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                                  * * * * *