reglab/statecodes huggingface dataset:
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.246. Removal of Adulterated Item From Stores

Sec. 431.246.  REMOVAL OF ADULTERATED ITEM FROM STORES.  The executive commissioner shall adopt rules that provide a system for removing adulterated items from the shelves of a grocery store or other retail establishment selling those items.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0994, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.247. Delegation of Powers or Duties

Sec. 431.247.  DELEGATION OF POWERS OR DUTIES.  (a)  Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.
(b)  A health authority may, unless otherwise restricted by law, delegate a power or duty imposed on the health authority by this chapter to an employee of the local health department, the local health unit, or the public health district in which the health authority serves.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(75), eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.248. Memorandum of Understanding With Department of Agriculture

Sec. 431.248.  MEMORANDUM OF UNDERSTANDING WITH DEPARTMENT OF AGRICULTURE.  (a)  The department and the Department of Agriculture shall execute a memorandum of understanding that:
(1)  requires each agency to disclose to the other agency any positive results of testing conducted by the agency for pesticides in food;  and
(2)  specifies how each agency will assist the other in performing its duties regarding pesticides in food.
(b)  The executive commissioner and the Department of Agriculture shall adopt the memorandum of understanding as a rule.
(c)  The department and the Department of Agriculture shall request the federal Food and Drug Administration to join in execution of the memorandum of understanding.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0995, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.249. Dissemination of Information

Sec. 431.249.  DISSEMINATION OF INFORMATION.  (a)  The department may publish reports summarizing the judgments, decrees, and court orders rendered under this chapter, including the nature and disposition of the charge.
(b)  The department may disseminate information regarding a food, drug, device, or cosmetic in a situation that the department determines to involve imminent danger to health or gross deception of consumers.
(c)  This section does not prohibit the department from collecting, reporting, and illustrating the results of an investigation by the department.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0996, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter K. General Administrative Provisions and Rulemaking Authority › Section 431.250. Public Comments for Federal Grants and Contracts

Sec. 431.250.  PUBLIC COMMENTS FOR FEDERAL GRANTS AND CONTRACTS.  (a)  The department shall annually solicit comments from interested persons regarding the grants and contracts the department has requested from or entered into with the United States Food and Drug Administration for implementing the federal Act and its amendments, including the Food Safety Modernization Act (21 U.S.C. Section 2201 et seq.).
(b)  The department shall solicit comments by posting on the department's Internet website a detailed description of and providing notice to interested persons of each grant and contract described by Subsection (a) requested or entered into during the previous year.  The description and notice must include the benefits to this state, the department, the regulated community, and the public.
(c)  The department shall respond to questions and comments about a grant or contract described by Subsection (a) to the best of the department's knowledge.  If an interested person requests that the department decline to receive future federal funding from the grant or contract, the department shall consider the request and determine whether the benefits of the grant or contract outweigh the person's concerns.
Added by Acts 2015, 84th Leg., R.S., Ch. 749 (H.B. 1846), Sec. 1, eff. September 1, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter L. Device Distributors and Manufacturers › Section 431.271. Definitions

Sec. 431.271.  DEFINITIONS.  In this subchapter:
(1)  "Distributor" means a person who furthers the marketing of a finished domestic or imported device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.  The term includes an importer or an own-label distributor.  The term does not include a person who repackages a finished device or who otherwise changes the container, wrapper, or labelling of the finished device or the finished device package.
(2)  "Finished device" means a device, or any accessory to a device, that is suitable for use, without regard to whether it is packaged or labelled for commercial distribution.
(3)  "Importer" means any person who initially distributes a device imported into the United States.
(4)  "Manufacturer" means a person who manufactures, fabricates, assembles, or processes a finished device.  The term includes a person who repackages or relabels a finished device.  The term does not include a person who only distributes a finished device.
(5)  "Place of business" means each location at which a finished device is manufactured or held for distribution.
Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.  Amended by Acts 1995, 74th Leg., ch. 1047, Sec. 2, eff. Sept. 1, 1995.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter L. Device Distributors and Manufacturers › Section 431.272. License Required; Minimum Standards

Sec. 431.272.  LICENSE REQUIRED;  MINIMUM STANDARDS.  (a)  Except as provided by Section 431.273, a person may not operate as a distributor or manufacturer of devices in this state unless the person has a license from the department for each place of business.
(b)  A distributor or manufacturer of devices in this state must comply with the minimum requirements specified in the federal Act and in this chapter.
Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.  Amended by Acts 1995, 74th Leg., ch. 1047, Sec. 2, eff. Sept. 1, 1995.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0997, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter L. Device Distributors and Manufacturers › Section 431.273. Exemption From Licensing

Sec. 431.273.  EXEMPTION FROM LICENSING.  (a)  A person is exempt from licensing under this subchapter if the person engages only in the following types of device distribution:
(1)  intracompany sales;
(2)  distribution from a place of business located outside of this state;  or
(3)  the sale, purchase, or trade of a distressed or reconditioned device by a salvage broker or a salvage operator licensed under Chapter 432 (Texas Food, Drug, Device, and Cosmetic Salvage Act).
(a-1)  A person is exempt from licensing under this subchapter if the person holds a registration certificate issued under Chapter 266, Occupations Code, and engages only in conduct within the scope of that registration.
(b)  An exemption from the licensing requirements under this section does not constitute an exemption from the other provisions of this chapter or the rules adopted by the executive commissioner to administer and enforce this chapter.
Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.  Amended by Acts 1995, 74th Leg., ch. 1047, Sec. 3, eff. Sept. 1, 1995.
Amended by:
Acts 2013, 83rd Leg., R.S., Ch. 302 (H.B. 1395), Sec. 1, eff. September 1, 2013.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0998, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter L. Device Distributors and Manufacturers › Section 431.274. License Application

Sec. 431.274.  LICENSE APPLICATION.  (a)  A person applying for a license under this subchapter shall provide, at a minimum, the following information on a license application form furnished by the department:
(1)  the name under which the business is conducted;
(2)  the address of each place of business that is licensed;
(3)  the name and residence address of:
(A)  the proprietor, if the business is a proprietorship;
(B)  all partners, if the business is a partnership; or
(C)  all principals, if the business is an association;
(4)  the date and place of incorporation if the business is a corporation;
(5)  the names and residence addresses of the individuals in an administrative capacity showing:
(A)  the managing proprietor, if the business is a proprietorship;
(B)  the managing partner, if the business is a partnership;
(C)  the officers and directors, if the business is a corporation; or
(D)  the persons in a managerial capacity, if the business is an association; and
(6)  the residence address of an individual in charge of each place of business.
(b)  The license application must be signed, verified, and completed in a manner described in department rules.
(c)  A person applying for a license under this subchapter must pay a licensing fee for each place of business.
Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0999, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter L. Device Distributors and Manufacturers › Section 431.276. Fees

Sec. 431.276.  FEES.  (a)  The department shall collect fees for:
(1)  a license that is filed or renewed;
(2)  a license that is amended, including notification of a change of location of a licensed place of business required under Section 431.278, a change of the name of an association or corporation, or a change in the ownership of the licensee;  and
(3)  an inspection performed to enforce this subchapter and rules adopted under this subchapter.
(b)  The department may charge fees every two years.
(c)  The executive commissioner by rule shall set the fees in amounts that allow the department to recover the biennial expenditures of state funds by the department in:
(1)  reviewing and acting on a license or renewal license;
(2)  amending a license;
(3)  inspecting a licensed facility; and
(4)  implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.
(d)  At least half of the licensing fees collected shall be used to inspect an applicant or licensed place of business.
(e)  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 this chapter.
Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1000, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter L. Device Distributors and Manufacturers › Section 431.278. Change of Location of Place of Business

Sec. 431.278.  CHANGE OF LOCATION OF PLACE OF BUSINESS.  (a)  Not fewer than 30 days in advance of the change, the licensee shall notify the department in writing of the licensee's intent to change the location of a licensed place of business.  The notice shall include the address of the new location and the name and residence address of the individual in charge of the business at the new location.
(b)  Not later than the 10th day after the date of completion of the change of location, the licensee shall notify the department in writing to verify the change of location, the address of the new location, and the name and residence address of the individual in charge of the business at the new address.
(c)  Notice is adequate if the licensee provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the central office of the department.
Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1001, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter L. Device Distributors and Manufacturers › Section 431.279. Refusal to License; Suspension or Revocation of License

Sec. 431.279.  REFUSAL TO LICENSE; SUSPENSION OR REVOCATION OF LICENSE.  (a)  The department may refuse an application or may suspend or revoke a license if the applicant or licensee:
(1)  has been convicted of a 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 rules implementing this chapter.
(b)  The department may refuse an application for a license or may suspend or revoke a license if the department 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 public safety director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or licensee to maintain.
(c)  The refusal to license an applicant or the suspension or revocation of a license by the department and the appeal from that action are governed by the department's formal hearing procedures and the procedures for a contested case hearing under Chapter 2001, Government Code.
Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.  Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1002, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter M. Drug Donation Program › Section 431.321. Definitions

Sec. 431.321.  DEFINITIONS.  (a)  "Charitable medical clinic" means a clinic, including a licensed pharmacy that is a community pharmaceutical access program provider, that provides medical care or drugs without charge or for a substantially reduced charge, complies with the insurance requirements of Chapter 84, Civil Practice and Remedies Code, and is exempt from federal income tax under Section 501(a) of the Internal Revenue Code of 1986 by being listed as an exempt organization in Section 501(c)(3) or 501(c)(4) of the code and is operated exclusively for the promotion of social welfare by being primarily engaged in promoting the common good and general welfare of the people in a community.
(b)  "Seller" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.
(c)  "Manufacturer" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.
(d)  "Charitable drug donor" means a licensed convalescent or nursing home or related institution, licensed hospice, hospital, physician, pharmacy, or a pharmaceutical seller or manufacturer that donates drugs pursuant to a qualified patient assistance program, that donates drugs to a charitable medical clinic.
(d-1)  In this subchapter, "community pharmaceutical access program" means a program offered by a licensed pharmacy under which the pharmacy assists financially disadvantaged persons to access prescription drugs at no charge or at a substantially reduced charge.
(e)  In this subchapter, "patient assistance program" means a qualified program offered by a pharmaceutical manufacturer under which the manufacturer provides drugs to financially disadvantaged persons at no charge or at a substantially reduced cost.  The term does not include the provision of a drug as part of a clinical trial.
Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 820 (S.B. 1896), Sec. 2, eff. June 15, 2007.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter M. Drug Donation Program › Section 431.322. Donation of Unused Drugs to Charitable Medical Clinic

Sec. 431.322.  DONATION OF UNUSED DRUGS TO CHARITABLE MEDICAL CLINIC.  (a)  A charitable drug donor may donate certain unused prescription drugs to a charitable medical clinic, and a charitable clinic may accept, dispense, or administer the donated drugs in accordance with this subchapter.
(b)  A seller or manufacturer of a drug may not donate drugs to a charitable medical clinic except pursuant to a qualified patient assistance program.  A seller or manufacturer of a drug that donates drugs through a qualified patient assistance program shall be considered a charitable drug donor.
(c)  The charitable drug donor shall use appropriate safeguards established by department rule to ensure that the drugs are not compromised or illegally diverted while being stored or transported to the charitable medical clinic.
(d)  The charitable medical clinic may not accept the donated drugs unless:
(1)  the charitable drug donor certifies that the drugs have been properly stored while in the possession of the donor or of the person for whom the drugs were originally dispensed;
(2)  the charitable drug donor provides the clinic with a verifiable address and telephone number;  and
(3)  the person transferring possession of the drugs presents the charitable medical clinic with photographic identification.
Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1003, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter M. Drug Donation Program › Section 431.323. Circumstances Under Which Donated Drugs May Be Accepted and Dispensed

Sec. 431.323.  CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY BE ACCEPTED AND DISPENSED.  (a)  A charitable medical clinic may accept and dispense or administer donated drugs only in accordance with this subchapter.
(b)  The donated drugs must be drugs that require a prescription.  A donated drug may not be a controlled substance under Chapter 481.
(c)  The donated drugs must be approved by the federal Food and Drug Administration and:
(1)  be sealed in the manufacturer's unopened original tamper-evident packaging and either:
(A)  individually packaged;  or
(B)  packaged in unit-dose packaging;
(2)  be oral or parenteral medication in sealed single-dose containers approved by the federal Food and Drug Administration;
(3)  be topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration;  or
(4)  be parenteral medication in sealed multiple-dose containers approved by the federal Food and Drug Administration from which no doses have been withdrawn;  and
(5)  must not be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer.
(d)  The charitable medical clinic may dispense or administer the donated drugs only:
(1)  before the expiration date or within the recommended shelf life of the donated drugs, as applicable;  and
(2)  after a licensed pharmacist has determined that the drugs are of an acceptable integrity.
(e)  The donated drugs may be accepted and dispensed or administered by the charitable medical clinic only in accordance with department rules.
Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1004, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter M. Drug Donation Program › Section 431.324. Rules

Sec. 431.324.  RULES.  The executive commissioner shall adopt rules to implement this subchapter that are designed to protect the public health and safety.
Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1005, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter M. Drug Donation Program › Section 431.325. Limitation on Liability

Sec. 431.325.  LIMITATION ON LIABILITY.  (a)  Charitable drug donors, charitable medical clinics, and their employees are not liable for harm caused by the accepting, dispensing, or administering of drugs donated in strict compliance with this subchapter unless the harm is caused by:
(i)  willful or wanton acts of negligence;
(ii)  conscious indifference or reckless disregard for the safety of others;  or
(iii)  intentional conduct.
(b)  This section does not limit, or in any way affect or diminish, the liability of a drug seller or manufacturer pursuant to Chapter 82, Civil Practice and Remedies Code.
(c)  This section shall not apply where harm results from the failure to fully and completely comply with the requirements of this subchapter.
(d)  This section shall not apply to a charitable medical clinic that fails to comply with the insurance provisions of Chapter 84, Civil Practice and Remedies Code.
Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.4011. Ongoing Relationship

Sec. 431.4011.  ONGOING RELATIONSHIP.  In this subchapter, "ongoing relationship" means an association that exists when a manufacturer and distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's products for a period of time or for a number of shipments.  If the distributor is not authorized to distribute the manufacturer's entire product line, the agreement must identify the specific drug products that the distributor is authorized to distribute.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.4012. Applicability of Subchapter

Sec. 431.4012.  APPLICABILITY OF SUBCHAPTER.  This subchapter applies only to the wholesale distribution of prescription drugs.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.402. License Required

Sec. 431.402.  LICENSE REQUIRED.  (a)  A person may not engage in wholesale distribution of prescription drugs in this state unless the person holds a wholesale drug distribution license under this subchapter for each place of business.
(b)  A license issued under this subchapter expires on the second anniversary of the date of issuance.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.403. Exemption From Licensing

Sec. 431.403.  EXEMPTION FROM LICENSING.  (a)  A person who engages in wholesale distribution of prescription drugs in this state for use in humans is exempt from this subchapter if the person is exempt under:
(1)  the Prescription Drug Marketing Act of 1987 (21 U.S.C. Section 353(c)(3)(B));
(2)  the regulations adopted by the secretary to administer and enforce that Act; or
(3)  the interpretations of that Act set out in the compliance policy manual of the United States Food and Drug Administration.
(b)  An exemption from the licensing requirements under this section does not constitute an exemption from the other provisions of this chapter or the rules adopted under this chapter to administer and enforce the other provisions of this chapter.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.4031. Exemption From Certain Provisions for Certain Wholesale Distributors

Sec. 431.4031.  EXEMPTION FROM CERTAIN PROVISIONS FOR CERTAIN WHOLESALE DISTRIBUTORS.  (a)  A wholesale distributor that distributes prescription drugs that are medical gases or a wholesale distributor that is a manufacturer or a third-party logistics provider on behalf of a manufacturer is exempt from Sections 431.404(a)(5) and (6), (b), and (c), 431.4045(2), 431.405, and 431.407.
(b)  A state agency or a political subdivision of this state that distributes prescription drugs using federal or state funding to nonprofit health care facilities, local mental health authorities, or local intellectual and developmental disability authorities for distribution to a pharmacy, practitioner, or patient is exempt from Sections 431.405(b), 431.407, 431.412, and 431.413.
(c)  The executive commissioner by rule may exempt specific purchases of prescription drugs by state agencies and political subdivisions of this state if the executive commissioner determines that the requirements of this subchapter would result in a substantial cost to the state or a political subdivision of the state.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 4, eff. September 1, 2007.
Acts 2009, 81st Leg., R.S., Ch. 1384 (S.B. 1645), Sec. 4, eff. June 19, 2009.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1006, eff. April 2, 2015.
Acts 2021, 87th Leg., R.S., Ch. 865 (S.B. 970), Sec. 9, eff. September 1, 2021.
Acts 2023, 88th Leg., R.S., Ch. 30 (H.B. 446), Sec. 6.04, eff. September 1, 2023.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.4045. Inspection Required

Sec. 431.4045.  INSPECTION REQUIRED.  The department may not issue a wholesale distributor license to an applicant under this subchapter unless the department:
(1)  conducts a physical inspection of the place of business at the address provided by the applicant under Section 431.404 or determines that an inspection is unnecessary after thoroughly evaluating the information in the application, the compliance history of the applicant and the applicant's principals, and the risk of counterfeiting in the applicant's product; and
(2)  determines that the designated representative of the place of business meets the qualifications required by Section 431.405.
Added by Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 6, eff. September 1, 2007.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.405. Qualifications for License

Sec. 431.405.  QUALIFICATIONS FOR LICENSE.  (a)  The department may not issue a wholesale distributor license to an applicant without considering the minimum federal information and related qualification requirements published in federal regulations at 21 C.F.R. Part 205, including:
(1)  factors in reviewing the qualifications of persons who engage in wholesale distribution, 21 C.F.R. Section 205.6;
(2)  appropriate education and experience for personnel employed in wholesale distribution, 21 C.F.R. Section 205.7; and
(3)  the storage and handling of prescription drugs and  the establishment and maintenance of prescription drug distribution records, 21 C.F.R. Section 205.50.
(b)  In addition to meeting the minimum federal requirements as provided by Subsection (a), to qualify for the issuance or renewal of a wholesale distributor license under this subchapter, the designated representative of an applicant or license holder must:
(1)  be at least 21 years of age;
(2)  have been employed full-time for at least three years by a pharmacy or a wholesale distributor in a capacity related to the dispensing or distributing of prescription drugs, including recordkeeping for the dispensing or distributing of prescription drugs;
(3)  be employed by the applicant full-time in a managerial-level position;
(4)  be actively involved in and aware of the actual daily operation of the wholesale distributor;
(5)  be physically present at the applicant's place of business during regular business hours, except when the absence of the designated representative is authorized, including sick leave and vacation leave;
(6)  serve as a designated representative for only one applicant at any one time, except in a circumstance, as the department determines reasonable, in which more than one licensed wholesale distributor is colocated in the same place of business and the wholesale distributors are members of an affiliated group, as defined by Section 1504, Internal Revenue Code of 1986;
(7)  not have been convicted of a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or the distribution of controlled substances; and
(8)  not have been convicted of a felony under a federal, state, or local law.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 7, eff. September 1, 2007.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.406. Effect of Operation in Other Jurisdictions; Reports

Sec. 431.406.  EFFECT OF OPERATION IN OTHER JURISDICTIONS; REPORTS.  (a)  A person who engages in the wholesale distribution of drugs outside this state may engage in the wholesale distribution of drugs in this state if the person holds a license issued by the department.
(b)  The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with this subchapter and the minimum standards adopted under this subchapter.
(c)  The department may issue a license to a person who engages in the wholesale distribution of drugs outside this state to engage in the wholesale distribution of drugs in this state if, after an examination of the reports of the person's compliance history and current compliance record, the department determines that the person is in compliance with this subchapter and the rules adopted under this subchapter.
(d)  The department shall consider each license application and any related documents or reports filed by or in connection with a person who wishes to engage in wholesale distribution of drugs in this state on an individual basis.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.407. Criminal History Record Information

Sec. 431.407.  CRIMINAL HISTORY RECORD INFORMATION.  The department shall submit to the Department of Public Safety the fingerprints provided by a person with an initial or a renewal license application to obtain the person's criminal history record information and may forward the fingerprints to the Federal Bureau of Investigation for a federal criminal history check.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.409. Fees

Sec. 431.409.  FEES.  (a)  The department shall collect fees for:
(1)  a license that is filed or renewed;
(2)  a license that is amended, including a notification of a change in the location of a licensed place of business required under Section 431.410; and
(3)  an inspection performed in enforcing this subchapter and rules adopted under this subchapter.
(b)  The executive commissioner by rule shall set the fees in amounts that are reasonable and necessary and allow the department to recover the biennial expenditures of state funds by the department in:
(1)  reviewing and acting on a license;
(2)  amending and renewing a license;
(3)  inspecting a licensed facility; and
(4)  implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.
(c)  Fees collected under this section shall be deposited to the credit of the food and drug registration fee account of the general revenue fund and appropriated to the department to carry out this chapter.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1008, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.4095. Renewal Notification; Change or Renewal

Sec. 431.4095.  RENEWAL NOTIFICATION; CHANGE OR RENEWAL.  (a)  Before the expiration of a license issued under this subchapter, the department shall send to each licensed wholesale distributor a form containing a copy of the information the distributor provided to the department under Section 431.404.
(b)  Not later than the 30th day after the date the wholesale distributor receives the form under Subsection (a), the wholesale distributor shall identify and state under oath to the department any change in or correction to the information.
Added by Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 9, eff. September 1, 2007.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.410. Change of Location of Place of Business

Sec. 431.410.  CHANGE OF LOCATION OF PLACE OF BUSINESS.  (a)  Not fewer than 30 days in advance of the change, the license holder shall notify the department in writing of the license holder's intent 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 license holder shall notify the department in writing to confirm the completion of the change of location and provide verification of the information previously provided or correct and confirm any information that has changed since providing the notice of intent.
(d)  The notice and confirmation required by this section are considered adequate if the license holder sends the notices by certified mail, return receipt requested, to the central office of the department or submits the notices electronically through the state electronic Internet portal.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2011, 82nd Leg., R.S., Ch. 973 (H.B. 1504), Sec. 30, eff. June 17, 2011.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.412. Pedigree Required

Sec. 431.412.  PEDIGREE REQUIRED.  (a)  A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but excluding the original manufacturer, shall provide a pedigree for each prescription drug for human consumption that leaves or at any time has left the normal distribution channel and is sold, traded, or transferred to any other person.
(b)  Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.
(b-1)  A retail pharmacy or pharmacy warehouse is required to comply with this section only if the pharmacy or warehouse engages in the wholesale distribution of a prescription drug.
(c)  Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.
(d)  A person who is engaged in the wholesale distribution of a prescription drug, including a repackager, but excluding the original manufacturer of the finished form of a prescription drug, and who is in possession of a pedigree for a prescription drug must verify before distributing the prescription drug that each transaction listed on the pedigree has occurred.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 11, eff. September 1, 2007.
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 14 eff. September 1, 2007.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.413. Pedigree Contents

Sec. 431.413.  PEDIGREE CONTENTS.  (a)  A pedigree must include all necessary identifying information concerning each sale in the product's chain of distribution from the manufacturer, through acquisition and sale by a wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug.  At a minimum, the chain of distribution information must include:
(1)  the name, address, telephone number, and, if available, the e-mail address of each person who owns the prescription drug and each wholesale distributor of the prescription drug;
(2)   the name and address of each location from which the product was shipped, if different from the owner's name and address;
(3)  the transaction dates; and
(4)  certification that each recipient has authenticated the pedigree.
(b)  The pedigree must include, at a minimum, the:
(1)  name of the prescription drug;
(2)  dosage form and strength of the prescription drug;
(3)  size of the container;
(4)  number of containers;
(5)  lot number of the prescription drug; and
(6)  name of the manufacturer of the finished dosage form.
(c)  Each pedigree statement must be:
(1)  maintained by the purchaser and the wholesale distributor for at least three years; and
(2)  available for inspection and photocopying not later than the second business day after the date a request is submitted by the department or a peace officer in this state.
(d)  The executive commissioner shall adopt rules to implement this section.
(e)  Expired.
(e-1)  If, after consulting with manufacturers, distributors, and pharmacies responsible for the sale and distribution of prescription drugs in this state, the department determines that electronic track and trace pedigree technology is universally available across the entire prescription pharmaceutical supply chain, the department shall establish a targeted implementation date for electronic track and trace pedigree technology.  After the department has established a targeted implementation date, the department may revise the date.  The targeted implementation date may not be earlier than July 1, 2010.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 12, eff. September 1, 2007.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1010, eff. April 2, 2015.
2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter N. Wholesale Distributors of Prescription Drugs › Section 431.414. Refusal to License; Suspension or Revocation of License

Sec. 431.414.  REFUSAL TO LICENSE; SUSPENSION OR REVOCATION OF LICENSE.  (a)  The department may refuse an application for a license or may suspend or revoke a license if the applicant or license holder:
(1)  has been convicted of a felony or misdemeanor that involves moral turpitude;
(2)  is an association, partnership, or corporation and the managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;
(3)  has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;
(4)  is an association, partnership, or corporation and the managing officer has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;
(5)  has not complied with this subchapter or the rules implementing this subchapter;
(6)  has violated Section 431.021(l)(3), relating to the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;
(7)  has violated Chapter 481 or 483; or
(8)  has violated the rules of the public safety director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or license holder to maintain.
(a-1)  The department may suspend or revoke a license if the license holder no longer meets the qualifications for obtaining a license under Section 431.405.
(b)  The executive commissioner by rule shall establish minimum standards required for the issuance or renewal of a license under this subchapter.
(c)  The department shall deny a license application that is incomplete, contains false, misleading, or incorrect information, or contains information that cannot be verified by the department.
(d)  The refusal to license an applicant or the suspension or revocation of a license by the department and the appeal from that action are governed by the procedures for a contested case hearing under Chapter 2001, Government Code.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 13, eff. September 1, 2007.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1011, eff. April 2, 2015.