Bill Text: TX HB3301 | 2013-2014 | 83rd Legislature | Introduced

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Bill Title: Relating to the regulation of controlled substances and the establishment of an electronic system for monitoring controlled substances; providing criminal penalties; authorizing a fee.

Sponsorship: Partisan Bill (Democrat 1)

Status: (Introduced - Dead) 2013-03-19 - Referred to Public Health [HB3301 Detail]

Download: Texas-2013-HB3301-Introduced.html

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83R10604 JSC-D
By: McClendon H.B. No. 3301

A BILL TO BE ENTITLED
AN ACT
relating to the regulation of controlled substances and the
establishment of an electronic system for monitoring controlled
substances; providing criminal penalties; authorizing a fee.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle J, Title 3, Occupations Code, is
amended by adding Chapter 570 to read as follows:
CHAPTER 570. CONTROLLED SUBSTANCE REGISTRATION;
PRESCRIPTION DRUG ORDER MONITORING PROGRAM
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 570.001. PURPOSE. This chapter is intended to improve
the state's ability to identify and stop diversion of Schedule II-V
controlled substance prescription drug orders or other
prescription drug orders in an efficient and cost-effective manner
that will not impede the appropriate medical utilization of
controlled substances or other potentially abusable drugs.
Sec. 570.002. DEFINITIONS. In this chapter:
(1) "Administer," "agent," "chemical laboratory
apparatus," "chemical precursor," "controlled premises,"
"controlled substance," "controlled substance analogue,"
"deliver," "dispense," "dispenser," "distribute," "distributor,"
"drug," "federal Controlled Substances Act," "federal Drug
Enforcement Administration," "institutional practitioner,"
"lawful possession," "manufacture," "medical purpose," "narcotic
drug," "patient," "person," "pharmacist," "pharmacy,"
"possession," "practitioner," "prescribe," and "prescription" have
the meanings assigned by Section 481.002, Health and Safety Code.
(2) "Board" has the meaning assigned by Section
551.003.
(3) "Hospital" means:
(A) a general or special hospital as defined by
Section 241.003, Health and Safety Code; or
(B) an ambulatory surgical center as defined by
Section 243.002, Health and Safety Code, and approved by the
federal government to perform surgery paid by Medicaid on patients
admitted for a period of not more than 24 hours.
(4) "Medication order" means an order from a
practitioner to dispense a drug to a patient in a hospital for
immediate administration while the patient is in the hospital or
for emergency use on the patient's release from the hospital.
(5) "Pharmacist-in-charge" means the pharmacist
designated on a pharmacy license as the pharmacist who has the
authority or responsibility for the pharmacy's compliance with this
chapter and other laws relating to pharmacy.
(6) "Principal place of business" means a location
where a person manufactures, distributes, dispenses, analyzes, or
possesses a controlled substance. The term does not include a
location where a practitioner dispenses a controlled substance on
an outpatient basis unless the controlled substance is stored at
that location.
(7) "Ultimate user" means a person who has lawfully
obtained and possesses a controlled substance for the person's own
use, for the use of a member of the person's household, or for
administering to an animal owned by the person or by a member of the
person's household.
Sec. 570.003. RULES. (a) The board may adopt the rules
necessary to implement this chapter.
(b) The board by rule shall establish and revise as
necessary a standardized database format that may be used by a
pharmacy to transmit the information required by this chapter to
the board electronically.
(c) The board, in consultation with the Department of State
Health Services, the Department of Public Safety, and the Texas
Medical Board, by rule may:
(1) remove a controlled substance listed in Schedules
II through V under Subchapter B, Chapter 481, Health and Safety
Code, from the prescription drug order monitoring program, if the
board determines that the burden imposed by the program
substantially outweighs the risk of diversion of the particular
controlled substance; or
(2) add a substance not listed in Schedules II through
V under Subchapter B, Chapter 481, Health and Safety Code, to the
prescription drug order monitoring program, if the board determines
that the risk of diversion substantially outweighs the burden
imposed by the program on the particular substance.
(d) The board by rule may:
(1) remove from or return to the prescription drug
order monitoring program any aspect of a practitioner's or
pharmacist's hospital practice, including administering or
dispensing substances subject to the prescription drug order
monitoring program;
(2) waive or delay any requirement relating to the
time or manner of reporting to the prescription drug order
monitoring program;
(3) establish compatibility protocols for electronic
data transfer hardware, software, or format;
(4) establish a procedure to control the release of
information under this chapter; and
(5) establish a minimum level of prescription drug
order activity below which a reporting activity may be modified or
discontinued.
(e) The board by rule shall authorize a practitioner to
determine whether it is necessary to obtain an individual's patient
identification number and to provide the number on the prescription
drug order.
Sec. 570.004. AUTHORITY TO CONTRACT. The board may
authorize a contract between the board and another agency of this
state or a private vendor as necessary to ensure the effective
operation of the prescription drug order monitoring program.
Sec. 570.005. ECONOMIC IMPACT CONSIDERATION. In adopting a
rule relating to the electronic transfer of information under this
chapter, the board shall:
(1) consider the economic impact of the proposed rule
on practitioners and pharmacists, including potential costs
related to computer hardware or software or to the transfer of
information; and
(2) to the extent permitted by law, act to minimize any
negative economic effect on practitioners or pharmacists.
Sec. 570.006. FEES. (a) The board may use fees collected
under Subchapter B to administer this chapter.
(b) The board may not impose a fee for the electronic
transfer of information in addition to the fees authorized by
Subchapter B.
(c) The board may charge:
(1) a nonrefundable fee of not more than $25 before
processing an application for annual registration; and
(2) a late fee of not more than $50 for each
application for renewal the board receives after the date the
applicant's registration expires.
(d) The board by rule shall set the fees under Subsection
(c) in the amounts necessary to cover the cost of administering and
enforcing this chapter.
(e) The board shall deposit the fees collected under this
chapter to the credit of the general revenue fund.
Sec. 570.007. GIFTS AND GRANTS. The board may accept gifts
or grants from private individuals, foundations, or the federal
government for the purposes authorized by this chapter.
SUBCHAPTER B. REGULATION OF MANUFACTURE, DISTRIBUTION, AND
DISPENSATION OF CONTROLLED SUBSTANCES, CHEMICAL PRECURSORS, AND
CHEMICAL LABORATORY APPARATUS
Sec. 570.051. REGISTRATION REQUIRED. (a) Except as
otherwise provided by this chapter, a person may not manufacture,
distribute, prescribe, possess, analyze, or dispense a controlled
substance in this state unless the person is registered by the board
under this subchapter.
(b) A person who is registered by the board to manufacture,
distribute, analyze, dispense, or conduct research with a
controlled substance may possess, manufacture, distribute,
analyze, dispense, or conduct research with that substance to the
extent authorized by the person's registration and in conformity
with this subchapter.
(c) Except as provided by Subsection (d), a separate
registration is required at each principal place of business or
professional practice where the applicant manufactures,
distributes, analyzes, dispenses, or possesses a controlled
substance.
(d) The board may not require separate registration for a
practitioner engaged in research with a nonnarcotic controlled
substance listed in Schedules II through V under Subchapter B,
Chapter 481, Health and Safety Code, if the practitioner is already
registered under this subchapter in another capacity.
(e) A person shall provide the board with the person's
Federal Drug Enforcement Administration number not later than the
45th day after the board issues a registration to the person under
this chapter.
Sec. 570.052. EXEMPTIONS. (a) The following persons are
not required to register under this subchapter and may possess a
controlled substance under this chapter:
(1) an agent or employee of a registered manufacturer,
distributor, analyzer, or dispenser of the controlled substance
acting in the usual course of business or employment;
(2) a common or contract carrier, a warehouseman, or
an employee of a carrier or warehouseman whose possession of the
controlled substance is in the usual course of business or
employment;
(3) an ultimate user or a person in possession of the
controlled substance under a lawful order of a practitioner or in
lawful possession of the controlled substance if it is listed in
Schedule V under Subchapter B, Chapter 481, Health and Safety Code;
(4) an officer or employee of this state, another
state, a political subdivision of this state or another state, or
the United States who is lawfully engaged in the enforcement of a
law relating to a controlled substance or drug or to a customs law
and authorized to possess the controlled substance in the discharge
of the person's official duties; or
(5) if the substance is tetrahydrocannabinol or one of
its derivatives:
(A) a Department of State Health Services
official, a medical school researcher, or a research program
participant possessing the substance as authorized under
Subchapter G, Chapter 481, Health and Safety Code; or
(B) a practitioner or an ultimate user possessing
the substance as a participant in a federally approved therapeutic
research program that the executive director has reviewed and
found, in writing, to contain a medically responsible research
protocol.
(b) The board by rule may waive the requirement for
registration of certain manufacturers, distributors, or dispensers
if the board finds it consistent with the public health and safety
and if the attorney general of the United States has issued a
similar waiver under the federal Controlled Substances Act.
Sec. 570.053. EXCEPTIONS. (a) This subchapter does not
apply to an educational or research program of a school district or
a public or private institution of higher education. This
subchapter does not apply to a manufacturer, wholesaler, retailer,
or other person who sells, transfers, or furnishes materials
covered by this subchapter to those educational or research
programs.
(b) The board and the Texas Higher Education Coordinating
Board shall adopt a memorandum of understanding that establishes
the responsibilities of each agency and the public or private
institutions of higher education in implementing and maintaining a
program for reporting information concerning controlled
substances, controlled substance analogues, chemical precursors,
and chemical laboratory apparatus used in educational or research
activities of institutions of higher education.
(c) The board and the Texas Education Agency shall adopt a
memorandum of understanding that establishes the responsibilities
of the agency, the board, and school districts in implementing and
maintaining a program for reporting information concerning
controlled substances, controlled substance analogues, chemical
precursors, and chemical laboratory apparatus used in educational
or research activities of those schools and school districts.
Sec. 570.054. REGISTRATION APPLICATION. An applicant for
registration under this subchapter shall submit an application to
the board on a form prescribed by the board.
Sec. 570.055. ISSUANCE OR DENIAL OF REGISTRATION. (a) The
board may refuse to issue a registration to a person to manufacture,
distribute, analyze, or conduct research with a controlled
substance if the person fails or refuses to provide to the board a
consent form signed by the person granting the board the right to
inspect the person's controlled premises and any record, controlled
substance, or other item covered by this chapter.
(b) The board may not issue a registration to a person to
dispense a controlled substance unless the board receives a consent
form signed by the person granting the board the right to inspect
records as required by this chapter.
(c) The board shall register a person to manufacture,
distribute, or analyze a controlled substance listed in Schedules
II through V under Subchapter B, Chapter 481, Health and Safety
Code, if:
(1) the person furnishes the board evidence that the
person is registered for that purpose under the federal Controlled
Substances Act;
(2) the person has made proper application and paid
the applicable fee; and
(3) the person has not been found by the board to have
violated a provision of Section 570.056.
(d) The board shall register a person to dispense or conduct
research with a controlled substance listed in Schedules II through
V under Subchapter B, Chapter 481, Health and Safety Code, if the
person:
(1) is a practitioner licensed under the laws of this
state;
(2) has made proper application and paid the
applicable fee; and
(3) has not been found by the board to have violated a
provision of Section 570.056.
Sec. 570.056. DENIAL; PROBATION. (a) An application for
registration to manufacture, distribute, analyze, dispense, or
conduct research with a controlled substance may be denied on a
finding that the applicant:
(1) has furnished material information in an
application filed under this chapter that the applicant knows is
false or fraudulent;
(2) has been convicted of or placed on community
supervision or other probation for:
(A) a felony;
(B) a violation of this chapter or of Chapters
481-485, Health and Safety Code; or
(C) an offense reasonably related to the
registration sought;
(3) has voluntarily surrendered or has had suspended,
denied, or revoked a registration or application for registration
to manufacture, distribute, analyze, or dispense controlled
substances under the federal Controlled Substances Act;
(4) has had suspended, probated, or revoked a
registration or a practitioner's license under the laws of this
state or another state;
(5) has intentionally or knowingly failed to establish
and maintain effective security controls against diversion of
controlled substances into other than legitimate medical,
scientific, or industrial channels as provided by federal
regulations or laws, this chapter, or a rule adopted under this
chapter;
(6) has intentionally or knowingly failed to maintain
records required to be kept by this chapter or a rule adopted under
this chapter;
(7) has refused to allow an inspection authorized by
this chapter or a rule adopted under this chapter;
(8) has intentionally or knowingly violated this
chapter or a rule adopted under this chapter; or
(9) has voluntarily surrendered a registration that
has not been reinstated.
(b) Chapter 2001, Government Code, does not apply to a
denial of a registration under Subsection (a)(2)(A) or (B), (a)(3),
(a)(4), or (a)(9).
(c) For good cause shown, the board may probate the denial
of an application for registration. If a denial of an application
is probated, the board may require the person to report regularly to
the board on matters that are the basis of the probation or may
limit activities of the person to those prescribed by the board, or
both.
Sec. 570.057. INSPECTION. The board may inspect the
premises or establishment of an applicant for registration in
accordance with this chapter.
Sec. 570.058. TERM OF REGISTRATION. A registration is valid
until the first anniversary of the date of issuance and may be
renewed annually under rules adopted by the board, unless a rule
provides for a longer period of validity or renewal.
Sec. 570.059. REGISTRATION FEES. (a) The board may charge
a nonrefundable fee of not more than $25 before processing an
application for annual registration and may charge a late fee of not
more than $50 for each application for renewal the board receives
after the date the registration expires.
(b) Not later than 60 days before the date the registration
expires, the board shall send a renewal notice to the registrant at
the last known address of the registrant according to board
records.
(c) The board shall deposit the fees collected under this
section to the credit of the general revenue fund.
Sec. 570.060. AUTHORIZATION FOR CERTAIN ACTIVITIES. (a)
The board may authorize the possession, distribution, planting, and
cultivation of controlled substances by a person engaged in
research, training animals to detect controlled substances, or
designing or calibrating devices to detect controlled substances.
A person who obtains an authorization under this subsection does
not commit an offense involving the possession or distribution of
controlled substances to the extent that the possession or
distribution is authorized.
(b) A person may conduct research with or analyze substances
listed in Schedule I under Subchapter B, Chapter 481, Health and
Safety Code, in this state only if the person is a practitioner
registered under federal law to conduct research with or analyze
those substances and the person provides the board with evidence of
federal registration.
Sec. 570.061. VOLUNTARY SURRENDER, CANCELLATION,
SUSPENSION, PROBATION, OR REVOCATION OF REGISTRATION. (a) The
board may accept a voluntary surrender of a registration.
(b) The board may cancel, suspend, or revoke a registration,
place on probation a person whose license has been suspended, or
reprimand a registrant for a cause described by Section 570.056(a).
(c) The board may cancel a registration that was issued in
error.
(d) The board may limit the cancellation, suspension,
probation, or revocation to the particular schedule or controlled
substance within a schedule under Subchapter B, Chapter 481, Health
and Safety Code, for which grounds for cancellation, suspension,
probation, or revocation exist.
(e) After accepting the voluntary surrender of a
registration or ordering the cancellation, suspension, probation,
or revocation of a registration, the board may seize or place under
seal all controlled substances owned or possessed by the registrant
under the authority of that registration. If the board orders the
cancellation, suspension, probation, or revocation of a
registration, a disposition may not be made of the seized or sealed
substances until the time for administrative appeal of the order
has elapsed or until all appeals have been concluded, except that
the board may order the sale of perishable substances and deposit of
the proceeds of the sale in a special interest-bearing account in
the general revenue fund. When a surrender or cancellation,
suspension, probation, or revocation order becomes final, all
controlled substances may be forfeited to this state as provided
under Subchapter E, Chapter 481, Health and Safety Code.
(f) The operation of a registrant in violation of this
section is a public nuisance, and the board may apply to any court
of competent jurisdiction for an injunction suspending the
registration of the registrant.
(g) Chapter 2001, Government Code, applies to a proceeding
under this section to the extent that that chapter does not conflict
with this subchapter. Chapter 2001, Government Code, does not
apply to a cancellation, suspension, probation, or revocation of a
registration for a cause described by Section 570.056(a)(2)(A) or
(B), (a)(3), (a)(4), or (a)(9).
(h) The board shall promptly notify appropriate state
agencies of an order accepting a voluntary surrender or canceling,
suspending, probating, or revoking a registration and the
forfeiture of controlled substances.
(i) The board shall give written notice to the applicant or
registrant of the acceptance of a voluntary surrender of a
registration, or of the cancellation, suspension, probation,
revocation, or denial of a registration. The notice shall be sent
by certified mail, return receipt requested, to the most current
address of the applicant or registrant contained in board files.
(j) After a voluntary surrender, cancellation, suspension,
probation, revocation, or denial of a registration, on petition of
the applicant or former registrant, the board may issue or
reinstate the registration for good cause shown by the petitioner.
Sec. 570.062. RECORDS. (a) A person who is registered to
manufacture, distribute, analyze, or dispense a controlled
substance shall keep records and maintain inventories in compliance
with recordkeeping and inventory requirements of federal law and
with additional rules adopted by the board.
(b) The pharmacist-in-charge of a pharmacy shall maintain
the records and inventories required by this section.
(c) A record required by this section must be made at the
time of the transaction that is the basis of the record. A record or
inventory required by this section must be kept or maintained for at
least two years after the date the record or inventory is made.
Sec. 570.063. CONFIDENTIALITY. (a) The board may
authorize a person engaged in research on the use and effects of a
controlled substance to withhold the names and other identifying
characteristics of individuals who are the subjects of the
research. A person who obtains the authorization may not be
compelled in a civil, criminal, administrative, legislative, or
other proceeding to identify the individuals who are the subjects
of the research for which the authorization is obtained.
(b) Except as provided by Section 570.069, a practitioner
engaged in authorized medical practice or research may not be
required to furnish the name or identity of a patient or research
subject to the board, the Department of State Health Services,
Division of Mental Health and Substance Abuse Services, or any
other agency, public official, or law enforcement officer. A
practitioner may not be compelled in a state or local civil,
criminal, administrative, legislative, or other proceeding to
furnish the name or identity of an individual that the practitioner
is obligated to keep confidential.
(c) The board may not provide to a federal, state, or local
law enforcement agency the name or identity of a patient or research
subject whose identity could not be obtained under Subsection (b).
Sec. 570.064. ORDER FORMS. A registrant may not distribute
or order a controlled substance listed in Schedule I or II under
Subchapter B, Chapter 481, Health and Safety Code, to or from
another registrant except under an order form. A registrant
complying with the federal law concerning order forms is in
compliance with this section.
Sec. 570.065. ADMINISTERING OR DISPENSING SCHEDULE I
CONTROLLED SUBSTANCE. Except as permitted by this chapter, a
person may not administer or dispense a controlled substance listed
in Schedule I under Subchapter B, Chapter 481, Health and Safety
Code.
Sec. 570.066. MEDICAL PURPOSE REQUIRED BEFORE PRESCRIBING,
DISPENSING, DELIVERING, OR ADMINISTERING CONTROLLED SUBSTANCE.
(a) A practitioner defined by Section 481.002(39)(A), Health and
Safety Code, may not prescribe, dispense, deliver, or administer a
controlled substance or cause a controlled substance to be
administered under the practitioner's direction and supervision
except for a valid medical purpose and in the course of medical
practice.
(b) An anabolic steroid or human growth hormone listed in
Schedule III of Subchapter B, Chapter 481, Health and Safety Code,
may only be:
(1) dispensed, prescribed, delivered, or administered
by a practitioner, as defined by Section 481.002(39)(A), Health and
Safety Code, for a valid medical purpose and in the course of
professional practice; or
(2) dispensed or delivered by a pharmacist according
to a prescription issued by a practitioner, as defined by Section
481.002(39)(A) or (C), Health and Safety Code, for a valid medical
purpose and in the course of professional practice.
(c) For the purposes of Subsection (b), bodybuilding,
muscle enhancement, or increasing muscle bulk or strength through
the use of an anabolic steroid or human growth hormone listed in
Schedule III of Subchapter B, Chapter 481, Health and Safety Code,
by a person who is in good health is not a valid medical purpose.
Sec. 570.067. MEDICAL PURPOSE REQUIRED BEFORE DISTRIBUTING
OR DISPENSING SCHEDULE V CONTROLLED SUBSTANCE. A person may not
distribute or dispense a controlled substance listed in Schedule V
under Subchapter B, Chapter 481, Health and Safety Code, except for
a valid medical purpose.
Sec. 570.068. COMMUNICATION OF PRESCRIPTIONS BY AGENT. (a)
Only a practitioner defined by Section 481.002(39)(A), Health and
Safety Code, and an agent designated in writing by the practitioner
in accordance with rules adopted by the board may communicate a
prescription by telephone. A pharmacy that receives a
telephonically communicated prescription shall promptly write the
prescription and file and retain the prescription in the manner
required by this subchapter. A practitioner who designates an
agent to communicate prescriptions shall maintain the written
designation of the agent in the practitioner's usual place of
business and shall make the designation available for inspection by
investigators for the Texas Medical Board, the State Board of
Dental Examiners, the State Board of Veterinary Medical Examiners,
and the board. A practitioner who designates a different agent
shall designate that agent in writing and maintain the designation
in the same manner in which the practitioner initially designated
an agent under this section.
(b) On the request of a pharmacist, a practitioner shall
furnish a copy of the written designation authorized under
Subsection (a).
(c) This section does not relieve a practitioner or the
practitioner's designated agent from the requirements of
Subchapter A, Chapter 562. A practitioner is personally responsible
for the actions of the designated agent in communicating a
prescription to a pharmacist.
Sec. 570.069. PRESCRIPTIONS. (a) A pharmacist may not:
(1) dispense or deliver a controlled substance or
cause a controlled substance to be dispensed or delivered under the
pharmacist's direction or supervision except under a valid
prescription and in the course of professional practice;
(2) dispense a controlled substance if the pharmacist
knows or should have known that the prescription was issued without
a valid patient-practitioner relationship;
(3) fill a prescription that is not prepared or issued
as prescribed by this chapter;
(4) permit or allow a person who is not a licensed
pharmacist or pharmacist intern to dispense, distribute, or in any
other manner deliver a controlled substance even if under the
supervision of a pharmacist, except that after the pharmacist or
pharmacist intern has fulfilled his professional and legal
responsibilities, a nonpharmacist may complete the actual cash or
credit transaction and delivery; or
(5) permit the delivery of a controlled substance to
any person not known to the pharmacist, the pharmacist intern, or
the person authorized by the pharmacist to deliver the controlled
substance without first requiring identification of the person
taking possession of the controlled substance, except as provided
by Subsection (o).
(b) Except in an emergency as defined by rule of the board or
as provided by Subsection (p), a person may not dispense or
administer a controlled substance listed in Schedule II under
Subchapter B, Chapter 481, Health and Safety Code, without a
written or electronic prescription of a practitioner. In an
emergency, a person may dispense or administer a controlled
substance listed in Schedule II on the oral or telephonically
communicated prescription of a practitioner. The person who
administers or dispenses the substance shall:
(1) if the person is a prescribing practitioner or a
pharmacist, promptly comply with Subsection (c); or
(2) if the person is not a prescribing practitioner or
a pharmacist, promptly write the oral or telephonically
communicated prescription and include in the written record of the
prescription the name, address, and federal Drug Enforcement
Administration number of the prescribing practitioner.
(c) Not later than the seventh day after the date a
prescribing practitioner authorizes an emergency oral or
telephonically communicated prescription, the prescribing
practitioner shall cause a written or electronic prescription to be
delivered to the dispensing pharmacist at the pharmacy where the
prescription was dispensed. A written prescription may be
delivered in person or by mail. The envelope of a prescription
delivered by mail must be postmarked not later than the seventh day
after the date the prescription was authorized.
(d) Except as specified in Subsections (f) and (g), the
board, by rule and in consultation with the Texas Medical Board,
shall establish the period after the date on which the prescription
is issued that a person may fill a prescription for a controlled
substance listed in Schedule II under Subchapter B, Chapter 481,
Health and Safety Code. A person may not refill a prescription for
a substance listed in Schedule II.
(e) Notwithstanding Subsection (d), a prescribing
practitioner may issue multiple prescriptions authorizing the
patient to receive a total of up to a 90-day supply of a controlled
substance listed in Schedule II under Subchapter B, Chapter 481,
Health and Safety Code, if:
(1) each separate prescription is issued for a
legitimate medical purpose by a prescribing practitioner acting in
the usual course of professional practice;
(2) the prescribing practitioner provides
instructions on each prescription to be filled at a later date
indicating the earliest date on which a pharmacy may fill each
prescription;
(3) the prescribing practitioner concludes that
providing the patient with multiple prescriptions in this manner
does not create an undue risk of diversion or abuse; and
(4) the issuance of multiple prescriptions complies
with other applicable state and federal laws.
(f) The partial filling of a prescription for a controlled
substance listed in Schedule II under Subchapter B, Chapter 481,
Health and Safety Code, is permissible, if the pharmacist is unable
to supply the full quantity called for in a written or electronic
prescription or emergency oral prescription and the pharmacist
makes a notation of the quantity supplied on the face of the written
prescription, on the written record of the emergency oral
prescription, or in the electronic prescription record. The
remaining portion of the prescription may be filled within 72 hours
of the first partial filling, except that if the remaining portion
is not or cannot be filled within the 72-hour period, the pharmacist
shall notify the prescribing practitioner. No further quantity may
be supplied beyond 72 hours without a new prescription.
(g) A prescription for a Schedule II controlled substance
under Subchapter B, Chapter 481, Health and Safety Code, that is
written for a patient in a long-term care facility (LTCF) or for a
patient with a medical diagnosis documenting a terminal illness may
be filled in partial quantities to include individual dosage units.
If there is any question about whether a patient may be classified
as having a terminal illness, the pharmacist must contact the
practitioner before partially filling the prescription. Both the
pharmacist and the practitioner have a corresponding
responsibility to assure that the controlled substance is for a
terminally ill patient. The pharmacist must record on the written
prescription or in the electronic prescription record whether the
patient is "terminally ill" or an "LTCF patient." A prescription
that is partially filled and does not contain the notation
"terminally ill" or "LTCF patient" is considered to have been
filled in violation of this chapter. For each partial filling, the
dispensing pharmacist shall record on the back of the written
prescription or in the electronic prescription record the date of
the partial filling, the quantity dispensed, the remaining quantity
authorized to be dispensed, and the identification of the
dispensing pharmacist. Before any subsequent partial filling, the
pharmacist must determine that the additional partial filling is
necessary. The total quantity of Schedule II controlled substances
dispensed in all partial fillings may not exceed the total quantity
prescribed. Schedule II prescriptions for patients in a long-term
care facility or patients with a medical diagnosis documenting a
terminal illness are valid for a period not to exceed 60 days
following the issue date unless sooner terminated by discontinuance
of the medication.
(h) A person may not dispense a controlled substance in
Schedule III or IV under Subchapter B, Chapter 481, Health and
Safety Code, that is a prescription drug under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) without a
written, electronic, oral, or telephonically communicated
prescription of a practitioner defined by Section 551.003(34)(A),
(C), or (D), and only if the pharmacist determines that the
prescription was issued for a valid medical purpose and in the
course of professional practice. A prescription for a controlled
substance listed in Schedule III or IV may not be filled or refilled
later than six months after the date on which the prescription is
issued and may not be refilled more than five times, unless the
prescription is renewed by the practitioner. A prescription under
this subsection must comply with other applicable state and federal
laws.
(i) A person may not dispense a controlled substance listed
in Schedule V under Subchapter B, Chapter 481, Health and Safety
Code, and containing 200 milligrams or less of codeine, or any of
its salts, per 100 milliliters or per 100 grams, or containing 100
milligrams or less of dihydrocodeine, or any of its salts, per 100
milliliters or per 100 grams, without the prescription of a
practitioner defined by Section 481.002(39)(A), Health and Safety
Code, except that a practitioner may dispense the substance
directly to an ultimate user. A prescription issued under this
subsection may not be filled or refilled later than six months after
the date the prescription is issued and may not be refilled more
than five times, unless the prescription is renewed by the
practitioner.
(j) A practitioner or institutional practitioner may not
allow a patient, on the patient's release from the hospital, to
possess a controlled substance prescribed by the practitioner
unless:
(1) the substance was dispensed under a medication
order while the patient was admitted to the hospital;
(2) the substance is in a properly labeled container;
and
(3) the patient possesses not more than a seven-day
supply of the substance.
(k) A prescription for a controlled substance must show:
(1) the quantity of the substance prescribed:
(A) numerically, followed by the number written
as a word, if the prescription is written;
(B) numerically, if the prescription is
electronic; or
(C) if the prescription is communicated orally or
telephonically, as transcribed by the receiving pharmacist;
(2) the date of issue and, if the prescription is
issued for a Schedule II controlled substance under Subchapter B,
Chapter 481, Health and Safety Code, to be filled at a later date
under Subsection (e), the earliest date on which a pharmacy may fill
the prescription;
(3) the name, address, and date of birth or age of the
patient or, if the controlled substance is prescribed for an
animal, the species of the animal and the name and address of its
owner;
(4) the name and strength of the controlled substance
prescribed;
(5) the directions for use of the controlled
substance;
(6) the intended use of the substance prescribed
unless the practitioner determines the furnishing of this
information is not in the best interest of the patient;
(7) the legibly printed or stamped name, address,
federal Drug Enforcement Administration registration number, and
telephone number of the practitioner at the practitioner's usual
place of business; and
(8) if the prescription is handwritten, the signature
of the prescribing practitioner.
(l) A pharmacist may exercise the pharmacist's professional
judgment in refilling a prescription for a controlled substance in
Schedule III, IV, or V under Subchapter B, Chapter 481, Health and
Safety Code, without the authorization of the prescribing
practitioner provided:
(1) failure to refill the prescription might result in
an interruption of a therapeutic regimen or create patient
suffering;
(2) either:
(A) a natural or manmade disaster has occurred
that prohibits the pharmacist from being able to contact the
practitioner; or
(B) the pharmacist is unable to contact the
practitioner after reasonable effort;
(3) the quantity of prescription drug dispensed does
not exceed a 72-hour supply;
(4) the pharmacist informs the patient or the
patient's agent at the time of dispensing that the refill is being
provided without that authorization and that authorization of the
practitioner is required for future refills; and
(5) the pharmacist informs the practitioner of the
emergency refill at the earliest reasonable time.
(m) Notwithstanding Subsection (l), in the event of a
natural or manmade disaster, a pharmacist may dispense not more
than a 30-day supply of a prescription drug, other than a controlled
substance listed in Schedule II under Subchapter B, Chapter 481,
Health and Safety Code, without the authorization of the
prescribing practitioner if:
(1) failure to refill the prescription might result in
an interruption of a therapeutic regimen or create patient
suffering;
(2) the natural or manmade disaster prohibits the
pharmacist from being able to contact the practitioner;
(3) the governor has declared a state of disaster
under Chapter 418, Government Code; and
(4) the board, through its executive director, has
notified pharmacies in this state that pharmacists may dispense up
to a 30-day supply of a prescription drug.
(n) The prescribing practitioner is not liable for an act or
omission by a pharmacist in dispensing a prescription drug under
Subsection (m).
(o) A pharmacist may permit the delivery of a controlled
substance by an authorized delivery person, by a person known to the
pharmacist, a pharmacist intern, or the authorized delivery person,
or by mail to the person or address of the person authorized by the
prescription to receive the controlled substance. If a pharmacist
permits delivery of a controlled substance under this subsection,
the pharmacist shall retain in the records of the pharmacy for a
period of not less than two years:
(1) the name of the authorized delivery person, if
delivery is made by that person;
(2) the name of the person known to the pharmacist, a
pharmacist intern, or the authorized delivery person if delivery is
made by that person; or
(3) the mailing address to which delivery is made, if
delivery is made by mail.
(p) A pharmacist may permit the delivery of a controlled
substance to a person not known to the pharmacist, a pharmacist
intern, or the authorized delivery person without first requiring
the identification of the person to whom the controlled substance
is delivered if the pharmacist determines that an emergency exists
and that the controlled substance is needed for the immediate
well-being of the patient for whom the controlled substance is
prescribed. If a pharmacist permits delivery of a controlled
substance under this subsection, the pharmacist shall retain in the
records of the pharmacy for a period of not less than two years all
information relevant to the delivery known to the pharmacist,
including the name, address, and date of birth or age of the person
to whom the controlled substance is delivered.
(q) A pharmacist may dispense a Schedule II controlled
substance listed in Subchapter B, Chapter 481, Health and Safety
Code, under a facsimile copy of a prescription completed in the
manner required by board rule and transmitted by the practitioner
or the practitioner's agent to the pharmacy if:
(1) the prescription is written for:
(A) a Schedule II narcotic or nonnarcotic
substance for a patient in a long-term care facility (LTCF), and the
practitioner notes on the prescription "LTCF patient";
(B) a Schedule II narcotic product to be
compounded for the direct administration to a patient by
parenteral, intravenous, intramuscular, subcutaneous, or
intraspinal infusion; or
(C) a Schedule II narcotic substance for a
patient with a medical diagnosis documenting a terminal illness or
a patient enrolled in a hospice care program certified or paid for
by Medicare under Title XVIII, Social Security Act (42 U.S.C.
Section 1395 et seq.), by Medicaid, or by a hospice program that is
licensed under Chapter 142, Health and Safety Code, and the
practitioner or the practitioner's agent notes on the prescription
"terminally ill" or "hospice patient"; and
(2) after transmitting the prescription, the
prescribing practitioner or the practitioner's agent:
(A) writes across the face of the prescription
"VOID--sent by fax to (name and telephone number of receiving
pharmacy)"; and
(B) files the prescription in the patient's
medical records instead of delivering it to the patient.
(r) On receipt of the prescription, the dispensing pharmacy
shall file the facsimile copy of the prescription and shall send
information relating to the prescription to the board as required
by board rule.
(s) A pharmacy in this state may fill a prescription for a
controlled substance listed in Schedule II under Subchapter B,
Chapter 481, Health and Safety Code, issued by a practitioner in
another state if:
(1) a share of the pharmacy's business involves the
dispensing and delivery or mailing of controlled substances;
(2) the prescription is issued by a prescribing
practitioner in the other state in the ordinary course of practice;
and
(3) the prescription is filled in compliance with a
written plan providing the manner in which the pharmacy may fill a
Schedule II prescription issued by a practitioner in another state
that:
(A) is submitted by the pharmacy to the board;
and
(B) is approved by the board.
(t) A prescription for a controlled substance must be on a
tamper-evident prescription form or an electronic prescription
that meets the requirements specified by the board by rule.
SUBCHAPTER C. CONTROLLED SUBSTANCE PRESCRIPTION DRUG ORDER
MONITORING SYSTEM
Sec. 570.101. ESTABLISHMENT OF SYSTEM. (a) The board shall
establish an electronic system for:
(1) tracking prescription drug orders for Schedule
II-V controlled substances as listed in Subchapter B, Chapter 481,
Health and Safety Code;
(2) monitoring Schedule II-V controlled substances
that are dispensed in this state by a pharmacy or dispensed to an
address in this state by a pharmacy licensed in this state;
(3) allowing a practitioner to have real-time Internet
access to data in the system for prescribing purposes and for
patient safety;
(4) allowing licensing agencies of practitioners
authorized to prescribe Schedule II-V controlled substances to
access the data; and
(5) alerting the board, licensing agencies of
practitioners authorized to prescribe Schedule II-V controlled
substances, or law enforcement agencies when episodes of
inappropriate activity are identified by the system.
(b) The board by rule shall design and implement a system
for submission of information to the board by electronic or other
means and for retrieval of information submitted to the board under
this subchapter. The board shall use automated information
security techniques and devices to preclude improper access to the
information.
Sec. 570.102. DATA SUBMITTED TO BOARD. (a) Each pharmacy
licensed in this state that is authorized to dispense a controlled
substance shall report to the board the data required by this
section in a timely manner as prescribed by board rule, except that
reporting may not be required for:
(1) a drug administered directly to a patient; or
(2) a drug dispensed by a practitioner at a health care
facility licensed in this state, provided that the quantity
dispensed is limited to an amount adequate to treat the patient for
a maximum of 48 hours.
(b) Data to be reported by a pharmacy for each controlled
substance prescription drug order that is dispensed shall include
the following:
(1) a name and date of birth or age of the patient, or
if the controlled substance is prescribed for an animal, the
species of the animal and the name and address of its owner;
(2) the name and strength of the drug dispensed;
(3) the date of dispensing;
(4) the quantity dispensed;
(5) the practitioner's name, address, and federal Drug
Enforcement Administration number;
(6) the name and address of the dispensing pharmacy;
and
(7) any other information required by board rule.
(c) A pharmacy or pharmacist shall provide the data required
under Subsection (b) to the board in the electronic format
specified by board rule unless a waiver has been granted by the
board to an individual pharmacy.
(d) The board shall establish acceptable error tolerance
rates for data submitted under this section. A pharmacy or
pharmacist who submits the data shall ensure that reports fall
within the acceptable tolerances.
(e) A pharmacy or pharmacist who submits incomplete or
inaccurate data shall correct the data on notification by the board
if the pharmacy or pharmacist exceeds the acceptable error
tolerance rates established by the board.
Sec. 570.103. DISCLOSURE OF DATA. (a) The board may not
permit any person to have access to information submitted to the
board under this subchapter except:
(1) an investigator for the Texas Medical Board, the
Texas State Board of Podiatric Medical Examiners, the State Board
of Dental Examiners, the State Board of Veterinary Medical
Examiners, the Texas Board of Nursing, the board, or an agency in
this state that licenses a practitioner who is authorized by state
law to prescribe or dispense controlled substances; or
(2) if the board finds that proper need has been shown
to the board:
(A) an officer of the Department of Public
Safety, a law enforcement or prosecutorial official engaged in the
administration, investigation, or enforcement of this chapter,
Chapter 481, Health and Safety Code, or another law governing
illicit drugs in this state or another state;
(B) a pharmacist or practitioner who is a
physician, dentist, veterinarian, podiatrist, or advanced practice
nurse or physician assistant or other health care professional
authorized to dispense or prescribe controlled substances in this
state and is inquiring about a recent Schedule II-V prescription
drug order history of a particular patient of the practitioner; or
(C) a pharmacist or practitioner who is inquiring
about the person's own dispensing or prescribing activity.
(b) This section does not prohibit the board from creating,
using, or disclosing statistical data about information received by
the board under this section if the board removes any information
reasonably likely to reveal the identity of each patient,
practitioner, or other person who is a subject of the information.
(c) Information submitted to the board under this section
may be used only for:
(1) the administration, investigation, or enforcement
of this chapter or another law governing illicit drugs in this state
or another state;
(2) investigatory or evidentiary purposes in
connection with the functions of an agency listed in Subsection
(a)(1); or
(3) dissemination by the board to the public in the
form of a statistical tabulation or report if all information
reasonably likely to reveal the identity of each patient,
practitioner, or other person who is a subject of the information
has been removed.
(d) Except as otherwise provided by this subsection, the
board shall remove from the information retrieval system, destroy,
and make irretrievable the record of the identity of a patient
submitted under this section to the board not later than the end of
the 12th calendar month after the month in which the identity is
entered into the system. The board may retain a patient identity
that is necessary for use in a specific ongoing investigation
conducted in accordance with this section until the 30th day after
the end of the month in which the necessity for retention of the
identity ends.
(e) If the board permits access to information under
Subsection (a)(2) relating to a person licensed or regulated by an
agency listed in Subsection (a)(1), the board shall notify and
cooperate with that agency regarding the disposition of the matter
before taking action against the person, unless the board
determines that notification is reasonably likely to interfere with
an administrative or criminal investigation or prosecution.
(f) If the board permits access to information under
Subsection (a)(2)(A) relating to a person licensed or regulated by
an agency listed in Subsection (a)(1), the board shall notify that
agency of the disclosure of the information not later than the 10th
working day after the date the information is disclosed.
(g) Information submitted to the board under this
subchapter is confidential and remains confidential regardless of
whether the board permits access to the information under this
section.
SUBCHAPTER D. CRIMINAL PENALTIES
Sec. 570.151. OFFENSE: FAILURE TO TRANSMIT DATA. (a) A
person commits an offense if the person:
(1) is a pharmacist or owner of a pharmacy required to
submit data under Section 570.102; and
(2) intentionally fails to transmit to the board the
data required by Section 570.102.
(b) Except as provided by Subsection (c), an offense under
Subsection (a) is a Class A misdemeanor.
(c) An offense under Subsection (a) is a state jail felony
if it is shown on the trial of the offense that the person has been
previously convicted of an offense under this section.
Sec. 570.152. OFFENSE: DISCLOSURE OF DATA. (a) A person
commits an offense if the person discloses information in violation
of Section 570.103.
(b) Except as provided by Subsection (c), an offense under
Subsection (a) is a state jail felony.
(c) An offense under Subsection (a) is a felony of the third
degree if it is shown on the trial of the offense that the person has
been previously convicted of an offense under this section.
SECTION 2. Section 481.002(45), Health and Safety Code, is
amended to read as follows:
(45) "Registrant" means a person who is registered
under Subchapter B, Chapter 570, Occupations Code [Section
481.063].
SECTION 3. Section 481.003(a), Health and Safety Code, is
amended to read as follows:
(a) The director may adopt rules to administer and enforce
this chapter, except that the Texas State Board of Pharmacy may
adopt rules relating to the registration to manufacture,
distribute, prescribe, possess, analyze, or dispense a controlled
substance in this state and issuance of prescriptions and
information submitted in connection with those prescriptions. The
department and the board by rule shall adopt a memorandum of
understanding outlining the responsibilities of each agency in
regulating controlled substances under this chapter.
SECTION 4. Section 481.061, Health and Safety Code, is
amended to read as follows:
Sec. 481.061. REGISTRATION REQUIRED. A [(a) Except as
otherwise provided by this chapter, a] person who is not registered
with the Texas State Board of Pharmacy under Chapter 570,
Occupations Code, [a registrant] may not manufacture, distribute,
prescribe, possess, analyze, or dispense a controlled substance in
this state.
[(b) A person who is registered by the director to
manufacture, distribute, analyze, dispense, or conduct research
with a controlled substance may possess, manufacture, distribute,
analyze, dispense, or conduct research with that substance to the
extent authorized by the person's registration and in conformity
with this chapter.
[(c) A separate registration is required at each principal
place of business or professional practice where the applicant
manufactures, distributes, analyzes, dispenses, or possesses a
controlled substance. However, the director may not require
separate registration for a practitioner engaged in research with a
nonnarcotic controlled substance listed in Schedules II through V
if the registrant is already registered under this subchapter in
another capacity.
[(d) A person shall provide the department with the person's
Federal Drug Enforcement Administration number not later than the
45th day after the director issues a registration to the person
under this subchapter.]
SECTION 5. Section 481.077(c), Health and Safety Code, is
amended to read as follows:
(c) This section and Section 481.078 do not apply to a
person to whom a registration has been issued under Subchapter B,
Chapter 570, Occupations Code [Section 481.063].
SECTION 6. Section 481.080(d), Health and Safety Code, is
amended to read as follows:
(d) This section and Section 481.081 do not apply to a
person to whom a registration has been issued under Subchapter B,
Chapter 570, Occupations Code [Section 481.063].
SECTION 7. 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 Subchapter B, Chapter 570, Occupations Code [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 8. Section 481.127(a), Health and Safety Code, is
amended to read as follows:
(a) A person commits an offense if the person knowingly
gives, permits, or obtains unauthorized access to information
submitted to the director under Section 570.069, Occupations Code
[481.075].
SECTION 9. Section 481.128(a), Health and Safety Code, is
amended to read as follows:
(a) A registrant or dispenser commits an offense if the
registrant or dispenser knowingly:
(1) distributes, delivers, administers, or dispenses
a controlled substance in violation of Sections 570.065-570.069,
Occupations Code [481.070-481.075];
(2) manufactures a controlled substance not
authorized by the person's registration or distributes or dispenses
a controlled substance not authorized by the person's registration
to another registrant or other person;
(3) refuses or fails to make, keep, or furnish a
record, report, notification, order form, statement, invoice, or
information required by this chapter;
(4) prints, manufactures, possesses, or produces an
official prescription form without the approval of the director;
(5) delivers or possesses a counterfeit official
prescription form;
(6) refuses an entry into a premise for an inspection
authorized by this chapter;
(7) [refuses or fails to return an official
prescription form as required by Section 481.075(k);
[(8)] refuses or fails to make, keep, or furnish a
record, report, notification, order form, statement, invoice, or
information required by a rule adopted by the director; or
(8) [(9)] refuses or fails to maintain security
required by this chapter or a rule adopted under this chapter.
SECTION 10. Section 481.1285(a), Health and Safety Code, is
amended to read as follows:
(a) This section applies only to a registrant, a dispenser,
or a person who, pursuant to Section 570.052(a)(1) [481.062(a)(1)]
or (2), Occupations Code, is not required to register under
Subchapter B, Chapter 570, Occupations Code [this subchapter].
SECTION 11. Section 481.129(a), Health and Safety Code, is
amended to read as follows:
(a) A person commits an offense if the person knowingly:
(1) distributes as a registrant or dispenser a
controlled substance listed in Schedule I or II, unless the person
distributes the controlled substance under an order form as
required by Section 570.064, Occupations Code [481.069];
(2) uses in the course of manufacturing, prescribing,
or distributing a controlled substance a registration number that
is fictitious, revoked, suspended, or issued to another person;
(3) issues a prescription bearing a forged or
fictitious signature;
(4) uses a prescription issued to another person to
prescribe a Schedule II controlled substance;
(5) possesses, obtains, or attempts to possess or
obtain a controlled substance or an increased quantity of a
controlled substance:
(A) by misrepresentation, fraud, forgery,
deception, or subterfuge;
(B) through use of a fraudulent prescription
form; or
(C) through use of a fraudulent oral or
telephonically communicated prescription; or
(6) furnishes false or fraudulent material
information in or omits material information from an application,
report, record, or other document required to be kept or filed under
this chapter.
SECTION 12. Section 481.159(a), Health and Safety Code, is
amended to read as follows:
(a) If a district court orders the forfeiture of a
controlled substance property or plant under Chapter 59, Code of
Criminal Procedure, or under this code, the court shall also order a
law enforcement agency to:
(1) retain the property or plant for its official
purposes, including use in the investigation of offenses under this
code;
(2) deliver the property or plant to a government
agency for official purposes;
(3) deliver the property or plant to a person
authorized by the court to receive it;
(4) deliver the property or plant to a person
authorized by the director to receive it for a purpose described by
Section 570.060(a), Occupations Code [481.065(a)]; or
(5) destroy the property or plant that is not
otherwise disposed of in the manner prescribed by this subchapter.
SECTION 13. Section 481.186(a), Health and Safety Code, is
amended to read as follows:
(a) The director shall cooperate with federal and state
agencies in discharging the director's responsibilities concerning
traffic in controlled substances and in suppressing the abuse of
controlled substances. The director may:
(1) arrange for the exchange of information among
government officials concerning the use and abuse of controlled
substances;
(2) cooperate in and coordinate training programs
concerning controlled substances law enforcement at local and state
levels;
(3) cooperate with the Federal Drug Enforcement
Administration and state agencies by establishing a centralized
unit to accept, catalog, file, and collect statistics, including
records on drug-dependent persons and other controlled substance
law offenders in this state and, except as provided by Section
570.063, Occupations Code [481.068], make the information
available for federal, state, and local law enforcement purposes;
and
(4) conduct programs of eradication aimed at
destroying wild or illegal growth of plant species from which
controlled substances may be extracted.
SECTION 14. Section 565.003(b), Occupations Code, is
amended to read as follows:
(b) Unless compliance would violate the pharmacy or drug
statutes or rules in the state in which the pharmacy is located the
board may discipline an applicant for or the holder of a Class E
pharmacy license if the board finds that the applicant or license
holder has failed to comply with:
(1) Section 570.069 [481.074 or 481.075, Health and
Safety Code];
(2) Texas substitution requirements regarding:
(A) the practitioner's directions concerning
generic substitution;
(B) the patient's right to refuse generic
substitution; or
(C) notification to the patient of the patient's
right to refuse substitution;
(3) any board rule relating to providing drug
information to the patient or the patient's agent in written form or
by telephone; or
(4) any board rule adopted under Section 554.051(a)
and determined by the board to be applicable under Section
554.051(b).
SECTION 15. The following provisions are repealed:
(1) Sections 481.002(10), (20), (28), (35), (42),
(46), (47), and (48), Health and Safety Code;
(2) Sections 481.062, 481.0621, 481.063, 481.064,
481.065, 481.066, 481.067, 481.068, 481.069, 481.070, 481.071,
481.072, 481.073, 481.074, 481.075, 481.076, and 481.0761, Health
and Safety Code;
(3) Subchapter H, Chapter 481, Health and Safety Code;
(4) Section 157.059(c), Occupations Code; and
(5) Section 552.118, Government Code.
SECTION 16. (a) An advisory committee is created to advise
the Texas State Board of Pharmacy on the implementation of Chapter
570, Occupations Code, as added by this Act.
(b) The advisory committee is composed of:
(1) the executive board of the Texas State Board of
Pharmacy or the executive board's designee;
(2) a physician appointed by the governor;
(3) a pharmacist appointed by the governor;
(4) a physician appointed by the lieutenant governor;
(5) a pharmacist appointed by the lieutenant governor;
(6) a physician appointed by the governor from a list
of names submitted by the speaker of the house of representatives;
(7) a pharmacist appointed by the governor from a list
of names submitted by the speaker of the house of representatives;
and
(8) one member from each of the following boards:
(A) Texas Medical Board;
(B) Texas State Board of Pharmacy;
(C) State Board of Dental Examiners; and
(D) Texas Board of Nursing.
(c) The executive board of the Texas State Board of Pharmacy
or the executive board's designee is the presiding officer of the
advisory committee. The committee shall meet at the call of the
presiding officer or at the request of any three members other than
the presiding officer.
(d) The advisory committee shall:
(1) develop recommendations regarding the
implementation of the electronic system for monitoring controlled
substances established under Chapter 570, Occupations Code, as
added by this Act;
(2) develop recommendations on the data that should be
provided to the Texas State Board of Pharmacy to support the
electronic system for monitoring controlled substances, including
provider identification information;
(3) monitor and develop recommendations regarding the
implementation and enforcement of the electronic system for
monitoring controlled substances;
(4) develop recommended procedures necessary for
real-time point-of-service access for a practitioner authorized to
prescribe or dispense controlled substances listed in Schedules II
through V under Subchapter B, Chapter 481, Health and Safety Code,
so that the practitioner may obtain:
(A) the prescription drug order history for a
particular patient; or
(B) the practitioner's own dispensing or
prescribing activity; and
(5) develop recommended procedures that should be
followed by the Texas State Board of Pharmacy and the applicable
licensing authority of this state, another state, or the United
States when:
(A) the board shares information related to
diversion of controlled substances with a licensing authority for
the purpose of licensing enforcement; or
(B) a licensing authority shares information
related to diversion of controlled substances with the board for
the purpose of criminal enforcement.
(e) The executive board of the Texas State Board of Pharmacy
shall report the recommendations developed under Subsection (d) of
this section to the governor, lieutenant governor, speaker of the
house of representatives, and appropriate committees of the senate
and the house of representatives not later than July 1, 2014.
(f) This section expires and the advisory committee is
abolished September 1, 2015.
SECTION 17. The executive board of the Texas State Board of
Pharmacy or the executive board's designee shall adopt any rules
necessary to administer and enforce Chapter 570, Occupations Code,
as added by this Act, not later than June 1, 2014.
SECTION 18. (a) The Department of Public Safety, Texas
Medical Board, Texas State Board of Pharmacy, State Board of Dental
Examiners, and Texas Board of Nursing shall submit to the presiding
officers of the Senate Committee on Health and Human Services and
the House Committee on Public Health a report that details the
number and type of actions relating to the prosecution of
violations of Chapter 481, Health and Safety Code, as amended by
this Act, or Chapter 570, Occupations Code, as added by this Act.
(b) Each agency shall submit its initial report under
Subsection (a) of this section not later than November 1, 2013.
Each agency shall submit an update of its initial report not later
than May 1 and November 1 of each year.
(c) This section expires November 1, 2017.
SECTION 19. (a) The Texas State Board of Pharmacy and the
public safety director of the Department of Public Safety shall
enter into the memorandum of understanding required by Section
481.003, Health and Safety Code, as amended by this Act, not later
than January 1, 2014.
(b) The Texas State Board of Pharmacy shall adopt any rules
required by Chapter 481, Health and Safety Code, as amended by this
Act, not later than September 1, 2014.
(c) Not later than September 1, 2014, the Department of
Public Safety shall transfer the records received under Sections
481.074, 481.076, and 481.0761, Health and Safety Code, before the
sections are repealed by this Act, to the Texas State Board of
Pharmacy.
(d) A rule, form, policy, procedure, or decision adopted
under Chapter 481, Health and Safety Code, as it existed before
amendment by this Act, continues in effect as a rule, form, policy,
procedure, or decision and remains in effect until amended or
replaced.
(e) A reference in law or an administrative rule to the
public safety director of the Department of Public Safety relating
to rulemaking authority given and duties transferred to the Texas
State Board of Pharmacy by this Act is a reference to the Texas
State Board of Pharmacy.
SECTION 20. The change in law made by this Act applies 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.
SECTION 21. (a) Except as provided by Subsections (b) and
(c) of this section, this Act takes effect September 1, 2013.
(b) Subchapter C, Chapter 570, Occupations Code, as added by
this Act, takes effect September 1, 2014.
(c) Sections 2 through 15 of this Act take effect September
1, 2014.