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TEXAS STATUTES AND CODES

CHAPTER 431. TEXAS FOOD, DRUG, AND COSMETIC ACT

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HEALTH AND SAFETY CODETITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCESSUBTITLE A. FOOD AND DRUG HEALTH REGULATIONSCHAPTER 431. TEXAS FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER A. GENERAL PROVISIONSSec. 431.001.SHORT TITLE.This chapter may be cited as theTexas 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 anymanner or by any means, other than by labeling, for the purposeof inducing, or that are likely to induce, directly orindirectly, the purchase of food, drugs, devices, or cosmetics.(2)"Animal feed," as used in Subdivision (23), in Section 512of the federal Act, and in provisions of this chapter referringto those paragraphs or sections, means an article intended foruse as food for animals other than man as a substantial source ofnutrients in the diet of the animals. The term is not limited toa mixture intended to be the sole ration of the animals.(3)"Authorized agent" means an employee of the department whois designated by the commissioner to enforce the provisions ofthis chapter.(4)"Board" means the Texas Board of Health.(5)"Butter" means the food product usually known as butter thatis made exclusively from milk or cream, or both, with or withoutcommon salt or additional coloring matter, and containing notless than 80 percent by weight of milk fat, after allowing forall tolerances.(6)(A) "Color additive" means a material that:(i)is a dye, pigment, or other substance made by a process ofsynthesis or similar artifice, or extracted, isolated, orotherwise derived, with or without intermediate or final changeof identity from a vegetable, animal, mineral, or other source;and(ii)when added or applied to a food, drug, or cosmetic, or tothe human body or any part of the human body, is capable, aloneor through reaction with other substance, of imparting color. Theterm does not include any material exempted under the federalAct.(B)"Color" includes black, white, and intermediate grays.(C)Paragraph (A) does not apply to any pesticide chemical, soilor plant nutrient, or other agricultural chemical solely becauseof its effect in aiding, retarding, or otherwise affecting,directly or indirectly, the growth or other natural physiologicalprocesses 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 thissubdivision, means any food, drug, device, or cosmetic, as thoseterms are defined by this chapter or by the federal Act, and anyother article, product, or commodity of any kind or class that iscustomarily produced or distributed for sale through retail salesagencies or instrumentalities for consumption by individuals, orfor use by individuals for purposes of personal care or in theperformance of services ordinarily rendered within the household,and that usually is consumed or expended in the course of theconsumption or use. The term does not include:(A)a meat or meat product, poultry or poultry product, ortobacco or tobacco product;(B)a commodity subject to packaging or labeling requirementsimposed under the Federal Insecticide, Fungicide, and RodenticideAct (7 U.S.C. 136), or The Virus-Serum-Toxin Act (21 U.S.C. 151et seq.);(C)a drug subject to the provisions of Section 431.113(c)(1) or431.112(j), or Section 503(b)(1) of the federal Act;(D)a beverage subject to or complying with packaging orlabeling requirements imposed under the Federal AlcoholAdministration 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 saleof 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 asmay be necessary by all reasonable means, from all foreign orinjurious contaminations.(10)"Cosmetic" means articles intended to be rubbed, poured,sprinkled, or sprayed on, introduced into, or otherwise appliedto the human body or any part of the human body for cleaning,beautifying, promoting attractiveness, or altering theappearance, and articles intended for use as a component of thosearticles. The term does not include soap.(11)"Counterfeit drug" means a drug, or the container orlabeling of a drug, that, without authorization, bears thetrademark, trade name or other identifying mark, imprint, ordevice of a drug manufacturer, processor, packer, or distributorother than the person who in fact manufactured, processed,packed, or distributed the drug, and that falsely purports or isrepresented to be the product of, or to have been packed ordistributed 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 vitroreagent, or other similar or related article, including anycomponent, part, or accessory, that is:(A)recognized in the official United States PharmacopoeiaNational Formulary or any supplement to it;(B)intended for use in the diagnosis of disease or otherconditions, or in the cure, mitigation, treatment, or preventionof disease in man or other animals; or(C)intended to affect the structure or any function of the bodyof man or other animals and that does not achieve any of itsprincipal intended purposes through chemical action within or onthe body of man or other animals and is not dependent onmetabolization for the achievement of any of its principalintended purposes.(14)"Drug" means articles recognized in the official UnitedStates 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 otheranimals, articles, other than food, intended to affect thestructure or any function of the body of man or other animals,and articles intended for use as a component of any articlespecified in this subdivision. The term does not include devicesor their components, parts, or accessories. A food for which aclaim is made in accordance with Section 403(r) of the federalAct, and for which the claim is approved by the secretary, is nota drug solely because the label or labeling contains such aclaim.(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(C)articles used for components of any such article.(17)"Food additive" means any substance the intended use ofwhich results or may reasonably be expected to result, directlyor indirectly, in its becoming a component or otherwise affectingthe characteristics of any food (including any substance intendedfor use in producing, manufacturing, packing, processing,preparing, treating, packaging, transporting, or holding food;and including any source of radiation intended for any use), ifsuch substance is not generally recognized, among expertsqualified by scientific training and experience to evaluate itssafety, as having been adequately shown through scientificprocedures (or, in the case of a substance used in food prior toJanuary 1, 1958, through either scientific procedures orexperience based on common use in food) to be safe under theconditions of its intended use; except that such term does notinclude:(A)a pesticide chemical in or on a raw agricultural commodity;(B)a pesticide chemical to the extent that it is intended foruse or is used in the production, storage, or transportation ofany raw agricultural commodity;(C)a color additive;(D)any substance used in accordance with a sanction or approvalgranted prior to the enactment of the Food Additives Amendment of1958, Pub. L. No. 85-929, 52 Stat. 1041 (codified as amended invarious sections of 21 U.S.C.), pursuant to the federal Act, thePoultry Products Inspection Act (21 U.S.C. 451 et seq.) or theMeat Inspection Act of 1907 (21 U.S.C. 603); or(E)a new animal drug.(18)"Health authority" means a physician designated toadminister 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 forspecial dietary use solely as a food for infants by reason of itssimulation of human milk or its suitability as a complete orpartial substitute for human milk.(21)"Label" means a display of written, printed, or graphicmatter upon the immediate container of any article; and arequirement made by or under authority of this chapter that anyword, statement, or other information that appears on the labelshall not be considered to be complied with unless the word,statement, or other information also appears on the outsidecontainer or wrapper, if any, of the retail package of thearticle, or is easily legible through the outside container orwrapper.(22)"Labeling" means all labels and other written, printed, orgraphic matter (1) upon any article or any of its containers orwrappers, or (2) accompanying such article.(23)"Manufacture" means:(A)the process of combining or purifying food or packaging foodfor sale to a person at wholesale or retail, and includesrepackaging, labeling, or relabeling of any food;(B)the process of preparing, propagating, compounding,processing, packaging, repackaging, labeling, testing, or qualitycontrol of a drug or drug product, but does not includecompounding that is done within the practice of pharmacy andpursuant to a prescription drug order or initiative from apractitioner for a patient or prepackaging that is done inaccordance with Section 562.154, Occupations Code;(C)the process of preparing, fabricating, assembling,processing, packing, repacking, labeling, or relabeling a device;or(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 foranimals other than man, including any drug intended for use inanimal feed:(A)the composition of which is such that the drug is notgenerally recognized among experts qualified by scientifictraining and experience to evaluate the safety and effectivenessof animal drugs as safe and effective for use under theconditions prescribed, recommended, or suggested in the labelingof the drug (except that such an unrecognized drug is not deemedto be a "new animal drug" if at any time before June 25, 1938, itwas subject to the Food and Drug Act of June 30, 1906, and if atthat time its labeling contained the same representationsconcerning the conditions of its use);(B)the composition of which is such that the drug, as a resultof investigations to determine its safety and effectiveness foruse under those conditions, has become recognized but that hasnot, otherwise than in the investigations, been used to amaterial extent or for a material time under those conditions; or(C)is composed wholly or partly of penicillin, streptomycin,chloratetracycline, chloramphenicol, or bacitracin, or anyderivative of those substances, unless:(i)a published order of the secretary is in effect thatdeclares the drug not to be a new animal drug on the grounds thatthe requirement of certification of batches of the drug, asprovided by Section 512(n) of the federal Act, is not necessaryto ensure that the objectives specified in Section 512(n)(3) ofthat Act are achieved; and(ii)Paragraph (A) or (B) of this subdivision does not apply tothe drug.(25)"New drug" means:(A)any drug, except a new animal drug, the composition of whichis such that such drug is not generally recognized among expertsqualified by scientific training and experience to evaluate thesafety and effectiveness of drugs, as safe and effective for useunder the conditions prescribed, recommended, or suggested in thelabeling thereof (except that such an unrecognized drug is not a"new drug" if at any time before May 26, 1985, it was subject tothe Food and Drug Act of June 30, 1906, and if at that time itslabeling contained the same representations concerning theconditions of its use); or(B)any drug, except a new animal drug, the composition of whichis such that such drug, as a result of investigations todetermine its safety and effectiveness for use under suchconditions, has become so recognized, but which has not,otherwise than in such investigations, been used to a materialextent or for a material time under such conditions.(26)"Official compendium" means the official United StatesPharmacopoeia National Formulary, or any supplement to it.(27)"Package" means any container or wrapping in which aconsumer commodity is enclosed for use in the delivery or displayof that consumer commodity to retail purchasers. The termincludes wrapped meats enclosed in papers or other materials asprepared by the manufacturers thereof for sale. The term does notinclude:(A)shipping containers or wrappings used solely for thetransportation of a consumer commodity in bulk or in quantity tomanufacturers, packers, or processors, or to wholesale or retaildistributors;(B)shipping containers or outer wrappings used by retailers toship or deliver a commodity to retail customers if the containersand wrappings do not bear printed matter relating to anyparticular commodity; or(C)containers subject to the provisions of the Standard BarrelAct (Apple Barrels) (15 U.S.C. 231, 21 U.S.C. 20) or the StandardBarrel Act (Fruits and Vegetables) (15 U.S.C. 234-236).(28)"Person" includes individual, partnership, corporation, andassociation.(29)"Pesticide chemical" means any substance which, alone, inchemical combination or in formulation with one or more othersubstances, is a "pesticide" within the meaning of the FederalInsecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136(u)), asnow 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 thatis most likely to be displayed, presented, shown, or examinedunder normal and customary conditions of display for retail sale.(31)"Raw agricultural commodity" means any food in its raw ornatural state, including all fruits that are washed, colored, orotherwise treated in their unpeeled natural form prior tomarketing.(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 StatesDepartment 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; Acts1997, 75th Leg., ch. 629, Sec. 1, eff. Sept. 1, 1997; Acts 2003,78th Leg., ch. 111, Sec. 1, eff. Sept. 1, 2003; Acts 2003, 78thLeg., 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 LABELINGOR ADVERTISING.If an article is alleged to be misbrandedbecause the labeling or advertising is misleading, then indetermining whether the labeling or advertising is misleading,there shall be taken into account, among other things, not onlyrepresentations made or suggested by statement, word, design,device, sound, or any combination of these, but also the extentto which the labeling or advertising fails to reveal factsmaterial in the light of such representations or material withrespect to consequences which may result from the use of thearticle to which the labeling or advertising relates under theconditions of use prescribed in the labeling or advertisingthereof, or under such conditions of use as are customary orusual.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.Therepresentation of a drug, in its labeling, as an antiseptic shallbe considered to be a representation that the drug is agermicide, except in the case of a drug purporting to be, orrepresented as, an antiseptic for inhibitory use as a wetdressing, ointment, dusting powder, or such other use as involvesprolonged 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 theselling of food, drugs, devices, or cosmetics, shall beconsidered to include the manufacture, production, processing,packaging, exposure, offer, possession, and holding of any sucharticle for sale; and the sale, dispensing, and giving of anysuch article, and the supplying or applying of any such articlesin 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 UnitedStates Food and Drug Administration determines, with respect to aproduct that is a combination of a drug and a device, that:(1)the primary mode of action of the product is as a drug, aperson who engages in wholesale distribution of the product issubject to licensure under Subchapter I; and(2)the primary mode of action of the product is as a device, adistributor or manufacturer of the product is subject tolicensure 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.Aperson who is subject to this chapter and who handles molluscanshellfish, as that term is defined by Section 436.002, shallcomply 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 ORRECONDITIONED MERCHANDISE AND CERTAIN LICENSED ENTITIES.(a)This chapter applies to a food, drug, device, or cosmetic that isdistressed merchandise for purposes of Chapter 432 or that hasbeen subject to reconditioning in accordance with Chapter 432.(b)Except as provided by Subsection (c), this chapter appliesto the conduct of a person licensed under Chapter 432.(c)A person who holds a license under Chapter 432 and isengaging in conduct within the scope of that license is notrequired to hold a license as a wholesale drug distributor underSubchapter I, a food wholesaler under Subchapter J, or a devicedistributor 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 frozendessert, a product sold in semblance of a frozen dessert, or amix for one of those products subject to Chapter 440. A frozendessert, an imitation frozen dessert, a product sold in semblanceof a frozen dessert, or a mix for one of those products is foodfor purposes of this chapter.(b)Except as provided by Subsection (c), this chapter appliesto the conduct of a person licensed under Chapter 440.(c)A person who holds a license under Chapter 440 related tothe manufacturing of a product regulated under that chapter andis engaging in conduct within the scope of that license is notrequired to hold a license as a food manufacturer or foodwholesaler 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 MILKPRODUCTS.(a)This chapter applies to milk or a milk productsubject to Chapter 435. Milk or a milk product is a food forpurposes of this chapter.(b)Except as provided by Subsection (c), this chapter appliesto the conduct of a person who holds a permit under Chapter 435.(c)A person who holds a permit under Chapter 435 related to theprocessing, producing, bottling, receiving, transferring, ortransporting of Grade A milk or milk products and who is engagingin conduct within the scope of that permit is not required tohold a license as a food manufacturer or food wholesaler underSubchapter J.Added by Acts 2003, 78th Leg., ch. 757, Sec. 1, eff. Sept. 1,2003.SUBCHAPTER B. PROHIBITED ACTSSec. 431.021.PROHIBITED ACTS.The following acts and thecausing of the following acts within this state are unlawful andprohibited:(a)the introduction or delivery for introduction into commerceof any food, drug, device, or cosmetic that is adulterated ormisbranded;(b)the adulteration or misbranding of any food, drug, device,or cosmetic in commerce;(c)the receipt in commerce of any food, drug, device, orcosmetic that is adulterated or misbranded, and the delivery orproffered delivery thereof for pay or otherwise;(d)the distribution in commerce of a consumer commodity, ifsuch commodity is contained in a package, or if there is affixedto that commodity a label that does not conform to the provisionsof this chapter and of rules adopted under the authority of thischapter; provided, however, that this prohibition shall not applyto persons engaged in business as wholesale or retaildistributors of consumer commodities except to the extent thatsuch persons:(1)are engaged in the packaging or labeling of suchcommodities; or(2)prescribe or specify by any means the manner in which suchcommodities are packaged or labeled;(e)the introduction or delivery for introduction into commerceof any article in violation of Section 431.084, 431.114, or431.115;(f)the dissemination of any false advertisement;(g)the refusal to permit entry or inspection, or to permit thetaking of a sample or to permit access to or copying of anyrecord as authorized by Sections 431.042-431.044;or the failureto establish or maintain any record or make any report requiredunder Section 512(j), (l), or (m) of the federal Act, or therefusal to permit access to or verification or copying of anysuch 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 inSection 431.059, which guaranty or undertaking is false, exceptby a person who relied on a guaranty or undertaking to the sameeffect signed by, and containing the name and address of theperson residing in this state from whom the person received ingood faith the food, drug, device, or cosmetic; or the giving ofa guaranty or undertaking referred to in Section 431.059, whichguaranty or undertaking is false;(j)the use, removal, or disposal of a detained or embargoedarticle in violation of Section 431.048;(k)the alteration, mutilation, destruction, obliteration, orremoval of the whole or any part of the labeling of, or the doingof any other act with respect to a food, drug, device, orcosmetic, if such act is done while such article is held for saleafter shipment in commerce and results in such article beingadulterated or misbranded;(l)(1)forging, counterfeiting, simulating, or falselyrepresenting, or without proper authority using any mark, stamp,tag, label, or other identification device authorized or requiredby rules adopted under this chapter or the regulationspromulgated 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 thetrademark, trade name, or other identifying mark, imprint, ordevice of another or any likeness of any of the foregoing on anydrug or container or labeling thereof so as to render such drug acounterfeit drug;(3)the doing of any act that causes a drug to be a counterfeitdrug, or the sale or dispensing, or the holding for sale ordispensing, of a counterfeit drug;(m)the using by any person to the person's own advantage, orrevealing, other than to the commissioner, an authorized agent, ahealth authority or to the courts when relevant in any judicialproceeding under this chapter, of any information acquired underthe authority of this chapter concerning any method or processthat as a trade secret is entitled to protection;(n)the using, on the labeling of any drug or device or in anyadvertising relating to such drug or device, of anyrepresentation or suggestion that approval of an application withrespect to such drug or device is in effect under Section 431.114or Section 505, 515, or 520(g) of the federal Act, as the casemay be, or that such drug or device complies with the provisionsof such sections;(o)the using, in labeling, advertising or other sales promotionof any reference to any report or analysis furnished incompliance with Sections 431.042-431.044 or Section 704 of thefederal Act;(p)in the case of a prescription drug distributed or offeredfor sale in this state, the failure of the manufacturer, packer,or distributor of the drug to maintain for transmittal, or totransmit, to any practitioner licensed by applicable law toadminister such drug who makes written request for information asto such drug, true and correct copies of all printed matter thatis required to be included in any package in which that drug isdistributed or sold, or such other printed matter as is approvedunder the federal Act.Nothing in this subsection shall beconstrued to exempt any person from any labeling requirementimposed by or under other provisions of this chapter;(q)(1)placing or causing to be placed on any drug or device orcontainer of any drug or device, with intent to defraud, thetrade name or other identifying mark, or imprint of another orany likeness of any of the foregoing;(2)selling, dispensing, disposing of or causing to be sold,dispensed, or disposed of, or concealing or keeping inpossession, control, or custody, with intent to sell, dispense,or dispose of, any drug, device, or any container of any drug ordevice, with knowledge that the trade name or other identifyingmark or imprint of another or any likeness of any of theforegoing has been placed thereon in a manner prohibited bySubdivision (1) of this subsection; or(3)making, selling, disposing of, causing to be made, sold, ordisposed of, keeping in possession, control, or custody, orconcealing with intent to defraud any punch, die, plate, stone,or other thing designed to print, imprint, or reproduce thetrademark, trade name, or other identifying mark, imprint, ordevice of another or any likeness of any of the foregoing on anydrug or container or labeling of any drug or container so as torender such drug a counterfeit drug;(r)dispensing or causing to be dispensed a different drug inplace of the drug ordered or prescribed without the expresspermission in each case of the person ordering or prescribing;(s)the failure to register in accordance with Section 510 ofthe federal Act, the failure to provide any information requiredby Section 510(j) or (k) of the federal Act, or the failure toprovide a notice required by Section 510(j)(2) of the federalAct;(t)(1)the failure or refusal to:(A)comply with any requirement prescribed under Section 518 or520(g) of the federal Act; or(B)furnish any notification or other material or informationrequired by or under Section 519 or 520(g) of the federal Act;(2)with respect to any device, the submission of any reportthat is required by or under this chapter that is false ormisleading in any material respect;(u)the movement of a device in violation of an order underSection 304(g) of the federal Act or the removal or alteration ofany mark or label required by the order to identify the device asdetained;(v)the failure to provide the notice required by Section 412(b)or 412(c), the failure to make the reports required by Section412(d)(1)(B), or the failure to meet the requirements prescribedunder Section 412(d)(2) of the federal Act;(w)except as provided under Subchapter M of this chapter andSection 562.1085, Occupations Code, the acceptance by a person ofan unused prescription or drug, in whole or in part, for thepurpose of resale, after the prescription or drug has beenoriginally dispensed, or sold;(x)engaging in the wholesale distribution of drugs or operatingas a distributor or manufacturer of devices in this state withoutobtaining a license issued by the department under Subchapter I,L, or N, as applicable;(y)engaging in the manufacture of food in this state oroperating as a warehouse operator in this state without having alicense as required by Section 431.222 or operating as a foodwholesaler in this state without having a license under Section431.222 or being registered under Section 431.2211, asappropriate;(z)unless approved by the United States Food and DrugAdministration pursuant to the federal Act, the sale, delivery,holding, or offering for sale of a self-testing kit designed toindicate whether a person has a human immunodeficiency virusinfection, acquired immune deficiency syndrome, or a relateddisorder or condition;(aa)making a false statement or false representation in anapplication for a license or in a statement, report, or otherinstrument to be filed with or requested by the department underthis chapter;(bb)failing to comply with a requirement or request to provideinformation or failing to submit an application, statement,report, or other instrument required by the department;(cc)performing, causing the performance of, or aiding andabetting the performance of an act described by Subdivision (x);(dd)purchasing or otherwise receiving a prescription drug froma pharmacy in violation of Section 431.411(a);(ee)selling, distributing, or transferring a prescription drugto a person who is not authorized under state or federal law toreceive the prescription drug in violation of Section 431.411(b);(ff)failing to deliver prescription drugs to specified premisesas required by Section 431.411(c);(gg)failing to maintain or provide pedigrees as required bySection 431.412 or 431.413;(hh)failing to obtain, pass, or authenticate a pedigree asrequired by Section 431.412 or 431.413;(ii)the introduction or delivery for introduction into commerceof 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, orsuspected of being counterfeit, and the delivery or proffereddelivery of such a drug for payment or otherwise; or(kk)the alteration, mutilation, destruction, obliteration, orremoval of all or any part of the labeling of a prescription drugor the commission of any other act with respect to a prescriptiondrug 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; Acts1995, 74th Leg., ch. 1047, Sec. 6, eff. Sept. 1, 1995; Acts 1997,75th Leg., ch. 282, Sec. 1, eff. Sept. 1, 1997; Acts 2001, 77thLeg., 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 thatrelates to a prescription drug does not apply to a prescriptiondrug manufacturer, or an agent of a prescription drugmanufacturer, who is obtaining or attempting to obtain aprescription drug for the sole purpose of testing theprescription 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 ephedrineto a person 17 years of age or younger, unless:(1)the actor is:(A)a practitioner or other health care provider licensed bythis state who has obtained, as required by law, consent to thetreatment of the person to whom the product is furnished; or(B)the parent, guardian, or managing conservator of the personto whom the product is furnished;(2)the person to whom the product is furnished has had thedisabilities of minority removed for general purposes underChapter 31, Family Code; or(3)the product is a drug.(b)An offense under this section is a Class C misdemeanorunless it is shown on the trial of the offense that the defendanthas been previously convicted of an offense under this section,in which event the offense is a Class B misdemeanor.(c)A product containing ephedrine that is not described inSubsection (a)(3) must be labeled in accordance with rulesadopted by the Texas Department of Health to indicate that saleto 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, orcosmetic that is distressed merchandise for purposes of Chapter432, Sections 431.021(a), (c), and (d) do not prohibit:(1)the introduction or delivery for introduction into commerceof the merchandise for the purpose of reconditioning inaccordance with Chapter 432 and not for sale to the ultimateconsumer;(2)the receipt in commerce of the merchandise for the purposeof reconditioning in accordance with Chapter 432 and not for saleto the ultimate consumer;(3)the holding of merchandise for the purpose of reconditioningin accordance with Chapter 432 and not for resale to the ultimateconsumer; or(4)the reconditioning of the merchandise in accordance withChapter 432.Added by Acts 2001, 77th Leg., ch. 265, Sec. 2, eff. May 22,2001.SUBCHAPTER C. ENFORCEMENTSec. 431.041.DEFINITION.In this subchapter, "detained orembargoed article" means a food, drug, device, cosmetic, orconsumer commodity that has been detained or embargoed underSection 431.048.Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.Sec. 431.042.INSPECTION.(a)To enforce this chapter, thecommissioner, an authorized agent, or a health authority may, onpresenting appropriate credentials to the owner, operator, oragent in charge:(1)enter at reasonable times an establishment, including afactory or warehouse, in which a food, drug, device, or cosmeticis manufactured, processed, packed, or held for introduction intocommerce 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, andin a reasonable manner, the establishment or vehicle and allequipment, finished and unfinished materials, containers, andlabeling of any item and obtain samples necessary for theenforcement of this chapter.(b)The inspection of an establishment, including a factory,warehouse, or consulting laboratory, in which a prescription drugor restricted device is manufactured, processed, packed, or heldfor 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, oroffered for sale under this chapter; or(3)is otherwise in violation of this chapter.(c)An inspection under Subsection (b) may not extend to:(1)financial data;(2)sales data other than shipment data;(3)pricing data;(4)personnel data other than data relating to thequalifications of technical and professional personnel performingfunctions 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 issuedunder Section 505(i) or (j), 519, or 520(g) of the federal Act;or(6)data relating to other drugs or devices that, in the case ofa new drug, would be subject to reporting or inspection underregulations issued under Section 505(j) of the federal Act.(d)An inspection under Subsection (b) shall be started andcompleted 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 ordevices on prescriptions of practitioners licensed to administerthe drugs or devices to their patients in the course of theirprofessional practice; and(C)does not, through a subsidiary or otherwise, manufacture,prepare, propagate, compound, or process a drug or device forsale other than in the regular course of its business ofdispensing or selling drugs or devices at retail;(2)a practitioner licensed to prescribe or administer a drugwho manufactures, prepares, propagates, compounds, or processesthe drug solely for use in the course of the practitioner'sprofessional practice;(3)a practitioner licensed to prescribe or use a device whomanufactures or processes the device solely for use in the courseof the practitioner's professional practice; or(4)a person who manufactures, prepares, propagates, compounds,or processes a drug or manufactures or processes a device solelyfor use in research, teaching, or chemical analysis and not forsale.(f)The board may exempt a class of persons from inspectionunder this section if the board finds that inspection as appliedto the class is not necessary for the protection of the publichealth.(g)An authorized agent or health authority who makes aninspection under this section to enforce the provisions of thischapter applicable to infant formula shall be permitted, at allreasonable times, to have access to and to copy and verifyrecords:(1)in order to determine whether the infant formulamanufactured or held in the inspected facility meets therequirements of this chapter; or(2)that are required by this chapter.(h)An authorized agent or health authority who makes aninspection of an establishment, including a factory or warehouse,and obtains a sample during or on completion of the inspectionand before leaving the establishment, shall give to the owner,operator, or the owner's or operator's agent a receipt describingthe 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 tomaintain records under this chapter or Section 519 or 520(g) ofthe federal Act or a person who is in charge or custody of thoserecords shall, at the request of an authorized agent or healthauthority, permit the authorized agent or health authority at allreasonable 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 orother person receiving a food, drug, device, or cosmetic incommerce or holding a food, drug, device, or cosmetic received incommerce shall, at the request of an authorized agent or healthauthority, permit the authorized agent or health authority at allreasonable times to have access to and to copy all recordsshowing:(1)the movement in commerce of the food, drug, device, orcosmetic;(2)the holding of the food, drug, device, or cosmetic aftermovement 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 andcopying of the requested record if the request is accompanied bya written statement that specifies the nature or kind of food,drug, device, or cosmetic to which the request relates.(c)Evidence obtained under this section or evidence that isdirectly or indirectly derived from the evidence obtained underthis section may not be used in a criminal prosecution of theperson from whom the evidence is obtained.(d)A carrier is not subject to other provisions of this chapterbecause of the carrier's receipt, carriage, holding, or deliveryof a food, drug, device, or cosmetic in the usual course ofbusiness as a carrier.Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.Sec. 431.045.EMERGENCY ORDER.(a)The commissioner or aperson designated by the commissioner may issue an emergencyorder, either mandatory or prohibitory in nature, in relation tothe manufacture or distribution of a food, drug, device, orcosmetic in the department's jurisdiction if the commissioner orthe 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 tohuman life or health; and(2)other procedures available to the department to remedy orprevent the occurrence of the situation will result inunreasonable delay.(b)The commissioner or a person designated by the commissionermay issue the emergency order without notice and hearing if thecommissioner or a person designated by the commissionerdetermines this is practicable under the circumstances.(c)If an emergency order is issued without a hearing, thedepartment shall determine a time and place for a hearing atwhich the emergency order is affirmed, modified, or set aside.The hearing shall be held under the contested case provisions ofChapter 2001, Government Code, and the board's formal hearingrules.(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 adoptedunder 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, anauthorized agent, or a health authority may petition the districtcourt for a temporary restraining order to restrain a continuingviolation of Subchapter B or a threat of a continuing violationof Subchapter B if the commissioner, authorized agent, or healthauthority finds that:(1)a person has violated, is violating, or is threatening toviolate Subchapter B; and(2)the violation or threatened violation creates an immediatethreat to the health and safety of the public.(b)A district court, on petition of the commissioner, anauthorized agent, or a health authority, and on a finding by thecourt that a person is violating or threatening to violateSubchapter B shall grant any injunctive relief warranted by thefacts.(c)Venue for a suit brought under this section is in the countyin which the violation or threat of violation is alleged to haveoccurred or in Travis County.(d)The commissioner and the attorney general may each recoverreasonable expenses incurred in obtaining injunctive relief underthis section, including investigative costs, court costs,reasonable attorney fees, witness fees, and deposition expenses.The expenses recovered by the commissioner are herebyappropriated to the department for the administration andenforcement of this chapter. The expenses recovered by theattorney 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)Thecommissioner or an authorized agent shall affix to an articlethat is a food, drug, device, cosmetic, or consumer commodity atag or other appropriate marking that gives notice that thearticle is, or is suspected of being, adulterated or misbrandedand that the article has been detained or embargoed if thecommissioner or the authorized agent finds or has probable causeto believe that the article:(1)is adulterated;(2)is misbranded so that the article is dangerous or fraudulentunder this chapter; or(3)violates Section 431.084, 431.114, or 431.115.(b)The tag or marking on a detained or embargoed article mustwarn all persons not to use the article, remove the article fromthe premises, or dispose of the article by sale or otherwiseuntil permission for use, removal, or disposal is given by thecommissioner, the authorized agent, or a court.(c)A person may not use a detained or embargoed article, removea detained or embargoed article from the premises, or dispose ofa detained or embargoed article by sale or otherwise withoutpermission of the commissioner, the authorized agent, or a court.The commissioner or the authorized agent may permit perishablegoods to be moved to a place suitable for proper storage.(d)The commissioner or an authorized agent shall remove the tagor other marking from an embargoed or detained article if thecommissioner or an authorized agent finds that the article is notadulterated or misbranded.(e)The commissioner or an authorized agent may not detain orembargo an article, including an article that is distressedmerchandise, that is in the possession of a person licensed underChapter 432 and that is being held for the purpose ofreconditioning in accordance with Chapter 432, unless thecommissioner or an authorized agent finds or has probable causeto believe that the article cannot be adequately reconditioned inaccordance 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 theclaimant's agent fails or refuses to transfer the articles to asecure place after the tag or other appropriate marking has beenaffixed as provided by Section 431.048, the commissioner or anauthorized agent may order the transfer of the articles to one ormore secure storage areas to prevent their unauthorized use,removal, or disposal.(b)The commissioner or an authorized agent may provide for thetransfer of the article if the claimant of the article or theclaimant's agent does not carry out the transfer order in atimely manner. The costs of the transfer shall be assessedagainst the claimant of the article or the claimant's agent.(c)The claimant of the article or the claimant's agent shallpay the costs of the transfer.(d)The commissioner may request the attorney general to bringan action in the district court in Travis County to recover thecosts of the transfer. In a judgment in favor of the state, thecourt may award costs, attorney fees, court costs, and interestfrom the time the expense was incurred through the date thedepartment 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 theissuance of an emergency order under Section 431.045 or thedetention or embargo of an article under Section 431.048, thecommissioner may order a food, drug, device, cosmetic, orconsumer commodity to be recalled from commerce.(b)The commissioner's recall order may require the articles tobe removed to one or more secure areas approved by thecommissioner or an authorized agent.(c)The recall order must be in writing and signed by thecommissioner.(d)The recall order may be issued before or in conjunction withthe affixing of the tag or other appropriate marking as providedby Section 431.048(a) or in conjunction with the commissioner'sissuance 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 condemnationunder Section 431.050; or(4)is set aside at the hearing provided to affirm, modify, orset aside an emergency order under Section 431.045.(f)The claimant of the articles or the claimant's agent shallpay the costs of the removal and storage of the articles removed.(g)If the claimant or the claimant's agent fails or refuses tocarry out the recall order in a timely manner, the commissionermay provide for the recall of the articles. The costs of therecall shall be assessed against the claimant of the articles orthe claimant's agent.(h)The commissioner may request the attorney general to bringan action in the district court of Travis County to recover thecosts of the recall. In a judgment in favor of the state, thecourt may award costs, attorney fees, court costs, and interestfrom the time the expense was incurred through the date thedepartment 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 ofan article may be brought before a court in whose jurisdictionthe article is located, detained, or embargoed if the article isadulterated, 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 orderthe destruction of a sampled article or a detained or embargoedarticle if the court finds that the article is adulterated ormisbranded.(b)After entry of the court's order, an authorized agent shallsupervise the destruction of the article.(c)The claimant of the article shall pay the cost of thedestruction of the article.(d)The court shall tax against the claimant of the article orthe claimant's agent all court costs and fees, and storage andother 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 detainedor embargoed article that is adulterated or misbranded to theclaimant of the article for labeling or processing under thesupervision of an agent of the commissioner or an authorizedagent 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 properlabeling or processing; and(4)a good and sufficient bond, conditioned on the correction ofthe adulteration or misbranding by proper labeling or processing,has been executed.(b)The claimant shall pay the costs of the supervision.(c)The court shall order that the article be returned to theclaimant and the bond discharged on the representation to thecourt by the commissioner or an authorized agent that the articleno longer violates this chapter and that the expenses of thesupervision are paid.Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.Sec. 431.053.CONDEMNATION OF PERISHABLE ARTICLES.(a)Thecommissioner or an authorized agent shall immediately condemn orrender by any means unsalable as human food an article that is anuisance under Subsection (b) and that the commissioner orauthorized agent finds in any room, building, or other structureor in a vehicle.(b)Any meat, seafood, poultry, vegetable, fruit, or otherperishable 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 otherwiseunsafe.Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.Sec. 431.054.ADMINISTRATIVE PENALTY.(a)The commissioner mayassess an administrative penalty against a person who violatesSubchapter B or an order adopted or registration issued underthis chapter.(b)In determining the amount of the penalty, the commissionershall 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.(c)The penalty may not exceed $25,000 a day for each violation.(d)Each day a violation continues may be considered a separateviolation.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 personcharged with a violation is given an opportunity for a hearing.(b)If a hearing is held, the commissioner shall make findingsof fact and shall issue a written decision regarding theoccurrence of the violation and the amount of the penalty thatmay be warranted.(c)If the person charged with the violation does not request ahearing, the commissioner may assess a penalty after determiningthat a violation has occurred and the amount of the penalty thatmay be warranted.(d)After making a determination under this section that apenalty is to be assessed against a person, the commissionershall issue an order requiring that the person pay the penalty.(e)The commissioner may consolidate a hearing held under thissection with another proceeding.Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.Sec. 431.056.PAYMENT OF ADMINISTRATIVE PENALTY.(a)Not laterthan the 30th day after the date an order finding that aviolation has occurred is issued, the commissioner shall informthe person against whom the order is issued of the amount of thepenalty for the violation.(b)Not later than the 30th day after the date on which adecision or order charging a person with a penalty is final, theperson shall:(1)pay the penalty in full; or(2)if the person seeks judicial review of the amount of thepenalty, the fact of the violation, or both:(A)send the amount of the penalty to the commissioner forplacement in an escrow account; or(B)post with the commissioner a bond for the amount of thepenalty.(c)A bond posted under this section must be in a form approvedby the commissioner and be effective until all judicial review ofthe order or decision is final.(d)A person who does not send money to the commissioner or postthe bond within the period prescribed by Subsection (b) waivesall 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 thanthe 30th day after the date of a judicial determination that anadministrative penalty against a person should be reduced or notassessed, the commissioner shall:(1)remit to the person the appropriate amount of any penaltypayment plus accrued interest; or(2)execute a release of the bond if the person has posted abond.Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.Sec. 431.058.RECOVERY OF ADMINISTRATIVE PENALTY BY ATTORNEYGENERAL.The attorney general at the request of the commissionermay bring a civil action to recover an administrative penaltyunder this subchapter.Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.Sec. 431.0585.CIVIL PENALTY.(a)At the request of thecommissioner, the attorney general or a district, county, or cityattorney shall institute an action in district court to collect acivil penalty from a person who has violated Section 431.021.(b)The civil penalty may not exceed $25,000 a day for eachviolation. Each day of violation constitutes a separate violationfor purposes of the penalty assessment.(c)The court shall consider the following in determining theamount of the penalty:(1)the person's history of any previous violations of Section431.021;(2)the seriousness of the violation;(3)any hazard posed to the public health and safety by theviolation; and(4)demonstrations of good faith by the person charged.(d)Venue for a suit brought under this section is in the cityor county in which the violation occurred or in Travis County.(e)A civil penalty recovered in a suit instituted by a localgovernment under this section shall be paid to that localgovernment.Added by Acts 1991, 72nd Leg., ch. 14, Sec. 154, eff. Sept. 1,1991.Sec. 431.059.CRIMINAL PENALTY; DEFENSES.(a)A person commitsan offense if the person violates any of the provisions ofSection 431.021 relating to unlawful or prohibited acts.A firstoffense under this subsection is a Class A misdemeanor unless itis shown on the trial of an offense under this subsection thatthe defendant was previously convicted of an offense under thissubsection, in which event the offense is a state jail felony.In a criminal proceeding under this section, it is not necessaryto prove intent, knowledge, recklessness, or criminal negligenceof the defendant beyond the degree of culpability, if any, statedin Subsection (a-2) or Section 431.021, as applicable, toestablish 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 havingdelivered or offered delivery of the article, if the delivery oroffer was made in good faith, unless the person refuses tofurnish on request
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  • 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.

    (C) Paragraph (A) does not apply to any pesticide chemical, soil

    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.);

    (C) a drug subject to the provisions of Section 431.113(c)(1) or

    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

    (C) intended to affect the structure or any function of the body

    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

    (C) articles used for components of any such article.

    (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;

    (C) a color additive;

    (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;

    (C) the process of preparing, fabricating, assembling,

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

    or

    (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

    (C) is composed wholly or partly of penicillin, streptomycin,

    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

    (C) containers subject to the provisions of the Standard Barrel

    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.

    (c) A person who holds a license under Chapter 432 and is

    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.

    (c) A person who holds a license under Chapter 440 related to

    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.

    (c) A person who holds a permit under Chapter 435 related to the

    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;

    (c) the receipt in commerce of any food, drug, device, or

    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.

    (c) A product containing ephedrine that is not described in

    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.

    (c) An inspection under Subsection (b) may not extend to:

    (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;

    or

    (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

    (C) does not, through a subsidiary or otherwise, manufacture,

    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.

    (c) Evidence obtained under this section or evidence that is

    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.

    (c) If an emergency order is issued without a hearing, the

    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.

    (c) Venue for a suit brought under this section is in the county

    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.

    (c) A person may not use a detained or embargoed article, remove

    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.

    (c) The claimant of the article or the claimant's agent shall

    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.

    (c) The recall order must be in writing and signed by the

    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.

    (c) The claimant of the article shall pay the cost of the

    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.

    (c) The court shall order that the article be returned to the

    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.

    (c) The penalty may not exceed $25,000 a day for each violation.

    (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.

    (c) If the person charged with the violation does not request a

    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.

    (c) A bond posted under this section must be in a form approved

    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.

    (c) The court shall consider the following in determining the

    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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