Title HS, Health and Safety Code

Sec. 431.011. APPLICABILITY OF CHAPTER TO CONSUMABLE HEMP PRODUCTS AND MANUFACTURERS. (a) This chapter applies to a consumable hemp product subject to Chapter 443. An article regulated under this chapter may not be deemed to be adulterated solely on the basis that the article is …

Sec. 431.021. PROHIBITED ACTS. The following acts and the causing of the following acts within this state are unlawful and prohibited: (a) the introduction or delivery for introduction into commerce of any food, drug, device, or cosmetic that is adulterated or misbranded; (b) the…

Sec. 431.02105. PROHIBITED ACT; TEMPORARY PROVISION. (a) The offering for sale or sale of cell-cultured protein for human consumption within this state is unlawful and prohibited. (b) A violation of this section may be enforced in the same manner as a violation of Section 431.021…

Sec. 431.0211. EXCEPTION. Any provision of Section 431.021 that relates to a prescription drug does not apply to a prescription drug manufacturer, or an agent of a prescription drug manufacturer, who is obtaining or attempting to obtain a prescription drug for the sole purpose of…

Sec. 431.022. OFFENSE: TRANSFER OF PRODUCT CONTAINING EPHEDRINE. (a) A person commits an offense if the person knowingly sells, transfers, or otherwise furnishes a product containing ephedrine to a person 17 years of age or younger, unless: (1) the actor is: (A) a practitioner or…

Sec. 431.023. LIMITED EXEMPTION FOR DISTRESSED FOOD, DRUGS, DEVICES, OR COSMETICS. In relation to a food, drug, device, or cosmetic that is distressed merchandise for purposes of Chapter 432, Sections 431.021(a), (c), and (d) do not prohibit: (1) the introduction or delivery for …

Sec. 431.024. ORTHODONTIC DEVICES. (a) In this section: (1) "Orthodontic device" means any class II or class III medical device, as defined by the United States Food and Drug Administration under 21 U.S.C. Section 360c and 21 C.F.R. Section 860.3, excluding a retainer used to kee…

Sec. 431.041. DEFINITION. In this subchapter, "detained or embargoed article" means a food, drug, device, cosmetic, or consumer commodity that has been detained or embargoed under Section 431.048. Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.042. INSPECTION. (a) To enforce this chapter, the department or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge: (1) enter at reasonable times an establishment, including a factory or warehouse, in which a food, dr…

Sec. 431.043. ACCESS TO RECORDS. A person who is required to maintain records under this chapter or Section 519 or 520(g) of the federal Act or a person who is in charge or custody of those records shall, at the request of the department or a health authority, permit the departme…

Sec. 431.044. ACCESS TO RECORDS SHOWING MOVEMENT IN COMMERCE. (a) To enforce this chapter, a carrier engaged in commerce or other person receiving a food, drug, device, or cosmetic in commerce or holding a food, drug, device, or cosmetic received in commerce shall, at the request…

Sec. 431.045. EMERGENCY ORDER. (a) The commissioner or a person designated by the commissioner may issue an emergency order, either mandatory or prohibitory in nature, in relation to the manufacture or distribution of a food, drug, device, or cosmetic in the department's jurisdic…

Sec. 431.046. VIOLATION OF RULES. A violation of a rule adopted under this chapter is a violation of this chapter. Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.047. VIOLATION; INJUNCTION. (a) The department or a health authority may petition the district court for a temporary restraining order to restrain a continuing violation of Subchapter B or a threat of a continuing violation of Subchapter B if the department or health aut…

Sec. 431.048. DETAINED OR EMBARGOED ARTICLE. (a) The department shall affix to an article that is a food, drug, device, cosmetic, or consumer commodity a tag or other appropriate marking that gives notice that the article is, or is suspected of being, adulterated or misbranded an…

Sec. 431.049. REMOVAL ORDER FOR DETAINED OR EMBARGOED ARTICLE. (a) If the claimant of the detained or embargoed articles or the claimant's agent fails or refuses to transfer the articles to a secure place after the tag or other appropriate marking has been affixed as provided by …

Sec. 431.0495. RECALL ORDERS. (a) In conjunction with the issuance of an emergency order under Section 431.045 or the detention or embargo of an article under Section 431.048, the commissioner may order a food, drug, device, cosmetic, or consumer commodity to be recalled from com…

Sec. 431.050. CONDEMNATION. An action for the condemnation of an article may be brought before a court in whose jurisdiction the article is located, detained, or embargoed if the article is adulterated, misbranded, or in violation of Section 431.084, 431.114, or 431.115. Acts 198…

Sec. 431.051. DESTRUCTION OF ARTICLE. (a) A court shall order the destruction of a sampled article or a detained or embargoed article if the court finds that the article is adulterated or misbranded. (b) After entry of the court's order, an authorized agent shall supervise the de…

Sec. 431.052. CORRECTION BY PROPER LABELING OR PROCESSING. (a) A court may order the delivery of a sampled article or a detained or embargoed article that is adulterated or misbranded to the claimant of the article for labeling or processing under the supervision of the departmen…

Sec. 431.053. CONDEMNATION OF PERISHABLE ARTICLES. (a) The department shall immediately condemn or render by any means unsalable as human food an article that is a nuisance under Subsection (b) and that the department finds in any room, building, or other structure or in a vehicl…

Sec. 431.054. ADMINISTRATIVE PENALTY. (a) The department may assess an administrative penalty against a person who violates Subchapter B or an order adopted or registration issued under this chapter. (b) In determining the amount of the penalty, the department shall consider: (1)…

Sec. 431.055. ADMINISTRATIVE PENALTY ASSESSMENT PROCEDURE. (a) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing. (b) If a hearing is held, an administrative law judge of the State Office of Administrative…

Sec. 431.056. PAYMENT OF ADMINISTRATIVE PENALTY. (a) Not later than the 30th day after the date an order finding that a violation has occurred is issued, the department shall inform the person against whom the order is issued of the amount of the penalty for the violation. (b) No…

Sec. 431.057. REFUND OF ADMINISTRATIVE PENALTY. On the date the court's judgment that an administrative penalty against a person should be reduced or not assessed becomes final, the court shall order that: (1) the appropriate amount of any penalty payment plus accrued interest be…

Sec. 431.058. RECOVERY OF ADMINISTRATIVE PENALTY BY ATTORNEY GENERAL. The attorney general at the request of the department may bring a civil action to recover an administrative penalty under this subchapter. Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by: …

Sec. 431.0585. CIVIL PENALTY. (a) At the request of the department, the attorney general or a district, county, or city attorney shall institute an action in district court to collect a civil penalty from a person who has violated Section 431.021. (b) The civil penalty may not ex…

Sec. 431.059. CRIMINAL PENALTY; DEFENSES. (a) A person commits an offense if the person violates any of the provisions of Section 431.021 relating to unlawful or prohibited acts. A first offense under this subsection is a Class A misdemeanor unless it is shown on the trial of an …

Sec. 431.060. INITIATION OF PROCEEDINGS. (a) The attorney general, or a district, county, or municipal attorney to whom the department or a health authority reports a violation of this chapter, shall initiate and prosecute appropriate proceedings without delay. (b) The department…

Sec. 431.061. MINOR VIOLATION. This chapter does not require the department or a health authority to report for prosecution or the institution of proceedings under this chapter a minor violation of this chapter if the department or health authority believes that the public intere…

Sec. 431.0805. DEFINITIONS. In this subchapter: (1) "Analogue product" means a food product derived by combining processed plant products, insects, or fungus with food additives to approximate the texture, flavor, appearance, or other aesthetic qualities or the chemical character…

Sec. 431.081. ADULTERATED FOOD. A food shall be deemed to be adulterated: (a) if: (1) it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance the food shall not be considered adultera…

Sec. 431.0815. FOOD CONTAINING ARTIFICIAL COLOR, ADDITIVES, OR CERTAIN BANNED CHEMICALS. (a) A food manufacturer shall ensure each food product the manufacturer offers for sale in this state includes a warning label disclosing the use of any of the following ingredients, if the U…

Sec. 431.0816. ENFORCEMENT BY ATTORNEY GENERAL. (a) If the attorney general believes a manufacturer has violated or is violating Section 431.0815, the attorney general may bring an action on behalf of this state to enjoin the manufacturer from violating that section. (b) In addit…

Sec. 431.0817. FEDERAL PREEMPTION. On and after September 1, 2025, and the effective date of a federal law or regulation issued by the United States Food and Drug Administration or the United States Department of Agriculture, Section 431.0815 has no effect if: (1) for a specific …

Sec. 431.082. MISBRANDED FOOD. A food shall be deemed to be misbranded: (a) if its labeling is false or misleading in any particular or fails to conform with the requirements of Section 431.181; (b) if, in the case of a food to which Section 411 of the federal Act applies, its ad…

Sec. 431.083. FOOD LABELING EXEMPTIONS. (a) Except as provided by Subsection (c), the executive commissioner shall adopt rules exempting from any labeling requirement of this chapter: (1) small open containers of fresh fruits and fresh vegetables; and (2) food that is in accordan…

Sec. 431.084. EMERGENCY PERMITS FOR FOODS CONTAMINATED WITH MICROORGANISMS. (a) The department shall provide for the issuance of temporary permits to a manufacturer, processor, or packer of a class of food in any locality that provides conditions for the manufacture, processing, …

Sec. 431.111. ADULTERATED DRUG OR DEVICE. A drug or device shall be deemed to be adulterated: (a)(1) if it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may ha…

Sec. 431.112. MISBRANDED DRUG OR DEVICE. A drug or device shall be deemed to be misbranded: (a)(1) if its labeling is false or misleading in any particular; or (2) if its labeling or packaging fails to conform with the requirements of Section 431.181. (b) if in a package form unl…

Sec. 431.113. EXEMPTION FOR CERTAIN DRUGS AND DEVICES. (a) The executive commissioner shall adopt rules exempting from any labeling or packaging requirement of this chapter drugs and devices that are, in accordance with the practice of the trade, to be processed, labeled, or repa…

Sec. 431.114. NEW DRUGS. (a) A person shall not sell, deliver, offer for sale, hold for sale or give away any new drug unless: (1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and (2) a copy of…

Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED ADVERSE EVENTS. (a) In this section, "serious adverse event" means an event that: (1) results in death; (2) is considered life-threatening; (3) results in inpatient hospitalization or an extension of the duration of an existi…

Sec. 431.115. NEW ANIMAL DRUGS. (a) A new animal drug shall, with respect to any particular use or intended use of the drug, be deemed unsafe for the purposes of this chapter unless: (1) there is in effect an approval of an application filed pursuant to Section 512(b) of the fede…

Sec. 431.116. AVERAGE MANUFACTURER PRICE. (a) In this section, "average manufacturer price" has the meaning assigned by 42 U.S.C. Section 1396r-8(k), as amended. (b) A person who manufactures a drug, including a person who manufactures a generic drug, that is sold in this state s…

Sec. 431.117. PRIORITY FOR HEALTH CARE PROVIDERS IN DISTRIBUTION OF INFLUENZA VACCINE. The executive commissioner shall study the wholesale distribution of influenza vaccine in this state to determine the feasibility of implementing a system that requires giving a priority in fil…