Title HS, Health and Safety Code

Sec. 440.017. REFUSAL TO GRANT LICENSE; SUSPENSION OR REVOCATION OF LICENSE. In accordance with rules adopted under Section 440.006, the department may refuse an application for a license under this chapter or may suspend or revoke a license issued under this chapter. Added by Ac…

Sec. 440.031. INSPECTION BY DEPARTMENT. (a) Under rules adopted by the executive commissioner, the department's authorized representatives have free access at all reasonable hours to any establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold…

Sec. 440.032. PENALTIES. (a) A person commits an offense if the person knowingly or intentionally violates Section 440.011 or a rule adopted under this chapter. (b) An offense under this section is a Class C misdemeanor. (c) The penalty prescribed by this section is in addition t…

Sec. 441.0001. DEFINITIONS. In this chapter: (1) "Animal health product" means a medical product approved and licensed for use in animal or veterinary medicine, including a pharmaceutical, a biologic, an insecticide, and a parasiticide. (2) "Pharmaceutical drug manufacturer" mean…

Sec. 441.0003. RULES. The executive commissioner may adopt rules to implement this chapter. Added by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 1, eff. September 1, 2021. SUBCHAPTER B. PRESCRIPTION DRUG PRICE DISCLOSURE

Sec. 441.0051. ANNUAL REPORT. Not later than the 15th day of each calendar year, a pharmaceutical drug manufacturer shall submit a report to the department stating the current wholesale acquisition cost information for the United States Food and Drug Administration-approved presc…

Sec. 441.0052. PRESCRIPTION DRUG PRICE INFORMATION INTERNET WEBSITE. The department shall develop an Internet website to provide to the general public prescription drug price information submitted under Section 441.0051. The Internet website shall be made available on the departm…

Sec. 441.0053. PRESCRIPTION DRUG COST INCREASE REPORT AND INFORMATION. (a) This subsection applies only to a prescription drug with a wholesale acquisition cost of at least $100 for a 30-day supply before the effective date of an increase described by this subsection. Not later t…

Sec. 441.0054. PUBLICATION OF COST INCREASE INFORMATION. Not later than the 60th day after receipt of the report submitted under Section 441.0051 or 441.0053(a), the department shall publish the cost increase information required by Section 441.0053 on the department's prescripti…

Sec. 441.0055. FEE. (a) A pharmaceutical drug manufacturer shall submit a fee in the amount provided by department rule with each report submitted under this subchapter. (b) The executive commissioner by rule shall set the fee in the amount necessary for the department to adminis…

Sec. 441.0101. RIGHT TO CORRECT. (a) If the department determines that a pharmaceutical drug manufacturer failed to submit a report or fee required under, or failed to submit the report or fee in the manner prescribed by, Subchapter B and the rules adopted under this chapter, the…

Sec. 441.0102. ADMINISTRATIVE PENALTY. (a) The department may assess an administrative penalty against a person who violates this chapter or a rule adopted under this chapter. (b) In determining the amount of the penalty, the department shall consider: (1) the person's previous v…

Sec. 441.0103. ADMINISTRATIVE PROCEDURE. A proceeding to impose an administrative penalty under Section 441.0102 is considered to be a contested case under Chapter 2001, Government Code. Added by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 5, eff. September 1, 2021.

Sec. 442.001. DEFINITIONS. In this chapter: (1) "Donor" means an individual, a prescription drug manufacturer, or a health care facility, including a pharmacy, that donates unused prescription drugs under this chapter to a participating provider. (2) "Health care facility" means …

Sec. 442.002. RULEMAKING AUTHORITY. The executive commissioner may adopt rules to implement this chapter. Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.003. CONSTRUCTION WITH OTHER LAW. This chapter does not limit the authority of this state or a political subdivision of this state to regulate or prohibit a prescription drug. Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017. SU…

Sec. 442.051. DONATION AND REDISTRIBUTION OF PRESCRIPTION DRUGS. (a) A donor may donate unused prescription drugs to a participating provider in accordance with this chapter and rules adopted under this chapter. (b) A participating provider may dispense donated prescription drugs…

Sec. 442.0515. REDISTRIBUTION OF DONATED PREPACKAGED PRESCRIPTION DRUGS. (a) A participating provider may dispense to a recipient donated prescription drugs that are prepackaged and labeled in accordance with this section and rules adopted by the Texas State Board of Pharmacy. (b…

Sec. 442.052. STANDARDS FOR DONATION AND REDISTRIBUTION. (a) The executive commissioner by rule shall adopt standards and procedures for: (1) accepting, storing, labeling, and dispensing donated prescription drugs; and (2) inspecting donated prescription drugs to determine whethe…

Sec. 442.053. REQUIREMENTS FOR DONATED PRESCRIPTION DRUGS. (a) A donated prescription drug may be accepted or dispensed under this chapter only if the drug is in its original, unopened, sealed, and tamper-evident bottle, container, or unit-dose packaging. A drug packaged in singl…

Sec. 442.054. DONATION PROCESS. (a) Before being dispensed to a recipient, a prescription drug donated under this chapter must be inspected by the participating provider in accordance with federal law, laws of this state, and department rule to determine whether the drug is adult…

Sec. 442.055. DONOR FORM. Before donating a prescription drug under this chapter, a donor shall sign a form prescribed by the department stating that: (1) the donor is the owner of the donated prescription drug; (2) the donated prescription drug has been properly stored and the c…

Sec. 442.056. RECIPIENT FORM. Before accepting a donated prescription drug under this chapter, a recipient shall sign a form prescribed by the department stating that: (1) the recipient acknowledges that if the donor is an individual, prescription drug manufacturer, or health car…

Sec. 442.057. LIMITATION OF LIABILITY. (a) A donor or participating provider who acts in good faith in donating, accepting, storing, labeling, distributing, or dispensing prescription drugs under this chapter: (1) is not criminally liable and is not subject to professional discip…

Sec. 442.058. DATABASE OF PARTICIPATING PROVIDERS. The department shall establish and maintain an electronic database that lists each participating provider. The department shall post the database on its Internet website. Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), …

Sec. 442A.001. DEFINITIONS. In this chapter: (1) "Board" means the Texas State Board of Pharmacy. (2) "Controlled substance" has the meaning assigned by Section 481.002. (3) "Pharmacy" means a facility licensed under Chapter 560, Occupations Code. (4) "Pilot program" means the pr…

Sec. 442A.002. PRESCRIPTION DRUG SAFE DISPOSAL PILOT PROGRAM. The board by rule shall develop and implement a prescription drug safe disposal pilot program to increase the number of locations in this state where unused, unwanted, or expired prescription drugs are collected from t…

Sec. 442A.051. PHARMACY ELIGIBILITY. A pharmacy operating in this state may apply to the board to participate in the pilot program if the pharmacy: (1) is registered as an authorized drug collection site with the United States Drug Enforcement Administration; (2) is not the subje…

Sec. 442A.052. APPLICATION AND SELECTION PROCESSES. (a) The board shall adopt rules prescribing: (1) the form and manner for a pharmacy to apply for participation in the pilot program; and (2) evaluation and selection criteria and processes. (b) The board shall give priority to a…

Sec. 442A.053. COLLECTION RECEPTACLE REQUIREMENTS. (a) A participating pharmacy that provides a collection receptacle for the safe disposal of prescription drugs shall ensure the receptacle: (1) meets the requirements of 21 C.F.R. Section 1317.75; (2) is accessible during the pha…

Sec. 442A.054. MAIL-BACK PROGRAM REQUIREMENTS. (a) A participating pharmacy that provides a collection receptacle for the safe disposal of prescription drugs may, under limited circumstances as the pharmacy determines necessary, provide at the time the pharmacy dispenses a contro…

Sec. 442A.055. PHARMACY MANAGEMENT; RECORDS. A participating pharmacy is responsible for the daily management and recordkeeping of the pharmacy's prescription drug safe disposal program in accordance with the pharmacy's United States Drug Enforcement Administration registration a…

Sec. 442A.056. TEXAS PREMIER PHARMACY DESIGNATION. (a) The board shall designate each pharmacy participating in the pilot program as a Texas premier pharmacy provider committed to safe prescription drug disposal. (b) A participating pharmacy may use the designation for marketing …

Sec. 442A.101. PILOT PROGRAM INCENTIVES. (a) The board shall assist each pharmacy participating in the pilot program, including by paying the costs of: (1) maintaining one collection receptacle at each participating pharmacy location and destroying through incineration of the rec…

Sec. 442A.102. COMMUNITY OUTREACH. (a) The board shall: (1) develop and distribute educational outreach materials for the public about the availability of safe prescription drug disposal in this state; (2) post the materials on the board's Internet website; and (3) provide the ma…

Sec. 442A.103. REPORT. Not later than December 1 of each even-numbered year, the board shall submit to the governor and the legislature a report that: (1) summarizes the results of the pilot program, including: (A) the number and geographic distribution of collection receptacles …

Sec. 442A.151. FUNDING. (a) Money contained in the opioid abatement account established under Section 403.505, Government Code, as added by Chapter 781 (S.B. 1827), Acts of the 87th Legislature, Regular Session, 2021, may be appropriated to the board to fund the pilot program est…

Sec. 442A.201. EXPIRATION. This chapter expires on the second anniversary of the date that all money appropriated for the pilot program has been expended. Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.

Sec. 443.001. DEFINITIONS. In this chapter: (1) "Consumable hemp product" means food, a drug, a device, or a cosmetic, as those terms are defined by Section 431.002, that contains hemp or one or more hemp-derived cannabinoids, including cannabidiol. (2) "Department" means the Dep…

Sec. 443.002. APPLICABILITY OF OTHER LAW. Except as provided by Section 431.011(c), Chapter 431 applies to a license holder and a consumable hemp product regulated under this chapter. Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.003. LOCAL REGULATION PROHIBITED. A municipality, county, or other political subdivision of this state may not enact, adopt, or enforce a rule, ordinance, order, resolution, or other regulation that prohibits the processing of hemp or the manufacturing or sale of a consu…

Sec. 443.004. SEVERABILITY. (a) A provision of this chapter or its application to any person or circumstance is invalid if the secretary of the United States Department of Agriculture determines that the provision or application conflicts with 7 U.S.C. Chapter 38, Subchapter VII,…

Sec. 443.051. RULEMAKING AUTHORITY OF EXECUTIVE COMMISSIONER. The executive commissioner shall adopt rules and procedures necessary to administer and enforce this chapter. Rules and procedures adopted under this section must be consistent with: (1) an approved state plan submitte…

Sec. 443.101. LICENSE REQUIRED; EXCEPTIONS. A person may not process hemp or manufacture a consumable hemp product in this state unless the person holds a license under this subchapter. Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.102. LICENSE INELIGIBILITY. (a) An individual who is or has been convicted of a felony relating to a controlled substance under federal law or the law of any state may not, before the 10th anniversary of the date of the conviction: (1) hold a license under this subchapte…

Sec. 443.103. APPLICATION; ISSUANCE. An individual or establishment may apply for a license under this subchapter by submitting an application to the department on a form and in the manner prescribed by the department. The application must be accompanied by: (1) a legal descripti…