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