GroundRules
Tex. Health and Safety Code § 431.006: CERTAIN COMBINATION PRODUCTS.
Where this section sits in the code
- HEALTH AND SAFETY CODE
- 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
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.
Collected 2026-08-27T01:47:17Z. Source file · JSON