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.
Structure Texas Statutes
Title 6 - Food, Drugs, Alcohol, and Hazardous Substances
Subtitle A - Food and Drug Health Regulations
Chapter 431 - Texas Food, Drug, and Cosmetic Act
Subchapter A. General Provisions
Section 431.003. Article Misbranded Because of Misleading Labeling or Advertising
Section 431.004. Representation of Drug as Antiseptic
Section 431.005. Provisions Regarding Sale of Food, Drugs, Devices, or Cosmetics
Section 431.006. Certain Combination Products
Section 431.007. Compliance With Other Law; Molluscan Shellfish
Section 431.009. Applicability of Chapter to Frozen Desserts
Section 431.010. Applicability of Chapter to Milk and Milk Products
Section 431.011. Applicability of Chapter to Consumable Hemp Products and Manufacturers