UT MPJE cheat sheet

Utah Pharmacy Practice Act = Utah Code Title 58, Chapter 17b; Utah Controlled Substances Act = Title 58, Chapter 37; Utah PDMP statute = Title 58, Chapter 37f.

DOPL (Division of Occupational and Professional Licensing), a division of the Utah Department of Commerce, administers and enforces the practice act; the Utah Board of Pharmacy is an advisory board.

Pharmacy rules appear in Utah Administrative Code R156-17b; controlled substance rules appear in R156-37; rules are adopted under the Utah Administrative Rulemaking Act, Title 63G, Chapter 3.

The federal Controlled Substances Act is 21 U.S.C. 801 et seq., implemented by DEA regulations at 21 C.F.R. Parts 1300-1321.

Federal law sets a floor for controlled substances: a state may impose stricter requirements (e.g., PDMP reporting, additional labeling) without being preempted.

Drug approval and marketing are governed by the FDCA (21 U.S.C. 355); prescription drug supply-chain security by DSCSA (21 U.S.C. 360eee et seq.).

The HIPAA Privacy and Security Rules (45 C.F.R. Parts 160 and 164) apply to pharmacies as covered entities.

DOPL authority includes investigating complaints, inspecting licensed premises, issuing citations, imposing discipline, and seeking court injunctions.

Utah Code 58-1-501 lists general grounds for discipline of all DOPL licensees; 58-17b-502 defines unprofessional conduct specific to pharmacy.

Utah licenses (rather than merely registers) pharmacists and pharmacy technicians; each license is issued by DOPL and can be verified through DOPL's online license lookup.

Every Utah pharmacy holds a site-specific pharmacy license; a change of location or ownership requires a new license or formal notice to the Division.

Each licensed pharmacy must designate a pharmacist-in-charge (PIC) who is accountable for compliance with drug laws and board rules.

A DEA registration, renewed every three years, is required in addition to state licensure for any pharmacy that handles controlled substances.

Utah separately requires a state controlled substance license from DOPL for practitioners and pharmacies that prescribe or dispense controlled substances.

Utah professional licenses renew biennially; pharmacists must complete board-approved continuing education (30 hours per two-year renewal cycle).

Nonresident pharmacies that ship, mail, or deliver prescription drugs to Utah patients must register with DOPL.

Practicing or dispensing on an expired or inactive license is unprofessional conduct and grounds for discipline.

Pharmacy interns must be registered with DOPL and may perform pharmacist functions only under pharmacist supervision.

A valid prescription must contain patient name, drug name/strength/dosage form, quantity, directions, date of issue, prescriber name and signature, and refills authorized.

Schedule II prescriptions may not be refilled; each dispensing requires a new prescription from the prescriber.

Schedule III-IV prescriptions may be refilled up to five times or within six months of the issue date, whichever occurs first.

Oral Schedule II orders are permitted only in a genuine emergency and must be followed by a written or electronic prescription within seven days.

A Schedule II prescription may be partially filled when the pharmacy lacks sufficient stock; the remainder must be supplied within 72 hours or a new prescription is required.

Non-controlled and Schedule III-V prescriptions may be transferred between pharmacies with required documentation; Schedule II prescriptions may not be transferred for refill.

Under the 2023 DEA rule, an electronic prescription for a Schedule II-V drug may be transferred one time between DEA-registered pharmacies for initial filling.

The pharmacist performing the final verification is responsible for confirming prescription validity, dose, interactions, and the prescriber's authority to prescribe.

Dispensing includes drug selection, preparation, packaging, labeling, and the offer of counseling; technicians may assist, but the pharmacist verifies the completed prescription.

CSA Schedule I drugs have no accepted medical use; Schedule II drugs have high abuse potential with severe dependence; Schedules III-V have progressively lower abuse potential.

A pharmacy takes a complete controlled substance inventory on the date its DEA registration begins and a biennial inventory every two years thereafter.

Schedule II records must be maintained separately from all other records; all controlled substance records are kept at least two years and made available for inspection.

Theft or significant loss of controlled substances must be reported in writing to the DEA field division within one business day of discovery, using DEA Form 106.

Controlled substances are destroyed using DEA Form 41 or transferred to a reverse distributor; pharmacies may also act as authorized collectors under DEA disposal rules.

The Utah Controlled Substances Database (Title 58-37f) receives dispenser reports of controlled substance dispensing and may be queried by authorized prescribers and pharmacists.

The prescriber must hold a valid DEA number and Utah controlled substance license; the pharmacist must resolve any doubt about prescriber authority before dispensing.

Schedule II drugs are ordered using DEA Form 222 or its electronic CSOS equivalent; the form must be completed accurately and retained as a record.

Prescription and controlled substance records must be retained at least two years and be readily retrievable for inspection by DEA, DOPL, and the Board.

DSCSA requires pharmacies to receive and keep transaction information, history, and statements and to verify product identifiers when investigating suspect product.

Suspect product must be quarantined and investigated; illegitimate product is reported to FDA and trading partners using Form FDA 3911.

On receipt of a recall notice, the pharmacy quarantines affected stock, documents the action taken, notifies patients when the recall directs, and returns product per instructions.

Class I recalls involve a reasonable probability of serious adverse health consequences or death; Class II and Class III recalls involve lower risk.

Expired, damaged, or recalled drugs must be segregated from active inventory and must never be dispensed.

Controlled substances may be returned only to a reverse distributor or authorized collector with documentation; they may not be returned to a wholesaler for credit.

Perpetual inventories and periodic audits of Schedule II drugs detect diversion; discrepancies must be investigated and documented.

Required label elements include pharmacy name, address, and phone; prescription number; date filled; patient name; prescriber; drug name, strength, and quantity; directions; refills; and beyond-use or expiration date.

Prescription labels for Schedule III-V controlled substances carry the federal warning that transfer of the prescription is prohibited.

A pharmacist must offer counseling on every new prescription and whenever the drug, dose, or dosage form changes; a patient's refusal must be documented.

Auxiliary labels are required for specific hazards, such as drowsiness or the need to take the drug with food.

HIPAA requires the minimum necessary use and disclosure of protected health information, a Notice of Privacy Practices, and breach notification.

Utah law gives patients access to their pharmacy records and imposes confidentiality duties; HIV, mental health, and substance use information receive extra protection.

Documented interventions, prescriber clarifications, and counseling refusals must be legible and retrievable on request.

Immunization records must be reported to the Utah Statewide Immunization Information System (USIIS) where required.

Utah pharmacists may administer immunizations under a prescriber's order or a standing order/protocol; minors require parental or guardian consent.

Utah allows pharmacists to dispense naloxone without an individual prescription under a protocol or standing order, with statutory immunity protections.

Utah's collaborative practice agreement statute in Title 58, Chapter 17b lets a pharmacist modify and manage drug therapy under a written agreement with a prescriber, with documentation and notification requirements.

Pharmacists may compound preparations pursuant to a patient-specific prescription; sterile compounding must follow USP <797> and nonsterile compounding USP <795>.

A 503B outsourcing facility must register with FDA and comply with current good manufacturing practice; it is not regulated as a traditional pharmacy.

Utah permits a pharmacist to dispense a prescription drug to a patient's authorized caregiver or agent where state law allows.

Pharmacy technicians may perform tasks delegated by a supervising pharmacist, but clinical judgment and patient counseling remain with the pharmacist.

Protocol-based dispensing authorities (immunizations, naloxone, and similar board-recognized protocols) do not require an individual patient prescription.

Unprofessional conduct under Utah Code 58-17b-502 includes dispensing without a valid prescription, practicing outside scope, falsifying records, and violating drug laws.

General grounds for DOPL discipline under 58-1-501 include fraud or deception, unprofessional conduct, impairment, violating a board order, and conviction of certain crimes.

Complaint process: DOPL investigation, notice of allegations, informal hearing, and, if unresolved, formal adjudication before an administrative law judge.

Available sanctions include citation or fine, remedial education, probation with monitoring, suspension, revocation, and public reprimand.

DOPL may issue cease and desist orders and seek injunctions to stop unlicensed or unlawful practice.

DEA administrative inspections of controlled substance records begin with a Notice of Inspection (DEA Form 82); if consent is refused, DEA must obtain an administrative warrant.

Final agency orders may be appealed to the Utah Court of Appeals.

Pharmacists must report suspected drug diversion or impaired practice; failure to report can itself constitute unprofessional conduct.