, or dispense a
                  controlled substance may not manufacture, distribute, or dispense a controlled substance to another
                  licensee or any other authorized person not authorized by this license.
                      (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a symbol
                  required by this chapter or by a rule issued under this chapter.
                      (m) A person licensed under this chapter may not refuse or fail to make, keep, or furnish any
                  record notification, order form, statement, invoice, or information required under this chapter.
                      (n) A person licensed under this chapter may not refuse entry into any premises for
                  inspection as authorized by this chapter.
                      (o) A person licensed under this chapter may not furnish false or fraudulent material
                  information in any application, report, or other document required to be kept by this chapter or

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                  willfully make any false statement in any prescription, order, report, or record required by this
                  chapter.
                      (8) (a) Any person licensed under this chapter who is found by the department to have
                  violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a fine not to exceed
                  $5,000. The department shall determine the procedure for adjudication of any violations in
                  accordance with Sections 58-1-106 and 58-1-108 .
                      (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (7)(j)
                  is:
                      (i) upon first conviction, guilty of a class B misdemeanor;
                      (ii) upon second conviction, guilty of a class A misdemeanor; and
                      (iii) on third or subsequent conviction, guilty of a third degree felony.
                      (c) Any person who knowingly and intentionally violates Subsections (7)(k) through (7)(o)
                  shall upon conviction be guilty of a third degree felony.
                      (9) Any information communicated to any licensed practitioner in an attempt to unlawfully
                  procure, or to procure the administration of, a controlled substance is not considered to be a
                  privileged communication.

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