Bill Text: TX HB2561 | 2017-2018 | 85th Legislature | Enrolled


Bill Title: Relating to the continuation and functions of the Texas State Board of Pharmacy and the regulation of certain prescription drugs, prescription drug prescribers and dispensers, and colleges of pharmacy; authorizing a reduction in fees.

Spectrum: Bipartisan Bill

Status: (Passed) 2017-06-09 - Effective on 9/1/17 [HB2561 Detail]

Download: Texas-2017-HB2561-Enrolled.html
 
 
  H.B. No. 2561
 
 
 
 
AN ACT
  relating to the continuation and functions of the Texas State Board
  of Pharmacy and the regulation of certain prescription drugs,
  prescription drug prescribers and dispensers, and colleges of
  pharmacy; authorizing a reduction in fees.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  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, other than Sections 481.073, 481.074, 481.075,
  481.076, [and] 481.0761, 481.0762, 481.0763, 481.0764, 481.0765,
  and 481.0766.  The board may adopt rules to administer Sections
  481.073, 481.074, 481.075, 481.076, [and] 481.0761, 481.0762,
  481.0763, 481.0764, 481.0765, and 481.0766.
         SECTION 2.  Section 481.074(q), Health and Safety Code, is
  amended to read as follows:
         (q)  Each dispensing pharmacist shall send all required
  information, including any information required to complete the
  Schedule III through V prescription forms, to the board by
  electronic transfer or another form approved by the board not later
  than the next business [seventh] day after the date the
  prescription is completely filled.
         SECTION 3.  Section 481.075(i), Health and Safety Code, is
  amended to read as follows:
         (i)  Each dispensing pharmacist shall:
               (1)  fill in on the official prescription form or note
  in the electronic prescription record each item of information
  given orally to the dispensing pharmacy under Subsection (h) and
  the date the prescription is filled, and:
                     (A)  for a written prescription, fill in the
  dispensing pharmacist's signature; or
                     (B)  for an electronic prescription,
  appropriately record the identity of the dispensing pharmacist in
  the electronic prescription record;
               (2)  retain with the records of the pharmacy for at
  least two years:
                     (A)  the official prescription form or the
  electronic prescription record, as applicable; and
                     (B)  the name or other patient identification
  required by Section 481.074(m) or (n); and
               (3)  send all required information, including any
  information required to complete an official prescription form or
  electronic prescription record, to the board by electronic transfer
  or another form approved by the board not later than the next
  business [seventh] day after the date the prescription is
  completely filled.
         SECTION 4.  Sections 481.076(a) and (d), Health and Safety
  Code, are amended to read as follows:
         (a)  The board may not permit any person to have access to
  information submitted to the board under Section 481.074(q) or
  481.075 except:
               (1)  [an investigator for] the board, the Texas Medical
  Board, the Texas State Board of Podiatric Medical Examiners, the
  State Board of Dental Examiners, the State Board of Veterinary
  Medical Examiners, the Texas Board of Nursing, or the Texas
  Optometry Board for the purpose of:
                     (A)  investigating a specific license holder; or
                     (B)  monitoring for potentially harmful
  prescribing or dispensing patterns or practices under Section
  481.0762;
               (2)  an authorized officer or member of the department
  or authorized employee of the board engaged in the administration,
  investigation, or enforcement of this chapter or another law
  governing illicit drugs in this state or another state;
               (3)  the department on behalf of 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)  a medical examiner conducting an investigation;
               (5)  provided that accessing the information is
  authorized under the Health Insurance Portability and
  Accountability Act of 1996 (Pub. L. No. 104-191) and regulations
  adopted under that Act:
                     (A)  a pharmacist or a pharmacy technician, as
  defined by Section 551.003, Occupations Code, acting at the
  direction of a pharmacist; or
                     (B)  a practitioner who:
                           (i)  is a physician, dentist, veterinarian,
  podiatrist, optometrist, or advanced practice nurse or is a
  physician assistant described by Section 481.002(39)(D) or an
  employee or other agent of a practitioner acting at the direction of
  a practitioner; and
                           (ii)  is inquiring about a recent Schedule
  II, III, IV, or V prescription history of a particular patient of
  the practitioner[, provided that the person accessing the
  information is authorized to do so under the Health Insurance
  Portability and Accountability Act of 1996 (Pub. L. No.   104-191)
  and rules adopted under that Act];
               (6)  a pharmacist or practitioner who is inquiring
  about the person's own dispensing or prescribing activity; or
               (7)  one or more states or an association of states with
  which the board has an interoperability agreement, as provided by
  Subsection (j).
         (d)  Information submitted to the board under this section
  may be used 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, or monitoring
  purposes in connection with the functions of an agency listed in
  Subsection (a)(1);
               (3)  the prescribing and dispensing of controlled
  substances by a person listed in Subsection (a)(5); or
               (4) [(3)]  dissemination by the board 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.
         SECTION 5.  Section 481.0761, Health and Safety Code, is
  amended by adding Subsections (h), (i), (j), and (k) to read as
  follows:
         (h)  The board, in consultation with the department and the
  regulatory agencies listed in Section 481.076(a)(1), shall
  identify prescribing practices that may be potentially harmful and
  patient prescription patterns that may suggest drug diversion or
  drug abuse. The board shall determine the conduct that constitutes
  a potentially harmful prescribing pattern or practice and develop
  indicators for levels of prescriber or patient activity that
  suggest a potentially harmful prescribing pattern or practice may
  be occurring or drug diversion or drug abuse may be occurring.
         (i)  The board, based on the indicators developed under
  Subsection (h), may send an electronic notification to a dispenser
  or prescriber if the information submitted under Section 481.074(q)
  or 481.075 indicates a potentially harmful prescribing pattern or
  practice may be occurring or drug diversion or drug abuse may be
  occurring.
         (j)  The board by rule may develop guidelines identifying
  behavior suggesting a patient is obtaining controlled substances
  that indicate drug diversion or drug abuse is occurring. A
  pharmacist who observes behavior described by this subsection by a
  person who is to receive a controlled substance shall access the
  information under Section 481.076(a)(5) regarding the patient for
  whom the substance is to be dispensed.
         (k)  The board by rule may develop guidelines identifying
  patterns that may indicate that a particular patient to whom a
  controlled substance is prescribed or dispensed is engaging in drug
  abuse or drug diversion. These guidelines may be based on the
  frequency of prescriptions issued to and filled by the patient, the
  types of controlled substances prescribed, and the number of
  prescribers who prescribe controlled substances to the patient.
  The board may, based on the guidelines developed under this
  subsection, send a prescriber or dispenser an electronic
  notification if there is reason to believe that a particular
  patient is engaging in drug abuse or drug diversion.
         SECTION 6.  Subchapter C, Chapter 481, Health and Safety
  Code, is amended by adding Sections 481.0762, 481.0763, 481.0764,
  481.0765, and 481.0766 to read as follows:
         Sec. 481.0762.  MONITORING BY REGULATORY AGENCY. (a) Each
  regulatory agency that issues a license, certification, or
  registration to a prescriber shall promulgate specific guidelines
  for prescribers regulated by that agency for the responsible
  prescribing of opioids, benzodiazepines, barbiturates, or
  carisoprodol.
         (b)  A regulatory agency that issues a license,
  certification, or registration to a prescriber shall periodically
  access the information submitted to the board under Sections
  481.074(q) and 481.075 to determine whether a prescriber is
  engaging in potentially harmful prescribing patterns or practices.
         (c)  If the board sends a prescriber an electronic
  notification authorized under Section 481.0761(i), the board shall
  immediately send an electronic notification to the appropriate
  regulatory agency.
         (d)  In determining whether a potentially harmful
  prescribing pattern or practice is occurring, the appropriate
  regulatory agency, at a minimum, shall consider:
               (1)  the number of times a prescriber prescribes
  opioids, benzodiazepines, barbiturates, or carisoprodol; and
               (2)  for prescriptions described by Subdivision (1),
  patterns of prescribing combinations of those drugs and other
  dangerous combinations of drugs identified by the board.
         (e)  If, during a periodic check under this section, the
  regulatory agency finds evidence that a prescriber may be engaging
  in potentially harmful prescribing patterns or practices, the
  regulatory agency may notify that prescriber.
         (f)  A regulatory agency may open a complaint against a
  prescriber if the agency finds evidence during a periodic check
  under this section that the prescriber is engaging in conduct that
  violates this subchapter or any other statute or rule.
         Sec. 481.0763.  REGISTRATION BY REGULATORY AGENCY. A
  regulatory agency that issues a license, certification, or
  registration to a prescriber or dispenser shall provide the board
  with any necessary information for each prescriber or dispenser,
  including contact information for the notifications described by
  Sections 481.0761(i) and (k), to register the prescriber or
  dispenser with the system by which the prescriber or dispenser
  receives information as authorized under Section 481.076(a)(5).
         Sec. 481.0764.  DUTIES OF PRESCRIBERS, PHARMACISTS, AND
  RELATED HEALTH CARE PRACTITIONERS. (a) A person authorized to
  receive information under Section 481.076(a)(5), other than a
  veterinarian, shall access that information with respect to the
  patient before prescribing or dispensing opioids, benzodiazepines,
  barbiturates, or carisoprodol.
         (b)  A person authorized to receive information under
  Section 481.076(a)(5) may access that information with respect to
  the patient before prescribing or dispensing any controlled
  substance.
         (c)  A veterinarian authorized to access information under
  Subsection (b) regarding a controlled substance may access the
  information for prescriptions dispensed only for the animals of an
  owner and may not consider the personal prescription history of the
  owner.
         (d)  A violation of Subsection (a) is grounds for
  disciplinary action by the regulatory agency that issued a license,
  certification, or registration to the person who committed the
  violation.
         (e)  This section does not grant a person the authority to
  issue prescriptions for or dispense controlled substances.
         Sec. 481.0765.  EXCEPTIONS. (a) A prescriber is not subject
  to the requirements of Section 481.0764(a) if:
               (1)  the patient has been diagnosed with cancer or the
  patient is receiving hospice care; and
               (2)  the prescriber clearly notes in the prescription
  record that the patient was diagnosed with cancer or is receiving
  hospice care, as applicable.
         (b)  A dispenser is not subject to the requirements of
  Section 481.0764(a) if it is clearly noted in the prescription
  record that the patient has been diagnosed with cancer or is
  receiving hospice care.
         (c)  A prescriber or dispenser is not subject to the
  requirements of Section 481.0764(a) and a dispenser is not subject
  to a rule adopted under Section 481.0761(j) if the prescriber or
  dispenser makes a good faith attempt to comply but is unable to
  access the information under Section 481.076(a)(5) because of
  circumstances outside the control of the prescriber or dispenser.
         Sec. 481.0766.  REPORTS OF WHOLESALE DISTRIBUTORS. (a) A
  wholesale distributor shall report to the board the information
  that the distributor is required to report to the Automation of
  Reports and Consolidated Orders System (ARCOS) of the Federal Drug
  Enforcement Administration for the distribution of a controlled
  substance by the distributor to a person in this state. The
  distributor shall report the information to the board in the same
  format and with the same frequency as the information is reported to
  ARCOS.
         (b)  Information reported to the board under Subsection (a)
  is confidential and not subject to disclosure under Chapter 552,
  Government Code.
         SECTION 7.  (a) Subtitle A, Title 6, Health and Safety Code,
  is amended by adding Chapter 442 to read as follows:
  CHAPTER 442. DONATION OF PRESCRIPTION DRUGS
  SUBCHAPTER A. GENERAL PROVISIONS
         Sec. 442.001.  DEFINITIONS. In this chapter:
               (1)  "Donor" means an individual who donates unused
  prescription drugs under this chapter to a participating provider.
               (2)  "Health care facility" means a facility that
  provides health care services to patients and maintains a pharmacy
  in the facility.  The term includes the following facilities if a
  pharmacy is maintained in the facility:
                     (A)  a general or special hospital as defined by
  Chapter 241;
                     (B)  an ambulatory surgical center licensed under
  Chapter 243; and
                     (C)  an institution licensed under Chapter 242.
               (3)  "Health care professional" means an individual
  licensed, certified, or otherwise authorized to administer health
  care and prescribe prescription drugs, for profit or otherwise, in
  the ordinary course of business or professional practice. The term
  does not include a health care facility.
               (4)  "Participating provider" means a health care
  facility or pharmacy, or a pharmacist who is an employee of the
  facility or pharmacy, that elects to participate in the collection
  and redistribution of donated prescription drugs under this
  chapter.
               (5)  "Pharmacist" means a person licensed under Chapter
  558, Occupations Code.
               (6)  "Pharmacy" means an entity licensed under Chapter
  560, Occupations Code.
               (7)  "Prescription drug" has the meaning assigned by
  Section 551.003, Occupations Code.
               (8)  "Recipient" means an individual who voluntarily
  receives donated prescription drugs under this chapter.
               (9)  "Tamper-evident" means packaging that allows for
  detection of unauthorized access to a prescription drug.
         Sec. 442.002.  RULEMAKING AUTHORITY. The executive
  commissioner may adopt rules to implement this chapter.
         Sec. 442.003.  CONSTRUCTION WITH OTHER LAW. This chapter
  does not limit the authority of this state or a political
  subdivision of this state to regulate or prohibit a prescription
  drug.
  SUBCHAPTER B. DONATION AND REDISTRIBUTION OF UNUSED PRESCRIPTION
  DRUGS
         Sec. 442.051.  DONATION AND REDISTRIBUTION OF PRESCRIPTION
  DRUGS. (a)  A donor may donate unused prescription drugs to a
  participating provider in accordance with this chapter and rules
  adopted under this chapter.
         (b)  A participating provider may dispense donated
  prescription drugs to a recipient in accordance with this chapter
  and rules adopted under this chapter.
         Sec. 442.052.  STANDARDS FOR DONATION AND REDISTRIBUTION.
  (a)  The executive commissioner by rule shall adopt standards and
  procedures for:
               (1)  accepting, storing, labeling, and dispensing
  donated prescription drugs; and
               (2)  inspecting donated prescription drugs to
  determine whether the drugs are adulterated and whether the drugs
  are safe and suitable for redistribution.
         (b)  In adopting standards and procedures under this
  section, the executive commissioner shall ensure that the donation
  and redistribution process is consistent with public health and
  safety standards.
         Sec. 442.053.  REQUIREMENTS FOR DONATED PRESCRIPTION DRUGS.
  (a)  A donated prescription drug may be accepted or dispensed under
  this chapter only if the drug is in its original, unopened, sealed,
  and tamper-evident unit-dose packaging. A drug packaged in single
  unit doses may be accepted and dispensed if the outside packaging is
  opened but the single unit-dose packaging is unopened.
         (b)  A donated prescription drug may not be accepted or
  dispensed under this chapter if:
               (1)  the drug is a controlled substance;
               (2)  the drug is adulterated or misbranded;
               (3)  the drug is not stored in compliance with the
  drug's product label; or
               (4)  the United States Food and Drug Administration
  requires the drug to have a risk evaluation or mitigation strategy.
         (c)  A participating provider shall comply with all
  applicable provisions of state and federal law relating to the
  inspection, storage, labeling, and dispensing of prescription
  drugs.
         Sec. 442.054.  DONATION PROCESS. (a)  Before being
  dispensed to a recipient, a prescription drug donated under this
  chapter must be inspected by the participating provider in
  accordance with federal law, laws of this state, and department
  rule to determine whether the drug is adulterated or misbranded and
  whether the drug has been stored in compliance with the
  requirements of the product label. 
         (b)  A donated prescription drug dispensed to a recipient
  under this chapter must be prescribed by a health care professional
  for use by the recipient.
         (c)  A participating provider may charge a handling fee not
  to exceed $20 to a recipient to cover the costs of inspecting,
  storing, labeling, and dispensing the donated prescription drug. A
  participating provider may not resell a prescription drug donated
  under this chapter. A donor may not sell a prescription drug to a
  participating provider.
         (d)  A participating provider may not submit a claim or
  otherwise seek reimbursement from any public or private third-party
  payor for donated prescription drugs dispensed to a recipient under
  this chapter. A public or private third-party payor is not required
  to provide reimbursement for donated drugs dispensed to a recipient
  under this chapter.
         Sec. 442.055.  DONOR FORM. Before donating a prescription
  drug under this chapter, a donor shall sign a form prescribed by the
  department stating that:
               (1)  the donor is the owner of the donated prescription
  drug;
               (2)  the donated prescription drug has been properly
  stored and the container has not been opened or tampered with;
               (3)  the donated prescription drug has not been
  adulterated or misbranded; and
               (4)  the donor is voluntarily donating the prescription
  drug.
         Sec. 442.056.  RECIPIENT FORM. Before accepting a donated
  prescription drug under this chapter, a recipient shall sign a form
  prescribed by the department stating that:
               (1)  the recipient acknowledges that the donor is not a
  pharmacist and the donor took ordinary care of the prescription
  drug;
               (2)  the recipient acknowledges that the donor is known
  to the participating provider and that there is no reason to believe
  that the prescription drug was improperly handled or stored;
               (3)  by accepting the prescription drug, the recipient
  accepts any risk that an accidental mishandling could create; and
               (4)  the recipient releases the donor, participating
  provider, and manufacturer of the drug from liability related to
  the prescription drug.
         Sec. 442.057.  LIMITATION OF LIABILITY. (a)  A donor or
  participating provider who acts in good faith in donating,
  accepting, storing, labeling, distributing, or dispensing
  prescription drugs under this chapter:
               (1)  is not criminally liable and is not subject to
  professional disciplinary action for those activities; and
               (2)  is not civilly liable for damages for bodily
  injury, death, or property damage that arises from those activities
  unless the injury, death, or damage arises from the donor or
  participating provider's recklessness or intentional conduct.
         (b)  A manufacturer of a prescription drug that donates a
  drug under this chapter is not, in the absence of bad faith,
  criminally or civilly liable for bodily injury, death, or property
  damage arising from the donation, acceptance, or dispensing of the
  drug, including the manufacturer's failure to communicate to a
  donor or other person:
               (1)  product or consumer information about the donated
  prescription drug; or
               (2)  the expiration date of the donated prescription
  drug.
         Sec. 442.058.  DATABASE OF PARTICIPATING PROVIDERS. The
  department shall establish and maintain an electronic database that
  lists each participating provider. The department shall post the
  database on its Internet website.
         (b)  If before implementing any provision of this section a
  state agency determines that a waiver or authorization from a
  federal agency is necessary for implementation of that provision,
  the agency affected by the provision shall request the waiver or
  authorization and may delay implementing that provision until the
  waiver or authorization is granted.
         SECTION 8.  Section 551.005, Occupations Code, is amended to
  read as follows:
         Sec. 551.005.  APPLICATION OF SUNSET ACT. The Texas State
  Board of Pharmacy is subject to Chapter 325, Government Code (Texas
  Sunset Act). Unless continued in existence as provided by that
  chapter, the board is abolished and this subtitle expires September
  1, 2029 [2017].
         SECTION 9.  Chapter 551, Occupations Code, is amended by
  adding Sections 551.006 and 551.008 to read as follows:
         Sec. 551.006.  EXCLUSIVE AUTHORITY. Notwithstanding any
  other law, a pharmacist has the exclusive authority to determine
  whether or not to dispense a drug.
         Sec. 551.008.  PROHIBITION ON RULE VIOLATING SINCERELY HELD
  RELIGIOUS BELIEF. (a) All rules, regulations, or policies adopted
  by the board may not violate Chapter 110, Civil Practice and
  Remedies Code.
         (b)  A person may assert a violation of Subsection (a) as an
  affirmative defense in an administrative hearing or as a claim or
  defense in a judicial proceeding under Chapter 37, Civil Practice
  and Remedies Code.
         SECTION 10.  Section 552.006, Occupations Code, is amended
  by amending Subsection (b) and adding Subsection (d) to read as
  follows:
         (b)  The training program must provide the person with
  information regarding:
               (1)  the law governing the board's operations;
               (2)  [this subtitle and] the programs, functions,
  rules, and budget of the board;
               (3)  the scope of and limitations on the rulemaking
  authority of the board;
               (4)  the types of board rules, interpretations, and
  enforcement actions that may implicate federal antitrust law by
  limiting competition or impacting prices charged by persons engaged
  in a profession or business the board regulates, including rules,
  interpretations, and enforcement actions that:
                     (A)  regulate the scope of practice of persons in
  a profession or business the board regulates;
                     (B)  restrict advertising by persons in a
  profession or business the board regulates;
                     (C)  affect the price of goods or services
  provided by persons in a profession or business the board
  regulates; and
                     (D)  restrict participation in a profession or
  business the board regulates;
               (5) [(2)]  the results of the most recent formal audit
  of the board;
               (6) [(3)]  the requirements of:
                     (A)  laws relating to open meetings, public
  information, administrative procedure, and disclosing conflicts of
  interest; and
                     (B)  other laws applicable to members of the board
  in performing their duties; and
               (7) [(4)]  any applicable ethics policies adopted by
  the board or the Texas Ethics Commission.
         (d)  The executive director shall create a training manual
  that includes the information required by Subsection (b). The
  executive director shall distribute a copy of the training manual
  annually to each board member. On receipt of the training manual,
  each board member shall sign and submit to the executive director a
  statement acknowledging receipt of the training manual. The board
  shall publish a copy of each signed statement on the board's
  Internet website.
         SECTION 11.  Section 553.003(b), Occupations Code, is
  amended to read as follows:
         (b)  The executive director is a full-time employee of the
  board and shall:
               (1)  serve as secretary to the board; [and]
               (2)  perform the regular administrative functions of
  the board and any other duty as the board directs; and
               (3)  under the direction of the board, perform the
  duties required by this subtitle or designated by the board.
         SECTION 12.  Subchapter A, Chapter 554, Occupations Code, is
  amended by adding Section 554.0011 to read as follows:
         Sec. 554.0011.  USE OF ALTERNATIVE RULEMAKING AND DISPUTE
  RESOLUTION. (a) The board shall develop a policy to encourage the
  use of:
               (1)  negotiated rulemaking procedures under Chapter
  2008, Government Code, for the adoption of board rules; and
               (2)  appropriate alternative dispute resolution
  procedures under Chapter 2009, Government Code, to assist in the
  resolution of internal and external disputes under the board's
  jurisdiction.
         (b)  The board's procedures relating to alternative dispute
  resolution must conform, to the extent possible, to any model
  guidelines issued by the State Office of Administrative Hearings
  for the use of alternative dispute resolution by state agencies.
         (c)  The board shall:
               (1)  coordinate the implementation of the policy
  adopted under Subsection (a);
               (2)  provide training as needed to implement the
  procedures for negotiated rulemaking or alternative dispute
  resolution; and
               (3)  collect data concerning the effectiveness of those
  procedures.
         SECTION 13.  Section 554.051(a-1), Occupations Code, is
  amended to read as follows:
         (a-1)  The board may adopt rules to administer Sections
  481.073, 481.074, 481.075, 481.076, [and] 481.0761, 481.0762,
  481.0763, 481.0764, 481.0765, and 481.0766, Health and Safety Code.
         SECTION 14.  Section 558.051(a), Occupations Code, is
  amended to read as follows:
         (a)  To qualify for a license to practice pharmacy, an
  applicant for licensing by examination must submit to the board:
               (1)  a license fee set by the board; and
               (2)  a completed application on a form prescribed by
  the board with satisfactory sworn evidence that the applicant:
                     (A)  is at least 18 years of age;
                     (B)  [is of good moral character;
                     [(C)]  has completed a minimum of a 1,000-hour
  internship or other program that has been approved by the board or
  has demonstrated, to the board's satisfaction, experience in the
  practice of pharmacy that meets or exceeds the board's minimum
  internship requirements;
                     (C) [(D)]  has graduated and received a
  professional practice degree, as defined by board rule, from an
  accredited pharmacy degree program approved by the board;
                     (D) [(E)]  has passed the examination required by
  the board; and
                     (E) [(F)]  has not had a pharmacist license
  granted by another state restricted, suspended, revoked, or
  surrendered, for any reason.
         SECTION 15.  Section 558.101(a), Occupations Code, is
  amended to read as follows:
         (a)  To qualify for a license to practice pharmacy, an
  applicant for licensing by reciprocity must:
               (1)  submit to the board:
                     (A)  a reciprocity fee set by the board; and
                     (B)  a completed application in the form
  prescribed by the board, given under oath;
               (2)  [be of good moral character;
               [(3)]  have graduated and received a professional
  practice degree, as defined by board rule, from an accredited
  pharmacy degree program approved by the board;
               (3) [(4)]  have presented to the board:
                     (A)  proof of current or initial licensing by
  examination; and
                     (B)  proof that the current license and any other
  license granted to the applicant by another state has not been
  restricted, suspended, revoked, or surrendered for any reason; and
               (4) [(5)]  pass the Texas Pharmacy Jurisprudence
  examination.
         SECTION 16.  Section 559.003, Occupations Code, is amended
  by adding Subsection (f) to read as follows:
         (f)  The board may refuse to renew a license to practice
  pharmacy for a license holder who is in violation of a board order.
         SECTION 17.  Section 562.110, Occupations Code, is amended
  by amending Subsections (a), (b), (d), (e), and (f) and adding
  Subsections (g), (h), and (i) to read as follows:
         (a)  In this section:
               (1)  "Provider pharmacy" means a Class A pharmacy that
  provides pharmacy services through a telepharmacy system at a
  remote dispensing site.
               (2)  "Remote dispensing site" means a location licensed
  as a telepharmacy that is authorized by a provider pharmacy through
  a telepharmacy system to store and dispense prescription drugs and
  devices, including dangerous drugs and controlled substances.
               (3)  "Telepharmacy[, "telepharmacy] system" means a
  system that monitors the dispensing of prescription drugs and
  provides for related drug use review and patient counseling
  services by an electronic method, including the use of the
  following types of technology:
                     (A) [(1)]  audio and video;
                     (B) [(2)]  still image capture; and
                     (C) [(3)]  store and forward.
         (b)  A Class A or Class C pharmacy located in this state may
  provide pharmacy services, including the dispensing of drugs,
  through a telepharmacy system at locations separate from [in a
  facility that is not at the same location as] the Class A or Class C
  pharmacy.
         (d)  A telepharmacy system may be located only at:
               (1)  a health care facility in this state that is
  regulated by this state or the United States; or
               (2)  a remote dispensing site.
         (e)  The board shall adopt rules regarding the use of a
  telepharmacy system under this section, including:
               (1)  the types of health care facilities at which a
  telepharmacy system may be located under Subsection (d)(1), which
  must include the following facilities:
                     (A)  a clinic designated as a rural health clinic
  regulated under 42 U.S.C. Section 1395x(aa)[, as amended]; and
                     (B)  a health center as defined by 42 U.S.C.
  Section 254b[, as amended];
               (2)  the locations eligible to be licensed as remote
  dispensing sites, which must include locations in medically
  underserved areas, areas with a medically underserved population,
  and health professional shortage areas determined by the United
  States Department of Health and Human Services;
               (3)  licensing and operating requirements for remote
  dispensing sites, including:
                     (A)  a requirement that a remote dispensing site
  license identify the provider pharmacy that will provide pharmacy
  services at the remote dispensing site;
                     (B)  a requirement that a provider pharmacy be
  allowed to provide pharmacy services at not more than two remote
  dispensing sites;
                     (C)  a requirement that a pharmacist employed by a
  provider pharmacy make at least monthly on-site visits to a remote
  dispensing site or more frequent visits if specified by board rule;
                     (D)  a requirement that each month the perpetual
  inventory of controlled substances at the remote dispensing site be
  reconciled to the on-hand count of those controlled substances at
  the site by a pharmacist employed by the provider pharmacy;
                     (E)  a requirement that a pharmacist employed by a
  provider pharmacy be physically present at a remote dispensing site
  when the pharmacist is providing services requiring the physical
  presence of the pharmacist, including immunizations;
                     (F)  a requirement that a remote dispensing site
  be staffed by an on-site pharmacy technician who is under the
  continuous supervision of a pharmacist employed by the provider
  pharmacy;
                     (G)  a requirement that all pharmacy technicians
  at a remote dispensing site be counted for the purpose of
  establishing the pharmacist-pharmacy technician ratio of the
  provider pharmacy, which, notwithstanding Section 568.006, may not
  exceed three pharmacy technicians for each pharmacist providing
  supervision;
                     (H)  a requirement that, before working at a
  remote dispensing site, a pharmacy technician must:
                           (i)  have worked at least one year at a
  retail pharmacy during the three years preceding the date the
  pharmacy technician begins working at the remote dispensing site;
  and
                           (ii)  have completed a board-approved
  training program on the proper use of a telepharmacy system; 
                     (I)  a requirement that pharmacy technicians at a
  remote dispensing site may not perform extemporaneous sterile or
  nonsterile compounding but may prepare commercially available
  medications for dispensing, including the reconstitution of orally
  administered powder antibiotics; and
                     (J)  any additional training or practice
  experience requirements for pharmacy technicians at a remote
  dispensing site;
               (4)  the areas that qualify under Subsection (f);
               (5) [(3)]  recordkeeping requirements; and
               (6) [(4)]  security requirements.
         (f)  A telepharmacy system located at a health care facility
  under Subsection (d)(1) may not be located in a community in which a
  Class A or Class C pharmacy is located as determined by board rule.
  If a Class A or Class C pharmacy is established in a community in
  which a telepharmacy system has been located under this section,
  the telepharmacy system may continue to operate in that community.
         (g)  A telepharmacy system located at a remote dispensing
  site under Subsection (d)(2) may not dispense a controlled
  substance listed in Schedule II as established by the commissioner
  of state health services under Chapter 481, Health and Safety Code,
  and may not be located within 22 miles by road of a Class A pharmacy.
         (h)  If a Class A pharmacy is established within 22 miles by
  road of a remote dispensing site that is currently operating, the
  remote dispensing site may continue to operate at that location.
         (i)  The board by rule shall require and develop a process
  for a remote dispensing site to apply for classification as a Class
  A pharmacy if the average number of prescriptions dispensed each
  day the remote dispensing site is open for business is more than
  125, as calculated each calendar year.
         SECTION 18.  Section 568.002(c), Occupations Code, is
  amended to read as follows:
         (c)  An applicant for registration as a pharmacy technician
  or a pharmacy technician trainee must[:
               [(1)  be of good moral character; and
               [(2)]  submit an application on a form prescribed by
  the board.
         SECTION 19.  Section 568.004, Occupations Code, is amended
  to read as follows:
         Sec. 568.004.  RENEWAL OF REGISTRATION. (a) The board may
  adopt a system in which the registrations of pharmacy technicians
  and pharmacy technician trainees expire on various dates during the
  year.
         (b)  To renew a pharmacy technician registration, the
  registrant must, before the expiration date of the registration:
               (1)  pay a renewal fee as determined by the board under
  Section 568.005; and
               (2)  comply with the continuing education requirements
  prescribed by the board in accordance with Section 568.0045.
         (c)  A person whose pharmacy technician registration has
  been expired for 90 days or less may renew the expired registration
  by paying to the board a renewal fee that is equal to one and
  one-half times the normally required renewal fee for the
  registration.
         (d)  A person whose pharmacy technician registration has
  been expired for more than 90 days but less than one year may renew
  the expired registration by paying to the board a renewal fee that
  is equal to two times the normally required renewal fee for the
  registration.
         (e)  A person whose pharmacy technician registration has
  been expired for one year or more may not renew the
  registration.  The person may register by complying with the
  requirements and procedures for initially registering, including
  the examination requirement.
         (f)  The board may refuse to renew a pharmacy technician
  registration for a registrant who is in violation of a board order.
         SECTION 20.  Chapter 568, Occupations Code, is amended by
  adding Section 568.0045 to read as follows:
         Sec. 568.0045.  RULES RELATING TO CONTINUING EDUCATION. The
  board shall adopt rules relating to the continuing education
  required for pharmacy technicians. The rules must include
  requirements for:
               (1)  the number of hours of continuing education;
               (2)  the methods for meeting the continuing education
  requirements;
               (3)  the approval of continuing education programs;
               (4)  reporting completion of continuing education;
               (5)  records of completion of continuing education; and
               (6)  board audits to ensure compliance with the
  continuing education requirements.
         SECTION 21.  Section 89.051(b), Education Code, is amended
  to read as follows:
         (b)  The college shall be known as The Texas A&M University
  System Health Science Center Irma Lerma Rangel College of Pharmacy,
  and the primary building in which the school is operated shall be
  located in Kleberg County and must include "Irma Rangel" in its
  official name.
         SECTION 22.  (a) A joint interim committee is created to
  conduct an interim study on the monitoring of the prescribing and
  dispensing of controlled substances in this state.
         (b)  The joint interim committee shall be composed of three
  senators appointed by the lieutenant governor and three members of
  the house of representatives appointed by the speaker of the house
  of representatives.
         (c)  The lieutenant governor and speaker of the house of
  representatives shall each designate a co-chair from among the
  joint interim committee members.
         (d)  The joint interim committee shall convene at the joint
  call of the co-chairs.
         (e)  The joint interim committee has all other powers and
  duties provided to a special or select committee by the rules of the
  senate and house of representatives, by Subchapter B, Chapter 301,
  Government Code, and by policies of the senate and house committees
  on administration.
         (f)  The interim study conducted by the joint interim
  committee must:
               (1)  include the number of prescribers and dispensers
  registered to receive information electronically under Section
  481.076, Health and Safety Code, as amended by this Act;
               (2)  evaluate the accessing of information under
  Section 481.076, Health and Safety Code, as amended by this Act, by
  regulatory agencies to monitor persons issued a license,
  certification, or registration by those agencies;
               (3)  address any complaints, technical difficulties,
  or other issues with electronically accessing and receiving
  information under Section 481.076, Health and Safety Code, as
  amended by this Act;
               (4)  examine controlled substance prescribing and
  dispensing trends that may be affected by the passage and
  implementation of this Act;
               (5)  evaluate the use and effectiveness of electronic
  notifications sent to prescribers and dispensers under Sections
  481.0761(i) and (k), Health and Safety Code, as added by this Act;
               (6)  evaluate the use and effectiveness of identifying
  geographic anomalies in comparing delivery and dispensing data;
               (7)  evaluate the integration of any new data elements
  required to be reported under this Act;
               (8)  evaluate the existence and scope of diversion of
  controlled substances by animal owners to whom the substances are
  dispensed by veterinarians;
               (9)  explore the best methods for preventing the
  diversion of controlled substances by animal owners; and
               (10)  determine how any future reporting by dispensing
  veterinarians might best be tailored to fit the practice of
  veterinary medicine.
         (g)  The committee shall solicit feedback from regulatory
  agencies, prescribers, dispensers, and patients affected by the
  passage of this Act.
         (h)  The committee shall submit a report to the legislature
  on the results of the interim study, including any legislative
  recommendations for improvements to information access and
  controlled substance prescription monitoring, not later than
  January 1, 2019.
         (i)  Subject to available resources, the Texas Legislative
  Council shall provide legal and policy research, drafts of proposed
  legislation, and statistical analysis services to the joint interim
  committee for the purpose of the study required under this section.
         (j)  Notwithstanding Section 481.076, Health and Safety
  Code, as amended by this Act, or any other law relating to access to
  or disclosure of prescription drug information maintained by the
  Texas State Board of Pharmacy, the Texas State Board of Pharmacy
  shall disclose any information maintained by the board under
  Section 481.076, Health and Safety Code, to the Texas Legislative
  Council on request of the council for the purpose of assisting with
  the study required under this section.
         (k)  Not later than November 1, 2017, the lieutenant governor
  and speaker of the house of representatives shall appoint the
  members of the joint interim committee in accordance with this
  section.
         (l)  The joint interim committee created under this section
  is abolished and this section expires January 2, 2019.
         SECTION 23.  A pharmacist is not required to comply with a
  rule adopted under Section 481.0761(j), Health and Safety Code, as
  added by this Act, before January 1, 2018.
         SECTION 24.  Section 481.0764(a), Health and Safety Code, as
  added by this Act, applies only to:
               (1)  a prescriber other than a veterinarian who issues
  a prescription for a controlled substance on or after September 1,
  2019; or
               (2)  a person authorized by law to dispense a
  controlled substance other than a veterinarian who dispenses a
  controlled substance on or after September 1, 2019.
         SECTION 25.  Not later than December 1, 2017, the executive
  commissioner of the Health and Human Services Commission shall
  adopt the rules necessary for the implementation of Chapter 442,
  Health and Safety Code, as added by this Act.
         SECTION 26.  (a) Except as provided by Subsection (b) of
  this section, Section 552.006, Occupations Code, as amended by this
  Act, applies to a member of the Texas State Board of Pharmacy
  appointed before, on, or after the effective date of this Act.
         (b)  A member of the Texas State Board of Pharmacy who,
  before the effective date of this Act, completed the training
  program required by Section 552.006, Occupations Code, as that law
  existed before the effective date of this Act, is required to
  complete additional training only on subjects added by this Act to
  the training program as required by Section 552.006, Occupations
  Code, as amended by this Act. A board member described by this
  subsection may not vote, deliberate, or be counted as a member in
  attendance at a meeting of the board held on or after December 1,
  2017, until the member completes the additional training.
         SECTION 27.  Sections 558.051, 558.101, and 568.002,
  Occupations Code, as amended by this Act, apply only to an
  application for a license to practice pharmacy or for registration
  as a pharmacy technician or pharmacy technician trainee filed on or
  after the effective date of this Act. An application for a license
  or registration filed before the effective date of this Act is
  governed by the law in effect on the date the application was filed,
  and the former law is continued in effect for that purpose.
         SECTION 28.  Section 559.003, Occupations Code, as amended
  by this Act, and Sections 568.004(b), (e), and (f), Occupations
  Code, as added by this Act, apply only to the renewal of a license to
  practice pharmacy or of a pharmacy technician registration on or
  after the effective date of this Act. The renewal of a license or
  registration 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 29.  The Texas State Board of Pharmacy shall adopt
  rules under Section 562.110, Occupations Code, as amended by this
  Act, not later than January 1, 2018.
         SECTION 30.  As soon as practicable after the effective date
  of this Act, the Texas State Board of Pharmacy shall adopt rules to
  reduce the amount of the fees imposed by the board for the renewal
  of an expired pharmacy technician registration to reflect the
  amounts provided for by Sections 568.004(c) and (d), Occupations
  Code, as added by this Act. A pharmacy technician who renews an
  expired registration certificate on or after the effective date of
  this Act shall pay the amount provided for by Section 568.004(c) or
  (d), Occupations Code, as added by this Act, instead of the amount
  provided for under board rules adopted before that date.
         SECTION 31.  This Act takes effect September 1, 2017.
 
 
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
 
 
         I certify that H.B. No. 2561 was passed by the House on May 2,
  2017, by the following vote:  Yeas 145, Nays 0, 1 present, not
  voting; and that the House concurred in Senate amendments to H.B.
  No. 2561 on May 26, 2017, by the following vote:  Yeas 131, Nays 15,
  1 present, not voting.
 
  ______________________________
  Chief Clerk of the House   
 
         I certify that H.B. No. 2561 was passed by the Senate, with
  amendments, on May 24, 2017, by the following vote:  Yeas 25, Nays
  6.
 
  ______________________________
  Secretary of the Senate   
  APPROVED: __________________
                  Date       
   
           __________________
                Governor       
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