By Van de Putte H.B. No. 1075
75R3605 SKB-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to prohibited acts, inspections, and emergency orders
1-3 under the Texas Food, Drug, and Cosmetic Act.
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
1-23 not apply to persons engaged in business as wholesale or retail
1-24 distributors of consumer commodities except to the extent that such
2-1 persons:
2-2 (1) are engaged in the packaging or labeling of
2-3 such commodities; or
2-4 (2) prescribe or specify by any means the manner
2-5 in which such commodities are packaged or labeled;
2-6 (e) the introduction or delivery for introduction into
2-7 commerce of any article in violation of Section 431.084, 431.114,
2-8 or 431.115;
2-9 (f) the dissemination of any false advertisement;
2-10 (g) the refusal to permit entry or inspection, or to
2-11 permit the taking of a sample or to permit access to or copying of
2-12 any record as authorized by Sections 431.042-431.044; or the
2-13 failure to establish or maintain any record or make any report
2-14 required under Section 512(j), (l), or (m) of the federal Act, or
2-15 the refusal to permit access to or verification or copying of any
2-16 such required record;
2-17 (h) the sale [manufacture] within this state of any
2-18 food, drug, device, or cosmetic that is adulterated or misbranded;
2-19 (i) the giving of a guaranty or undertaking referred
2-20 to in Section 431.059, which guaranty or undertaking is false,
2-21 except by a person who relied on a guaranty or undertaking to the
2-22 same effect signed by, and containing the name and address of the
2-23 person residing in this state from whom the person received in good
2-24 faith the food, drug, device, or cosmetic; or the giving of a
2-25 guaranty or undertaking referred to in Section 431.059, which
2-26 guaranty or undertaking is false;
2-27 (j) the removal or disposal of a detained or embargoed
3-1 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
3-27 acquired under the authority of this chapter concerning any method
4-1 or process that as a trade secret is entitled to protection;
4-2 (n) the using, on the labeling of any drug or device
4-3 or in any advertising relating to such drug or device, of any
4-4 representation or suggestion that approval of an application with
4-5 respect to such drug or device is in effect under Section 431.114
4-6 or Section 505, 515, or 520(g) of the federal Act, as the case may
4-7 be, or that such drug or device complies with the provisions of
4-8 such sections;
4-9 (o) the using, in labeling, advertising or other sales
4-10 promotion of any reference to any report or analysis furnished in
4-11 compliance with Sections 431.042-431.044 or Section 704 of the
4-12 federal Act;
4-13 (p) in the case of a [prescription] drug distributed
4-14 or offered for sale in this state, the failure of the manufacturer,
4-15 packer, or distributor of the drug to maintain for transmittal, or
4-16 to transmit, to any practitioner licensed by applicable law to
4-17 administer such drug who makes written request for information as
4-18 to such drug, true and correct copies of all printed matter that is
4-19 required to be included in any package in which that drug is
4-20 distributed or sold, or such other printed matter as is approved
4-21 under the federal Act. Nothing in this subsection shall be
4-22 construed to exempt any person from any labeling requirement
4-23 imposed by or under other provisions of this chapter;
4-24 (q)(1) placing or causing to be placed on any drug or
4-25 device or container of any drug or device, with intent to defraud,
4-26 the trade name or other identifying mark, or imprint of another or
4-27 any likeness of any of the foregoing;
5-1 (2) selling, dispensing, disposing of or causing
5-2 to be sold, dispensed, or disposed of, or concealing or keeping in
5-3 possession, control, or custody, with intent to sell, dispense, or
5-4 dispose of, any drug, device, or any container of any drug or
5-5 device, with knowledge that the trade name or other identifying
5-6 mark or imprint of another or any likeness of any of the foregoing
5-7 has been placed thereon in a manner prohibited by Subdivision (1)
5-8 of this subsection; or
5-9 (3) making, selling, disposing of, causing to be
5-10 made, sold, or disposed of, keeping in possession, control, or
5-11 custody, or concealing with intent to defraud any punch, die,
5-12 plate, stone, or other thing designed to print, imprint, or
5-13 reproduce the trademark, trade name, or other identifying mark,
5-14 imprint, or device of another or any likeness of any of the
5-15 foregoing on any drug or container or labeling of any drug or
5-16 container so as to render such drug a counterfeit drug;
5-17 (r) dispensing or causing to be dispensed a different
5-18 drug in place of the drug ordered or prescribed without the express
5-19 permission in each case of the person ordering or prescribing;
5-20 (s) the failure to register in accordance with Section
5-21 510 of the federal Act, the failure to provide any information
5-22 required by Section 510(j) or (k) of the federal Act, or the
5-23 failure to provide a notice required by Section 510(j)(2) of the
5-24 federal Act;
5-25 (t)(1) the failure or refusal to:
5-26 (A) comply with any requirement prescribed
5-27 under Section 518 or 520(g) of the federal Act; or
6-1 (B) furnish any notification or other
6-2 material or information required by or under Section 519 or 520(g)
6-3 of the federal Act;
6-4 (2) with respect to any device, the submission
6-5 of any report that is required by or under this chapter that is
6-6 false or misleading in any material respect;
6-7 (u) the movement of a device in violation of an order
6-8 under Section 304(g) of the federal Act or the removal or
6-9 alteration of any mark or label required by the order to identify
6-10 the device as detained;
6-11 (v) the failure to provide the notice required by
6-12 Section 412(b) or 412(c), the failure to make the reports required
6-13 by Section 412(d)(1)(B), or the failure to meet the requirements
6-14 prescribed under Section 412(d)(2) of the federal Act;
6-15 (w) the acceptance by a person of an unused
6-16 prescription or drug, in whole or in part, for the purpose of
6-17 resale, after the prescription or drug has been originally
6-18 dispensed, or sold;
6-19 (x) engaging in the wholesale distribution of drugs or
6-20 operating as a distributor or manufacturer of devices in this state
6-21 without filing a licensing statement with the commissioner as
6-22 required by Section 431.202 or having a license as required by
6-23 Section 431.272, as applicable;
6-24 (y) engaging in the manufacture of food in this state
6-25 without first registering with the department as required by
6-26 Section 431.222; or
6-27 (z) unless approved by the United States Food and Drug
7-1 Administration pursuant to the federal Act, the sale, delivery,
7-2 holding, or offering for sale of a self-testing kit designed to
7-3 indicate whether a person has a human immunodeficiency virus
7-4 infection, acquired immune deficiency syndrome, or a related
7-5 disorder or condition.
7-6 SECTION 2. Sections 431.042(b) and (c), Health and Safety
7-7 Code, are amended to read as follows:
7-8 (b) The inspection of an establishment, including a factory,
7-9 warehouse, or consulting laboratory, in which a [prescription]
7-10 drug, [or restricted] device, or cosmetic is manufactured,
7-11 processed, packed, or held for introduction into commerce extends
7-12 to any place or thing, including a record, file, paper, process,
7-13 control, or facility, in order to determine whether the drug, [or]
7-14 device, or cosmetic:
7-15 (1) is adulterated or misbranded;
7-16 (2) may not be manufactured, introduced into commerce,
7-17 sold, or offered for sale under this chapter; or
7-18 (3) is otherwise in violation of this chapter.
7-19 (c) An inspection under Subsection (b) may not extend to:
7-20 (1) financial data that is not related to the
7-21 investigation of the sale of a drug in violation of a purchasing
7-22 agreement;
7-23 (2) sales data other than shipment data;
7-24 (3) pricing data;
7-25 (4) personnel data other than data relating to the
7-26 qualifications of technical and professional personnel performing
7-27 functions under this chapter;
8-1 (5) research data other than data:
8-2 (A) relating to new drugs, antibiotic drugs, and
8-3 devices; and
8-4 (B) subject to reporting and inspection under
8-5 regulations issued under Section 505(i) or (j), 507(d) or (g), 519,
8-6 or 520(g) of the federal Act; or
8-7 (6) data relating to other drugs or devices that, in
8-8 the case of a new drug, would be subject to reporting or inspection
8-9 under regulations issued under Section 505(j) of the federal Act.
8-10 SECTION 3. Section 431.045(a), Health and Safety Code, is
8-11 amended to read as follows:
8-12 (a) The commissioner or a person designated by the
8-13 commissioner may issue an emergency order, either mandatory or
8-14 prohibitory in nature, in relation to the sale [manufacture] of a
8-15 food, drug, device, or cosmetic in the department's jurisdiction if
8-16 the commissioner or the person designated by the commissioner
8-17 determines that:
8-18 (1) the sale [manufacture] of the food, drug, device,
8-19 or cosmetic creates or poses an immediate and serious threat to
8-20 human life or health; and
8-21 (2) other procedures available to the department to
8-22 remedy or prevent the occurrence of the situation will result in
8-23 unreasonable delay.
8-24 SECTION 4. This Act takes effect September 1, 1997.
8-25 SECTION 5. The importance of this legislation and the
8-26 crowded condition of the calendars in both houses create an
8-27 emergency and an imperative public necessity that the
9-1 constitutional rule requiring bills to be read on three several
9-2 days in each house be suspended, and this rule is hereby suspended.