1-1 AN ACT
1-2 relating to certain misbranded drugs and devices and the use of
1-3 certain detained or embargoed articles.
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 manufacture within this state of any food,
2-18 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 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
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 or
4-14 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 431.048(b) and (c), Health and Safety
7-7 Code, are amended to read as follows:
7-8 (b) The tag or marking on a detained or embargoed article
7-9 must warn all persons not to use the article, remove the article
7-10 from the premises, or dispose of the article by sale or otherwise
7-11 until permission for use, removal, or disposal is given by the
7-12 commissioner, the authorized agent, or a court.
7-13 (c) A person may not use a detained or embargoed article,
7-14 remove a detained or embargoed article from the premises, or
7-15 dispose of a detained or embargoed article [it] by sale or
7-16 otherwise without permission of the commissioner, the authorized
7-17 agent, or a court. The commissioner or the authorized agent may
7-18 permit perishable goods to be moved to a place suitable for proper
7-19 storage.
7-20 SECTION 3. Section 431.049(a), Health and Safety Code, is
7-21 amended to read as follows:
7-22 (a) If the claimant of the detained or embargoed articles or
7-23 the claimant's agent fails or refuses to transfer the articles to a
7-24 secure place after the tag or other appropriate marking has been
7-25 affixed as provided by Section 431.048, the commissioner or an
7-26 authorized agent may order the transfer of the articles to one or
7-27 more secure storage areas to prevent their unauthorized use,
8-1 removal, or disposal.
8-2 SECTION 4. Section 431.112, Health and Safety Code, is
8-3 amended to read as follows:
8-4 Sec. 431.112. Misbranded Drug or Device. A drug or device
8-5 shall be deemed to be misbranded:
8-6 (a)(1) if its labeling is false or misleading in any
8-7 particular; or
8-8 (2) if its labeling or packaging fails to
8-9 conform with the requirements of Section 431.181.
8-10 (b) if in a package form unless it bears a label
8-11 containing (1) the name and place of business of the manufacturer,
8-12 packer, or distributor; and (2) an accurate statement of the
8-13 quantity of the contents in terms of weight, measure, or numerical
8-14 count; provided, that under Subdivision (2) reasonable variations
8-15 shall be permitted, and exemptions as to small packages shall be
8-16 allowed in accordance with regulations prescribed by the secretary
8-17 under the federal Act;
8-18 (c) if any word, statement, or other information
8-19 required by or under authority of this chapter to appear on the
8-20 label or labeling is not prominently placed thereon with such
8-21 conspicuousness (as compared with other words, statements, designs,
8-22 or devices, in the labeling) and in such terms as to render it
8-23 likely to be read and understood by the ordinary individual under
8-24 customary conditions of purchase and use;
8-25 (d) if it is for use by man and contains any quantity
8-26 of the narcotic or hypnotic substance alpha-eucaine, barbituric
8-27 acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca,
9-1 cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde,
9-2 peyote, or sulphonmethane, or any chemical derivative of such
9-3 substance, which derivative, after investigation, has been found to
9-4 be designated as habit forming, by regulations issued by the
9-5 secretary under Section 502(d) of the federal Act, unless its label
9-6 bears the name and quantity or proportion of such substance or
9-7 derivative and in juxtaposition therewith the statement,
9-8 "Warning: May be habit forming";
9-9 (e)(1) if it is a drug, unless:
9-10 (A) its label bears, to the exclusion of
9-11 any other nonproprietary name (except the applicable systematic
9-12 chemical name or the chemical formula):
9-13 (i) the established name
9-14 (as defined in Subdivision (3)) of the drug, if any; and
9-15 (ii) in case it is
9-16 fabricated from two or more ingredients, the established name and
9-17 quantity of each active ingredient, including the quantity, kind,
9-18 and proportion of any alcohol, and also including, whether active
9-19 or not, the established name and quantity or proportion of any
9-20 bromides, ether, chloroform, acetanilid, acetphenetidin,
9-21 amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic,
9-22 digitalis, digitalis glucosides, mercury, ouabain, strophanthin,
9-23 strychnine, thyroid, or any derivative or preparation of any such
9-24 substances, contained therein; provided, that the requirement for
9-25 stating the quantity of the active ingredients, other than the
9-26 quantity of those specifically named in this subparagraph shall
9-27 apply only to prescription drugs; and
10-1 (B) for any prescription drug the
10-2 established name of the drug or ingredient, as the case may be, on
10-3 the label (and on any labeling on which a name for such drug or
10-4 ingredient is used) is printed prominently and in type at least
10-5 half as large as that used thereon for any proprietary name or
10-6 designation for such drug or ingredient; and provided, that to the
10-7 extent that compliance with the requirements of Paragraph (A)(ii)
10-8 or this paragraph is impracticable, exemptions shall be allowed
10-9 under regulations promulgated by the secretary under the federal
10-10 Act;
10-11 (2) if it is a device and it has an established
10-12 name, unless its label bears, to the exclusion of any other
10-13 nonproprietary name, its established name (as defined in
10-14 Subdivision (4)) prominently printed in type at least half as large
10-15 as that used thereon for any proprietary name or designation for
10-16 such device, except that to the extent compliance with this
10-17 subdivision is impracticable, exemptions shall be allowed under
10-18 regulations promulgated by the secretary under the federal Act;
10-19 (3) as used in Subdivision (1), the term
10-20 "established name," with respect to a drug or ingredient thereof,
10-21 means:
10-22 (A) the applicable official name
10-23 designated pursuant to Section 508 of the federal Act; or
10-24 (B) if there is no such name and such
10-25 drug, or such ingredient, is an article recognized in an official
10-26 compendium, then the official title thereof in such compendium; or
10-27 (C) if neither Paragraph (A) nor Paragraph
11-1 (B) applies, then the common or usual name, if any, of such drug or
11-2 of such ingredient; provided further, that where Paragraph (B)
11-3 applies to an article recognized in the United States Pharmacopoeia
11-4 National Formulary, the official title used in the United States
11-5 Pharmacopoeia National Formulary shall apply;
11-6 (4) as used in Subdivision (2), the term
11-7 "established name" with respect to a device means:
11-8 (A) the applicable official name of the
11-9 device designated pursuant to Section 508 of the federal Act;
11-10 (B) if there is no such name and such
11-11 device is an article recognized in an official compendium, then the
11-12 official title thereof in such compendium; or
11-13 (C) if neither Paragraph (A) nor Paragraph
11-14 (B) applies, then any common or usual name of such device;
11-15 (f) unless its labeling bears:
11-16 (1) adequate directions for use; and
11-17 (2) such adequate warnings against use in those
11-18 pathological conditions or by children where its use may be
11-19 dangerous to health, or against unsafe dosage or methods or
11-20 durations of administration or application, in such manner and
11-21 form, as are necessary for the protection of users unless the drug
11-22 or device has been exempted from those requirements by the
11-23 regulations adopted by the secretary;
11-24 (g) if it purports to be a drug the name of which is
11-25 recognized in an official compendium, unless it is packaged and
11-26 labeled as prescribed therein unless the method of packing has been
11-27 modified with the consent of the secretary. Whenever a drug is
12-1 recognized in the United States Pharmacopoeia National Formulary,
12-2 it shall be subject to the requirements of the United States
12-3 Pharmacopoeia National Formulary with respect to packaging and
12-4 labeling. If there is an inconsistency between the requirements of
12-5 this subsection and those of Subsection (e) as to the name by which
12-6 the drug or its ingredients shall be designated, the requirements
12-7 of Subsection (e) prevail;
12-8 (h) if it has been found by the secretary to be a drug
12-9 liable to deterioration, unless it is packaged in such form and
12-10 manner, and its label bears a statement of such precautions, as the
12-11 secretary shall by regulations require as necessary for the
12-12 protection of public health;
12-13 (i) if:
12-14 (1) it is a drug and its container is so made,
12-15 formed, or filled as to be misleading; or
12-16 (2) it is an imitation of another drug; or
12-17 (3) it is offered for sale under the name of
12-18 another drug;
12-19 (j) if it is dangerous to health when used in the
12-20 dosage, or manner or with the frequency or duration prescribed,
12-21 recommended, or suggested in the labeling thereof;
12-22 (k) if it is, or purports to be, or is represented as
12-23 a drug composed wholly or partly of insulin, unless:
12-24 (1) it is from a batch with respect to which a
12-25 certificate or release has been issued pursuant to Section 506 of
12-26 the federal Act; and
12-27 (2) such certificate or release is in effect
13-1 with respect to such drug;
13-2 (l) if it is, or purports to be, or is represented as
13-3 a drug (except a drug for use in animals other than man) composed
13-4 wholly or partly of any kind of penicillin, streptomycin,
13-5 chlortetracycline, chloramphenicol, bacitracin, or any other
13-6 antibiotic drug, or any derivative thereof, unless:
13-7 (1) it is from a batch with respect to which a
13-8 certificate or release has been issued pursuant to Section 507 of
13-9 the federal Act; and
13-10 (2) the certificate or release is in effect with
13-11 respect to the drug; provided, that this subdivision shall not
13-12 apply to any drug or class of drugs exempted by regulations
13-13 promulgated under Section 507(c) or (d) of the federal Act;
13-14 (m) if it is a color additive, the intended use of
13-15 which is for the purpose of coloring only, unless its packaging and
13-16 labeling are in conformity with such packaging and labeling
13-17 requirements applicable to such color additive, as may be contained
13-18 in rules issued under Section 431.161(b);
13-19 (n) in the case of any prescription drug distributed
13-20 or offered for sale in this state, unless the manufacturer, packer,
13-21 or distributor thereof includes in all advertisements and other
13-22 descriptive printed matter issued or caused to be issued by the
13-23 manufacturer, packer, or distributor with respect to that drug a
13-24 true statement of:
13-25 (1) the established name as defined in
13-26 Subsection (e), printed prominently and in type at least half as
13-27 large as that used for any trade or brand name;
14-1 (2) the formula showing quantitatively each
14-2 ingredient of the drug to the extent required for labels under
14-3 Subsection (e); and
14-4 (3) other information in brief summary relating
14-5 to side effects, contraindications, and effectiveness as required
14-6 in regulations issued under Section 701(e) of the federal Act;
14-7 (o) if it was manufactured, prepared, propagated,
14-8 compounded, or processed in an establishment in this state not
14-9 registered under Section 510 of the federal Act, if it was not
14-10 included in a list required by Section 510(j) of the federal Act,
14-11 if a notice or other information respecting it was not provided as
14-12 required by that section or Section 510(k) of the federal Act, or
14-13 if it does not bear symbols from the uniform system for
14-14 identification of devices prescribed under Section 510(e) of the
14-15 federal Act as required by regulation;
14-16 (p) if it is a drug and its packaging or labeling is
14-17 in violation of an applicable regulation issued under Section 3 or
14-18 4 of the Federal Poison Prevention Packaging Act of 1970 (21 U.S.C.
14-19 1472 or 1473);
14-20 (q) if a trademark, trade name, or other identifying
14-21 mark, imprint or device of another, or any likeness of the
14-22 foregoing has been placed thereon or on its container with intent
14-23 to defraud;
14-24 (r) in the case of any restricted device distributed
14-25 or offered for sale in this state, if:
14-26 (1) its advertising is false or misleading in
14-27 any particular; or
15-1 (2) it is sold, distributed, or used in
15-2 violation of regulations prescribed under Section 520(e) of the
15-3 federal Act [Subsection (e)];
15-4 (s) in the case of any restricted device distributed
15-5 or offered for sale in this state, unless the manufacturer, packer,
15-6 or distributor thereof includes in all advertisements and other
15-7 descriptive printed matter issued by the manufacturer, packer, or
15-8 distributor with respect to that device:
15-9 (1) a true statement of the device's established
15-10 name as defined in Section 502(e) of the federal Act, printed
15-11 prominently and in type at least half as large as that used for any
15-12 trade or brand name thereof; and
15-13 (2) a brief statement of the intended uses of
15-14 the device and relevant warnings, precautions, side effects, and
15-15 contraindications and in the case of specific devices made subject
15-16 to regulations issued under the federal Act, a full description of
15-17 the components of such device or the formula showing quantitatively
15-18 each ingredient of such device to the extent required in
15-19 regulations under the federal Act;
15-20 (t) if it is a device subject to a performance
15-21 standard established under Section 514 of the federal Act, unless
15-22 it bears such labeling as may be prescribed in such performance
15-23 standard; or
15-24 (u) if it is a device and there was a failure or
15-25 refusal:
15-26 (1) to comply with any requirement prescribed
15-27 under Section 518 of the federal Act respecting the device; or
16-1 (2) to furnish material required by or under
16-2 Section 519 of the federal Act respecting the device.
16-3 SECTION 5. The importance of this legislation and the
16-4 crowded condition of the calendars in both houses create an
16-5 emergency and an imperative public necessity that the
16-6 constitutional rule requiring bills to be read on three several
16-7 days in each house be suspended, and this rule is hereby suspended,
16-8 and that this Act take effect and be in force from and after its
16-9 passage, and it is so enacted.
_______________________________ _______________________________
President of the Senate Speaker of the House
I certify that H.B. No. 358 was passed by the House on April
9, 1997, by a non-record vote; and that the House concurred in
Senate amendments to H.B. No. 358 on May 12, 1997, by a non-record
vote.
_______________________________
Chief Clerk of the House
I certify that H.B. No. 358 was passed by the Senate, with
amendments, on May 7, 1997, by the following vote: Yeas 31, Nays
0.
_______________________________
Secretary of the Senate
APPROVED: _____________________
Date
_____________________
Governor