1-1 By: Moncrief S.B. No. 1046
1-2 (In the Senate - Filed March 2, 2001; March 5, 2001, read
1-3 first time and referred to Committee on Health and Human Services;
1-4 April 11, 2001, reported adversely, with favorable Committee
1-5 Substitute by the following vote: Yeas 7, Nays 0; April 11, 2001,
1-6 sent to printer.)
1-7 COMMITTEE SUBSTITUTE FOR S.B. No. 1046 By: Moncrief
1-8 A BILL TO BE ENTITLED
1-9 AN ACT
1-10 relating to the enforcement powers of the Texas Department of
1-11 Health over food, drugs, devices, and cosmetics.
1-12 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-13 SECTION 1. Section 431.021, Health and Safety Code, is
1-14 amended to read as follows:
1-15 Sec. 431.021. PROHIBITED ACTS. The following acts and the
1-16 causing of the following acts within this state are unlawful and
1-17 prohibited:
1-18 (a) the introduction or delivery for introduction into
1-19 commerce of any food, drug, device, or cosmetic that is adulterated
1-20 or misbranded;
1-21 (b) the adulteration or misbranding of any food, drug,
1-22 device, or cosmetic in commerce;
1-23 (c) the receipt in commerce of any food, drug, device,
1-24 or cosmetic that is adulterated or misbranded, and the delivery or
1-25 proffered delivery thereof for pay or otherwise;
1-26 (d) the distribution in commerce of a consumer
1-27 commodity, if such commodity is contained in a package, or if there
1-28 is affixed to that commodity a label that does not conform to the
1-29 provisions of this chapter and of rules adopted under the authority
1-30 of this chapter; provided, however, that this prohibition shall not
1-31 apply to persons engaged in business as wholesale or retail
1-32 distributors of consumer commodities except to the extent that such
1-33 persons:
1-34 (1) are engaged in the packaging or labeling of
1-35 such commodities; or
1-36 (2) prescribe or specify by any means the manner
1-37 in which such commodities are packaged or labeled;
1-38 (e) the introduction or delivery for introduction into
1-39 commerce of any article in violation of Section 431.084, 431.114,
1-40 or 431.115;
1-41 (f) the dissemination of any false advertisement;
1-42 (g) the refusal to permit entry or inspection, or to
1-43 permit the taking of a sample or to permit access to or copying of
1-44 any record as authorized by Sections 431.042-431.044; or the
1-45 failure to establish or maintain any record or make any report
1-46 required under Section 512(j), (l), or (m) of the federal Act, or
1-47 the refusal to permit access to or verification or copying of any
1-48 such required record;
1-49 (h) the manufacture within this state of any food,
1-50 drug, device, or cosmetic that is adulterated or misbranded;
1-51 (i) the giving of a guaranty or undertaking referred
1-52 to in Section 431.059, which guaranty or undertaking is false,
1-53 except by a person who relied on a guaranty or undertaking to the
1-54 same effect signed by, and containing the name and address of the
1-55 person residing in this state from whom the person received in good
1-56 faith the food, drug, device, or cosmetic; or the giving of a
1-57 guaranty or undertaking referred to in Section 431.059, which
1-58 guaranty or undertaking is false;
1-59 (j) the use, removal, or disposal of a detained or
1-60 embargoed article in violation of Section 431.048;
1-61 (k) the alteration, mutilation, destruction,
1-62 obliteration, or removal of the whole or any part of the labeling
1-63 of, or the doing of any other act with respect to a food, drug,
1-64 device, or cosmetic, if such act is done while such article is held
2-1 for sale after shipment in commerce and results in such article
2-2 being adulterated or misbranded;
2-3 (l)(1) forging, counterfeiting, simulating, or falsely
2-4 representing, or without proper authority using any mark, stamp,
2-5 tag, label, or other identification device authorized or required
2-6 by rules adopted under this chapter or the regulations promulgated
2-7 under the provisions of the federal Act;
2-8 (2) making, selling, disposing of, or keeping in
2-9 possession, control, or custody, or concealing any punch, die,
2-10 plate, stone, or other thing designed to print, imprint, or
2-11 reproduce the trademark, trade name, or other identifying mark,
2-12 imprint, or device of another or any likeness of any of the
2-13 foregoing on any drug or container or labeling thereof so as to
2-14 render such drug a counterfeit drug;
2-15 (3) the doing of any act that causes a drug to
2-16 be a counterfeit drug, or the sale or dispensing, or the holding
2-17 for sale or dispensing, of a counterfeit drug;
2-18 (m) the using by any person to the person's own
2-19 advantage, or revealing, other than to the commissioner, an
2-20 authorized agent, a health authority or to the courts when relevant
2-21 in any judicial proceeding under this chapter, of any information
2-22 acquired under the authority of this chapter concerning any method
2-23 or process that as a trade secret is entitled to protection;
2-24 (n) the using, on the labeling of any drug or device
2-25 or in any advertising relating to such drug or device, of any
2-26 representation or suggestion that approval of an application with
2-27 respect to such drug or device is in effect under Section 431.114
2-28 or Section 505, 515, or 520(g) of the federal Act, as the case may
2-29 be, or that such drug or device complies with the provisions of
2-30 such sections;
2-31 (o) the using, in labeling, advertising or other sales
2-32 promotion of any reference to any report or analysis furnished in
2-33 compliance with Sections 431.042-431.044 or Section 704 of the
2-34 federal Act;
2-35 (p) in the case of a prescription drug distributed or
2-36 offered for sale in this state, the failure of the manufacturer,
2-37 packer, or distributor of the drug to maintain for transmittal, or
2-38 to transmit, to any practitioner licensed by applicable law to
2-39 administer such drug who makes written request for information as
2-40 to such drug, true and correct copies of all printed matter that is
2-41 required to be included in any package in which that drug is
2-42 distributed or sold, or such other printed matter as is approved
2-43 under the federal Act. Nothing in this subsection shall be
2-44 construed to exempt any person from any labeling requirement
2-45 imposed by or under other provisions of this chapter;
2-46 (q)(1) placing or causing to be placed on any drug or
2-47 device or container of any drug or device, with intent to defraud,
2-48 the trade name or other identifying mark, or imprint of another or
2-49 any likeness of any of the foregoing;
2-50 (2) selling, dispensing, disposing of or causing
2-51 to be sold, dispensed, or disposed of, or concealing or keeping in
2-52 possession, control, or custody, with intent to sell, dispense, or
2-53 dispose of, any drug, device, or any container of any drug or
2-54 device, with knowledge that the trade name or other identifying
2-55 mark or imprint of another or any likeness of any of the foregoing
2-56 has been placed thereon in a manner prohibited by Subdivision (1)
2-57 of this subsection; or
2-58 (3) making, selling, disposing of, causing to be
2-59 made, sold, or disposed of, keeping in possession, control, or
2-60 custody, or concealing with intent to defraud any punch, die,
2-61 plate, stone, or other thing designed to print, imprint, or
2-62 reproduce the trademark, trade name, or other identifying mark,
2-63 imprint, or device of another or any likeness of any of the
2-64 foregoing on any drug or container or labeling of any drug or
2-65 container so as to render such drug a counterfeit drug;
2-66 (r) dispensing or causing to be dispensed a different
2-67 drug in place of the drug ordered or prescribed without the express
2-68 permission in each case of the person ordering or prescribing;
2-69 (s) the failure to register in accordance with Section
3-1 510 of the federal Act, the failure to provide any information
3-2 required by Section 510(j) or (k) of the federal Act, or the
3-3 failure to provide a notice required by Section 510(j)(2) of the
3-4 federal Act;
3-5 (t)(1) the failure or refusal to:
3-6 (A) comply with any requirement prescribed
3-7 under Section 518 or 520(g) of the federal Act; or
3-8 (B) furnish any notification or other
3-9 material or information required by or under Section 519 or 520(g)
3-10 of the federal Act;
3-11 (2) with respect to any device, the submission
3-12 of any report that is required by or under this chapter that is
3-13 false or misleading in any material respect;
3-14 (u) the movement of a device in violation of an order
3-15 under Section 304(g) of the federal Act or the removal or
3-16 alteration of any mark or label required by the order to identify
3-17 the device as detained;
3-18 (v) the failure to provide the notice required by
3-19 Section 412(b) or 412(c), the failure to make the reports required
3-20 by Section 412(d)(1)(B), or the failure to meet the requirements
3-21 prescribed under Section 412(d)(2) of the federal Act;
3-22 (w) the acceptance by a person of an unused
3-23 prescription or drug, in whole or in part, for the purpose of
3-24 resale, after the prescription or drug has been originally
3-25 dispensed, or sold;
3-26 (x) engaging in the wholesale distribution of drugs or
3-27 operating as a distributor or manufacturer of devices in this state
3-28 without filing a licensing statement with the commissioner as
3-29 required by Section 431.202 or having a license as required by
3-30 Section 431.272, as applicable;
3-31 (y) engaging in the manufacture of food in this state
3-32 or operating as a food wholesaler in this state without having a
3-33 license [first registering with the department] as required by
3-34 Section 431.222; or
3-35 (z) unless approved by the United States Food and Drug
3-36 Administration pursuant to the federal Act, the sale, delivery,
3-37 holding, or offering for sale of a self-testing kit designed to
3-38 indicate whether a person has a human immunodeficiency virus
3-39 infection, acquired immune deficiency syndrome, or a related
3-40 disorder or condition.
3-41 SECTION 2. Subsection (a), Section 431.045, Health and
3-42 Safety Code, is amended to read as follows:
3-43 (a) The commissioner or a person designated by the
3-44 commissioner may issue an emergency order, either mandatory or
3-45 prohibitory in nature, in relation to the manufacture or
3-46 distribution of a food, drug, device, or cosmetic in the
3-47 department's jurisdiction if the commissioner or the person
3-48 designated by the commissioner determines that:
3-49 (1) the manufacture or distribution of the food, drug,
3-50 device, or cosmetic creates or poses an immediate and serious
3-51 threat to human life or health; and
3-52 (2) other procedures available to the department to
3-53 remedy or prevent the occurrence of the situation will result in
3-54 unreasonable delay.
3-55 SECTION 3. Section 431.2211, Health and Safety Code, is
3-56 amended to read as follows:
3-57 Sec. 431.2211. APPLICATION OF SUBCHAPTER. (a) A person is
3-58 not required to hold a license under this [This] subchapter if the
3-59 person is [does not apply to]:
3-60 (1) a person, firm, or corporation that only harvests,
3-61 packages, washes, or ships raw fruits or vegetables;
3-62 (2) an individual who only sells prepackaged
3-63 nonperishable foods, including dietary supplements, from a private
3-64 home as a direct seller; or
3-65 (3) a person who holds a license under Chapter 432 and
3-66 who only engages in conduct within the scope of that license.
3-67 (b) An exemption from the licensing requirements prescribed
3-68 by this subchapter does not exempt the person from other provisions
3-69 prescribed by this subchapter or from rules adopted by the board to
4-1 administer and enforce those provisions.
4-2 (c) This subchapter does not apply to [engaged solely in]
4-3 the distribution of [alcoholic] beverages in sealed containers by
4-4 holders of licenses or permits issued under Chapter 19, 20, 21, 23,
4-5 64, or 65, Alcoholic Beverage Code. The provisions of the
4-6 Alcoholic Beverage Code prevail to the extent of any conflict with
4-7 this chapter.
4-8 SECTION 4. This Act takes effect September 1, 2001.
4-9 * * * * *