reglab/statecodes huggingface dataset:
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter C. License to Operate as Dispensing Organization › Section 487.105. Criminal History Background Check

Sec. 487.105.  CRIMINAL HISTORY BACKGROUND CHECK.  (a)  An applicant for the issuance or renewal of a license to operate as a dispensing organization shall provide the department with the applicant's name and the name of each of the applicant's directors, managers, and employees.
(b)  Before a dispensing organization licensee hires a manager or employee for the organization, the licensee must provide the department with the name of the prospective manager or employee.  The licensee may not transfer the license to another person before that prospective applicant and the applicant's directors, managers, and employees pass a criminal history background check and are registered as required by Subchapter D.
(c)  The department shall conduct a criminal history background check on each individual whose name is provided to the department under Subsection (a) or (b).  The director by rule shall:
(1)  require each individual whose name is provided to the department under Subsection (a) or (b) to submit a complete set of fingerprints to the department on a form prescribed by the department for purposes of a criminal history background check under this section; and
(2)  establish criteria for determining whether an individual passes the criminal history background check for the purposes of this section.
(d)  After conducting a criminal history background check under this section, the department shall notify the relevant applicant or organization and the individual who is the subject of the criminal history background check as to whether the individual passed the criminal history background check.
Added by Acts 2015, 84th Leg., R.S., Ch. 301 (S.B. 339), Sec. 1, eff. June 1, 2015.
Amended by:
Acts 2019, 86th Leg., R.S., Ch. 595 (S.B. 616), Sec. 4.010, eff. September 1, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter C. License to Operate as Dispensing Organization › Section 487.106. Duty to Maintain Eligibility

Sec. 487.106.  DUTY TO MAINTAIN ELIGIBILITY.  A dispensing organization must maintain compliance at all times with the eligibility requirements described by Section 487.102.
Added by Acts 2015, 84th Leg., R.S., Ch. 301 (S.B. 339), Sec. 1, eff. June 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter C. License to Operate as Dispensing Organization › Section 487.107. Duties Relating to Dispensing Prescription

Sec. 487.107.  DUTIES RELATING TO DISPENSING PRESCRIPTION.  (a)  Before dispensing low-THC cannabis to a person for whom the low-THC cannabis is prescribed under Chapter 169, Occupations Code, the dispensing organization must verify that the prescription presented:
(1)  is for a person listed as a patient in the compassionate-use registry;
(2)  matches the entry in the compassionate-use registry with respect to the total amount of low-THC cannabis required to fill the prescription; and
(3)  has not previously been filled by a dispensing organization as indicated by an entry in the compassionate-use registry.
(b)  After dispensing low-THC cannabis to a patient for whom the low-THC cannabis is prescribed under Chapter 169, Occupations Code, the dispensing organization shall record in the compassionate-use registry the form and quantity of low-THC cannabis dispensed and the date and time of dispensation.
Added by Acts 2015, 84th Leg., R.S., Ch. 301 (S.B. 339), Sec. 1, eff. June 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter C. License to Operate as Dispensing Organization › Section 487.108. License Suspension or Revocation

Sec. 487.108.  LICENSE SUSPENSION OR REVOCATION.  (a)  The department may at any time suspend or revoke a license issued under this chapter if the department determines that the licensee has not maintained the eligibility requirements described by Section 487.102 or has failed to comply with a duty imposed under this chapter.
(b)  The director shall give written notice to the dispensing organization of a license suspension or revocation under this section and the grounds for the suspension or revocation.  The notice must be sent by certified mail, return receipt requested.
(c)  After suspending or revoking a license issued under this chapter, the director may seize or place under seal all low-THC cannabis and drug paraphernalia owned or possessed by the dispensing organization.  If the director orders the revocation of the license, a disposition may not be made of the seized or sealed low-THC cannabis or drug paraphernalia until the time for administrative appeal of the order has elapsed or until all appeals have been concluded.  When a revocation order becomes final, all low-THC cannabis and drug paraphernalia may be forfeited to the state as provided under Subchapter E, Chapter 481.
(d)  Chapter 2001, Government Code, applies to a proceeding under this section.
Added by Acts 2015, 84th Leg., R.S., Ch. 301 (S.B. 339), Sec. 1, eff. June 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter D. Registration of Certain Individuals › Section 487.151. Registration Required

Sec. 487.151.  REGISTRATION REQUIRED.  (a)  An individual who is a director, manager, or employee of a dispensing organization must apply for and obtain a registration under this section.
(b)  An applicant for a registration under this section must:
(1)  be at least 18 years of age;
(2)  submit a complete set of fingerprints to the department in the manner required by department rule; and
(3)  pass a fingerprint-based criminal history background check as required by Section 487.105.
(c)  A registration expires on the second anniversary of the date of the registration's issuance, unless suspended or revoked under rules adopted under this chapter.
Added by Acts 2015, 84th Leg., R.S., Ch. 301 (S.B. 339), Sec. 1, eff. June 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter E. Duties of Counties and Municipalities › Section 487.201. Counties and Municipalities May Not Prohibit Low-Thc Cannabis

Sec. 487.201.  COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT LOW-THC CANNABIS.  A municipality, county, or other political subdivision may not enact, adopt, or enforce a rule, ordinance, order, resolution, or other regulation that prohibits the cultivation, production, dispensing, or possession of low-THC cannabis, as authorized by this chapter.
Added by Acts 2015, 84th Leg., R.S., Ch. 301 (S.B. 339), Sec. 1, eff. June 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter F. Compassionate-Use Research and Reporting › Section 487.251. Definitions

Sec. 487.251.  DEFINITIONS.  In this subchapter:
(1)  "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.
(2)  "Institutional review board" means a compassionate-use institutional review board established under Section 487.253.
Added by Acts 2021, 87th Leg., R.S., Ch. 660 (H.B. 1535), Sec. 1, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter F. Compassionate-Use Research and Reporting › Section 487.252. Rules

Sec. 487.252.  RULES.  (a)  Except as otherwise provided by Subsection (b), the executive commissioner shall adopt all necessary rules to implement this subchapter, including rules designating the medical conditions for which a patient may be treated with low-THC cannabis as part of an approved research program conducted under this subchapter.
(b)  The Texas Medical Board may adopt rules regarding the certification of a physician by an institutional review board.
Added by Acts 2021, 87th Leg., R.S., Ch. 660 (H.B. 1535), Sec. 1, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter F. Compassionate-Use Research and Reporting › Section 487.253. Compassionate-Use Institutional Review Boards

Sec. 487.253.  COMPASSIONATE-USE INSTITUTIONAL REVIEW BOARDS.  (a)  One or more compassionate-use institutional review boards may be established to:
(1)  evaluate and approve proposed research programs to study the medical use of low-THC cannabis in treating a medical condition designated by rule of the executive commissioner under Section 487.252(a); and
(2)  oversee patient treatment undertaken as part of an approved research program, including the certification of treating physicians.
(b)  An institutional review board must be affiliated with a dispensing organization and meet one of the following conditions:
(1)  be affiliated with a medical school, as defined by Section 61.501, Education Code;
(2)  be affiliated with a hospital licensed under Chapter 241 that has at least 150 beds;
(3)  be accredited by the Association for the Accreditation of Human Research Protection Programs;
(4)  be registered by the United States Department of Health and Human Services, Office for Human Research Protections, in accordance with 21 C.F.R. Part 56; or
(5)  be accredited by a national accreditation organization acceptable to the Texas Medical Board.
Added by Acts 2021, 87th Leg., R.S., Ch. 660 (H.B. 1535), Sec. 1, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter F. Compassionate-Use Research and Reporting › Section 487.254. Reports by Institutional Review Boards

Sec. 487.254.  REPORTS BY INSTITUTIONAL REVIEW BOARDS.  Each institutional review board shall submit written reports that describe and assess the research findings of each approved research program to:
(1)  the Health and Human Services Commission, not later than October 1 of each year; and
(2)  the legislature, not later than October 1 of each even-numbered year.
Added by Acts 2021, 87th Leg., R.S., Ch. 660 (H.B. 1535), Sec. 1, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter F. Compassionate-Use Research and Reporting › Section 487.255. Patient Treatment

Sec. 487.255.  PATIENT TREATMENT.  (a)  Patient treatment provided as part of an approved research program under this subchapter may be administered only by a physician certified by an institutional review board to participate in the program.
(b)  A patient participating in a research program under this subchapter must be a permanent resident of this state.
Added by Acts 2021, 87th Leg., R.S., Ch. 660 (H.B. 1535), Sec. 1, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 487 - Texas Compassionate-Use Act › Subchapter F. Compassionate-Use Research and Reporting › Section 487.256. Informed Consent

Sec. 487.256.  INFORMED CONSENT.  (a)  Before receiving treatment under an approved research program, each patient must sign a written informed consent form.
(b)  If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, guardian, or conservator may provide informed consent on the patient's behalf.
(c)  An institutional review board overseeing a research program under this subchapter may adopt a form to be used for the informed consent required by this section.
Added by Acts 2021, 87th Leg., R.S., Ch. 660 (H.B. 1535), Sec. 1, eff. September 1, 2021.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 488 - Over-the-Counter Sales of Dextromethorphan › Section 488.001. Definitions

Sec. 488.001.  DEFINITIONS.  (a)  In this chapter:
(1)  "Dextromethorphan" means any compound, mixture, or preparation containing any detectable amount of that substance, including its salts, optical isomers, and salts of optical isomers.
(2)  "Sale" includes a conveyance, exchange, barter, or trade.
(b)  A term that is used in this chapter but is not defined by Subsection (a) has the meaning assigned by Section 481.002 if the term is defined in that section.
Added by Acts 2019, 86th Leg., R.S., Ch. 46 (H.B. 1518), Sec. 1, eff. September 1, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 488 - Over-the-Counter Sales of Dextromethorphan › Section 488.002. Nonapplicability

Sec. 488.002.  NONAPPLICABILITY.  (a)  This chapter does not apply to the sale of any product dispensed or delivered by a pharmacist according to a prescription issued by a practitioner for a valid medical purpose within the scope of the practitioner's practice as authorized by the practitioner's license issued under Title 3, Occupations Code.
(b)  This chapter does not require a business establishment to:
(1)  keep specific records of transactions covered by this chapter; or
(2)  store dextromethorphan in a specific location in a business establishment or otherwise restrict the availability of dextromethorphan to customers.
Added by Acts 2019, 86th Leg., R.S., Ch. 46 (H.B. 1518), Sec. 1, eff. September 1, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 488 - Over-the-Counter Sales of Dextromethorphan › Section 488.003. Distribution to Minors Prohibited; Prerequisite to Sale

Sec. 488.003.  DISTRIBUTION TO MINORS PROHIBITED; PREREQUISITE TO SALE. (a) A business establishment may not dispense, distribute, or sell dextromethorphan to a customer under 18 years of age.
(b)  Before dispensing, distributing, or selling dextromethorphan over the counter, a business establishment must require the customer obtaining the drug to display a driver's license or other form of identification containing the customer's photograph and indicating that the customer is 18 years of age or older, unless from the customer's outward appearance the person making the sale may reasonably presume the customer to be 27 years of age or older.
Added by Acts 2019, 86th Leg., R.S., Ch. 46 (H.B. 1518), Sec. 1, eff. September 1, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 488 - Over-the-Counter Sales of Dextromethorphan › Section 488.004. Violation; Civil Penalty

Sec. 488.004.  VIOLATION; CIVIL PENALTY.  (a)  A county or district attorney shall issue a warning to a business establishment for a first violation of this chapter.
(b)  After receiving a warning for the first violation under Subsection (a), a business establishment is liable to the state for a civil penalty of:
(1)  $150 for the second violation; and
(2)  $250 for each subsequent violation.
(c)  It is a defense in an action brought under this section that the person to whom the dextromethorphan was dispensed, distributed, or sold presented to the business establishment apparently valid proof of identification.
(d)  A proof of identification satisfies the requirements of Subsection (c) if it contains a physical description and photograph consistent with the person's appearance, purports to establish that the person is 18 years of age or older, and was issued by a governmental agency.  The proof of identification may include a driver's license issued by this state or another state, a passport, or an identification card issued by a state or the federal government.
(e)  It is a defense in an action brought under this section that the business establishment made a good faith effort to comply with this section.
Added by Acts 2019, 86th Leg., R.S., Ch. 46 (H.B. 1518), Sec. 1, eff. September 1, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 488 - Over-the-Counter Sales of Dextromethorphan › Section 488.005. Prohibited Local Regulation

Sec. 488.005.  PROHIBITED LOCAL REGULATION.  (a)  A political subdivision of this state may not adopt or enforce an ordinance, order, rule, regulation, or policy that governs the sale, distribution, or possession of dextromethorphan.
(b)  An ordinance, order, rule, regulation, or policy described by Subsection (a) is void and unenforceable.
Added by Acts 2019, 86th Leg., R.S., Ch. 46 (H.B. 1518), Sec. 1, eff. September 1, 2019.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter A. General Provisions › Section 489.001. Definitions

Sec. 489.001.  DEFINITIONS.  In this chapter:
(1)  "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration and remains under investigation in the clinical trial.
(2)  "Terminal illness" means an advanced stage of a disease with an unfavorable prognosis that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Terminal Illnesses › Section 489.051. Patient Eligibility

Sec. 489.051.  PATIENT ELIGIBILITY.  A patient is eligible to access and use an investigational drug, biological product, or device under this chapter if:
(1)  the patient has a terminal illness, attested to by the patient's treating physician; and
(2)  the patient's physician:
(A)  in consultation with the patient, has considered all other treatment options currently approved by the United States Food and Drug Administration and determined that those treatment options are unavailable or unlikely to prolong the patient's life; and
(B)  has recommended or prescribed in writing that the patient use a specific class of investigational drug, biological product, or device.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Terminal Illnesses › Section 489.052. Informed Consent

Sec. 489.052.  INFORMED CONSENT.  (a)  Before receiving an investigational drug, biological product, or device, an eligible patient must sign a written informed consent.  If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide informed consent on the patient's behalf.
(b)  The executive commissioner of the Health and Human Services Commission by rule may adopt a form for the informed consent under this section.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Terminal Illnesses › Section 489.053. Provision of Investigational Drug, Biological Product, or Device by Manufacturer

Sec. 489.053.  PROVISION OF INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER.  (a)  A manufacturer of an investigational drug, biological product, or device may make available the manufacturer's investigational drug, biological product, or device to eligible patients in accordance with this chapter if the patient provides to the manufacturer the informed consent required under Section 489.052.
(b)  This chapter does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
(c)  If a manufacturer makes available an investigational drug, biological product, or device to an eligible patient under this subchapter, the manufacturer must provide the investigational drug, biological product, or device to the eligible patient without receiving compensation.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Terminal Illnesses › Section 489.054. No Cause of Action Created

Sec. 489.054.  NO CAUSE OF ACTION CREATED.  This chapter does not create a private or state cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from the investigational drug, biological product, or device.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Terminal Illnesses › Section 489.055. State May Not Interfere With Access to Investigational Drug, Biological Product, or Device

Sec. 489.055.  STATE MAY NOT INTERFERE WITH ACCESS TO INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE.  An official, employee, or agent of this state may not block or attempt to block an eligible patient's access to an investigational drug, biological product, or device under this chapter.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter C. Health Insurance › Section 489.101. Effect on Health Care Coverage for Clinical Trial Enrollees

Sec. 489.101.  EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL TRIAL ENROLLEES.  This chapter does not affect the coverage of enrollees in clinical trials under Chapter 1379, Insurance Code.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses › Subchapter D. Physicians › Section 489.151. Action Against Physician's License Prohibited

Sec. 489.151.  ACTION AGAINST PHYSICIAN'S LICENSE PROHIBITED.  Notwithstanding any other law, the Texas Medical Board may not revoke, fail to renew, suspend, or take any action against a physician's license under Subchapter B, Chapter 164, Occupations Code, based solely on the physician's recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device, provided that the recommendations made to the patient meet the medical standard of care.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter A. General Provisions › Section 490.001. Definitions

Sec. 490.001.  DEFINITIONS.  In this chapter:
(1)  "Commissioner" means the commissioner of state health services.
(2)  "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.
(3)  "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase one of a clinical trial but the United States Food and Drug Administration or its international equivalent has not yet approved for general use and that remains under investigation in the clinical trial.  The term does not include low-THC cannabis, as defined by Section 169.001, Occupations Code, or a product containing marihuana, as defined by Section 481.002, regardless of whether the cannabis or product successfully completed phase one of a clinical trial.
(4)  "Severe chronic disease" means a condition, injury, or illness that:
(A)  may be treated;
(B)  may not be cured or eliminated; and
(C)  entails significant functional impairment or severe pain.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter A. General Provisions › Section 490.002. Designation of Severe Chronic Diseases

Sec. 490.002.  DESIGNATION OF SEVERE CHRONIC DISEASES.  The commissioner shall designate the medical conditions considered to be severe chronic diseases under this chapter.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter A. General Provisions › Section 490.003. Rules

Sec. 490.003.  RULES.  The executive commissioner shall adopt rules necessary to administer this chapter.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Severe Chronic Diseases › Section 490.051. Patient Eligibility

Sec. 490.051.  PATIENT ELIGIBILITY.  A patient is eligible to access and use an investigational drug, biological product, or device under this chapter if:
(1)  the patient has a severe chronic disease the commissioner designates under Section 490.002 that the patient's treating physician confirms in writing;
(2)  the use of the investigational drug, biological product, or device is consistent with this chapter and rules adopted under this chapter; and
(3)  the patient's physician:
(A)  in consultation with the patient, considers all other treatment options the United States Food and Drug Administration has currently approved and determines those treatment options are unavailable or unlikely to provide relief for the significant impairment or severe pain associated with the patient's severe chronic disease; and
(B)  recommends or prescribes in writing the patient's use of a specific class of investigational drug, biological product, or device.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Severe Chronic Diseases › Section 490.052. Informed Consent

Sec. 490.052.  INFORMED CONSENT.  (a)  Before receiving an investigational drug, biological product, or device, an eligible patient must sign a written informed consent.  If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, guardian, or conservator may provide informed consent on the patient's behalf.
(b)  The commissioner may prescribe a form for the informed consent required under this section.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Severe Chronic Diseases › Section 490.053. Provision of Investigational Drug, Biological Product, or Device by Manufacturer

Sec. 490.053.  PROVISION OF INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER.  (a)  A manufacturer of an investigational drug, biological product, or device may make available the manufacturer's investigational drug, biological product, or device to eligible patients in accordance with this chapter if the patient provides to the manufacturer the informed consent required under Section 490.052.
(b)  This chapter does not require a manufacturer to make available an investigational drug, biological product, or device to an eligible patient.
(c)  If a manufacturer makes available an investigational drug, biological product, or device to an eligible patient under this subchapter, the manufacturer must provide the investigational drug, biological product, or device to the eligible patient without receiving compensation.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Severe Chronic Diseases › Section 490.054. Cause of Action Not Created

Sec. 490.054.  CAUSE OF ACTION NOT CREATED.  This chapter does not create a private or state cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm to the patient resulting from the investigational drug, biological product, or device.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter B. Access to Investigational Drugs, Biological Products, and Devices for Patients With Severe Chronic Diseases › Section 490.055. State May Not Interfere With Access to Investigational Drug, Biological Product, or Device

Sec. 490.055.  STATE MAY NOT INTERFERE WITH ACCESS TO INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE.  An official, employee, or agent of this state may not block or attempt to block an eligible patient's access to an investigational drug, biological product, or device under this chapter unless the drug, biological product, or device is considered adulterated or misbranded under Chapter 431.  For purposes of this section, a governmental entity may not consider the drug, biological product, or device to be adulterated or misbranded based solely on the United States Food and Drug Administration not yet finally approving the drug, biological product, or device.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter C. Health Insurance › Section 490.101. Effect on Health Care Coverage for Clinical Trial Enrollees

Sec. 490.101.  EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL TRIAL ENROLLEES.  This chapter does not affect the coverage of enrollees in clinical trials under Chapter 1379, Insurance Code.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle C - Substance Abuse Regulation and Crimes › Chapter 490 - Access to Investigational Treatments for Patients With Severe Chronic Diseases › Subchapter D. Physicians › Section 490.151. Action Against Physician's License Prohibited

Sec. 490.151.  ACTION AGAINST PHYSICIAN'S LICENSE PROHIBITED.  Notwithstanding any other law, the Texas Medical Board may not revoke, fail  to renew, suspend, or take any action against a physician's license under Subchapter B, Chapter 164, Occupations Code, based solely on the physician's recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device, provided that the recommendations meet the requirements of this chapter and rules adopted under this chapter.
Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle D - Hazardous Substances › Chapter 501 - Hazardous Substances › Subchapter A. General Provisions › Section 501.001. Definitions

Sec. 501.001.  DEFINITIONS.  In this chapter:
(1)  Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(96), eff. April 2, 2015.
(2)  "Commerce" includes the operation of a business or service establishment and other commerce in this state that is subject to the jurisdiction of this state.
(3)  "Commissioner" means the commissioner of state health services.
(4)  "Department" means the Department of State Health Services.
(4-a)  "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.
(5)  "Label" means a display of written, printed, or other graphic matter:
(A)  on the immediate container, excluding the package liner, of any substance;  or
(B)  directly on the article or on a tag or other suitable material affixed to the article, if the article is unpackaged or not packaged in an immediate container intended or suitable for delivery to the ultimate consumer.
(6)  "Misbranded hazardous substance" means either of the following that is not properly packaged or does not bear a proper label required by this chapter:
(A)  a hazardous substance;  or
(B)  a toy or other article intended for use by children that bears or contains a hazardous substance in a manner that is accessible by a child to whom the toy or other article is entrusted, intended, or packaged in a form suitable for use in a household or by children.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 2001, 77th Leg., ch. 360, Sec. 1, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1259, eff. April 2, 2015.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(96), eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle D - Hazardous Substances › Chapter 501 - Hazardous Substances › Subchapter A. General Provisions › Section 501.003. Designation of Radioactive Substance as Hazardous

Sec. 501.003.  DESIGNATION OF RADIOACTIVE SUBSTANCE AS HAZARDOUS.  The executive commissioner by rule shall designate a radioactive substance to be a hazardous substance if, with respect to the substance as used in a particular class of article or as packaged, the executive commissioner finds that the substance is sufficiently hazardous as to require labeling as a hazardous substance under this chapter in order to protect the public health.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1261, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle D - Hazardous Substances › Chapter 501 - Hazardous Substances › Subchapter A. General Provisions › Section 501.004. Designation of Strong Sensitizer

Sec. 501.004.  DESIGNATION OF STRONG SENSITIZER.  Before designating a substance as a strong sensitizer, the department must determine that the substance has a significant potential for causing hypersensitivity considering the frequency of occurrence and the severity of the reaction.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle D - Hazardous Substances › Chapter 501 - Hazardous Substances › Subchapter A. General Provisions › Section 501.005. Exclusion

Sec. 501.005.  EXCLUSION.  This chapter does not apply to the manufacture, distribution, sale, or use of diapers.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle D - Hazardous Substances › Chapter 501 - Hazardous Substances › Subchapter B. Regulation of Substances › Section 501.021. Flammability Standards; Determination of Flammability

Sec. 501.021.  FLAMMABILITY STANDARDS;  DETERMINATION OF FLAMMABILITY.  (a)  The executive commissioner by rule shall establish the methods for determining the flammability of solids, fabrics, children's clothing, household furnishings, and the contents of self-pressurized containers that the executive commissioner finds are generally applicable to those materials or containers.
(b)  The executive commissioner by rule shall establish flammability standards for articles described by Subsection (a).  The standards must conform to standards prescribed by federal regulations adopted under the federal Flammable Fabrics Act (15 U.S.C. Section 1191 et seq.), as amended, the Federal Hazardous Substances Act (15 U.S.C. Section 1261 et seq.), as amended, and the federal Consumer Product Safety Act (15 U.S.C. Section 2051 et seq.), as amended.  Until the executive commissioner adopts standards, the flammability standards for articles described by Subsection (a) are the standards prescribed by federal regulations adopted under the federal Flammable Fabrics Act (15 U.S.C. Section 1191 et seq.), the Federal Hazardous Substances Act (15 U.S.C. Section 1261 et seq.), and the federal Consumer Product Safety Act (15 U.S.C. Section 2051 et seq.) as of September 1, 2001.
(c)  The department may obtain samples of articles described by Subsection (a) and determine the flammability of the articles for compliance with applicable standards established under this section.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 2001, 77th Leg., ch. 360, Sec. 3, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1262, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle D - Hazardous Substances › Chapter 501 - Hazardous Substances › Subchapter B. Regulation of Substances › Section 501.022. Designation of Banned Hazardous Substances

Sec. 501.022.  DESIGNATION OF BANNED HAZARDOUS SUBSTANCES.  (a)  The executive commissioner by rule shall designate as a banned hazardous substance any article, including clothing intended for the use of children, that is not properly packaged or that does not comply with applicable flammability standards established by the executive commissioner.  The executive commissioner's determination that articles of clothing of a specified range of sizes are intended for the use of a child 14 years of age or younger is conclusive.
(b)  The executive commissioner by rule shall designate as a banned hazardous substance any toy or other article, other than clothing, intended for the use of children that is a hazardous substance or bears or contains a hazardous substance in a manner accessible by a child to whom the toy or other article is entrusted.
(c)  The executive commissioner by rule shall designate as a banned hazardous substance any hazardous substance intended or packaged in a form suitable for use in a household that, notwithstanding cautionary labeling required by this chapter, is potentially so dangerous or hazardous when present or used in a household that the protection of the public health and safety may be adequately served only by keeping the substance out of commerce.
(d)  The executive commissioner by rule shall designate as a banned hazardous substance any article subject to this chapter that cannot be labeled adequately to protect the public health and safety or that presents an imminent danger to the public health and safety.
(e)  This section does not apply to a toy or article such as a chemical set that because of its functional purpose requires the inclusion of a hazardous substance or necessarily presents an electrical, mechanical, or thermal hazard if the toy or article:
(1)  bears labeling that in the judgment of the department gives adequate directions and warnings for safe use; and
(2)  is intended for use by children who have attained sufficient maturity and may reasonably be expected to read and heed those directions and warnings.
(f)  This section does not apply to the manufacture, sale, distribution, or use of fireworks of any class.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 2001, 77th Leg., ch. 360, Sec. 4, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1263, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle D - Hazardous Substances › Chapter 501 - Hazardous Substances › Subchapter B. Regulation of Substances › Section 501.023. General Labeling and Packaging Requirements

Sec. 501.023.  GENERAL LABELING AND PACKAGING REQUIREMENTS.  (a)  The department shall ensure that each hazardous substance is labeled sufficiently to inform its user of the dangers involved in using, storing, or handling the substance, of actions to be taken or avoided, and to give instructions as necessary for proper first aid treatment.  The department shall develop labeling instructions consistent with and in conformity with federal requirements.
(b)  A statement required by Subsection (a) must be located prominently and written in English in conspicuous and legible type that contrasts in typography, layout, or color with other printed matter on the label.  The department may also require the statement to be written in Spanish.
(c)  The statement must also appear:
(1)  on the outside container or wrapper of a substance and on a container sold separately and intended for the storage of a hazardous substance unless the statement required by Subsection (a) is easily legible through the outside container or wrapper;  and
(2)  on all accompanying literature containing directions for use, whether written or in other form.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 2001, 77th Leg., ch. 360, Sec. 5, eff. Sept. 1, 2001.
Sec. 501.0231.  LABELING OF CERTAIN TOYS AND GAMES.  (a)  Toys or games intended for use by children, including the parts of those toys or games, shall be labeled in the manner required by department rule.  The rules adopted under this subsection shall be consistent with federal guidelines and regulations adopted under the Federal Hazardous Substances Act (15 U.S.C. Section 1261 et seq.), as amended.  Until the executive commissioner adopts rules under this subsection, the toys, games, and parts shall be labeled in the manner required by federal guidelines and regulations adopted under the Federal Hazardous Substances Act (15 U.S.C. Section 1261 et seq.) as of September 1, 2001.
(b)  Latex balloons, small balls, marbles, and any toy or game that contains such a balloon, ball, or marble shall be labeled in the manner required by department rule.  The rules adopted under this subsection shall be consistent with federal guidelines and regulations adopted under the Federal Hazardous Substances Act (15 U.S.C. Section 1261 et seq.), as amended.  Until the executive commissioner adopts rules under this subsection, latex balloons, small balls, marbles, and any toy or game that contains such a balloon, ball, or marble shall be labeled in the manner required by federal guidelines and regulations adopted under the Federal Hazardous Substances Act (15 U.S.C. Section 1261 et seq.) as of September 1, 2001.
Added by Acts 2001, 77th Leg., ch. 360, Sec. 6, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1264, eff. April 2, 2015.