<<Prev Rule

Texas Administrative Code

Next Rule>>
TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER OLICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.243Definitions

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

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

  (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 the Act.

  (4) Change of ownership--A sole proprietor who transfers all or part of the facility's ownership to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a facility owned by a partnership; a corporate sale, transfer, reorganization, or merger of the corporation which owns the facility if sale, transfer, reorganization, or merger causes a change in the facility'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--Commissioner of the Department of State Health Services.

  (6) Cosmetic--Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleaning, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of those articles. The term does not include soap.

  (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, 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.

  (9) Drug--Articles recognized in the official United States Pharmacopoeia National Formulary, or any supplement to it, articles designated or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, articles, other than food, intended to affect the structure or any function of the body of man or other animals, and articles intended for use as a component of any such article. The term does not include devices or their components, parts, or accessories. A food for which a claim is made in accordance with the Federal Act, §403(r), and for which the claim is approved by the U.S. Food and Drug Administration, is not a drug solely because the label or labeling contains such a claim.

  (10) Federal Act--Federal Food, Drug, and Cosmetic Act, 21 United States Code, et seq., as amended.

  (11) 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.

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

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

    (B) accompanying such drug.

  (13) Manufacturer--A person who manufactures, prepares, propagates, compounds, processes, packages, or repackages nonprescription drugs, or a person who changes the container, wrapper, or labeling of any nonprescription drug package.

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

  (15) Nonprescription drug--Any drug that is not a prescription drug, and includes the term "Over the Counter Drug."

  (16) Nonprescription drug product--A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active nonprescription drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. Any nonprescription drug product that is also a cosmetic or device or component thereof is also subject to the applicable requirements of the Federal Act, Chapters V and VI, and Subchapters E and F; and Subchapter D of this chapter (relating to Regulation of Cosmetics) and Subchapter X (relating to Licensing of Device Distributors and Manufacturers).

  (17) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity.

  (18) Place of business--Each location at which a nonprescription drug for wholesale distribution is located.

  (19) Prescription drug--Any drug (including any biological product, except for blood and blood components intended for transfusion or biological products that are also medical devices) required by Federal law (including Federal regulation) to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to the Federal Act, §503(b).

  (20) Wholesale distribution--Distribution to a person other than a consumer or patient, including, but not limited to distribution to any person by a manufacturer, repackager, own label distributor, broker, jobber, warehouse, or wholesaler.


Source Note: The provisions of this §229.243 adopted to be effective February 1, 2007, 32 TexReg 315

Next Page Previous Page



Home TxReg TAC OM NewTac Public Footer Bar