1-1 By: Maxey (Senate Sponsor - Zaffirini) H.B. No. 358
1-2 (In the Senate - Received from the House April 10, 1997;
1-3 April 11, 1997, read first time and referred to Committee on Health
1-4 and Human Services; May 5, 1997, reported adversely, with favorable
1-5 Committee Substitute by the following vote: Yeas 11, Nays 0;
1-6 May 5, 1997, sent to printer.)
1-7 COMMITTEE SUBSTITUTE FOR H.B. No. 358 By: Moncrief
1-8 A BILL TO BE ENTITLED
1-9 AN ACT
1-10 relating to certain misbranded drugs and devices and the use of
1-11 certain detained or embargoed articles.
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
1-31 not 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 without first registering with the department as required by
3-33 Section 431.222; or
3-34 (z) unless approved by the United States Food and Drug
3-35 Administration pursuant to the federal Act, the sale, delivery,
3-36 holding, or offering for sale of a self-testing kit designed to
3-37 indicate whether a person has a human immunodeficiency virus
3-38 infection, acquired immune deficiency syndrome, or a related
3-39 disorder or condition.
3-40 SECTION 2. Sections 431.048(b) and (c), Health and Safety
3-41 Code, are amended to read as follows:
3-42 (b) The tag or marking on a detained or embargoed article
3-43 must warn all persons not to use the article, remove the article
3-44 from the premises, or dispose of the article by sale or otherwise
3-45 until permission for use, removal, or disposal is given by the
3-46 commissioner, the authorized agent, or a court.
3-47 (c) A person may not use a detained or embargoed article,
3-48 remove a detained or embargoed article from the premises, or
3-49 dispose of a detained or embargoed article [it] by sale or
3-50 otherwise without permission of the commissioner, the authorized
3-51 agent, or a court. The commissioner or the authorized agent may
3-52 permit perishable goods to be moved to a place suitable for proper
3-53 storage.
3-54 SECTION 3. Section 431.049(a), Health and Safety Code, is
3-55 amended to read as follows:
3-56 (a) If the claimant of the detained or embargoed articles or
3-57 the claimant's agent fails or refuses to transfer the articles to a
3-58 secure place after the tag or other appropriate marking has been
3-59 affixed as provided by Section 431.048, the commissioner or an
3-60 authorized agent may order the transfer of the articles to one or
3-61 more secure storage areas to prevent their unauthorized use,
3-62 removal, or disposal.
3-63 SECTION 4. Section 431.112, Health and Safety Code, is
3-64 amended to read as follows:
3-65 Sec. 431.112. Misbranded Drug or Device. A drug or device
3-66 shall be deemed to be misbranded:
3-67 (a)(1) if its labeling is false or misleading in any
3-68 particular; or
3-69 (2) if its labeling or packaging fails to
4-1 conform with the requirements of Section 431.181.
4-2 (b) if in a package form unless it bears a label
4-3 containing (1) the name and place of business of the manufacturer,
4-4 packer, or distributor; and (2) an accurate statement of the
4-5 quantity of the contents in terms of weight, measure, or numerical
4-6 count; provided, that under Subdivision (2) reasonable variations
4-7 shall be permitted, and exemptions as to small packages shall be
4-8 allowed in accordance with regulations prescribed by the secretary
4-9 under the federal Act;
4-10 (c) if any word, statement, or other information
4-11 required by or under authority of this chapter to appear on the
4-12 label or labeling is not prominently placed thereon with such
4-13 conspicuousness (as compared with other words, statements, designs,
4-14 or devices, in the labeling) and in such terms as to render it
4-15 likely to be read and understood by the ordinary individual under
4-16 customary conditions of purchase and use;
4-17 (d) if it is for use by man and contains any quantity
4-18 of the narcotic or hypnotic substance alpha-eucaine, barbituric
4-19 acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca,
4-20 cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde,
4-21 peyote, or sulphonmethane, or any chemical derivative of such
4-22 substance, which derivative, after investigation, has been found to
4-23 be designated as habit forming, by regulations issued by the
4-24 secretary under Section 502(d) of the federal Act, unless its label
4-25 bears the name and quantity or proportion of such substance or
4-26 derivative and in juxtaposition therewith the statement,
4-27 "Warning: May be habit forming";
4-28 (e)(1) if it is a drug, unless:
4-29 (A) its label bears, to the exclusion of
4-30 any other nonproprietary name (except the applicable systematic
4-31 chemical name or the chemical formula):
4-32 (i) the established name
4-33 (as defined in Subdivision (3)) of the drug, if any; and
4-34 (ii) in case it is
4-35 fabricated from two or more ingredients, the established name and
4-36 quantity of each active ingredient, including the quantity, kind,
4-37 and proportion of any alcohol, and also including, whether active
4-38 or not, the established name and quantity or proportion of any
4-39 bromides, ether, chloroform, acetanilid, acetphenetidin,
4-40 amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic,
4-41 digitalis, digitalis glucosides, mercury, ouabain, strophanthin,
4-42 strychnine, thyroid, or any derivative or preparation of any such
4-43 substances, contained therein; provided, that the requirement for
4-44 stating the quantity of the active ingredients, other than the
4-45 quantity of those specifically named in this subparagraph shall
4-46 apply only to prescription drugs; and
4-47 (B) for any prescription drug the
4-48 established name of the drug or ingredient, as the case may be, on
4-49 the label (and on any labeling on which a name for such drug or
4-50 ingredient is used) is printed prominently and in type at least
4-51 half as large as that used thereon for any proprietary name or
4-52 designation for such drug or ingredient; and provided, that to the
4-53 extent that compliance with the requirements of Paragraph (A)(ii)
4-54 or this paragraph is impracticable, exemptions shall be allowed
4-55 under regulations promulgated by the secretary under the federal
4-56 Act;
4-57 (2) if it is a device and it has an established
4-58 name, unless its label bears, to the exclusion of any other
4-59 nonproprietary name, its established name (as defined in
4-60 Subdivision (4)) prominently printed in type at least half as large
4-61 as that used thereon for any proprietary name or designation for
4-62 such device, except that to the extent compliance with this
4-63 subdivision is impracticable, exemptions shall be allowed under
4-64 regulations promulgated by the secretary under the federal Act;
4-65 (3) as used in Subdivision (1), the term
4-66 "established name," with respect to a drug or ingredient thereof,
4-67 means:
4-68 (A) the applicable official name
4-69 designated pursuant to Section 508 of the federal Act; or
5-1 (B) if there is no such name and such
5-2 drug, or such ingredient, is an article recognized in an official
5-3 compendium, then the official title thereof in such compendium; or
5-4 (C) if neither Paragraph (A) nor Paragraph
5-5 (B) applies, then the common or usual name, if any, of such drug or
5-6 of such ingredient; provided further, that where Paragraph (B)
5-7 applies to an article recognized in the United States Pharmacopoeia
5-8 National Formulary, the official title used in the United States
5-9 Pharmacopoeia National Formulary shall apply;
5-10 (4) as used in Subdivision (2), the term
5-11 "established name" with respect to a device means:
5-12 (A) the applicable official name of the
5-13 device designated pursuant to Section 508 of the federal Act;
5-14 (B) if there is no such name and such
5-15 device is an article recognized in an official compendium, then the
5-16 official title thereof in such compendium; or
5-17 (C) if neither Paragraph (A) nor Paragraph
5-18 (B) applies, then any common or usual name of such device;
5-19 (f) unless its labeling bears:
5-20 (1) adequate directions for use; and
5-21 (2) such adequate warnings against use in those
5-22 pathological conditions or by children where its use may be
5-23 dangerous to health, or against unsafe dosage or methods or
5-24 durations of administration or application, in such manner and
5-25 form, as are necessary for the protection of users unless the drug
5-26 or device has been exempted from those requirements by the
5-27 regulations adopted by the secretary;
5-28 (g) if it purports to be a drug the name of which is
5-29 recognized in an official compendium, unless it is packaged and
5-30 labeled as prescribed therein unless the method of packing has been
5-31 modified with the consent of the secretary. Whenever a drug is
5-32 recognized in the United States Pharmacopoeia National Formulary,
5-33 it shall be subject to the requirements of the United States
5-34 Pharmacopoeia National Formulary with respect to packaging and
5-35 labeling. If there is an inconsistency between the requirements of
5-36 this subsection and those of Subsection (e) as to the name by which
5-37 the drug or its ingredients shall be designated, the requirements
5-38 of Subsection (e) prevail;
5-39 (h) if it has been found by the secretary to be a drug
5-40 liable to deterioration, unless it is packaged in such form and
5-41 manner, and its label bears a statement of such precautions, as the
5-42 secretary shall by regulations require as necessary for the
5-43 protection of public health;
5-44 (i) if:
5-45 (1) it is a drug and its container is so made,
5-46 formed, or filled as to be misleading; or
5-47 (2) it is an imitation of another drug; or
5-48 (3) it is offered for sale under the name of
5-49 another drug;
5-50 (j) if it is dangerous to health when used in the
5-51 dosage, or manner or with the frequency or duration prescribed,
5-52 recommended, or suggested in the labeling thereof;
5-53 (k) if it is, or purports to be, or is represented as
5-54 a drug composed wholly or partly of insulin, unless:
5-55 (1) it is from a batch with respect to which a
5-56 certificate or release has been issued pursuant to Section 506 of
5-57 the federal Act; and
5-58 (2) such certificate or release is in effect
5-59 with respect to such drug;
5-60 (l) if it is, or purports to be, or is represented as
5-61 a drug (except a drug for use in animals other than man) composed
5-62 wholly or partly of any kind of penicillin, streptomycin,
5-63 chlortetracycline, chloramphenicol, bacitracin, or any other
5-64 antibiotic drug, or any derivative thereof, unless:
5-65 (1) it is from a batch with respect to which a
5-66 certificate or release has been issued pursuant to Section 507 of
5-67 the federal Act; and
5-68 (2) the certificate or release is in effect with
5-69 respect to the drug; provided, that this subdivision shall not
6-1 apply to any drug or class of drugs exempted by regulations
6-2 promulgated under Section 507(c) or (d) of the federal Act;
6-3 (m) if it is a color additive, the intended use of
6-4 which is for the purpose of coloring only, unless its packaging and
6-5 labeling are in conformity with such packaging and labeling
6-6 requirements applicable to such color additive, as may be contained
6-7 in rules issued under Section 431.161(b);
6-8 (n) in the case of any prescription drug distributed
6-9 or offered for sale in this state, unless the manufacturer, packer,
6-10 or distributor thereof includes in all advertisements and other
6-11 descriptive printed matter issued or caused to be issued by the
6-12 manufacturer, packer, or distributor with respect to that drug a
6-13 true statement of:
6-14 (1) the established name as defined in
6-15 Subsection (e), printed prominently and in type at least half as
6-16 large as that used for any trade or brand name;
6-17 (2) the formula showing quantitatively each
6-18 ingredient of the drug to the extent required for labels under
6-19 Subsection (e); and
6-20 (3) other information in brief summary relating
6-21 to side effects, contraindications, and effectiveness as required
6-22 in regulations issued under Section 701(e) of the federal Act;
6-23 (o) if it was manufactured, prepared, propagated,
6-24 compounded, or processed in an establishment in this state not
6-25 registered under Section 510 of the federal Act, if it was not
6-26 included in a list required by Section 510(j) of the federal Act,
6-27 if a notice or other information respecting it was not provided as
6-28 required by that section or Section 510(k) of the federal Act, or
6-29 if it does not bear symbols from the uniform system for
6-30 identification of devices prescribed under Section 510(e) of the
6-31 federal Act as required by regulation;
6-32 (p) if it is a drug and its packaging or labeling is
6-33 in violation of an applicable regulation issued under Section 3 or
6-34 4 of the Federal Poison Prevention Packaging Act of 1970 (21 U.S.C.
6-35 1472 or 1473);
6-36 (q) if a trademark, trade name, or other identifying
6-37 mark, imprint or device of another, or any likeness of the
6-38 foregoing has been placed thereon or on its container with intent
6-39 to defraud;
6-40 (r) in the case of any restricted device distributed
6-41 or offered for sale in this state, if:
6-42 (1) its advertising is false or misleading in
6-43 any particular; or
6-44 (2) it is sold, distributed, or used in
6-45 violation of regulations prescribed under Section 520(e) of the
6-46 federal Act [Subsection (e)];
6-47 (s) in the case of any restricted device distributed
6-48 or offered for sale in this state, unless the manufacturer, packer,
6-49 or distributor thereof includes in all advertisements and other
6-50 descriptive printed matter issued by the manufacturer, packer, or
6-51 distributor with respect to that device:
6-52 (1) a true statement of the device's established
6-53 name as defined in Section 502(e) of the federal Act, printed
6-54 prominently and in type at least half as large as that used for any
6-55 trade or brand name thereof; and
6-56 (2) a brief statement of the intended uses of
6-57 the device and relevant warnings, precautions, side effects, and
6-58 contraindications and in the case of specific devices made subject
6-59 to regulations issued under the federal Act, a full description of
6-60 the components of such device or the formula showing quantitatively
6-61 each ingredient of such device to the extent required in
6-62 regulations under the federal Act;
6-63 (t) if it is a device subject to a performance
6-64 standard established under Section 514 of the federal Act, unless
6-65 it bears such labeling as may be prescribed in such performance
6-66 standard; or
6-67 (u) if it is a device and there was a failure or
6-68 refusal:
6-69 (1) to comply with any requirement prescribed
7-1 under Section 518 of the federal Act respecting the device; or
7-2 (2) to furnish material required by or under
7-3 Section 519 of the federal Act respecting the device.
7-4 SECTION 5. The importance of this legislation and the
7-5 crowded condition of the calendars in both houses create an
7-6 emergency and an imperative public necessity that the
7-7 constitutional rule requiring bills to be read on three several
7-8 days in each house be suspended, and this rule is hereby suspended,
7-9 and that this Act take effect and be in force from and after its
7-10 passage, and it is so enacted.
7-11 * * * * *