Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.243 - Definitions
Current through Reg. 49, No. 38; September 20, 2024
The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.
(1) Act--The Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431.
(2) Adulterated drug--Has the meaning specified in the Act at §431.111.
(3) Authorized agent--An employee of the department who is designated by the commissioner to enforce the provisions of the Act.
(4) Broker--A person engaged in offering or contracting for wholesale distribution sale or transfer of a nonprescription drug into, within, or out of Texas and who does not take title to or physical possession of the nonprescription drug.
(5) 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.
(6) Commissioner--Commissioner of the Texas Department of State Health Services.
(7) Component--Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.
(8) 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.
(9) Department--The Texas Department of State Health Services.
(10) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:
(11) 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 humans or other animals; articles, other than food, intended to affect the structure or any function of the body of humans 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), 21 USC § 343, and for which the claim is approved by the United States Food and Drug Administration (FDA) is not a drug solely because the label or labeling contains such a claim.
(12) Federal Act--Federal Food, Drug, and Cosmetic Act, 21 USC § 301, et seq., as amended.
(13) 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.
(14) Inactive ingredient--Any component other than an active ingredient, including any excipient, flavor, fragrance, and color.
(15) Labeling--All labels and other written, printed, or graphic matter:
(16) 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.
(17) Misbranded drug--Has the meaning specified in the Act at §431.112.
(18) Nonprescription drug--Any drug that is not a prescription drug, including the terms Over-the-Counter Drug and Non-legend Drug.
(19) Nonprescription drug product--A finished dosage form, for example, tablet, capsule, solution, etc., containing an active nonprescription ingredient. 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 of this chapter (relating to Licensing of Device Distributors and Manufacturers).
(20) Over-the-Counter (OTC) drugs--Drugs that are safe and effective for use by the general public without seeking treatment by a health professional.
(21) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity.
(22) Place of business--Each location at which a nonprescription drug for wholesale distribution is located.
(23) 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 at §503(b).
(24) Wholesale distribution--Distribution to a person other than a consumer or patient, including distribution to any person by a manufacturer, repackager, own label distributor, broker, jobber, warehouse, or wholesaler. This term does not include:
