10.2 Drug Product Selection: Generic Equivalents, Therapeutically Similar Drugs & Interchangeable Biologics

10.2 Drug Product Selection: Generic Equivalents, Therapeutically Similar Drugs & Interchangeable Biologics

Utah's product-selection law is permissive: the pharmacist may substitute. It is also consent-based: the purchaser must request or consent. Utah also has an unusual therapeutically similar substitution pathway.

Drug product equivalents (generic substitution) (§ 58-17b-605(2)(a))

When a prescription names a drug by brand, a pharmacist or intern may substitute a drug product equivalent if:

1. the purchaser specifically requests or consents to the substitution;
2. the equivalent is of the same generic type and is rated therapeutically equivalent in the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). In practice this means an "A"-rated product; "B"-rated products are not equivalents;
3. the product may lawfully move in interstate commerce;
4. the pharmacist or intern counsels the patient on the use and expected response to the drug, whether or not it is a substitute;
5. the substitution is not otherwise prohibited by law; and
6. the prescriber has not prohibited substitution.

Without the prescriber's authorization, a pharmacist may not substitute on a trade-name prescription unless the Orange Book lists the product as therapeutically equivalent (§ 58-17b-605(4)).

How a prescriber prohibits substitution (§ 58-17b-605(6))

• On a written prescription: by writing "dispense as written," or by signing in the space where two lines are preprinted and captioned "dispense as written" or "substitution permitted." A preprinted two-line format is expressly valid.
• On an oral prescription: the prescriber states the prohibition, and the pharmacist or intern writes the prescriber's name, the words "orally by," and their own initials.
• A prescriber's failure to prohibit substitution is not evidence of negligence (§ 58-17b-605(10)).

Duties when substituting (§ 58-17b-605(7))

• Tell the purchaser about the substitution.
• Label the container with the name of the drug dispensed.
• On the prescription file copy, record both the prescribed drug and the drug dispensed. A technician may make this entry.
• Out-of-state mail service (Class D) pharmacies must notify the patient of a substitution by telephone or in writing (§ 58-17b-605(3)).
• A pharmacist who substitutes assumes no greater liability than if the prescribed drug had been dispensed (§ 58-17b-605(5)), and substitution is not the practice of medicine (§ 58-17b-607).

The 2026 amendments (H.B. 264) removed a requirement that a pharmacy notify the provider when substituting as the prescription authorizes. The seizure-drug notice below remains.

Seizure medications (§ 58-17b-605(8))

• A prescriber who finds that substitution is not in a seizure patient's best interest must prohibit it in the usual way.
• A pharmacist who cannot dispense the prescribed anti-seizure drug and needs to substitute a drug product equivalent (generic to generic, generic to brand, brand to brand, or brand to generic) must notify the prescriber before substituting.
• No notice is required if the equivalent is paid for in whole or in part by Medicaid.

Therapeutically similar drug products (Utah-specific) (§ 58-17b-605(2)(b), (9); R156-17b-612c)

Utah lets a pharmacist substitute a different but therapeutically similar drug, not just a generic, when:

1. the prescriber has written "similar substitution authorized" or otherwise indicated it is desired;
2. the substitute is on DOPL's Therapeutically Similar Drug List as a substitute for the prescribed drug;
3. the purchaser requests or consents;
4. the drug may move in interstate commerce;
5. the patient is counseled;
6. the substitution is not otherwise prohibited; and
7. the substitution lowers the patient's cost, or is covered as preferred or at the same or a lower tier, or is needed because the prescribed drug isn't available, or the patient and pharmacist agree it benefits the patient.

DOPL builds the list with the Board of Pharmacy and the Medical Licensing Board. Either board can block an addition or removal. The statute told DOPL to consider albuterol inhalers, injectable insulins, and diabetic test strips first. The current list covers insulins, with clinical notes. For example, Lantus, Basaglar, Rezvoglar, and Semglee may be interchanged at the same dose, and 80% of the dose is used when switching from Toujeo to another long-acting insulin. Separately, R156-17b-626 lets a pharmacist substitute any albuterol inhaler with the same milligram dose per actuation, documenting the substitution.

Interchangeable biological products (§ 58-17b-605.5)

• Substitution is allowed only with a product FDA has determined to be interchangeable (or rated therapeutically equivalent in the Orange Book), with purchaser consent, counseling, no prescriber prohibition, and interstate-commerce eligibility.
• The prescriber blocks substitution the same way as for generics ("dispense as written" or the two-line format; "orally by" notation).
• Tell the purchaser, label the product dispensed, and record both products on the file copy. Class D pharmacies notify the patient by phone or in writing.
• Within five business days after dispensing any biological product, the pharmacist or designee must record the product name and manufacturer in an interoperable EHR, e-prescribing system, PBM system, or other record the prescriber can access. Otherwise, communicate it to the prescriber by fax, phone, or electronic means. No communication is required if no interchangeable product exists, if an unchanged refill is dispensed, or if the patient pays cash.

Related flexibility (§ 58-17b-602.1)

Without specific authorization, a pharmacist or intern may dispense:

• a different quantity if the prescribed quantity or package size is not commercially available; and
• a different dosage form if, in professional judgment, it is in the patient's best interest.

Neither applies if the change would affect bioavailability or treatment parameters, or if the prescriber wrote "dispense as written."

Medicaid generic rule (§ 58-17b-606)

DHHS may not keep a restrictive formulary that blocks FDA-approved legend drugs (except cosmetic drugs). But when a multisource drug is available generically, Medicaid may reimburse only the generic unless the physician shows medical necessity. DHHS pharmacists may override that rule if doing so saves the state money.