The following words and terms, when used in this subchapter, must 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, §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 the offering or contracting for wholesale distribution; sale and/or transfer of a prescription drug into, within, or out of Texas; and, who does not take physical possession of the prescription 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) Co-licensed product partner--One of two or more parties that have the right to engage in the manufacturing or marketing of a prescription drug consistent with the United States Food and Drug Administration's regulations and guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293). (7) Commissioner--Commissioner of the Department of State Health Services. (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) Drop shipment--The sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug, or by the manufacturer's co-licensed product partner, third-party logistics provider, or exclusive distributor, in which: (A) the wholesale distributor takes title but not physical possession of the prescription drug; (B) the wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer the drug to a patient; and (C) the pharmacy, pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer or the manufacturer's third-party logistics provider or exclusive distributor. (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 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. (12) Emergency medical reasons--Includes transfers of a prescription drug between a wholesale distributor or pharmacy to alleviate a temporary shortage of a prescription drug arising from delays in or interruption of regular distribution schedules; sales to nearby emergency medical services, i.e., ambulance companies and firefighting organizations in the same state or same marketing or service area, or nearby licensed practitioners of drugs for use in the treatment of acutely ill or injured persons; provision of minimal emergency supplies of drugs to nearby nursing homes for use in emergencies or during hours of the day when necessary drugs cannot be obtained; and transfers of prescription drugs by a retail pharmacy to alleviate a temporary shortage. (13) Federal Act--Federal Food, Drug, and Cosmetic Act, 21 United States Code (U.S.C.), §301, et seq., as amended. (14) 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. (15) 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. (16) Manufacturer--A person who manufactures, prepares, propagates, compounds, processes, packages, or repackages prescription drugs, or a person who changes the container, wrapper, or labeling of any prescription drug package. A person licensed or approved by the United States Food and Drug Administration to engage in the manufacture of drugs or devices, consistent with the federal agency's definition of "manufacturer" under the agency's regulations and guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293). The term does not include a pharmacist engaged in compounding that is done within the practice of pharmacy and pursuant to a prescription drug order or initiative from a practitioner for a patient or prepackaging that is done in accordance with Occupations Code, §562.154. (17) Manufacturer's exclusive distributor--A person who holds a wholesale distributor license under this subchapter, who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, and who takes title to, but does not have general responsibility to direct the sale or disposition of, the manufacturer's prescription drug. A manufacturer's exclusive distributor must be an authorized distributor of record to be considered part of the normal distribution channel. (18) Misbranded drug--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §431.112. (19) Nonprescription drug--Any drug that is not a prescription drug. (20) Normal distribution channel--A chain of custody for a prescription drug, either directly or by drop shipment, from the manufacturer of the prescription drug, the manufacturer to the manufacturer's co-licensed product partner, the manufacturer to the manufacturer's third-party logistics provider, or the manufacturer to the manufacturer's exclusive distributor, to: (A) a pharmacy to: (i) a patient; or (ii) another designated person authorized by law to dispense or administer the drug to a patient; (B) an authorized distributor of record to: (i) a pharmacy to a patient; or (ii) another designated person authorized by law to dispense or administer the drug to a patient; (C) an authorized distributor of record to a wholesale distributor licensed under this subchapter to another designated person authorized by law to administer the drug to a patient; (D) an authorized distributor of record to a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy; (E) a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy or another designated person authorized by law to dispense or administer the drug to a patient; (F) a person authorized by law to prescribe a prescription drug that by law may be administered only under the supervision of the prescriber; or (G) an authorized distributor of record to one other authorized distributor of record to a licensed practitioner for office use. (21) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity. (22) Pharmacy warehouse--A location for which a person holds a wholesale drug distribution license under this subchapter, that serves as a central warehouse for drugs or devices, and from which intracompany sales or transfers of drugs or devices are made to a group of pharmacies under common ownership and control. Cont'd... |
