By Nelson S.B. No. 1236 76R3429 DLF-F A BILL TO BE ENTITLED 1-1 AN ACT 1-2 relating to regulation of a product that is a combination of a drug 1-3 and a device. 1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-5 SECTION 1. Subchapter A, Chapter 431, Health and Safety 1-6 Code, is amended by adding Section 431.006 to read as follows: 1-7 Sec. 431.006. CERTAIN COMBINATION PRODUCTS. If the United 1-8 States Food and Drug Administration determines, with respect to a 1-9 product that is a combination of a drug and a device, that: 1-10 (1) the primary mode of action of the product is as a 1-11 drug, a person who engages in wholesale distribution of the product 1-12 is subject to licensure under Subchapter I; and 1-13 (2) the primary mode of action of the product is as a 1-14 device, a distributor or manufacturer of the product is subject to 1-15 licensure under Subchapter L. 1-16 SECTION 2. The importance of this legislation and the 1-17 crowded condition of the calendars in both houses create an 1-18 emergency and an imperative public necessity that the 1-19 constitutional rule requiring bills to be read on three several 1-20 days in each house be suspended, and this rule is hereby suspended, 1-21 and that this Act take effect and be in force from and after its 1-22 passage, and it is so enacted.