By: Van de Putte  S.B. No. 1100
         (In the Senate - Filed March 5, 2013; March 12, 2013, read
  first time and referred to Committee on Health and Human Services;
  April 25, 2013, reported adversely, with favorable Committee
  Substitute by the following vote:  Yeas 7, Nays 0; April 25, 2013,
  sent to printer.)
 
  COMMITTEE SUBSTITUTE FOR S.B. No. 1100 By:  Deuell
 
 
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.
 
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