TITLE 22.EXAMINING BOARDS

Part 15. TEXAS STATE BOARD OF PHARMACY

Chapter 281. ADMINISTRATIVE PRACTICE AND PROCEDURES

Subchapter B. GENERAL PROCEDURES IN A CONTESTED CASE

22 TAC §281.20

The Texas State Board of Pharmacy proposes new §281.20, concerning Criminal Convictions. The rule, if adopted, will clarify the reasons a particular crime is considered to relate to the practice of pharmacy and specify other criteria that affect the decisions of the Board in compliance with §53.025 of the Occupations Code.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state government as a result of enforcing or administering the rule. There are no anticipated fiscal implications for local government.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be the establishment of standards for the handling of criminal convictions. There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Written comments on the new section may be submitted to Gay Dodson, R.Ph., Executive Director/Secretary, Texas State Board of Pharmacy, 333 Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 1, 2003.

The new section is proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code) and §53.025 of the Texas Occupations Code. The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051, as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §53.025 as authorizing the agency to issue guidelines relating to decisions involving criminal convictions.

The statutes affected by this rule: Chapters 53, 551 - 566, and 568 - 569, Texas Occupations Code.

§281.20.Criminal Convictions.

(a) The purpose of this section is to establish guidelines and criteria on the eligibility of persons with criminal backgrounds to obtain a license from the board and on the disciplinary actions taken by the board.

(b) The board may suspend, revoke, or impose other authorized disciplinary action on a current license, disqualify a person from receiving a license, or deny to a person the opportunity to be examined for a license because of a person's conviction of a crime that directly relates to the duties and responsibilities of a licensee or of an owner of a pharmacy. This subsection applies to persons who are not imprisoned at the time the board considers the conviction.

(c) The board shall revoke a license upon the imprisonment of the licensee or the owner of a pharmacy following a felony conviction or revocation of felony community supervision, parole, or mandatory supervision.

(d) A person in prison is not eligible for a license.

(e) An applicant for a license from the board shall disclose in writing to the board any conviction against him or her at the time of application. A current licensee shall disclose in writing to the board any conviction against him or her at the time of renewal.

(f) In considering whether a criminal conviction directly relates to the occupation of a licensee or the operation of a pharmacy, the board shall consider:

(1) the nature and seriousness of the crime;

(2) the relationship of the crime to the purposes for requiring a license to engage in the occupation of the licensee or the operation of a pharmacy.

(3) the extent to which a license might afford the licensee an opportunity to repeat the criminal activity in which the person had been involved; and

(4) the relationship of the crime to the ability, capacity, or fitness required to perform the duties and discharge the responsibilities of the licensee.

(g) In reaching a decision regarding the type of disciplinary sanction to impose on license, the board shall also determine the person's fitness to perform the duties and discharge the responsibilities of a licensee based on:

(1) the extent and nature of the person's past criminal activity;

(2) the age of the person at the time of the commission of the crime;

(3) the amount of time that has elapsed since the person's last criminal activity;

(4) the conduct and work activity of the person prior to and following the criminal activity;

(5) evidence of the person's rehabilitation or rehabilitative effort while incarcerated or following release; and

(6) other evidence of the person's present fitness, including letters of recommendation from:

(A) prosecution, law enforcement, and correctional officers who prosecuted, arrested, or had custodial responsibility for the person;

(B) the sheriff and chief of police in the community where the person resides; and

(C) any other persons in contact with the convicted person.

(h) A person with a conviction shall:

(1) to the extent possible, secure and provide to the board the recommendations of the prosecution, law enforcement, and correctional authorities specified in subsection (g)(6) of this section;

(2) cooperate with the board by providing the information required by this section, including proof that he or she has:

(A) maintained a record of steady employment, as evidenced by salary stubs, income tax records or other employment records for the time since the conviction and/or release from imprisonment;

(B) supported his or her dependents, as evidenced by salary stubs, income tax records or other employment records for the time since the conviction and/or release from imprisonment, and a letter from the spouse or other parent;

(C) maintained a record of good conduct as evidenced by letters of recommendation, absence of other criminal activity or documentation of community service since conviction; and

(D) paid all outstanding court costs, supervision fees, fines, and restitution as may have been ordered in all criminal cases in which he or she has been convicted, as evidenced by certified copies of a court release or other documentation from the court system that all monies have been paid.

(i) The following crimes relate to board licensees. The commission of each indicates an inability or a tendency for the person to be unable to perform or to be unfit for licensure, because violation of such crimes indicates a lack of integrity and respect for one's fellow human being and the community at large. The direct relationship to a license is presumed when the crime occurs in connection with the practice of pharmacy or the operation of a pharmacy.

(1) practicing or operating a pharmacy without a license and other violations of the Pharmacy Act;

(2) deceptive business practices;

(3) medicare or medicaid fraud;

(4) a misdemeanor or felony offense involving:

(A) murder;

(B) assault;

(C) burglary;

(D) robbery;

(E) theft;

(F) sexual assault;

(G) injury to a child;

(H) injury to an elderly person;

(I) child abuse or neglect;

(J) tampering with a governmental record;

(K) forgery;

(L) perjury;

(M) failure to report abuse;

(N) bribery;

(O) harassment;

(P) insurance claim fraud;

(Q) solicitation of professional employment under the Penal Code §38.12(d) or Occupations Code, Chapter 102; or

(R) mail fraud;

(5) delivery, possession, manufacture, or use of, or dispensing or prescribing a controlled substance, dangerous drug, or narcotic; or

(6) other misdemeanors or felonies, including violations of the Penal Code, Titles 4, 5, 7, 9, and 10, which indicate an inability or tendency for the person to be unable to perform as a licensee or to be unfit for licensure, if action by the board will promote the intent of the Pharmacy Act, board rules including this chapter, and Occupations Code, Chapter 53.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 11, 2003.

TRD-200303513

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 27, 2003

For further information, please call: (512) 305-8028


22 TAC §281.22

The Texas State Board of Pharmacy proposes amendments to §281.22, concerning Informal Disposition of a Contested Case. These amendments, if adopted, will allow the Board to informally dispose of a case by entering a default order without the necessity of proceeding to a hearing at the State Office of Administrative Hearings (SOAH). A default order is only applicable when the licensee fails to respond to the notice of allegations by the Board.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state government as a result of enforcing or administering the rule. There are no anticipated fiscal implications for local government.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be the establishment of standards for handling default cases against licensees, allowing the Board to process disciplinary cases in a more efficient and timely manner. There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Written comments on the amendments may be submitted to Gay Dodson, R.Ph., Executive Director/Secretary, Texas State Board of Pharmacy, 333 Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 1, 2003.

The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051, as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by this proposal: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§281.22.Informal Disposition of a Contested Case.

(a) (No change.)

(b) Prior to the imposition of disciplinary sanction(s) against a license, the board shall provide the licensee with written notice of the matters asserted, including: [ the licensee shall be offered an opportunity to attend an informal conference and show compliance with all requirements of law, in accordance with §2001.054(c) of the Administrative Procedure Act. ]

(1) a statement of the legal authority, jurisdiction, and alleged conduct under which the enforcement action is based, with a reference to the particular section(s) of the statutes and rules involved;

(2) an offer for the licensee to attend an informal conference at a specified time and place and show compliance with all requirements of law, in accordance with §2001.054(c) of the Administrative Procedure Act;

(3) a statement that the licensee has an opportunity for a hearing before the State Office of Administrative Hearings on the allegations; and

(4) the following statement in capital letters in 12 point boldface type: FAILURE TO RESPOND TO THE ALLEGATIONS, BY EITHER PERSONAL APPEARANCE AT THE INFORMAL CONFERENCE OR IN WRITING, WILL RESULT IN THE ALLEGATIONS BEING ADMITTED AS TRUE AND THE RECOMMENDED SANCTION MADE AT THE INFORMAL CONFERENCE BEING GRANTED BY DEFAULT. The notice shall be served by delivering a copy to the licensee in person, by courier receipted delivery, by first class mail, or by certified or registered mail, return receipt requested to the licensee's last known address of record as shown by agency records.

(c) The licensee shall respond by either personal appearance at the informal conference or in writing no later than the date of the informal conference. If the licensee chooses to respond in writing, the response shall admit or deny each of the allegations. If the licensee intends to deny only a part of an allegation, the licensee shall specify so much of it is true and shall deny only the remainder. The response shall also include any other matter, whether of law or fact, upon which the licensee intends to rely for his or her defense. If the licensee fails to respond to the notice specified in subsection (b) of this section, the matter will be considered as a default case and the licensee will be deemed to have:

(1) admitted all the factual allegations in the notice specified in subsection (b) of this section;

(2) waived the opportunity to show compliance with the law;

(3) waived notice of a hearing;

(4) waived the opportunity for a hearing on the allegations; and

(5) waived objection to the recommended sanctions made at the informal conference.

(d) The informal conference panel may recommend that the board enter a default order, based upon the allegations set out in the notice specified in subsection (b) of this section, adopting the recommended sanctions made at the informal conference. Upon consideration of the case, the Board may enter a default order under §2001.056 of the Administrative Procedure Act or direct that the case be set for a hearing at the State Office of Administrative Hearings.

(e) Any default judgment granted under this section will be entered on the basis of the factual allegations in the notice specified in subsection (b) off this section, and upon proof of proper notice to the licensee's address of record. For purposes of this section, proper notice means notice sufficient to meet the provisions of §2001.054 of the Administrative Procedure Act and §281.25 of these rules.

(f) A motion for rehearing which requests that the Board vacate its default order under this section shall be granted if the motion presents convincing evidence that the failure to respond to the notice specified in subsection (b) of this section was not intentional or the result of conscious indifference, but due to accident or mistake, provided that the licensee has a meritorious defense to the factual allegations contained in the notice specified in subsection (b) of this section and the granting thereof will not result in delay or injury to the public or the Board.

(g) [ (c) ] Informal conferences shall be attended by the executive director/secretary or designated representative, legal counsel of the agency or an attorney employed by the office of the attorney general, and other representative(s) of the agency as the executive director/secretary and legal counsel may deem necessary for proper conduct of the conference. The licensee and/or the licensee's authorized representative(s) may attend the informal conference and shall be provided an opportunity to be heard.

(h) [ (d) ] In any case where charges are based upon information provided by a person (complainant) who filed a complaint with the board, the complainant may attend the informal conference, unless the proceedings are confidential under §564.002 and §564.003 of the Texas Pharmacy Act or other applicable law. A complainant who chooses to attend an informal conference shall be provided an opportunity to be heard with regard to charges based upon the information provided by the complainant. Nothing herein requires a complainant to attend an informal conference.

(i) [ (e) ] Informal conferences shall not be deemed meetings of the board and no formal record of the proceedings at such conferences shall be made or maintained.

(j) [ (f) ] Any proposed consent order shall be presented to the board in open meeting for its review. At the conclusion of its review, the board shall approve or disapprove the proposed consent order. Should the board approve the proposed consent order, the appropriate notation shall be made in minutes of the board and the proposed consent order shall be entered as an official action of the board. Should the board disapprove the proposed consent order, the matter shall be scheduled for public hearing.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 11, 2003.

TRD-200303514

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 27, 2003

For further information, please call: (512) 305-8028


Chapter 283. LICENSING REQUIREMENTS FOR PHARMACISTS

22 TAC §283.6

The Texas State Board of Pharmacy proposes amendments to §283.6, concerning Preceptor Requirements. These amendments, if adopted, will change the initial and continuing education requirements for a preceptor to allow courses approved by the colleges of pharmacy as well as courses developed by the colleges.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state government as a result of enforcing or administering the rule. There are no anticipated fiscal implications for local government.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be the establishment of standards for preceptor training. There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Written comments on the amendments may be submitted to Gay Dodson, R.Ph., Executive Director/Secretary, Texas State Board of Pharmacy, 333 Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 1, 2003.

The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051 as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by this proposal: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§283.6.Preceptor Requirements.

(a) - (b) (No change.)

(c) For certification as a preceptor a pharmacist must:

(1) (No change.)

(2) have completed:

(A) for initial certification, three hours of preceptor training provided by an ACPE approved provider within the previous two years. Such training shall be:

(i) developed by a Texas college of pharmacy [ and provided by an ACPE approved provider within the previous two years ]; or

(ii) approved by:

(I) a committee comprised of the Texas colleges of pharmacy; or

(II) the board; or

(B) to continue certification, three hours of preceptor training provided by an ACPE approved provider within the preceptor pharmacist's current license renewal period. Such training shall be:

(i) developed by a Texas college of pharmacy [ and provided by an ACPE approved provider within the preceptor pharmacist's current license renewal period ]; or [ and ]

(ii) approved by:

(I) a committee comprised of the Texas colleges of pharmacy; or

(II) the board; and

(3) meet the requirements of subsection (f) of this section.

[(d) Beginning July 1, 2002, approval and certification as a preceptor shall coincide with the preceptor pharmacist's license renewal period. For preceptors whose preceptor certification expires on or after July 1, 2002, the Board shall extend their preceptor expiration date to the next expiration date of the preceptor pharmacist's license.]

(d) [ (e) ] A preceptor may supervise only one pharmacist-intern at any given time. Texas Colleges of Pharmacy may request a different preceptor to pharmacist-intern ratio during the board's annual review and approval of their college based, structured internship program. Any such ratio shall apply only to the internship experience acquired as a part of the college based, structured internship program.

(e) [ (f) ] No pharmacist may serve as a preceptor if his or her license to practice pharmacy has been the subject of an order of the board imposing any penalty set out in the Act, §565.051, during the period he or she is serving as a preceptor or within the three-year period immediately preceding application for approval as a preceptor. Provided, however, a pharmacist who has been the subject of such an order of the board may petition the board, in writing, for approval to act as a preceptor.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 11, 2003.

TRD-200303515

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 27, 2003

For further information, please call: (512) 305-8028


Chapter 291. PHARMACIES

Subchapter B. COMMUNITY PHARMACY (CLASS A)

22 TAC §291.35

The Texas State Board of Pharmacy proposes amendments to §291.35, concerning Triplicate Prescription Requirements. These amendments, if adopted, will correct the title of the section and correct statutory references to Texas Department of Public Safety (DPS) rules.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state government as a result of enforcing or administering the rule. There are no anticipated fiscal implications for local government.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be the establishment of standards for the official prescriptions. There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Written comments on the amendments may be submitted to Gay Dodson, R.Ph., Executive Director/Secretary, Texas State Board of Pharmacy, 333 Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 1, 2003.

The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051, as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by this proposal: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.

§291.35. Official [ Triplicate ] Prescription Requirements.

The Texas State Board of Pharmacy adopts by reference the rules promulgated by the Texas Department of Public Safety, which are set forth in Subchapter D of 37 TAC §§13.71 - 13.86 concerning official prescriptions. [ Subchapter F of 37 TAC §§13.101 - 13.113 concerning triplicate prescriptions ].

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 11, 2003.

TRD-200303516

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 27, 2003

For further information, please call: (512) 305-8028