CHAPTER 431. TEXAS FOOD, DRUG, AND COSMETIC ACT

Statutes > Texas Statutes > HEALTH AND SAFETY CODE > TITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCES > CHAPTER 431. TEXAS FOOD, DRUG, AND COSMETIC ACT

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 A. GENERAL PROVISIONS

Sec. 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.

Sec. 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, or that are likely to induce, directly or

indirectly, the purchase of food, drugs, devices, or cosmetics.

(2) "Animal feed," as used in Subdivision (23), in Section 512

of the federal Act, and in provisions of this chapter referring

to those paragraphs or sections, means an article intended for

use as food for animals other than man as a substantial source of

nutrients in the diet of the animals. The term is not limited to

a mixture intended to be the sole ration of the animals.

(3) "Authorized agent" means an employee of the department who

is designated by the commissioner to enforce the provisions of

this chapter.

(4) "Board" means the Texas Board of Health.

(5) "Butter" means the food product usually known as butter that

is made exclusively from milk or cream, or both, with or without

common salt or additional coloring matter, and containing not

less than 80 percent by weight of milk fat, after allowing for

all tolerances.

(6)(A) "Color additive" means a material that:

(i) is a dye, pigment, or other substance made by a process of

synthesis or similar artifice, or extracted, isolated, or

otherwise derived, with or without intermediate or final change

of identity from a vegetable, animal, mineral, or other source;

and

(ii) when added or applied to a food, drug, or cosmetic, or to

the human body or any part of the human body, is capable, alone

or through reaction with other substance, of imparting color. The

term does not include any material exempted under the federal

Act.

(B) "Color" includes black, white, and intermediate grays.

or plant nutrient, or other agricultural chemical solely because

of its effect in aiding, retarding, or otherwise affecting,

directly or indirectly, the growth or other natural physiological

processes of produce of the soil and thereby affecting its color,

whether before or after harvest.

(7) "Commissioner" means the commissioner of health.

(8) "Consumer commodity," except as otherwise provided by this

subdivision, means any food, drug, device, or cosmetic, as those

terms are defined by this chapter or by the federal Act, and any

other article, product, or commodity of any kind or class that is

customarily produced or distributed for sale through retail sales

agencies or instrumentalities for consumption by individuals, or

for use by individuals for purposes of personal care or in the

performance of services ordinarily rendered within the household,

and that usually is consumed or expended in the course of the

consumption or use. The term does not include:

(A) a meat or meat product, poultry or poultry product, or

tobacco or tobacco product;

(B) a commodity subject to packaging or labeling requirements

imposed under the Federal Insecticide, Fungicide, and Rodenticide

Act (7 U.S.C. 136), or The Virus-Serum-Toxin Act (21 U.S.C. 151

et seq.);

431.112(j), or Section 503(b)(1) of the federal Act;

(D) a beverage subject to or complying with packaging or

labeling requirements imposed under the Federal Alcohol

Administration Act (27 U.S.C. 205(e)); or

(E) a commodity subject to the provisions of Chapter 61,

Agriculture Code, relating to the inspection, labeling, and sale

of agricultural and vegetable seed.

(9) "Contaminated with filth" applies to any food, drug, device,

or cosmetic not securely protected from dust, dirt, and as far as

may be necessary by all reasonable means, from all foreign or

injurious contaminations.

(10) "Cosmetic" means articles intended to be rubbed, poured,

sprinkled, or sprayed on, introduced into, or otherwise applied

to the human body or any part of the human body for cleaning,

beautifying, promoting attractiveness, or altering the

appearance, and articles intended for use as a component of those

articles. The term does not include soap.

(11) "Counterfeit drug" means a drug, or the container or

labeling of a drug, that, without authorization, bears the

trademark, trade name or other identifying mark, imprint, or

device of a drug manufacturer, processor, packer, or distributor

other than the person who in fact manufactured, processed,

packed, or distributed the drug, and that falsely purports or is

represented to be the product of, or to have been packed or

distributed by, the other drug manufacturer, processor, packer,

or distributor.

(12) "Department" means the Texas Department of Health.

(13) "Device," except when used in Sections 431.003, 431.021(l),

431.082(g), 431.112(c) and 431.142(c), means an instrument,

apparatus, implement, machine, contrivance, implant, in vitro

reagent, or other similar or related article, including any

component, part, or accessory, that is:

(A) recognized in the official United States Pharmacopoeia

National Formulary or any supplement to it;

(B) intended for use in the diagnosis of disease or other

conditions, or in the cure, mitigation, treatment, or prevention

of disease in man or other animals; or

of man or other animals and that does not achieve any of its

principal intended purposes through chemical action within or on

the body of man or other animals and is not dependent on

metabolization for the achievement of any of its principal

intended purposes.

(14) "Drug" means articles recognized in the official United

States Pharmacopoeia National Formulary, or any supplement to it,

articles designed or intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in man or other

animals, articles, other than food, intended to affect the

structure or any function of the body of man or other animals,

and articles intended for use as a component of any article

specified in this subdivision. The term does not include devices

or their components, parts, or accessories. A food for which a

claim is made in accordance with Section 403(r) of the federal

Act, and for which the claim is approved by the secretary, is not

a drug solely because the label or labeling contains such a

claim.

(15) "Federal Act" means the Federal Food, Drug and Cosmetic Act

(Title 21 U.S.C. 301 et seq.).

(16) "Food" means:

(A) articles used for food or drink for man;

(B) chewing gum; and

(17) "Food additive" means any substance the intended use of

which results or may reasonably be expected to result, directly

or indirectly, in its becoming a component or otherwise affecting

the characteristics of any food (including any substance intended

for use in producing, manufacturing, packing, processing,

preparing, treating, packaging, transporting, or holding food;

and including any source of radiation intended for any use), if

such substance is not generally recognized, among experts

qualified by scientific training and experience to evaluate its

safety, as having been adequately shown through scientific

procedures (or, in the case of a substance used in food prior to

January 1, 1958, through either scientific procedures or

experience based on common use in food) to be safe under the

conditions of its intended use; except that such term does not

include:

(A) a pesticide chemical in or on a raw agricultural commodity;

(B) a pesticide chemical to the extent that it is intended for

use or is used in the production, storage, or transportation of

any raw agricultural commodity;

(D) any substance used in accordance with a sanction or approval

granted prior to the enactment of the Food Additives Amendment of

1958, Pub. L. No. 85-929, 52 Stat. 1041 (codified as amended in

various sections of 21 U.S.C.), pursuant to the federal Act, the

Poultry Products Inspection Act (21 U.S.C. 451 et seq.) or the

Meat Inspection Act of 1907 (21 U.S.C. 603); or

(E) a new animal drug.

(18) "Health authority" means a physician designated to

administer state and local laws relating to public health.

(19) "Immediate container" does not include package liners.

(20) "Infant formula" means a food that is represented for

special dietary use solely as a food for infants by reason of its

simulation of human milk or its suitability as a complete or

partial substitute for human milk.

(21) "Label" means a display of written, printed, or graphic

matter upon the immediate container of any article; and a

requirement made by or under authority of this chapter that any

word, statement, or other information that appears on the label

shall not be considered to be complied with unless the word,

statement, or other information also appears on the outside

container or wrapper, if any, of the retail package of the

article, or is easily legible through the outside container or

wrapper.

(22) "Labeling" means all labels and other written, printed, or

graphic matter (1) upon any article or any of its containers or

wrappers, or (2) accompanying such article.

(23) "Manufacture" means:

(A) the process of combining or purifying food or packaging food

for sale to a person at wholesale or retail, and includes

repackaging, labeling, or relabeling of any food;

(B) the process of preparing, propagating, compounding,

processing, packaging, repackaging, labeling, testing, or quality

control of a drug or drug product, but does not include

compounding that is done within the practice of pharmacy and

pursuant to a prescription drug order or initiative from a

practitioner for a patient or prepackaging that is done in

accordance with Section 562.154, Occupations Code;

processing, packing, repacking, labeling, or relabeling a device;

(D) the making of any cosmetic product by chemical, physical,

biological, or other procedures, including manipulation,

sampling, testing, or control procedures applied to the product.

(24) "New animal drug" means any drug intended for use for

animals other than man, including any drug intended for use in

animal feed:

(A) the composition of which is such that the drug is not

generally recognized among experts qualified by scientific

training and experience to evaluate the safety and effectiveness

of animal drugs as safe and effective for use under the

conditions prescribed, recommended, or suggested in the labeling

of the drug (except that such an unrecognized drug is not deemed

to be a "new animal drug" if at any time before June 25, 1938, it

was subject to the Food and Drug Act of June 30, 1906, and if at

that time its labeling contained the same representations

concerning the conditions of its use);

(B) the composition of which is such that the drug, as a result

of investigations to determine its safety and effectiveness for

use under those conditions, has become recognized but that has

not, otherwise than in the investigations, been used to a

material extent or for a material time under those conditions; or

chloratetracycline, chloramphenicol, or bacitracin, or any

derivative of those substances, unless:

(i) a published order of the secretary is in effect that

declares the drug not to be a new animal drug on the grounds that

the requirement of certification of batches of the drug, as

provided by Section 512(n) of the federal Act, is not necessary

to ensure that the objectives specified in Section 512(n)(3) of

that Act are achieved; and

(ii) Paragraph (A) or (B) of this subdivision does not apply to

the drug.

(25) "New drug" means:

(A) any drug, except a new animal drug, the composition of which

is such that such drug is not generally recognized among experts

qualified by scientific training and experience to evaluate the

safety and effectiveness of drugs, as safe and effective for use

under the conditions prescribed, recommended, or suggested in the

labeling thereof (except that such an unrecognized drug is not a

"new drug" if at any time before May 26, 1985, it was subject to

the Food and Drug Act of June 30, 1906, and if at that time its

labeling contained the same representations concerning the

conditions of its use); or

(B) any drug, except a new animal drug, the composition of which

is such that such drug, as a result of investigations to

determine its safety and effectiveness for use under such

conditions, has become so recognized, but which has not,

otherwise than in such investigations, been used to a material

extent or for a material time under such conditions.

(26) "Official compendium" means the official United States

Pharmacopoeia National Formulary, or any supplement to it.

(27) "Package" means any container or wrapping in which a

consumer commodity is enclosed for use in the delivery or display

of that consumer commodity to retail purchasers. The term

includes wrapped meats enclosed in papers or other materials as

prepared by the manufacturers thereof for sale. The term does not

include:

(A) shipping containers or wrappings used solely for the

transportation of a consumer commodity in bulk or in quantity to

manufacturers, packers, or processors, or to wholesale or retail

distributors;

(B) shipping containers or outer wrappings used by retailers to

ship or deliver a commodity to retail customers if the containers

and wrappings do not bear printed matter relating to any

particular commodity; or

Act (Apple Barrels) (15 U.S.C. 231, 21 U.S.C. 20) or the Standard

Barrel Act (Fruits and Vegetables) (15 U.S.C. 234-236).

(28) "Person" includes individual, partnership, corporation, and

association.

(29) "Pesticide chemical" means any substance which, alone, in

chemical combination or in formulation with one or more other

substances, is a "pesticide" within the meaning of the Federal

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136(u)), as

now in force or as amended, and that is used in the production,

storage, or transportation of raw agricultural commodities.

(30) "Principal display panel" means that part of a label that

is most likely to be displayed, presented, shown, or examined

under normal and customary conditions of display for retail sale.

(31) "Raw agricultural commodity" means any food in its raw or

natural state, including all fruits that are washed, colored, or

otherwise treated in their unpeeled natural form prior to

marketing.

(32) "Saccharin" includes calcium saccharin, sodium saccharin,

and ammonium saccharin.

(33) "Safe" refers to the health of humans or animals.

(34) "Secretary" means the secretary of the United States

Department of Health and Human Services.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 149, eff. Sept. 1,

1991; Acts 1991, 72nd Leg., ch. 539, Sec. 1, eff. Sept. 1, 1991;

Acts 1993, 73rd Leg., ch. 459, Sec. 1, eff. Sept. 1, 1993; Acts

1997, 75th Leg., ch. 629, Sec. 1, eff. Sept. 1, 1997; Acts 2003,

78th Leg., ch. 111, Sec. 1, eff. Sept. 1, 2003; Acts 2003, 78th

Leg., ch. 383, Sec. 1, eff. Sept. 1, 2003; Acts 2003, 78th Leg.,

ch. 982, Sec. 1, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch.

1099, Sec. 1, eff. Sept. 1, 2003.

Amended by:

Acts 2005, 79th Leg., Ch.

28, Sec. 5, eff. September 1, 2005.

Sec. 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,

there shall be taken into account, among other things, not only

representations made or suggested by statement, word, design,

device, sound, or any combination of these, but also the extent

to which the labeling or advertising fails to reveal facts

material in the light of such representations or material with

respect to consequences which may result from the use of the

article to which the labeling or advertising relates under the

conditions of use prescribed in the labeling or advertising

thereof, or under such conditions of use as are customary or

usual.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 150, eff. Sept. 1,

1991.

Sec. 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 in the case of a drug purporting to be, or

represented as, an antiseptic for inhibitory use as a wet

dressing, ointment, dusting powder, or such other use as involves

prolonged contact with the body.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 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, offer, possession, and holding of any such

article for sale; and the sale, dispensing, and giving of any

such article, and the supplying or applying of any such articles

in the conduct of any food, drug, or cosmetic establishment.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 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:

(1) the primary mode of action of the product is as a drug, a

person who engages in wholesale distribution of the product is

subject to licensure under Subchapter I; and

(2) the primary mode of action of the product is as a device, a

distributor or manufacturer of the product is subject to

licensure under Subchapter L.

Added by Acts 1999, 76th Leg., ch. 132, Sec. 1, eff. May 20,

1999.

Sec. 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 436.105.

Added by Acts 1999, 76th Leg., ch. 1298, Sec. 1, eff. June 18,

1999. Renumbered from Sec. 431.006 by Acts 2001, 77th Leg., ch.

1420, Sec. 21.001(78), eff. Sept. 1, 2001.

Sec. 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 to reconditioning in accordance with Chapter 432.

(b) Except as provided by Subsection (c), this chapter applies

to the conduct of a person licensed under Chapter 432.

engaging in conduct within the scope of that license is not

required to hold a license as a wholesale drug distributor under

Subchapter I, a food wholesaler under Subchapter J, or a device

distributor under Subchapter L.

Added by Acts 2001, 77th Leg., ch. 265, Sec. 1, eff. May 22,

2001.

Sec. 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 one of those products subject to Chapter 440. A frozen

dessert, an imitation frozen dessert, a product sold in semblance

of a frozen dessert, or a mix for one of those products is food

for purposes of this chapter.

(b) Except as provided by Subsection (c), this chapter applies

to the conduct of a person licensed under Chapter 440.

the manufacturing of a product regulated under that chapter and

is engaging in conduct within the scope of that license is not

required to hold a license as a food manufacturer or food

wholesaler under Subchapter J.

Added by Acts 2003, 78th Leg., ch. 112, Sec. 1, eff. Sept. 1,

2003.

Sec. 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 this chapter.

(b) Except as provided by Subsection (c), this chapter applies

to the conduct of a person who holds a permit under Chapter 435.

processing, producing, bottling, receiving, transferring, or

transporting of Grade A milk or milk products and who is engaging

in conduct within the scope of that permit is not required to

hold a license as a food manufacturer or food wholesaler under

Subchapter J.

Added by Acts 2003, 78th Leg., ch. 757, Sec. 1, eff. Sept. 1,

2003.

SUBCHAPTER B. PROHIBITED ACTS

Sec. 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 commerce

of any food, drug, device, or cosmetic that is adulterated or

misbranded;

(b) the adulteration or misbranding of any food, drug, device,

or cosmetic in commerce;

cosmetic that is adulterated or misbranded, and the delivery or

proffered delivery thereof for pay or otherwise;

(d) the distribution in commerce of a consumer commodity, if

such commodity is contained in a package, or if there is affixed

to that commodity a label that does not conform to the provisions

of this chapter and of rules adopted under the authority of this

chapter; provided, however, that this prohibition shall not apply

to persons engaged in business as wholesale or retail

distributors of consumer commodities except to the extent that

such persons:

(1) are engaged in the packaging or labeling of such

commodities; or

(2) prescribe or specify by any means the manner in which such

commodities are packaged or labeled;

(e) the introduction or delivery for introduction into commerce

of any article in violation of Section 431.084, 431.114, or

431.115;

(f) the dissemination of any false advertisement;

(g) the refusal to permit entry or inspection, or to permit the

taking of a sample or to permit access to or copying of any

record as authorized by Sections 431.042-431.044; or the failure

to establish or maintain any record or make any report required

under Section 512(j), (l), or (m) of the federal Act, or the

refusal to permit access to or verification or copying of any

such required record;

(h) the manufacture within this state of any food, drug, device,

or cosmetic that is adulterated or misbranded;

(i) the giving of a guaranty or undertaking referred to in

Section 431.059, which guaranty or undertaking is false, except

by a person who relied on a guaranty or undertaking to the same

effect signed by, and containing the name and address of the

person residing in this state from whom the person received in

good faith the food, drug, device, or cosmetic; or the giving of

a guaranty or undertaking referred to in Section 431.059, which

guaranty or undertaking is false;

(j) the use, removal, or disposal of a detained or embargoed

article in violation of Section 431.048;

(k) the alteration, mutilation, destruction, obliteration, or

removal of the whole or any part of the labeling of, or the doing

of any other act with respect to a food, drug, device, or

cosmetic, if such act is done while such article is held for sale

after shipment in commerce and results in such article being

adulterated or misbranded;

(l)(1) forging, counterfeiting, simulating, or falsely

representing, or without proper authority using any mark, stamp,

tag, label, or other identification device authorized or required

by rules adopted under this chapter or the regulations

promulgated under the provisions of the federal Act;

(2) making, selling, disposing of, or keeping in possession,

control, or custody, or concealing any punch, die, plate, stone,

or other thing designed to print, imprint, or reproduce the

trademark, trade name, or other identifying mark, imprint, or

device of another or any likeness of any of the foregoing on any

drug or container or labeling thereof so as to render such drug a

counterfeit drug;

(3) the doing of any act that causes a drug to be a counterfeit

drug, or the sale or dispensing, or the holding for sale or

dispensing, of a counterfeit drug;

(m) the using by any person to the person's own advantage, or

revealing, other than to the commissioner, an authorized agent, a

health authority or to the courts when relevant in any judicial

proceeding under this chapter, of any information acquired under

the authority of this chapter concerning any method or process

that as a trade secret is entitled to protection;

(n) the using, on the labeling of any drug or device or in any

advertising relating to such drug or device, of any

representation or suggestion that approval of an application with

respect to such drug or device is in effect under Section 431.114

or Section 505, 515, or 520(g) of the federal Act, as the case

may be, or that such drug or device complies with the provisions

of such sections;

(o) the using, in labeling, advertising or other sales promotion

of any reference to any report or analysis furnished in

compliance with Sections 431.042-431.044 or Section 704 of the

federal Act;

(p) in the case of a prescription drug distributed or offered

for sale in this state, the failure of the manufacturer, packer,

or distributor of the drug to maintain for transmittal, or to

transmit, to any practitioner licensed by applicable law to

administer such drug who makes written request for information as

to such drug, true and correct copies of all printed matter that

is required to be included in any package in which that drug is

distributed or sold, or such other printed matter as is approved

under the federal Act. Nothing in this subsection shall be

construed to exempt any person from any labeling requirement

imposed by or under other provisions of this chapter;

(q)(1) placing or causing to be placed on any drug or device or

container of any drug or device, with intent to defraud, the

trade name or other identifying mark, or imprint of another or

any likeness of any of the foregoing;

(2) selling, dispensing, disposing of or causing to be sold,

dispensed, or disposed of, or concealing or keeping in

possession, control, or custody, with intent to sell, dispense,

or dispose of, any drug, device, or any container of any drug or

device, with knowledge that the trade name or other identifying

mark or imprint of another or any likeness of any of the

foregoing has been placed thereon in a manner prohibited by

Subdivision (1) of this subsection; or

(3) making, selling, disposing of, causing to be made, sold, or

disposed of, keeping in possession, control, or custody, or

concealing with intent to defraud any punch, die, plate, stone,

or other thing designed to print, imprint, or reproduce the

trademark, trade name, or other identifying mark, imprint, or

device of another or any likeness of any of the foregoing on any

drug or container or labeling of any drug or container so as to

render such drug a counterfeit drug;

(r) dispensing or causing to be dispensed a different drug in

place of the drug ordered or prescribed without the express

permission in each case of the person ordering or prescribing;

(s) the failure to register in accordance with Section 510 of

the federal Act, the failure to provide any information required

by Section 510(j) or (k) of the federal Act, or the failure to

provide a notice required by Section 510(j)(2) of the federal

Act;

(t)(1) the failure or refusal to:

(A) comply with any requirement prescribed under Section 518 or

520(g) of the federal Act; or

(B) furnish any notification or other material or information

required by or under Section 519 or 520(g) of the federal Act;

(2) with respect to any device, the submission of any report

that is required by or under this chapter that is false or

misleading in any material respect;

(u) the movement of a device in violation of an order under

Section 304(g) of the federal Act or the removal or alteration of

any mark or label required by the order to identify the device as

detained;

(v) the failure to provide the notice required by Section 412(b)

or 412(c), the failure to make the reports required by Section

412(d)(1)(B), or the failure to meet the requirements prescribed

under Section 412(d)(2) of the federal Act;

(w) except as provided under Subchapter M of this chapter and

Section 562.1085, Occupations Code, the acceptance by a person of

an unused prescription or drug, in whole or in part, for the

purpose of resale, after the prescription or drug has been

originally dispensed, or sold;

(x) engaging in the wholesale distribution of drugs or operating

as a distributor or manufacturer of devices in this state without

obtaining a license issued by the department under Subchapter I,

L, or N, as applicable;

(y) engaging in the manufacture of food in this state or

operating as a warehouse operator in this state without having a

license as required by Section 431.222 or operating as a food

wholesaler in this state without having a license under Section

431.222 or being registered under Section 431.2211, as

appropriate;

(z) unless approved by the United States Food and Drug

Administration pursuant to the federal Act, the sale, delivery,

holding, or offering for sale of a self-testing kit designed to

indicate whether a person has a human immunodeficiency virus

infection, acquired immune deficiency syndrome, or a related

disorder or condition;

(aa) making a false statement or false representation in an

application for a license or in a statement, report, or other

instrument to be filed with or requested by the department under

this chapter;

(bb) failing to comply with a requirement or request to provide

information or failing to submit an application, statement,

report, or other instrument required by the department;

(cc) performing, causing the performance of, or aiding and

abetting the performance of an act described by Subdivision (x);

(dd) purchasing or otherwise receiving a prescription drug from

a pharmacy in violation of Section 431.411(a);

(ee) selling, distributing, or transferring a prescription drug

to a person who is not authorized under state or federal law to

receive the prescription drug in violation of Section 431.411(b);

(ff) failing to deliver prescription drugs to specified premises

as required by Section 431.411(c);

(gg) failing to maintain or provide pedigrees as required by

Section 431.412 or 431.413;

(hh) failing to obtain, pass, or authenticate a pedigree as

required by Section 431.412 or 431.413;

(ii) the introduction or delivery for introduction into commerce

of a drug or prescription device at a flea market;

(jj) the receipt of a prescription drug that is adulterated,

misbranded, stolen, obtained by fraud or deceit, counterfeit, or

suspected of being counterfeit, and the delivery or proffered

delivery of such a drug for payment or otherwise; or

(kk) the alteration, mutilation, destruction, obliteration, or

removal of all or any part of the labeling of a prescription drug

or the commission of any other act with respect to a prescription

drug that results in the prescription drug being misbranded.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 151, eff. Sept. 1,

1991; Acts 1991, 72nd Leg., ch. 539, Sec. 2, eff. Sept. 1, 1991;

Acts 1993, 73rd Leg., ch. 440, Sec. 1, eff. Sept. 1, 1993; Acts

1995, 74th Leg., ch. 1047, Sec. 6, eff. Sept. 1, 1995; Acts 1997,

75th Leg., ch. 282, Sec. 1, eff. Sept. 1, 1997; Acts 2001, 77th

Leg., ch. 262, Sec. 1, eff. Sept. 1, 2001; Acts 2001, 77th Leg.,

ch. 1138, Sec. 2, eff. Jan. 1, 2002; Acts 2003, 78th Leg., ch.

198, Sec. 2.71, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch.

321, Sec. 2, eff. June 18, 2003; Acts 2003, 78th Leg., ch. 383,

Sec. 2, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 982, Sec.

2, eff. Sept. 1, 2003.

Amended by:

Acts 2005, 79th Leg., Ch.

282, Sec. 3(i), eff. March 1, 2006.

Acts 2007, 80th Leg., R.S., Ch.

980, Sec. 1, eff. September 1, 2007.

Sec. 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 drug

manufacturer, who is obtaining or attempting to obtain a

prescription drug for the sole purpose of testing the

prescription drug for authenticity.

Added by Acts 2007, 80th Leg., R.S., Ch.

980, Sec. 2, eff. September 1, 2007.

Sec. 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 age or younger, unless:

(1) the actor is:

(A) a practitioner or other health care provider licensed by

this state who has obtained, as required by law, consent to the

treatment of the person to whom the product is furnished; or

(B) the parent, guardian, or managing conservator of the person

to whom the product is furnished;

(2) the person to whom the product is furnished has had the

disabilities of minority removed for general purposes under

Chapter 31, Family Code; or

(3) the product is a drug.

(b) An offense under this section is a Class C misdemeanor

unless it is shown on the trial of the offense that the defendant

has been previously convicted of an offense under this section,

in which event the offense is a Class B misdemeanor.

Subsection (a)(3) must be labeled in accordance with rules

adopted by the Texas Department of Health to indicate that sale

to persons 17 years of age or younger is prohibited.

Added by Acts 1999, 76th Leg., ch. 151, Sec. 1, eff. Sept. 1,

1999.

Sec. 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 prohibit:

(1) the introduction or delivery for introduction into commerce

of the merchandise for the purpose of reconditioning in

accordance with Chapter 432 and not for sale to the ultimate

consumer;

(2) the receipt in commerce of the merchandise for the purpose

of reconditioning in accordance with Chapter 432 and not for sale

to the ultimate consumer;

(3) the holding of merchandise for the purpose of reconditioning

in accordance with Chapter 432 and not for resale to the ultimate

consumer; or

(4) the reconditioning of the merchandise in accordance with

Chapter 432.

Added by Acts 2001, 77th Leg., ch. 265, Sec. 2, eff. May 22,

2001.

SUBCHAPTER C. ENFORCEMENT

Sec. 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.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.042. INSPECTION. (a) To enforce this chapter, the

commissioner, an authorized agent, or a health authority may, on

presenting appropriate credentials to the owner, operator, or

agent in charge:

(1) enter at reasonable times an establishment, including a

factory or warehouse, in which a food, drug, device, or cosmetic

is manufactured, processed, packed, or held for introduction into

commerce or held after the introduction;

(2) enter a vehicle being used to transport or hold the food,

drug, device, or cosmetic in commerce; or

(3) inspect at reasonable times, within reasonable limits, and

in a reasonable manner, the establishment or vehicle and all

equipment, finished and unfinished materials, containers, and

labeling of any item and obtain samples necessary for the

enforcement of this chapter.

(b) The inspection of an establishment, including a factory,

warehouse, or consulting laboratory, in which a prescription drug

or restricted device is manufactured, processed, packed, or held

for introduction into commerce extends to any place or thing,

including a record, file, paper, process, control, or facility,

in order to determine whether the drug or device:

(1) is adulterated or misbranded;

(2) may not be manufactured, introduced into commerce, sold, or

offered for sale under this chapter; or

(3) is otherwise in violation of this chapter.

(1) financial data;

(2) sales data other than shipment data;

(3) pricing data;

(4) personnel data other than data relating to the

qualifications of technical and professional personnel performing

functions under this chapter;

(5) research data other than data:

(A) relating to new drugs, antibiotic drugs, and devices; and

(B) subject to reporting and inspection under regulations issued

under Section 505(i) or (j), 519, or 520(g) of the federal Act;

(6) data relating to other drugs or devices that, in the case of

a new drug, would be subject to reporting or inspection under

regulations issued under Section 505(j) of the federal Act.

(d) An inspection under Subsection (b) shall be started and

completed with reasonable promptness.

(e) This section does not apply to:

(1) a pharmacy that:

(A) complies with Subtitle J, Title 3, Occupations Code;

(B) regularly engages in dispensing prescription drugs or

devices on prescriptions of practitioners licensed to administer

the drugs or devices to their patients in the course of their

professional practice; and

prepare, propagate, compound, or process a drug or device for

sale other than in the regular course of its business of

dispensing or selling drugs or devices at retail;

(2) a practitioner licensed to prescribe or administer a drug

who manufactures, prepares, propagates, compounds, or processes

the drug solely for use in the course of the practitioner's

professional practice;

(3) a practitioner licensed to prescribe or use a device who

manufactures or processes the device solely for use in the course

of the practitioner's professional practice; or

(4) a person who manufactures, prepares, propagates, compounds,

or processes a drug or manufactures or processes a device solely

for use in research, teaching, or chemical analysis and not for

sale.

(f) The board may exempt a class of persons from inspection

under this section if the board finds that inspection as applied

to the class is not necessary for the protection of the public

health.

(g) An authorized agent or health authority who makes an

inspection under this section to enforce the provisions of this

chapter applicable to infant formula shall be permitted, at all

reasonable times, to have access to and to copy and verify

records:

(1) in order to determine whether the infant formula

manufactured or held in the inspected facility meets the

requirements of this chapter; or

(2) that are required by this chapter.

(h) An authorized agent or health authority who makes an

inspection of an establishment, including a factory or warehouse,

and obtains a sample during or on completion of the inspection

and before leaving the establishment, shall give to the owner,

operator, or the owner's or operator's agent a receipt describing

the sample.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.793, eff.

Sept. 1, 2001; Acts 2003, 78th Leg., ch. 111, Sec. 2, eff. Sept.

1, 2003.

Sec. 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 in charge or custody of those

records shall, at the request of an authorized agent or health

authority, permit the authorized agent or health authority at all

reasonable times access to and to copy and verify the records.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 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 food, drug, device, or cosmetic received in

commerce shall, at the request of an authorized agent or health

authority, permit the authorized agent or health authority at all

reasonable times to have access to and to copy all records

showing:

(1) the movement in commerce of the food, drug, device, or

cosmetic;

(2) the holding of the food, drug, device, or cosmetic after

movement in commerce; and

(3) the quantity, shipper, and consignee of the food, drug,

device, or cosmetic.

(b) The carrier or other person may not refuse access to and

copying of the requested record if the request is accompanied by

a written statement that specifies the nature or kind of food,

drug, device, or cosmetic to which the request relates.

directly or indirectly derived from the evidence obtained under

this section may not be used in a criminal prosecution of the

person from whom the evidence is obtained.

(d) A carrier is not subject to other provisions of this chapter

because of the carrier's receipt, carriage, holding, or delivery

of a food, drug, device, or cosmetic in the usual course of

business as a carrier.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 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 manufacture or distribution of a food, drug, device, or

cosmetic in the department's jurisdiction if the commissioner or

the person designated by the commissioner determines that:

(1) the manufacture or distribution of the food, drug, device,

or cosmetic creates or poses an immediate and serious threat to

human life or health; and

(2) other procedures available to the department to remedy or

prevent the occurrence of the situation will result in

unreasonable delay.

(b) The commissioner or a person designated by the commissioner

may issue the emergency order without notice and hearing if the

commissioner or a person designated by the commissioner

determines this is practicable under the circumstances.

department shall determine a time and place for a hearing at

which the emergency order is affirmed, modified, or set aside.

The hearing shall be held under the contested case provisions of

Chapter 2001, Government Code, and the board's formal hearing

rules.

(d) This section prevails over Sections 11.013 and 12.001.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1997, 75th Leg., ch. 629, Sec. 4, eff. Sept. 1,

1997; Acts 2001, 77th Leg., ch. 262, Sec. 2, eff. Sept. 1, 2001.

Sec. 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. 1, 1989.

Sec. 431.047. VIOLATION; INJUNCTION. (a) The commissioner, an

authorized agent, or a health authority may petition the district

court for a temporary restraining order to restrain a continuing

violation of Subchapter B or a threat of a continuing violation

of Subchapter B if the commissioner, authorized agent, or health

authority finds that:

(1) a person has violated, is violating, or is threatening to

violate Subchapter B; and

(2) the violation or threatened violation creates an immediate

threat to the health and safety of the public.

(b) A district court, on petition of the commissioner, an

authorized agent, or a health authority, and on a finding by the

court that a person is violating or threatening to violate

Subchapter B shall grant any injunctive relief warranted by the

facts.

in which the violation or threat of violation is alleged to have

occurred or in Travis County.

(d) The commissioner and the attorney general may each recover

reasonable expenses incurred in obtaining injunctive relief under

this section, including investigative costs, court costs,

reasonable attorney fees, witness fees, and deposition expenses.

The expenses recovered by the commissioner are hereby

appropriated to the department for the administration and

enforcement of this chapter. The expenses recovered by the

attorney general are hereby appropriated to the attorney general.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 3, eff. Sept. 1,

1991.

Sec. 431.048. DETAINED OR EMBARGOED ARTICLE. (a) The

commissioner or an authorized agent shall affix to an article

that is a food, drug, device, cosmetic, or consumer commodity a

tag or other appropriate marking that gives notice that the

article is, or is suspected of being, adulterated or misbranded

and that the article has been detained or embargoed if the

commissioner or the authorized agent finds or has probable cause

to believe that the article:

(1) is adulterated;

(2) is misbranded so that the article is dangerous or fraudulent

under this chapter; or

(3) violates Section 431.084, 431.114, or 431.115.

(b) The tag or marking on a detained or embargoed article must

warn all persons not to use the article, remove the article from

the premises, or dispose of the article by sale or otherwise

until permission for use, removal, or disposal is given by the

commissioner, the authorized agent, or a court.

a detained or embargoed article from the premises, or dispose of

a detained or embargoed article by sale or otherwise without

permission of the commissioner, the authorized agent, or a court.

The commissioner or the authorized agent may permit perishable

goods to be moved to a place suitable for proper storage.

(d) The commissioner or an authorized agent shall remove the tag

or other marking from an embargoed or detained article if the

commissioner or an authorized agent finds that the article is not

adulterated or misbranded.

(e) The commissioner or an authorized agent may not detain or

embargo an article, including an article that is distressed

merchandise, that is in the possession of a person licensed under

Chapter 432 and that is being held for the purpose of

reconditioning in accordance with Chapter 432, unless the

commissioner or an authorized agent finds or has probable cause

to believe that the article cannot be adequately reconditioned in

accordance with that chapter and applicable rules.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1997, 75th Leg., ch. 282, Sec. 2, eff. Sept. 1,

1997; Acts 2001, 77th Leg., ch. 265, Sec. 3, eff. May 22, 2001.

Sec. 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 after the tag or other appropriate marking has been

affixed as provided by Section 431.048, the commissioner or an

authorized agent may order the transfer of the articles to one or

more secure storage areas to prevent their unauthorized use,

removal, or disposal.

(b) The commissioner or an authorized agent may provide for the

transfer of the article if the claimant of the article or the

claimant's agent does not carry out the transfer order in a

timely manner. The costs of the transfer shall be assessed

against the claimant of the article or the claimant's agent.

pay the costs of the transfer.

(d) The commissioner may request the attorney general to bring

an action in the district court in Travis County to recover the

costs of the transfer. In a judgment in favor of the state, the

court may award costs, attorney fees, court costs, and interest

from the time the expense was incurred through the date the

department is reimbursed.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 152, eff. Sept. 1,

1991; Acts 1997, 75th Leg., ch. 282, Sec. 3, eff. Sept. 1, 1997.

Sec. 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

commissioner may order a food, drug, device, cosmetic, or

consumer commodity to be recalled from commerce.

(b) The commissioner's recall order may require the articles to

be removed to one or more secure areas approved by the

commissioner or an authorized agent.

commissioner.

(d) The recall order may be issued before or in conjunction with

the affixing of the tag or other appropriate marking as provided

by Section 431.048(a) or in conjunction with the commissioner's

issuance of an emergency order under Section 431.045.

(e) The recall order is effective until the order:

(1) expires on its own terms;

(2) is withdrawn by the commissioner;

(3) is reversed by a court in an order denying condemnation

under Section 431.050; or

(4) is set aside at the hearing provided to affirm, modify, or

set aside an emergency order under Section 431.045.

(f) The claimant of the articles or the claimant's agent shall

pay the costs of the removal and storage of the articles removed.

(g) If the claimant or the claimant's agent fails or refuses to

carry out the recall order in a timely manner, the commissioner

may provide for the recall of the articles. The costs of the

recall shall be assessed against the claimant of the articles or

the claimant's agent.

(h) The commissioner may request the attorney general to bring

an action in the district court of Travis County to recover the

costs of the recall. In a judgment in favor of the state, the

court may award costs, attorney fees, court costs, and interest

from the time the expense was incurred through the date the

department is reimbursed.

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 153, eff. Sept. 1,

1991.

Sec. 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 the article is

adulterated, misbranded, or in violation of Section 431.084,

431.114, or 431.115.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 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 adulterated or

misbranded.

(b) After entry of the court's order, an authorized agent shall

supervise the destruction of the article.

destruction of the article.

(d) The court shall tax against the claimant of the article or

the claimant's agent all court costs and fees, and storage and

other proper expenses.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 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 of the article for labeling or processing under the

supervision of an agent of the commissioner or an authorized

agent if:

(1) the decree has been entered in the suit;

(2) the costs, fees, and expenses of the suit have been paid;

(3) the adulteration or misbranding can be corrected by proper

labeling or processing; and

(4) a good and sufficient bond, conditioned on the correction of

the adulteration or misbranding by proper labeling or processing,

has been executed.

(b) The claimant shall pay the costs of the supervision.

claimant and the bond discharged on the representation to the

court by the commissioner or an authorized agent that the article

no longer violates this chapter and that the expenses of the

supervision are paid.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.053. CONDEMNATION OF PERISHABLE ARTICLES. (a) The

commissioner or an authorized agent shall immediately condemn or

render by any means unsalable as human food an article that is a

nuisance under Subsection (b) and that the commissioner or

authorized agent finds in any room, building, or other structure

or in a vehicle.

(b) Any meat, seafood, poultry, vegetable, fruit, or other

perishable article is a nuisance if it:

(1) is unsound;

(2) contains a filthy, decomposed, or putrid substance; or

(3) may be poisonous or deleterious to health or otherwise

unsafe.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.054. ADMINISTRATIVE PENALTY. (a) The commissioner may

assess an administrative penalty against a person who violates

Subchapter B or an order adopted or registration issued under

this chapter.

(b) In determining the amount of the penalty, the commissioner

shall consider:

(1) the person's previous violations;

(2) the seriousness of the violation;

(3) any hazard to the health and safety of the public;

(4) the person's demonstrated good faith; and

(5) such other matters as justice may require.

(d) Each day a violation continues may be considered a separate

violation.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 4, eff. Sept. 1,

1991.

Sec. 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 hearing is held, the commissioner shall make findings

of fact and shall issue a written decision regarding the

occurrence of the violation and the amount of the penalty that

may be warranted.

hearing, the commissioner may assess a penalty after determining

that a violation has occurred and the amount of the penalty that

may be warranted.

(d) After making a determination under this section that a

penalty is to be assessed against a person, the commissioner

shall issue an order requiring that the person pay the penalty.

(e) The commissioner may consolidate a hearing held under this

section with another proceeding.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 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 commissioner shall inform

the person against whom the order is issued of the amount of the

penalty for the violation.

(b) Not later than the 30th day after the date on which a

decision or order charging a person with a penalty is final, the

person shall:

(1) pay the penalty in full; or

(2) if the person seeks judicial review of the amount of the

penalty, the fact of the violation, or both:

(A) send the amount of the penalty to the commissioner for

placement in an escrow account; or

(B) post with the commissioner a bond for the amount of the

penalty.

by the commissioner and be effective until all judicial review of

the order or decision is final.

(d) A person who does not send money to the commissioner or post

the bond within the period prescribed by Subsection (b) waives

all rights to contest the violation or the amount of the penalty.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.057. REFUND OF ADMINISTRATIVE PENALTY. Not later than

the 30th day after the date of a judicial determination that an

administrative penalty against a person should be reduced or not

assessed, the commissioner shall:

(1) remit to the person the appropriate amount of any penalty

payment plus accrued interest; or

(2) execute a release of the bond if the person has posted a

bond.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.058. RECOVERY OF ADMINISTRATIVE PENALTY BY ATTORNEY

GENERAL. The attorney general at the request of the commissioner

may bring a civil action to recover an administrative penalty

under this subchapter.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.0585. CIVIL PENALTY. (a) At the request of the

commissioner, the attorney general or a district, county, or city

attorney shall institute an action in district court to collect a

civil penalty from a person who has violated Section 431.021.

(b) The civil penalty may not exceed $25,000 a day for each

violation. Each day of violation constitutes a separate violation

for purposes of the penalty assessment.

amount of the penalty:

(1) the person's history of any previous violations of Section

431.021;

(2) the seriousness of the violation;

(3) any hazard posed to the public health and safety by the

violation; and

(4) demonstrations of good faith by the person charged.

(d) Venue for a suit brought under this section is in the city

or county in which the violation occurred or in Travis County.

(e) A civil penalty recovered in a suit instituted by a local

government under this section shall be paid to that local

government.

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 154, eff. Sept. 1,

1991.

Sec. 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

offense under this subsection is a Class A misdemeanor unless it

is shown on the trial of an offense under this subsection that

the defendant was previously convicted of an offense under this

subsection, in which event the offense is a state jail felony.

In a criminal proceeding under this section, it is not necessary

to prove intent, knowledge, recklessness, or criminal negligence

of the defendant beyond the degree of culpability, if any, stated

in Subsection (a-2) or Section 431.021, as applicable, to

establish criminal responsibility for the violation.

(a-1) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.

(a-2) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.

(b) A person is not subject to the penalties of Subsection (a):

(1) for having received an article in commerce and having

delivered or offered delivery of the article, if the delivery or

offer was made in good faith, unless the person refuses to

furnish on request

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Texas Codes and Statutes

CHAPTER 431. TEXAS FOOD, DRUG, AND COSMETIC ACT