Commerce

Professional Licensing

Rule 37: Utah Controlled Substances Act Rule

Effective Date: 02/24/2025

Admin. Code Reference: R156-37

Rule Type: Current Rule

R156. Commerce, Professional Licensing.

R156-37. Utah Controlled Substances Act Rule.

R156-37-101. Title - Authority.

(1) This rule is known as the "Utah Controlled Substances Act Rule."

(2) This rule is adopted by the Division under the authority of Subsections 58-1-106(1)(a) and 58-37-6(1)(a) to enable the Division to administer Title 58, Chapter 37, Utah Controlled Substances Act.

(3) The organization of this rule and its relationship to Rule R156-1 is as described in Section R156-1-101.

R156-37-102. Definitions.

Terms used in this rule are defined in Title 58, Chapter 1, Division of Professional Licensing Act, and Title 58, Chapter 37, Utah Controlled Substances Act. In addition:

(1) "DEA" means the Drug Enforcement Administration of the United States Department of Justice.

(2) "Electronic Controlled Substance Prescribing Extension" means the prescribing practitioner or pharmacy has a controlled substance designation class indicated on the license, approved by the Division under Section R156-37-610, and does not participate in electronic prescriptions for controlled substances.

(3) "Emergency situation" for purposes of Subsection 58-37-6(7)(c)(iii) and Section R156-37-605 for emergency verbal prescriptions, Subsection 58-37-6(7)(d) for prescription signature and information requirements, and Subsection 58-37-22(1)(e) for electronic prescription requirements:

(a) means a situation in which the prescribing practitioner who intends to prescribe a controlled substance, or the pharmacy that intends to dispense a controlled substance, has determined that:

(i) the controlled substance prescription cannot be issued, filled, compounded, dispensed, or transmitted electronically as an electronic prescription in compliance with the statutory requirement without causing a delay;

(ii) the delay would adversely impact the patient's medical condition; and

(iii) the prompt prescribing or dispensing of the controlled substance is necessary for the proper treatment of the patient; and

(b) includes a situation when a prescription is written for an emergent or urgent condition:

(i) at a time when the prescribing practitioner is not reasonably able to transmit an electronic prescription to the patient's desired pharmacy for dispensing; or

(ii) after normal pharmacy business hours including weekends, holidays, late evening or overnight, and the patient cannot fill the prescription secondary to limited access to 24-hour pharmacy locations and no access to their regular pharmacy.

(4) "Forward" in Subsection R156-37-609(4)(a) means an original unfilled electronic controlled substance prescription.

(5) "NABP" means the National Association of Boards of Pharmacy.

(6) "Principal place of business or professional practice" in Subsection 58-37-6(2)(e), means any location where controlled substances are received or stored.

(7) "Schedule II controlled stimulant" means any material, compound, mixture, or preparation listed in Subsection 58-37-4(2)(b)(iii).

(8) "SBIRT training" means training in the Screening, Brief Intervention, and Referral to Treatment approach used by the federal Substance Abuse and Mental Health Services Administration, as defined in Subsection 58-37-6.5(1)(e) .

(9) "Technical difficulty or electronic failure" in Subsection 58-37-22(1)(d) means a loss of electrical power or internet service, a failure of a computer system, application, or device, or other service interruption to a computer system that reasonably prevents:

(a) a practitioner from transmitting an electronic controlled substance prescription to a pharmacy;

(b) a pharmacy from receiving an electronic controlled substance prescription or transmitting an electronic controlled substance prescription to a different pharmacy in accordance with Subsection 58-37-22(3); or

(c) compliance by a practitioner or a pharmacy with the requirements of state or federal law, including 21 CFR Part 1311 (April 1, 2024), which is incorporated by reference.

(10) "Unprofessional conduct" as defined in Title 58, Occupations and Professions, is further defined in accordance with Subsections 58-1-203(1)(e) and 58-37-6(1)(a), in Section R156-37-502.

R156-37-301. License Classifications - Restrictions.

(1) Under Subsection 58-37-6(2), the Division may issue a controlled substance license to:

(a) a qualified person licensed in good standing in the classification of:

(i) pharmacist;

(ii) optometrist;

(iii) podiatric physician;

(iv) dentist;

(v) osteopathic physician and surgeon;

(vi) physician and surgeon;

(vii) physician assistant;

(viii) veterinarian;

(ix) advanced practice registered nurse or advanced practice registered nurse-certified registered nurse anesthetist;

(x) certified nurse midwife;

(xi) naturopathic physician;

(xii) anesthesiologist assistant;

(xiii) Class A pharmacy under Subsection R156-17b-302(1);

(xiv) Class B pharmacy under Subsection R156-17b-302(2);

(xv) Class C pharmacy under Subsection R156-17b-302(3);

(xvi) Class D pharmacy under Subsection R156-17b-302(4); or

(xvii) Class E pharmacy under Subsection R156-17b-302(5); or

(xvii) the Utah Department of Corrections, for the conduct of execution by the administration of lethal injection in accordance with Section 77-18-113.

(2) The Division may restrict a controlled substance license to the extent the Division, in collaboration with the appropriate licensing boards, determines necessary to protect the health, safety, or welfare of:

(a) the public; or

(b) the licensee.

(3) A person holding a restricted controlled substance license may use the license only to the extent of the restricted terms and conditions.

R156-37-302. Qualifications for Licensure - Application Requirements.

(1) An applicant for a controlled substance license shall:

(a) submit an application in a form prescribed by the Division;

(b) pay the fee established by the Division under Section 63J-1-504; and

(3) The Division and the reviewing board may request from the applicant information that is reasonable and necessary to permit an evaluation of:

(a) the applicant's qualifications to engage in practice with controlled substances; and

(b) the public interest in the issuance of a controlled substance license to the applicant.

(4) To determine if an applicant is qualified for licensure, the Division may:

(a) assign the application to a qualified and appropriate licensing board for review and recommendation to the Division; and

(b) conduct site inspections, review research protocol, conduct interviews with persons knowledgeable about the applicant, and conduct any other investigation that is reasonable and necessary to determine the applicant is qualified to receive a controlled substance license.

R156-37-305. Qualifications for Licensure -- Drug Enforcement Administration (DEA) Registration - Active License.

(1)(a) Except as specified in Subsection (1)(b), an individual who obtains a controlled substance license shall obtain a DEA registration within 120 days of the date the controlled substance license is issued.

(b) A controlled substance licensee who has written consent from the licensee's employer to use the employer's hospital or institution DEA registration to administer or prescribe controlled substances, or both, is not required to obtain an individual practitioner DEA registration.

(2) A person who holds a controlled substance license shall maintain their license under Subsection R156-37-301(1) active and in good standing.

(3) If a person's license under Subsection R156-37-301(1) expires or is revoked, surrendered, or suspended, the Division shall:

(a) immediately suspend the person's controlled substance license; and

(b) reinstate the person's controlled substance license only upon reinstatement of the underlying license, without further administrative action that would be grounds for the continued denial of the controlled substance license.

R156-37-306. Exemption from Licensure -- Law Enforcement Personnel, University Research, Narcotic Detection Training of Animals, and Animal Control.

Under Subsection 58-37-6(2)(d), the following persons are exempt from licensure under Title 58, Chapter 37, Utah Controlled Substances Act:

(1)(a) except as specified in Subsection (1)(b), law enforcement agencies and their sworn personnel, to the extent their official duties require them to possess controlled substances, if they:

(i) act within the scope of their enforcement responsibilities;

(ii) maintain accurate records of controlled substances that come into their possession; and

(iii) maintain an effective audit trail;

(b) law enforcement personnel may not purchase or possess controlled substances for administration to animals unless the purchase or possession is in accordance with a controlled substance license;

(2) individuals and entities engaged in research using pharmaceuticals as defined in Subsection 58-17b-102(66) within a research facility as defined in Subsection R156-17b-102(48); and

(3) individuals employed by a facility engaged in the following activities, if the facility employing that individual has a controlled substance license in Utah and a DEA registration number, and uses the controlled substances according to a written protocol:

(a) narcotic detection training of animals for law enforcement use; or

(b) animal control, including:

(i) animal euthanasia; or

(ii) animal immobilization.

R156-37-401. Grounds for Denial of License - Disciplinary Proceedings.

Grounds for refusing to issue a license to an applicant, for refusing to renew the license of a licensee, for revoking, suspending, restricting, or placing on probation the license of a licensee, for issuing a public or private reprimand to a licensee, and for issuing a cease and desist order shall be in accordance with Section 58-1-401.

R156-37-402. Continuing Education for Controlled Substance Prescribers.

Under Section 58-37-6.5, qualified continuing professional education requirements for controlled substance prescribers are further established as follows:

(1) Continuing education under this section shall:

(a) be prepared and presented by individuals who are qualified by education, training, and experience to provide the controlled substance prescriber continuing education; and

(b) have a method of verification of attendance and a post-course knowledge assessment or examination.

(2) Under Subsections 58-37-6.5(2)(b), 58-37-6.5(5), 58-37-6.5(7), and 58-37-6.5(8), the controlled substance prescribing classes and SBIRT training that satisfy the Division's continuing education requirements for license renewal, and that are delivered by an accredited or approved continuing education provider recognized by the Division as offering appropriate continuing education, are posted on the Division's website at dopl.utah.gov.

(3) The Division shall recognize credit for continuing education as follows:

(a) allow unlimited hours for continuing education completed in blocks of time of at least 50 minutes;

(b) prorate from date of licensure continuing education hours for licensees who have not been licensed for the entire two-year period; and

(c) under Subsection 58-37f-304(3), waive the required 1/2 hour of continuing education for the online tutorial and test relating to the controlled substance database if the prescriber attests on the license renewal form that:

(i) in the past license period, the prescriber accessed the controlled substance database; and

(ii) upon the prescriber's information and belief, the prescriber's use of the database reduced the prescribing, dispensing, and use of opioids in an unprofessional or unlawful manner, or in quantities or frequencies inconsistent with generally recognized standards of dosage for an opioid.

(4)(a) A licensee shall maintain documentation sufficient to prove the licensee's compliance with Section 58-37-6.5 and this section, for a period of two years after the end of the renewal cycle for which the continuing education is due.

(b) The Division may review controlled substance database usage by the prescriber or proxy to audit an attestation under Subsection (3)(c).

R156-37-502. Unprofessional Conduct.

"Unprofessional conduct" includes:

(1) as a licensee with authority to prescribe or administer controlled substances:

(a) prescribing or administering to oneself any Schedule II or III controlled substance that is not lawfully prescribed by another licensed practitioner having authority to prescribe the drug;

(b) prescribing or administering a controlled substance for a condition that the licensee is not licensed or competent to treat;

(2) violating a federal or state law relating to controlled substances;

(3) failing to deliver to the Division each controlled substance license certificate issued by the Division upon an action that revokes, suspends, or limits the license;

(4) failing to maintain controls over controlled substances that a prudent licensee would maintain as effective against diversion, theft, or shortage of controlled substances;

(5) failing to account for shortages of controlled substance inventory for which the licensee has responsibility;

(6) knowingly prescribing, selling, giving away, or administering, directly or indirectly, or offering to prescribe, sell, furnish, give away, or administer any controlled substance to a drug dependent person, as defined in Subsection 58-37-2(1)(s), except for legitimate medical purposes as permitted by law;

(7) refusing to make available for inspection controlled substance stock, inventory, or records as required under Rule R156-37 or other law regulating controlled substances and controlled substance records;

(8) failing to submit controlled substance prescription information to the Database Manager after being notified in writing by the Division to do so;

(9) failing to get a DEA registration within the time frame in Section R156-37-305;

(10) as a prescribing practitioner, failing to seek to correct a technical difficulty or electronic failure under Subsection 58-37-22(1)(d) that is reasonably within the prescribing practitioner's control; or

(11) as a pharmacy, failing to seek to correct a technical difficulty or electronic failure under Subsection 58-37-22(1)(d) that is reasonably within the pharmacy's control.

R156-37-601. Access to Records, Facilities, and Inventory.

During regular business hours, and at other reasonable times, each applicant for licensure and licensee shall make available for inspection to a person authorized to conduct an administrative inspection under federal law, Title 58, Chapter 37, Utah Controlled Substances Act, or Rule R156-37, their:

(1) controlled substance stock or inventory;

(2) records required in accordance with state and federal laws and rules; and

(3) facilities related to activities involving controlled substances.

R156-37-602. Records.

(1)(a) Records of controlled substances shall be kept in accordance with state and federal laws and rules for their:

(i) purchase;

(ii) distribution;

(iii) dispensing;

(iv) prescribing and

(v) administration.

(b) Prescribing practitioners shall keep accurate records for each patient reflecting:

(i) examination;

(ii) evaluation; and

(iii) treatment.

(i) accurately reflect the prescription or administration of controlled substances in the treatment of the patient;

(ii) the purpose for which the controlled substance is utilized; and

(iii) information upon which the diagnosis is based.

(d) Practitioners shall keep records apart from patient records of each controlled substance purchased, and with respect to each controlled substance, its disposition, whether by administration or any other means, date of disposition, to whom given, and the quantity given.

(2) A licensee who experiences any theft, including diversion, or significant loss of controlled substances shall immediately:

(a) file the appropriate forms with the DEA, with a copy to the Division directed to the attention of the Investigation Bureau; and

(b) report the incident to the local law enforcement agency.

(3) Each record required by federal and state laws or rules shall be maintained by the licensee for five years. If a licensee sells or transfers ownership of records in any way, those records shall be maintained separately from other records of the new owner.

(4) Prescription records may be maintained electronically if:

(a) the original of each prescription, including telephone prescriptions, is maintained in a physical file and contains the information required by federal and state law; and

(b) an automated data processing system is used for the storage and immediate retrieval of refill information for prescription orders for controlled substances in Schedule III and IV, in accordance with federal guidelines.

(5) Each record relating to Schedule II controlled substances received, purchased, administered, or dispensed by the practitioner shall be maintained separately from other records of the pharmacy or practice.

(6) Each record relating to Schedules III, IV, and V controlled substances received, purchased, administered, or dispensed by the practitioner shall be maintained separately from other records of the pharmacy or practice.

R156-37-603. Restrictions Upon the Prescription, Dispensing, and Administration of Controlled Substances.

(1) A practitioner may prescribe or administer the Schedule II controlled substance cocaine hydrochloride only as:

(a) a topical anesthetic for mucous membranes in surgical situations in which it is indicated; and

(b) as local anesthetic for the repair of facial and pediatric lacerations, if the controlled substance is mixed and dispensed by a licensed pharmacist in the proper formulation and dosage.

(2) A practitioner may not prescribe or administer a controlled substance without taking into account the drug's potential for abuse, and the possibility:

(a) that the drug may lead to dependence;

(b) that patient may get the drug for a nontherapeutic use or to distribute to others; and

(3) Under Subsection 58-37-6(7)(f)(vii), unless the prescribing practitioner determines there is a valid medical reason to allow an earlier dispensing date, the dispensing date of a second or third prescription shall be at least 30 days from the dispensing date of the previous prescription, to allow for receipt of the subsequent prescription before the previous prescription runs out.

(4)(a) If a practitioner fails to document the practitioner's intentions relative to refills of controlled substances in Schedules III through V on a prescription form, it shall mean no refills are authorized.

(b) A refill is not permitted on a prescription for a Schedule II controlled substance.

(5) Refills of controlled substance prescriptions shall be permitted for the following periods from the original date of the prescription:

(a) Schedules III and IV, for six months from the original date of the prescription; and

(b) Schedule V, for one year from the original date of the prescription.

(6) A refill may not be dispensed until sufficient time has passed since the date of the last dispensing that 80% of the medication in the previous dispensing should have been consumed if taken according to the prescribing practitioner's instruction.

(7) A controlled substance prescription may not be issued or dispensed without specific instructions from the prescribing practitioner on how and when the drug is to be used.

(8) Refills after expiration of the original prescription term shall require issuance of a new prescription by the prescribing practitioner.

(9) Each prescription for a controlled substance and the number of refills authorized shall be documented in the patient records by the prescribing practitioner.

(10) A practitioner may prescribe, dispense, or administer a Schedule II controlled stimulant when indicated if, before initiating treatment using the Schedule II controlled stimulant, the practitioner:

(a) obtains an appropriate history and physical examination;

(b) rules out the existence of recognized contraindications; and

(c) has no reason to believe that the patient has consumed or disposed of any controlled stimulant other than in compliance with the treating practitioner's directions.

R156-37-604. Prescribing of Controlled Substances for Weight Reduction or Control.

(1) A practitioner may not prescribe, dispense, or administer a Schedule II or Schedule III controlled substance for weight reduction or control.

(2) A prescribing practitioner may prescribe or administer a Schedule IV controlled substance in treating excessive weight leading to increased health risks only if the prescribing practitioner complies with each of the following conditions:

(a) medication is used only as an adjunct to a comprehensive weight loss program based on supplemental weight loss activities including changing lifestyle counseling, nutritional education, and a regular, individualized exercise regimen;

(b) before initiating treatment the prescribing practitioner:

(i) determines through thorough review of past medical records that the patient has made a substantial good-faith effort to lose weight in a comprehensive weight loss program without the use of controlled substances, and the previous regimen has not been effective;

(ii) obtains a complete history, performs a complete physical examination of the patient, and rules out the existence of recognized contraindications to the use of the medication;

(iii) determines and documents the assessment in the patient's medical record, that the health benefit to the patient greatly outweighs the possible risks of the medications prescribed; and

(iv) discusses with the patient the possible risks associated with the medication, and has on record an informed consent that clearly documents that the long term effects of using controlled substances for weight loss or weight control are not known;

(i) supervises, oversees, and regularly monitors the patient, including the patient's participation in supplemental weight loss activities, efficacy of the medication, and advisability of continuing to prescribe the weight loss or weight control medication; and

(ii) maintains a central medical record that contains at least the following information:

(A) the goal of treatment or target weight;

(B) the ongoing progress toward that goal or maintenance of the weight loss;

(C) the patient's supplemental weight loss activities with documentation of compliance with the comprehensive weight loss program; and

(d) the prescribing practitioner shall immediately discontinue the weight loss medication if:

(i) the practitioner knows or should know that the patient is pregnant;

(ii) the patient has consumed or disposed of any controlled substance other than in compliance with the prescribing practitioner's directions;

(iii) the patient is abusing the controlled substance being prescribed for weight loss;

(iv) the patient develops a contraindication of therapy;

(v) the medication is not effective; or

(vi) the patient is not complying with the agreed upon comprehensive weight loss program.

R156-37-605. Emergency Verbal Prescription of Schedule II Controlled Substances.

(1) Under Subsection 58-37-6(7), in an emergency situation a prescribing practitioner may give an oral prescription for a Schedule II controlled substance if:

(a) the quantity dispensed is only sufficient to cover the patient for the emergency period, not to exceed 72 hours;

(b)(i) the prescribing practitioner has examined the patient within the past 30 days;

(ii) the patient is under the continuing care of the prescribing practitioner for a chronic disease or ailment; or

(iii) the prescribing practitioner is covering for another practitioner and has knowledge of the patient's condition; and

(2) Under Subsection 58-37-6(7), in an emergency situation a pharmacist may fill an oral prescription from a prescribing practitioner for a Schedule II controlled substance if:

(a) the amount does not exceed a 72 hour supply; and

(b) the pharmacist reasonably believes, or makes a reasonable effort to determine, that the prescribing practitioner is licensed to prescribe the controlled substance.

R156-37-606. Disposal of Controlled Substances.

(1) A licensee shall dispose of controlled substances in accordance with 21 CFR Part 1317 (July 26, 2022) which is incorporated by reference.

(2) A licensee who disposes of controlled substances shall:

(a) maintain records of the disposal for five years from the date of disposal; and

(b) make the records available for inspection upon request to the Division or its agents.

R156-37-607. Surrender of Suspended or Revoked License.

(1) A licensee whose license has been restricted, suspended, or revoked shall surrender the license to the Division within 30 days of the effective date of the order.

(2) The Division shall consider compliance with this section in evaluating an application for relicensing.

R156-37-608. Restricted Applicability - Herbs, Herbal Products, or Food Supplements.

Under Section 58-37-2.5, the Division may not apply Title 58, Chapter 37, Utah Controlled Substance Act or Rule R156-37 to restrict citizens or practitioners, regardless of their license status, from the sale or use of herbs, herbal products, or food supplements that are not scheduled as controlled substances by state or federal law.

R156-37-609. Electronic Prescriptions for Controlled Substances.

(1) Under Subsection 58-37-22(2)(a), a prescribing practitioner or pharmacy experiencing a temporary technical difficulty or electronic failure under Subsection 58-37-22(1)(d) shall document the nature of the technical difficulty or electronic failure on the prescription's hard copy.

(2) A pharmacist who receives a written, oral, or faxed controlled substance prescription is not required to verify that the prescription qualifies for an exemption under this section, and may dispense and deliver medication from an otherwise valid written, oral, or faxed controlled substance prescription.

(3) Under Subsection 58-37-22(2)(c), a prescribing practitioner or pharmacy is exempt from the electronic prescription requirements of Section 58-37-22 if:

(a)(i)(A) the prescribing practitioner is licensed in a jurisdiction other than Utah; and

(B) the receiving pharmacy orally confirms the prescription with the prescribing practitioner;

(ii) the prescribing practitioner and dispensing pharmacy are the same entity;

(iii) the prescription is a Schedule II oral prescription issued in an emergency situation under Section R156-37-605;

(iv) the federal Food and Drug Administration requires the prescription to contain elements that cannot be included in an electronic prescription;

(v) the prescription drug is under a research protocol;

(vi) the prescription is for a medication that requires compounding two or more ingredients;

(vii) the prescribing practitioner or pharmacy is located in the geographic area of an emergency or disaster that is identified by the Centers for Medicaid (CMS) as a qualifying emergency or disaster on the CMS Electronic Prescribing for Controlled Substances (EPCS) website; or

(viii) the prescribing practitioner qualifies for a small prescriber exemption under Section R156-37-610; and

(b) the prescribing practitioner or pharmacy documents the exemption on the prescription's hard copy.

(4) Under Subsection 58-37-22(2)(e), if an originating pharmacy that has received an electronic controlled substance prescription cannot fill the prescription, the following protocol shall apply:

(a) if the pharmacy can electronically transmit the prescription, the pharmacy shall:

(i) contact the ultimate user to determine a pharmacy to receive the forward prescription; and

(ii) document in the automated pharmacy system the identity of the pharmacy receiving the forward prescription;

(b) if the pharmacy cannot electronically transmit the prescription:

(i) the pharmacy shall:

(A) contact the prescribing practitioner and state the pharmacy cannot fill or transmit the prescription;

(B) document in the automated pharmacy system the individual contacted at the prescribing office; and

(ii) the prescribing practitioner may electronically transmit a new prescription to a different pharmacy.

(5) Under Subsection 58-37-22(2)(f), an electronic prescription shall be issued and dispensed in accordance with 21 CFR Part 1311 (April 1, 2024), which is incorporated by reference.

R156-37-610. Small Prescriber Exemption.

(1)(a) A prescribing practitioner is automatically exempt from the electronic prescription requirements of Section 58-37-22 if the prescribing practitioner issues:

(i) 300 or fewer controlled substance prescriptions in a calendar year; or

(ii) 25 or fewer controlled substance prescriptions in a calendar month.

(b) The measurement in Subsection (1)(a) does not include or count any prescription in a measured calendar year or month that:

(i) is otherwise exempt from the electronic prescription requirement; or

(ii) is a prescription refill, except for a refill that is the first occurrence of the unique prescription in a measured calendar year.

(2) A prescribing practitioner does not need to register with or report data to the Division to be eligible for the small prescriber exemption of this section.

(3) The Division shall measure a prescribing practitioner's compliance with the small prescriber exemption based on the prescribing practitioner's National Provider Identifier (NPI) and by analyzing the prescribing practitioner's prescriptions recorded in the Controlled Substances Database created in Section 58-37f-201.

(4) A prescribing practitioner is responsible for monitoring their compliance with the small prescriber exemption, and may check their eligibility by accessing the Controlled Substance Database and reviewing their issued prescriptions.

(5)(a) If the Division determines that a prescribing practitioner is noncompliant with this section, the Division may send the prescribing practitioner a notice of noncompliance, and may take action against the prescribing practitioner for unprofessional conduct under Section R156-37-502.

(b) The Division may notify any prescribing practitioner at any time that the prescribing practitioner is not eligible for a small prescriber exemption under this section.

(c) A prescribing practitioner who receives notice from the Division under Subsection (5)(b) may not use the small prescriber exemption unless the prescribing practitioner receives subsequent written approval from the Division.

KEY: controlled substances, licensing

Date of Last Change: February 24, 2025

Notice of Continuation: October 1, 2026

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37-6(1)(a); 58-37f-301(1)