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78R1424 DLF-D
By: Burnam H.B. No. 3389
A BILL TO BE ENTITLED
AN ACT
relating to regulation of distressed devices.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
ARTICLE 1. REGULATION OF DISTRESSED DEVICES
SECTION 1.01. Subtitle A, Title 6, Health and Safety Code, is
amended by adding Chapter 442 to read as follows:
CHAPTER 442. REGULATION OF DISTRESSED DEVICES
Sec. 442.001. DEFINITIONS. In this chapter:
(1) "Department" means the Texas Department of Health.
(2) "Device" means an instrument, apparatus, or
contrivance, or a component, part, or accessory of an instrument,
apparatus, or contrivance, that is designed or intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of
disease in humans or other animals, or that is designed or intended
to affect the structure or any function of the body of a human or
other animal.
Sec. 442.002. DISTRESSED DEVICE; APPLICATION. A device is
distressed for purposes of this chapter if the device has been
subjected to fire, flood, excessive heat or cold, or other
conditions that affect or may have affected the device's fitness
for use.
Sec. 442.003. NOTICE BEFORE SALE OR DISTRIBUTION;
INSPECTION. (a) A person who knowingly holds a distressed device
shall notify the department before the sale or distribution of the
device. This subsection applies without regard to whether the
person is the owner of the distressed device.
(b) On receipt of a notice under Subsection (a), the
department may require that the device be inspected before the
device is sold or distributed.
Sec. 442.004. PROHIBITION. A person may not sell or
distribute a distressed device if the device has been declared
unfit for use by the department.
ARTICLE 2. CONFORMING AMENDMENTS
SECTION 2.01. Section 431.008(a), Health and Safety Code,
is amended to read as follows:
(a) This chapter applies to a food, drug, [device,] or
cosmetic that is distressed merchandise for purposes of Chapter 432
or that has been subject to reconditioning in accordance with
Chapter 432.
SECTION 2.02. The chapter heading to Chapter 432, Health
and Safety Code, is amended to read as follows:
CHAPTER 432. FOOD, DRUG, [DEVICE,] AND COSMETIC SALVAGE ACT
SECTION 2.03. Sections 432.001 and 432.002, Health and
Safety Code, are amended to read as follows:
Sec. 432.001. SHORT TITLE. This chapter may be cited as the
Texas Food, Drug, [Device,] and Cosmetic Salvage Act.
Sec. 432.002. PURPOSE. The purpose of this chapter is to
protect the health of the people of this state by preventing the
sale or distribution of adulterated or misbranded food, drugs,
[devices,] or cosmetics.
SECTION 2.04. Sections 432.003(6), (9), and (10), Health
and Safety Code, are amended to read as follows:
(6) "Distressed merchandise" means any food, drug,
[device,] or cosmetic that is adulterated or misbranded for
purposes of Section 431.081 (Adulterated Food), 431.082
(Misbranded Food), 431.111 (Adulterated Drug or Device), 431.112
(Misbranded Drug or Device), 431.141 (Adulterated Cosmetic), or
431.142 (Misbranded Cosmetic), as interpreted by board rule and
judicial decision. The term includes a food, drug, [device,] or
cosmetic that:
(A) has lost its label or is otherwise
unidentified;
(B) has been subjected to prolonged or improper
storage;
(C) has been subjected for any reason to abnormal
environmental conditions, including temperature extremes,
humidity, smoke, water, fumes, pressure, or radiation;
(D) has been subjected to conditions that result
in either its strength, purity, or quality falling below that which
it purports or is represented to possess; or
(E) may have been rendered unsafe or unsuitable
for human consumption or use for any reason other than those
specified by this subdivision.
(9) "Manufacture" means the combining, purifying,
processing, packing, or repacking of food, drugs, [devices,] or
cosmetics for wholesale or retail sale.
(10) "Manufacturer" includes a person who represents
himself as responsible for the purity and proper labeling of a food,
drug, [device,] or cosmetic.
SECTION 2.05. Section 432.004, Health and Safety Code, is
amended by adding Subsection (c) to read as follows:
(c) This chapter does not apply to the manufacture, sale or
distribution, or processing of a distressed device.
SECTION 2.06. Section 432.010, Health and Safety Code, is
amended to read as follows:
Sec. 432.010. FUND. A fee collected by the department under
this chapter shall be deposited in the state treasury to the credit
of the food, drug, [device,] and cosmetic salvage fund. The fund may
be used only to implement this chapter.
SECTION 2.07. Section 432.011(b), Health and Safety Code,
is amended to read as follows:
(b) The rules shall prescribe standards for food, drugs,
[devices,] and cosmetics in separate subchapters.
SECTION 2.08. Section 432.020(a), Health and Safety Code,
is amended to read as follows:
(a) The commissioner or the commissioner's designee may
issue an emergency order, either mandatory or prohibitory,
concerning the sale or distribution of distressed foods, drugs,
[devices,] or cosmetics in the department's jurisdiction if the
commissioner or the commissioner's designee determines that:
(1) the sale or distribution of those foods, drugs,
[devices,] or cosmetics creates or poses an immediate and serious
threat to human life or health; and
(2) other procedures available to the department to
remedy or prevent the occurrence of the situation will result in
unreasonable delay.
ARTICLE 3. EFFECTIVE DATE
SECTION 3.01. This Act takes effect immediately if it
receives a vote of two-thirds of all the members elected to each
house, as provided by Section 39, Article III, Texas Constitution.
If this Act does not receive the vote necessary for immediate
effect, this Act takes effect September 1, 2003.