Law:Title 3. Health Professions. Subtitle J. Pharmacy And Pharmacists from Chapter 565. Disciplinary Actions And Procedures; Reinstatement Of License (Texas)

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Subtitle J. Pharmacy And Pharmacists

Contents

Chapter 565. Disciplinary Actions And Procedures; Reinstatement Of License

Subchapter A. Grounds For Discipline Of Applicant Or License Holder

Section  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.



Section 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.



Section  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

Section 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.



Section  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.



Section 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.



Section  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.



Section  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.



Section  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.



Section  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.



Section  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.



Section 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.



Section  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.



Section  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.



Section  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.



Section  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

Section  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.



Section  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.



Section  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.


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