10.1 Prescription Labels: Utah Minimum Elements, Controlled Substance & Opioid Warnings, and Special Labels

10.1 Prescription Labels: Utah Minimum Elements, Controlled Substance & Opioid Warnings, and Special Labels

Blueprint item 3.5 covers labeling of dispensed drugs. Utah's rules are in § 58-17b-602(5)–(8), § 58-37-112, R156-17b-614a(2), and several special-purpose provisions.

Minimum label elements (§ 58-17b-602(5)(a))

Every drug dispensed must have a securely affixed label showing at least:

1. the name, address, and telephone number of the pharmacy;
2. the serial (prescription) number the pharmacy assigned;
3. the filling date, or the last dispensing date;
4. the patient's name, or for an animal, the owner's name and the species;
5. the prescriber's name;
6. the directions for use and any cautionary statements in the prescription or otherwise needed;
7. the trade, generic, or chemical name, the amount dispensed, and the strength (for multiple-ingredient products with established names, those names may be used); and
8. the beyond-use date.

Exceptions and variations:

• If the prescriber specifically directs that the drug name not appear, the drug name and strength are left off (§ 58-17b-602(7)).
• Items 1–6 do not apply to containers of drugs that a health care provider administers at a pharmaceutical administration facility or a licensed hospital (§ 58-17b-602(5)(b)).
• DOPL encourages, but does not require, including the condition being treated on the label, unless the prescriber or patient objects (§ 58-17b-602.5).
• A substituted product must be labeled with the name of the drug actually dispensed (§ 58-17b-605(7)(b)).
• Under expedited partner therapy, the patient's identifying information may be omitted from the partner's label (§ 58-1-501.3(4)).

Controlled substance labels (§ 58-37-112)

• Controlled substances must be packaged and labeled as federal law requires. Only a pharmacist filling a prescription may alter, deface, or remove a manufacturer's label.
• The dispensing label must show the pharmacy name and address, serial number, date of initial filling, prescription number, patient name (or owner and species), prescriber, and directions.
• Schedule II and III opiates: affix the warning "Caution: Opioid. Risk of overdose and addiction" (or DHHS-approved language) to the container or lid.
• Naloxone offer (since January 1, 2024): offer to counsel on the use and availability of an opiate antagonist, and offer to dispense one (on a prescription or under the standing order), when:
  • a single opioid prescription is 50 MME/day or more;
  • an opioid is dispensed and the pharmacy dispensed a benzodiazepine to the patient in the previous 30 days; or
  • a benzodiazepine is dispensed and the pharmacy dispensed an opioid to the patient in the previous 30 days.
• Display DHHS's opioid informational pamphlet at the point of sale, if DHHS makes it available.
• Federal CS transfer warning (21 CFR 290.5): "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is required on Schedule II, III, and IV prescription labels. It is not required on Schedule V.

Compounded preparations (R156-17b-614a(2))

When dispensed to a patient, labels for compounded sterile and non-sterile preparations must include the § 58-17b-602 minimum information plus:

• the generic name;
• the quantity or concentration of each active ingredient; and
• for sterile parenteral preparations, the diluent, the compounding record or lot number, and the phrase "compounded preparation."

Compounded or repackaged drugs sold to a practitioner for office administration must be labeled "for office use only" (§ 58-17b-624).

Special-purpose labels

Federal labeling points

• FDA side-effects statement (21 CFR Part 209): with each new and refill prescription, give patients the statement "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088," on the label or cap, a sticker, the pharmacy leaflet, or the Medication Guide.
• Medication Guides (21 CFR Part 208): must be given with specified drugs when dispensed to outpatients.
• USP <17> recommends patient-centered label design: patient name, drug, and clear directions most prominent. It is a best-practice standard, not a Utah statute.

Scenario

A patient receives a first fill of hydrocodone/acetaminophen for 60 MME/day. The pharmacy already dispensed alprazolam to this patient two weeks ago. The label must carry the Utah opioid warning and the federal transfer caution. The pharmacy must offer naloxone counseling and dispensing, since both the 50 MME trigger and the opioid-benzodiazepine trigger apply.