81R9297 JSC-F
By: McReynolds H.B. No. 3962
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. Section 481.002, Health and Safety Code, is
amended by adding Subdivision (2-a) and amending Subdivision (22)
to read as follows:
(2-a) "Board" means the Texas State Board of Pharmacy.
(22) "Immediate precursor" means a substance
designated [the director finds to be and] by rule under this chapter
[designates] as being:
(A) a principal compound commonly used or
produced primarily for use in the manufacture of a controlled
substance;
(B) a substance that is an immediate chemical
intermediary used or likely to be used in the manufacture of a
controlled substance; and
(C) a substance the control of which is necessary
to prevent, curtail, or limit the manufacture of a controlled
substance.
SECTION 2. 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 board may adopt rules relating to the
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 3. Section 481.034(h), Health and Safety Code, is
amended to read as follows:
(h) Not later than the 10th day after the date on which the
commissioner designates, deletes, or reschedules a substance under
Subsection (a), the commissioner shall give written notice of that
action to the director, the board, and [to] each state licensing
agency having jurisdiction over practitioners.
SECTION 4. Section 481.064(c), Health and Safety Code, is
amended to read as follows:
(c) The director shall deposit the collected fees to the
credit of the [operator's and chauffeur's license account in the]
general revenue fund. The fees may be used only by the department
and the board in the administration or enforcement of this
subchapter.
SECTION 5. Section 481.074, Health and Safety Code, is
amended by amending Subsections (b), (c), (d), (f), (k), (p), and
(q), and reenacting and amending Subsection (o), as amended by
Chapters 349 (S.B. 1188) and 1345 (S.B. 410), Acts of the 79th
Legislature, Regular Session, 2005, to read as follows:
(b) Except in an emergency as defined by rule of the board
[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)].
(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 prescription[, completed in the
manner required by Section 481.075,] to be delivered in person or
mailed to the dispensing pharmacist at the pharmacy where the
prescription was dispensed. The envelope of a prescription
delivered by mail must be postmarked not later than the seventh day
after the date the prescription was authorized. [On receipt of the
prescription, the dispensing pharmacy shall file the transcription
of the telephonically communicated prescription and the pharmacy
copy and shall send information to the director as required by
Section 481.075.]
(d) Except as specified in Subsections (e) and (f), the
board [director], by rule and in consultation with the Texas
Medical Board and the department [Texas State Board of Pharmacy],
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. A person may not refill a
prescription for a substance listed in Schedule II.
(f) A prescription for a Schedule II controlled substance
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 [the
prescription on an official prescription form and must indicate] on
the prescription [form] 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 [official] prescription [form] 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.
(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, 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[; and
[(9) if the prescribing practitioner is licensed in
this state, the practitioner's department registration number].
(o) A pharmacist may dispense a Schedule II controlled
substance pursuant to a facsimile copy of a [an official]
prescription completed in the manner required by board rule
[Section 481.075] 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.), as amended, by Medicaid, or by a hospice
program that is licensed under Chapter 142, 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 [official]
prescription "VOID--sent by fax to (name and telephone number of
receiving pharmacy)"; and
(B) files the [official] prescription in the
patient's medical records instead of delivering it to the patient.
(p) 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 [director] as
required by board rule [Section 481.075].
(q) Each dispensing pharmacist shall send all information
required by the board [director], including any information
required to complete the Schedule III through V prescription forms,
to the board [director] by electronic transfer or another form
approved by the board [director] not later than the 15th day after
the last day of the month in which the prescription is completely
filled. The board shall submit any information received under this
section to the director on request.
SECTION 6. Section 481.076, Health and Safety Code, is
amended to read as follows:
Sec. 481.076. [OFFICIAL] PRESCRIPTION INFORMATION. (a)
The board [director] may not permit any person to have access to
information submitted to the board [director] under Section
481.074(q) [or 481.075] except:
(1) an investigator for the Texas Medical Board, the
Texas State Board of Podiatric Medical Examiners, the State Board
of Dental Examiners, or 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 board [director] finds that proper need has
been shown to the board, [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;
(4) [(B)] a pharmacist or practitioner who is a
physician, dentist, veterinarian, podiatrist, or advanced practice
nurse or physician assistant described by Section 481.002(39)(D)
and is inquiring about a recent Schedule II, III, IV, or V
prescription history of a particular patient of the practitioner;
or
(5) [(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 [director] from
creating, using, or disclosing statistical data about information
received by the board [director] under this section if the board
[director] removes any information reasonably likely to reveal the
identity of each patient, practitioner, or other person who is a
subject of the information.
(c) The board [director] by rule shall design and implement
a system for submission of information to the board [director] by
electronic or other means and for retrieval of information
submitted to the board [director] under this section and Section
[Sections] 481.074 [and 481.075]. The board [director] shall use
automated information security techniques and devices to preclude
improper access to the information. The board [director] shall
submit the system design to the director [Texas State Board of
Pharmacy] and the Texas Medical Board 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.
(d) Information submitted to the board [director] under
this section shall be released to the department upon request and
may be used by the department or the board 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 director] 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.
(e) The board [director] 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
[director] not later than the end of the 12th calendar month after
the month in which the identity is entered into the system.
However, the board or the director may retain a patient identity
that is necessary for use in a specific ongoing investigation
conducted by the department 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.
(f) If the board or the director permits access to
information under Subsection (a)(2) relating to a person licensed
or regulated by an agency listed in Subsection (a)(1), the director
shall notify and cooperate with that agency regarding the
disposition of the matter before taking action against the person,
unless the director determines that notification is reasonably
likely to interfere with an administrative or criminal
investigation or prosecution.
(g) If the board or the director permits access to
information under Subsection (a)(3) [(a)(3)(A)] relating to a
person licensed or regulated by an agency listed in Subsection
(a)(1), the board or the director shall notify that agency of the
disclosure of the information not later than the 10th working day
after the date the information is disclosed.
(h) If the board or the director withholds notification to
an agency under Subsection (f), the board or the director shall
notify the agency of the disclosure of the information and the
reason for withholding notification when the director determines
that notification is no longer likely to interfere with an
administrative or criminal investigation or prosecution.
(i) Information submitted to the board or the director under
Section 481.074(q) [481.075] is confidential and remains
confidential regardless of whether the board or the director
permits access to the information under this section.
SECTION 7. Sections 481.0761(a), (c), and (e), Health and
Safety Code, are amended to read as follows:
(a) The board [director] shall consult with the director and
the Texas Medical [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 [481.074(q)] and 481.076 [481.075(i)] to the board
[director] electronically or to deliver the information on storage
media, including disks, tapes, and cassettes.
(c) The board [director] by rule may:
(1) permit more than one prescription to be
administered or dispensed and recorded on one 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;
(3) [(4)] establish compatibility protocols for
electronic data transfer hardware, software, or format;
(4) [(5)] establish a procedure to control the release
of information under Sections 481.074[, 481.075,] and 481.076; and
(5) [(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 board [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 board [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 authorized by Section 481.064.
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 board [director] under Section 481.074 [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 481.070-481.074
[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 552.118, Government Code, is amended to
read as follows:
Sec. 552.118. EXCEPTION: [OFFICIAL] PRESCRIPTION
INFORMATION [FORM]. Information is excepted from the requirements
of Section 552.021 if it is:
(1) information on or derived from an official
prescription form filed with the director of the Department of
Public Safety under Section 481.075, Health and Safety Code, as
that section existed before September 1, 2010; or
(2) other information collected under Section
481.074(q) or 481.075, Health and Safety Code, as that section
existed before September 1, 2010 [of that code].
SECTION 11. 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 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 12. The following provisions are repealed:
(1) Section 481.002(47), Health and Safety Code;
(2) Section 481.075, Health and Safety Code;
(3) Sections 481.0761(b), (d), and (f), Health and
Safety Code;
(4) Subchapter H, Chapter 481, Health and Safety Code;
(5) Section 157.059(c), Occupations Code; and
(6) Sections 7 and 8, Chapter 1391 (S.B. 1879), Acts of
the 80th Legislature, Regular Session, 2007.
SECTION 13. (a) An advisory committee is created to advise
the Texas State Board of Pharmacy on the implementation of this Act.
(b) The advisory committee is composed of:
(1) the executive director of the Texas State Board of
Pharmacy or the executive director's designee;
(2) the public safety director of the Department of
Public Safety or the director's designee;
(3) a physician appointed by the governor;
(4) a pharmacist appointed by the governor;
(5) a physician appointed by the lieutenant governor;
(6) a pharmacist appointed by the lieutenant governor;
(7) a physician appointed by the governor from a list
of names submitted by the speaker of the house of representatives;
(8) a pharmacist appointed by the governor from a list
of names submitted by the speaker of the house of representatives;
and
(9) one member from each of the following boards:
(A) the Texas Medical Board;
(B) the Texas State Board of Pharmacy;
(C) the State Board of Dental Examiners; and
(D) the Texas Board of Nursing.
(c) The executive director of the Texas State Board of
Pharmacy or the executive director'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 an electronic controlled substance monitoring
system that would be used for prescriptions of controlled
substances listed in Schedule II through V as established under
Subchapter B, Chapter 481, Health and Safety Code;
(2) develop recommendations as to which data should be
provided to the Texas State Board of Pharmacy to support a
controlled substance monitoring system recommended under
Subdivision (1), including provider identification information;
(3) monitor and develop recommendations regarding the
implementation and enforcement of a controlled substance
monitoring system recommended under Subdivision (1);
(4) develop recommended procedures necessary for
real-time point-of-service access for a practitioner authorized to
prescribe or dispense controlled substances listed in Schedule II
through V to enable the practitioner to obtain:
(A) the prescription 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 Texas State Board of Pharmacy shares
information related to the 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 department
for the purpose of criminal enforcement.
(e) The executive director or the executive director's
designee of the Texas State Board of Pharmacy shall report the
recommendations developed under Subsection (d) of this section to
the governor, the lieutenant governor, speaker of the house of
representatives, and appropriate committees of the senate and the
house of representatives not later than July 1, 2011.
(f) This section expires and the advisory committee is
abolished on September 1, 2011.
SECTION 14. (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.
(b) Each agency shall submit its initial report under
Subsection (a) of this section not later than November 1, 2009.
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, 2013.
SECTION 15. (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, 2010.
(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, 2010.
(c) Not later than September 1, 2010, the Department of
Public Safety shall transfer the records received under Sections
481.074, 481.076, and 481.0761, Health and Safety Code, 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 16. The changes in law made by this Act in amending
Sections 481.074, 481.076, and 481.127, Health and Safety Code, and
in repealing Sections 481.002(47) and 481.075, Health and Safety
Code, and Section 157.059(c), Occupations Code, take effect
September 1, 2010.
SECTION 17. Except as otherwise provided by this Act, this
Act takes effect September 1, 2009.