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.