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By: Estes, et al. S.B. No. 107
(In the Senate - Filed November 22, 2004; February 1, 2005,
read first time and referred to Committee on Health and Human
Services; May 6, 2005, reported adversely, with favorable
Committee Substitute by the following vote: Yeas 9, Nays 0;
May 6, 2005, sent to printer.)
COMMITTEE SUBSTITUTE FOR S.B. No. 107 By: Janek
A BILL TO BE ENTITLED
AN ACT
relating to prohibitions on engaging in conduct related to the
manufacture of methamphetamine and to the regulation and wholesale
distribution of certain chemical substances; providing penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
ARTICLE 1. CRIMINAL CONSEQUENCES OF ENGAGING IN CONDUCT
RELATED TO THE MANUFACTURE OF METHAMPHETAMINE
SECTION 1.01. Subsection (b), Section 481.124, Health and
Safety Code, is amended to read as follows:
(b) For purposes of this section, an intent to unlawfully
manufacture the controlled substance methamphetamine is presumed
if the actor possesses or transports:
(1) anhydrous ammonia in a container or receptacle
that is not designed and manufactured to lawfully hold or transport
anhydrous ammonia;
(2) lithium metal removed from a battery and immersed
in kerosene, mineral spirits, or similar liquid that prevents or
retards hydration; or
(3) in one container, vehicle, or building,
phenylacetic acid, or more than nine grams, three containers
packaged for retail sale, or 300 tablets or capsules of a product
containing ephedrine or pseudoephedrine, and:
(A) anhydrous ammonia;
(B) at least three of the following categories of
substances commonly used in the manufacture of methamphetamine:
(i) lithium or sodium metal or red
phosphorus, iodine, or iodine crystals;
(ii) lye, sulfuric acid, hydrochloric acid,
or muriatic acid;
(iii) an organic solvent, including ethyl
ether, alcohol, or acetone;
(iv) a petroleum distillate, including
naphtha, paint thinner, or charcoal lighter fluid; or
(v) aquarium, rock, or table salt; or
(C) at least three of the following items:
(i) an item of equipment subject to
regulation under Section 481.080, if the person is not registered
under Section 481.063; or
(ii) glassware, a plastic or metal
container, tubing, a hose, or other item specially designed,
assembled, or adapted for use in the manufacture, processing,
analyzing, storing, or concealing of methamphetamine.
SECTION 1.02. Subchapter D, Chapter 481, Health and Safety
Code, is amended by adding Section 481.1245 to read as follows:
Sec. 481.1245. OFFENSE: POSSESSION OR TRANSPORT OF
ANHYDROUS AMMONIA; USE OF OR TAMPERING WITH EQUIPMENT. (a) A
person commits an offense if the person:
(1) possesses or transports anhydrous ammonia in a
container or receptacle that is not designed or manufactured to
hold or transport anhydrous ammonia;
(2) uses, transfers, or sells a container or
receptacle that is designed or manufactured to hold anhydrous
ammonia without the express consent of the owner of the container or
receptacle; or
(3) tampers with equipment that is manufactured or
used to hold, apply, or transport anhydrous ammonia without the
express consent of the owner of the equipment.
(b) An offense under this section is a felony of the third
degree.
SECTION 1.03. Chapter 504, Health and Safety Code, is
repealed.
SECTION 1.04. The changes in law made by this article apply
only to an offense committed on or after the effective date of this
Act. An offense committed before the effective date of this Act is
governed by the law in effect when the offense was committed, and
the former law is continued in effect for that purpose. For
purposes of this section, an offense was committed before the
effective date of this Act if any element of the offense was
committed before that date.
ARTICLE 2. REGULATION OF
CHEMICAL PRECURSORS TO METHAMPHETAMINE UNDER
THE CONTROLLED SUBSTANCES ACT
SECTION 2.01. Subchapter B, Chapter 481, Health and Safety
Code, is amended by adding Section 481.037 to read as follows:
Sec. 481.037. DESIGNATION OF EPHEDRINE, PSEUDOEPHEDRINE,
AND NORPSEUDOEPHEDRINE. (a) In this section, "ephedrine,"
"pseudoephedrine," and "norpseudoephedrine" mean any compound,
mixture, or preparation containing any detectable amount of that
substance, including its salts, optical isomers, and salts of
optical isomers. The term does not include any compound, mixture,
or preparation that is in liquid, liquid capsule, or liquid gel
capsule form.
(b) Notwithstanding Section 481.033 or any other provision
of this subchapter, Schedule V includes:
(1) ephedrine;
(2) pseudoephedrine; and
(3) norpseudoephedrine.
SECTION 2.02. Subchapter C, Chapter 481, Health and Safety
Code, is amended by adding Section 481.0721 to read as follows:
Sec. 481.0721. OVER-THE-COUNTER SALES OF EPHEDRINE,
PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE. (a) This section
applies to any product containing ephedrine, pseudoephedrine, or
norpseudoephedrine added to Schedule V by Section 481.037.
(b) Notwithstanding Section 481.074, a business
establishment may engage in over-the-counter sales of products
containing ephedrine, pseudoephedrine, or norpseudoephedrine if
the establishment:
(1) operates a pharmacy licensed by the Texas State
Board of Pharmacy;
(2) engages only in direct retail sales to patrons of
the establishment for the patrons' personal use; and
(3) complies with the requirements of this section.
(c) A business establishment that engages in
over-the-counter sales of products containing ephedrine,
pseudoephedrine, or norpseudoephedrine shall:
(1) maintain those products in a secure location
accessible to a patron of the establishment only with the
assistance of an employee of the establishment; and
(2) ensure that those products are sold to a patron of
the establishment only by an employee of the establishment who is
licensed under Chapter 557, 558, or 568, Occupations Code.
(d) Before completing an over-the-counter sale of a product
containing ephedrine, pseudoephedrine, or norpseudoephedrine, a
business establishment shall:
(1) require the person purchasing the product to:
(A) display a driver's license or other form of
identification containing the person's photograph and date of
birth; and
(B) sign for the purchase;
(2) make a record of the sale, including the name and
date of birth of the person making the purchase, the date of
purchase, and the item and number of grams purchased; and
(3) take actions necessary to prevent a person who
makes over-the-counter purchases of one or more products containing
ephedrine, pseudoephedrine, or norpseudoephedrine from obtaining
from the establishment more than:
(A) three grams of those substances in a single
transaction; or
(B) nine grams of those substances in any 30-day
period.
(e) The business establishment shall maintain each record
made under Subsection (d)(2) for at least two years after the date
the record is made and shall make each record available on request
by the department or the Texas State Board of Pharmacy.
SECTION 2.03. Subsection (l), Section 481.077, Health and
Safety Code, is amended to read as follows:
(l) This section does not apply to the sale or transfer of
any compound, mixture, or preparation containing [a nonnarcotic
product that:
[(1) includes:
[(A)] ephedrine,[;
[(B)] pseudoephedrine, or[;
[(C)] norpseudoephedrine that is in liquid,
liquid capsule, or liquid gel capsule form[; or
[(D) phenylpropanolamine; and
[(2) is sold with a prescription or over the counter in
accordance with a federal statute or rule].
ARTICLE 3. REGULATION OF WHOLESALE NONPRESCRIPTION DRUG
DISTRIBUTORS
UNDER THE TEXAS FOOD, DRUG, AND COSMETIC ACT
SECTION 3.01. The heading to Subchapter I, Chapter 431,
Health and Safety Code, is amended to read as follows:
SUBCHAPTER I. WHOLESALE [DRUG] DISTRIBUTORS
OF NONPRESCRIPTION DRUGS
SECTION 3.02. Section 431.201, Health and Safety Code, is
amended to read as follows:
Sec. 431.201. DEFINITIONS. In this subchapter:
(1) "Nonprescription drug" means any drug that is not
a prescription drug as defined by Section 431.401.
(2) "Place of business" means each location at which a
drug for wholesale distribution is located.
(3) "Wholesale distribution" means distribution to a
person other than a consumer or patient, and includes distribution
by a manufacturer, repackager [repacker], own label distributor,
broker, jobber, warehouse, or wholesaler.
[(2) "Place of business" means each location at which
a drug for wholesale distribution is located.]
SECTION 3.03. Subchapter I, Chapter 431, Health and Safety
Code, is amended by adding Section 431.2011 to read as follows:
Sec. 431.2011. APPLICABILITY OF SUBCHAPTER. This
subchapter applies only to the wholesale distribution of
nonprescription drugs.
SECTION 3.04. Section 431.202, Health and Safety Code, is
amended to read as follows:
Sec. 431.202. LICENSE [STATEMENT] REQUIRED. (a) A person
may not engage in wholesale distribution of nonprescription drugs
in this state unless the person holds a wholesale drug distribution
license issued by the department under this subchapter or
Subchapter N [has filed with the commissioner a signed and verified
license statement on a form furnished by the commissioner].
(b) An applicant for a license under this subchapter must
submit an application to the department on the form prescribed by
the department or electronically on the TexasOnline Internet
website [The license statement must be filed annually].
(c) A license issued under this subchapter expires on the
second anniversary of the date of issuance.
SECTION 3.05. Section 431.204, Health and Safety Code, is
amended to read as follows:
Sec. 431.204. FEES. (a) The department [board] shall
collect fees for:
(1) a license that is filed or renewed;
(2) a license that is amended, including a
notification of a change in the location of a licensed place of
business required under Section 431.206; and
(3) an inspection performed in enforcing this
subchapter and rules adopted under this subchapter.
(b) The executive commissioner of the Health and Human
Services Commission [board may charge annual fees.
[(c) The board] by rule shall set the fees in amounts that
allow the department to recover [at least 50 percent of] the
biennial [annual] expenditures of state funds by the department in:
(1) reviewing and acting on a license;
(2) amending and renewing a license;
(3) inspecting a licensed facility; and
(4) implementing and enforcing this subchapter,
including a rule or order adopted or a license issued under this
subchapter.
(c) [(d)] Fees collected under this section shall be
deposited to the credit of the food and drug registration fee
account of the general revenue fund and [may be] appropriated to the
department [only] to carry out the administration and enforcement
of this chapter.
SECTION 3.06. Sections 431.206 and 431.207, Health and
Safety Code, are amended to read as follows:
Sec. 431.206. CHANGE OF LOCATION OF PLACE OF BUSINESS.
(a) Not fewer than 30 days in advance of the change, the licensee
shall notify the department [commissioner or the commissioner's
designee] in writing of the licensee's intent to change the
location of a licensed place of business.
(b) The notice shall include the address of the new
location, and the name and residence address of the individual in
charge of the business at the new location.
(c) Not more than 10 days after the completion of the change
of location, the licensee shall notify the department [commissioner
or the commissioner's designee] in writing to confirm the
completion of [verify] the change of location and provide
verification of the information previously provided or correct and
confirm any information that has changed since providing the notice
of intent[, the address of the new location, and the name and
residence address of the individual in charge of the business at the
new address].
(d) The notice and confirmation required by this section are
[Notice will be] deemed adequate if the licensee sends [provides]
the [intent and verification] notices [to the commissioner or the
commissioner's designee] by certified mail, return receipt
requested, [mailed] to the central office of the department or
submits them electronically through the TexasOnline Internet
website.
Sec. 431.207. REFUSAL TO LICENSE; SUSPENSION OR REVOCATION
OF LICENSE. (a) The commissioner of state health services may
refuse an application for a license or may suspend or revoke a
license if the applicant or licensee:
(1) has been convicted of a felony or misdemeanor that
involves moral turpitude;
(2) is an association, partnership, or corporation and
the managing officer has been convicted of a felony or misdemeanor
that involves moral turpitude;
(3) has been convicted in a state or federal court of
the illegal use, sale, or transportation of intoxicating liquors,
narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their
compounds or derivatives, or any other dangerous or habit-forming
drugs;
(4) is an association, partnership, or corporation and
the managing officer has been convicted in a state or federal court
of the illegal use, sale, or transportation of intoxicating
liquors, narcotic drugs, barbiturates, amphetamines,
desoxyephedrine, their compounds or derivatives, or any other
dangerous or habit-forming drugs; [or]
(5) has not complied with this chapter or the [board's]
rules implementing this chapter;
(6) has violated Section 431.021(l)(3), relating to
the counterfeiting of a drug or the sale or holding for sale of a
counterfeit drug;
(7) has violated Chapter 481 (Texas Controlled
Substances Act) or 483 (Texas Dangerous Drug Act);
(8) has violated the rules of the public safety
director of the Department of Public Safety, including being
responsible for a significant discrepancy in the records that state
law requires the applicant or licensee to maintain; or
(9) fails to complete a license application or submits
an application that contains false, misleading, or incorrect
information or contains information that cannot be verified by the
department.
(b) The executive commissioner of the Health and Human
Services Commission by rule shall establish minimum standards
required for the issuance or renewal of a license under this
subchapter [may refuse an application for a license or may suspend
or revoke a license if the commissioner determines from evidence
presented during a hearing that the applicant or licensee:
[(1) has violated Section 431.021(l)(3), relating to
the counterfeiting of a drug or the sale or holding for sale of a
counterfeit drug;
[(2) has violated Chapter 481 (Texas Controlled
Substances Act) or 483 (Dangerous Drugs); or
[(3) has violated the rules of the director of the
Department of Public Safety, including being responsible for a
significant discrepancy in the records that state law requires the
applicant or licensee to maintain].
(c) The refusal to license an applicant or the suspension or
revocation of a license by the department [commissioner] and the
appeal from that action are governed by [the board's formal hearing
procedures and] the procedures for a contested case hearing under
Chapter 2001, Government Code.
SECTION 3.07. 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 [filing a licensing statement with the
commissioner as required by Section 431.202 or having a license as
required by Section 431.272], 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; [or]
(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 [the
board, the commissioner, or 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;
or
(cc) performing, causing the performance of, or aiding
and abetting the performance of an act described by Subdivision
(x).
SECTION 3.08. Sections 431.2021 and 431.205, Health and
Safety Code, are repealed.
SECTION 3.09. Not later than January 1, 2006, the executive
commissioner of the Health and Human Services Commission shall
adopt the rules necessary to implement the changes in law made by
this article by amending Subchapter I, Chapter 431, Health and
Safety Code.
SECTION 3.10. Not later than January 1, 2006, the
Department of State Health Services shall prescribe the forms
required to implement the changes in law made by this article by the
amendment of Subchapter I, Chapter 431, Health and Safety Code.
SECTION 3.11. The change in law made by this article applies
only to an offense committed on or after March 1, 2006. An offense
committed before that date is covered by the law in effect when the
offense was committed, and the former law is continued in effect for
that purpose. For purposes of this section, an offense was
committed before March 1, 2006, if any element of the offense was
committed before that date.
SECTION 3.12. (a) Subject to Subsection (b) of this
section, this article takes effect on the date designated by
Section 4.01 of this Act, except that Sections 3.01 through 3.07 of
this article take effect March 1, 2006.
(b) This article takes effect only if Senate Bill 1685 or
another similar bill of the Regular Session of the 79th Legislature
adding Subchapter N, Chapter 431, Health and Safety Code,
regulating wholesale prescription drug distributors is enacted and
becomes law. If Senate Bill 1685 or another similar bill of the
Regular Session of the 79th Legislature adding Subchapter N,
Chapter 431, Health and Safety Code, regulating wholesale
prescription drug distributors does not become law, this article
does not take effect.
ARTICLE 4. EFFECTIVE DATE
SECTION 4.01. This Act takes effect on June 1, 2005, if it
receives a vote of two-thirds of all the members elected to each
house, as provided by Section 39, Article III, Texas Constitution.
If this Act does not receive the vote necessary to take effect on
that date, this Act takes effect September 1, 2005.
* * * * *