Texas Health and Safety Code 431.006 – Certain Combination Products
Current as of: 2024 | Check for updates
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Terms Used In Texas Health and Safety Code 431.006
- Person: includes corporation, organization, government or governmental subdivision or agency, business trust, estate, trust, partnership, association, and any other legal entity. See Texas Government Code 311.005
- United States: includes a department, bureau, or other agency of the United States of America. See Texas Government Code 311.005
If the United States Food and Drug Administration determines, with respect to a product that is a combination of a drug and a device, that:
(1) the primary mode of action of the product is as a drug, a person who engages in wholesale distribution of the product is subject to licensure under Subchapter I; and
(2) the primary mode of action of the product is as a device, a distributor or manufacturer of the product is subject to licensure under Subchapter L.