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By: Janek S.B. No. 1392
A BILL TO BE ENTITLED
AN ACT
relating to medical device licensing under the Texas Food, Drug,
and Cosmetic Salvage Act.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 431.008, Health and Safety Code, is
amended by amending Subsections (a) and (c) 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.
(c) A person who holds a license under Chapter 432 and is
engaging in conduct within the scope of that license is not required
to hold a license as a wholesale drug distributor under Subchapter
I, a food wholesaler under Subchapter J[, or a device distributor
under Subchapter L].
SECTION 2. Section 431.023, Health and Safety Code, is
amended to read as follows:
Sec. 431.023. Limited Exemption for Distressed Food, Drugs,
[Devices,] or Cosmetics. In relation to a food, drug, [device,] or
cosmetic that is distressed merchandise for purposes of Chapter
432, Sections 431.021(a), (c), and (d) do not prohibit:
(1) the introduction or delivery for introduction into
commerce of the merchandise for the purpose of reconditioning in
accordance with Chapter 432 and not for sale to the ultimate
consumer;
(2) the receipt in commerce of the merchandise for the
purpose of reconditioning in accordance with Chapter 432 and not
for sale to the ultimate consumer;
(3) the holding of merchandise for the purpose of
reconditioning in accordance with Chapter 432 and not for resale to
the ultimate consumer; or
(4) the reconditioning of the merchandise in
accordance with Chapter 432.
SECTION 3. Chapter 432, Health and Safety Code, is amended
to read as follows:
CHAPTER 432. FOOD, DRUG, [DEVICE,] AND COSMETIC SALVAGE ACT
SECTION 4. Section 432.001, Chapter 432, Health and Safety
Code, is 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.
SECTION 5. Section 432.002, Chapter 432, Health and Safety
Code, is amended to read as follows:
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 6. Section 432.003, Chapter 432, Health and Safety
Code, is amended by amending Subsection 6 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.
SECTION 7. Section 432.003, Chapter 432, Health and Safety
Code, is amended by adding Subsection 19 to read as follows:
(19) "Refurbishing a device" means painting, cleaning,
routine maintenance or repair, or similar activity that does not
change original manufacturer safety or performance specifications,
or original intended use of a medical device.
SECTION 8. Section 432.004, Chapter 432, Health and Safety
Code, is amended by amending Subsection (a) as follows:
Sec. 432.004. Exemptions. (a) This chapter does not apply
to:
(1) a manufacturer, distributor, or processor of a
food, drug, [device,] or cosmetic who, in the normal course of
business, reconditions the items manufactured, distributed, or
processed by or for that person and not purchased by that person
solely for the purpose of reconditioning and sale;
(2) a common carrier, or the common carrier's agent,
who disposes of or otherwise transfers undamaged or distressed
food, drugs, [devices,] or cosmetics to a person who is exempt under
this section or to a licensed salvage broker or salvage operator;
(3) a person who transfers distressed merchandise to a
licensed salvage broker or salvage operator; or
(4) a nonprofit organization that distributes food to
the needy under Chapter 76, Civil Practice and Remedies Code (Good
Faith Donor Act), but that does not recondition the food.
(5) a person or organization who engages in
refurbishing medical devices for purposes of selling.
SECTION 9. Section 432.010, Chapter 432, 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 10. Section 432.011, Chapter 432, Health and Safety
Code, is amended by amending Subsection (b) as follows:
(b) The rules shall prescribe standards for food, drugs,
[devices,] and cosmetics in separate subchapters.
SECTION 11. Section 432.020, Chapter 432, Health and Safety
Code, is amended to read as follows:
Sec. 432.020. Emergency Order. (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:
SECTION 12. This Act takes effect September 1, 2003.