By Maxey H.B. No. 358
75R2758 MCK-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the use of certain detained or embargoed articles.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Section 431.021, Health and Safety Code, is
1-5 amended to read as follows:
1-6 Sec. 431.021. PROHIBITED ACTS. The following acts and the
1-7 causing of the following acts within this state are unlawful and
1-8 prohibited:
1-9 (a) the introduction or delivery for introduction into
1-10 commerce of any food, drug, device, or cosmetic that is adulterated
1-11 or misbranded;
1-12 (b) the adulteration or misbranding of any food, drug,
1-13 device, or cosmetic in commerce;
1-14 (c) the receipt in commerce of any food, drug, device,
1-15 or cosmetic that is adulterated or misbranded, and the delivery or
1-16 proffered delivery thereof for pay or otherwise;
1-17 (d) the distribution in commerce of a consumer
1-18 commodity, if such commodity is contained in a package, or if there
1-19 is affixed to that commodity a label that does not conform to the
1-20 provisions of this chapter and of rules adopted under the authority
1-21 of this chapter; provided, however, that this prohibition shall
1-22 not apply to persons engaged in business as wholesale or retail
1-23 distributors of consumer commodities except to the extent that such
1-24 persons:
2-1 (1) are engaged in the packaging or labeling of
2-2 such commodities; or
2-3 (2) prescribe or specify by any means the manner
2-4 in which such commodities are packaged or labeled;
2-5 (e) the introduction or delivery for introduction into
2-6 commerce of any article in violation of Section 431.084, 431.114,
2-7 or 431.115;
2-8 (f) the dissemination of any false advertisement;
2-9 (g) the refusal to permit entry or inspection, or to
2-10 permit the taking of a sample or to permit access to or copying of
2-11 any record as authorized by Sections 431.042-431.044; or the
2-12 failure to establish or maintain any record or make any report
2-13 required under Section 512(j), (l), or (m) of the federal Act, or
2-14 the refusal to permit access to or verification or copying of any
2-15 such required record;
2-16 (h) the manufacture within this state of any food,
2-17 drug, device, or cosmetic that is adulterated or misbranded;
2-18 (i) the giving of a guaranty or undertaking referred
2-19 to in Section 431.059, which guaranty or undertaking is false,
2-20 except by a person who relied on a guaranty or undertaking to the
2-21 same effect signed by, and containing the name and address of the
2-22 person residing in this state from whom the person received in good
2-23 faith the food, drug, device, or cosmetic; or the giving of a
2-24 guaranty or undertaking referred to in Section 431.059, which
2-25 guaranty or undertaking is false;
2-26 (j) the use, removal, or disposal of a detained or
2-27 embargoed article in violation of Section 431.048;
3-1 (k) the alteration, mutilation, destruction,
3-2 obliteration, or removal of the whole or any part of the labeling
3-3 of, or the doing of any other act with respect to a food, drug,
3-4 device, or cosmetic, if such act is done while such article is held
3-5 for sale after shipment in commerce and results in such article
3-6 being adulterated or misbranded;
3-7 (l)(1) forging, counterfeiting, simulating, or falsely
3-8 representing, or without proper authority using any mark, stamp,
3-9 tag, label, or other identification device authorized or required
3-10 by rules adopted under this chapter or the regulations promulgated
3-11 under the provisions of the federal Act;
3-12 (2) making, selling, disposing of, or keeping in
3-13 possession, control, or custody, or concealing any punch, die,
3-14 plate, stone, or other thing designed to print, imprint, or
3-15 reproduce the trademark, trade name, or other identifying mark,
3-16 imprint, or device of another or any likeness of any of the
3-17 foregoing on any drug or container or labeling thereof so as to
3-18 render such drug a counterfeit drug;
3-19 (3) the doing of any act that causes a drug to
3-20 be a counterfeit drug, or the sale or dispensing, or the holding
3-21 for sale or dispensing, of a counterfeit drug;
3-22 (m) the using by any person to the person's own
3-23 advantage, or revealing, other than to the commissioner, an
3-24 authorized agent, a health authority or to the courts when relevant
3-25 in any judicial proceeding under this chapter, of any information
3-26 acquired under the authority of this chapter concerning any method
3-27 or process that as a trade secret is entitled to protection;
4-1 (n) the using, on the labeling of any drug or device
4-2 or in any advertising relating to such drug or device, of any
4-3 representation or suggestion that approval of an application with
4-4 respect to such drug or device is in effect under Section 431.114
4-5 or Section 505, 515, or 520(g) of the federal Act, as the case may
4-6 be, or that such drug or device complies with the provisions of
4-7 such sections;
4-8 (o) the using, in labeling, advertising or other sales
4-9 promotion of any reference to any report or analysis furnished in
4-10 compliance with Sections 431.042-431.044 or Section 704 of the
4-11 federal Act;
4-12 (p) in the case of a prescription drug distributed or
4-13 offered for sale in this state, the failure of the manufacturer,
4-14 packer, or distributor of the drug to maintain for transmittal, or
4-15 to transmit, to any practitioner licensed by applicable law to
4-16 administer such drug who makes written request for information as
4-17 to such drug, true and correct copies of all printed matter that is
4-18 required to be included in any package in which that drug is
4-19 distributed or sold, or such other printed matter as is approved
4-20 under the federal Act. Nothing in this subsection shall be
4-21 construed to exempt any person from any labeling requirement
4-22 imposed by or under other provisions of this chapter;
4-23 (q)(1) placing or causing to be placed on any drug or
4-24 device or container of any drug or device, with intent to defraud,
4-25 the trade name or other identifying mark, or imprint of another or
4-26 any likeness of any of the foregoing;
4-27 (2) selling, dispensing, disposing of or causing
5-1 to be sold, dispensed, or disposed of, or concealing or keeping in
5-2 possession, control, or custody, with intent to sell, dispense, or
5-3 dispose of, any drug, device, or any container of any drug or
5-4 device, with knowledge that the trade name or other identifying
5-5 mark or imprint of another or any likeness of any of the foregoing
5-6 has been placed thereon in a manner prohibited by Subdivision (1)
5-7 of this subsection; or
5-8 (3) making, selling, disposing of, causing to be
5-9 made, sold, or disposed of, keeping in possession, control, or
5-10 custody, or concealing with intent to defraud any punch, die,
5-11 plate, stone, or other thing designed to print, imprint, or
5-12 reproduce the trademark, trade name, or other identifying mark,
5-13 imprint, or device of another or any likeness of any of the
5-14 foregoing on any drug or container or labeling of any drug or
5-15 container so as to render such drug a counterfeit drug;
5-16 (r) dispensing or causing to be dispensed a different
5-17 drug in place of the drug ordered or prescribed without the express
5-18 permission in each case of the person ordering or prescribing;
5-19 (s) the failure to register in accordance with Section
5-20 510 of the federal Act, the failure to provide any information
5-21 required by Section 510(j) or (k) of the federal Act, or the
5-22 failure to provide a notice required by Section 510(j)(2) of the
5-23 federal Act;
5-24 (t)(1) the failure or refusal to:
5-25 (A) comply with any requirement prescribed
5-26 under Section 518 or 520(g) of the federal Act; or
5-27 (B) furnish any notification or other
6-1 material or information required by or under Section 519 or 520(g)
6-2 of the federal Act;
6-3 (2) with respect to any device, the submission
6-4 of any report that is required by or under this chapter that is
6-5 false or misleading in any material respect;
6-6 (u) the movement of a device in violation of an order
6-7 under Section 304(g) of the federal Act or the removal or
6-8 alteration of any mark or label required by the order to identify
6-9 the device as detained;
6-10 (v) the failure to provide the notice required by
6-11 Section 412(b) or 412(c), the failure to make the reports required
6-12 by Section 412(d)(1)(B), or the failure to meet the requirements
6-13 prescribed under Section 412(d)(2) of the federal Act;
6-14 (w) the acceptance by a person of an unused
6-15 prescription or drug, in whole or in part, for the purpose of
6-16 resale, after the prescription or drug has been originally
6-17 dispensed, or sold;
6-18 (x) engaging in the wholesale distribution of drugs or
6-19 operating as a distributor or manufacturer of devices in this state
6-20 without filing a licensing statement with the commissioner as
6-21 required by Section 431.202 or having a license as required by
6-22 Section 431.272, as applicable;
6-23 (y) engaging in the manufacture of food in this state
6-24 without first registering with the department as required by
6-25 Section 431.222; or
6-26 (z) unless approved by the United States Food and Drug
6-27 Administration pursuant to the federal Act, the sale, delivery,
7-1 holding, or offering for sale of a self-testing kit designed to
7-2 indicate whether a person has a human immunodeficiency virus
7-3 infection, acquired immune deficiency syndrome, or a related
7-4 disorder or condition.
7-5 SECTION 2. Sections 431.048(b) and (c), Health and Safety
7-6 Code, are amended to read as follows:
7-7 (b) The tag or marking on a detained or embargoed article
7-8 must warn all persons not to use the article, remove the article
7-9 from the premises, or dispose of the article by sale or otherwise
7-10 until permission for use, removal, or disposal is given by the
7-11 commissioner, the authorized agent, or a court.
7-12 (c) A person may not use a detained or embargoed article,
7-13 remove a detained or embargoed article from the premises, or
7-14 dispose of a detained or embargoed article [it] by sale or
7-15 otherwise without permission of the commissioner, the authorized
7-16 agent, or a court. The commissioner or the authorized agent may
7-17 permit perishable goods to be moved to a place suitable for proper
7-18 storage.
7-19 SECTION 3. Section 431.049(a), Health and Safety Code, is
7-20 amended to read as follows:
7-21 (a) If the claimant of the detained or embargoed articles or
7-22 the claimant's agent fails or refuses to transfer the articles to a
7-23 secure place after the tag or other appropriate marking has been
7-24 affixed as provided by Section 431.048, the commissioner or an
7-25 authorized agent may order the transfer of the articles to one or
7-26 more secure storage areas to prevent their unauthorized use,
7-27 removal, or disposal.
8-1 SECTION 4. The importance of this legislation and the
8-2 crowded condition of the calendars in both houses create an
8-3 emergency and an imperative public necessity that the
8-4 constitutional rule requiring bills to be read on three several
8-5 days in each house be suspended, and this rule is hereby suspended,
8-6 and that this Act take effect and be in force from and after its
8-7 passage, and it is so enacted.