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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER DDREGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS
RULE §229.633Definitions

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 cosmetic--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.141.

  (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) 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.

  (7) Cosmetic manufacturer--Includes a person who represents himself as responsible for the purity and proper labeling of a cosmetic.

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

  (9) 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.

  (10) Distressed cosmetic--Any cosmetic that is adulterated or misbranded within the meaning of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §§431.141 and 431.142. The term includes a cosmetic that:

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

    (B) has been subjected to prolonged or improper storage, including insanitary conditions whereby the cosmetic 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.

  (11) 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.

  (12) Food--

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

    (B) chewing gum; or

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

  (13) 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.

  (14) Manufacture--The combining, preparing, propagation, compounding, purifying, processing, packing, repacking, wrapping, and labeling of cosmetics.

  (15) Misbranded cosmetic--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.142.

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

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

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

  (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 cosmetics.

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

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

  (22) 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.

  (23) 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.

  (24) 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.

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

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

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

  (28) Salvaged cosmetics--Any distressed cosmetic that has been reconditioned.

  (29) 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.

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


Source Note: The provisions of this §229.633 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986

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