TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 229. FOOD AND DRUG

SUBCHAPTER X. LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS

The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts amendments to §§229.432 - 229.437, and 229.439 - 229.443, concerning Licensing of Device Distributors and Manufacturers, and the repeal of §229.444 concerning Device Distributors and Manufacturers Advisory Committee.

Sections 229.433, 229.440, and 229.443 are adopted with changes to the proposed text as published in the October 3, 2025, issue of the Texas Register (50 TexReg 6451). These rules will be republished.

Sections 229.432, 229.434 - 229.439, 229.441, 229.442, and the repeal of 229.444 are adopted without changes to the proposed text as published in the October 3, 2025, issue of the Texas Register (50 TexReg 6451). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The amendments and repeal are necessary to continue adherence with applicable federal laws pertaining to medical devices. The adopted amendments align the minimum standards in the Texas Administrative Code with new device Good Manufacturing Practice requirements under 21 Code of Federal Regulations Part 820, which take effect on February 2, 2026. The adopted amendments update the licensure fees based on a licensee's gross sales, update definitions to clarify intent, and improve compliance by harmonizing state and federal regulations. The repeal of §229.444 is required because the advisory committee no longer exists. Lastly, the adopted amendments update the rules with plain language requirements to improve readability.

COMMENTS

The 31-day comment period ended November 3, 2025.

During this period, DSHS did not receive any comments regarding the proposed rules.

Minor editorial changes were made to §229.433(8)(c), §229.433(26), §229.443(d)(3)(E)(ii), §229.443(f)(1) to correct statutory references.

Minor editorial changes were made to §229.440(a)(1), §229.440(a)(2), and §229.443(a)(7) to add clarification.

A minor editorial change was made to §229.443(g).

25 TAC §§229.432 - 229.437, 229.439 - 229.443

STATUTORY AUTHORITY

The amendments are adopted under Texas Government Code §524.0151 and Texas Health and Safety Code §1001.075, which authorize the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001 and §431.241.

§229.433. Definitions.

The following words and terms, when used in these sections, have the following meanings, unless the context clearly indicates otherwise.

(1) Act--The Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code (HSC) Chapter 431.

(2) Adulterated Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, HSC §431.111.

(3) Advertising--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.

(4) Authorized agent--An employee of the department who is designated by the commissioner to enforce the provisions of this chapter.

(5) Commissioner--The commissioner of the Department of State Health Services, or the commissioner's successor or designee.

(6) Counterfeit device--A device which, or the container, packaging or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.

(7) Department--The Department of State Health Services.

(8) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:

(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. The term "device" does not include software functions excluded by the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360j.

(9) Distributor--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 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 labeling of the finished device or the finished device package.

(10) Electronic product radiation--Any ionizing or nonionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

(11) Finished device--A device, or any accessory to a device, that is suitable for use, whether or not packaged or labeled for commercial distribution.

(12) Health authority--A physician designated to administer state and local laws relating to public health.

(13) Importer--Any person who initially distributes a device imported into the United States.

(14) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles.

(15) Labeling--All labels and other written, printed, or graphic matter:

(A) upon any article or any of its containers or wrappers; or

(B) accompanying such article.

(16) Manufacture--The making by chemical, physical, biological, or other procedures of any article that meets the definition of device. The term includes the following activities:

(A) repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;

(B) initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications; or

(17) Manufacturer--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.

(18) Misbranded Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, HSC §431.112.

(19) Person--Includes individual, partnership, corporation, and association.

(20) Place of business--Each location at which a device is manufactured or held for distribution.

(21) Practitioner--As defined in HSC §483.001(12).

(22) Prescription device--A restricted device that, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which adequate directions for use cannot be prepared.

(23) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

(24) Radioactive material--Any material (solid, liquid, or gas) that emits radiation spontaneously.

(25) Reconditioning--Any appropriate process or procedure by which distressed merchandise can be brought into compliance with departmental standards as specified in the Texas Food, Drug, Device, and Cosmetic Salvage Act, HSC §432.003, as defined in the rules in §229.603 of this chapter (relating to Definitions).

(26) Restricted device--A device subject to certain controls related to sale, distribution, or use as specified in the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360j.

§229.440. Refusal, Cancellation, Suspension, or Revocation of License.

(a) The commissioner may refuse an application or may suspend or revoke a license if the applicant or licensee:

(1) has a conviction of a misdemeanor that involves moral turpitude or a felony;

(2) is an association, partnership, or corporation and the managing officer has a conviction of a misdemeanor that involves moral turpitude or a felony;

(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 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 violated any of the provisions of the Texas Food, Drug, and Cosmetic Act, HSC Chapter 431 (Act) or these sections;

(6) has failed to pay any fees for licensing or renewal;

(7) has failed to pay administrative penalties in full more than 30 days after the decision or order assessing the penalty is final, and has not filed a petition for judicial review of the order assessing the penalty; or

(8) has obtained or attempted to obtain a license by fraud or deception.

(b) The commissioner 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 HSC §431.021(l)(3), concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

(2) has violated HSC Chapter 481 (Texas Controlled Substances Act), or HSC Chapter 483 (Texas Dangerous Drug Act); or

(3) has violated rules established by the director of the Department of Public Safety, including being responsible for a significant discrepancy in records the applicant or licensee is required to maintain under state law.

(c) After providing an opportunity for a hearing, the department may refuse, suspend, or revoke a license for a device distributor or manufacturer if the applicant violates any requirements in these sections or for any reasons described in the Act.

(d) Any hearings for the refusal, revocation, or suspension of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).

(e) A license issued under these sections must be returned to the department if the device distributor's or manufacturer's place of business:

(1) ceases business or otherwise ceases operation on a permanent basis;

(2) relocates; or

(3) changes name or ownership. A corporation transferring 5.0% or more of the share of stock from one person to another is considered to have had an ownership change and must return the license to the department.

§229.443. Enforcement and Penalties.

(a) General enforcement actions. The department may take enforcement action for the following:

(1) failing to comply with Texas Food, Drug, and Cosmetic Act, HSC Chapter 431 (Act) or these sections;

(2) falsifying information provided in an application for a license, or making a false or misleading statement in connection with the initial or renewal application, either in the formal application itself or in any other instrument relating to the application submitted to the department;

(3) refusing to allow the department to conduct an inspection or collect samples;

(4) interfering with the department in the performance of its duties;

(5) removing or disposing a detained device;

(6) misrepresenting any regulated product sold to the public; or

(7) receiving a conviction of a misdemeanor that involves moral turpitude or a felony.

(b) Administrative penalty. If a person, whether licensed or unlicensed by the department, violates these sections or an order adopted or license issued under the Act, the commissioner may assess an administrative penalty against the person.

(1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.

(2) Violations subject to this subsection must be categorized into severity levels as determined in §229.261 of this chapter (relating to Assessment of Administrative Penalties).

(3) An administrative penalty may be assessed only after the person charged with a violation is given an opportunity for a hearing.

(4) If the person charged with the violation does not request a hearing, or defaults, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.

(5) After making a determination under this subsection that a penalty is to be assessed, the commissioner must issue an order requiring that the person pay the penalty.

(6) Not later than the 30th calendar day after the date of issuance of an order finding that a violation has occurred, the commissioner must inform the person against whom the order is issued of the amount of the penalty.

(1) The commissioner or a person designated by the commissioner may issue a mandatory or prohibitory emergency order, without notice, in relation to the manufacture or distribution of a food, drug, device, or cosmetic upon determination that: the manufacture or distribution creates or poses an immediate and serious threat to human life or health, and other procedures available to the department to remedy or prevent the occurrence of the situation will result in unreasonable delay.

(2) If an emergency order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, must propose a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing must be held under departmental formal hearing rules governed by §§1.21, 1.23, 1.25, and 1.27 of this title.

(3) The department must transmit the order in person or by electronic mail or by registered or certified mail to the license or registration holder. If the license or registration holder cannot be located for a notice required under this section, the department must provide notice by posting a copy of the order on the front door of the premises of the license or registration holder.

(d) Inspection.

(1) To enforce these sections or the Act, the department or authorized agent may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:

(A) enter, at reasonable times, a place of business, including a factory or warehouse, where a device is manufactured, assembled, packed, or held for introduction into commerce or held after the introduction;

(B) enter a vehicle being used to transport or hold a device in commerce; or

(C) inspect, at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicle, including all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.

(2) The inspection of a place of business, including a factory, warehouse, or consulting laboratory, where a restricted device is manufactured, assembled, packed, or held for introduction into commerce may include any place or item, such as a record, file, paper, process, control, or facility, needed to determine whether the device:

(A) is adulterated or misbranded;

(B) is prohibited from being manufactured, introduced into commerce, sold, or offered for sale under the Act; or

(3) An inspection under paragraph (2) of this subsection may not extend to:

(A) financial data;

(B) sales data, except for shipment data;

(D) personnel data, except for data relating to the qualifications of technical and professional personnel performing functions under the Act; or

(E) research data, except data that:

(i) relates to devices; and

(ii) is subject to reporting and inspection under regulations issued under the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360i or §360j, as amended.

(4) An inspection under paragraph (2) of this subsection must be started and completed with reasonable promptness.

(e) Receipt for samples. An authorized agent or health authority who inspects a place of business, including a factory or warehouse, and obtains a sample during the inspection must give to the owner, operator, or the owner's or operator's agent a receipt describing the sample before leaving the place of business.

(f) Access to records.

(1) A person who is required to maintain records referenced in these sections, the Act, or the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360i, or a person who is in charge or custody of those records must, upon request by an authorized agent or health authority, provide access to the records, at all reasonable times, for copying and verification of the records.

(2) A person who is subject to licensure under these sections of this subchapter must, at the request of an authorized agent or health authority, provide access to the records, at all reasonable times, for copying and verification of all records showing:

(A) the movement in commerce of any device;

(B) the holding of any device after movement in commerce; and

(g) Retention of records. Records required by this subchapter must be maintained at the place of business or another reasonably accessible location for a period of at least two years following disposition of the device, unless a longer retention period is required by laws and regulations adopted in §229.432 of this subchapter (relating to Applicable Laws and Regulations).

(h) Adulterated and misbranded device. If the department identifies an adulterated or misbranded device, the department may impose the applicable provisions of Subchapter C of the Act, including detention, emergency order, recall, condemnation, destruction, injunction, civil penalties, criminal penalties, and administrative and civil penalties. Administrative penalties will be assessed using the severity levels contained in §229.261 of this chapter (relating to Assessment of Administrative Penalties).

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 16, 2025.

TRD-202504670

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: January 5, 2026

Proposal publication date: October 3, 2025

For further information, please call: (512) 834-6755

25 TAC §229.444