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 438 - Public Health Measures Relating to Food › Subchapter D. Food Service Programs › Section 438.0431. Basic Food Safety Accreditation

Sec. 438.0431.  BASIC FOOD SAFETY ACCREDITATION.  (a)  Notwithstanding Section 438.043, the department may accredit an education or training program for basic food safety for food handlers as provided by this section.
(b)  The executive commissioner shall by rule define the basic food safety training or education required to be included in a course curriculum.  The course curriculum must include the food allergen awareness information described by Section 437.027(b). The course length may not exceed two hours.
(c)  A training or education program accredited under this section may require a participant to achieve a passing score on an examination to successfully complete the course for certification.
(d)  A program accredited under this section may be delivered through the Internet.
Added by Acts 2007, 80th Leg., R.S., Ch. 1299 (S.B. 552), Sec. 2, eff. September 1, 2007.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1136, eff. April 2, 2015.
Acts 2023, 88th Leg., R.S., Ch. 1031 (S.B. 812), Sec. 4, 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 438 - Public Health Measures Relating to Food › Subchapter D. Food Service Programs › Section 438.044. Application for Accreditation

Sec. 438.044.  APPLICATION FOR ACCREDITATION.  (a)  A person seeking accreditation for an education or training program must apply to the department for accreditation.  The applicant must demonstrate to the department the contents of the course.
(b)  The department shall accredit a course that meets the minimum requirements of this subchapter.
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 A - Food and Drug Health Regulations › Chapter 438 - Public Health Measures Relating to Food › Subchapter D. Food Service Programs › Section 438.045. Audit of Education and Training Programs

Sec. 438.045.  AUDIT OF EDUCATION AND TRAINING PROGRAMS.  The department shall conduct a regular audit of each program accredited under this subchapter to ensure compliance with this subchapter.
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 A - Food and Drug Health Regulations › Chapter 438 - Public Health Measures Relating to Food › Subchapter D. Food Service Programs › Section 438.046. List of Accredited Programs

Sec. 438.046.  LIST OF ACCREDITED PROGRAMS.  (a)  The department shall maintain a registry of course programs accredited under this subchapter.
(b)  A food service worker trained in a course for the employees of a single entity is considered to have met a local health jurisdiction's training, testing, and permitting requirements only as to food service performed for that entity.
(b-1)  A food service worker trained in a food handler training course that is accredited by the American National Standards Institute or that is accredited by the department and listed with the registry is considered to have met a local health jurisdiction's training, testing, and permitting requirements.  A local health jurisdiction may require a food establishment, as that term is defined by Section 438.101, to maintain on the premises of the food establishment a certificate of completion of the training course for employees of the food establishment.
(c)  A local health jurisdiction may not charge a fee or require or issue a local food handler card for a certificate issued to a food service worker who provides proof of completion of an accredited course described by Subsection (b-1).
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 16, eff. Sept. 1, 1991;  Acts 1995, 74th Leg., ch. 822, Sec. 2, eff. Aug. 28, 1995.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 843 (S.B. 582), Sec. 1, eff. June 17, 2015.
Acts 2017, 85th Leg., R.S., Ch. 728 (S.B. 1089), Sec. 1, eff. June 12, 2017.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 438 - Public Health Measures Relating to Food › Subchapter D. Food Service Programs › Section 438.047. Fees

Sec. 438.047.  FEES.  The department in accordance with department rules shall charge an application fee and an audit fee sufficient to cover the entire cost of accreditation, audit, and maintenance of the registry.
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. 3.1137, 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 438 - Public Health Measures Relating to Food › Subchapter F. Food Inspections › Section 438.061. Food Inspections by Type a General-Law Municipality

Sec. 438.061.  FOOD INSPECTIONS BY TYPE A GENERAL-LAW MUNICIPALITY.  (a)  The governing body of a Type A general-law municipality may regulate the inspection of beef, pork, flour, meal, salt, and other provisions.
(b)  The governing body of a Type A general-law municipality may appoint weighers, gaugers, and inspectors, and may prescribe their duties and regulate their fees.
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 A - Food and Drug Health Regulations › Chapter 438 - Public Health Measures Relating to Food › Subchapter G. Certification of Food Managers › Section 438.101. Definitions

Sec. 438.101.  DEFINITIONS.  In this subchapter:
(1)  Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(82), eff. April 2, 2015.
(2)  "Food establishment" means a fixed or mobile location retail establishment in which food is prepared on-site for sale to the public.
(3)  "Food manager" means an individual who conducts, manages, or operates a food establishment.
Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(82), 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 438 - Public Health Measures Relating to Food › Subchapter G. Certification of Food Managers › Section 438.102. Certification Program

Sec. 438.102.  CERTIFICATION PROGRAM.  (a)  The executive commissioner shall establish a certification program for food managers in accordance with this subchapter.
(b)  The executive commissioner by rule shall prescribe the requirements for issuance and renewal of a food manager certificate under this subchapter.
Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1138, 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 438 - Public Health Measures Relating to Food › Subchapter G. Certification of Food Managers › Section 438.103. Certification and Renewal of Certification; Examination Required

Sec. 438.103.  CERTIFICATION AND RENEWAL OF CERTIFICATION;  EXAMINATION REQUIRED.  (a)  A person who satisfies the requirements of this subchapter may receive and renew a food manager certificate by passing a state-approved examination.
(b)  A state-approved examination for issuance or renewal of a food manager certificate must test an applicant on the food allergen awareness information described by Section 437.027(b).
Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.
Amended by:
Acts 2023, 88th Leg., R.S., Ch. 1031 (S.B. 812), Sec. 5, 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 438 - Public Health Measures Relating to Food › Subchapter G. Certification of Food Managers › Section 438.104. Approval of Examinations; Selection of Examination Sites

Sec. 438.104.  APPROVAL OF EXAMINATIONS;  SELECTION OF EXAMINATION SITES.  (a)  The executive commissioner shall adopt criteria to approve examinations.
(b)  In administering this subchapter, the department shall consider the impact of the traveling distance and time required for a food manager to obtain certification.  The department shall give particular consideration to mitigating the impact of this subchapter on food managers in rural areas.  The department shall use the Internet to implement the certification and may develop a system to permit administration of the examination using the Internet.
Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1139, 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 438 - Public Health Measures Relating to Food › Subchapter G. Certification of Food Managers › Section 438.105. Certificate as Evidence of Compliance With Other Law

Sec. 438.105.  CERTIFICATE AS EVIDENCE OF COMPLIANCE WITH OTHER LAW.  A food manager certificate, including a renewal certificate, obtained under this subchapter shall be accepted as meeting the training and testing requirements under Section 438.046(b).
Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 438 - Public Health Measures Relating to Food › Subchapter G. Certification of Food Managers › Section 438.1055. Prohibited Requirement of Local Food Manager Card or Local Fee

Sec. 438.1055.  PROHIBITED REQUIREMENT OF LOCAL FOOD MANAGER CARD OR LOCAL FEE.  A local health jurisdiction may not require a food manager who holds a food manager certificate issued under this subchapter to hold a local food manager card or charge a fee for issuance of the certificate under this subchapter.
Added by Acts 2023, 88th Leg., R.S., Ch. 245 (S.B. 577), 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 438 - Public Health Measures Relating to Food › Subchapter G. Certification of Food Managers › Section 438.106. Powers and Duties of Executive Commissioner; Fees

Sec. 438.106.  POWERS AND DUTIES OF EXECUTIVE COMMISSIONER;  FEES.  (a)  The executive commissioner by rule may adopt a fee for issuance or renewal of a food manager certificate under this subchapter in amounts reasonable and necessary to administer this subchapter, but not to exceed $35.
(b)  The executive commissioner by rule may adopt a fee, in an amount not to exceed $10, for an examination administered by the department under this subchapter.
(c)  The executive commissioner may adopt rules for the denial, suspension, and revocation of a food manager certificate issued under this subchapter.
(d)  The executive commissioner by rule may prescribe standards for:
(1)  examination sites;
(2)  expenses of administration of examinations under this subchapter; and
(3)  site audits for administration of this subchapter.
Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1140, 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 438 - Public Health Measures Relating to Food › Subchapter H. Information on Department or Local Health Jurisdiction Food Regulation › Section 438.151. Definition

Sec. 438.151.  DEFINITION.  In this subchapter, "local health jurisdiction" means a public health district, county, or municipality that regulates food service establishments, retail food stores, mobile food units, temporary food service establishments, or roadside food vendors.
Added by Acts 2019, 86th Leg., R.S., Ch. 309 (H.B. 2107), Sec. 2, 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 438 - Public Health Measures Relating to Food › Subchapter H. Information on Department or Local Health Jurisdiction Food Regulation › Section 438.152. Request for Information

Sec. 438.152.  REQUEST FOR INFORMATION.  Unless otherwise prohibited by state or federal law, on receipt of a written request for information pertaining to the regulation of food under this subtitle, the department or a local health jurisdiction shall provide a reasonable and substantial response to the request not later than the 30th day after the date the department or local health jurisdiction receives the request.
Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.
Amended by:
Acts 2019, 86th Leg., R.S., Ch. 309 (H.B. 2107), Sec. 3, 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 438 - Public Health Measures Relating to Food › Subchapter H. Information on Department or Local Health Jurisdiction Food Regulation › Section 438.153. Request for Official Determination

Sec. 438.153.  REQUEST FOR OFFICIAL DETERMINATION.  (a)  On receipt of a written request regarding the applicability to a specific circumstance of a regulation or the requirements for compliance with the regulation, the department or local health jurisdiction shall provide an official written determination regarding the applicability of the regulation or the requirements for compliance with the regulation to the requestor not later than the 30th day after the date the department or local health jurisdiction receives the request.
(b)  An official determination made under this section is valid until the regulation that is the subject of the determination is amended by statute, department rule, or local health jurisdiction regulation.
Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.
Amended by:
Acts 2019, 86th Leg., R.S., Ch. 309 (H.B. 2107), Sec. 4, 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 438 - Public Health Measures Relating to Food › Subchapter H. Information on Department or Local Health Jurisdiction Food Regulation › Section 438.154. Effect of Official Determination

Sec. 438.154.  EFFECT OF OFFICIAL DETERMINATION.  An  inspector may not issue to a person a citation for a violation of a food regulation governed by this subtitle if the person provides the inspector with an official determination made under Section 438.153 that contradicts the opinion of the inspector.
Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 438 - Public Health Measures Relating to Food › Subchapter H. Information on Department or Local Health Jurisdiction Food Regulation › Section 438.155. Rules

Sec. 438.155.  RULES.  (a)  The executive commissioner shall adopt rules to implement this subchapter.
(b)  The executive commissioner periodically shall evaluate the department's food safety rules and modify the rules as necessary to improve consistency and communication in food regulation in this state.
Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 438 - Public Health Measures Relating to Food › Subchapter I. Miscellaneous Provisions › Section 438.201. No Private Cause of Action

Sec. 438.201.  NO PRIVATE CAUSE OF ACTION.  The provisions of this chapter related to food allergens do not create a private cause of action or change any common law or statutory duty.
Added by Acts 2023, 88th Leg., R.S., Ch. 1031 (S.B. 812), Sec. 6, 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 438 - Public Health Measures Relating to Food › Subchapter I. Miscellaneous Provisions › Section 438.202. Certain Regulations Prohibited

Sec. 438.202.  CERTAIN REGULATIONS PROHIBITED.  Notwithstanding any other law, a county, municipality, or public health district may not adopt or enforce an order, ordinance, rule, or other measure related to food allergens that is inconsistent with or exceeds the requirements of this chapter or Section 437.027.
Added by Acts 2023, 88th Leg., R.S., Ch. 1031 (S.B. 812), Sec. 6, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter A. Laetrile › Section 439.001. Definition

Sec. 439.001.  DEFINITION.  In this chapter, "laetrile" means amygdalin.
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 A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter A. Laetrile › Section 439.002. Manufacture and Sale

Sec. 439.002.  MANUFACTURE AND SALE.  Unless prohibited by federal law, laetrile may be manufactured in this state in accordance with Chapter 431 (Texas Food, Drug, and Cosmetic Act) and may be sold in this state for distribution by licensed physicians.
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. 3.1141, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter A. Laetrile › Section 439.003. Prescription and Administration

Sec. 439.003.  PRESCRIPTION AND ADMINISTRATION.  (a)  Unless prohibited by federal law, a licensed physician may prescribe or administer laetrile in the treatment of cancer.
(b)  A physician acting in accordance with federal and state law is not subject to disciplinary action by the Texas Medical Board for prescribing or administering laetrile to a patient under the physician's care who has requested the substance unless that board makes a formal finding that the substance is harmful.
(c)  A finding under Subsection (b) must be made in a hearing conducted as provided by Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1142, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter A. Laetrile › Section 439.005. Records; Disciplinary Actions

Sec. 439.005.  RECORDS;  DISCIPLINARY ACTIONS.  (a)  A physician shall keep records of the physician's purchases and disposals, including sales and dispensations, of laetrile.  The records shall include the date of each purchase or disposal by the physician, the name and address of the person receiving laetrile, and the reason for the disposal of laetrile to that person.
(b)  The Texas Medical Board may suspend, cancel, or revoke the license of any physician who:
(1)  fails to keep complete and accurate records of purchases and disposals of laetrile;
(2)  prescribes or dispenses laetrile to a person known to be a habitual user of narcotic or dangerous drugs or to a person who the physician should have known was a habitual user of narcotic or dangerous drugs;
(3)  uses any advertising that tends to mislead or deceive the public;  or
(4)  is unable to practice medicine with reasonable skill and safety to patients because of any mental or physical condition, including age, illness, or drunkenness, or because of excessive use of drugs, narcotics, chemicals, or any other type of material.
(c)  Subsection (b)(2) does not apply to a person being treated by the physician for narcotic use after the physician notifies the Texas Medical Board in writing of the name and address of the patient being treated.
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. 3.1143, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter B. Dimethyl Sulfoxide › Section 439.011. Definition

Sec. 439.011.  DEFINITION.  In this subchapter, "DMSO" means sterile and pyrogen-free dimethyl sulfoxide.
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 A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter B. Dimethyl Sulfoxide › Section 439.012. Manufacture and Sale

Sec. 439.012.  MANUFACTURE AND SALE.  DMSO may be manufactured in this state and may be sold in this state for human use when prescribed or administered by a licensed physician or dispensed by a licensed pharmacist as prescribed by a licensed physician.
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 A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter B. Dimethyl Sulfoxide › Section 439.013. Prescription, Administration, and Dispensation

Sec. 439.013.  PRESCRIPTION, ADMINISTRATION, AND DISPENSATION.  (a)  Except as prohibited by Subsection (b), a licensed physician may prescribe or administer DMSO.
(b)  A physician may not prescribe or administer DMSO in a formulation not approved for human use by the Food and Drug Administration of the United States Department of Health and Human Services unless the physician:
(1)  provides a written statement to the patient informing the patient that DMSO, in the formulation to be prescribed or administered, has not been approved for human use by the United States Food and Drug Administration;  and
(2)  informs the patient of the alternative methods of treatment for the patient's disorder and the potential of alternative methods for cure.
(c)  A licensed pharmacist may dispense DMSO on the written prescription of a licensed physician.
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 A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter B. Dimethyl Sulfoxide › Section 439.014. Regulation by Health Care Facility

Sec. 439.014.  REGULATION BY HEALTH CARE FACILITY.  (a)  A hospital or health care facility may not forbid or restrict the use of DMSO prescribed or administered by a licensed physician having staff privileges at that hospital or facility unless the hospital or facility:
(1)  makes a formal finding that the DMSO as prescribed or administered by the physician is or will be harmful to the patient;  or
(2)  determines that the prescription or administration of DMSO creates an immediate danger to the public.
(b)  A hospital or health care facility that forbids or restricts the use of DMSO under Subsection (a)(2) shall conduct a hearing on the restriction or prohibition as soon as practicable after its determination.
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 A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter B. Dimethyl Sulfoxide › Section 439.015. Records; Disciplinary Actions

Sec. 439.015.  RECORDS;  DISCIPLINARY ACTIONS.  (a)  A physician shall keep records of the physician's purchases and disposals, including sales and dispensations, of DMSO.  The records shall include the date of each purchase or disposal by the physician, the name and address of the person receiving DMSO, and the reason for the disposal of DMSO to that person.
(b)  The Texas Medical Board may suspend, cancel, or revoke the license of any physician who:
(1)  fails to keep complete and accurate records of purchases and disposals of DMSO in a formulation not approved for human use;  or
(2)  prescribes or administers DMSO in a manner that has been proven, in a formal hearing held by the board, to be harmful to the patient.
(c)  The Texas Medical Board may temporarily suspend the license of a physician who prescribes or administers DMSO in a manner that, in the board's opinion, creates an immediate danger to the public.  The board must conduct a hearing on the temporary suspension as soon as practicable after the suspension.
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. 3.1144, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter B. Dimethyl Sulfoxide › Section 439.016. Misrepresentation; Criminal Penalty

Sec. 439.016.  MISREPRESENTATION;  CRIMINAL PENALTY.  (a)  A person commits an offense if, in connection with advertising or promoting the sale of DMSO, the person knowingly or intentionally represents DMSO as a cure for any human disease, ailment, or disorder.
(b)  An offense under this section is a Class B misdemeanor.
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 A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter B. Dimethyl Sulfoxide › Section 439.017. Restrictions on Manufacture, Distribution, and Sale; Criminal Penalty

Sec. 439.017.  RESTRICTIONS ON MANUFACTURE, DISTRIBUTION, AND SALE;  CRIMINAL PENALTY.  (a)  A person commits an offense if the person manufactures, distributes, or sells a dimethyl sulfoxide formulation that is not sterile and pyrogen-free unless the substance is packaged in a container with a label that includes:
(1)  information about the concentration of the dimethyl sulfoxide;  and
(2)  the following statement: "Avoid contact with your skin.  This dimethyl sulfoxide is not sterile and pyrogen-free DMSO approved for human use.  It may contain harmful impurities that can be absorbed through the skin.  Dimethyl sulfoxide is a potent solvent that may have adverse effects on fabrics, plastics, and other materials."
(b)  An offense under this section is a Class B misdemeanor.
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 A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter C. Preservation and Distribution of Certain Unused Drugs › Section 439.021. Shipment to Foreign Countries

Sec. 439.021.  SHIPMENT TO FOREIGN COUNTRIES.  (a)  A consulting pharmacist of a nursing home may select, from a supply of drugs due for destruction, certain drugs to be used for shipment to a foreign country as provided by this subchapter.
(b)  The supply of drugs due for destruction are those drugs accumulated because of the death of a resident of the nursing home or because a physician has ordered the use of the drug to be discontinued.
(c)  Quarterly, before the drugs are destroyed, the consulting pharmacist may, in the pharmacist's professional judgment, select the drugs to be used under this subchapter and seal them in a box for shipment.
(d)  The consulting pharmacist shall account to the department for all drugs selected for shipment under this subchapter.
(e)  This subchapter does not apply if the unused drug is a controlled substance as defined by Chapter 481 (Texas Controlled Substances Act).
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. 3.1145, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter C. Preservation and Distribution of Certain Unused Drugs › Section 439.022. Administration

Sec. 439.022.  ADMINISTRATION.  (a)  The executive commissioner shall adopt rules consistent with federal and state law to implement this subchapter, including rules relating to:
(1)  the packaging and inventory of drugs for shipment;
(2)  the manner of shipment of the drugs from original shipment under this subchapter until the final destination; and
(3)  safeguards to ensure the proper handling of and accounting for all drugs shipped.
(b)  The executive commissioner by rule shall determine, in consultation with the United States Department of State and other appropriate federal agencies, the foreign countries to receive the drugs.
(c)  The salvaging of drugs under this subchapter is not subject to Chapter 431 (Texas Food, Drug, and Cosmetic Act).
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. 3.1146, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter C. Preservation and Distribution of Certain Unused Drugs › Section 439.023. Contracts; Funds

Sec. 439.023.  CONTRACTS;  FUNDS.  (a)  The department may contract with other entities, including local governments and civic organizations, to implement this subchapter.
(b)  The department may accept gifts, grants, and any other funds to implement this subchapter.
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. 3.1147, 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 439 - Manufacture and Distribution of Certain Drugs › Subchapter D. Insulin › Section 439.101. Definition

Text of section effective on September 01, 2024
Sec. 439.101.  DEFINITION.  In this subchapter, "manufacturer" has the meaning assigned by Section 531.070, Government Code.
Added by Acts 2023, 88th Leg., R.S., Ch. 244 (S.B. 241), Sec. 1, eff. September 1, 2024.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 439 - Manufacture and Distribution of Certain Drugs › Subchapter D. Insulin › Section 439.102. Written Verification Required for Brand Name Insulin Drug Manufacturer

Text of section effective on September 01, 2024
Sec. 439.102.  WRITTEN VERIFICATION REQUIRED FOR BRAND NAME INSULIN DRUG MANUFACTURER.  (a)  The manufacturer of a brand name insulin prescription drug for which a generic or biosimilar prescription drug is not available and that is included in the Medicaid vendor drug program formulary must submit to the Health and Human Services Commission a written verification stating whether or not the unavailability of the generic or biosimilar prescription drug is the result, wholly or partly, of:
(1)  a scheme by the manufacturer to pay a generic or biosimilar prescription drug manufacturer to delay manufacturing or marketing the generic or biosimilar drug;
(2)  a legal or business strategy to extend the life of a patent on the brand name prescription drug;
(3)  the manufacturer directly manipulating a patent on the brand name prescription drug; or
(4)  the manufacturer facilitating an action described by Subdivisions (1)-(3) on behalf of another entity.
(b)  The executive commissioner shall adopt rules prescribing the form and manner for submission of the written verification required under Subsection (a).
Added by Acts 2023, 88th Leg., R.S., Ch. 244 (S.B. 241), Sec. 1, eff. September 1, 2024.
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 A. General Provisions › Section 440.001. Short Title

Sec. 440.001.  SHORT TITLE.  This chapter may be cited as the Frozen Desserts Manufacturer Licensing Act.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
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 A. General Provisions › Section 440.002. Purpose

Sec. 440.002.  PURPOSE.  The legislature finds that a statewide licensing act is needed to:
(1)  regulate manufacturers of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products;
(2)  provide for uniformity of inspections of the premises of frozen dessert manufacturers;
(3)  protect the health and safety of consumers by preventing the manufacture or distribution of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products that do not meet state standards or related requirements of purity or labeling;  and
(4)  assist manufacturers in meeting state standards or related requirements.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
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 A. General Provisions › Section 440.004. Exemptions

Sec. 440.004.  EXEMPTIONS.  This chapter does not apply to:
(1)  a person operating a frozen desserts retail establishment;  or
(2)  a person operating a retail store unless the person is also a manufacturer.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
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 A. General Provisions › Section 440.005. Hearings

Sec. 440.005.  HEARINGS.   A hearing conducted in the administration of this chapter is governed by Chapter 2001, Government Code.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.  Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1149, 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 440 - Frozen Desserts Manufacturer Licensing Act › Subchapter A. General Provisions › Section 440.006. Powers of Executive Commissioner

Sec. 440.006.  POWERS OF EXECUTIVE COMMISSIONER.  The executive commissioner may:
(1)  adopt rules prescribing standards or related requirements for the operation of establishments for the manufacture of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products, including standards or requirements for the:
(A)  health, cleanliness, education, and training of personnel who are employed in the establishments;
(B)  protection of raw materials, manufactured merchandise, and merchandise held for sale;
(C)  design, construction, installation, and cleanliness of equipment and utensils;
(D)  sanitary facilities and controls of the establishments;
(E)  establishment construction and maintenance, including vehicles;
(F)  production processes and controls; and
(G)  institution and content of a system of records to be maintained by the establishment; and
(2)  adopt rules prescribing procedures for the enforcement of the standards or related requirements prescribed under Subdivision (1), including procedures for the:
(A)  requirement of a valid license to operate an establishment;
(B)  issuance, suspension, revocation, and reinstatement of licenses;
(C)  administrative hearings held under this chapter;
(D)  institution of certain court proceedings by the department or its designee;
(E)  inspection of establishments and securing of samples of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products;
(F)  access to the establishments and to the vehicles used in operations;
(G)  compliance by manufacturers outside the jurisdiction of the state; and
(H)  review of plans for future construction.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1150, 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 440 - Frozen Desserts Manufacturer Licensing Act › Subchapter A. General Provisions › Section 440.007. Applicability of Other Law

Sec. 440.007.  APPLICABILITY OF OTHER LAW.  Except as provided by Section 431.009(c), Chapter 431 applies to a person or product regulated under this chapter, including a frozen dessert manufacturer, a frozen dessert, an imitation frozen dessert, a product sold in semblance of a frozen dessert, and a mix for one of those products.
Added by Acts 2003, 78th Leg., ch. 112, Sec. 3, eff. Sept. 1, 2003.
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 B. Licensing › Section 440.011. Prohibited Act

Sec. 440.011.  PROHIBITED ACT.  (a)  A person may not operate an establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products in this state unless the person has a valid license issued under this chapter.
(b)  A political subdivision or agency of the state, other than the department, may not impose a license fee on any manufacturer covered by this section.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
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 B. Licensing › Section 440.012. License

Sec. 440.012.  LICENSE.  (a)  A person desiring to operate an establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products may apply to the department for a license.  A license shall be granted under the department's procedural rules and shall be issued only for the purpose and use as stated on the application for a license.
(b)  The department shall inspect the establishment under Section 440.031 before issuing a license.
(c)  A license may not be issued to a person who does not comply with the standards prescribed by department rule under this chapter.
(d)  A license issued under this chapter must be renewed every two years in accordance with department rules.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1151, 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 440 - Frozen Desserts Manufacturer Licensing Act › Subchapter B. Licensing › Section 440.013. Fees

Sec. 440.013.  FEES.  (a)  A nonrefundable fee for each establishment in an amount set by the executive commissioner by rule as prescribed by Section 12.0111 must accompany each application for a license.
(b)  The department also shall assess the following fees in the amounts set by the executive commissioner by rule as prescribed by Section 12.0111:
(1)  a fee for a frozen dessert manufacturer located in this state in an amount per 100 pounds of manufactured or processed frozen dessert manufactured or processed and distributed in this state by that manufacturer;
(2)  a fee for a frozen dessert manufacturer not located in this state in an amount per 100 pounds of frozen desserts manufactured or processed by the manufacturer in another state and imported for sale in this state;  and
(3)  a fee for the actual cost of analyzing samples of frozen desserts for a frozen dessert manufacturer not located in this state.
(c)  The executive commissioner shall adopt rules to collect fees imposed under this section monthly based on amounts due by the frozen dessert manufacturer.
(d)  The department may revoke a license to operate a frozen desserts plant if the licensee fails to make a timely payment of the monthly fees required under this section.  The department's rules of procedure for a contested case hearing and Chapter 2001, Government Code govern the revocation of a license.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.  Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1152, 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 440 - Frozen Desserts Manufacturer Licensing Act › Subchapter B. Licensing › Section 440.014. Recordkeeping

Sec. 440.014.  RECORDKEEPING.  The executive commissioner shall adopt rules establishing minimum standards for recordkeeping by persons required to pay fees under this chapter and the records shall be made available to the department on request.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1153, 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 440 - Frozen Desserts Manufacturer Licensing Act › Subchapter B. Licensing › Section 440.015. Establishments Outside State

Sec. 440.015.  ESTABLISHMENTS OUTSIDE STATE.  A frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products from a manufacturer located outside this state may be sold or distributed in this state if the manufacturer complies with this chapter or complies with other regulatory requirements that are substantially equivalent to those of this state.  To determine the extent of the manufacturer's compliance, the department may accept reports from responsible authorities in the jurisdiction in which the manufacturer is located.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
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 B. Licensing › Section 440.016. Temporary Permit

Sec. 440.016.  TEMPORARY PERMIT.  The department may issue a temporary permit to continue the operation of an establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or mix for one of those products until the department performs the inspection required by this chapter.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.
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 B. Licensing › Section 440.017. Refusal to Grant License; Suspension or Revocation of License

Sec. 440.017.  REFUSAL TO GRANT LICENSE;  SUSPENSION OR REVOCATION OF LICENSE.  In accordance with rules adopted under Section 440.006, the department may refuse an application for a license under this chapter or may suspend or revoke a license issued under this chapter.
Added by Acts 2003, 78th Leg., ch. 112, Sec. 4, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1154, 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 440 - Frozen Desserts Manufacturer Licensing Act › Subchapter C. Enforcement › Section 440.031. Inspection by Department

Sec. 440.031.  INSPECTION BY DEPARTMENT.  (a)  Under rules adopted by the executive commissioner, the department's authorized representatives have free access at all reasonable hours to any establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products or to any vehicle being used to transport in commerce a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products for the purpose of:
(1)  inspecting the establishment or vehicle to determine compliance with the standards or related requirements prescribed under this chapter; or
(2)  securing samples of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or a mix for one of those products for the purpose of making or causing to be made an examination of the samples to determine compliance with the standards or related requirements prescribed under this chapter.
(b)  A political subdivision or an agency other than the department that collects samples described by Subsection (a)(2) shall bear the cost of the samples and any analyses of the samples.
(c)  The inspection procedures provided by this section are in addition to the procedures provided by Chapter 431.
Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.  Amended by Acts 2003, 78th Leg., ch. 112, Sec. 5, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1155, eff. April 2, 2015.