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 |
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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, [ |
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and 481.0766. The board may adopt rules to administer Sections | ||
481.073, 481.074, 481.075, 481.076, [ |
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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 [ |
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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 [ |
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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) [ |
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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[ |
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(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, [ |
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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) [ |
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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 [ |
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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) [ |
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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) [ |
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of the board; | ||
(6) [ |
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(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) [ |
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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; [ |
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(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, [ |
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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) [ |
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[ |
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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) [ |
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professional practice degree, as defined by board rule, from an | ||
accredited pharmacy degree program approved by the board; | ||
(D) [ |
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the board; and | ||
(E) [ |
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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) [ |
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[ |
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practice degree, as defined by board rule, from an accredited | ||
pharmacy degree program approved by the board; | ||
(3) [ |
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(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) [ |
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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[ |
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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) [ |
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(B) [ |
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(C) [ |
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(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 [ |
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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)[ |
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(B) a health center as defined by 42 U.S.C. | ||
Section 254b[ |
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(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) [ |
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(6) [ |
||
(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[ |
||
[ |
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[ |
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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 |