| |
| |
|
|
A BILL TO BE ENTITLED
|
|
|
AN ACT
|
|
|
relating to the licensing and regulation of pharmacies, |
|
|
pharmacists, and pharmacy technicians. |
|
|
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
|
|
SECTION 1. Section 551.003(9), Occupations Code, is amended |
|
|
to read as follows: |
|
|
(9) "Compounding" means the preparation, mixing, |
|
|
assembling, packaging, and [or] labeling of a drug or device: |
|
|
(A) as the result of a practitioner's |
|
|
prescription drug order based on the |
|
|
practitioner-patient-pharmacist relationship in the course of |
|
|
professional practice; |
|
|
(B) for administration to a patient by a |
|
|
practitioner as the result of a practitioner's initiative based on |
|
|
the practitioner-patient-pharmacist relationship in the course of |
|
|
professional practice; |
|
|
(C) in anticipation of a prescription drug order |
|
|
based on a routine, regularly observed prescribing pattern; or |
|
|
(D) for or as an incident to research, teaching, |
|
|
or chemical analysis and not for selling or dispensing, except as |
|
|
allowed under Section 562.154 or Chapter 563. |
|
|
SECTION 2. Subchapter C, Chapter 560, Occupations Code, is |
|
|
amended by adding Section 560.1025 to read as follows: |
|
|
Sec. 560.1025. PHARMACY OPERATIONS REQUIRED. The board |
|
|
shall revoke a pharmacy license issued under this chapter if the |
|
|
pharmacy has not begun operations as a pharmacy within six months |
|
|
after the date the pharmacy license is issued. |
|
|
SECTION 3. Chapter 561, Occupations Code, is amended by |
|
|
adding Section 561.006 to read as follows: |
|
|
Sec. 561.006. PROHIBITED ISSUANCE OF CERTAIN RENEWAL |
|
|
CERTIFICATES. The board may not issue a license renewal |
|
|
certificate for a pharmacy that the board determines, on inspection |
|
|
of the address of the pharmacy on file with the board, is not |
|
|
operating at that location. |
|
|
SECTION 4. 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, if the board finds that the applicant or license |
|
|
holder has: |
|
|
(1) been convicted of or placed on deferred |
|
|
adjudication community supervision or deferred disposition or the |
|
|
applicable federal equivalent for: |
|
|
(A) a misdemeanor: |
|
|
(i) involving moral turpitude; or |
|
|
(ii) under Chapter 481, 482, [or] 483, or |
|
|
486, 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) had [been responsible for] a drug audit shortage; |
|
|
(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 5. Section 568.001(a), Occupations Code, is amended |
|
|
to read as follows: |
|
|
(a) In establishing rules under Section 554.053(c), the |
|
|
board shall require that: |
|
|
(1) a pharmacy technician: |
|
|
(A) have a high school diploma or a high school |
|
|
equivalency certificate or be working to achieve an equivalent |
|
|
diploma or certificate; [and] |
|
|
(B) have passed a board-approved pharmacy |
|
|
technician certification examination; and |
|
|
(C) have completed a training program that meets |
|
|
criteria established by board rule; and |
|
|
(2) a pharmacy technician trainee have a high school |
|
|
diploma or a high school equivalency certificate or be working to |
|
|
achieve an equivalent diploma or certificate. |
|
|
SECTION 6. Subchapter C, Chapter 481, Health and Safety |
|
|
Code, is amended by adding Section 481.0751 to read as follows: |
|
|
Sec. 481.0751. SUBMISSION OF CERTAIN INFORMATION TO BOARD. |
|
|
(a) If any pharmacist who is an owner or employee of a pharmacy is |
|
|
not required to submit information to the board under Section |
|
|
481.074(q) or 481.075 for a seven-day period, the pharmacy shall |
|
|
notify the board that the pharmacy did not fill a prescription that |
|
|
required the submission of information under those sections during |
|
|
that period. The pharmacy shall send the notice not later than the |
|
|
seventh day after the last day of the period. |
|
|
(b) The board by rule shall establish a standardized process |
|
|
for a pharmacy to transmit electronically the notification required |
|
|
by this section. |
|
|
SECTION 7. Section 481.353(a), Health and Safety Code, is |
|
|
amended to read as follows: |
|
|
(a) The work group shall meet as necessary at the call of the |
|
|
chair [at least quarterly]. |
|
|
SECTION 8. (a) Sections 554.016, 556.0555, 560.001(c), |
|
|
560.0525, and 562.111, Occupations Code, are repealed. |
|
|
(b) Subchapter E, Chapter 562, Occupations Code, is |
|
|
repealed. |
|
|
SECTION 9. Section 565.002(a), Occupations Code, as amended |
|
|
by this Act, applies only to conduct that occurs on or after the |
|
|
effective date of this Act. Conduct that occurred before the |
|
|
effective date of this Act is governed by the law in effect on the |
|
|
date the conduct occurred, and the former law is continued in effect |
|
|
for that purpose. For purposes of this section, conduct occurred |
|
|
before the effective date of this Act if any part of the conduct |
|
|
occurred before that date. |
|
|
SECTION 10. This Act takes effect September 1, 2017. |