§ 431.006 Certain Combination Products
§ 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; [FN1] 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. [FN2]
[FN1] V.T.C.A., Health & Safety Code § 431.201 et seq.
[FN2] V.T.C.A., Health & Safety Code § 431.271 et seq.