reglab/statecodes huggingface dataset:
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 440 - Frozen Desserts Manufacturer Licensing Act › Subchapter C. Enforcement › Section 440.032. Penalties

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 to any civil or administrative penalty or sanction otherwise imposed under Chapter 431 or other law.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.  Amended by Acts 2003, 78th Leg., ch. 112, Sec. 6, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1156, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter A. General Provisions › Section 441.0001. Definitions

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" means a person engaged in the business of producing, preparing, propagating, compounding, converting, processing, packaging, labeling, or distributing a drug.  The term does not include a wholesale distributor or retailer of prescription drugs or a pharmacist licensed under Subtitle J, Title 3, Occupations Code.
(3)  "Prescription drug" and "drug" have the meanings assigned by Section 551.003, Occupations Code, except that the term "prescription drug" does not include a device or an animal health product.
(4)  "Wholesale acquisition cost" means, with respect to a drug, the pharmaceutical drug manufacturer's list price for the drug charged to wholesalers or direct purchasers in the United States, as reported in wholesale price guides or other publications of drug pricing data.  The cost does not include any rebates, prompt pay or other discounts, or other reductions in price.
Added by Acts 2019, 86th Leg., R.S., Ch. 1291 (H.B. 2536), Sec. 1, eff. September 1, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter A. General Provisions › Section 441.0003. Rules

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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter B. Prescription Drug Price Disclosure › Section 441.0051. Annual Report

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 prescription drugs sold in or into this state by that manufacturer.
Added by Acts 2019, 86th Leg., R.S., Ch. 1291 (H.B. 2536), Sec. 1, eff. September 1, 2019.
Transferred, redesignated and amended from Health and Safety Code, Section 441.0002 by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 3, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter B. Prescription Drug Price Disclosure › Section 441.0052. Prescription Drug Price Information Internet Website

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 department's Internet website with a dedicated link that is prominently displayed on the home page or by a separate easily identifiable Internet address.
Added by Acts 2019, 86th Leg., R.S., Ch. 1291 (H.B. 2536), Sec. 1, eff. September 1, 2019.
Transferred, redesignated and amended by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 3, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter B. Prescription Drug Price Disclosure › Section 441.0053. Prescription Drug Cost Increase Report and Information

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 than the 30th day after the effective date of an increase of 40 percent or more over the preceding three calendar years or 15 percent or more in the preceding calendar year in the wholesale acquisition cost of a prescription drug to which this subsection applies, a pharmaceutical drug manufacturer shall submit a report to the executive commissioner. The report must include the following information:
(1)  the name of the prescription drug;
(2)  whether the prescription drug is a brand name or generic;
(3)  the effective date of the change in wholesale acquisition cost; and
(4)  a statement regarding the factor or factors that caused the increase in the wholesale acquisition cost and an explanation of the role of each factor's impact on the cost.
(b)  If during a calendar year a prescription drug with a wholesale acquisition cost of at least $100 for a 30-day supply increases in price by 40 percent or more over the preceding three calendar years or 15 percent or more in the preceding calendar year in the wholesale acquisition cost of the prescription drug, the pharmaceutical drug manufacturer must include in the annual report submitted under Section 441.0051 the following information:
(1)  aggregate, company-level research and development costs for the most recent year for which final audit data is available;
(2)  the name of each of the manufacturer's prescription drugs approved by the United States Food and Drug Administration in the previous three calendar years; and
(3)  the name of each of the manufacturer's prescription drugs that lost patent exclusivity in the United States in the previous three calendar years.
(c)  The quality and types of information and data that a pharmaceutical drug manufacturer submits to the department under Subsections (a) and (b) must be consistent with the quality and types of information and data that the manufacturer includes in the manufacturer's annual consolidated report on Securities and Exchange Commission Form 10-K or any other public disclosure.
Added by Acts 2019, 86th Leg., R.S., Ch. 1291 (H.B. 2536), Sec. 1, eff. September 1, 2019.
Transferred, redesignated and amended by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 3, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter B. Prescription Drug Price Disclosure › Section 441.0054. Publication of Cost Increase Information

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 prescription drug price information Internet website.
Added by Acts 2019, 86th Leg., R.S., Ch. 1291 (H.B. 2536), Sec. 1, eff. September 1, 2019.
Transferred, redesignated and amended by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 3, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter B. Prescription Drug Price Disclosure › Section 441.0055. Fee

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 administer this chapter, not to exceed $400.
Added by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 4, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter C. Enforcement › Section 441.0101. Right to Correct

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 department shall provide written notice of the failure to the manufacturer.
(b)  On receipt of notice described by Subsection (a), a pharmaceutical drug manufacturer shall submit, as applicable:
(1)  a report that:
(A)  complies with Subchapter B and rules adopted under this chapter; and
(B)  addresses the issues raised in the notice; or
(2)  the fee required by Section 441.0055.
(c)  The department may not assess an administrative penalty under Section 441.0102 against a pharmaceutical drug manufacturer that submits to the department the required report or fee, as applicable, on or before the 45th day after the date the manufacturer receives notice under Subsection (a).
Added by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 5, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter C. Enforcement › Section 441.0102. Administrative Penalty

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 violations;
(2)  the seriousness of the violation;
(3)  the person's demonstrated good faith; and
(4)  any other matters as justice may require.
(c)  The penalty may not exceed $1,000 a day for each violation.
(d)  Each day a violation continues may be considered a separate violation.
(e)  The enforcement of the penalty may be stayed during the time the order is under judicial review if the person pays the penalty to the clerk of the court or files a supersedeas bond with the court in the amount of the penalty.  A person who cannot afford to pay the penalty or file the bond may stay the enforcement by filing an affidavit in the manner required by the Texas Rules of Civil Procedure for a party who cannot afford to file security for costs, subject to the right of the board to contest the affidavit as provided by those rules.
(f)  The attorney general may sue to collect the penalty.  Money collected under this section shall be deposited in the state treasury and may be appropriated only to the department for the purposes of administrating this chapter.
Added by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 5, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 441 - Drug Cost Transparency › Subchapter C. Enforcement › Section 441.0103. Administrative Procedure

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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter A. General Provisions › Section 442.001. Definitions

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 a facility that provides health care services to patients and maintains a pharmacy in the facility.  The term includes the following facilities if a pharmacy is maintained in the facility:
(A)  a general or special hospital as defined by Chapter 241;
(B)  an ambulatory surgical center licensed under Chapter 243; and
(C)  an institution licensed under Chapter 242.
(3)  "Health care professional" means an individual licensed, certified, or otherwise authorized to administer health care and prescribe prescription drugs, for profit or otherwise, in the ordinary course of business or professional practice.  The term does not include a health care facility.
(4)  "Participating provider" means a health care facility or pharmacy, or a pharmacist who is an employee of the facility or pharmacy, that elects to participate in the collection and redistribution of donated prescription drugs under this chapter.
(5)  "Pharmacist" means a person licensed under Chapter 558, Occupations Code.
(6)  "Pharmacy" means an entity licensed under Chapter 560, Occupations Code.
(6-a)  "Prepackage" means the act of repackaging and relabeling varying quantities of prescription drugs from a manufacturer's original commercial container into a prescription container, unit-dose packaging, or a multi-compartment container for a pharmacist to dispense to a consumer.
(7)  "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code.
(8)  "Recipient" means an individual who voluntarily receives donated prescription drugs under this chapter.
(9)  "Tamper-evident" means packaging that allows for detection of unauthorized access to a prescription drug.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
Amended by:
Acts 2023, 88th Leg., R.S., Ch. 761 (H.B. 4331), Sec. 1, eff. September 1, 2023.
Acts 2023, 88th Leg., R.S., Ch. 762 (H.B. 4332), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter A. General Provisions › Section 442.002. Rulemaking Authority

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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter A. General Provisions › Section 442.003. Construction With Other Law

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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.051. Donation and Redistribution of Prescription Drugs

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 to a recipient in accordance with this chapter and rules adopted under this chapter.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.0515. Redistribution of Donated Prepackaged 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)  A prepackaged prescription drug a participating provider dispenses to a recipient must contain a label that includes:
(1)  the drug's brand name or, for a generic version of the drug, the drug's generic name and the manufacturer or distributor of the drug;
(2)  the amount of the drug in a given dose;
(3)  the drug's lot number;
(4)  the earliest expiration date of the drug for that drug lot number; and
(5)  the quantity of any drug the provider dispenses in more than one dose.
(c)  A participating provider shall maintain a record of each prepackaged prescription drug dispensed to a recipient.  The record must include:
(1)  the drug's name, the amount of the drug in a given dose, and the dosage size or frequency;
(2)  the provider's lot number for that drug;
(3)  the drug's manufacturer or distributor;
(4)  the manufacturer's lot number for that drug;
(5)  the expiration dates of the drug from that drug's lot number;
(6)  the quantity of the drug in each prepackaged unit;
(7)  the number of prepackaged units that include the drug;
(8)  the date the drug was prepackaged;
(9)  the name, initials, or written or electronic signature of the individual who prepackaged the drug; and
(10)  the written or electronic signature of the pharmacist responsible for the drug's prepackaging.
Added by Acts 2023, 88th Leg., R.S., Ch. 762 (H.B. 4332), Sec. 2, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.052. Standards for Donation and Redistribution

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 whether the drugs are adulterated and whether the drugs are safe and suitable for redistribution.
(b)  In adopting standards and procedures under this section, the executive commissioner shall ensure that the donation and redistribution process is consistent with public health and safety standards.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.053. Requirements for Donated Prescription Drugs

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 single unit doses may be accepted and dispensed if the outside packaging is opened but the single unit-dose packaging is unopened.
(b)  A donated prescription drug may not be accepted or dispensed under this chapter if:
(1)  the drug is a controlled substance;
(2)  the drug is adulterated or misbranded;
(3)  the drug is not stored in compliance with the drug's product label; or
(4)  the United States Food and Drug Administration requires the drug to have a risk evaluation or mitigation strategy.
(c)  A participating provider shall comply with all applicable provisions of state and federal law relating to the inspection, storage, labeling, and dispensing of prescription drugs.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
Amended by:
Acts 2023, 88th Leg., R.S., Ch. 758 (H.B. 4166), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.054. Donation Process

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 adulterated or misbranded and whether the drug has been stored in compliance with the requirements of the product label.
(b)  A donated prescription drug dispensed to a recipient under this chapter must be prescribed by a health care professional for use by the recipient.
(c)  A participating provider may charge a handling fee not to exceed $20 to a recipient to cover the costs of inspecting, storing, labeling, and dispensing the donated prescription drug.  A participating provider may not resell a prescription drug donated under this chapter.  A donor may not sell a prescription drug to a participating provider.
(d)  A participating provider may not submit a claim or otherwise seek reimbursement from any public or private third-party payor for donated prescription drugs dispensed to a recipient under this chapter.  A public or private third-party payor is not required to provide reimbursement for donated drugs dispensed to a recipient under this chapter.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.055. Donor Form

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 container has not been opened or tampered with;
(3)  the donated prescription drug has not been adulterated or misbranded; and
(4)  the donor is voluntarily donating the prescription drug.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.056. Recipient Form

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 care facility other than a pharmacy, the donor is not a pharmacist and the donor took ordinary care of the prescription drug;
(2)  the recipient acknowledges that the donor is known to the participating provider and that there is no reason to believe that the prescription drug was improperly handled or stored;
(3)  by accepting the prescription drug, the recipient accepts any risk that an accidental mishandling could create; and
(4)  the recipient releases the donor, participating provider, and manufacturer of the drug from liability related to the prescription drug.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
Amended by:
Acts 2023, 88th Leg., R.S., Ch. 761 (H.B. 4331), Sec. 2, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.057. Limitation of Liability

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 disciplinary action for those activities; and
(2)  is not civilly liable for damages for bodily injury, death, or property damage that arises from those activities unless the injury, death, or damage arises from the donor or participating provider's recklessness or intentional conduct.
(b)  A manufacturer of a prescription drug that donates a drug under this chapter is not, in the absence of bad faith, criminally or civilly liable for bodily injury, death, or property damage arising from the donation, acceptance, or dispensing of the drug, including the manufacturer's failure to communicate to a donor or other person:
(1)  product or consumer information about the donated prescription drug; or
(2)  the expiration date of the donated prescription drug.
Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442 - Donation of Prescription Drugs › Subchapter B. Donation and Redistribution of Unused Prescription Drugs › Section 442.058. Database of Participating Providers

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. 7(a), eff. September 1, 2017.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter A. General Provisions › Section 442A.001. Definitions

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 prescription drug safe disposal pilot program established under this chapter.
(5)  "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code.
(6)  "Ultimate user" has the meaning assigned by 21 U.S.C. Section 802.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter A. General Provisions › Section 442A.002. Prescription Drug Safe Disposal Pilot Program

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 the public for safe disposal.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter B. Pharmacy Participation › Section 442A.051. Pharmacy Eligibility

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 subject of state or federal opioid litigation; and
(3)  meets the eligibility requirements established by 21 C.F.R. Section 1317.40 and board rules.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter B. Pharmacy Participation › Section 442A.052. Application and Selection Processes

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 pharmacy applicant that:
(1)  does not collect unused ultimate user prescription drugs under 21 C.F.R. Part 1317 at the time the applicant submits the application; or
(2)  is located in a rural or underserved area the board designates.
(c)  A pharmacy that operates multiple locations must submit an application for each location.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter B. Pharmacy Participation › Section 442A.053. Collection Receptacle Requirements

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 pharmacy's regular hours of operation;
(3)  allows for the anonymous deposit of unused controlled substance prescription drugs listed in Schedules II, III, IV, and V; and
(4)  provides disposal of unused prescription drugs at no cost to the ultimate user.
(b)  Controlled substance prescription drugs and noncontrolled substance prescription drugs may be collected together and comingled.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter B. Pharmacy Participation › Section 442A.054. Mail-Back Program Requirements

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 controlled substance prescription drug to the ultimate user a vendor's mail-back envelope, at no cost to the ultimate user.  The mail-back envelope must:
(1)  be pre-addressed and return postage paid; and
(2)  meet the requirements of 21 C.F.R. Section 1317.70.
(b)  A participating pharmacy may provide not more than 250 mail-back envelopes during the duration of the pilot program to encourage use of the pharmacy's collection receptacle.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter B. Pharmacy Participation › Section 442A.055. Pharmacy Management; Records

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 and board rules.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter B. Pharmacy Participation › Section 442A.056. Texas Premier Pharmacy Designation

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 purposes.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter C. Board Duties › Section 442A.101. Pilot Program Incentives

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 receptacle's full inner liner the prescription drugs deposited in the receptacle;
(2)  ordering and distributing pre-addressed, return postage paid mail-back envelopes from a third-party mail-back program and destroying through incineration the returned mail-back envelopes containing the collected prescription drugs; and
(3)  other operational needs the board determines appropriate.
(b)  The board:
(1)  shall directly reimburse a participating pharmacy for costs the pharmacy incurs under Subsection (a); and
(2)  may not reimburse a participating pharmacy for the cost of using a third-party incineration facility unless the facility is appropriately registered with the United States Drug Enforcement Administration.
(c)  Subject to money available for purposes of this chapter, the board may provide financial incentives to a pharmacy to continue providing prescription drug collection services or expand those services to accommodate controlled substance prescriptions.  The board may provide financial incentives to a chain retail pharmacy for not more than 15 locations.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter C. Board Duties › Section 442A.102. Community Outreach

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 materials to other state agencies for those agencies to conduct the community outreach.
(b)  The educational outreach materials must be in English, Spanish, and for specific areas of this state as the board determines appropriate, another language spoken by a substantial portion of the area's residents.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter C. Board Duties › Section 442A.103. Report

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 at participating pharmacies;
(B)  the estimated amount of prescription drugs collected by participating pharmacies under the program, measured by:
(i)  the number of inner liners fully filled with collected prescription drugs and sent for incineration by the pharmacies;
(ii)  the number of mail-back envelopes distributed by the pharmacies; and
(iii)  the weight, measured in pounds, of:
(a)  inner liners described by Subparagraph (i); and
(b)  returned mail-back envelopes filled with collected prescription drugs;
(C)  the amount of money distributed under the pilot program and the identity of each participating pharmacy to which money is distributed; and
(D)  a description of the board's educational efforts and outcomes; and
(2)  recommends whether the pilot program should continue, be expanded, or terminate or whether the board should permanently implement a prescription drug safe disposal program.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter D. Funding › Section 442A.151. Funding

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 established under this chapter.
(b)  The board may collect gifts, grants, and donations to fund the program.
Added by Acts 2023, 88th Leg., R.S., Ch. 293 (S.B. 2173), Sec. 1, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 442A - Prescription Drug Safe Disposal Pilot Program › Subchapter E. Expiration › Section 442A.201. Expiration

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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter A. General Provisions › Section 443.001. Definitions

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 Department of State Health Services.
(3)  "Establishment" means each location where a person processes hemp or manufactures a consumable hemp product.
(4)  "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.
(5)  "Hemp" has the meaning assigned by Section 121.001, Agriculture Code.
(6)  "License" means a consumable hemp product manufacturer's license issued under this chapter.
(7)  "License holder" means an individual or business entity holding a license.
(8)  "Manufacture" has the meaning assigned by Section 431.002.
(9)  "Process" means to extract a component of hemp, including cannabidiol or another cannabinoid, that is:
(A)  sold as a consumable hemp product;
(B)  offered for sale as a consumable hemp product;
(C)  incorporated into a consumable hemp product; or
(D)  intended to be incorporated into a consumable hemp product.
(10)  "QR code" means a quick response machine-readable code that can be read by a camera, consisting of an array of black and white squares used for storing information or directing or leading a user to additional information.
(11)  "Smoking" means burning or igniting a substance and inhaling the smoke or heating a substance and inhaling the resulting vapor or aerosol.
Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter A. General Provisions › Section 443.002. Applicability of Other Law

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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter A. General Provisions › Section 443.003. Local Regulation Prohibited

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 consumable hemp product as authorized by this chapter.
Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter A. General Provisions › Section 443.004. Severability

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, and prevents the approval of the state plan submitted under Chapter 121, Agriculture Code.
(b)  The invalidity of a provision or application under Subsection (a) does not affect the other provisions or applications of this chapter that can be given effect without the invalid provision or application, and to this end the provisions of this chapter are declared to be severable.
Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter B. Powers and Duties › Section 443.051. Rulemaking Authority of Executive Commissioner

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 submitted to the United States Department of Agriculture under Chapter 121, Agriculture Code; and
(2)  7 U.S.C. Chapter 38, Subchapter VII, and federal regulations adopted under that subchapter.
Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter C. Consumable Hemp Product Manufacturer License › Section 443.101. License Required; Exceptions

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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter C. Consumable Hemp Product Manufacturer License › Section 443.102. License Ineligibility

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 subchapter; or
(2)  be a governing person of an establishment that holds a license under this subchapter.
(b)  The department may not issue a license under this subchapter to a person who materially falsifies any information contained in an application submitted to the department under Section 443.103.
Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter C. Consumable Hemp Product Manufacturer License › Section 443.103. Application; Issuance

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 description of each location where the applicant intends to process hemp or manufacture consumable hemp products and the global positioning system coordinates for the perimeter of each location;
(2)  written consent from the applicant or the property owner if the applicant is not the property owner allowing the department, the Department of Public Safety, and any other state or local law enforcement agency to enter onto all premises where hemp is processed or consumable hemp products are manufactured to conduct a physical inspection or to ensure compliance with this chapter and rules adopted under this chapter;
(3)  any fees required by the department to be submitted with the application; and
(4)  any other information required by department rule.
Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 443 - Manufacture, Distribution, and Sale of Consumable Hemp Products › Subchapter C. Consumable Hemp Product Manufacturer License › Section 443.104. Term; Renewal

Sec. 443.104.  TERM; RENEWAL.  (a)  A license is valid for one year and may be renewed as provided by this section.
(b)  The department shall renew a license if the license holder:
(1)  is not ineligible to hold the license under Section 443.102;
(2)  submits to the department any license renewal fee; and
(3)  does not owe any outstanding fees to the department.
Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.