By: Moncrief S.B. No. 1046
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the enforcement powers of the Texas Department of
1-3 Health over food, drugs, devices, and cosmetics.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Section 431.021, Health and Safety Code, is
1-6 amended to read as follows:
1-7 Sec. 431.021. PROHIBITED ACTS. The following acts and the
1-8 causing of the following acts within this state are unlawful and
1-9 prohibited:
1-10 (a) the introduction or delivery for introduction into
1-11 commerce of any food, drug, device, or cosmetic that is adulterated
1-12 or misbranded;
1-13 (b) the adulteration or misbranding of any food, drug,
1-14 device, or cosmetic in commerce;
1-15 (c) the receipt in commerce of any food, drug, device,
1-16 or cosmetic that is adulterated or misbranded, and the delivery or
1-17 proffered delivery thereof for pay or otherwise;
1-18 (d) the distribution in commerce of a consumer
1-19 commodity, if such commodity is contained in a package, or if there
1-20 is affixed to that commodity a label that does not conform to the
1-21 provisions of this chapter and of rules adopted under the authority
1-22 of this chapter; provided, however, that this prohibition shall not
1-23 apply to persons engaged in business as wholesale or retail
1-24 distributors of consumer commodities except to the extent that such
1-25 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
3-1 embargoed article in violation of Section 431.048;
3-2 (k) the alteration, mutilation, destruction,
3-3 obliteration, or removal of the whole or any part of the labeling
3-4 of, or the doing of any other act with respect to a food, drug,
3-5 device, or cosmetic, if such act is done while such article is held
3-6 for sale after shipment in commerce and results in such article
3-7 being adulterated or misbranded;
3-8 (l)(1) forging, counterfeiting, simulating, or falsely
3-9 representing, or without proper authority using any mark, stamp,
3-10 tag, label, or other identification device authorized or required
3-11 by rules adopted under this chapter or the regulations promulgated
3-12 under the provisions of the federal Act;
3-13 (2) making, selling, disposing of, or keeping in
3-14 possession, control, or custody, or concealing any punch, die,
3-15 plate, stone, or other thing designed to print, imprint, or
3-16 reproduce the trademark, trade name, or other identifying mark,
3-17 imprint, or device of another or any likeness of any of the
3-18 foregoing on any drug or container or labeling thereof so as to
3-19 render such drug a counterfeit drug;
3-20 (3) the doing of any act that causes a drug to
3-21 be a counterfeit drug, or the sale or dispensing, or the holding
3-22 for sale or dispensing, of a counterfeit drug;
3-23 (m) the using by any person to the person's own
3-24 advantage, or revealing, other than to the commissioner, an
3-25 authorized agent, a health authority or to the courts when relevant
3-26 in any judicial proceeding under this chapter, of any information
4-1 acquired under the authority of this chapter concerning any method
4-2 or process that as a trade secret is entitled to protection;
4-3 (n) the using, on the labeling of any drug or device
4-4 or in any advertising relating to such drug or device, of any
4-5 representation or suggestion that approval of an application with
4-6 respect to such drug or device is in effect under Section 431.114
4-7 or Section 505, 515, or 520(g) of the federal Act, as the case may
4-8 be, or that such drug or device complies with the provisions of
4-9 such sections;
4-10 (o) the using, in labeling, advertising or other sales
4-11 promotion of any reference to any report or analysis furnished in
4-12 compliance with Sections 431.042-431.044 or Section 704 of the
4-13 federal Act;
4-14 (p) in the case of a prescription drug distributed or
4-15 offered for sale in this state, the failure of the manufacturer,
4-16 packer, or distributor of the drug to maintain for transmittal, or
4-17 to transmit, to any practitioner licensed by applicable law to
4-18 administer such drug who makes written request for information as
4-19 to such drug, true and correct copies of all printed matter that is
4-20 required to be included in any package in which that drug is
4-21 distributed or sold, or such other printed matter as is approved
4-22 under the federal Act. Nothing in this subsection shall be
4-23 construed to exempt any person from any labeling requirement
4-24 imposed by or under other provisions of this chapter;
4-25 (q)(1) placing or causing to be placed on any drug or
4-26 device or container of any drug or device, with intent to defraud,
5-1 the trade name or other identifying mark, or imprint of another or
5-2 any likeness of any of the foregoing;
5-3 (2) selling, dispensing, disposing of or causing
5-4 to be sold, dispensed, or disposed of, or concealing or keeping in
5-5 possession, control, or custody, with intent to sell, dispense, or
5-6 dispose of, any drug, device, or any container of any drug or
5-7 device, with knowledge that the trade name or other identifying
5-8 mark or imprint of another or any likeness of any of the foregoing
5-9 has been placed thereon in a manner prohibited by Subdivision (1)
5-10 of this subsection; or
5-11 (3) making, selling, disposing of, causing to be
5-12 made, sold, or disposed of, keeping in possession, control, or
5-13 custody, or concealing with intent to defraud any punch, die,
5-14 plate, stone, or other thing designed to print, imprint, or
5-15 reproduce the trademark, trade name, or other identifying mark,
5-16 imprint, or device of another or any likeness of any of the
5-17 foregoing on any drug or container or labeling of any drug or
5-18 container so as to render such drug a counterfeit drug;
5-19 (r) dispensing or causing to be dispensed a different
5-20 drug in place of the drug ordered or prescribed without the express
5-21 permission in each case of the person ordering or prescribing;
5-22 (s) the failure to register in accordance with Section
5-23 510 of the federal Act, the failure to provide any information
5-24 required by Section 510(j) or (k) of the federal Act, or the
5-25 failure to provide a notice required by Section 510(j)(2) of the
5-26 federal Act;
6-1 (t)(1) the failure or refusal to:
6-2 (A) comply with any requirement prescribed
6-3 under Section 518 or 520(g) of the federal Act; or
6-4 (B) furnish any notification or other
6-5 material or information required by or under Section 519 or 520(g)
6-6 of the federal Act;
6-7 (2) with respect to any device, the submission
6-8 of any report that is required by or under this chapter that is
6-9 false or misleading in any material respect;
6-10 (u) the movement of a device in violation of an order
6-11 under Section 304(g) of the federal Act or the removal or
6-12 alteration of any mark or label required by the order to identify
6-13 the device as detained;
6-14 (v) the failure to provide the notice required by
6-15 Section 412(b) or 412(c), the failure to make the reports required
6-16 by Section 412(d)(1)(B), or the failure to meet the requirements
6-17 prescribed under Section 412(d)(2) of the federal Act;
6-18 (w) the acceptance by a person of an unused
6-19 prescription or drug, in whole or in part, for the purpose of
6-20 resale, after the prescription or drug has been originally
6-21 dispensed, or sold;
6-22 (x) engaging in the wholesale distribution of drugs or
6-23 operating as a distributor or manufacturer of devices in this state
6-24 without filing a licensing statement with the commissioner as
6-25 required by Section 431.202 or having a license as required by
6-26 Section 431.272, as applicable;
7-1 (y) engaging in the manufacture of food in this state
7-2 or operating as a food wholesaler in this state without having a
7-3 license [first registering with the department] as required by
7-4 Section 431.222; or
7-5 (z) unless approved by the United States Food and Drug
7-6 Administration pursuant to the federal Act, the sale, delivery,
7-7 holding, or offering for sale of a self-testing kit designed to
7-8 indicate whether a person has a human immunodeficiency virus
7-9 infection, acquired immune deficiency syndrome, or a related
7-10 disorder or condition.
7-11 SECTION 2. Subsection (a), Section 431.045, Health and
7-12 Safety Code, is amended to read as follows:
7-13 (a) The commissioner or a person designated by the
7-14 commissioner may issue an emergency order, either mandatory or
7-15 prohibitory in nature, in relation to the manufacture or
7-16 distribution of a food, drug, device, or cosmetic in the
7-17 department's jurisdiction if the commissioner or the person
7-18 designated by the commissioner determines that:
7-19 (1) the manufacture or distribution of the food, drug,
7-20 device, or cosmetic creates or poses an immediate and serious
7-21 threat to human life or health; and
7-22 (2) other procedures available to the department to
7-23 remedy or prevent the occurrence of the situation will result in
7-24 unreasonable delay.
7-25 SECTION 3. Section 431.2211, Health and Safety Code, is
7-26 amended to read as follows:
8-1 Sec. 431.2211. APPLICATION OF SUBCHAPTER. (a) A person is
8-2 not required to hold a license under this [This] subchapter if the
8-3 person is [does not apply to]:
8-4 (1) a person, firm, or corporation that only harvests,
8-5 packages, washes, or ships raw fruits or vegetables;
8-6 (2) an individual who only sells prepackaged
8-7 nonperishable foods, including dietary supplements, from a private
8-8 home as a direct seller; or
8-9 (3) a person who holds a license under Chapter 432 and
8-10 who only engages in conduct within the scope of that license.
8-11 (b) An exemption from the licensing requirements prescribed
8-12 by this subchapter does not exempt the person from other provisions
8-13 prescribed by this subchapter or from rules adopted by the board to
8-14 administer and enforce those provisions.
8-15 (c) This subchapter does not apply to [engaged solely in]
8-16 the distribution of [alcoholic] beverages in sealed containers by
8-17 holders of licenses or permits issued under Chapter 19, 20, 21, 23,
8-18 64, or 65, Alcoholic Beverage Code. The provisions of the
8-19 Alcoholic Beverage Code prevail to the extent of any conflict with
8-20 this chapter.
8-21 SECTION 4. This Act takes effect September 1, 2001.