Bill Text: TX SB460 | 2015-2016 | 84th Legislature | Enrolled


Bill Title: Relating to the licensing and regulation of pharmacists and pharmacies.

Spectrum: Partisan Bill (Republican 2-0)

Status: (Passed) 2015-06-16 - Effective on 9/1/15 [SB460 Detail]

Download: Texas-2015-SB460-Enrolled.html
 
 
  S.B. No. 460
 
 
 
 
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.
 
 
 
 
 
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
 
         I hereby certify that S.B. No. 460 passed the Senate on
  April 14, 2015, by the following vote:  Yeas 31, Nays 0.
 
 
  ______________________________
  Secretary of the Senate    
 
         I hereby certify that S.B. No. 460 passed the House on
  May 22, 2015, by the following vote:  Yeas 137, Nays 3, two
  present not voting.
 
 
  ______________________________
  Chief Clerk of the House   
 
 
 
  Approved:
 
  ______________________________ 
              Date
 
 
  ______________________________ 
            Governor
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