By: Williams, Van de Putte S.B. No. 1879
 
 
A BILL TO BE ENTITLED
AN ACT
relating to the regulation of controlled substances.
       BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
       SECTION 1.  Subsection (a), Section 481.064, Health and
Safety Code, is amended to read as follows:
       (a)  The director 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 department receives after the date the registration
expires. The director by rule shall set the amounts [amount] of the
fees [fee] at the amounts [amount] that are [is] necessary to cover
the cost of administering and enforcing this subchapter. Except as
provided by Subsection (b), registrants shall pay the fees to the
director.
       SECTION 2.  Section 481.074, Health and Safety Code, is
amended by amending Subsections (b), (d), and (k) and adding
Subsection (q) to read as follows:
       (b)  Except in an emergency as defined by rule of the
director or as provided by Subsection (o) or Section 481.075(j) or
(m), a person may not dispense or administer a controlled substance
listed in Schedule II without the written prescription of a
practitioner on an official prescription form that meets the
requirements of and is completed by the practitioner in accordance
with Section 481.075. 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, department registration number,
and Federal Drug Enforcement Administration number of the
prescribing practitioner, all information required to be provided
by a practitioner under Section 481.075(e)(1), and all information
required to be provided by a dispensing pharmacist under Section
481.075(e)(2).
       (d)  Except as specified in Subsections (e) and (f) [of this
section], the director, by rule and in consultation with the Texas
Medical Board and the Texas State Board of Pharmacy, shall
establish the period after the date on which the prescription is
issued that a person may [not] fill a prescription for a controlled
substance listed in Schedule II [after the end of the seventh day
after the date on which the prescription is issued]. A person may
not refill a prescription for a substance listed in Schedule II.
       (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; or
                   (B)  if the prescription is communicated orally or
telephonically, as transcribed by the receiving pharmacist;
             (2)  the date of issue;
             (3)  the name, [and] 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; [and]
             (7)  the legibly printed or stamped name, address,
Federal Drug Enforcement Administration registration number,
department 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.
       (q)  Each dispensing pharmacist shall send all information
required by the director, including any information required to
complete the Schedule III through V prescription forms, to the
director by electronic transfer or another form approved by the
director not later than the 15th day after the last day of the month
in which the prescription is completely filled.
       SECTION 3.  Subsections (a) and (c), Section 481.076, Health
and Safety Code, are amended to read as follows:
       (a)  The director may not permit any person to have access to
information submitted to the director under Section 481.074(q) or
481.075 except:
             (1)  an investigator for the Texas [State Board of]
Medical Board [Examiners], the Texas State Board of Podiatric
Medical Examiners, the State Board of Dental Examiners, the State
Board of Veterinary Medical Examiners, or the Texas State Board of
Pharmacy;
             (2)  an authorized officer or member of the department
engaged in the administration, investigation, or enforcement of
this chapter or another law governing illicit drugs in this state or
another state; or
             (3)  if the director finds that proper need has been
shown to the director:
                   (A)  a law enforcement or prosecutorial official
engaged in the administration, investigation, or enforcement of
this chapter or another law governing illicit drugs in this state or
another state;
                   (B)  a pharmacist or practitioner who is a
physician, dentist, veterinarian, or podiatrist and is inquiring
about the recent Schedule II prescription 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.
       (c)  The director by rule shall design and implement a system
for submission of information to the director by electronic or
other means and for retrieval of information submitted to the
director under this section and Sections 481.074 and [Section]
481.075. The director shall use automated information security
techniques and devices to preclude improper access to the
information. The director shall submit the system design to the
Texas State Board of Pharmacy and the Texas [State Board of] Medical
Board [Examiners] for review and approval or comment a reasonable
time before implementation of the system and shall comply with the
comments of those agencies unless it is unreasonable to do so.
       SECTION 4.  Subsections (a), (b), (c), and (e), Section
481.0761, Health and Safety Code, are amended to read as follows:
       (a)  The director shall consult with the Texas State Board of
Pharmacy and by rule establish and revise as necessary a
standardized database format that may be used by a pharmacy to
transmit the information required by Sections 481.074(q) and
[Section] 481.075(i) to the director electronically or to deliver
the information on storage media, including disks, tapes, and
cassettes.
       (b)  The director shall consult with the [Texas] Department
of State Health Services, the Texas State Board of Pharmacy, and the
Texas [State Board of] Medical Board [Examiners] and by rule may:
             (1)  remove a controlled substance listed in Schedules
[Schedule] II through V from the official prescription program, if
the director determines that the burden imposed by the program
substantially outweighs the risk of diversion of the particular
controlled substance; or
             (2)  return a substance previously removed from
Schedules [Schedule] II through V to the official prescription
program, if the director determines that the risk of diversion
substantially outweighs the burden imposed by the program on the
particular controlled substance.
       (c)  The director by rule may:
             (1)  permit more than one prescription to be
administered or dispensed and recorded on one [official]
prescription form for a Schedule III through V controlled
substance;
             (2)  remove from or return to the official prescription
program any aspect of a practitioner's or pharmacist's hospital
practice, including administering or dispensing;
             (3)  waive or delay any requirement relating to the
time or manner of reporting;
             (4)  establish compatibility protocols for electronic
data transfer hardware, software, or format;
             (5)  establish a procedure to control the release of
information under Sections 481.074, 481.075, and 481.076; and
             (6)  establish a minimum level of prescription activity
below which a reporting activity may be modified or deleted.
       (e)  In adopting a rule relating to the electronic transfer
of information under this subchapter, the director shall consider
the economic impact of the rule on practitioners and pharmacists
and, to the extent permitted by law, act to minimize any negative
economic impact, including the imposition of costs related to
computer hardware or software or to the transfer of information.
The director may not adopt a rule relating to the electronic
transfer of information under this subchapter that imposes a fee in
addition to the fees [fee] authorized by Section 481.064.
       SECTION 5.  Chapter 481, Health and Safety Code, is amended
by adding Subchapter H to read as follows:
SUBCHAPTER H.  ADMINISTRATIVE PENALTY
       Sec. 481.301.  IMPOSITION OF PENALTY.  The department may
impose an administrative penalty on a person who violates Section
481.061, 481.066, 481.067, 481.069-481.075, 481.077, 481.0771,
481.078, 481.080, or 481.081 or a rule or order adopted under any of
those sections.
       Sec. 481.302.  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 $20,000.
       (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. 481.303.  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 to
the person by certified mail, registered mail, personal delivery,
or another manner of delivery that records the person's receipt of
the notice.
       (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. 481.304.  PENALTY TO BE PAID OR INFORMAL HEARING
REQUESTED. (a)  Before the 21st day after the date the person
receives notice under Section 481.303, the person in writing may:
             (1)  accept the determination and recommended penalty;
or
             (2)  make a request for an informal hearing held by the
department on the occurrence of the violation, the amount of the
penalty, or both.
       (b)  At the conclusion of an informal hearing requested under
Subsection (a), the department may modify the amount of the
recommended penalty.
       (c)  If the person accepts the determination and recommended
penalty, including any modification of the amount, or if the person
fails to timely respond to the notice, the director by order shall
approve the determination and impose the recommended penalty.
       Sec. 481.305.  FORMAL HEARING. (a)  The person may request
a formal hearing only after participating in an informal hearing.
       (b)  The request must be submitted in writing and received by
the department before the 21st day after the date the person is
notified of the decision from the informal hearing.
       (c)  If a timely request for a formal hearing is not
received, the director by order shall approve the determination
from the informal hearing and impose the recommended penalty.
       (d)  If the person timely requests a formal hearing, the
director 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
director and to the person. An administrative law judge of the
State Office of Administrative Hearings shall conduct the hearing.
       (e)  The administrative law judge shall make findings of fact
and conclusions of law and promptly issue to the director a proposal
for a decision about the occurrence of the violation and the amount
of any proposed penalty.
       (f)  If a penalty is proposed under Subsection (e), the
administrative law judge shall include in the proposal for a
decision a finding setting out costs, fees, expenses, and
reasonable and necessary attorney's fees incurred by the state in
bringing the proceeding. The director may adopt the finding and
impose the costs, fees, and expenses on the person as part of the
final order entered in the proceeding.
       Sec. 481.306.  DECISION. (a)  Based on the findings of
fact, conclusions of law, and proposal for a decision, the director
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 director'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. 481.307.  OPTIONS FOLLOWING DECISION: PAY OR APPEAL.
Before the 31st day after the date the order under Section 481.306
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. 481.308.  STAY OF ENFORCEMENT OF PENALTY. (a)  Within
the period prescribed by Section 481.307, 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
director by certified mail.
       (b)  Following receipt of a copy of an affidavit under
Subsection (a)(2), the director 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. 481.309.  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. 481.310.  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. 481.311.  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. 481.312.  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. 481.313.  ADMINISTRATIVE PROCEDURE. A proceeding to
impose the penalty is considered to be a contested case under
Chapter 2001, Government Code.
       SECTION 6.  The public safety director of the Department of
Public Safety of the State of Texas shall adopt any rules necessary
to administer and enforce Subchapter H, Chapter 481, Health and
Safety Code, as added by this Act, not later than September 1, 2007,
except that if this section does not take effect before that date,
the public safety director shall adopt the rules as soon as possible
after that date.
       SECTION 7.  (a)  Except as provided by Subsections (b), (c),
and (d) of this section, this Act takes effect September 1, 2007.
       (b)  Section 6 of this Act takes effect immediately if this
Act 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 for immediate
effect, Section 6 of this Act takes effect September 1, 2007.
       (c)  Except as otherwise provided by Subsection (d) of this
section, the changes in law made by this Act in amending Subsection
(k), Section 481.074, and Section 481.076, Health and Safety Code,
and in adding Subsection (q), Section 481.074 of that code, take
effect September 1, 2008. The public safety director of the
Department of Public Safety of the State of Texas shall adopt any
rules necessary to administer and enforce the changes in law made by
those provisions not later than September 1, 2008.
       (d)  The change in law made by this Act in amending
Subsections (b) and (k), Section 481.074, Health and Safety Code,
to require the use of registration numbers issued by the Department
of Public Safety of the State of Texas takes effect only after the
department establishes a means by which pharmacies are able to
electronically access and verify the accuracy of the registration
numbers.