SECTION 229.603. Definitions

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

(1) Act--The Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter 432.

(2) Adulterated device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.111.

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

(4) Change of ownership--A sole proprietor who transfers all or part of the salvage establishment or salvage broker business to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a salvage establishment or salvage broker business owned by a partnership; a corporate sale, transfer; reorganization; or merger of the corporation which owns the salvage establishment or salvage broker business if the sale, transfer, reorganization, or merger causes a change in the salvage establishment's or salvage broker business's ownership to another person or persons; or if any other type of association, the removal, addition, or substitution of a person or persons as a principal of such association.

(5) Class I exempt device--A class I device not labeled or otherwise represented as sterile that has been determined by the U.S. Food and Drug Administration to be exempt from the current good manufacturing practice requirements in 21 CFR, Part 820 (quality system regulation), except for general requirements concerning records (21 CFR, §820.180) and complaint files (21 CFR, §820.198).

(6) Class I device--A device determined by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, §513, to be subject to only the general controls authorized by or under §§501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the Federal Food, Drug, and Cosmetic Act.

(7) Class II device--A device determined by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, §513, to be subject to or eventually subject to special controls, such as performance standards, postmarket surveillance, patient registries, or guidance documents.

(8) Class III device--A device determined by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, §513, to be subject to or eventually subject to the premarket approval requirements in the Federal Food, Drug, and Cosmetic Act, §515.

(9) Commissioner--The Commissioner of Health or his successor.

(10) Cosmetic--Any article or substance intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearances; or an article or substance for use as a component of such an article, except that the term does not include soap.

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

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

(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or

(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.

(13) Device 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.

(14) Distressed device--Any device that is adulterated or misbranded within the meaning of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §§431.111 and 431.112. The term includes a device that:

(A) has lost its labeling or is otherwise unidentified;

(B) has been subjected to prolonged or improper storage, including insanitary conditions whereby the device may have been contaminated with filth or whereby it may have been rendered injurious to health;

(C) has been subjected for any reason to abnormal environmental conditions, including temperature extremes, humidity, smoke, water, fumes, pressure, or radiation;

(D) has been subjected to conditions that result in either its strength, purity, or quality falling below that which it purports or is represented to possess; or

(E) may have been rendered unsafe or unsuitable for its intended use according to the manufacturer's recommendations or specifications; or for any reason other than those specified by this paragraph.

(15) Drug--

(A) an article or substance recognized in the official United States Pharmacopoeia, the official Homeopathic Pharmacopoeia of the United States, the official National Formulary, or any supplement of them;

(B) an article or substance designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;

(C) an article or substance, other than food, intended to affect the structure or any function of the body of man or other animals; or

(D) an article or substance intended for use as a component of any article or substance specified in this definition.

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

(17) Flea market--A location at which booths or similar spaces are rented or otherwise made available temporarily to two or more persons and at which the persons offer tangible personal property for sale.

(18) Food--

(A) any article of food or drink for man;

(B) chewing gum; or

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

(19) 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.

(20) Misbranded device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.112.

(21) Nonprofit organization--An organization that has received an exemption from federal taxation under 26 U.S.C., §501(c)(3).

(22) Nonsalvageable device--A distressed device, as defined in this section, which cannot be safely or practically reconditioned.

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

(24) Personnel--Any person employed by a salvage establishment or salvage broker who does or may in any manner handle or come in contact with the handling; storing; transporting; or selling and distributing of salvageable or salvaged devices.

(25) Place of business--Each location from which a salvage establishment or salvage broker operates. The term does not include a salvage warehouse.

(26) Practitioner--A person licensed by the Texas State Board of Medical Examiners, State Board of Dental Examiners, Texas State Board of Podiatric Medical Examiners, Texas Optometry Board, or State Board of Veterinary Medical Examiners to prescribe and administer prescription devices.

(27) Prescription device--A device which, 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.

(28) Quality audit--An independent examination of a salvage establishment, including the organizational structure and responsibilities, procedures, and processes necessary to ensure that such resources and activities comply with the requirements of these sections and result in the adequate reconditioning of a distressed device.

(29) Reconditioning--Any appropriate process or procedure by which a distressed device can be brought into compliance with the standards of the department for use by the public. In addition, all reconditioned devices must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.

(30) Sale or distribution--The act of selling or distributing, whether for compensation or not; and includes delivery; holding; or offering for sale; transfer, auction; storage; or other means of handling or trafficking.

(31) Salvage broker--A person who engages in the business of selling, distributing, or otherwise trafficking in any distressed or salvaged food, drug, device, or cosmetic and who does not operate a salvage establishment.

(32) Salvage establishment--Any place of business engaged in reconditioning or by other means salvaging distressed food, drugs, devices, or cosmetics, or that sells, buys, or distributes for human use any salvaged food, drug, device, or cosmetic.

(33) Salvage operator--A person who is engaged in the business of operating a salvage establishment.

(34) Salvage warehouse--A separate storage facility used by a salvage broker or salvage establishment for the purpose of holding distressed or salvaged devices.

(35) Salvageable device--Any distressed device, as defined in this section, which can be reconditioned to departmental standards.

(36) Salvaged device--Any distressed device that has been reconditioned.

(37) Vehicle--Any truck, car, bus, or other means by which distressed, salvageable, or salvaged devices are transported from one location to another.

Source Note: The provisions of this §229.603 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11985