1-1 By: Nelson S.B. No. 1236 1-2 (In the Senate - Filed March 11, 1999; March 11, 1999, read 1-3 first time and referred to Committee on Health Services; 1-4 March 24, 1999, reported favorably by the following vote: Yeas 5, 1-5 Nays 0; March 24, 1999, sent to printer.) 1-6 A BILL TO BE ENTITLED 1-7 AN ACT 1-8 relating to regulation of a product that is a combination of a drug 1-9 and a device. 1-10 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-11 SECTION 1. Subchapter A, Chapter 431, Health and Safety 1-12 Code, is amended by adding Section 431.006 to read as follows: 1-13 Sec. 431.006. CERTAIN COMBINATION PRODUCTS. If the United 1-14 States Food and Drug Administration determines, with respect to a 1-15 product that is a combination of a drug and a device, that: 1-16 (1) the primary mode of action of the product is as a 1-17 drug, a person who engages in wholesale distribution of the product 1-18 is subject to licensure under Subchapter I; and 1-19 (2) the primary mode of action of the product is as a 1-20 device, a distributor or manufacturer of the product is subject to 1-21 licensure under Subchapter L. 1-22 SECTION 2. The importance of this legislation and the 1-23 crowded condition of the calendars in both houses create an 1-24 emergency and an imperative public necessity that the 1-25 constitutional rule requiring bills to be read on three several 1-26 days in each house be suspended, and this rule is hereby suspended, 1-27 and that this Act take effect and be in force from and after its 1-28 passage, and it is so enacted. 1-29 * * * * *