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