By: Schwertner S.B. No. 460
(Crownover)
A BILL TO BE ENTITLED
AN ACT
relating to the licensing and regulation of pharmacists and
pharmacies.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 483.047, Health and Safety Code, is
amended by amending Subsection (a) and adding Subsections (b-1) and
(b-2) to read as follows:
(a) Except as authorized by Subsections [Subsection] (b)
and (b-1), a pharmacist commits an offense if the pharmacist
refills a prescription unless:
(1) the prescription contains an authorization by the
practitioner for the refilling of the prescription, and the
pharmacist refills the prescription in the manner provided by the
authorization; or
(2) at the time of refilling the prescription, the
pharmacist is authorized to do so by the practitioner who issued the
prescription.
(b-1) Notwithstanding Subsection (b), in the event of a
natural or manmade disaster, a pharmacist may dispense not more
than a 30-day supply of a dangerous drug 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 the executive director, has
notified pharmacies in this state that pharmacists may dispense up
to a 30-day supply of a dangerous drug.
(b-2) The prescribing practitioner is not liable for an act
or omission by a pharmacist in dispensing a dangerous drug under
Subsection (b-1).
SECTION 2. Section 555.002(a), Occupations Code, is amended
to read as follows:
(a) The board by rule shall establish methods by which
consumers and service recipients are notified of the name, mailing
address, and telephone number of the board for the purpose of
directing complaints to the board. The board may provide for that
notice:
(1) on each registration form, application, or written
contract for services of a person regulated by the board;
(2) on a sign prominently displayed in the place of
business of each person regulated by the board; [or]
(3) on an electronic messaging system in a font
specified by board rule prominently displayed in the place of
business of each person regulated by the board; or
(4) in a bill for service provided by a person
regulated by the board.
SECTION 3. Section 556.051, Occupations Code, is amended to
read as follows:
Sec. 556.051. AUTHORIZATION TO ENTER AND INSPECT. (a) The
board or a representative of the board may enter and inspect a
facility relative to the following:
(1) drug storage and security;
(2) equipment;
(3) components used in compounding, finished and
unfinished products, containers, and labeling of any item;
(4) sanitary conditions; [or]
(5) records, reports, or other documents required to
be kept or made under this subtitle, Chapter 481 or 483, Health and
Safety Code, or the Comprehensive Drug Abuse Prevention and Control
Act of 1970 (21 U.S.C. Section 801 et seq.) or rules adopted under
one of those laws; or
(6) subject to Subsection (b), financial records
relating to the operation of the facility.
(b) The board or a representative of the board may inspect
financial records under Subsection (a) only in the course of the
investigation of a specific complaint. The board or representative
may inspect only records related to the specific complaint. The
inspection is subject to Section 565.055.
SECTION 4. Section 556.054, Occupations Code, is amended to
read as follows:
Sec. 556.054. CONFIDENTIALITY OF CERTAIN INFORMATION
[LIMITATION ON INSPECTION]. The following information obtained by
the board during an inspection of a facility is confidential and not
subject to disclosure under Chapter 552, Government Code [Unless
the owner, pharmacist, or agent in charge of a facility consents in
writing, an inspection of the facility authorized by this chapter
may not extend to]:
(1) financial data;
(2) sales data, other than shipment data; and [or]
(3) pricing data.
SECTION 5. Subchapter B, Chapter 556, Occupations Code, is
amended by adding Section 556.057 to read as follows:
Sec. 556.057. INSPECTION OF PHARMACIST RECORDS. A
pharmacist shall provide to the board, on request, records of the
pharmacist's practice that occurs outside of a pharmacy. The
pharmacist shall provide the records at a time specified by board
rule.
SECTION 6. Sections 558.055(a) and (b), Occupations Code,
are amended to read as follows:
(a) An applicant who on the applicant's first attempt fails
the examination may take the examination four [two] additional
times.
(b) Before an applicant who has failed the examination five
[three] times is allowed to retake the examination, the applicant
must provide documentation from a college of pharmacy that the
applicant has successfully completed additional college course
work in each examination subject area the applicant failed.
SECTION 7. Section 560.052(b), Occupations Code, is amended
to read as follows:
(b) To qualify for a pharmacy license, an applicant must
submit to the board:
(1) a license fee set by the board, except as provided
by Subsection (d); and
(2) a completed application that:
(A) is on a form prescribed by the board;
(B) is given under oath;
(C) includes proof that:
(i) a pharmacy license held by the
applicant in this state or another state, if applicable, has not
been restricted, suspended, revoked, or surrendered for any reason;
and
(ii) no owner of the pharmacy for which the
application is made has held a pharmacist license in this state or
another state, if applicable, that has been restricted, suspended,
revoked, or surrendered for any reason; and
(D) includes a statement of:
(i) the ownership;
(ii) the location of the pharmacy;
(iii) the license number of each pharmacist
who is employed by the pharmacy, if the pharmacy is located in this
state, or who is licensed to practice pharmacy in this state, if the
pharmacy is located in another state;
(iv) the pharmacist license number of the
pharmacist-in-charge; and
(v) any other information the board
determines necessary.
SECTION 8. Section 561.003(e), Occupations Code, is amended
to read as follows:
(e) If a pharmacy's license has been expired for 91 days
[one year] or more, the pharmacy may not renew the license. The
pharmacy may obtain a new license by complying with the
requirements and procedures for obtaining an original license.
SECTION 9. Sections 562.056(a) and (a-1), Occupations Code,
are amended to read as follows:
(a) Before dispensing a prescription, a pharmacist shall
determine, in the exercise of sound professional judgment, that the
prescription is a valid prescription. A pharmacist may not
dispense a prescription drug if the pharmacist knows or should know
that the prescription was issued [on the basis of an Internet-based
or telephonic consultation] without a valid practitioner-patient
relationship.
(a-1) To be a valid prescription, a prescription [for a
controlled substance] must be issued for a legitimate medical
purpose by a practitioner acting in the usual course of the
practitioner's professional practice. The responsibility for the
proper prescribing and dispensing of prescription drugs
[controlled substances] is on the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills
the prescription.
SECTION 10. Section 562.106, Occupations Code, is amended
by amending Subsection (a) and adding Subsection (a-1) to read as
follows:
(a) A pharmacy shall report in writing to the board not
later than the 10th day after the date of:
(1) a permanent closing of the pharmacy;
(2) a change of ownership of the pharmacy;
(3) [a change of location of the pharmacy;
[(4)] a change of the person designated as the
pharmacist-in-charge of the pharmacy;
(4) [(5)] a sale or transfer of any controlled
substance or dangerous drug as a result of the permanent closing or
change of ownership of the pharmacy;
(5) [(6)] any matter or occurrence that the board
requires by rule to be reported;
(6) [(7)] as determined by the board, an out-of-state
purchase of any controlled substance;
(7) [(8)] a final order against the pharmacy license
holder by the regulatory or licensing agency of the state in which
the pharmacy is located if the pharmacy is located in another state;
or
(8) [(9)] a final order against a pharmacist who is
designated as the pharmacist-in-charge of the pharmacy by the
regulatory or licensing agency of the state in which the pharmacy is
located if the pharmacy is located in another state.
(a-1) A pharmacy shall report in writing to the board not
later than the 30th day before the date of a change of location of
the pharmacy.
SECTION 11. Section 565.002(a), Occupations Code, is
amended to read as follows:
(a) The board may discipline an applicant for or the holder
of a pharmacy license, including a Class E pharmacy license subject
to Section 565.003 [565.003(b)], if the board finds that the
applicant or license holder has:
(1) been convicted of or placed on deferred
adjudication community supervision or deferred disposition or the
applicable federal equivalent for:
(A) a misdemeanor:
(i) involving moral turpitude; or
(ii) under Chapter 481 or 483, Health and
Safety Code, or the Comprehensive Drug Abuse Prevention and Control
Act of 1970 (21 U.S.C. Section 801 et seq.); or
(B) a felony;
(2) advertised a prescription drug or device in a
deceitful, misleading, or fraudulent manner;
(3) violated any provision of this subtitle or any
rule adopted under this subtitle or that an owner or employee of a
pharmacy has violated any provision of this subtitle or any rule
adopted under this subtitle;
(4) sold without legal authorization a prescription
drug or device to a person other than:
(A) a pharmacy licensed by the board;
(B) a practitioner;
(C) a person who procures a prescription drug or
device for lawful research, teaching, or testing, and not for
resale;
(D) a manufacturer or wholesaler licensed by the
commissioner of public health as required by Chapter 431, Health
and Safety Code; or
(E) a carrier or warehouseman;
(5) allowed an employee who is not a pharmacist to
practice pharmacy;
(6) sold an adulterated or misbranded prescription or
nonprescription drug;
(7) failed to engage in or ceased to engage in the
business described in the application for a license;
(8) failed to maintain records as required by this
subtitle, Chapter 481 or 483, Health and Safety Code, the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21
U.S.C. Section 801 et seq.), or any rule adopted under this subtitle
or Chapter 483, Health and Safety Code;
(9) failed to establish and maintain effective
controls against diversion of prescription drugs into other than a
legitimate medical, scientific, or industrial channel as provided
by this subtitle, another state statute or rule, or a federal
statute or rule;
(10) engaged in fraud, deceit, or misrepresentation as
defined by board rule in operating a pharmacy or in applying for a
license to operate a pharmacy;
(11) violated a disciplinary order;
(12) been responsible for a drug audit shortage; [or]
(13) been disciplined by the regulatory board of
another state for conduct substantially equivalent to conduct
described under this subsection; or
(14) waived, discounted, or reduced, or offered to
waive, discount, or reduce, a patient copayment or deductible for a
compounded drug in the absence of:
(A) a legitimate, documented financial hardship
of the patient; or
(B) evidence of a good faith effort to collect
the copayment or deductible from the patient.
SECTION 12. Section 565.060(d), Occupations Code, is
amended to read as follows:
(d) If a license holder complies with and successfully
completes the terms of a remedial plan, the board shall remove all
records of the remedial plan from the board's records at the end of
the state fiscal year in which [on] the fifth anniversary of the
date the board issued the terms of the remedial plan occurs.
SECTION 13. Section 565.061(a), Occupations Code, is
amended to read as follows:
(a) Except as provided by Chapter 564, a disciplinary action
taken by the board [under Section 565.060 or] on the basis of a
ground for discipline under Subchapter A is governed by Chapter
2001, Government Code, and the rules of practice and procedure
before the board.
SECTION 14. The following provisions of the Occupations
Code are repealed:
(1) Section 561.003(d);
(2) Section 562.009(a-1); and
(3) Section 562.051.
SECTION 15. The change in law made by this Act to Section
483.047, Health and Safety Code, 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 on the date 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 occurred before that date.
SECTION 16. Section 560.052(b), Occupations Code, as
amended by this Act, applies only to an application for a pharmacy
license submitted on or after the effective date of this Act. An
application submitted before the effective date of this Act is
governed by the law in effect on the date the application was
submitted, and the former law is continued in effect for that
purpose.
SECTION 17. Section 561.003(e), Occupations Code, as
amended by this Act, and the repeal by this Act of Section
561.003(d), Occupations Code, apply only to a pharmacy license that
expires on or after the effective date of this Act. A pharmacy
license that expired before the effective date of this Act is
governed by the law in effect on the date the license expired, and
the former law is continued in effect for that purpose.
SECTION 18. Section 562.106(a), Occupations Code, as
amended by this Act, and Section 562.106(a-1), Occupations Code, as
added by this Act, apply only to a pharmacy that changes location on
or after October 1, 2015. A pharmacy that changes location before
that date is governed by the law in effect immediately before the
effective date of this Act, and the former law is continued in
effect for that purpose.
SECTION 19. The change in law made by this Act to Section
565.002(a), Occupations Code, applies only to conduct that occurs
on or after the effective date of this Act. Conduct that occurs
before that date is governed by the law in effect on the date the
conduct occurred, and the former law is continued in effect for that
purpose.
SECTION 20. The change in law made by this Act to Section
565.061(a), Occupations Code, is a clarification of existing law
and does not imply that existing law may be construed as
inconsistent with the law as amended by this Act.
SECTION 21. This Act takes effect September 1, 2015.