Certain Combination Products

Tex. Health and Safety Code § 431.006, under Texas Food, Drug, and Cosmetic Act.

Tex. Health and Safety Code § 431.006

Sec. 431.006. CERTAIN COMBINATION PRODUCTS. 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. Added by Acts 1999, 76th Leg., ch. 132, Sec. 1, eff. May 20, 1999.