Bill Text: TX SB460 | 2015-2016 | 84th Legislature | Enrolled
Bill Title: Relating to the licensing and regulation of pharmacists and pharmacies.
Spectrum: Partisan Bill (Republican 2-0)
Status: (Passed) 2015-06-16 - Effective on 9/1/15 [SB460 Detail]
Download: Texas-2015-SB460-Enrolled.html
S.B. No. 460 |
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relating to the licensing and regulation of pharmacists and | ||
pharmacies. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Section 483.047, Health and Safety Code, is | ||
amended by amending Subsection (a) and adding Subsections (b-1) and | ||
(b-2) to read as follows: | ||
(a) Except as authorized by Subsections [ |
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and (b-1), a pharmacist commits an offense if the pharmacist | ||
refills a prescription unless: | ||
(1) the prescription contains an authorization by the | ||
practitioner for the refilling of the prescription, and the | ||
pharmacist refills the prescription in the manner provided by the | ||
authorization; or | ||
(2) at the time of refilling the prescription, the | ||
pharmacist is authorized to do so by the practitioner who issued the | ||
prescription. | ||
(b-1) Notwithstanding Subsection (b), in the event of a | ||
natural or manmade disaster, a pharmacist may dispense not more | ||
than a 30-day supply of a dangerous drug without the authorization | ||
of the prescribing practitioner if: | ||
(1) failure to refill the prescription might result in | ||
an interruption of a therapeutic regimen or create patient | ||
suffering; | ||
(2) the natural or manmade disaster prohibits the | ||
pharmacist from being able to contact the practitioner; | ||
(3) the governor has declared a state of disaster | ||
under Chapter 418, Government Code; and | ||
(4) the board, through the executive director, has | ||
notified pharmacies in this state that pharmacists may dispense up | ||
to a 30-day supply of a dangerous drug. | ||
(b-2) The prescribing practitioner is not liable for an act | ||
or omission by a pharmacist in dispensing a dangerous drug under | ||
Subsection (b-1). | ||
SECTION 2. Section 555.002(a), Occupations Code, is amended | ||
to read as follows: | ||
(a) The board by rule shall establish methods by which | ||
consumers and service recipients are notified of the name, mailing | ||
address, and telephone number of the board for the purpose of | ||
directing complaints to the board. The board may provide for that | ||
notice: | ||
(1) on each registration form, application, or written | ||
contract for services of a person regulated by the board; | ||
(2) on a sign prominently displayed in the place of | ||
business of each person regulated by the board; [ |
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(3) on an electronic messaging system in a font | ||
specified by board rule prominently displayed in the place of | ||
business of each person regulated by the board; or | ||
(4) in a bill for service provided by a person | ||
regulated by the board. | ||
SECTION 3. Section 556.051, Occupations Code, is amended to | ||
read as follows: | ||
Sec. 556.051. AUTHORIZATION TO ENTER AND INSPECT. (a) The | ||
board or a representative of the board may enter and inspect a | ||
facility relative to the following: | ||
(1) drug storage and security; | ||
(2) equipment; | ||
(3) components used in compounding, finished and | ||
unfinished products, containers, and labeling of any item; | ||
(4) sanitary conditions; [ |
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(5) records, reports, or other documents required to | ||
be kept or made under this subtitle, Chapter 481 or 483, Health and | ||
Safety Code, or the Comprehensive Drug Abuse Prevention and Control | ||
Act of 1970 (21 U.S.C. Section 801 et seq.) or rules adopted under | ||
one of those laws; or | ||
(6) subject to Subsection (b), financial records | ||
relating to the operation of the facility. | ||
(b) The board or a representative of the board may inspect | ||
financial records under Subsection (a) only in the course of the | ||
investigation of a specific complaint. The board or representative | ||
may inspect only records related to the specific complaint. The | ||
inspection is subject to Section 565.055. | ||
SECTION 4. Section 556.054, Occupations Code, is amended to | ||
read as follows: | ||
Sec. 556.054. CONFIDENTIALITY OF CERTAIN INFORMATION | ||
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the board during an inspection of a facility is confidential and not | ||
subject to disclosure under Chapter 552, Government Code [ |
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(1) financial data; | ||
(2) sales data, other than shipment data; and [ |
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(3) pricing data. | ||
SECTION 5. Subchapter B, Chapter 556, Occupations Code, is | ||
amended by adding Section 556.057 to read as follows: | ||
Sec. 556.057. INSPECTION OF PHARMACIST RECORDS. A | ||
pharmacist shall provide to the board, on request, records of the | ||
pharmacist's practice that occurs outside of a pharmacy. The | ||
pharmacist shall provide the records at a time specified by board | ||
rule. | ||
SECTION 6. Sections 558.055(a) and (b), Occupations Code, | ||
are amended to read as follows: | ||
(a) An applicant who on the applicant's first attempt fails | ||
the examination may take the examination four [ |
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times. | ||
(b) Before an applicant who has failed the examination five | ||
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must provide documentation from a college of pharmacy that the | ||
applicant has successfully completed additional college course | ||
work in each examination subject area the applicant failed. | ||
SECTION 7. Section 560.052(b), Occupations Code, is amended | ||
to read as follows: | ||
(b) To qualify for a pharmacy license, an applicant must | ||
submit to the board: | ||
(1) a license fee set by the board, except as provided | ||
by Subsection (d); and | ||
(2) a completed application that: | ||
(A) is on a form prescribed by the board; | ||
(B) is given under oath; | ||
(C) includes proof that: | ||
(i) a pharmacy license held by the | ||
applicant in this state or another state, if applicable, has not | ||
been restricted, suspended, revoked, or surrendered for any reason; | ||
and | ||
(ii) no owner of the pharmacy for which the | ||
application is made has held a pharmacist license in this state or | ||
another state, if applicable, that has been restricted, suspended, | ||
revoked, or surrendered for any reason; and | ||
(D) includes a statement of: | ||
(i) the ownership; | ||
(ii) the location of the pharmacy; | ||
(iii) the license number of each pharmacist | ||
who is employed by the pharmacy, if the pharmacy is located in this | ||
state, or who is licensed to practice pharmacy in this state, if the | ||
pharmacy is located in another state; | ||
(iv) the pharmacist license number of the | ||
pharmacist-in-charge; and | ||
(v) any other information the board | ||
determines necessary. | ||
SECTION 8. Section 561.003(e), Occupations Code, is amended | ||
to read as follows: | ||
(e) If a pharmacy's license has been expired for 91 days | ||
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pharmacy may obtain a new license by complying with the | ||
requirements and procedures for obtaining an original license. | ||
SECTION 9. Sections 562.056(a) and (a-1), Occupations Code, | ||
are amended to read as follows: | ||
(a) Before dispensing a prescription, a pharmacist shall | ||
determine, in the exercise of sound professional judgment, that the | ||
prescription is a valid prescription. A pharmacist may not | ||
dispense a prescription drug if the pharmacist knows or should know | ||
that the prescription was issued [ |
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relationship. | ||
(a-1) To be a valid prescription, a prescription [ |
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purpose by a practitioner acting in the usual course of the | ||
practitioner's professional practice. The responsibility for the | ||
proper prescribing and dispensing of prescription drugs | ||
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corresponding responsibility rests with the pharmacist who fills | ||
the prescription. | ||
SECTION 10. Section 562.106, Occupations Code, is amended | ||
by amending Subsection (a) and adding Subsection (a-1) to read as | ||
follows: | ||
(a) A pharmacy shall report in writing to the board not | ||
later than the 10th day after the date of: | ||
(1) a permanent closing of the pharmacy; | ||
(2) a change of ownership of the pharmacy; | ||
(3) [ |
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pharmacist-in-charge of the pharmacy; | ||
(4) [ |
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substance or dangerous drug as a result of the permanent closing or | ||
change of ownership of the pharmacy; | ||
(5) [ |
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requires by rule to be reported; | ||
(6) [ |
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purchase of any controlled substance; | ||
(7) [ |
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holder by the regulatory or licensing agency of the state in which | ||
the pharmacy is located if the pharmacy is located in another state; | ||
or | ||
(8) [ |
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designated as the pharmacist-in-charge of the pharmacy by the | ||
regulatory or licensing agency of the state in which the pharmacy is | ||
located if the pharmacy is located in another state. | ||
(a-1) A pharmacy shall report in writing to the board not | ||
later than the 30th day before the date of a change of location of | ||
the pharmacy. | ||
SECTION 11. Section 565.002(a), Occupations Code, is | ||
amended to read as follows: | ||
(a) The board may discipline an applicant for or the holder | ||
of a pharmacy license, including a Class E pharmacy license subject | ||
to Section 565.003 [ |
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applicant or license holder has: | ||
(1) been convicted of or placed on deferred | ||
adjudication community supervision or deferred disposition or the | ||
applicable federal equivalent for: | ||
(A) a misdemeanor: | ||
(i) involving moral turpitude; or | ||
(ii) under Chapter 481 or 483, Health and | ||
Safety Code, or the Comprehensive Drug Abuse Prevention and Control | ||
Act of 1970 (21 U.S.C. Section 801 et seq.); or | ||
(B) a felony; | ||
(2) advertised a prescription drug or device in a | ||
deceitful, misleading, or fraudulent manner; | ||
(3) violated any provision of this subtitle or any | ||
rule adopted under this subtitle or that an owner or employee of a | ||
pharmacy has violated any provision of this subtitle or any rule | ||
adopted under this subtitle; | ||
(4) sold without legal authorization a prescription | ||
drug or device to a person other than: | ||
(A) a pharmacy licensed by the board; | ||
(B) a practitioner; | ||
(C) a person who procures a prescription drug or | ||
device for lawful research, teaching, or testing, and not for | ||
resale; | ||
(D) a manufacturer or wholesaler licensed by the | ||
commissioner of public health as required by Chapter 431, Health | ||
and Safety Code; or | ||
(E) a carrier or warehouseman; | ||
(5) allowed an employee who is not a pharmacist to | ||
practice pharmacy; | ||
(6) sold an adulterated or misbranded prescription or | ||
nonprescription drug; | ||
(7) failed to engage in or ceased to engage in the | ||
business described in the application for a license; | ||
(8) failed to maintain records as required by this | ||
subtitle, Chapter 481 or 483, Health and Safety Code, the | ||
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 | ||
U.S.C. Section 801 et seq.), or any rule adopted under this subtitle | ||
or Chapter 483, Health and Safety Code; | ||
(9) failed to establish and maintain effective | ||
controls against diversion of prescription drugs into other than a | ||
legitimate medical, scientific, or industrial channel as provided | ||
by this subtitle, another state statute or rule, or a federal | ||
statute or rule; | ||
(10) engaged in fraud, deceit, or misrepresentation as | ||
defined by board rule in operating a pharmacy or in applying for a | ||
license to operate a pharmacy; | ||
(11) violated a disciplinary order; | ||
(12) been responsible for a drug audit shortage; [ |
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(13) been disciplined by the regulatory board of | ||
another state for conduct substantially equivalent to conduct | ||
described under this subsection; or | ||
(14) waived, discounted, or reduced, or offered to | ||
waive, discount, or reduce, a patient copayment or deductible for a | ||
compounded drug in the absence of: | ||
(A) a legitimate, documented financial hardship | ||
of the patient; or | ||
(B) evidence of a good faith effort to collect | ||
the copayment or deductible from the patient. | ||
SECTION 12. Section 565.060(d), Occupations Code, is | ||
amended to read as follows: | ||
(d) If a license holder complies with and successfully | ||
completes the terms of a remedial plan, the board shall remove all | ||
records of the remedial plan from the board's records at the end of | ||
the state fiscal year in which [ |
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date the board issued the terms of the remedial plan occurs. | ||
SECTION 13. Section 565.061(a), Occupations Code, is | ||
amended to read as follows: | ||
(a) Except as provided by Chapter 564, a disciplinary action | ||
taken by the board [ |
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ground for discipline under Subchapter A is governed by Chapter | ||
2001, Government Code, and the rules of practice and procedure | ||
before the board. | ||
SECTION 14. The following provisions of the Occupations | ||
Code are repealed: | ||
(1) Section 561.003(d); | ||
(2) Section 562.009(a-1); and | ||
(3) Section 562.051. | ||
SECTION 15. The change in law made by this Act to Section | ||
483.047, Health and Safety Code, applies only to an offense | ||
committed on or after the effective date of this Act. An offense | ||
committed before the effective date of this Act is governed by the | ||
law in effect on the date the offense was committed, and the former | ||
law is continued in effect for that purpose. For purposes of this | ||
section, an offense was committed before the effective date of this | ||
Act if any element of the offense occurred before that date. | ||
SECTION 16. Section 560.052(b), Occupations Code, as | ||
amended by this Act, applies only to an application for a pharmacy | ||
license submitted on or after the effective date of this Act. An | ||
application submitted before the effective date of this Act is | ||
governed by the law in effect on the date the application was | ||
submitted, and the former law is continued in effect for that | ||
purpose. | ||
SECTION 17. Section 561.003(e), Occupations Code, as | ||
amended by this Act, and the repeal by this Act of Section | ||
561.003(d), Occupations Code, apply only to a pharmacy license that | ||
expires on or after the effective date of this Act. A pharmacy | ||
license that expired before the effective date of this Act is | ||
governed by the law in effect on the date the license expired, and | ||
the former law is continued in effect for that purpose. | ||
SECTION 18. Section 562.106(a), Occupations Code, as | ||
amended by this Act, and Section 562.106(a-1), Occupations Code, as | ||
added by this Act, apply only to a pharmacy that changes location on | ||
or after October 1, 2015. A pharmacy that changes location before | ||
that date is governed by the law in effect immediately before the | ||
effective date of this Act, and the former law is continued in | ||
effect for that purpose. | ||
SECTION 19. The change in law made by this Act to Section | ||
565.002(a), Occupations Code, applies only to conduct that occurs | ||
on or after the effective date of this Act. Conduct that occurs | ||
before that date is governed by the law in effect on the date the | ||
conduct occurred, and the former law is continued in effect for that | ||
purpose. | ||
SECTION 20. The change in law made by this Act to Section | ||
565.061(a), Occupations Code, is a clarification of existing law | ||
and does not imply that existing law may be construed as | ||
inconsistent with the law as amended by this Act. | ||
SECTION 21. This Act takes effect September 1, 2015. | ||
______________________________ | ______________________________ | |
President of the Senate | Speaker of the House | |
I hereby certify that S.B. No. 460 passed the Senate on | ||
April 14, 2015, by the following vote: Yeas 31, Nays 0. | ||
______________________________ | ||
Secretary of the Senate | ||
I hereby certify that S.B. No. 460 passed the House on | ||
May 22, 2015, by the following vote: Yeas 137, Nays 3, two | ||
present not voting. | ||
______________________________ | ||
Chief Clerk of the House | ||
Approved: | ||
______________________________ | ||
Date | ||
______________________________ | ||
Governor |