By:  Berman, Flynn, Phillips, Madden, Driver,                     H.B. No. 164
 
    et al.                                                                   

A BILL TO BE ENTITLED
AN ACT
relating to the civil and criminal consequences of engaging in certain conduct related to the manufacture of methamphetamine and to the distribution and retail sales of pseudoephedrine; providing penalties. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
ARTICLE 1. CIVIL AND CRIMINAL CONSEQUENCES OF
ENGAGING IN CERTAIN CONDUCT RELATED TO
THE MANUFACTURE OF METHAMPHETAMINE
SECTION 1.01. Section 481.124(b), Health and Safety Code, is amended to read as follows: (b) For purposes of this section, an intent to unlawfully manufacture the controlled substance methamphetamine is presumed if the actor possesses or transports: (1) anhydrous ammonia in a container or receptacle that is not designed and manufactured to lawfully hold or transport anhydrous ammonia; (2) lithium metal removed from a battery and immersed in kerosene, mineral spirits, or similar liquid that prevents or retards hydration; or (3) in one container, vehicle, or building, phenylacetic acid, or more than nine grams, three containers packaged for retail sale, or 300 tablets or capsules of a product containing ephedrine or pseudoephedrine, and: (A) anhydrous ammonia; (B) at least three of the following categories of substances commonly used in the manufacture of methamphetamine: (i) lithium or sodium metal or red phosphorus, iodine, or iodine crystals; (ii) lye, sulfuric acid, hydrochloric acid, or muriatic acid; (iii) an organic solvent, including ethyl ether, alcohol, or acetone; (iv) a petroleum distillate, including naphtha, paint thinner, or charcoal lighter fluid; or (v) aquarium, rock, or table salt; or (C) at least three of the following items: (i) an item of equipment subject to regulation under Section 481.080, if the person is not registered under Section 481.063; or (ii) glassware, a plastic or metal container, tubing, a hose, or another item specially designed, assembled, or adapted for use in the manufacture, processing, analyzing, storing, or concealing of methamphetamine. SECTION 1.02. Section 481.136(a), Health and Safety Code, is amended to read as follows: (a) A person commits an offense if the person sells, transfers, furnishes, or receives a chemical precursor subject to Section 481.077(a) and the person: (1) does not hold a chemical precursor transfer permit as required by Section 481.078 at the time of the transaction; (2) does not comply with Section 481.077 or 481.0771; (3) knowingly makes a false statement in a report or record required by Section 481.077, 481.0771, or 481.078; or (4) knowingly violates a rule adopted under Section 481.077, 481.0771, or 481.078. SECTION 1.03. Section 99.003, Civil Practice and Remedies Code, is amended to read as follows: Sec. 99.003. STRICT LIABILITY AND MINIMUM DAMAGES FOR EXPOSURE. A person who manufactures methamphetamine is strictly liable for any exposure by an individual to the manufacturing process, including exposure to the methamphetamine itself or any of the by-products or waste products incident to the manufacture, for the greater of: (1) actual damages for personal injury, death, or property damage as a result of the exposure; or (2) $20,000 [$10,000] for each incident of exposure. SECTION 1.04. Section 262.104, Family Code, is amended to read as follows: Sec. 262.104. TAKING POSSESSION OF A CHILD IN EMERGENCY WITHOUT A COURT ORDER. (a) If there is no time to obtain a temporary restraining order or attachment before taking possession of a child consistent with the health and safety of that child, an authorized representative of the Department of Family and Protective [and Regulatory] Services, a law enforcement officer, or a juvenile probation officer may take possession of a child without a court order under the following conditions, only: (1) on personal knowledge of facts that would lead a person of ordinary prudence and caution to believe that there is an immediate danger to the physical health or safety of the child; (2) on information furnished by another that has been corroborated by personal knowledge of facts and all of which taken together would lead a person of ordinary prudence and caution to believe that there is an immediate danger to the physical health or safety of the child; (3) on personal knowledge of facts that would lead a person of ordinary prudence and caution to believe that the child has been the victim of sexual abuse; (4) on information furnished by another that has been corroborated by personal knowledge of facts and all of which taken together would lead a person of ordinary prudence and caution to believe that the child has been the victim of sexual abuse; or (5) on information furnished by another that has been corroborated by personal knowledge of facts and all of which taken together would lead a person of ordinary prudence and caution to believe that the parent or person who has possession of the child is currently using a controlled substance as defined by Chapter 481, Health and Safety Code, and the use constitutes an immediate danger to the physical health or safety of the child. (b) An authorized representative of the Department of Family and Protective Services, a law enforcement officer, or a juvenile probation officer may take possession of a child under Subsection (a) on personal knowledge or information furnished by another, that has been corroborated by personal knowledge, that would lead a person of ordinary prudence and caution to believe that the parent or person who has possession of the child has permitted the child to remain on premises used for the manufacture of methamphetamine. SECTION 1.05. Section 22.041, Penal Code, is amended by adding Subsection (c-1) to read as follows: (c-1) For purposes of Subsection (c), it is presumed that a person engaged in conduct that places a child in imminent danger of death, bodily injury, or physical or mental impairment if the person manufactured the controlled substance methamphetamine in the presence of the child. SECTION 1.06. Sections 481.124 and 481.136, Health and Safety Code, as amended by this Act, and Section 22.041(c-1), Penal Code, as added by this Act, apply only to an offense committed on or after September 1, 2005. An offense committed before September 1, 2005, is covered by the law in effect when the offense was committed, and the former law is continued in effect for that purpose. For purposes of this section, an offense was committed before September 1, 2005, if any element of the offense was committed before that date. SECTION 1.07. Section 99.003, Civil Practice and Remedies Code, as amended by this Act, applies only to a cause of action that accrues on or after September 1, 2005. An action that accrued before September 1, 2005, is governed by the law applicable to the action immediately before September 1, 2005, and that law is continued in effect for that purpose.
ARTICLE 2. DISTRIBUTION AND RETAIL SALES OF
PSEUDOEPHEDRINE
SECTION 2.01. Section 481.077(l), Health and Safety Code, is amended to read as follows: (l) This section does not apply to the sale or transfer of any compound, mixture, or preparation containing [a nonnarcotic product that: [(1) includes: [(A)] ephedrine,[; [(B)] pseudoephedrine, or[; [(C)] norpseudoephedrine that is in liquid, liquid capsule, or gel capsule form and that contains at least one active ingredient other than ephedrine, pseudoephedrine, or norpseudoephedrine[; or [(D) phenylpropanolamine; and [(2) is sold with a prescription or over the counter in accordance with a federal statute or rule]. SECTION 2.02. Subchapter C, Chapter 481, Health and Safety Code, is amended by adding Section 481.0771 to read as follows: Sec. 481.0771. RECORDS AND REPORTS ON PSEUDOEPHEDRINE. (a) A wholesaler who sells, transfers, or otherwise furnishes pseudoephedrine to a retailer shall make available to the director all records of the transaction in accordance with department rule. (b) Not later than five business days after receipt of an order for pseudoephedrine, a wholesaler shall submit to the director in accordance with department rule a report of the order if the order requests delivery of a suspicious quantity of pseudoephedrine as determined by department rule. (c) A wholesaler who, with reckless disregard for the duty to report under Subsection (b), fails to report as required by that subsection may be subject to disciplinary action in accordance with department rule. SECTION 2.03. Subtitle C, Title 6, Health and Safety Code, is amended by adding Chapter 486 to read as follows:
CHAPTER 486. PSEUDOEPHEDRINE
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 486.001. DEFINITIONS. (a) In this chapter: (1) "Commissioner" means the commissioner of state health services. (2) "Council" means the State Health Services Council. (3) "Department" means the Department of State Health Services. (4) "Pseudoephedrine" means any compound, mixture, or preparation containing any detectable amount of pseudoephedrine, including its salts, optical isomers, and salts of optical isomers. The term does not include any compounds, mixtures, or preparations that are in liquid, liquid capsule, or gel capsule form and in which pseudoephedrine is not the only active ingredient. (5) "Sale" includes a conveyance, exchange, barter, or trade. (b) A term that is used in this chapter but is not defined by Subsection (a) has the meaning assigned by Section 481.002. Sec. 486.002. APPLICABILITY. This chapter does not apply to the sale of any product dispensed or delivered by a pharmacist according to a prescription issued by a practitioner for a valid medical purpose and in the course of professional practice. Sec. 486.003. RULES. The council shall adopt rules necessary to implement and enforce this chapter. Sec. 486.004. FEES. (a) The department shall collect fees for: (1) the issuance of a certificate of authority under this chapter; and (2) an inspection performed in enforcing this chapter and rules adopted under this chapter. (b) The commissioner by rule shall set the fees in amounts that allow the department to recover the biennial expenditures of state funds by the department in: (1) reviewing applications for the issuance of a certificate of authority under this chapter; (2) issuing certificates of authority under this chapter; (3) inspecting and auditing a business establishment that is issued a certificate of authority under this chapter; and (4) otherwise implementing and enforcing this chapter. (c) Fees collected under this section shall be deposited to the credit of a special account in the general revenue fund and appropriated to the department to implement and enforce this chapter. Sec. 486.005. STATEWIDE APPLICATION AND UNIFORMITY. (a) To ensure uniform and equitable implementation and enforcement throughout this state, this chapter constitutes the whole field of regulation regarding over-the-counter sales of products that contain pseudoephedrine. (b) This chapter preempts and supersedes a local ordinance, rule, or regulation adopted by a political subdivision of this state pertaining to over-the-counter sales of products that contain pseudoephedrine. (c) This section does not preclude a political subdivision from imposing administrative sanctions on the holder of a business or professional license or permit issued by the political subdivision who engages in conduct that violates this chapter.
[Sections 486.006-486.010 reserved for expansion]
SUBCHAPTER B. OVER-THE-COUNTER SALES OF PSEUDOEPHEDRINE
Sec. 486.011. SALES BY PHARMACIES. A business establishment that operates a pharmacy licensed by the Texas State Board of Pharmacy may engage in over-the-counter sales of pseudoephedrine. Sec. 486.012. SALES BY ESTABLISHMENTS OTHER THAN PHARMACIES; CERTIFICATE OF AUTHORITY. (a) A business establishment that does not operate a pharmacy licensed by the Texas State Board of Pharmacy may engage in over-the-counter sales of pseudoephedrine only if the establishment holds a certificate of authority issued under this section. (b) The department may issue a certificate of authority to engage in over-the-counter sales of pseudoephedrine to a business establishment that does not operate a pharmacy licensed by the Texas State Board of Pharmacy if the establishment: (1) applies to the department for the certificate in accordance with department rule; and (2) complies with the requirements established by the department for issuance of a certificate. (c) The department by rule shall establish requirements for the issuance of a certificate of authority under this section. The rules must include a consideration by the department of whether the establishment: (1) complies with the requirements of the Texas State Board of Pharmacy for the issuance of a license to operate a pharmacy; (2) sells a wide variety of pharmaceutical products; and (3) employs sales techniques and other measures designed to deter the theft of products containing pseudoephedrine and other items used in the manufacture of methamphetamine. (d) The department may inspect or audit a business establishment that is issued a certificate of authority under this section at any time the department determines necessary. Sec. 486.013. RESTRICTION OF ACCESS TO PSEUDOEPHEDRINE. A business establishment that engages in over-the-counter sales of pseudoephedrine shall display the pseudoephedrine in a manner that makes the pseudoephedrine accessible to a patron of the business establishment only with the assistance of an employee of the establishment. Sec. 486.014. PREREQUISITES TO SALE OF PSEUDOEPHEDRINE. Before completing an over-the-counter sale of pseudoephedrine, a business establishment that engages in those sales shall: (1) require the person purchasing pseudoephedrine to: (A) display a driver's license or other form of identification containing the person's photograph and indicating that the person is 16 years of age or older; and (B) sign for the purchase; (2) make a record of the sale, including the name of the person purchasing pseudoephedrine, the date of purchase, and the number of grams of pseudoephedrine purchased; and (3) take actions necessary to prevent a person who makes over-the-counter purchases of one or more products containing pseudoephedrine from obtaining from the establishment in a single transaction more than: (A) two packages of a product containing pseudoephedrine; or (B) six grams of pseudoephedrine. Sec. 486.015. MAINTENANCE OF RECORDS. A business establishment that engages in over-the-counter sales of pseudoephedrine shall maintain all records made under Section 486.014(2) in a secure centralized location. The establishment shall maintain each record until at least the second anniversary of the date the record is made.
[Sections 486.016-486.020 reserved for expansion]
SUBCHAPTER C. ADMINISTRATIVE PENALTY
Sec. 486.021. IMPOSITION OF PENALTY. The department may impose an administrative penalty on a person who violates this chapter. Sec. 486.022. AMOUNT OF PENALTY. (a) The amount of the penalty may not exceed $1,000 for each violation, and each day a violation continues or occurs is a separate violation for purposes of imposing a penalty. The total amount of the penalty assessed for a violation continuing or occurring on separate days under this subsection may not exceed $10,000. (b) The amount shall be based on: (1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation; (2) the threat to health or safety caused by the violation; (3) the history of previous violations; (4) the amount necessary to deter a future violation; (5) whether the violator demonstrated good faith, including when applicable whether the violator made good faith efforts to correct the violation; and (6) any other matter that justice may require. Sec. 486.023. REPORT AND NOTICE OF VIOLATION AND PENALTY. (a) If the department initially determines that a violation occurred, the department shall give written notice of the report by certified mail to the person. (b) The notice must: (1) include a brief summary of the alleged violation; (2) state the amount of the recommended penalty; and (3) inform the person of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both. Sec. 486.024. PENALTY TO BE PAID OR HEARING REQUESTED. (a) Before the 21st day after the date the person receives notice under Section 486.023, the person in writing may: (1) accept the determination and recommended penalty; or (2) make a request for a hearing on the occurrence of the violation, the amount of the penalty, or both. (b) If the person accepts the determination and recommended penalty or if the person fails to respond to the notice, the commissioner by order shall approve the determination. Sec. 486.025. HEARING. (a) If the person requests a hearing, the commissioner shall refer the matter to the State Office of Administrative Hearings, which shall promptly set a hearing date and give written notice of the time and place of the hearing to the person. An administrative law judge of the State Office of Administrative Hearings shall conduct the hearing. (b) The administrative law judge shall make findings of fact and conclusions of law and promptly issue to the commissioner a proposal for a decision about the occurrence of the violation and the amount of a proposed penalty. Sec. 486.026. DECISION. (a) Based on the findings of fact, conclusions of law, and proposal for a decision, the commissioner by order may: (1) find that a violation occurred and impose a penalty; or (2) find that a violation did not occur. (b) The notice of the commissioner's order under Subsection (a) that is sent to the person in the manner provided by Chapter 2001, Government Code, must include a statement of the right of the person to judicial review of the order. Sec. 486.027. OPTIONS FOLLOWING DECISION: PAY OR APPEAL. Before the 31st day after the date the order under Section 486.026 that imposes an administrative penalty becomes final, the person shall: (1) pay the penalty; or (2) file a petition for judicial review of the order contesting the occurrence of the violation, the amount of the penalty, or both. Sec. 486.028. STAY OF ENFORCEMENT OF PENALTY. (a) Within the period prescribed by Section 486.027, a person who files a petition for judicial review may: (1) stay enforcement of the penalty by: (A) paying the penalty to the court for placement in an escrow account; or (B) giving the court a supersedeas bond approved by the court that: (i) is for the amount of the penalty; and (ii) is effective until all judicial review of the order is final; or (2) request the court to stay enforcement of the penalty by: (A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and (B) sending a copy of the affidavit to the commissioner by certified mail. (b) Following receipt of a copy of an affidavit under Subsection (a)(2), the commissioner may file with the court, before the sixth day after the date of receipt, a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond. Sec. 486.029. COLLECTION OF PENALTY. (a) If the person does not pay the penalty and the enforcement of the penalty is not stayed, the penalty may be collected. (b) The attorney general may sue to collect the penalty. Sec. 486.030. DECISION BY COURT. (a) If the court sustains the finding that a violation occurred, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty. (b) If the court does not sustain the finding that a violation occurred, the court shall order that a penalty is not owed. Sec. 486.031. REMITTANCE OF PENALTY AND INTEREST. (a) If the person paid the penalty and if the amount of the penalty is reduced or the penalty is not upheld by the court, the court shall order, when the court's judgment becomes final, that the appropriate amount plus accrued interest be remitted to the person before the 31st day after the date that the judgment of the court becomes final. (b) The interest accrues at the rate charged on loans to depository institutions by the New York Federal Reserve Bank. (c) The interest shall be paid for the period beginning on the date the penalty is paid and ending on the date the penalty is remitted. Sec. 486.032. RELEASE OF BOND. (a) If the person gave a supersedeas bond and the penalty is not upheld by the court, the court shall order, when the court's judgment becomes final, the release of the bond. (b) If the person gave a supersedeas bond and the amount of the penalty is reduced, the court shall order the release of the bond after the person pays the reduced amount. Sec. 486.033. ADMINISTRATIVE PROCEDURE. A proceeding to impose the penalty is considered to be a contested case under Chapter 2001, Government Code. SECTION 2.04. The director of the Department of Public Safety shall adopt any rules necessary to administer and enforce Section 481.0771, Health and Safety Code, as added by this Act, not later than September 1, 2006. SECTION 2.05. The State Health Services Council shall adopt rules to implement and enforce Chapter 486, Health and Safety Code, as added by this Act, not later than September 1, 2006.
ARTICLE 3. REGULATION OF WHOLESALE NONPRESCRIPTION DRUG DISTRIBUTORS
UNDER THE TEXAS FOOD, DRUG, AND COSMETIC ACT
SECTION 3.01. The heading to Subchapter I, Chapter 431, Health and Safety Code, is amended to read as follows:
SUBCHAPTER I. WHOLESALE [DRUG] DISTRIBUTORS
OF NONPRESCRIPTION DRUGS
SECTION 3.02. Section 431.201, Health and Safety Code, is amended to read as follows: Sec. 431.201. DEFINITIONS. In this subchapter: (1) "Nonprescription drug" means any drug that is not a prescription drug as defined by Section 431.401. (2) "Place of business" means each location at which a drug for wholesale distribution is located. (3) "Wholesale distribution" means distribution to a person other than a consumer or patient, and includes distribution by a manufacturer, repackager [repacker], own label distributor, broker, jobber, warehouse, or wholesaler. [(2) "Place of business" means each location at which a drug for wholesale distribution is located.] SECTION 3.03. Subchapter I, Chapter 431, Health and Safety Code, is amended by adding Section 431.2011 to read as follows: Sec. 431.2011. APPLICABILITY OF SUBCHAPTER. This subchapter applies only to the wholesale distribution of nonprescription drugs. SECTION 3.04. Section 431.202, Health and Safety Code, is amended to read as follows: Sec. 431.202. LICENSE [STATEMENT] REQUIRED. (a) A person may not engage in wholesale distribution of nonprescription drugs in this state unless the person holds a wholesale drug distribution license issued by the department under this subchapter or Subchapter N [has filed with the commissioner a signed and verified license statement on a form furnished by the commissioner]. (b) An applicant for a license under this subchapter must submit an application to the department on the form prescribed by the department or electronically on the TexasOnline Internet website [The license statement must be filed annually]. (c) A license issued under this subchapter expires on the second anniversary of the date of issuance. SECTION 3.05. Section 431.204, Health and Safety Code, is amended to read as follows: Sec. 431.204. FEES. (a) The department [board] shall collect fees for: (1) a license that is filed or renewed; (2) a license that is amended, including a notification of a change in the location of a licensed place of business required under Section 431.206; and (3) an inspection performed in enforcing this subchapter and rules adopted under this subchapter. (b) The executive commissioner of the Health and Human Services Commission [board may charge annual fees. [(c) The board] by rule shall set the fees in amounts that allow the department to recover [at least 50 percent of] the biennial [annual] expenditures of state funds by the department in: (1) reviewing and acting on a license; (2) amending and renewing a license; (3) inspecting a licensed facility; and (4) implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter. (c) [(d)] Fees collected under this section shall be deposited to the credit of the food and drug registration fee account of the general revenue fund and [may be] appropriated to the department [only] to carry out the administration and enforcement of this chapter. SECTION 3.06. Sections 431.206 and 431.207, Health and Safety Code, are amended to read as follows: Sec. 431.206. CHANGE OF LOCATION OF PLACE OF BUSINESS. (a) Not fewer than 30 days in advance of the change, the licensee shall notify the department [commissioner or the commissioner's designee] in writing of the licensee's intent to change the location of a licensed place of business. (b) The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location. (c) Not more than 10 days after the completion of the change of location, the licensee shall notify the department [commissioner or the commissioner's designee] in writing to confirm the completion of [verify] the change of location and provide verification of the information previously provided or correct and confirm any information that has changed since providing the notice of intent[, the address of the new location, and the name and residence address of the individual in charge of the business at the new address]. (d) The notice and confirmation required by this section are [Notice will be] deemed adequate if the licensee sends [provides] the [intent and verification] notices [to the commissioner or the commissioner's designee] by certified mail, return receipt requested, [mailed] to the central office of the department or submits them electronically through the TexasOnline Internet website. Sec. 431.207. REFUSAL TO LICENSE; SUSPENSION OR REVOCATION OF LICENSE. (a) The commissioner of state health services may refuse an application for a license or may suspend or revoke a license if the applicant or licensee: (1) has been convicted of a felony or misdemeanor that involves moral turpitude; (2) is an association, partnership, or corporation and the managing officer has been convicted of a felony or misdemeanor that involves moral turpitude; (3) has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs; (4) is an association, partnership, or corporation and the managing officer has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs; [or] (5) has not complied with this chapter or the [board's] rules implementing this chapter; (6) has violated Section 431.021(l)(3), relating to the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug; (7) has violated Chapter 481 (Texas Controlled Substances Act) or 483 (Texas Dangerous Drug Act); (8) has violated the rules of the director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or licensee to maintain; or (9) fails to complete a license application or submits an application that contains false, misleading, or incorrect information or contains information that cannot be verified by the department. (b) The executive commissioner of the Health and Human Services Commission by rule shall establish minimum standards required for the issuance or renewal of a license under this subchapter [may refuse an application for a license or may suspend or revoke a license if the commissioner determines from evidence presented during a hearing that the applicant or licensee: [(1) has violated Section 431.021(l)(3), relating to the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug; [(2) has violated Chapter 481 (Texas Controlled Substances Act) or 483 (Dangerous Drugs); or [(3) has violated the rules of the director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or licensee to maintain]. (c) The refusal to license an applicant or the suspension or revocation of a license by the department [commissioner] and the appeal from that action are governed by [the board's formal hearing procedures and] the procedures for a contested case hearing under Chapter 2001, Government Code. SECTION 3.07. Section 431.021, Health and Safety Code, is amended to read as follows: 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 [filing a licensing statement with the commissioner as required by Section 431.202 or having a license as required by Section 431.272], 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; [or] (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 [the board, the commissioner, or 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; or (cc) performing, causing the performance of, or aiding and abetting the performance of an act described by Subdivision (x). SECTION 3.08. Sections 431.2021 and 431.205, Health and Safety Code, are repealed. SECTION 3.09. Not later than January 1, 2006, the executive commissioner of the Health and Human Services Commission shall adopt the rules necessary to implement the changes in law made by this article by amending Subchapter I, Chapter 431, Health and Safety Code. SECTION 3.10. Not later than January 1, 2006, the Department of State Health Services shall prescribe the forms required to implement the changes in law made by this article by the amendment of Subchapter I, Chapter 431, Health and Safety Code. SECTION 3.11. The change in law made by this article applies only to an offense committed on or after March 1, 2006. An offense committed before that date is covered by the law in effect when the offense was committed, and the former law is continued in effect for that purpose. For purposes of this section, an offense was committed before March 1, 2006, if any element of the offense was committed before that date. SECTION 3.12. (a) Subject to Subsection (b) of this section, this article takes effect on the date designated by Section 4.01 of this Act, except that Sections 3.01-3.07 of this article take effect March 1, 2006. (b) This article takes effect only if Senate Bill 1685 or another similar bill of the Regular Session of the 79th Legislature adding Subchapter N, Chapter 431, Health and Safety Code, regulating wholesale prescription drug distributors is enacted and becomes law. If Senate Bill 1685 or another similar bill of the Regular Session of the 79th Legislature adding Subchapter N, Chapter 431, Health and Safety Code, regulating wholesale prescription drug distributors does not become law, this article does not take effect.
ARTICLE 4. EFFECTIVE DATE
SECTION 4.01. This Act takes effect September 1, 2005.