This website will be unavailable from Friday, April 26, 2024 at 6:00 p.m. through Monday, April 29, 2024 at 7:00 a.m. due to data center maintenance.
79R16323 PEP-D
By: Estes, et al. S.B. No. 107
Substitute the following for S.B. No. 107:
By: Hegar C.S.S.B. No. 107
A BILL TO BE ENTITLED
AN ACT
relating to the civil and criminal consequences of engaging in
certain conduct related to the manufacture of methamphetamine and
to the distribution and retail sales of pseudoephedrine; providing
penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
ARTICLE 1. CIVIL AND CRIMINAL CONSEQUENCES OF
ENGAGING IN CERTAIN CONDUCT RELATED TO
THE MANUFACTURE OF METHAMPHETAMINE
SECTION 1.01. Section 481.124(b), 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 another item specially designed,
assembled, or adapted for use in the manufacture, processing,
analyzing, storing, or concealing of methamphetamine.
SECTION 1.02. Section 481.136(a), Health and Safety Code,
is amended to read as follows:
(a) A person commits an offense if the person sells,
transfers, furnishes, or receives a chemical precursor subject to
Section 481.077(a) and the person:
(1) does not hold a chemical precursor transfer permit
as required by Section 481.078 at the time of the transaction;
(2) does not comply with Section 481.077 or 481.0771;
(3) knowingly makes a false statement in a report or
record required by Section 481.077, 481.0771, or 481.078; or
(4) knowingly violates a rule adopted under Section
481.077, 481.0771, or 481.078.
SECTION 1.03. Section 99.003, Civil Practice and Remedies
Code, is amended to read as follows:
Sec. 99.003. STRICT LIABILITY AND MINIMUM DAMAGES FOR
EXPOSURE. A person who manufactures methamphetamine is strictly
liable for any exposure by an individual to the manufacturing
process, including exposure to the methamphetamine itself or any of
the by-products or waste products incident to the manufacture, for
the greater of:
(1) actual damages for personal injury, death, or
property damage as a result of the exposure; or
(2) $20,000 [$10,000] for each incident of exposure.
SECTION 1.04. Section 262.104, Family Code, is amended to
read as follows:
Sec. 262.104. TAKING POSSESSION OF A CHILD IN EMERGENCY
WITHOUT A COURT ORDER. (a) If there is no time to obtain a
temporary restraining order or attachment before taking possession
of a child consistent with the health and safety of that child, an
authorized representative of the Department of Family and
Protective [and Regulatory] Services, a law enforcement officer, or
a juvenile probation officer may take possession of a child without
a court order under the following conditions, only:
(1) on personal knowledge of facts that would lead a
person of ordinary prudence and caution to believe that there is an
immediate danger to the physical health or safety of the child;
(2) on information furnished by another that has been
corroborated by personal knowledge of facts and all of which taken
together would lead a person of ordinary prudence and caution to
believe that there is an immediate danger to the physical health or
safety of the child;
(3) on personal knowledge of facts that would lead a
person of ordinary prudence and caution to believe that the child
has been the victim of sexual abuse;
(4) on information furnished by another that has been
corroborated by personal knowledge of facts and all of which taken
together would lead a person of ordinary prudence and caution to
believe that the child has been the victim of sexual abuse; or
(5) on information furnished by another that has been
corroborated by personal knowledge of facts and all of which taken
together would lead a person of ordinary prudence and caution to
believe that the parent or person who has possession of the child is
currently using a controlled substance as defined by Chapter 481,
Health and Safety Code, and the use constitutes an immediate danger
to the physical health or safety of the child.
(b) An authorized representative of the Department of
Family and Protective Services, a law enforcement officer, or a
juvenile probation officer may take possession of a child under
Subsection (a) on personal knowledge or information furnished by
another, that has been corroborated by personal knowledge, that
would lead a person of ordinary prudence and caution to believe that
the parent or person who has possession of the child has permitted
the child to remain on premises used for the manufacture of
methamphetamine.
SECTION 1.05. Section 22.041, Penal Code, is amended by
adding Subsection (c-1) to read as follows:
(c-1) For purposes of Subsection (c), it is presumed that a
person engaged in conduct that places a child in imminent danger of
death, bodily injury, or physical or mental impairment if the
person manufactured the controlled substance methamphetamine in
the presence of the child.
SECTION 1.06. Sections 481.124 and 481.136, Health and
Safety Code, as amended by this Act, and Section 22.041(c-1), Penal
Code, as added by this Act, apply only to an offense committed on or
after September 1, 2005. An offense committed before September 1,
2005, 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 September 1, 2005, if any element of the offense was
committed before that date.
SECTION 1.07. Section 99.003, Civil Practice and Remedies
Code, as amended by this Act, applies only to a cause of action that
accrues on or after September 1, 2005. An action that accrued
before September 1, 2005, is governed by the law applicable to the
action immediately before September 1, 2005, and that law is
continued in effect for that purpose.
ARTICLE 2. DISTRIBUTION AND RETAIL SALES OF
PSEUDOEPHEDRINE
SECTION 2.01. Subchapter C, Chapter 481, Health and Safety
Code, is amended by adding Section 481.0771 to read as follows:
Sec. 481.0771. RECORDS AND REPORTS ON PSEUDOEPHEDRINE. (a)
A wholesaler who sells, transfers, or otherwise furnishes
pseudoephedrine to a retailer shall make available to the director
all records of the transaction in accordance with department rule.
(b) Not later than five business days after receipt of an
order for pseudoephedrine, a wholesaler shall submit to the
director in accordance with department rule a report of the order if
the order requests delivery of a suspicious quantity of
pseudoephedrine as determined by department rule.
(c) A wholesaler who, with reckless disregard for the duty
to report under Subsection (b), fails to report as required by that
subsection may be subject to disciplinary action in accordance with
department rule.
SECTION 2.02. Subtitle C, Title 6, Health and Safety Code,
is amended by adding Chapter 486 to read as follows:
CHAPTER 486. PSEUDOEPHEDRINE
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 486.001. DEFINITIONS. (a) In this chapter:
(1) "Commissioner" means the commissioner of state
health services.
(2) "Council" means the State Health Services Council.
(3) "Department" means the Department of State Health
Services.
(4) "Pseudoephedrine" means any compound, mixture, or
preparation containing any detectable amount of pseudoephedrine,
including its salts, optical isomers, and salts of optical isomers.
The term does not include any compounds, mixtures, or preparations
that are in liquid, liquid capsule, or gel capsule form and in which
pseudoephedrine is not the only active ingredient.
(5) "Sale" includes a conveyance, exchange, barter, or
trade.
(b) A term that is used in this chapter but is not defined by
Subsection (a) has the meaning assigned by Section 481.002.
Sec. 486.002. APPLICABILITY. This chapter does not apply
to the sale of any product dispensed or delivered by a pharmacist
according to a prescription issued by a practitioner for a valid
medical purpose and in the course of professional practice.
Sec. 486.003. RULES. The council shall adopt rules
necessary to implement and enforce this chapter.
Sec. 486.004. FEES. (a) The department shall collect fees
for:
(1) the issuance of a certificate of authority under
this chapter; and
(2) an inspection performed in enforcing this chapter
and rules adopted under this chapter.
(b) The commissioner by rule shall set the fees in amounts
that allow the department to recover the biennial expenditures of
state funds by the department in:
(1) reviewing applications for the issuance of a
certificate of authority under this chapter;
(2) issuing certificates of authority under this
chapter;
(3) inspecting and auditing a business establishment
that is issued a certificate of authority under this chapter; and
(4) otherwise implementing and enforcing this
chapter.
(c) Fees collected under this section shall be deposited to
the credit of a special account in the general revenue fund and
appropriated to the department to implement and enforce this
chapter.
[Sections 486.005-486.010 reserved for expansion]
SUBCHAPTER B. OVER-THE-COUNTER SALES OF PSEUDOEPHEDRINE
Sec. 486.011. SALES BY PHARMACIES. A business
establishment that operates a pharmacy licensed by the Texas State
Board of Pharmacy may engage in over-the-counter sales of
pseudoephedrine.
Sec. 486.012. SALES BY ESTABLISHMENTS OTHER THAN
PHARMACIES; CERTIFICATE OF AUTHORITY. (a) A business
establishment that does not operate a pharmacy licensed by the
Texas State Board of Pharmacy may engage in over-the-counter sales
of pseudoephedrine only if the establishment holds a certificate of
authority issued under this section.
(b) The department may issue a certificate of authority to
engage in over-the-counter sales of pseudoephedrine to a business
establishment that does not operate a pharmacy licensed by the
Texas State Board of Pharmacy if the establishment:
(1) applies to the department for the certificate in
accordance with department rule; and
(2) complies with the requirements established by the
department for issuance of a certificate.
(c) The department by rule shall establish requirements for
the issuance of a certificate of authority under this section. The
rules must include a consideration by the department of whether the
establishment:
(1) complies with the requirements of the Texas State
Board of Pharmacy for the issuance of a license to operate a
pharmacy;
(2) sells a wide variety of pharmaceutical products;
and
(3) employs sales techniques and other measures
designed to deter the theft of products containing pseudoephedrine
and other items used in the manufacture of methamphetamine.
(d) The department may inspect or audit a business
establishment that is issued a certificate of authority under this
section at any time the department determines necessary.
Sec. 486.013. RESTRICTION OF ACCESS TO PSEUDOEPHEDRINE. A
business establishment that engages in over-the-counter sales of
pseudoephedrine shall display the pseudoephedrine in a manner that
makes the pseudoephedrine accessible to a patron of the business
establishment only with the assistance of an employee of the
establishment.
Sec. 486.014. PREREQUISITES TO SALE OF PSEUDOEPHEDRINE.
Before completing an over-the-counter sale of pseudoephedrine, a
business establishment that engages in those sales shall:
(1) require the person purchasing pseudoephedrine to:
(A) display a driver's license or other form of
identification containing the person's photograph and indicating
that the person is 16 years of age or older; and
(B) sign for the purchase;
(2) make a record of the sale, including the name of
the person purchasing pseudoephedrine, the date of purchase, and
the number of grams of pseudoephedrine purchased; and
(3) take actions necessary to prevent a person who
makes over-the-counter purchases of one or more products containing
pseudoephedrine from obtaining from the establishment in a single
transaction more than:
(A) two packages of a product containing
pseudoephedrine; or
(B) six grams of pseudoephedrine.
Sec. 486.015. MAINTENANCE OF RECORDS. A business
establishment that engages in over-the-counter sales of
pseudoephedrine shall maintain all records made under Section
486.014(2) in a secure centralized location. The establishment
shall maintain each record until at least the second anniversary of
the date the record is made.
[Sections 486.016-486.020 reserved for expansion]
SUBCHAPTER C. ADMINISTRATIVE PENALTY
Sec. 486.021. IMPOSITION OF PENALTY. The department may
impose an administrative penalty on a person who violates this
chapter.
Sec. 486.022. AMOUNT OF PENALTY. (a) The amount of the
penalty may not exceed $1,000 for each violation, and each day a
violation continues or occurs is a separate violation for purposes
of imposing a penalty. The total amount of the penalty assessed for
a violation continuing or occurring on separate days under this
subsection may not exceed $10,000.
(b) The amount shall be based on:
(1) the seriousness of the violation, including the
nature, circumstances, extent, and gravity of the violation;
(2) the threat to health or safety caused by the
violation;
(3) the history of previous violations;
(4) the amount necessary to deter a future violation;
(5) whether the violator demonstrated good faith,
including when applicable whether the violator made good faith
efforts to correct the violation; and
(6) any other matter that justice may require.
Sec. 486.023. REPORT AND NOTICE OF VIOLATION AND PENALTY.
(a) If the department initially determines that a violation
occurred, the department shall give written notice of the report by
certified mail to the person.
(b) The notice must:
(1) include a brief summary of the alleged violation;
(2) state the amount of the recommended penalty; and
(3) inform the person of the person's right to a
hearing on the occurrence of the violation, the amount of the
penalty, or both.
Sec. 486.024. PENALTY TO BE PAID OR HEARING REQUESTED. (a)
Before the 21st day after the date the person receives notice under
Section 486.023, the person in writing may:
(1) accept the determination and recommended penalty;
or
(2) make a request for a hearing on the occurrence of
the violation, the amount of the penalty, or both.
(b) If the person accepts the determination and recommended
penalty or if the person fails to respond to the notice, the
commissioner by order shall approve the determination.
Sec. 486.025. HEARING. (a) If the person requests a
hearing, the commissioner shall refer the matter to the State
Office of Administrative Hearings, which shall promptly set a
hearing date and give written notice of the time and place of the
hearing to the person. An administrative law judge of the State
Office of Administrative Hearings shall conduct the hearing.
(b) The administrative law judge shall make findings of fact
and conclusions of law and promptly issue to the commissioner a
proposal for a decision about the occurrence of the violation and
the amount of a proposed penalty.
Sec. 486.026. DECISION. (a) Based on the findings of fact,
conclusions of law, and proposal for a decision, the commissioner
by order may:
(1) find that a violation occurred and impose a
penalty; or
(2) find that a violation did not occur.
(b) The notice of the commissioner's order under Subsection
(a) that is sent to the person in the manner provided by Chapter
2001, Government Code, must include a statement of the right of the
person to judicial review of the order.
Sec. 486.027. OPTIONS FOLLOWING DECISION: PAY OR APPEAL.
Before the 31st day after the date the order under Section 486.026
that imposes an administrative penalty becomes final, the person
shall:
(1) pay the penalty; or
(2) file a petition for judicial review of the order
contesting the occurrence of the violation, the amount of the
penalty, or both.
Sec. 486.028. STAY OF ENFORCEMENT OF PENALTY. (a) Within
the period prescribed by Section 486.027, a person who files a
petition for judicial review may:
(1) stay enforcement of the penalty by:
(A) paying the penalty to the court for placement
in an escrow account; or
(B) giving the court a supersedeas bond approved
by the court that:
(i) is for the amount of the penalty; and
(ii) is effective until all judicial review
of the order is final; or
(2) request the court to stay enforcement of the
penalty by:
(A) filing with the court a sworn affidavit of
the person stating that the person is financially unable to pay the
penalty and is financially unable to give the supersedeas bond; and
(B) sending a copy of the affidavit to the
commissioner by certified mail.
(b) Following receipt of a copy of an affidavit under
Subsection (a)(2), the commissioner may file with the court, before
the sixth day after the date of receipt, a contest to the affidavit.
The court shall hold a hearing on the facts alleged in the affidavit
as soon as practicable and shall stay the enforcement of the penalty
on finding that the alleged facts are true. The person who files an
affidavit has the burden of proving that the person is financially
unable to pay the penalty or to give a supersedeas bond.
Sec. 486.029. COLLECTION OF PENALTY. (a) If the person
does not pay the penalty and the enforcement of the penalty is not
stayed, the penalty may be collected.
(b) The attorney general may sue to collect the penalty.
Sec. 486.030. DECISION BY COURT. (a) If the court sustains
the finding that a violation occurred, the court may uphold or
reduce the amount of the penalty and order the person to pay the
full or reduced amount of the penalty.
(b) If the court does not sustain the finding that a
violation occurred, the court shall order that a penalty is not
owed.
Sec. 486.031. REMITTANCE OF PENALTY AND INTEREST. (a) If
the person paid the penalty and if the amount of the penalty is
reduced or the penalty is not upheld by the court, the court shall
order, when the court's judgment becomes final, that the
appropriate amount plus accrued interest be remitted to the person
before the 31st day after the date that the judgment of the court
becomes final.
(b) The interest accrues at the rate charged on loans to
depository institutions by the New York Federal Reserve Bank.
(c) The interest shall be paid for the period beginning on
the date the penalty is paid and ending on the date the penalty is
remitted.
Sec. 486.032. RELEASE OF BOND. (a) If the person gave a
supersedeas bond and the penalty is not upheld by the court, the
court shall order, when the court's judgment becomes final, the
release of the bond.
(b) If the person gave a supersedeas bond and the amount of
the penalty is reduced, the court shall order the release of the
bond after the person pays the reduced amount.
Sec. 486.033. ADMINISTRATIVE PROCEDURE. A proceeding to
impose the penalty is considered to be a contested case under
Chapter 2001, Government Code.
SECTION 2.03. The director of the Department of Public
Safety shall adopt any rules necessary to administer and enforce
Section 481.0771, Health and Safety Code, as added by this Act, not
later than September 1, 2006.
SECTION 2.04. The State Health Services Council shall adopt
rules to implement and enforce Chapter 486, Health and Safety Code,
as added by this Act, not later than September 1, 2006.
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 Drugs Act);
(8) 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; 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 3.01-3.07 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.