SUBCHAPTER A GENERAL PROVISIONS
- Texas Section 431.001 - Short Title
This chapter may be cited as the Texas Food, Drug, and Cosmetic Act. Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
- Texas Section 431.002 - Definitions
In this chapter: (1) "Advertising" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing,...
- Texas Section 431.003 - Article Misbranded Because Of Misleading Labeling Or Advertising
If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading,...
- Texas Section 431.004 - Representation Of Drug As Antiseptic
The representation of a drug, in its labeling, as an antiseptic shall be considered to be a representation that the drug is a germicide, except...
- Texas Section 431.005 - Provisions Regarding Sale Of Food, Drugs, Devices, Or Cosmetics
The provisions of this chapter regarding the selling of food, drugs, devices, or cosmetics, shall be considered to include the manufacture, production, processing, packaging, exposure,...
- Texas Section 431.006 - Certain Combination Products
If the United States Food and Drug Administration determines, with respect to a product that is a combination of a drug and a device, that:...
- Texas Section 431.007 - Compliance With Other Law; Molluscan Shellfish
A person who is subject to this chapter and who handles molluscan shellfish, as that term is defined by Section 436.002, shall comply with Section...
- Texas Section 431.008 - Applicability Of Chapter To Distressed Or Reconditioned Merchandise And Certain Licensed Entities
(a) This chapter applies to a food, drug, device, or cosmetic that is distressed merchandise for purposes of Chapter 432 or that has been subject...
- Texas Section 431.009 - Applicability Of Chapter To Frozen Desserts
(a) This chapter applies to a frozen dessert, an imitation frozen dessert, a product sold in semblance of a frozen dessert, or a mix for...
SUBCHAPTER B PROHIBITED ACTS
- Texas Section 431.010 - Applicability Of Chapter To Milk And Milk Products
(a) This chapter applies to milk or a milk product subject to Chapter 435. Milk or a milk product is a food for purposes of...
- Texas Section 431.021 - Prohibited Acts
The following acts and the causing of the following acts within this state are unlawful and prohibited: (a) the introduction or delivery for introduction into...
- Texas Section 431.0211 - Exception
Any provision of Section 431.021 that relates to a prescription drug does not apply to a prescription drug manufacturer, or an agent of a prescription...
- Texas Section 431.022 - Offense: Transfer Of Product Containing Ephedrine
(a) A person commits an offense if the person knowingly sells, transfers, or otherwise furnishes a product containing ephedrine to a person 17 years of...
SUBCHAPTER C ENFORCEMENT
- Texas Section 431.023 - Limited Exemption For Distressed Food, Drugs, Devices, Or Cosmetics
In relation to a food, drug, device, or cosmetic that is distressed merchandise for purposes of Chapter 432, Sections 431.021(a), (c), and (d) do not...
- Texas Section 431.041 - Definition
In this subchapter, "detained or embargoed article" means a food, drug, device, cosmetic, or consumer commodity that has been detained or embargoed under Section 431.048....
- Texas Section 431.042 - Inspection
(a) To enforce this chapter, the department or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge: (1)...
- Texas Section 431.043 - Access To Records
A person who is required to maintain records under this chapter or Section 519 or 520(g) of the federal Act or a person who is...
- Texas Section 431.044 - Access To Records Showing Movement In Commerce
(a) To enforce this chapter, a carrier engaged in commerce or other person receiving a food, drug, device, or cosmetic in commerce or holding a...
- Texas Section 431.045 - Emergency Order
(a) The commissioner or a person designated by the commissioner may issue an emergency order, either mandatory or prohibitory in nature, in relation to the...
- Texas Section 431.046 - Violation Of Rules
A violation of a rule adopted under this chapter is a violation of this chapter. Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept....
- Texas Section 431.047 - Violation; Injunction
(a) The department or a health authority may petition the district court for a temporary restraining order to restrain a continuing violation of Subchapter B...
- Texas Section 431.048 - Detained Or Embargoed Article
(a) The department shall affix to an article that is a food, drug, device, cosmetic, or consumer commodity a tag or other appropriate marking that...
- Texas Section 431.049 - Removal Order For Detained Or Embargoed Article
(a) If the claimant of the detained or embargoed articles or the claimant's agent fails or refuses to transfer the articles to a secure place...
- Texas Section 431.0495 - Recall Orders
(a) In conjunction with the issuance of an emergency order under Section 431.045 or the detention or embargo of an article under Section 431.048, the...
- Texas Section 431.050 - Condemnation
An action for the condemnation of an article may be brought before a court in whose jurisdiction the article is located, detained, or embargoed if...
- Texas Section 431.051 - Destruction Of Article
(a) A court shall order the destruction of a sampled article or a detained or embargoed article if the court finds that the article is...
- Texas Section 431.052 - Correction By Proper Labeling Or Processing
(a) A court may order the delivery of a sampled article or a detained or embargoed article that is adulterated or misbranded to the claimant...
- Texas Section 431.053 - Condemnation Of Perishable Articles
(a) The department shall immediately condemn or render by any means unsalable as human food an article that is a nuisance under Subsection (b) and...
- Texas Section 431.054 - Administrative Penalty
(a) The department may assess an administrative penalty against a person who violates Subchapter B or an order adopted or registration issued under this chapter....
- Texas Section 431.055 - Administrative Penalty Assessment Procedure
(a) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing. (b) If a...
- Texas Section 431.056 - Payment Of Administrative Penalty
(a) Not later than the 30th day after the date an order finding that a violation has occurred is issued, the department shall inform the...
- Texas Section 431.057 - Refund Of Administrative Penalty
On the date the court's judgment that an administrative penalty against a person should be reduced or not assessed becomes final, the court shall order...
- Texas Section 431.058 - Recovery Of Administrative Penalty By Attorney General
The attorney general at the request of the department may bring a civil action to recover an administrative penalty under this subchapter. Acts 1989, 71st...
- Texas Section 431.0585 - Civil Penalty
(a) At the request of the department, the attorney general or a district, county, or city attorney shall institute an action in district court to...
- Texas Section 431.059 - Criminal Penalty; Defenses
(a) A person commits an offense if the person violates any of the provisions of Section 431.021 relating to unlawful or prohibited acts. A first...
- Texas Section 431.060 - Initiation Of Proceedings
(a) The attorney general, or a district, county, or municipal attorney to whom the department or a health authority reports a violation of this chapter,...
SUBCHAPTER D FOOD
- Texas Section 431.061 - Minor Violation
This chapter does not require the department or a health authority to report for prosecution or the institution of proceedings under this chapter a minor...
- Texas Section 431.081 - Adulterated Food
A food shall be deemed to be adulterated: (a) if: (1) it bears or contains any poisonous or deleterious substance which may render it injurious...
- Texas Section 431.082 - Misbranded Food
A food shall be deemed to be misbranded: (a) if its labeling is false or misleading in any particular or fails to conform with the...
- Texas Section 431.083 - Food Labeling Exemptions
(a) Except as provided by Subsection (c), the executive commissioner shall adopt rules exempting from any labeling requirement of this chapter: (1) small open containers...
SUBCHAPTER E DRUGS AND DEVICES
- Texas Section 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...
- Texas Section 431.111 - Adulterated Drug Or Device
A drug or device shall be deemed to be adulterated: (a)(1) if it consists in whole or in part of any filthy, putrid, or decomposed...
- Texas Section 431.112 - Misbranded Drug Or Device
A drug or device shall be deemed to be misbranded: (a)(1) if its labeling is false or misleading in any particular; or (2) if its...
- Texas Section 431.113 - Exemption For Certain Drugs And Devices
(a) The executive commissioner shall adopt rules exempting from any labeling or packaging requirement of this chapter drugs and devices that are, in accordance with...
- Texas Section 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...
- Texas Section 431.115 - New Animal Drugs
(a) A new animal drug shall, with respect to any particular use or intended use of the drug, be deemed unsafe for the purposes of...
- Texas Section 431.116 - Average Manufacturer Price
(a) In this section, "average manufacturer price" has the meaning assigned by 42 U.S.C. Section 1396r-8(k), as amended. (b) A person who manufactures a drug,...
SUBCHAPTER F COSMETICS
- Texas Section 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...
- Texas Section 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...
SUBCHAPTER G POISONOUS OR DELETERIOUS SUBSTANCES
- Texas Section 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...
SUBCHAPTER G-1 ABUSABLE SYNTHETIC SUBSTANCES
- Texas Section 431.161 - Poisonous Or Deleterious Substances
(a) Any poisonous or deleterious substance, food additive, pesticide chemical in or on a raw agricultural commodity, or color additive shall, with respect to any...
- Texas Section 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...
SUBCHAPTER H FAIR PACKAGING AND LABELING; FALSE ADVERTISING
- Texas Section 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...
- Texas Section 431.181 - Fair Packaging And Labeling
(a) All labels of consumer commodities, as defined by this chapter, shall conform with the requirements for the declaration of net quantity of contents of...
- Texas Section 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....
SUBCHAPTER I WHOLESALE DISTRIBUTORS
- Texas Section 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;...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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;...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
SUBCHAPTER J FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS
- Texas Section 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...
- Texas Section 431.221 - Definitions
In this subchapter: (1) "Place of business" means: (A) each location where: (i) a person manufactures food; or (ii) food for wholesale is distributed; or...
- Texas Section 431.2211 - Application Of Subchapter
(a) A person is not required to hold a license under this subchapter if the person is: (1) a person, firm, or corporation that only...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
- Texas Section 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...
SUBCHAPTER K GENERAL ADMINISTRATIVE PROVISIONS AND RULEMAKING AUTHORITY
- Texas Section 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...
- Texas Section 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,...
- Texas Section 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.,...
- Texas Section 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,...
- Texas Section 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...
- Texas Section 431.246 - Removal Of Adulterated Item From Stores
The executive commissioner shall adopt rules that provide a system for removing adulterated items from the shelves of a grocery store or other retail establishment...
- Texas Section 431.247 - Delegation Of Powers Or Duties
(a) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015. (b) A health authority may, unless otherwise restricted by...
- Texas Section 431.248 - Memorandum Of Understanding With Department Of Agriculture
(a) The department and the Department of Agriculture shall execute a memorandum of understanding that: (1) requires each agency to disclose to the other agency...
- Texas Section 431.249 - Dissemination Of Information
(a) The department may publish reports summarizing the judgments, decrees, and court orders rendered under this chapter, including the nature and disposition of the charge....
SUBCHAPTER L DEVICE DISTRIBUTORS AND MANUFACTURERS
- Texas Section 431.250 - Public Comments For Federal Grants And Contracts
(a) The department shall annually solicit comments from interested persons regarding the grants and contracts the department has requested from or entered into with the...
- Texas Section 431.271 - Definitions
In this subchapter: (1) "Distributor" means a person who furthers the marketing of a finished domestic or imported device from the original place of manufacture...
- Texas Section 431.272 - License Required; Minimum Standards
(a) Except as provided by Section 431.273, a person may not operate as a distributor or manufacturer of devices in this state unless the person...
- Texas Section 431.273 - Exemption From Licensing
(a) A person is exempt from licensing under this subchapter if the person engages only in the following types of device distribution: (1) intracompany sales;...
- Texas Section 431.274 - License Application
(a) A person applying for a license under this subchapter shall provide, at a minimum, the following information on a license application form furnished by...
- Texas Section 431.276 - Fees
(a) The department shall collect fees for: (1) a license that is filed or renewed; (2) a license that is amended, including notification of a...
- Texas Section 431.278 - 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...
SUBCHAPTER M DRUG DONATION PROGRAM
- Texas Section 431.279 - Refusal To License; Suspension Or Revocation Of License
(a) The department may refuse an application or may suspend or revoke a license if the applicant or licensee: (1) has been convicted of a...
- Texas Section 431.321 - Definitions
(a) "Charitable medical clinic" means a clinic, including a licensed pharmacy that is a community pharmaceutical access program provider, that provides medical care or drugs...
- Texas Section 431.322 - Donation Of Unused Drugs To Charitable Medical Clinic
(a) A charitable drug donor may donate certain unused prescription drugs to a charitable medical clinic, and a charitable clinic may accept, dispense, or administer...
- Texas Section 431.323 - Circumstances Under Which Donated Drugs May Be Accepted And Dispensed
(a) A charitable medical clinic may accept and dispense or administer donated drugs only in accordance with this subchapter. (b) The donated drugs must be...
- Texas Section 431.324 - Rules
The executive commissioner shall adopt rules to implement this subchapter that are designed to protect the public health and safety. Added by Acts 2001, 77th...
SUBCHAPTER N WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS
- Texas Section 431.325 - Limitation On Liability
(a) Charitable drug donors, charitable medical clinics, and their employees are not liable for harm caused by the accepting, dispensing, or administering of drugs donated...
- Texas Section 431.401 - Definitions
In this subchapter: (1) "Authentication" means to affirmatively verify before any wholesale distribution of a prescription drug occurs that each transaction listed on the pedigree...
- Texas Section 431.4011 - Ongoing Relationship
In this subchapter, "ongoing relationship" means an association that exists when a manufacturer and distributor enter into a written agreement under which the distributor is...
- Texas Section 431.4012 - Applicability Of Subchapter
This subchapter applies only to the wholesale distribution of prescription drugs. Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March...
- Texas Section 431.402 - License Required
(a) A person may not engage in wholesale distribution of prescription drugs in this state unless the person holds a wholesale drug distribution license under...
- Texas Section 431.403 - Exemption From Licensing
(a) A person who engages in wholesale distribution of prescription drugs in this state for use in humans is exempt from this subchapter if the...
- Texas Section 431.4031 - Exemption From Certain Provisions For Certain Wholesale Distributors
(a) A wholesale distributor that distributes prescription drugs that are medical gases or a wholesale distributor that is a manufacturer or a third-party logistics provider...
- Texas Section 431.404 - License Application
Sec. 431.404. LICENSE APPLICATION. (a) An applicant for a license under this subchapter must submit an application to the department on the form prescribed by...
- Texas Section 431.4045 - Inspection Required
The department may not issue a wholesale distributor license to an applicant under this subchapter unless the department: (1) conducts a physical inspection of the...
- Texas Section 431.405 - Qualifications For License
(a) The department may not issue a wholesale distributor license to an applicant without considering the minimum federal information and related qualification requirements published in...
- Texas Section 431.406 - 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...
- Texas Section 431.407 - Criminal History Record Information
The department shall submit to the Department of Public Safety the fingerprints provided by a person with an initial or a renewal license application to...
- Texas Section 431.408 - Bond
(a) A wholesale distributor applying for or renewing a license shall submit payable to this state a bond or other equivalent security acceptable to the...
- Texas Section 431.409 - 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...
- Texas Section 431.4095 - Renewal Notification; Change Or Renewal
(a) Before the expiration of a license issued under this subchapter, the department shall send to each licensed wholesale distributor a form containing a copy...
- Texas Section 431.410 - Change Of Location Of Place Of Business
(a) Not fewer than 30 days in advance of the change, the license holder shall notify the department in writing of the license holder's intent...
- Texas Section 431.411 - Minimum Restrictions On Transactions
(a) A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse in accordance with the terms and conditions of...
- Texas Section 431.412 - Pedigree Required
(a) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but excluding the original manufacturer, shall provide a...
- Texas Section 431.413 - Pedigree Contents
Sec. 431.413. PEDIGREE CONTENTS. (a) A pedigree must include all necessary identifying information concerning each sale in the product's chain of distribution from the manufacturer,...
- Texas Section 431.414 - 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 license holder: (1) has...
SUBCHAPTER O PRESCRIPTION DRUG DONATION PILOT PROGRAM
- Texas Section 431.415 - Order To Cease Distribution
(a) The department shall issue an order requiring a person, including a manufacturer, distributor, or retailer of a prescription drug, to immediately cease distribution of...
- Texas Section 431.451 - Definitions
In this subchapter: (1) "Charitable drug donor" means: (A) a licensed convalescent or nursing facility or related institution, licensed hospice, hospital, physician, or pharmacy; (B)...
- Texas Section 431.452 - Establishment Of Pilot Program
(a) The department shall establish a pilot program for donation and redistribution of prescription drugs under this subchapter. (b) The department shall conduct the pilot...
- Texas Section 431.453 - Donation Of Unused Drugs
(a) A charitable drug donor may donate certain unused prescription drugs to the department for the pilot program under this subchapter. (b) A seller or...
- Texas Section 431.454 - Circumstances Under Which Donated Drugs May Be Accepted
(a) The department may accept donated drugs only in accordance with this subchapter. (b) The donated drugs must be: (1) prescription drugs; and (2) approved...
- Texas Section 431.455 - Prescription, Provision, And Administration Of Donated Drugs
(a) The donated drugs may be accepted and provided or administered to patients only by: (1) a charitable medical clinic; (2) a physician's office using...
- Texas Section 431.456 - Central Drug Repository
The department shall establish a location to centrally store drugs donated under this subchapter for distribution to qualifying recipients. Added by Acts 2015, 84th Leg.,...
- Texas Section 431.457 - Database Of Donated Drugs
The department shall establish and maintain an electronic database in which: (1) the department shall list the name and quantity of each drug donated to...
- Texas Section 431.458 - Rules
This subchapter shall be governed by department rules that are designed to protect the public health and safety, including: (1) the maximum handling fee that...
- Texas Section 431.459 - Limitation On Civil And Criminal Liability
(a) Charitable drug donors, manufacturers and sellers of donated drugs, charitable medical clinics, physicians, penal institutions, and their employees acting in good faith in providing...
- Texas Section 431.460 - Reports To Legislature
Not later than January 1 of each odd-numbered year, the department shall report to the legislature on the results of the pilot program. The report...