This website will be unavailable from Thursday, May 30, 2024 at 6:00 p.m. through Monday, June 3, 2024 at 7:00 a.m. due to data center maintenance.
Amend SB 943 (House Committee Report) by striking SECTION 14
of the bill adding Sections 431.416 and 431.417, Health and Safety
Code (page 18, line 21, through page 21, line 16), and substituting
the following appropriately numbered SECTIONS:
SECTION ____. Section 431.021, Health and Safety Code, is
amended to read as follows:
Sec. 431.021. PROHIBITED ACTS. The following acts and the
causing of the following acts within this state are unlawful and
prohibited:
(a) the introduction or delivery for introduction into
commerce of any food, drug, device, or cosmetic that is adulterated
or misbranded;
(b) the adulteration or misbranding of any food, drug,
device, or cosmetic in commerce;
(c) the receipt in commerce of any food, drug, device, or
cosmetic that is adulterated or misbranded, and the delivery or
proffered delivery thereof for pay or otherwise;
(d) the distribution in commerce of a consumer commodity, if
such commodity is contained in a package, or if there is affixed to
that commodity a label that does not conform to the provisions of
this chapter and of rules adopted under the authority of this
chapter; provided, however, that this prohibition shall not apply
to persons engaged in business as wholesale or retail distributors
of consumer commodities except to the extent that such persons:
(1) are engaged in the packaging or labeling of such
commodities; or
(2) prescribe or specify by any means the manner in
which such commodities are packaged or labeled;
(e) the introduction or delivery for introduction into
commerce of any article in violation of Section 431.084, 431.114,
or 431.115;
(f) the dissemination of any false advertisement;
(g) the refusal to permit entry or inspection, or to permit
the taking of a sample or to permit access to or copying of any
record as authorized by Sections 431.042-431.044; or the failure
to establish or maintain any record or make any report required
under Section 512(j), (l), or (m) of the federal Act, or the refusal
to permit access to or verification or copying of any such required
record;
(h) the manufacture within this state of any food, drug,
device, or cosmetic that is adulterated or misbranded;
(i) the giving of a guaranty or undertaking referred to in
Section 431.059, which guaranty or undertaking is false, except by
a person who relied on a guaranty or undertaking to the same effect
signed by, and containing the name and address of the person
residing in this state from whom the person received in good faith
the food, drug, device, or cosmetic; or the giving of a guaranty or
undertaking referred to in Section 431.059, which guaranty or
undertaking is false;
(j) the use, removal, or disposal of a detained or embargoed
article in violation of Section 431.048;
(k) the alteration, mutilation, destruction, obliteration,
or removal of the whole or any part of the labeling of, or the doing
of any other act with respect to a food, drug, device, or cosmetic,
if such act is done while such article is held for sale after
shipment in commerce and results in such article being adulterated
or misbranded;
(l)(1) forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp,
tag, label, or other identification device authorized or required
by rules adopted under this chapter or the regulations promulgated
under the provisions of the federal Act;
(2) making, selling, disposing of, or keeping in
possession, control, or custody, or concealing any punch, die,
plate, stone, or other thing designed to print, imprint, or
reproduce the trademark, trade name, or other identifying mark,
imprint, or device of another or any likeness of any of the
foregoing on any drug or container or labeling thereof so as to
render such drug a counterfeit drug;
(3) the doing of any act that causes a drug to be a
counterfeit drug, or the sale or dispensing, or the holding for sale
or dispensing, of a counterfeit drug;
(m) the using by any person to the person's own advantage,
or revealing, other than to the commissioner, an authorized agent,
a health authority or to the courts when relevant in any judicial
proceeding under this chapter, of any information acquired under
the authority of this chapter concerning any method or process that
as a trade secret is entitled to protection;
(n) the using, on the labeling of any drug or device or in
any advertising relating to such drug or device, of any
representation or suggestion that approval of an application with
respect to such drug or device is in effect under Section 431.114 or
Section 505, 515, or 520(g) of the federal Act, as the case may be,
or that such drug or device complies with the provisions of such
sections;
(o) the using, in labeling, advertising or other sales
promotion of any reference to any report or analysis furnished in
compliance with Sections 431.042-431.044 or Section 704 of the
federal Act;
(p) in the case of a prescription drug distributed or
offered for sale in this state, the failure of the manufacturer,
packer, or distributor of the drug to maintain for transmittal, or
to transmit, to any practitioner licensed by applicable law to
administer such drug who makes written request for information as
to such drug, true and correct copies of all printed matter that is
required to be included in any package in which that drug is
distributed or sold, or such other printed matter as is approved
under the federal Act. Nothing in this subsection shall be
construed to exempt any person from any labeling requirement
imposed by or under other provisions of this chapter;
(q)(1) placing or causing to be placed on any drug or device
or container of any drug or device, with intent to defraud, the
trade name or other identifying mark, or imprint of another or any
likeness of any of the foregoing;
(2) selling, dispensing, disposing of or causing to be
sold, dispensed, or disposed of, or concealing or keeping in
possession, control, or custody, with intent to sell, dispense, or
dispose of, any drug, device, or any container of any drug or
device, with knowledge that the trade name or other identifying
mark or imprint of another or any likeness of any of the foregoing
has been placed thereon in a manner prohibited by Subdivision (1) of
this subsection; or
(3) making, selling, disposing of, causing to be made,
sold, or disposed of, keeping in possession, control, or custody,
or concealing with intent to defraud any punch, die, plate, stone,
or other thing designed to print, imprint, or reproduce the
trademark, trade name, or other identifying mark, imprint, or
device of another or any likeness of any of the foregoing on any
drug or container or labeling of any drug or container so as to
render such drug a counterfeit drug;
(r) dispensing or causing to be dispensed a different drug
in place of the drug ordered or prescribed without the express
permission in each case of the person ordering or prescribing;
(s) the failure to register in accordance with Section 510
of the federal Act, the failure to provide any information required
by Section 510(j) or (k) of the federal Act, or the failure to
provide a notice required by Section 510(j)(2) of the federal Act;
(t)(1) the failure or refusal to:
(A) comply with any requirement prescribed under
Section 518 or 520(g) of the federal Act; or
(B) furnish any notification or other material or
information required by or under Section 519 or 520(g) of the
federal Act;
(2) with respect to any device, the submission of any
report that is required by or under this chapter that is false or
misleading in any material respect;
(u) the movement of a device in violation of an order under
Section 304(g) of the federal Act or the removal or alteration of
any mark or label required by the order to identify the device as
detained;
(v) the failure to provide the notice required by Section
412(b) or 412(c), the failure to make the reports required by
Section 412(d)(1)(B), or the failure to meet the requirements
prescribed under Section 412(d)(2) of the federal Act;
(w) except as provided under Subchapter M of this chapter
and Section 562.1085, Occupations Code, the acceptance by a person
of an unused prescription or drug, in whole or in part, for the
purpose of resale, after the prescription or drug has been
originally dispensed, or sold;
(x) engaging in the wholesale distribution of drugs or
operating as a distributor or manufacturer of devices in this state
without obtaining a license issued by the department under
Subchapter I, L, or N, as applicable;
(y) engaging in the manufacture of food in this state or
operating as a warehouse operator in this state without having a
license as required by Section 431.222 or operating as a food
wholesaler in this state without having a license under Section
431.222 or being registered under Section 431.2211, as appropriate;
(z) unless approved by the United States Food and Drug
Administration pursuant to the federal Act, the sale, delivery,
holding, or offering for sale of a self-testing kit designed to
indicate whether a person has a human immunodeficiency virus
infection, acquired immune deficiency syndrome, or a related
disorder or condition;
(aa) making a false statement or false representation in an
application for a license or in a statement, report, or other
instrument to be filed with or requested by the department under
this chapter;
(bb) failing to comply with a requirement or request to
provide information or failing to submit an application, statement,
report, or other instrument required by the department;
(cc) performing, causing the performance of, or aiding and
abetting the performance of an act described by Subdivision (x);
(dd) purchasing or otherwise receiving a prescription drug
from a pharmacy in violation of Section 431.411(a);
(ee) selling, distributing, or transferring a prescription
drug to a person who is not authorized under state or federal law to
receive the prescription drug in violation of Section 431.411(b);
(ff) failing to deliver prescription drugs to specified
premises as required by Section 431.411(c);
(gg) failing to maintain or provide pedigrees as required by
Section 431.412 or 431.413;
(hh) failing to obtain, pass, or authenticate a pedigree as
required by Section 431.412 or 431.413; [or]
(ii) the introduction or delivery for introduction into
commerce of a drug or prescription device at a flea market;
(jj) the receipt of a prescription drug that is adulterated,
misbranded, stolen, obtained by fraud or deceit, counterfeit, or
suspected of being counterfeit, and the delivery or proffered
delivery of such a drug for payment or otherwise; or
(kk) the alteration, mutilation, destruction,
obliteration, or removal of all or any part of the labeling of a
prescription drug or the commission of any other act with respect to
a prescription drug that results in the prescription drug being
misbranded.
SECTION ____. Subchapter B, Chapter 431, Health and Safety
Code, is amended by adding Section 431.0211 to read as follows:
Sec. 431.0211. EXCEPTION. Any provision of Section 431.021
that relates to a prescription drug does not apply to a prescription
drug manufacturer, or an agent of a prescription drug manufacturer,
who is obtaining or attempting to obtain a prescription drug for the
sole purpose of testing the prescription drug for authenticity.