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.
_______________________________ _______________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 1236 passed the Senate on
April 8, 1999, by the following vote: Yeas 30, Nays 0.
_______________________________
Secretary of the Senate
I hereby certify that S.B. No. 1236 passed the House on
May 4, 1999, by the following vote: Yeas 144, Nays 0, two present
not voting.
_______________________________
Chief Clerk of the House
Approved:
_______________________________
Date
_______________________________
Governor