Section 229.573 - DefinitionsThe 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 drug--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) Commissioner--The Commissioner of Health, or his successor.(6) Department--The Department of State Health Services.(7) 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 manor 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.(8) Distressed drug--Any drug 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 drug that:(A) has lost its labeling or is otherwise unidentified;(B) has been subjected to prolonged or improper storage, including unsanitary conditions whereby the drug may have become contaminated with filth or whereby it may be been rendered injurious to health;(C) has been subjected for any reason to abnormal environmental condition, 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) has been rendered unsafe or unsuitable for human consumption or use for any other reason.(9) 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.(10) Drug Manufacturer--Includes a person who manufactures, prepares, propagates, compounds, processes, repackages, or changes the container, wrapper, or labeling of any drug.(11) Food-- (A) any article of food or drink for man;(C) an article used for components of any such article.(12) 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.(13) Manufacture--The combining, preparing, propagation, compounding, purifying, processing, packing, repacking, wrapping, and labeling of drugs.(14) Misbranded drug--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.112.(15) Nonprofit organization--An organization that has received an exemption from federal taxation under 26 U.S.C., §501(c)(3).(16) Nonsalvageable drug--Distressed drug, as defined in this section, which cannot be safely or practically reconditioned.(17) Perishable--Capable of spoilage or deterioration due to improper refrigeration or handling.(18) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity.(19) 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 drugs.(20) Place of business--Each location from which a salvage establishment or salvage broker operates.(21) 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 drugs.(22) Reconditioning--Any appropriate process or procedure by which distressed drugs can be brought into compliance with the standards of the department for consumption or use by the public. In addition, all reconditioned drugs must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(23) 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.(24) 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.(25) 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. For the purpose of licensing under these sections, a drug reclamation center is a salvage establishment.(26) Salvage operator--A person who is engaged in the business of operating a salvage establishment.(27) Salvage warehouse--A separate storage facility used by a salvage broker or salvage establishment for the purpose of holding distressed or salvaged drug.(28) Salvageable drug--Any distressed drug, as defined in this section, which can be reconditioned to departmental standards.(29) Salvaged drug--Any distressed drug that has been reconditioned.(30) Sanitize--Adequate treatment of surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other microorganisms. Such treatments shall not adversely affect the product and shall be safe to the consumer.(31) Vehicles--Any truck, car, bus, or other means by which distressed, salvageable, or salvaged drugs is transported from one location to another.25 Tex. Admin. Code § 229.573
The provisions of this §229.573 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984