By: Van de Putte S.B. No. 1100
(King of Taylor)
A BILL TO BE ENTITLED
AN ACT
relating to the licensing and inspection of certain out-of-state
pharmacies by the Texas State Board of Pharmacy; authorizing fees.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter B, Chapter 556, Occupations Code, is
amended by adding Section 556.0551 to read as follows:
Sec. 556.0551. INSPECTION OF LICENSED NONRESIDENT
PHARMACY. (a) The board may inspect a nonresident pharmacy
licensed by the board that compounds sterile preparations as
necessary to ensure compliance with the safety standards and other
requirements of this subtitle and board rules.
(b) A nonresident pharmacy shall reimburse the board for all
expenses, including travel, incurred by the board in inspecting the
pharmacy as provided by Subsection (a).
SECTION 2. Subsection (b), Section 560.001, Occupations
Code, is amended to read as follows:
(b) A pharmacy located in another state may not ship, mail,
or deliver to this state a prescription drug or device dispensed
under a prescription drug order, or dispensed or delivered as
authorized by Subchapter D, Chapter 562, [to a resident of this
state] unless the pharmacy is licensed by the board or is exempt
under Section 560.004.
SECTION 3. Section 560.052, Occupations Code, is amended by
amending Subsections (b) and (c) and adding Subsections (g) and (h)
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; and
(C) 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 [a Class E pharmacy];
(iv) the license number of the
pharmacist-in-charge; and
(v) any other information the board
determines necessary.
(c) A pharmacy located in another state that applies for a
license [To qualify for a Class E pharmacy license, an applicant],
in addition to satisfying the other requirements of this chapter,
must provide to the board:
(1) evidence that the applicant holds a pharmacy
license, registration, or permit in good standing issued by the
state in which the pharmacy is located;
(2) the name of the owner and pharmacist-in-charge of
the pharmacy for service of process;
(3) evidence of the applicant's ability to provide to
the board a record of a prescription drug order dispensed or
delivered as authorized by Subchapter D, Chapter 562, by the
applicant to a resident of or practitioner in this state not later
than 72 hours after the time the board requests the record;
(4) an affidavit by the pharmacist-in-charge that
states that the pharmacist has read and understands the laws and
rules relating to the applicable license [a Class E pharmacy];
(5) proof of creditworthiness; [and]
(6) an inspection report issued:
(A) not more than two years before the date the
license application is received; and
(B) by the pharmacy licensing board in the state
of the pharmacy's physical location, except as provided by
Subsection (f); and
(7) any other information the board determines
necessary.
(g) A license may not be issued to a pharmacy that compounds
sterile preparations unless the pharmacy has been inspected by the
board to ensure the pharmacy meets the safety standards and other
requirements of this subtitle and board rules.
(h) The board may accept, as satisfying the inspection
requirement in Subsection (g) for a pharmacy located in another
state, an inspection report issued by the pharmacy licensing board
in the state in which the pharmacy is located if:
(1) the board determines that the other state has
comparable standards and regulations applicable to pharmacies,
including standards and regulations related to health and safety;
and
(2) the pharmacy provides to the board any requested
documentation related to the inspection.
SECTION 4. Chapter 561, Occupations Code, is amended by
adding Section 561.0032 to read as follows:
Sec. 561.0032. ADDITIONAL RENEWAL REQUIREMENT FOR
COMPOUNDING PHARMACY. (a) In addition to the renewal requirements
under Section 561.003, a pharmacy that compounds sterile
preparations may not renew a pharmacy license unless the pharmacy:
(1) has been inspected as provided by board rule; and
(2) if the pharmacy is located in another state, has
reimbursed the board for all expenses, including travel, incurred
by the board in inspecting the pharmacy during the term of the
expiring license.
(b) The board may accept, as satisfying the inspection
requirement in Subsection (a) for a pharmacy located in another
state, an inspection report issued by the pharmacy licensing board
in the state in which the pharmacy is located if:
(1) the board determines that the other state has
comparable standards and regulations applicable to pharmacies,
including standards and regulations related to health and safety;
and
(2) the pharmacy provides to the board any requested
documentation related to the inspection.
SECTION 5. Subsection (a), Section 562.106, Occupations
Code, is amended 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;
(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;
(6) any matter or occurrence that the board requires
by rule to be reported;
(7) as determined by the board, an out-of-state
purchase of any controlled substance;
(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 [a
Class E pharmacy]; or
(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 Class E
pharmacy].
SECTION 6. Subchapter D, Chapter 562, Occupations Code, is
amended by adding Section 562.156 to read as follows:
Sec. 562.156. COMPOUNDED STERILE PREPARATION; NOTICE TO
BOARD. (a) A pharmacy may not compound and dispense a sterile
preparation unless the pharmacy holds a license as required by
board rule.
(b) A pharmacy that compounds a sterile preparation shall
notify the board:
(1) immediately of any adverse effects reported to the
pharmacy or that are known by the pharmacy to be potentially
attributable to a sterile preparation compounded by the pharmacy;
and
(2) not later than 24 hours after the pharmacy issues a
recall for a sterile preparation compounded by the pharmacy.
SECTION 7. Section 565.003, Occupations Code, is amended to
read as follows:
Sec. 565.003. ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING
APPLICANT FOR OR HOLDER OF NONRESIDENT [CLASS E] PHARMACY LICENSE.
[(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 nonresident
[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 8. Section 565.053, Occupations Code, is amended to
read as follows:
Sec. 565.053. DISCIPLINE OF NONRESIDENT [CLASS E] PHARMACY;
NOTICE TO RESIDENT STATE. The board shall give notice of a
disciplinary action by the board against a license [the] holder
located in another state [of a Class E pharmacy license] to the
regulatory or licensing agency of the state in which the pharmacy is
located.
SECTION 9. The heading to Section 565.054, Occupations
Code, is amended to read as follows:
Sec. 565.054. SERVICE OF PROCESS ON NONRESIDENT [CLASS E]
PHARMACY.
SECTION 10. Subsection (a), Section 565.054, Occupations
Code, is amended to read as follows:
(a) Service of process on a nonresident [Class E] pharmacy
under Section 565.058 or 566.051 or for disciplinary action taken
by the board under Section 565.061 shall be on the owner and
pharmacist-in-charge of the pharmacy, as designated on the
pharmacy's license application.
SECTION 11. Not later than March 1, 2014, the Texas State
Board of Pharmacy shall adopt rules necessary to implement the
changes in law made by this Act.
SECTION 12. Section 560.052, Occupations Code, as amended
by this Act, applies only to an application for a pharmacy license
submitted to the Texas State Board of Pharmacy on or after the
effective date of this Act. An application for a license 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 13. Section 561.0032, Occupations Code, as added by
this Act, applies only to the renewal of a pharmacy license that
expires on or after the effective date of this Act. A license that
expires 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 14. This Act takes effect September 1, 2013.