01-02 17:00 H.B. 84
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Vaccine Amendments
2025 GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Trevor Lee
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LONG TITLE
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General Description:
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This bill addresses vaccines or vaccine material.
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Highlighted Provisions:
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This bill:
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▸ defines terms;
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▸ designates food intended for human consumption that contains a vaccine or vaccine
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materials as a drug; and
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▸ makes technical amendments.
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Money Appropriated in this Bill:
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None
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Other Special Clauses:
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None
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Utah Code Sections Affected:
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AMENDS:
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26B-7-108, as renumbered and amended by Laws of Utah 2023, Chapter 308
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58-37-2, as last amended by Laws of Utah 2024, Chapter 35
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ENACTS:
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4-5-107, Utah Code Annotated 1953
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Be it enacted by the Legislature of the state of Utah:
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Section 1. Section 4-5-107 is enacted to read:
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4-5-107 . Food containing vaccine.
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(1) As used in this section, "vaccine or vaccine material" means a substance that is:
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(a) intended for use in humans to stimulate the production of antibodies and provide
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immunity against disease;
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(b) prepared from the causative agent of a disease, the disease's products, or a synthetic
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substitute treated to act as an antigen without including the disease; and
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(c) authorized or approved by the United States Food and Drug Administration. H.B. 84 01-02 17:00
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(2) A food intended for human consumption that contains a vaccine or vaccine material is
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considered a drug for purposes of this chapter, Section 26B-7-108, and Title 58, Chapter
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37, Utah Controlled Substances Act.
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Section 2. Section 26B-7-108 is amended to read:
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26B-7-108 . Rules for sale of drugs, cosmetics, and medical devices.
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(1) The department shall [establish] make rules, in accordance with Title 63G, Chapter
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3, Utah Administrative Rulemaking Act, and enforce the rules for the sale or distribution
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of human drugs, cosmetics, and medical devices.
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(2) Food intended for human consumption that contains a vaccine or vaccine material is
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considered a human drug for purposes of this section as provided in Section 4-5-107.
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(3) The rules adopted under this section shall be no more stringent than those established by
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federal law.
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Section 3. Section 58-37-2 is amended to read:
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58-37-2 . Definitions.
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(1) As used in this chapter:
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(a) "Administer" means the direct application of a controlled substance, whether by
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injection, inhalation, ingestion, or any other means, to the body of a patient or
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research subject by:
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(i) a practitioner or, in the practitioner's presence, by the practitioner's authorized
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agent; or
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(ii) the patient or research subject at the direction and in the presence of the
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practitioner.
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(b) "Agent" means an authorized person who acts on behalf of or at the direction of a
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manufacturer, distributor, or practitioner but does not include a motor carrier, public
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warehouseman, or employee of any of them.
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(c) "Consumption" means ingesting or having any measurable amount of a controlled
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substance in a person's body, but this Subsection (1)(c) does not include the
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metabolite of a controlled substance.
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(d) "Continuing criminal enterprise" means any individual, sole proprietorship,
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partnership, corporation, business trust, association, or other legal entity, and any
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union or groups of individuals associated in fact although not a legal entity, and
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includes illicit as well as licit entities created or maintained for the purpose of
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engaging in conduct which constitutes the commission of episodes of activity made
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unlawful by [Chapter 37, Utah Controlled Substances Act] this chapter, Chapter 37a,
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Utah Drug Paraphernalia Act, Chapter 37b, Imitation Controlled Substances Act,
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Chapter 37c, Utah Controlled Substance Precursor Act, or Chapter 37d, Clandestine
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Drug Lab Act, which episodes are not isolated, but have the same or similar
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purposes, results, participants, victims, methods of commission, or otherwise are
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interrelated by distinguishing characteristics. Taken together, the episodes shall
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demonstrate continuing unlawful conduct and be related either to each other or to the
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enterprise.
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(e) "Control" means to add, remove, or change the placement of a drug, substance, or
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immediate precursor under Section 58-37-3.
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(f)(i) "Controlled substance" means a drug or substance:
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(A) included in Schedules I, II, III, IV, or V of Section 58-37-4;
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(B) included in Schedules I, II, III, IV, or V of the federal Controlled Substances
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Act, Title II, P.L. 91-513;
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(C) that is a controlled substance analog; or
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(D) listed in Section 58-37-4.2.
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(ii) "Controlled substance" does not include:
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(A) distilled spirits, wine, or malt beverages, as those terms are defined in Title
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32B, Alcoholic Beverage Control Act;
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(B) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment,
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or prevention of disease in human or other animals, which contains ephedrine,
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pseudoephedrine, norpseudoephedrine, or phenylpropanolamine if the drug is
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lawfully purchased, sold, transferred, or furnished as an over-the-counter
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medication without prescription; or
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(C) dietary supplements, vitamins, minerals, herbs, or other similar substances
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including concentrates or extracts, which:
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(I) are not otherwise regulated by law; and
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(II) may contain naturally occurring amounts of chemical or substances listed
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in this chapter, or in rules adopted pursuant to Title 63G, Chapter 3, Utah
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Administrative Rulemaking Act.
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(g)(i) "Controlled substance analog" means:
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(A) a substance the chemical structure of which is substantially similar to the
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chemical structure of a controlled substance listed in Schedules I and II of
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Section 58-37-4, a substance listed in Section 58-37-4.2, or in Schedules I and
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II of the federal Controlled Substances Act, Title II, P.L. 91-513;
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(B) a substance [which] that has a stimulant, depressant, or hallucinogenic effect
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on the central nervous system substantially similar to the stimulant, depressant,
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or hallucinogenic effect on the central nervous system of controlled substances
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listed in Schedules I and II of Section 58-37-4, substances listed in Section
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58-37-4.2, or substances listed in Schedules I and II of the federal Controlled
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Substances Act, Title II, P.L. 91-513; or
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(C) A substance [which] that, with respect to a particular individual, is represented
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or intended to have a stimulant, depressant, or hallucinogenic effect on the
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central nervous system substantially similar to the stimulant, depressant, or
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hallucinogenic effect on the central nervous system of controlled substances
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listed in Schedules I and II of Section 58-37-4, substances listed in Section
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58-37-4.2, or substances listed in Schedules I and II of the federal Controlled
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Substances Act, Title II, P.L. 91-513.
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(ii) "Controlled substance analog" does not include:
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(A) a controlled substance currently scheduled in Schedules I through V of
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Section 58-37-4;
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(B) a substance for which there is an approved new drug application;
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(C) a substance with respect to which an exemption is in effect for investigational
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use by a particular person under Section 505 of the Food, Drug, and Cosmetic
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Act, 21 U.S.C. 355, to the extent the conduct with respect to the substance is
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permitted by the exemption;
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(D) any substance to the extent not intended for human consumption before an
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exemption takes effect with respect to the substance;
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(E) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment,
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or prevention of disease in man or other animals, which contains ephedrine,
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pseudoephedrine, norpseudoephedrine, or phenylpropanolamine if the drug is
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lawfully purchased, sold, transferred, or furnished as an over-the-counter
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medication without prescription; or
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(F) dietary supplements, vitamins, minerals, herbs, or other similar substances
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including concentrates or extracts, which are not otherwise regulated by law,
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which may contain naturally occurring amounts of chemical or substances
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listed in this chapter, or in rules adopted pursuant to Title 63G, Chapter 3, Utah
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Administrative Rulemaking Act.
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(h)(i) "Conviction" means a determination of guilt by verdict, whether jury or bench,
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or plea, whether guilty or no contest, for any offense proscribed by:
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(A) [Chapter 37, Utah Controlled Substances Act] this chapter;
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(B) Chapter 37a, Utah Drug Paraphernalia Act;
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(C) Chapter 37b, Imitation Controlled Substances Act;
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(D) Chapter 37c, Utah Controlled Substance Precursor Act; or
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(E) Chapter 37d, Clandestine Drug Lab Act; or
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(ii) for any offense under the laws of the United States and any other state which, if
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committed in this state, would be an offense under:
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(A) [Chapter 37, Utah Controlled Substances Act] this chapter;
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(B) Chapter 37a, Utah Drug Paraphernalia Act;
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(C) Chapter 37b, Imitation Controlled Substances Act;
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(D) Chapter 37c, Utah Controlled Substance Precursor Act; or
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(E) Chapter 37d, Clandestine Drug Lab Act.
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(i) "Counterfeit substance" means:
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(i) any controlled substance or container or labeling of any controlled substance that:
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(A) without authorization bears the trademark, trade name, or other identifying
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mark, imprint, number, device, or any likeness of them, of a manufacturer,
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distributor, or dispenser other than the person or persons who in fact
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manufactured, distributed, or dispensed the substance which falsely purports to
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be a controlled substance distributed by any other manufacturer, distributor, or
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dispenser; and
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(B) a reasonable person would believe to be a controlled substance distributed by
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an authorized manufacturer, distributor, or dispenser based on the appearance
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of the substance as described under Subsection (1)(i)(i)(A) or the appearance of
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the container of that controlled substance; or
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(ii) any substance other than under Subsection (1)(i)(i) that:
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(A) is falsely represented to be any legally or illegally manufactured controlled
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substance; and
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(B) a reasonable person would believe to be a legal or illegal controlled substance.
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(j) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a
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controlled substance or a listed chemical, whether or not an agency relationship exists.
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(k) "Department" means the Department of Commerce.
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(l) "Depressant or stimulant substance" means:
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(i) a drug which contains any quantity of barbituric acid or any of the salts of
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barbituric acid;
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(ii) a drug which contains any quantity of:
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(A) amphetamine or any of its optical isomers;
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(B) any salt of amphetamine or any salt of an optical isomer of amphetamine; or
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(C) any substance which the Secretary of Health and Human Services or the
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Attorney General of the United States after investigation has found and by
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regulation designated habit-forming because of its stimulant effect on the
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central nervous system;
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(iii) lysergic acid diethylamide; or
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(iv) any drug which contains any quantity of a substance which the Secretary of
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Health and Human Services or the Attorney General of the United States after
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investigation has found to have, and by regulation designated as having, a
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potential for abuse because of its depressant or stimulant effect on the central
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nervous system or its hallucinogenic effect.
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(m) "Dispense" means the delivery of a controlled substance by a pharmacist to an
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ultimate user pursuant to the lawful order or prescription of a practitioner, and
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includes distributing to, leaving with, giving away, or disposing of that substance as
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well as the packaging, labeling, or compounding necessary to prepare the substance
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for delivery.
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(n) "Dispenser" means a pharmacist who dispenses a controlled substance.
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(o) "Distribute" means to deliver other than by administering or dispensing a controlled
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substance or a listed chemical.
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(p) "Distributor" means a person who distributes controlled substances.
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(q) "Division" means the Division of Professional Licensing created in Section 58-1-103.
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(r)(i) "Drug" means:
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(A) a substance recognized in the official United States Pharmacopoeia, Official
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Homeopathic Pharmacopoeia of the United States, or Official National
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Formulary, or any supplement to any of them, intended for use in the
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diagnosis, cure, mitigation, treatment, or prevention of disease in humans or
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animals;
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(B) a substance that is required by any applicable federal or state law or rule to be
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dispensed by prescription only or is restricted to administration by practitioners
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only;
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(C) a substance other than food intended to affect the structure or any function of
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the body of humans or other animals; and
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(D) substances intended for use as a component of any substance specified in
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Subsections (1)(r)(i)(A), (B), and (C).
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(ii) "Drug" does not include dietary supplements.
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(iii) "Drug" includes a food intended for human consumption that contains a vaccine
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or vaccine material as provided in Section 4-5-107.
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(s) "Drug dependent person" means any individual who unlawfully and habitually uses
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any controlled substance to endanger the public morals, health, safety, or welfare, or
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who is so dependent upon the use of controlled substances as to have lost the power
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of self-control with reference to the individual's dependency.
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(t)(i) "Food" means:
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[(i)] (A) any nutrient or substance of plant, mineral, or animal origin other than a
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drug as specified in this chapter, and normally ingested by human beings; and
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[(ii)] (B) foods for special dietary uses as exist by reason of a physical,
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physiological, pathological, or other condition including[ but not limited to] the
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conditions of disease, convalescence, pregnancy, lactation, allergy,
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hypersensitivity to food, underweight, and overweight; uses for supplying a
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particular dietary need which exist by reason of age including[ but not limited
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to] the ages of infancy and childbirth, and also uses for supplementing and for
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fortifying the ordinary or unusual diet with any vitamin, mineral, or other
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dietary property for use of a food.
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(ii) Any particular use of a food is a special dietary use regardless of the nutritional
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purposes.
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(u) "Immediate precursor" means a substance which the Attorney General of the United
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States has found to be, and by regulation designated as being, the principal compound
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used or produced primarily for use in the manufacture of a controlled substance, or
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which is an immediate chemical intermediary used or likely to be used in the
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manufacture of a controlled substance, the control of which is necessary to prevent,
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curtail, or limit the manufacture of the controlled substance.
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(v) "Indian" means a member of an Indian tribe.
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(w) "Indian religion" means [any] a religion:
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(i) the origin and interpretation of which is from within a traditional Indian culture or
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community; and
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(ii) [which] that is practiced by Indians.
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(x) "Indian tribe" means any tribe, band, nation, pueblo, or other organized group or
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community of Indians, including any Alaska Native village, which is legally
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recognized as eligible for and is consistent with the special programs, services, and
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entitlements provided by the United States to Indians because of their status as
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Indians.
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(y) "Manufacture" means the production, preparation, propagation, compounding, or
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processing of a controlled substance, either directly or indirectly by extraction from
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substances of natural origin, or independently by means of chemical synthesis or by a
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combination of extraction and chemical synthesis.
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(z) "Manufacturer" includes any person who packages, repackages, or labels any
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container of any controlled substance, except pharmacists who dispense or compound
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prescription orders for delivery to the ultimate consumer.
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(aa)(i) "Marijuana" means all species of the genus cannabis and all parts of the
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genus, whether growing or not, including:
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(A) seeds;
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(B) resin extracted from any part of the plant, including the resin extracted from
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the mature stalks;
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(C) every compound, manufacture, salt, derivative, mixture, or preparation of the
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plant, seeds, or resin;
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(D) any synthetic equivalents of the substances contained in the plant cannabis
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sativa or any other species of the genus cannabis which are chemically
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indistinguishable and pharmacologically active; and
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(E) any component part or cannabinoid extracted or isolated from the plant,
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including extracted or isolated tetrahydrocannabinols.
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(ii) "Marijuana" does not include:
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(A) the mature stalks of the plant;
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(B) fiber produced from the stalks;
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(C) oil or cake made from the seeds of the plant;
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(D) except as provided in Subsection (1)(aa)(i), any other compound,
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manufacture, salt, derivative, mixture, or preparation of the mature stalks,
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fiber, oil or cake;
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(E) the sterilized seed of the plant which is incapable of germination;
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(F) any compound, mixture, or preparation approved by the federal Food and
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Drug Administration under the federal Food, Drug, and Cosmetic Act, 21
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U.S.C. Sec. 301 et seq. that is not listed in a schedule of controlled substances
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in Section 58-37-4 or in the federal Controlled Substances Act, Title II, P.L.
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91-513; or
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(G) transportable industrial hemp concentrate as that term is defined in Section
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4-41-102.
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(bb) "Money" means officially issued coin and currency of the United States or any
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foreign country.
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(cc) "Narcotic drug" means any of the following, whether produced directly or indirectly
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by extraction from substances of vegetable origin, or independently by means of
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chemical synthesis, or by a combination of extraction and chemical synthesis:
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(i) opium, coca leaves, and opiates;
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(ii) a compound, manufacture, salt, derivative, or preparation of opium, coca leaves,
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or opiates;
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(iii) opium poppy and poppy straw; or
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(iv) a substance, and any compound, manufacture, salt, derivative, or preparation of
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the substance, which is chemically identical with any of the substances referred to
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in Subsection (1)(cc)(i), (ii), or (iii), except narcotic drug does not include
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decocainized coca leaves or extracts of coca leaves which do not contain cocaine
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or ecgonine.
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(dd) "Negotiable instrument" means documents, containing an unconditional promise to
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pay a sum of money, which are legally transferable to another party by endorsement
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or delivery.
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(ee) "Opiate" means any drug or other substance having an addiction-forming or
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addiction-sustaining liability similar to morphine or being capable of conversion into
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a drug having addiction-forming or addiction-sustaining liability.
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(ff) "Opium poppy" means the plant of the species papaver somniferum L., except the
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seeds of the plant.
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(gg) "Person" means any corporation, association, partnership, trust, other institution or
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entity or one or more individuals.
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(hh) "Poppy straw" means all parts, except the seeds, of the opium poppy, after mowing.
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(ii) "Possession" or "use" means the joint or individual ownership, control, occupancy,
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holding, retaining, belonging, maintaining, or the application, inhalation, swallowing,
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injection, or consumption, as distinguished from distribution, of controlled
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substances and includes individual, joint, or group possession or use of controlled
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substances. For a person to be a possessor or user of a controlled substance, it is not
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required that the person be shown to have individually possessed, used, or controlled
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the substance, but it is sufficient if it is shown that the person jointly participated with
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one or more persons in the use, possession, or control of any substances with
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knowledge that the activity was occurring, or the controlled substance is found in a
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place or under circumstances indicating that the person had the ability and the intent
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to exercise dominion and control over [it] the controlled substance.
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(jj) "Practitioner" means a physician, dentist, naturopathic physician, veterinarian,
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pharmacist, scientific investigator, pharmacy, hospital, or other person licensed,
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registered, or otherwise permitted to distribute, dispense, conduct research with
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respect to, administer, or use in teaching or chemical analysis a controlled substance
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in the course of professional practice or research in this state.
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(kk) "Prescribe" means to issue a prescription:
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(i) orally or in writing; or
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(ii) by telephone, facsimile transmission, computer, or other electronic means of
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communication as defined by division rule.
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(ll) "Prescription" means an order issued:
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(i) by a licensed practitioner, in the course of that practitioner's professional practice
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or by collaborative pharmacy practice agreement; and
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(ii) for a controlled substance or other prescription drug or device for use by a patient
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or an animal.
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(mm) "Production" means the manufacture, planting, cultivation, growing, or harvesting
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of a controlled substance.
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(nn) "Securities" means any stocks, bonds, notes, or other evidences of debt or of
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property.
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(oo) "State" means the state of Utah.
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(pp) "Ultimate user" means any person who lawfully possesses a controlled substance
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for the person's own use, for the use of a member of the person's household, or for
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administration to an animal owned by the person or a member of the person's
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household.
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(2) If a term used in this chapter is not defined, the definition and terms of Title 76, Utah
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Criminal Code, shall apply.
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Section 4. Effective Date.
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This bill takes effect on May 7, 2025.
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