58-37-6 - License to manufacture, produce, distribute, dispense, administer, or conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records required -- Prescriptions.
58-37-6. License to manufacture, produce, distribute, dispense, administer, orconduct research -- Issuance by division -- Denial, suspension, or revocation -- Recordsrequired -- Prescriptions.
(1) (a) The division may adopt rules relating to the licensing and control of themanufacture, distribution, production, prescription, administration, dispensing, conducting ofresearch with, and performing of laboratory analysis upon controlled substances within this state.
(b) The division may assess reasonable fees to defray the cost of issuing original andrenewal licenses under this chapter pursuant to Section 63J-1-504.
(2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,administers, conducts research with, or performs laboratory analysis upon any controlledsubstance in Schedules II through V within this state, or who proposes to engage inmanufacturing, producing, distributing, prescribing, dispensing, administering, conductingresearch with, or performing laboratory analysis upon controlled substances included inSchedules II through V within this state shall obtain a license issued by the division.
(ii) The division shall issue each license under this chapter in accordance with a two-yearrenewal cycle established by rule. The division may by rule extend or shorten a renewal periodby 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 IIthrough V within this state may possess, manufacture, produce, distribute, prescribe, dispense,administer, conduct research with, or perform laboratory analysis upon those substances to theextent authorized by their license and in conformity with this chapter.
(c) The following persons are not required to obtain a license and may lawfully possesscontrolled 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 theusual course of the person's business or employment; however, nothing in this subsection shall beinterpreted to permit an agent, employee, sales representative, or detail man to maintain aninventory of controlled substances separate from the location of the person's employer'sregistered and licensed place of business;
(ii) a motor carrier or warehouseman, or an employee of a motor carrier orwarehouseman, who possesses any controlled substance in the usual course of the person'sbusiness or employment; and
(iii) an ultimate user, or any person who possesses any controlled substance pursuant to alawful order of a practitioner.
(d) The division may enact rules waiving the license requirement for certainmanufacturers, producers, distributors, prescribers, dispensers, administrators, researchpractitioners, 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 professionalpractice where the applicant manufactures, produces, distributes, dispenses, conducts researchwith, or performs laboratory analysis upon controlled substances.
(f) The division may enact rules providing for the inspection of a licensee or applicant'sestablishment, and may inspect the establishment according to those rules.
(3) (a) Upon proper application, the division shall license a qualified applicant tomanufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
controlled substances included in Schedules I through V, unless it determines that issuance of alicense is inconsistent with the public interest. The division shall not issue a license to anyperson to prescribe, dispense, or administer a Schedule I controlled substance. In determiningpublic interest, the division shall consider whether or not the applicant has:
(i) maintained effective controls against diversion of controlled substances and anySchedule I or II substance compounded from any controlled substance into other than legitimatemedical, 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 division establishes that promote the publichealth 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 controlledsubstances in Schedule I other than those specified in the license.
(c) (i) Practitioners shall be licensed to administer, dispense, or conduct research withsubstances in Schedules II through V if they are authorized to administer, dispense, or conductresearch under the laws of this state.
(ii) The division need not require a separate license for practitioners engaging in researchwith nonnarcotic controlled substances in Schedules II through V where the licensee is alreadylicensed under this chapter in another capacity.
(iii) With respect to research involving narcotic substances in Schedules II through V, orwhere the division by rule requires a separate license for research of nonnarcotic substances inSchedules II through V, a practitioner shall apply to the division prior to conducting research.
(iv) Licensing for purposes of bona fide research with controlled substances by apractitioner considered qualified may be denied only on a ground specified in Subsection (4), orupon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard adequatelythe practitioner's supply of substances against diversion from medical or scientific use.
(v) Practitioners registered under federal law to conduct research in Schedule Isubstances may conduct research in Schedule I substances within this state upon furnishing thedivision evidence of federal registration.
(d) Compliance by manufacturers, producers, and distributors with the provisions offederal law respecting registration, excluding fees, entitles them to be licensed under this chapter.
(e) The division shall initially license those persons who own or operate an establishmentengaged in the manufacture, production, distribution, dispensation, or administration ofcontrolled 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, placedon probation, or revoked by the division 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, orany 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 statewithin five years of the date of the issuance of the license;
(iv) had a federal license denied, suspended, or revoked by competent federal authorityand is no longer authorized to engage in the manufacturing, distribution, or dispensing ofcontrolled substances;
(v) had the licensee's license suspended or revoked by competent authority of anotherstate for violation of laws or regulations comparable to those of this state relating to themanufacture, distribution, or dispensing of controlled substances;
(vi) violated any division rule that reflects adversely on the licensee's reliability andintegrity with respect to controlled substances;
(vii) refused inspection of records required to be maintained under this chapter by aperson authorized to inspect them; or
(viii) prescribed, dispensed, administered, or injected an anabolic steroid for the purposeof manipulating human hormonal structure so as to:
(A) increase muscle mass, strength, or weight without medical necessity and without awritten prescription by any practitioner in the course of the practitioner's professional practice; or
(B) improve performance in any form of human exercise, sport, or game.
(b) The division may limit revocation or suspension of a license to a particular controlledsubstance with respect to which grounds for revocation or suspension exist.
(c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant tothis section and in accordance with the procedures set forth in Title 58, Chapter 1, Division ofOccupational and Professional Licensing Act, and conducted in conjunction with the appropriaterepresentative committee designated by the director of the department.
(ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and ProfessionalLicensing exclusive authority in proceedings to deny, revoke, or suspend licenses, except wherethe division is designated by law to perform those functions, or, when not designated by law, isdesignated by the executive director of the Department of Commerce to conduct the proceedings.
(d) (i) The division may suspend any license simultaneously with the institution ofproceedings under this section if it finds there is an imminent danger to the public health orsafety.
(ii) Suspension shall continue in effect until the conclusion of proceedings, includingjudicial review, unless withdrawn by the division or dissolved by a court of competentjurisdiction.
(e) (i) If a license is suspended or revoked under this Subsection (4), all controlledsubstances owned or possessed by the licensee may be placed under seal in the discretion of thedivision.
(ii) Disposition may not be made of substances under seal until the time for taking anappeal 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 division shall notify promptly the Drug Enforcement Administration of all orderssuspending or revoking a license and all forfeitures of controlled substances.
(5) (a) Persons licensed under Subsection (2) or (3) shall maintain records andinventories in conformance with the record keeping and inventory requirements of federal andstate law and any additional rules issued by the division.
(b) (i) Every physician, dentist, naturopathic physician, veterinarian, practitioner, or otherperson 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, orprofessionally used by him otherwise than by a prescription.
(ii) A person using small quantities or solutions or other preparations of those drugs forlocal application has complied with this Subsection (5)(b) if the person keeps a record of thequantity, 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 licenseeand pursuant to an order form prepared in compliance with division rules or a lawful order underthe rules and regulations of the United States.
(7) (a) A person may not write or authorize a prescription for a controlled substanceunless the person is:
(i) a practitioner authorized to prescribe drugs and medicine under the laws of this stateor under the laws of another state having similar standards; and
(ii) licensed under this chapter or under the laws of another state having similarstandards.
(b) A person other than a pharmacist licensed under the laws of this state, or thepharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304, may notdispense a controlled substance.
(c) (i) A controlled substance may not be dispensed without the written prescription of apractitioner, if the written prescription is required by the federal Controlled Substances Act.
(ii) That written prescription shall be made in accordance with Subsection (7)(a) and inconformity with Subsection (7)(d).
(iii) In emergency situations, as defined by division rule, controlled substances may bedispensed upon oral prescription of a practitioner, if reduced promptly to writing on formsdesignated by the division and filed by the pharmacy.
(iv) Prescriptions reduced to writing by a pharmacist shall be in conformity withSubsection (7)(d).
(d) Except for emergency situations designated by the division, a person may not issue,fill, compound, or dispense a prescription for a controlled substance unless the prescription issigned by the prescriber in ink or indelible pencil or is signed with an electronic signature of theprescriber as authorized by division rule, 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 isissued;
(iii) the date of issuance of the prescription; and
(iv) the name, quantity, and specific directions for use by the ultimate user of thecontrolled substance.
(e) A prescription may not be written, issued, filled, or dispensed for a Schedule Icontrolled substance.
(f) Except when administered directly to an ultimate user by a licensed practitioner,controlled substances are subject to the following restrictions:
(i) (A) A prescription for a Schedule II substance may not be refilled.
(B) A Schedule II controlled substance may not be filled in a quantity to exceed aone-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 berefilled 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'sprescription directs, but they may not be refilled one year after the date the prescription wasissued unless renewed by the practitioner.
(iv) Any prescription for a Schedule II substance may not be dispensed if it is notpresented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 daysafter the date the prescription was issued, or 30 days after the dispensing date, if that date isspecified separately from the date of issue.
(v) A practitioner may issue more than one prescription at the same time for the sameSchedule II controlled substance, but only under the following conditions:
(A) no more than three prescriptions for the same Schedule II controlled substance maybe 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 fordispensing; and
(D) unless the practitioner determines there is a valid medical reason to the contrary, thedate for dispensing a second or third prescription may not be fewer than 30 days from thedispensing date of the previous prescription.
(vi) Each prescription for a controlled substance may contain only one controlledsubstance 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 inpatientor an outpatient of a licensed hospital is exempt from all requirements of this Subsection (7) ifthe order is:
(i) issued or made by a prescribing practitioner who holds an unrestricted registrationwith the federal Drug Enforcement Administration, and an active Utah controlled substancelicense in good standing issued by the division under this section, or a medical resident who isexempted from licensure under Subsection 58-1-307(1)(c);
(ii) authorized by the prescribing practitioner treating the patient and the prescribingpractitioner designates the quantity ordered;
(iii) entered upon the record of the patient, the record is signed by the prescriberaffirming the prescriber's authorization of the order within 48 hours after filling or administeringthe order, and the patient's record reflects the quantity actually administered; and
(iv) filled and dispensed by a pharmacist practicing the pharmacist's profession withinthe physical structure of the hospital, or the order is taken from a supply lawfully maintained bythe hospital and the amount taken from the supply is administered directly to the patientauthorized to receive it.
(h) A practitioner licensed under this chapter may not prescribe, administer, or dispense acontrolled substance to a child, without first obtaining the consent required in Section 78B-3-406of a parent, guardian, or person standing in loco parentis of the child except in cases of anemergency. For purposes of this Subsection (7)(h), "child" has the same meaning as defined inSection 78A-6-105, and "emergency" means any physical condition requiring the administrationof a controlled substance for immediate relief of pain or suffering.
(i) A practitioner licensed under this chapter may not prescribe or administer dosages ofa 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 dispenseany 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 acontrolled substance may not manufacture, distribute, or dispense a controlled substance toanother 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 asymbol 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 furnishany record notification, order form, statement, invoice, or information required under thischapter.
(n) A person licensed under this chapter may not refuse entry into any premises forinspection as authorized by this chapter.
(o) A person licensed under this chapter may not furnish false or fraudulent materialinformation in any application, report, or other document required to be kept by this chapter orwillfully make any false statement in any prescription, order, report, or record required by thischapter.
(8) (a) (i) Any person licensed under this chapter who is found by the division to haveviolated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a penalty not toexceed $5,000. The division shall determine the procedure for adjudication of any violations inaccordance with Sections 58-1-106 and 58-1-108.
(ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in theGeneral Fund as a dedicated credit to be used by the division under Subsection 58-37f-502(1).
(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 tounlawfully procure, or to procure the administration of, a controlled substance is not consideredto be a privileged communication.
Amended by Chapter 287, 2010 General Session