CHAPTER 565. DISCIPLINARY ACTIONS AND PROCEDURES; REINSTATEMENT OF LICENSE
OCCUPATIONS CODE
TITLE 3. HEALTH PROFESSIONS
SUBTITLE J. PHARMACY AND PHARMACISTS
CHAPTER 565. DISCIPLINARY ACTIONS AND PROCEDURES; REINSTATEMENT
OF LICENSE
SUBCHAPTER A. GROUNDS FOR DISCIPLINE OF APPLICANT OR LICENSE
HOLDER
Sec. 565.001. APPLICANT FOR OR HOLDER OF LICENSE TO PRACTICE
PHARMACY. (a) The board may discipline an applicant for or the
holder of a current or expired license to practice pharmacy if
the board finds that the applicant or license holder has:
(1) violated this subtitle or a board rule adopted under this
subtitle;
(2) engaged in unprofessional conduct as defined by board rule;
(3) engaged in gross immorality as defined by board rule;
(4) developed an incapacity that prevents the applicant or
license holder from practicing pharmacy with reasonable skill,
competence, and safety to the public;
(5) engaged in fraud, deceit, or misrepresentation, as defined
by board rule, in practicing pharmacy or in seeking a license to
practice pharmacy;
(6) 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;
(7) used alcohol or drugs in an intemperate manner that, in the
board's opinion, could endanger a patient's life;
(8) failed to maintain records required by this subtitle or
failed to maintain complete and accurate records of purchases or
disposals of drugs listed in 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.);
(9) violated any provision of:
(A) 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 relating to one of those
laws; or
(B) Section 485.031, 485.032, 485.033, or 485.034, Health and
Safety Code;
(10) aided or abetted an unlicensed person in the practice of
pharmacy if the pharmacist knew or reasonably should have known
that the person was unlicensed at the time;
(11) refused entry into a pharmacy for an inspection authorized
by this subtitle if the pharmacist received notification from
which the pharmacist knew or reasonably should have known that
the attempted inspection was authorized;
(12) violated any pharmacy or drug statute or rule of this
state, another state, or the United States;
(13) been negligent in the practice of pharmacy;
(14) failed to submit to an examination after hearing and being
ordered to do so by the board under Section 565.052;
(15) dispensed a prescription drug while acting outside the
usual course and scope of professional practice;
(16) been disciplined by the regulatory board of another state
for conduct substantially equivalent to conduct described under
this subsection;
(17) violated a disciplinary order, including a confidential
order or contract under the program to aid impaired pharmacists
and pharmacy students under Chapter 564;
(18) failed to adequately supervise a task delegated to a
pharmacy technician;
(19) inappropriately delegated a task delegated to a pharmacy
technician; or
(20) been responsible for a drug audit shortage.
(b) A certified copy of the record of the state taking action
described by Subsection (a)(16) is conclusive evidence of the
action taken by that state.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1254, Sec. 9, eff. Sept. 1,
2001; Acts 2001, 77th Leg., ch. 1463, Sec. 3, eff. Sept. 1, 2001.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 25, eff. September 1, 2005.
Sec. 565.002. APPLICANT FOR OR HOLDER OF PHARMACY LICENSE. (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(b), 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 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; or
(13) been disciplined by the regulatory board of another state
for conduct substantially equivalent to conduct described under
this subsection.
(b) This subsection applies only to an applicant or license
holder that is a legal business entity. The board may discipline
an applicant for or the holder of a pharmacy license, including a
Class E pharmacy license, if the board finds that a managing
officer of the applicant or license holder has been convicted of
or placed on deferred adjudication community supervision or
deferred disposition or the applicable federal equivalent for:
(1) a misdemeanor:
(A) involving moral turpitude; or
(B) 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
(2) a felony.
(c) A certified copy of the record of the state taking action
described by Subsection (a)(13) is conclusive evidence of the
action taken by that state.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 26, eff. September 1, 2005.
Sec. 565.003. ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING
APPLICANT FOR OR HOLDER OF CLASS E PHARMACY LICENSE. (a)
Repealed by Acts 2005, 79th Leg., Ch. 1345, Sec. 45, eff.
September 1, 2005.
(b) Unless compliance would violate the pharmacy or drug
statutes or rules in the state in which the pharmacy is located
the board may discipline an applicant for or the holder of a
Class E pharmacy license if the board finds that the applicant or
license holder has failed to comply with:
(1) Section 481.074 or 481.075, Health and Safety Code;
(2) Texas substitution requirements regarding:
(A) the practitioner's directions concerning generic
substitution;
(B) the patient's right to refuse generic substitution; or
(C) notification to the patient of the patient's right to refuse
substitution;
(3) any board rule relating to providing drug information to the
patient or the patient's agent in written form or by telephone;
or
(4) any board rule adopted under Section 554.051(a) and
determined by the board to be applicable under Section
554.051(b).
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 45, eff. September 1, 2005.
SUBCHAPTER B. DISCIPLINARY ACTIONS AND PROCEDURES
Sec. 565.051. DISCIPLINE AUTHORIZED. On a determination that a
ground for discipline exists under Subchapter A, or that a
violation of this subtitle or a rule adopted under this subtitle
has been committed by a license holder or applicant for a license
or renewal of a license, the board may:
(1) suspend the person's license;
(2) revoke the person's license;
(3) restrict the person's license to prohibit the person from
performing certain acts or from practicing pharmacy or operating
a pharmacy in a particular manner for a term and under conditions
determined by the board;
(4) impose an administrative penalty under Chapter 566;
(5) refuse to issue or renew the person's license;
(6) place the offender's license on probation and supervision by
the board for a period determined by the board and impose a
requirement that the license holder:
(A) report regularly to the board on matters that are the basis
of the probation;
(B) limit practice to the areas prescribed by the board;
(C) continue or review professional education until the license
holder attains a degree of skill satisfactory to the board in
each area that is the basis of the probation; or
(D) pay the board a probation fee to defray the costs of
monitoring the license holder during the period of probation;
(7) reprimand the person;
(8) retire the person's license as provided by board rule; or
(9) impose more than one of the sanctions listed in this
subsection.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 27, eff. September 1, 2005.
Sec. 565.052. SUBMISSION TO MENTAL OR PHYSICAL EXAMINATION. (a)
In enforcing Section 565.001(a)(4), the board on probable cause
shall request a pharmacist, pharmacist applicant,
pharmacist-intern, or pharmacist-intern applicant to submit to a
mental or physical examination by a physician or other health
care professional designated by the board.
(b) If the pharmacist, pharmacist applicant, pharmacist-intern,
or pharmacist-intern applicant refuses to submit to the
examination, the board shall issue an order requiring the
pharmacist, pharmacist applicant, pharmacist-intern, or
pharmacist-intern applicant to show cause why the pharmacist,
pharmacist applicant, pharmacist-intern, or pharmacist-intern
applicant will not submit to the examination and shall schedule a
hearing on the order not later than the 30th day after the date
notice is served on the pharmacist, pharmacist applicant,
pharmacist-intern, or pharmacist-intern applicant. The
pharmacist, pharmacist applicant, pharmacist-intern, or
pharmacist-intern applicant shall be notified by either personal
service or certified mail with return receipt requested.
(c) At the hearing, the pharmacist, pharmacist applicant,
pharmacist-intern, or pharmacist-intern applicant and an attorney
are entitled to present testimony or other evidence to show why
the pharmacist, pharmacist applicant, pharmacist-intern, or
pharmacist intern-applicant should not be required to submit to
the examination.
(d) After the hearing, the board shall by order require the
pharmacist, pharmacist applicant, pharmacist-intern, or
pharmacist-intern applicant to submit to the examination or
withdraw the request for examination.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.053. DISCIPLINE OF CLASS E PHARMACY; NOTICE TO RESIDENT
STATE. The board shall give notice of a disciplinary action by
the board against the holder of a Class E pharmacy license to the
regulatory or licensing agency of the state in which the pharmacy
is located.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 28, eff. September 1, 2005.
Sec. 565.054. SERVICE OF PROCESS ON CLASS E PHARMACY. (a)
Service of process on a Class E pharmacy under Section 565.058 or
566.051 or for disciplinary action taken by the board under
Section 565.061 shall be on the owner and pharmacist-in-charge of
the pharmacy, as designated on the pharmacy's license
application.
(b) The complaining party shall mail by certified mail, return
receipt requested and postage prepaid, a copy of the process
served to the license holder at the address of the license holder
designated on the license application.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.055. INVESTIGATION; CONFIDENTIALITY OF INFORMATION.
(a) The board or the board's authorized representative may
investigate and gather evidence concerning any alleged violation
of this subtitle or a board rule.
(b) Information or material compiled by the board in connection
with an investigation, including an investigative file of the
board, is confidential and not subject to:
(1) disclosure under Chapter 552, Government Code; or
(2) any means of legal compulsion for release, including
disclosure, discovery, or subpoena, to anyone other than the
board or a board employee or board agent involved in discipline
of a license holder.
(c) Notwithstanding Subsection (b), information or material
compiled by the board in connection with an investigation may be
disclosed to:
(1) a person involved with the board in a disciplinary action
against the license holder;
(2) an entity in another jurisdiction that licenses or
disciplines pharmacists or pharmacies;
(3) a pharmaceutical or pharmacy peer review committee as
described under Chapter 564;
(4) a law enforcement agency; or
(5) a person engaged in bona fide research, if all information
identifying a specific individual has been deleted.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.311(a), eff.
Sept. 1, 2001.
Sec. 565.056. INFORMAL PROCEEDINGS. (a) The board by rule
shall adopt a procedure governing:
(1) informal disposition of a contested case under Chapter 2001,
Government Code; and
(2) an informal proceeding held in compliance with Chapter 2001,
Government Code.
(b) A rule adopted under this section must:
(1) provide the complainant, if applicable and permitted by law,
and the license holder an opportunity to be heard; and
(2) require the presence of an attorney to advise the board or a
board employee.
(c) The attorney must be a member of the board's legal staff, if
the board has a legal staff. If the board does not have a legal
staff, the attorney must be an employee of the office of the
attorney general.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.057. MONITORING OF LICENSE HOLDER. (a) The board
shall develop a policy and procedure for monitoring a license
holder's compliance with this subtitle.
(b) A policy or procedure adopted under this section must
include a procedure to:
(1) monitor for compliance a license holder who is ordered by
the board to perform a certain act; and
(2) identify and monitor a license holder who represents a risk
to the public.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.058. SUBPOENA AUTHORITY. (a) The board or an officer
of the board may:
(1) issue subpoenas ad testificandum or subpoenas duces tecum to
compel the attendance of witnesses or the production of items,
including books, records, or documents;
(2) administer oaths; and
(3) take testimony concerning matters in the board's or
officer's jurisdiction.
(b) A person designated in the subpoena may serve the subpoena.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.059. TEMPORARY SUSPENSION OF LICENSE OR REGISTRATION.
(a) The president of the board shall appoint a three-member
disciplinary panel consisting of board members to determine
whether a license or registration under this subtitle should be
temporarily suspended or restricted. If a majority of the
disciplinary panel determines from evidence or information
presented to the panel that the holder of a license or
registration by continuation in practice would constitute a
continuing threat to the public welfare, the panel shall
temporarily suspend the license or registration.
(b) The disciplinary panel may temporarily suspend the license
or registration without notice or hearing if, at the time the
suspension is ordered, a hearing before the panel on whether
disciplinary proceedings under this chapter should be initiated
against the holder of a license or registration is scheduled to
be held not later than the 14th day after the date of the
suspension.
(c) A second hearing on the suspended license or registration
shall be held by the State Office of Administrative Hearings not
later than the 60th day after the date of the suspension. If the
State Office of Administrative Hearings does not hold the second
hearing in the time required by this subsection, the suspended
license or registration is automatically reinstated.
(d) Notwithstanding Chapter 551, Government Code, the
disciplinary panel may hold a meeting by telephone conference
call if immediate action is required and convening of the panel
at one location is inconvenient for any member of the
disciplinary panel.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by:
Acts 2005, 79th Leg., Ch.
1345, Sec. 29, eff. September 1, 2005.
Sec. 565.061. ADMINISTRATIVE PROCEDURE. (a) Except as provided
by Chapter 564, a disciplinary action taken by the board under
Section 565.060 or on the basis of a ground for discipline under
Subchapter A is governed by Chapter 2001, Government Code, and
the rules of practice and procedure before the board.
(b) A final decision of the board under this chapter is subject
to judicial review under Chapter 2001, Government Code.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.062. BURDEN OF PROOF. (a) In a proceeding under this
subtitle, including a trial or hearing, the state is not required
to negate an exemption or exception set forth by this subtitle in
a pleading, including in a complaint, information, or indictment.
(b) The burden of going forward with the evidence with respect
to an exemption or exception is on the person claiming the
benefit of the exemption or exception.
(c) In the absence of proof that a person is the authorized
holder of an appropriate license issued under this subtitle, the
person is presumed not to be the holder of the license. The
presumption is subject to rebuttal by a person charged with an
offense under this subtitle.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.063. LIABILITY. This subtitle does not impose
liability on an authorized board employee or person acting under
the supervision of a board employee, or on a state, county, or
municipal officer, engaged in the lawful enforcement of this
subtitle.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Sec. 565.064. CONSTRUCTION. This subtitle does not bar a
criminal prosecution for a violation of this subtitle if the
violation is a criminal offense under another law of this state
or a law of the United States.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
SUBCHAPTER C. PETITION FOR REINSTATEMENT OR REMOVAL OF
RESTRICTION
Sec. 565.101. PETITION FOR REINSTATEMENT OR REMOVAL OF
RESTRICTION. (a) A person whose pharmacy license, license to
practice pharmacy, or pharmacy technician registration in this
state has been revoked or restricted under this subtitle, whether
voluntarily or by board action, may, after the first anniversary
of the effective date of the revocation or restriction, petition
the board for reinstatement or removal of the restriction of the
license or registration.
(b) The petition must be in writing and in the form prescribed
by the board.
(c) A person petitioning for reinstatement or removal of a
restriction has the burden of proof.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.312(a), eff.
Sept. 1, 2001.
Sec. 565.102. ACTION BY BOARD. (a) On investigation and review
of a petition under this subchapter, the board may grant or deny
the petition or may modify the board's original finding to
reflect a circumstance that has changed sufficiently to warrant
the modification.
(b) If the board denies the petition, the board may not consider
a subsequent petition from the petitioner until the first
anniversary of the date of denial of the previous petition.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.312(a), eff.
Sept. 1, 2001.
Sec. 565.103. CONDITION FOR REINSTATEMENT OR REMOVAL OF
RESTRICTION. The board may require a person to pass one or more
examinations to reenter the practice of pharmacy.
Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.
Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.312(a), eff.
Sept. 1, 2001.