78R991 YDB-D
By: Zedler H.B. No. 1891
A BILL TO BE ENTITLED
AN ACT
relating to the labeling of certain drugs.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 431.002(8), Health and Safety Code, is
amended to read as follows:
(8) "Consumer commodity," except as otherwise
provided by this subdivision, means any food, drug, device, or
cosmetic, as those terms are defined by this chapter or by the
federal Act, and any other article, product, or commodity of any
kind or class that is customarily produced or distributed for sale
through retail sales agencies or instrumentalities for consumption
by individuals, or for use by individuals for purposes of personal
care or in the performance of services ordinarily rendered within
the household, and that usually is consumed or expended in the
course of the consumption or use. The term does not include:
(A) a meat or meat product, poultry or poultry
product, or tobacco or tobacco product;
(B) a commodity subject to packaging or labeling
requirements imposed under the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136), or The [Section 8,]
Virus-Serum-Toxin Act (21 U.S.C. 151 et seq. [158]);
(C) a drug subject to the provisions of Section
431.113(c)(1) or 431.112(j) [431.112(k)], or Section 503(b)(1) [or
506] of the federal Act;
(D) a beverage subject to or complying with
packaging or labeling requirements imposed under the Federal
Alcohol Administration Act (27 U.S.C. 205(e)); or
(E) a commodity subject to the provisions of
Chapter 61, Agriculture Code, relating to the inspection, labeling,
and sale of agricultural and vegetable seed.
SECTION 2. Section 431.042(c), Health and Safety Code, is
amended to read as follows:
(c) An inspection under Subsection (b) may not extend to:
(1) financial data;
(2) sales data other than shipment data;
(3) pricing data;
(4) personnel data other than data relating to the
qualifications of technical and professional personnel performing
functions under this chapter;
(5) research data other than data:
(A) relating to new drugs, antibiotic drugs, and
devices; and
(B) subject to reporting and inspection under
regulations issued under Section 505(i) or (j), [507(d) or (g),]
519, or 520(g) of the federal Act; or
(6) data relating to other drugs or devices that, in
the case of a new drug, would be subject to reporting or inspection
under regulations issued under Section 505(j) of the federal Act.
SECTION 3. Section 431.059(b), Health and Safety Code, is
amended to read as follows:
(b) A person is not subject to the penalties of Subsection
(a):
(1) for having received an article in commerce and
having delivered or offered delivery of the article, if the
delivery or offer was made in good faith, unless the person refuses
to furnish on request of the commissioner, an authorized agent, or a
health authority, the name and address of the person from whom the
article was received and copies of any documents relating to the
receipt of the article;
(2) for having violated Section 431.021(a) or (e) if
the person establishes a guaranty or undertaking signed by, and
containing the name and address of, the person residing in this
state from whom the person received in good faith the article, to
the effect that:
(A) in the case of an alleged violation of
Section 431.021(a), the article is not adulterated or misbranded
within the meaning of this chapter; and
(B) in the case of an alleged violation of
Section 431.021(e), the article is not an article that may not,
under the provisions of Section 404 or 405 of the federal Act or
Section 431.084 or 431.114, be introduced into commerce;
(3) for having violated Section 431.021, if the
violation exists because the article is adulterated by reason of
containing a color additive not from a batch certified in
accordance with regulations promulgated under the federal Act, if
the person establishes a guaranty or undertaking signed by, and
containing the name and address of, the manufacturer of the color
additive, to the effect that the color additive was from a batch
certified in accordance with the applicable regulations
promulgated under the federal Act;
(4) for having violated Section 431.021(b), (c), or
(k) by failure to comply with Section 431.112(i) [431.112(j)] with
respect to an article received in commerce to which neither Section
503(a) nor Section 503(b)(1) of the federal Act applies if the
delivery or offered delivery was made in good faith and the labeling
at the time of the delivery or offer contained the same directions
for use and warning statements as were contained in the labeling at
the same time of the receipt of the article; or
(5) for having violated Section 431.021(l)(2) if the
person acted in good faith and had no reason to believe that use of
the punch, die, plate, stone, or other thing would result in a drug
being a counterfeit drug, or for having violated Section
431.021(l)(3) if the person doing the act or causing it to be done
acted in good faith and had no reason to believe that the drug was a
counterfeit drug.
SECTION 4. Section 431.112, Health and Safety Code, is
amended to read as follows:
Sec. 431.112. MISBRANDED DRUG OR DEVICE. A drug or device
shall be deemed to be misbranded:
(a)(1) if its labeling is false or misleading in any
particular; or
(2) if its labeling or packaging fails to conform with
the requirements of Section 431.181.
(b) if in a package form unless it bears a label containing
(1) the name and place of business of the manufacturer, packer, or
distributor; and (2) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count;
provided, that under Subdivision (2) reasonable variations shall be
permitted, and exemptions as to small packages shall be allowed in
accordance with regulations prescribed by the secretary under the
federal Act;
(c) if any word, statement, or other information required by
or under authority of this chapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to render
it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use;
(d) [if it is for use by man and contains any quantity of the
narcotic or hypnotic substance alpha-eucaine, barbituric acid,
betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine,
codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote,
or sulphonmethane, or any chemical derivative of such substance,
which derivative, after investigation, has been found to be
designated as habit forming, by regulations issued by the secretary
under Section 502(d) of the federal Act, unless its label bears the
name and quantity or proportion of such substance or derivative and
in juxtaposition therewith the statement, "Warning: May be habit
forming";
[(e)] (1) if it is a drug, unless:
(A) its label bears, to the exclusion of any
other nonproprietary name (except the applicable systematic
chemical name or the chemical formula):
(i) the established name (as defined in
Subdivision (3)) of the drug, if any; and
(ii) in case it is fabricated from two or
more ingredients, the established name and quantity of each active
ingredient, including the quantity, kind, and proportion of any
alcohol, and also including, whether active or not, the established
name and quantity or proportion of any bromides, ether, chloroform,
acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,
mercury, ouabain, strophanthin, strychnine, thyroid, or any
derivative or preparation of any such substances, contained
therein; provided, that the requirement for stating the quantity
of the active ingredients, other than the quantity of those
specifically named in this subparagraph shall apply only to
prescription drugs; and
(B) for any prescription drug the established
name of the drug or ingredient, as the case may be, on the label (and
on any labeling on which a name for such drug or ingredient is used)
is printed prominently and in type at least half as large as that
used thereon for any proprietary name or designation for such drug
or ingredient; and provided, that to the extent that compliance
with the requirements of Paragraph (A)(ii) or this paragraph is
impracticable, exemptions shall be allowed under regulations
promulgated by the secretary under the federal Act;
(2) if it is a device and it has an established name,
unless its label bears, to the exclusion of any other
nonproprietary name, its established name (as defined in
Subdivision (4)) prominently printed in type at least half as large
as that used thereon for any proprietary name or designation for
such device, except that to the extent compliance with this
subdivision is impracticable, exemptions shall be allowed under
regulations promulgated by the secretary under the federal Act;
(3) as used in Subdivision (1), the term "established
name," with respect to a drug or ingredient thereof, means:
(A) the applicable official name designated
pursuant to Section 508 of the federal Act; or
(B) if there is no such name and such drug, or
such ingredient, is an article recognized in an official
compendium, then the official title thereof in such compendium; or
(C) if neither Paragraph (A) nor Paragraph (B)
applies, then the common or usual name, if any, of such drug or of
such ingredient; provided further, that where Paragraph (B) applies
to an article recognized in the United States Pharmacopoeia
National Formulary, the official title used in the United States
Pharmacopoeia National Formulary shall apply;
(4) as used in Subdivision (2), the term "established
name" with respect to a device means:
(A) the applicable official name of the device
designated pursuant to Section 508 of the federal Act;
(B) if there is no such name and such device is an
article recognized in an official compendium, then the official
title thereof in such compendium; or
(C) if neither Paragraph (A) nor Paragraph (B)
applies, then any common or usual name of such device;
(e) [(f)] unless its labeling bears:
(1) adequate directions for use; and
(2) such adequate warnings against use in those
pathological conditions or by children where its use may be
dangerous to health, or against unsafe dosage or methods or
durations of administration or application, in such manner and
form, as are necessary for the protection of users unless the drug
or device has been exempted from those requirements by the
regulations adopted by the secretary;
(f) [(g)] if it purports to be a drug the name of which is
recognized in an official compendium, unless it is packaged and
labeled as prescribed therein unless the method of packing has been
modified with the consent of the secretary. Whenever a drug is
recognized in the United States Pharmacopoeia National Formulary,
it shall be subject to the requirements of the United States
Pharmacopoeia National Formulary with respect to packaging and
labeling. If there is an inconsistency between the requirements of
this subsection and those of Subsection (d) [(e)] as to the name by
which the drug or its ingredients shall be designated, the
requirements of Subsection (d) [(e)] prevail;
(g) [(h)] if it has been found by the secretary to be a drug
liable to deterioration, unless it is packaged in such form and
manner, and its label bears a statement of such precautions, as the
secretary shall by regulations require as necessary for the
protection of public health;
(h) [(i)] if:
(1) it is a drug and its container is so made, formed,
or filled as to be misleading; or
(2) it is an imitation of another drug; or
(3) it is offered for sale under the name of another
drug;
(i) [(j)] if it is dangerous to health when used in the
dosage, or manner or with the frequency or duration prescribed,
recommended, or suggested in the labeling thereof;
(j) [(k)] if it is, or purports to be, or is represented as a
drug composed wholly or partly of insulin[, unless:
[(1) it is from a batch with respect to which a
certificate or release has been issued pursuant to Section 506 of
the federal Act; and
[(2) such certificate or release is in effect with
respect to such drug];
(k) [(l)] if it is, or purports to be, or is represented as a
drug (except a drug for use in animals other than man) composed
wholly or partly of any kind of penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other
antibiotic drug, or any derivative thereof[, unless:
[(1) it is from a batch with respect to which a
certificate or release has been issued pursuant to Section 507 of
the federal Act; and
[(2) the certificate or release is in effect with
respect to the drug; provided, that this subdivision shall not
apply to any drug or class of drugs exempted by regulations
promulgated under Section 507(c) or (d) of the federal Act];
(l) [(m)] if it is a color additive, the intended use of
which is for the purpose of coloring only, unless its packaging and
labeling are in conformity with such packaging and labeling
requirements applicable to such color additive, as may be contained
in rules issued under Section 431.161(b);
(m) [(n)] in the case of any prescription drug distributed
or offered for sale in this state, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other
descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to that drug a
true statement of:
(1) the established name as defined in Subsection (d)
[(e)], printed prominently and in type at least half as large as
that used for any trade or brand name;
(2) the formula showing quantitatively each
ingredient of the drug to the extent required for labels under
Subsection (d) [(e)]; and
(3) other information in brief summary relating to
side effects, contraindications, and effectiveness as required in
regulations issued under Section 701(e) of the federal Act;
(n) [(o)] if it was manufactured, prepared, propagated,
compounded, or processed in an establishment in this state not
registered under Section 510 of the federal Act, if it was not
included in a list required by Section 510(j) of the federal Act, if
a notice or other information respecting it was not provided as
required by that section or Section 510(k) of the federal Act, or if
it does not bear symbols from the uniform system for identification
of devices prescribed under Section 510(e) of the federal Act as
required by regulation;
(o) [(p)] if it is a drug and its packaging or labeling is in
violation of an applicable regulation issued under Section 3 or 4 of
the federal [Federal] Poison Prevention Packaging Act of 1970 (15
[21] U.S.C. 1472 or 1473);
(p) [(q)] if a trademark, trade name, or other identifying
mark, imprint or device of another, or any likeness of the foregoing
has been placed thereon or on its container with intent to defraud;
(q) [(r)] in the case of any restricted device distributed
or offered for sale in this state, if:
(1) its advertising is false or misleading in any
particular; or
(2) it is sold, distributed, or used in violation of
regulations prescribed under Section 520(e) of the federal Act;
(r) [(s)] in the case of any restricted device distributed
or offered for sale in this state, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other
descriptive printed matter issued by the manufacturer, packer, or
distributor with respect to that device:
(1) a true statement of the device's established name
as defined in Section 502(e) of the federal Act, printed
prominently and in type at least half as large as that used for any
trade or brand name thereof; and
(2) a brief statement of the intended uses of the
device and relevant warnings, precautions, side effects, and
contraindications and in the case of specific devices made subject
to regulations issued under the federal Act, a full description of
the components of such device or the formula showing quantitatively
each ingredient of such device to the extent required in
regulations under the federal Act;
(s) [(t)] if it is a device subject to a performance
standard established under Section 514 of the federal Act, unless
it bears such labeling as may be prescribed in such performance
standard; or
(t) [(u)] if it is a device and there was a failure or
refusal:
(1) to comply with any requirement prescribed under
Section 518 of the federal Act respecting the device; or
(2) to furnish material required by or under Section
519 of the federal Act respecting the device.
SECTION 5. Section 431.113(c), Health and Safety Code, is
amended to read as follows:
(c)(1) A drug intended for use by man that:
(A) [is a habit-forming drug to which Section
431.112(d) applies; or
[(B)] because of its toxicity or other
potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe for use except
under the supervision of a practitioner licensed by law to
administer such drug; or
(B) [(C)] is limited by an approved application
under Section 505 of the federal Act to use under the professional
supervision of a practitioner licensed by law to administer such
drug shall be dispensed only:
(i) on a written prescription of a
practitioner licensed by law to administer such drug; or
(ii) on an oral prescription of such
practitioner that is reduced promptly to writing and filed by the
pharmacist; or
(iii) by refilling any such written or oral
prescription if such refilling is authorized by the prescriber
either in the original prescription or by oral order that is reduced
promptly to writing and filed by the pharmacist. The act of
dispensing a drug contrary to the provisions of this paragraph
shall be deemed to be an act that results in a drug being misbranded
while held for sale.
(2) Any drug dispensed by filling or refilling a
written or oral prescription of a practitioner licensed by law to
administer such drug shall be exempt from the requirements of
Section 431.112, except Sections 431.112(a)(1), (h)(2), (h)(3),
(j), and [(i)(2), (i)(3),] (k), [and (l),] and the packaging
requirements of Sections 431.112(f), (g), and (o) [431.112(g), (h),
and (p)], if the drug bears a label containing the name and address
of the dispenser, the serial number and date of the prescription or
of its filling, the name of the prescriber, and, if stated in the
prescription, the name of the patient, and the directions for use
and cautionary statements, if any, contained in such prescription.
This exemption shall not apply to any drugs dispensed in the course
of the conduct of business of dispensing drugs pursuant to
diagnosis by mail, or to a drug dispensed in violation of
Subdivision (1).
(3) [The board may, by rule, remove drugs subject to
Section 431.112(d) and Section 505 of the federal Act from the
requirements of Subdivision (1) when such requirements are not
necessary for the protection of the public health.
[(4)] A drug that is subject to Subdivision (1) shall
be deemed to be misbranded if at any time prior to dispensing its
label fails to bear at a minimum, the symbol "RX Only [the statement
"Caution: Federal Law Prohibits Dispensing Without Prescription,"
or "Caution: State Law Prohibits Dispensing Without
Prescription]." A drug to which Subdivision (1) does not apply
shall be deemed to be misbranded if at any time prior to dispensing
its label bears the caution statement quoted in the preceding
sentence.
SECTION 6. Section 431.114(b), Health and Safety Code, is
amended to read as follows:
(b) A person shall not use in or on human beings or animals a
new drug or new animal drug limited to investigational use unless
the person has filed with the Federal Food and Drug Administration a
completed and signed "Notice of claimed investigational exemption
for a new drug" form in accordance with 21 C.F.R. 312.1 (1980) and
the exemption has not been terminated. The drug shall be plainly
labeled in compliance with Section 505(i) [or 507(d)] of the
federal Act.
SECTION 7. This Act applies only to the dispensing of a drug
as provided by Sections 431.112 and 431.113, Health and Safety
Code, as amended by this Act, on or after the effective date of this
Act.
SECTION 8. (a) The change in law made by this Act applies
only to an offense committed on or after the effective date of this
Act. For purposes of this section, an offense is committed before
the effective date of this Act if any element of the offense occurs
before that date.
(b) An offense committed before the effective date of this
Act is covered by the law in effect when the offense was committed,
and the former law is continued in effect for that purpose.
SECTION 9. This Act takes effect September 1, 2003.