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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter D. Food › Section 431.084. Emergency Permits for Foods Contaminated With Microorganisms

Sec. 431.084.  EMERGENCY PERMITS FOR FOODS CONTAMINATED WITH MICROORGANISMS.  (a)  The department shall provide for the issuance of temporary permits to a manufacturer, processor, or packer of a class of food in any locality that provides conditions for the manufacture, processing, or packing for the class of food as necessary to protect the public health only if the department finds after investigation that:
(1)  the distribution in this state of a class of food may, because the food is contaminated with microorganisms during the manufacture, processing, or packing of the food in any locality, be injurious to health; and
(2)  the injurious nature of the food cannot be adequately determined after the food has entered commerce.
(b)  The executive commissioner by rule shall establish standards and procedures for the enforcement of this section.
(c)  During the period for which permits are issued for a class of food determined by the department to be injurious under Subsection (a), a person may not introduce or deliver for introduction into commerce the food unless the person is a manufacturer, processor, or packer who has a permit issued by the department as authorized by rules adopted under this section.
(d)  The department may immediately suspend a permit issued under this section if a condition of the permit is violated.  An immediate suspension is effective on notice to the permit holder.
(e)  A holder of a permit that has been suspended may at any time apply for the reinstatement of the permit.  Immediately after a hearing and an inspection of the permit holder's establishment, the department shall reinstate the permit if adequate measures have been taken to comply with and maintain the conditions of the permit as originally issued or as amended.
(f)  A permit holder shall provide access to the permit holder's factory or establishment to the department to allow the department to determine whether the permit holder complies with the conditions of the permit.  Denial of access is grounds for suspension of the permit until the permit holder freely provides the access.
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. 3.0967, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter E. Drugs and Devices › Section 431.114. New Drugs

Sec. 431.114.  NEW DRUGS.  (a)  A person shall not sell, deliver, offer for sale, hold for sale or give away any new drug unless:
(1)  an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and
(2)  a copy of the letter of approval or approvability issued by the United States Food and Drug Administration is on file with the department if the product is manufactured in this state.
(b)  A person shall not use in or on human beings or animals a new drug or new animal drug limited to investigational use unless the person has filed with the United States Food and Drug Administration a completed and signed investigational new drug (IND) application in accordance with 21 C.F.R. 312.20-312.38 and the exemption has not been terminated.  The drug shall be plainly labeled in compliance with Section 505(i) of the federal Act.
(c)  This section shall not apply:
(1)  to any drug that is not a new drug as defined in the federal Act;
(2)  to any drug that is licensed under the Public Health Service Act (42 U.S.C. 201 et seq.); or
(3)  to any drug approved by the department by the authority of any prior law.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 157, eff. Sept. 1, 1991;  Acts 2003, 78th Leg., ch. 111, Sec. 6, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0970, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter E. Drugs and Devices › Section 431.117. Priority for Health Care Providers in Distribution of Influenza Vaccine

Sec. 431.117.  PRIORITY FOR HEALTH CARE PROVIDERS IN DISTRIBUTION OF INFLUENZA VACCINE.  The executive commissioner shall study the wholesale distribution of influenza vaccine in this state to determine the feasibility of implementing a system that requires giving a priority in filling orders for influenza vaccine to physicians and other licensed health care providers authorized to administer influenza vaccine over retail establishments. The executive commissioner may implement such a system if it is determined to be feasible.
Added by Acts 2007, 80th Leg., R.S., Ch. 922 (H.B. 3184), Sec. 2, eff. June 15, 2007.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0973, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter F. Cosmetics › Section 431.141. Adulterated Cosmetic

Sec. 431.141.  ADULTERATED COSMETIC.  A cosmetic shall be deemed to be adulterated:
(a)  if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual;  provided, that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon;  "Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows;  to do so may cause blindness";  and the labeling of which bears adequate directions for such preliminary testing.  For the purposes of this subsection and Subsection (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes;
(b)  if it consists in whole or in part of any filthy, putrid, or decomposed substance;
(c)  if it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(d)  if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(e)  if it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of Section 431.161(a).
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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter F. Cosmetics › Section 431.142. Misbranded Cosmetic

Sec. 431.142.  MISBRANDED COSMETIC.  (1)  A cosmetic shall be deemed to be misbranded:
(a)  if:
(1)  its labeling is false or misleading in any particular; and
(2)  its labeling or packaging fails to conform with the requirements of Section 431.181;
(b)  if in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor;  and (2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count, which statement shall be separately and accurately stated in a uniform location on the principal display panel of the label;  provided, that under Subdivision (2) reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by department rules;
(c)  if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(d)  if its container is so made, formed, or filled as to be misleading;
(e)  if it is a color additive, unless its packaging and labeling are in conformity with the packaging and labeling requirements, applicable to the color additive, prescribed under Section 721 of the federal Act.  This subsection shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes, as defined by Section 431.141(a); or
(f)  if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 3 or 4 of the federal Poison Prevention Packaging Act of 1970 (15 U.S.C. 1472 or 1473).
(2)  The executive commissioner shall adopt rules exempting from any labeling requirement of this chapter cosmetics that are in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed, on condition that the cosmetics are not adulterated or misbranded under the provisions of this chapter on removal from the processing, labeling, or repacking establishment.  Cosmetic labeling exemptions adopted under the federal Act shall apply to cosmetics in this state except insofar as modified or rejected by department rules.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 159, eff. Sept. 1, 1991.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0974, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter G. -1. Abusable Synthetic Substances › Section 431.171. Designation of Consumer Commodity as Abusable Synthetic Substance

Sec. 431.171.  DESIGNATION OF CONSUMER COMMODITY AS ABUSABLE SYNTHETIC SUBSTANCE.  (a) The commissioner may designate a consumer commodity as an abusable synthetic substance if the commissioner determines that the consumer commodity is likely an abusable synthetic substance and the importation, manufacture, distribution, or retail sale of the commodity poses a threat to public health.
(b)  In determining whether a consumer commodity is an abusable synthetic substance, the commissioner may consider:
(1)  whether the commodity is sold at a price higher than similar commodities are ordinarily sold;
(2)  any evidence of clandestine importation, manufacture, distribution, or diversion from legitimate channels;
(3)  any evidence suggesting the product is intended for human consumption, regardless of any consumption prohibitions or warnings on the packaging of the commodity; or
(4)  whether any of the following factors suggest the commodity is an abusable synthetic substance intended for illicit drug use:
(A)  the appearance of the packaging of the commodity;
(B)  oral or written statements or representations of a person who sells, manufactures, distributes, or imports the commodity;
(C)  the methods by which the commodity is distributed; and
(D)  the manner in which the commodity is sold to the public.
Added by Acts 2015, 84th Leg., R.S., Ch. 712 (H.B. 1212), Sec. 2, eff. September 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter G. -1. Abusable Synthetic Substances › Section 431.172. Applicability of Chapter to Abusable Synthetic Substance

Sec. 431.172.  APPLICABILITY OF CHAPTER TO ABUSABLE SYNTHETIC SUBSTANCE.  A commodity classified as an abusable synthetic substance by the commissioner under Section 431.171 is subject to:
(1)  the provisions of this chapter that apply to food and cosmetics, including provisions relating to adulteration, packaging, misbranding, and inspection; and
(2)  all enforcement actions under Subchapter C.
Added by Acts 2015, 84th Leg., R.S., Ch. 712 (H.B. 1212), Sec. 2, eff. September 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter H. Fair Packaging and Labeling; False Advertising › Section 431.182. False Advertisement

Sec. 431.182.  FALSE ADVERTISEMENT.  (a)  An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular.
(b)  The advertising of a food that incorporates a health claim not in conformance with or defined by Section 403(r) of the federal Act is deemed to be false or misleading for the purposes of this chapter.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1993, 73rd Leg., ch. 459, Sec. 5, eff. Sept. 1, 1993.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter H. Fair Packaging and Labeling; False Advertising › Section 431.183. False Advertisement of Drug or Device

Sec. 431.183.  FALSE ADVERTISEMENT OF DRUG OR DEVICE.  (a)  An advertisement of a drug or device is false if the advertisement represents that the drug or device affects:
(1)  infectious and parasitic diseases;
(2)  neoplasms;
(3)  endocrine, nutritional, and metabolic diseases and immunity disorders;
(4)  diseases of blood and blood-forming organs;
(5)  mental disorders;
(6)  diseases of the nervous system and sense organs;
(7)  diseases of the circulatory system;
(8)  diseases of the respiratory system;
(9)  diseases of the digestive system;
(10)  diseases of the genitourinary system;
(11)  complications of pregnancy, childbirth, and the puerperium;
(12)  diseases of the skin and subcutaneous tissue;
(13)  diseases of the musculoskeletal system and connective tissue;
(14)  congenital anomalies;
(15)  certain conditions originating in the perinatal period;
(16)  symptoms, signs, and ill-defined conditions;  or
(17)  injury and poisoning.
(b)  Subsection (a) does not apply to an advertisement of a drug or device if the advertisement does not violate Section 431.182 and is disseminated:
(1)  to the public for self-medication and is consistent with the labeling claims permitted by the federal Food and Drug Administration;
(2)  only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions;  or
(3)  only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the drug or device.
(c)  The executive commissioner by rule shall authorize the advertisement of a drug having a curative or therapeutic effect for a disease listed under Subsection (a) if the executive commissioner determines that an advance in medical science has made any type of self-medication safe for the disease.  The executive commissioner may impose conditions and restrictions on the advertisement of the drug necessary in the interest of public health.
(d)  This section does not indicate that self-medication for a disease other than a disease listed under Subsection (a) is safe or effective.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 160, eff. Sept. 1, 1991.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0977, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.201. Definitions

Sec. 431.201.  DEFINITIONS.  In this subchapter:
(1)  "Nonprescription drug" means any drug that is not a prescription drug as defined by Section 431.401.
(2)  "Place of business" means each location at which a drug for wholesale distribution is located.
(3)  "Wholesale distribution" means distribution to a person other than a consumer or patient, and includes distribution by a manufacturer, repackager, own label distributor, broker, jobber, warehouse, or wholesaler.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by:
Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(b), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.2011. Applicability of Subchapter

Sec. 431.2011.  APPLICABILITY OF SUBCHAPTER.  This subchapter applies only to the wholesale distribution of nonprescription drugs.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(c), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.202. License Required

Sec. 431.202.  LICENSE REQUIRED.  (a)  A person may not engage in wholesale distribution of nonprescription drugs in this state unless the person holds a wholesale drug distribution license issued by the department under this subchapter or Subchapter N.
(b)  An applicant for a license under this subchapter must submit an application to the department on the form prescribed by the department or electronically on the state electronic Internet portal.
(c)  A license issued under this subchapter expires on the second anniversary of the date of issuance.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 161, eff. Sept. 1, 1991;  Acts 1991, 72nd Leg., ch. 539, Sec. 5, eff. Sept. 1, 1991.
Amended by:
Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(d), eff. March 1, 2006.
Acts 2011, 82nd Leg., R.S., Ch. 973 (H.B. 1504), Sec. 28, eff. June 17, 2011.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.203. Contents of License Statement

Sec. 431.203.  CONTENTS OF LICENSE STATEMENT.  The license statement must contain:
(1)  the name under which the business is conducted;
(2)  the address of each place of business that is licensed;
(3)  the name and residence address of:
(A)  the proprietor, if the business is a proprietorship;
(B)  all partners, if the business is a partnership;  or
(C)  all principals, if the business is an association;
(4)  the date and place of incorporation, if the business is a corporation;
(5)  the names and residence addresses of the individuals in an administrative capacity showing:
(A)  the managing proprietor, if the business is a proprietorship;
(B)  the managing partner, if the business is a partnership;
(C)  the officers and directors, if the business is a corporation;  or
(D)  the persons in a managerial capacity, if the business is an association;  and
(6)  the residence address of an individual in charge of each place of business.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 7, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.2031. Effect of Operation in Other Jurisdictions; Reports

Sec. 431.2031.  EFFECT OF OPERATION IN OTHER JURISDICTIONS;  REPORTS.  (a)  A person who engages in the wholesale distribution of drugs outside this state may engage in the wholesale distribution of drugs in this state if the person holds a license issued by the department.
(b)  The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with this chapter and the minimum standards adopted under this chapter.
(c)  The department may issue a license to a person who engages in the wholesale distribution of drugs outside this state to engage in the wholesale distribution of drugs in this state, if after an examination of the reports of the person's compliance history and current compliance record, the department determines that the person is in compliance with this subchapter and department rules.
(d)  The department shall consider each licensing statement filed by a person who wishes to engage in wholesale distribution of drugs in this state on an individual basis.
Added by Acts 1991, 72nd Leg., ch. 539, Sec. 8, eff. Sept. 1, 1991.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0978, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.204. Fees

Sec. 431.204.  FEES.  (a)  The department shall collect fees for:
(1)  a license that is filed or renewed;
(2)  a license that is amended, including a notification of a change in the location of a licensed place of business required under Section 431.206; and
(3)  an inspection performed in enforcing this subchapter and rules adopted under this subchapter.
(b)  The executive commissioner by rule shall set the fees in amounts that allow the department to recover the biennial expenditures of state funds by the department in:
(1)  reviewing and acting on a license;
(2)  amending and renewing a license;
(3)  inspecting a licensed facility; and
(4)  implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.
(c)  Fees collected under this section shall be deposited to the credit of the food and drug registration fee account of the general revenue fund and appropriated to the department to carry out the administration and enforcement of this chapter.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 9, eff. Sept. 1, 1991.
Amended by:
Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(e), eff. March 1, 2006.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0979, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.206. Change of Location of Place of Business

Sec. 431.206.  CHANGE OF LOCATION OF PLACE OF BUSINESS.  (a)  Not fewer than 30 days in advance of the change, the licensee shall notify the department in writing of the licensee's intent to change the location of a licensed place of business.
(b)  The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location.
(c)  Not more than 10 days after the completion of the change of location, the licensee shall notify the department in writing to confirm the completion of the change of location and provide verification of the information previously provided or correct and confirm any information that has changed since providing the notice of intent.
(d)  The notice and confirmation required by this section are deemed adequate if the licensee sends the notices by certified mail, return receipt requested, to the central office of the department or submits them electronically through the state electronic Internet portal.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 9, eff. Sept. 1, 1991.
Amended by:
Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(f), eff. March 1, 2006.
Acts 2011, 82nd Leg., R.S., Ch. 973 (H.B. 1504), Sec. 29, eff. June 17, 2011.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.207. Refusal to License; Suspension or Revocation of License

Sec. 431.207.  REFUSAL TO LICENSE; SUSPENSION OR REVOCATION OF LICENSE.  (a)  The department may refuse an application for a license or may suspend or revoke a license if the applicant or licensee:
(1)  has been convicted of a felony or misdemeanor that involves moral turpitude;
(2)  is an association, partnership, or corporation and the managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;
(3)  has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;
(4)  is an association, partnership, or corporation and the managing officer has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;
(5)  has not complied with this chapter or the rules implementing this chapter;
(6)  has violated Section 431.021(l)(3), relating to the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;
(7)  has violated Chapter 481 or 483;
(8)  has violated the rules of the public safety director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or licensee to maintain; or
(9)  fails to complete a license application or submits an application that contains false, misleading, or incorrect information or contains information that cannot be verified by the department.
(b)  The executive commissioner by rule shall establish minimum standards required for the issuance or renewal of a license under this subchapter.
(c)  The refusal to license an applicant or the suspension or revocation of a license by the department and the appeal from that action are governed by the procedures for a contested case hearing under Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 9, eff. Sept. 1, 1991;  Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.
Amended by:
Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(f), eff. March 1, 2006.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0980, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter I. Wholesale Distributors › Section 431.208. Reporting of Purchase Price

Sec. 431.208.  REPORTING OF PURCHASE PRICE.  (a)  On the department's request, a person who engages in the wholesale distribution of drugs in this state shall file with the department information showing the actual price at which the wholesale distributor sells a particular drug to a retail pharmacy.
(b)  The executive commissioner shall adopt rules to implement this section.
(c)  The department and the attorney general may investigate the distributor to determine the accuracy of the information provided under Subsection (a).  The attorney general may take action to enforce this section.
(d)  Repealed by Acts 2005, 79th Leg., Ch. 349, Sec. 29, eff. September 1, 2007.
Added by Acts 2001, 77th Leg., ch. 1003, Sec. 3, eff. Sept. 1, 2001.
Amended by:
Acts 2005, 79th Leg., Ch. 349 (S.B. 1188), Sec. 29, eff. September 1, 2007.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0981, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.222. License Required; Licensing Fees

Sec. 431.222.  LICENSE REQUIRED;  LICENSING FEES.  (a)  Except as provided by Section 431.2211, a food manufacturer, food wholesaler, or warehouse operator in this state must apply for and obtain from the department every two years a license for each place of business that the food manufacturer, food wholesaler, or warehouse operator operates in this state.  The food manufacturer, food wholesaler, or warehouse operator must pay a licensing fee for each establishment.
(b)  The department shall require a food manufacturer that distributes only food manufactured by that firm to obtain only a license as a food manufacturer.  A person that does not manufacture food and serves only as a food wholesaler must obtain only a food wholesaler's license.  A person that distributes both its own manufactured food and food it does not manufacture must obtain only a food manufacturer's license.  A warehouse operator who also distributes food is required to obtain only a warehouse operator license.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 162, eff. Sept. 1, 1991;  Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993;  Acts 2003, 78th Leg., ch. 383, Sec. 7, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0983, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.223. Contents of License Application

Sec. 431.223.  CONTENTS OF LICENSE APPLICATION.  (a)  The person applying for a license under this subchapter must provide, at a minimum, the following information in a license application:
(1)  the name under which the food manufacturer, wholesale distributor, or warehouse operator conducts business;
(2)  the address of each place of business in this state that is licensed;
(3)  if the food manufacturer, wholesale distributor, or warehouse operator is an individual, a partnership, or an association, the name or names of:
(A)  the proprietor, if the business is a sole proprietorship;
(B)  all partners, if the business is a partnership;  or
(C)  all principals, if the business is an association;
(4)  if the food manufacturer, wholesale distributor, or wholesale operator is a corporation, the date and place of incorporation and the name and address of its registered agent in this state;
(5)  the names and residences of the individuals in an administrative capacity, showing:
(A)  the managing proprietor, if the business is a sole proprietorship;
(B)  the managing partner, if the business is a partnership;
(C)  the officers and directors, if the business is a corporation;  or
(D)  the persons in a managerial capacity, if the business is an association;  and
(6)  the residence address of a person in charge of each place of business.
(b)  The license application must be signed, verified, and filed on a form furnished by the department according to department rules.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993;  Acts 2003, 78th Leg., ch. 383, Sec. 8, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0984, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.224. Fees

Sec. 431.224.  FEES.  (a)  The department shall collect fees for:
(1)  a license that is filed or renewed;
(2)  a license that is amended, including a notification of a change in the location of a licensed place of business required under Section 431.2251; and
(3)  an inspection performed to enforce this subchapter and rules adopted under this subchapter.
(b)  The department may charge fees every two years.
(c)  The executive commissioner by rule shall set the fees in amounts that allow the department to recover the biennial expenditures of state funds by the department in:
(1)  reviewing and acting on a license;
(2)  amending and renewing a license;
(3)  inspecting a licensed facility; and
(4)  implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.
(d)  The department shall use not less than one-half of license fees collected for inspecting a licensed place of business or enforcing this subchapter, and the remainder for the administration of this subchapter.
(e)  All license fees received by the department under this subchapter shall be deposited in the state treasury to the credit of the food and drug registration account.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 163, eff. Sept. 1, 1991;  Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0985, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.2245. Processing of Licensing Fees

Sec. 431.2245.  PROCESSING OF LICENSING FEES.  (a)  The department shall establish a system for processing licensing fees under this chapter, including vended water facility licensing fees.
(b)  Under the fee processing system, the maximum time for processing a fee payment made by a negotiable instrument may not exceed 48 hours, beginning at the time that the negotiable instrument is first received by the department and ending at the time that the fee payment is submitted for deposit by the department to the treasury division of the office of the comptroller.
(c)  The comptroller shall cooperate with the department in developing the fee processing system.
Added by Acts 1999, 76th Leg., ch. 697, Sec. 1, eff. Aug. 30, 1999.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0986, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.225. Expiration Date

Sec. 431.225.  EXPIRATION DATE.  (a)  The executive commissioner by rule may provide that licenses expire on different dates.
(b)  If the license expiration date is changed, license fees shall be prorated so that each license holder pays only that portion of the license fee allocable to the number of months during which the license is valid.  On renewal of the license on the new expiration date, the total license renewal fee is payable.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 164, eff. Sept. 1, 1991;  Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0987, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.2251. Change in Location of Place of Business

Sec. 431.2251.  CHANGE IN LOCATION OF PLACE OF BUSINESS.  Not later than the 31st day before the date of the change, the license holder shall notify in writing the department of the license holder's intent to change the location of a licensed place of business.  The notice shall include the address of the new location and the name and residence address of the individual in charge of the place of business.  Not later than the 10th day after the completion of the change of location, the license holder shall forward to the department the name and residence address of the individual in charge of the new place of business.  Notice is considered adequate if the license holder provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the central office of the department.
Added by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0988, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.226. Refusal to Grant License; Suspension or Revocation of License

Sec. 431.226.  REFUSAL TO GRANT LICENSE; SUSPENSION OR REVOCATION OF LICENSE.  (a)  The department may refuse an application for a license or may suspend or revoke a license.
(b)  The executive commissioner by rule shall establish minimum standards for granting and maintaining a license.  In adopting rules under this section, the executive commissioner shall:
(1)  ensure that the minimum standards prioritize safe handling of fruits and vegetables based on known safety risks, including any history of outbreaks of food-borne communicable diseases; and
(2)  consider acceptable produce safety standards developed by a federal agency, state agency, or university.
(c)  The refusal or the suspension or revocation of a license by the department and the appeal from that action are governed by the procedures for a contested case hearing under Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993;  Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.
Amended by:
Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 2, eff. September 1, 2011.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0989, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter J. Food Manufacturers, Food Wholesalers, and Warehouse Operators › Section 431.227. Food Safety Best Practice Education Program

Sec. 431.227.  FOOD SAFETY BEST PRACTICE EDUCATION PROGRAM.  (a)  The department shall approve food safety best practice education programs for places of business licensed under this chapter.
(b)  A place of business that completes a food safety best practice education program approved by the department shall receive a certificate valid for five years from the date of completion of the program.
(c)  When determining which places of business to inspect under Section 431.042, the appropriate inspecting authority shall consider whether the place of business holds a valid certificate from a food safety best practice education program under this section.
(d)  The executive commissioner shall adopt rules to implement this section.
Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 3, eff. September 1, 2011.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0990, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.241. Rulemaking Authority

Sec. 431.241.  RULEMAKING AUTHORITY.  (a)  The executive commissioner may adopt rules for the efficient enforcement of this chapter.
(b)  The executive commissioner may conform rules adopted under this chapter, if practicable, with regulations adopted under the federal Act.
(c)  The enumeration of specific federal laws and regulations in Sections 431.244 and 431.245 does not limit the general authority granted to the executive commissioner in Subsection (b) to conform rules adopted under this chapter to those adopted under the federal Act.
(d)  The executive commissioner may adopt the federal regulations issued by the secretary pursuant to the Prescription Drug Marketing Act of 1987 (21 U.S.C. Sections 331, 333, 353, and 381), as necessary or desirable so that the state wholesale drug distributor licensing program in Subchapter N may achieve compliance with that Act.
(e)  The executive commissioner shall not establish a drug formulary that restricts by any prior or retroactive approval process a physician's ability to treat a patient with a prescription drug that has been approved and designated as safe and effective by the United States Food and Drug Administration, in compliance with federal law and subject to review by the executive commissioner.
(f)  Nothing in this section shall effect a prior approval program in operation on the effective date of this section nor shall any portion of this chapter prohibit a prior approval process on any federally exempted products.
(g)  The department may assess a fee for the issuance of a certificate of free sale and another certification issued under this chapter.  The executive commissioner by rule shall set each fee in an amount sufficient to recover the cost to the department of issuing the particular certificate.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 11, eff. Sept. 1, 1991;  Acts 1993, 73rd Leg., ch. 675, Sec. 7, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0991, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.242. Contested Case Hearings and Appeals

Sec. 431.242.  CONTESTED CASE HEARINGS AND APPEALS.  A hearing under this chapter or an appeal from a final administrative decision shall be conducted under 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.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.244. Federal Regulations Adopted as State Rules

Sec. 431.244.  FEDERAL REGULATIONS ADOPTED AS STATE RULES.  (a)  A regulation adopted by the secretary under the federal Act concerning pesticide chemicals, food additives, color additives, special dietary use, processed low acid food, acidified food, infant formula, bottled water, or vended bottled water is a rule for the purposes of this chapter, unless the executive commissioner modifies or rejects the rule.
(b)  A regulation adopted under the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.) is a rule for the purposes of this chapter, unless the executive commissioner modifies or rejects the rule.  The executive commissioner may not adopt a rule that conflicts with the labeling requirements for the net quantity of contents required under Section 4 of the Fair Packaging and Labeling Act (15 U.S.C. 1453) and the regulations adopted under that Act.
(c)  A regulation adopted by the secretary under Sections 403(b) through (i) of the federal Act is a rule for the purposes of this chapter unless the executive commissioner modifies or rejects the rule.  The executive commissioner may not adopt a rule that conflicts with the limitations provided by Sections 403(q) and (r) of the federal Act.
(d)  A federal regulation that this section provides as a rule for the purposes of this chapter is effective:
(1)  on the date that the regulation becomes effective as a federal regulation; and
(2)  whether or not the executive commissioner or department has fulfilled the rulemaking provisions of Chapter 2001, Government Code.
(e)  If the executive commissioner modifies or rejects a federal regulation, the executive commissioner shall comply with the rulemaking provisions of Chapter 2001, Government Code.
(f)  For any federal regulation adopted as a state rule under this chapter, including a regulation considered to be a rule for purposes of this chapter under Subsection (a), (b), or (c), the department shall provide on its Internet website:
(1)  a link to the text of the federal regulation;
(2)  a clear explanation of the substance of and purpose for the regulation; and
(3)  information on providing comments in response to any proposed or pending federal regulation, including an address to which and the manner in which comments may be submitted.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 12, eff. Sept. 1, 1991;  Acts 1993, 73rd Leg., ch. 459, Sec. 6, eff. Sept. 1, 1993;  Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.
Amended by:
Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 4, eff. September 1, 2011.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0992, 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 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.245. Definition or Standard of Identity, Quality, or Fill of Container

Sec. 431.245.  DEFINITION OR STANDARD OF IDENTITY, QUALITY, OR FILL OF CONTAINER.  (a)  A definition or standard of identity, quality, or fill of container of the federal Act is a definition or standard of identity, quality, or fill of container in this chapter, except as modified by department rules.
(b)  The executive commissioner by rule may establish definitions and standards of identity, quality, and fill of container for a food if:
(1)  a federal regulation does not apply to the food; and
(2)  the executive commissioner determines that adopting the rules will promote honest and fair dealing in the interest of consumers.
(c)  A temporary permit granted for interstate shipment of an experimental pack of food that varies from the requirements of federal definitions and standards of identity is automatically effective in this state under the conditions of the permit.
(d)  The department may issue additional permits if the department determines that:
(1)  it is necessary for the completion of an otherwise adequate investigation; and
(2)  the interests of consumers are safeguarded.
(e)  A permit issued under Subsection (d) is subject to the terms and conditions of department rules.
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. 3.0993, eff. April 2, 2015.