By Maxey H.B. No. 492
75R2551 SKB-F
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to activities covered by the Texas Food, Drug and Cosmetic
1-3 Act.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Section 431.002(23), Health and Safety Code, is
1-6 amended to read as follows:
1-7 (23) "Manufacture" means:
1-8 (A) the process of combining or purifying food
1-9 or [and] packaging food for sale to a person [consumer] at
1-10 wholesale or retail, and includes repackaging or otherwise changing
1-11 the container, wrapper, or labeling of any food;
1-12 (B) the process of preparing, propagating,
1-13 compounding, processing, packaging, holding, repackaging, labeling,
1-14 testing, or quality control of a drug or drug product;
1-15 (C) the process of preparing, fabricating,
1-16 assembling, processing, packing, repacking, labeling, or relabeling
1-17 a device; or
1-18 (D) the making of any cosmetic product by
1-19 chemical, physical, biological, or other procedures, including
1-20 manipulation, sampling, testing, or control procedures applied to
1-21 the product.
1-22 SECTION 2. Section 431.021, Health and Safety Code, is
1-23 amended to read as follows:
1-24 Sec. 431.021. Prohibited Acts. The following acts and the
2-1 causing of the following acts within this state are unlawful and
2-2 prohibited:
2-3 (a) the introduction or delivery for introduction into
2-4 commerce of any food, drug, device, or cosmetic that is adulterated
2-5 or misbranded;
2-6 (b) the adulteration or misbranding of any food, drug,
2-7 device, or cosmetic in commerce;
2-8 (c) the receipt in commerce of any food, drug, device, or
2-9 cosmetic that is adulterated or misbranded, and the delivery or
2-10 proffered delivery thereof for pay or otherwise;
2-11 (d) the distribution in commerce of a consumer commodity, if
2-12 such commodity is contained in a package, or if there is affixed to
2-13 that commodity a label that does not conform to the provisions of
2-14 this chapter and of rules adopted under the authority of this
2-15 chapter; provided, however, that this prohibition shall not apply
2-16 to persons engaged in business as wholesale or retail distributors
2-17 of consumer commodities except to the extent that such persons:
2-18 (1) are engaged in the packaging or labeling of such
2-19 commodities; or
2-20 (2) prescribe or specify by any means the manner in
2-21 which such commodities are packaged or labeled;
2-22 (e) the introduction or delivery for introduction into
2-23 commerce of any article in violation of Section 431.084, 431.114,
2-24 or 431.115;
2-25 (f) the dissemination of any false advertisement;
2-26 (g) the refusal to permit entry or inspection, or to permit
2-27 the taking of a sample or to permit access to or copying of any
3-1 record as authorized by Sections 431.042-431.044; or the failure to
3-2 establish or maintain any record or make any report required under
3-3 Section 512(j), (l), or (m) of the federal Act, or the refusal to
3-4 permit access to or verification or copying of any such required
3-5 record;
3-6 (h) the manufacture or sale within this state of any food,
3-7 drug, device, or cosmetic that is adulterated or misbranded;
3-8 (i) the giving of a guaranty or undertaking referred to in
3-9 Section 431.059, which guaranty or undertaking is false, except by
3-10 a person who relied on a guaranty or undertaking to the same effect
3-11 signed by, and containing the name and address of the person
3-12 residing in this state from whom the person received in good faith
3-13 the food, drug, device, or cosmetic; or the giving of a guaranty or
3-14 undertaking referred to in Section 431.059, which guaranty or
3-15 undertaking is false;
3-16 (j) the removal or disposal of a detained or embargoed
3-17 article in violation of Section 431.048;
3-18 (k) the alteration, mutilation, destruction, obliteration,
3-19 or removal of the whole or any part of the labeling of, or the
3-20 doing of any other act with respect to a food, drug, device, or
3-21 cosmetic, if such act is done while such article is held for sale
3-22 after shipment in commerce and results in such article being
3-23 adulterated or misbranded;
3-24 (l)(1) forging, counterfeiting, simulating, or falsely
3-25 representing, or without proper authority using any mark, stamp,
3-26 tag, label, or other identification device authorized or required
3-27 by rules adopted under this chapter or the regulations promulgated
4-1 under the provisions of the federal Act;
4-2 (2) making, selling, disposing of, or keeping in
4-3 possession, control, or custody, or concealing any punch, die,
4-4 plate, stone, or other thing designed to print, imprint, or
4-5 reproduce the trademark, trade name, or other identifying mark,
4-6 imprint, or device of another or any likeness of any of the
4-7 foregoing on any drug or container or labeling thereof so as to
4-8 render such drug a counterfeit drug;
4-9 (3) the doing of any act that causes a drug to be a
4-10 counterfeit drug, or the sale or dispensing, or the holding for
4-11 sale or dispensing, of a counterfeit drug;
4-12 (m) the using by any person to the person's own advantage,
4-13 or revealing, other than to the commissioner, an authorized agent,
4-14 a health authority or to the courts when relevant in any judicial
4-15 proceeding under this chapter, of any information acquired under
4-16 the authority of this chapter concerning any method or process that
4-17 as a trade secret is entitled to protection;
4-18 (n) the using, on the labeling of any drug or device or in
4-19 any advertising relating to such drug or device, of any
4-20 representation or suggestion that approval of an application with
4-21 respect to such drug or device is in effect under Section 431.114
4-22 or Section 505, 515, or 520(g) of the federal Act, as the case may
4-23 be, or that such drug or device complies with the provisions of
4-24 such sections;
4-25 (o) the using, in labeling, advertising or other sales
4-26 promotion of any reference to any report or analysis furnished in
4-27 compliance with Sections 431.042-431.044 or Section 704 of the
5-1 federal Act;
5-2 (p) in the case of a prescription drug distributed or
5-3 offered for sale in this state, the failure of the manufacturer,
5-4 packer, or distributor of the drug to maintain for transmittal, or
5-5 to transmit, to any practitioner licensed by applicable law to
5-6 administer such drug who makes written request for information as
5-7 to such drug, true and correct copies of all printed matter that is
5-8 required to be included in any package in which that drug is
5-9 distributed or sold, or such other printed matter as is approved
5-10 under the federal Act. Nothing in this subsection shall be
5-11 construed to exempt any person from any labeling requirement
5-12 imposed by or under other provisions of this chapter;
5-13 (q)(1) placing or causing to be placed on any drug or device
5-14 or container of any drug or device, with intent to defraud, the
5-15 trade name or other identifying mark, or imprint of another or any
5-16 likeness of any of the foregoing;
5-17 (2) selling, dispensing, disposing of or causing to be
5-18 sold, dispensed, or disposed of, or concealing or keeping in
5-19 possession, control, or custody, with intent to sell, dispense, or
5-20 dispose of, any drug, device, or any container of any drug or
5-21 device, with knowledge that the trade name or other identifying
5-22 mark or imprint of another or any likeness of any of the foregoing
5-23 has been placed thereon in a manner prohibited by Subdivision (1)
5-24 of this subsection; or
5-25 (3) making, selling, disposing of, causing to be made,
5-26 sold, or disposed of, keeping in possession, control, or custody,
5-27 or concealing with intent to defraud any punch, die, plate, stone,
6-1 or other thing designed to print, imprint, or reproduce the
6-2 trademark, trade name, or other identifying mark, imprint, or
6-3 device of another or any likeness of any of the foregoing on any
6-4 drug or container or labeling of any drug or container so as to
6-5 render such drug a counterfeit drug;
6-6 (r) dispensing or causing to be dispensed a different drug
6-7 in place of the drug ordered or prescribed without the express
6-8 permission in each case of the person ordering or prescribing;
6-9 (s) the failure to register in accordance with Section 510
6-10 of the federal Act, the failure to provide any information required
6-11 by Section 510(j) or (k) of the federal Act, or the failure to
6-12 provide a notice required by Section 510(j)(2) of the federal Act;
6-13 (t)(1) the failure or refusal to:
6-14 (A) comply with any requirement prescribed under
6-15 Section 518 or 520(g) of the federal Act; or
6-16 (B) furnish any notification or other material
6-17 or information required by or under Section 519 or 520(g) of the
6-18 federal Act;
6-19 (2) with respect to any device, the submission of any
6-20 report that is required by or under this chapter that is false or
6-21 misleading in any material respect;
6-22 (u) the movement of a device in violation of an order under
6-23 Section 304(g) of the federal Act or the removal or alteration of
6-24 any mark or label required by the order to identify the device as
6-25 detained;
6-26 (v) the failure to provide the notice required by Section
6-27 412(b) or 412(c), the failure to make the reports required by
7-1 Section 412(d)(1)(B), or the failure to meet the requirements
7-2 prescribed under Section 412(d)(2) of the federal Act;
7-3 (w) the acceptance by a person of an unused prescription or
7-4 drug, in whole or in part, for the purpose of resale, after the
7-5 prescription or drug has been originally dispensed, or sold;
7-6 (x) engaging in the wholesale distribution of drugs or
7-7 operating as a distributor or manufacturer of devices in this state
7-8 without filing a licensing statement with the commissioner as
7-9 required by Section 431.202 or having a license as required by
7-10 Section 431.272, as applicable;
7-11 (y) engaging in the manufacture of food in this state
7-12 without first registering with the department as required by
7-13 Section 431.222; or
7-14 (z) unless approved by the United States Food and Drug
7-15 Administration pursuant to the federal Act, the sale, delivery,
7-16 holding, or offering for sale of a self-testing kit designed to
7-17 indicate whether a person has a human immunodeficiency virus
7-18 infection, acquired immune deficiency syndrome, or a related
7-19 disorder or condition.
7-20 SECTION 3. Section 431.042(b), Health and Safety Code, is
7-21 amended to read as follows:
7-22 (b) The inspection of an establishment, including a factory,
7-23 warehouse, or consulting laboratory, in which a [prescription]
7-24 drug, [or restricted] device, or cosmetic is manufactured,
7-25 processed, packed, or held for introduction into commerce extends
7-26 to any place or thing, including a record, file, paper, process,
7-27 control, or facility, in order to determine whether the drug, [or]
8-1 device, or cosmetic:
8-2 (1) is adulterated or misbranded;
8-3 (2) may not be manufactured, introduced into commerce,
8-4 sold or offered for sale under this chapter; or
8-5 (3) is otherwise in violation of this chapter.
8-6 SECTION 4. Sections 431.045(a) and (c), Health and Safety
8-7 Code, are amended to read as follows:
8-8 (a) The commissioner or a person designated by the
8-9 commissioner may issue an emergency order that is restrictive,
8-10 [either] mandatory, or prohibitory in nature [,] in relation to the
8-11 manufacture or sale of a food, drug, device, or cosmetic in the
8-12 department's jurisdiction if the commissioner or the person
8-13 designated by the commissioner determines that:
8-14 (1) the manufacture or sale of the food, drug, device,
8-15 or cosmetic creates or poses an immediate and serious threat to
8-16 human life or health; and
8-17 (2) other procedures available to the department to
8-18 remedy or prevent the occurrence of the situation will result in
8-19 unreasonable delay.
8-20 (c) If an emergency order is issued without a hearing, the
8-21 department shall determine a time and place for a hearing at which
8-22 the emergency order is affirmed, modified, or set aside. The
8-23 hearing shall be held under the contested case provisions of
8-24 Chapter 2001, Government Code, and the board's formal hearing
8-25 [departmental] rules.
8-26 SECTION 5. This Act takes effect September 1, 1997.
8-27 SECTION 6. The importance of this legislation and the
9-1 crowded condition of the calendars in both houses create an
9-2 emergency and an imperative public necessity that the
9-3 constitutional rule requiring bills to be read on three several
9-4 days in each house be suspended, and this rule is hereby suspended.