TITLE examining-boards

Part VI. Texas Board of Professional Engineers

Chapter 131. Practice and Procedure

Bylaws and Definitions

22 TAC §§131.1-131.3, 131.7-131.10, 131.12, 131.14, 131.15, 131.17-131.19

The Texas Board of Professional Engineers proposes amendments to §§131.1-131.3, 131.7-131.10, 131.12, 131.14, 131.15, and 131.17-131.19, concerning bylaws and definitions.

The amendments will provide consistency with the provisions of Senate Bill 623 and clarify the board's bylaws and definitions.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the sections are in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the sections are in effect the public benefit anticipated as a result of enforcing the sections will be consistency with Senate Bill 623 and clarity in the board's bylaws and definitions.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendments are proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §§2, 7, and 8 is affected by these proposed amendments.

§131.1. Headquarters of the Board.

The [ This board being constituted under the provisions of Senate Bill 74, 45th Legislature, shall be known as the ] Texas [ State ] Board of [ Registration for ] Professional Engineers (board) [ and shall, hereinafter, be referred to as the board. The headquarters of the board ] shall be headquartered in Austin.

§131.2. Organization of the Board.

(a)

The board shall elect from its own membership a chairman, vice chairman, and secretary [ (Texas Civil Statutes, Article 3271a, 7a) ]. These [ The ] officers shall serve from September 1 through August 31 and shall be elected annually at the [ regular July ] board meeting immediately prior to [ each year, and they shall take office the following ] September 1.

(b)

The board as a whole may act as an [ the ] executive committee.

(c)

(No change.)

§131.3. Chairman of the Board.

The chairman shall be the executive officer of the board. When present, the chairman shall preside at all meetings. The chairman shall appoint such committees required by rule and may appoint any additional committees as needed. The chairman shall [ as the board may authorize and ] perform all other duties usually pertaining to the office of chairman and permitted by law , [ . ] and shall have the authority to delegate any of those duties [ The duties of the chairman set out in the Act, 9, may be delegated ] to the executive director. The chairman shall have the authority to review the performance of the executive director and initiate alterations in the executive director's job requirements or employment status. The chairman shall select and determine the agenda for meetings of the full board and may delegate that authority to the executive director.

§131.7. Vacancies in the Board.

If for any reason a vacancy shall occur in the board, the chairman shall prepare [ call a special meeting for the purpose of preparing ] a notice to the governor asking for the appointment of a new member to fill the unexpired term. If the vacancy shall occur in the office of the chairman, the vice chairman shall serve as the board chairman until such time as [ call the meeting. In such case, ] the board shall elect from its own membership a new chairman [ to serve for the balance of the unexpired term as chairman ].

§131.8. All Meetings Open to the Public.

All [ Regular board meetings, called special board meetings, committee meetings, and other ] official meetings of the board and its standing committees shall be held [ open to the public and notice shall be provided ] in accordance with the Texas Open Meetings Act (Texas Civil Statutes, Article 6252-17).

§131.9. Regular Board Meetings.

Regular board meetings shall be held at least four times per fiscal year (September 1 - August 31) [ each calendar quarter ] at any [ such designated ] place, date, and time [ as may be ] determined by the board. The meetings will normally be held in November, February, June, and August. [ the months of January, April, July, and October, but may be held later in the quarter at the discretion of the board. ] Five members of the board shall constitute a quorum. [ In addition to the notice required by the Texas Open Meetings Act, the executive director shall notify the board members of the date, time and place of the meeting not less than 72 hours in advance of the meeting. ]

§131.10. Special Board Meetings.

Special meetings may be called at any time by order of the chairman, or shall be called on the written request of any other three members of the board. [ In addition to the notice required by the Texas Open Meetings Act, the executive director shall notify the board members of the date, time and place of the meeting not less than 72 hours in advance of the time of the meeting, provided, however, that such meetings may be held on shorter notice whenever telephonic consent is obtained from at least five members of the board. ]

§131.12. Order of Business.

(a)

Meetings of the board should include but are not limited to the following items of business [ The order of business at all regular and special meetings of the board will, when practicable, be as follows ]:

(1)-(4)

(No change.)

(5)

reports and recommendations from committees [ personal appearances ];

(6)

communications and public comment ;

(7)

personal interviews and examination of applications [ old business ];

(8)

old [ new ] business;

(9)

new business [ examination of applications ];

(10)

issues from board members for future meetings; [ adjournment. ]

(11) adjournment.

(b)

The chairman or executive director of the board may [ reserves the right to ] delete and/or rearrange the order of business [ specified in subsection (a) of this section ] where required by law or [ deemed by the board ] to be more efficient in the conduct of [ its ] business.

(c)

The executive director shall prepare a meeting [ an advance ] agenda and distribute it [ to be submitted ] to each board member prior to the [ each regular board ] meeting . [ outlining matters to be considered by the board. Additional matter that may arise prior to the meeting, together with additions requested by board members, will constitute the final agenda. Even though members of ] The public may attend board meetings in accordance with the Texas Open Meetings Act, but shall limit any comments and involvement permitted by the chairman to [ it does not entitle members of the public to discuss ] subjects on the agenda or to agenda items designated for general public comment. Time and topical limits may be imposed upon individuals by the chairman or executive director.

§131.14. Seal of the Board.

The seal of the board shall be an embossed circular seal [ 2 1/4 inches in diameter, ] consisting of two concentric circles. The diameter of the inner circle shall be approximately 60% of the size of [ 1 3/8 inches in diameter and shall be ] the outer circle which shall be [ of ] the official seal of the State of Texas. The area between the two circles shall contain the wording "Texas [ State ] Board of [ Registration for ] Professional Engineers." The executive director shall be the custodian of the seal. The seal may be reproduced in other sizes provided the dimensions remain proportionate.

§131.15. Executive Director.

The executive director shall be employed by the board to be the administrator of the board office. The executive director shall be a licensed professional engineer, and shall faithfully execute all directives of the Texas Board of Professional Engineers that are within the scope of the board's legal authority. The executive director shall have sole authority to employ a staff within the budget authorized; perform all supervisory functions including employee evaluations, promotions, disciplinary actions and terminations; and develop and implement all agency policies and procedures concerning the operation of the agency office. The executive director shall be evaluated by the chairman as needed. The executive director serves at the pleasure of the board and employment may be terminated at any time by a negative vote of confidence from a simple majority of the full board.

§131.17. National Council.

The board shall [ may ] affiliate with the National Council of Examiners for Engineering and Surveying. Each board member shall become a member of the council and the [ The ] executive director and other staff members designated by the board shall [ may ] be associate members of [ ex officio the delegate of the board to ] the council.

§131.18. Definitions.

In applying the Texas Engineering Practice Act and the board rules, the following definitions shall prevail unless the word or phrase is defined in the text for a particular usage. Singular [ The singular shall be construed to include the plural and vice versa, ] and [ the ] masculine terms shall be construed to include plural and [ the ] feminine terms [ or neuter ] and vice versa.

(1)

Act-The Texas Engineering Practice Act.

(2)

Administrative Act-The Administrative Procedure [ and Texas Register ] Act.

(3)

Agency or Board-[ The ] Texas [ State ] Board of [ Registration for ] Professional Engineers.

(4)

Applicant-A person making application for an engineering license [ registration ].

(5)

Application-The [ process of submitting the necessary ] forms, information, and fees necessary to obtain a license [ registration ] as a professional engineer [ or engineer-in-training (EIT) certification in accordance with the provisions of the Act, the board rules of practice and procedure, and by law ].

(6)

Certificate of registration- An earlier term replaced by the term "license"; the term is still valid and may be used interchangeably with "license" when necessary. Also a [ A ] document previously issued by the board for the State of Texas granting the holder the right to be licensed to practice engineering in Texas by paying the annual license renewal fee prescribed by the Act.

(7)

Complainant-Any party who has filed a complaint with the board against any party subject to the jurisdiction of the board.

(8)

Contested case-A proceeding, including but not restricted to ratemaking and licensing, in which the legal rights, duties, or privileges of a party are to be determined by an agency after an opportunity for adjudicative hearing.

(9)

Direct supervision- Critical [ The responsibility for the critical ] watching, evaluating, and directing of engineering activities with the authority to review, enforce, and control compliance with all engineering design criteria, specifications, and procedures as the work progresses. Direct supervision will consist of an acceptable combination of: exertion of significant control over the engineering work, regular personal presence, reasonable geographic proximity to the location of the performance of the work, and an acceptable employment relationship with the supervised persons. Engineers providing direct supervision of engineering under the Texas Engineering Practice Act, 18(b), shall be personally present during such work.

(10)

Engineering-The profession in which a knowledge of the mathematical, physical, engineering, and natural sciences gained by education [ study ], experience, and practice is applied with judgment to develop ways to utilize, economically, the materials and forces of nature for the benefit of mankind. [ Examiner or hearing officer-Any person appointed by the executive director or the board to conduct hearings on matters within the board's jurisdiction. ]

(11)

Gross negligence- Any willful or knowing conduct, or pattern of conduct, which includes but is not limited to conduct that demonstrates a disregard or indifference to the rights, health, safety, welfare, and property of the public or clients. Gross negligence may result in financial loss, injury or damage to life or property, but such results need not occur for the establishment of such conduct. [ An act or course of action which demonstrates a conscious disregard or indifference to the rights, safety, or welfare of others and which does or could result in financial loss or in injury or damage to life and property. ]

(12)

Incompetence [ Incompetency ]- An act or omission of malpractice which may include but is not limited to recklessness or excessive errors, omissions or failures in the license holder's record of professional practice; or an act or omission in connection with a disability which includes but is not limited to mental or physical disability or addiction to alcohol or drugs as to endanger health, safety and interest of the public by impairing skill and care in the provision of professional services. [ A general lack of present ability to perform a given duty, or a deficiency of disposition to use one's ability or experience properly. ]

(13)

Intervenor-Any party otherwise not defined.

(14)

License- The legal authority granting [ That part of a certificate of registration which allows ] the holder to actively practice engineering upon the payment of the annual renewal fee. Also, a certificate issued by the board showing such authority.

(15)

License Holder [ Licensee ] - Any [ registrant ] person whose license to practice engineering is current [ and in force and has not been suspended by disciplinary action of the board ].

(16)

Licensure - The granting of an original certificate and license to an individual.

(17)

Misconduct-The [ willful ] violation of any provision of the Texas Engineering Practice Act and board rules. A conviction of a felony or misdemeanor that falls under the provisions of Texas Civil Statutes, Article 6252-13c and Article 6252-13d, will also be misconduct under the Texas Engineering Practice Act.

(18)

Party-Each person or agency named or admitted as a party to a proceeding under the Administrative Procedure [ and Texas Register ] Act.

(19)

Person-Any individual, firm, partnership, corporation, association, governmental subdivision, or public or private organization of any character other than an agency.

(20)

Petitioner-Any party requesting the adoption of a rule by the board.

(21)

Pleading-Written allegations filed by parties concerning their respective claims.

(22)

Professional engineering--Professional service which may include consultation, investigation, evaluation, planning, designing, or direct supervision of construction, in connection with any public or private utilities, structures, buildings, machines, equipment, processes, works, or projects wherein the public welfare, or the safeguarding of life, health, and property is concerned or involved, when such professional service requires the application of engineering principles and the interpretation of engineering data.

(23)

Professional engineering services-Services which must be performed by or under the direct supervision of a licensed [ registered ] engineer and which meet the definition of the practice of engineering as defined in the Texas Engineering Practice Act, 2. A service shall be conclusively considered a professional engineering service if it is delineated in that section; other services requiring a professional engineer by contract, or services where the adequate performance of that service requires an engineering education, training, or experience in the application of special knowledge or judgment of the mathematical, physical or engineering sciences to that service shall also be conclusively considered a professional engineering service. [ require the application of engineering principles, or the interpretation of engineering data. These engineering services may be in connection with any public or private utilities, structures, buildings, machines, equipment, processes, works or projects including: consultation; planning; designing; construction; alteration or repair of real property; or other engineering or incidental services which engineering professionals (and individuals in their employ) may logically or justifiably perform, such as studies, investigations, mapping, testing, evaluations, program management, conceptual designs, plans and specifications, value engineering, soils engineering, drawing reviews, preparation of operating and maintenance manuals, and other related services. ]

(24)

Protestant-Any party opposing an application or petition filed with the board. [ Registrant-Any individual holding a certificate of registration issued by the board that has not been revoked or expired for two or more years. Such registrant will be subject to the administrative and disciplinary powers of the board whether or not the license to practice is current. ]

(25)

Registration- An earlier term replaced by the term "licensing" or "licensure"; the term is still valid and may be used interchangeably with "licensing" or "licensure" when necessary. [ The granting of an original certificate and license by an agency to an individual. ] [ Reregistration-The subsequent licensing by an agency of a former registrant whose expired certificate was not renewable by operation of law. ]

(26)

Resident- An individual physically residing at a Texas address.

(27)

Respondent-Any party against whom any complaint has been filed with the board.

(28)

Responsible charge- An earlier term synonymous with the term "direct supervision"; the term is still valid and may be used interchangeably with "direct supervision" when necessary. [ The direction of engineering work by an engineer to the extent that successful completion of the work is dependent on the decisions made by the engineer without advice or approval by others. ]

(29)

Responsible supervision- An earlier term synonymous with the term "direct supervision"; the term is still valid and may be used interchangeably with "direct supervision" when necessary. [ The supervision of another person's work by a professional engineer to the extent that the engineer assumes the professional responsibility for the work. ]

[ Rule

-Any agency statement of general applicability that implements, interprets, or prescribes law or policy, or describes the procedure or practice requirements of an agency. The term includes the amendment or repeal of a prior rule but does not include statements concerning only the internal management or organization of any agency and not affecting private rights or procedures. ]

§131.19. Requests for Information.

The executive director shall be the official custodian of all board records and shall process and respond to all requests for information in the manner prescribed by law. [ Any written reports, statistics, or other information requested by the board as a whole or any member thereof shall be made available to all members of the board. A copy of any written request and a summary of the results there of shall be made a part of the minutes of the appropriate board meeting. ]

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717190

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Application for License

22 TAC §§131.52-131.55

The Texas Board of Professional Engineers proposes amendments to §§131.52-131.55, concerning application for license.

The amendments will clarify the subdisciplines within electrical engineering and also the requirements for submission of an application for a license.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the sections are in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the sections are in effect the public benefit anticipated as a result of enforcing the sections will be clarity of the subdisciplines within electrical engineering and the requirements for submission of an application for a license.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendments are proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §12 and §13 is affected by these proposed amendments.

§131.52. Applications for a Professional Engineer License.

(a)-(f)

(No change.)

(g)

Applicants shall indicate a primary branch of engineering under which experience has been gained. Applicants seeking permission to take the Principles and Practice of Engineering examination shall indicate a primary branch for which there is an available National Council of Examiners for Engineering and Surveying (NCEES) examination. The available branches and their corresponding alphabetical code are:

(1)-(4)

(No change.)

(5)

(E) electrical, electronic, computer, communications;

(6)-(15)

(No change.)

(h)-(i)

(No change.)

§131.53. Applications - General.

(a)-(c)

(No change.)

(d)

Any transcripts, reference statements, evaluations, experience records or other similar materials submitted to the board in previous applications may be included in a current application provided the applicant requests its use in writing at the time the application is filed and the executive director authorizes its use.

(e)

[ (d) ] Upon completion of all processes, including passage or waiver of examinations, applicants whose applications have been approved shall be issued a license and applicants whose applications have been non-approved shall be denied a license.

§131.54. Applications from Former Texas License Holders.

(a)-(b)

(No change.)

(c)

Any transcripts, reference statements, evaluations, experience records or other similar materials submitted to the board in previous applications may be included in a current application provided the applicant requests its use in writing at the time the application is filed and the executive director authorizes its use. [ The board may waive the submission of materials required in 131.52 of this title (relating to Applications for a Professional Engineer License) provided those materials are already available in the board records. Applicants must submit a written waiver request to the executive director. The board shall process the application and issue a new license and serial number if the application is approved. ]

(d)

(No change.)

§131.55. Certification of Qualifications.

The National Council of Examiners for Engineering and Surveying certifications may be [ certification shall not ] accepted as verification of an original transcript from a U.S. school, or to verify licenses held, or to verify examinations taken. Other uses of the certification may be granted by the executive director on a case-by-case basis [ in lieu of the board's application and other required information ].

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717189

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

References

22 TAC §131.71

The Texas Board of Professional Engineers proposes an amendment to §131.71, concerning references.

The amendment will provide the stipulation that engineers serving as references cannot be compensated.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the section is in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be the stipulation that engineers serving as references cannot be compensated.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendment is proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §13 is affected by the proposed amendment.

§131.71. References.

(a)

(No change.)

(b)

Applicants for a license shall provide at least five references to the board, unless more references are required to meet the requirements of §131.81(a)(3) of this title (relating to Experience Evaluation) or §131.101(g) of this title (relating to Engineering Examinations Required for a License to Practice as a Professional Engineer). At least three of these references shall be currently licensed professional engineers who have personal knowledge of the applicant's engineering experience. References on file with the board from previous applications may be used with the approval of the executive director. Professional engineers who have not worked with an applicant may review and judge the applicant's experience and may serve as a licensed engineer reference; such review shall be noted on the reference statement. Professional engineers serving as references shall not be compensated.

(c)-(e)

(No change.)

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717188

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Engineering Experience

22 TAC §131.81

The Texas Board of Professional Engineers proposes an amendment to §131.81, concerning engineering experience.

The amendment will provide clarification of the documents that must be submitted for applicants requesting a waiver from one or both examinations.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the section is in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be the clarification of documents that must submitted for applicants requesting a waiver from one or both examinations.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendment is proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineerswith the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §12 and §13 is affected by the proposed amendment.

§131.81. Experience Evaluation.

(a)

Applicants shall submit a supplementary experience record to the board as a part of the application. The supplementary experience record is a written narrative documenting all of the applicant's engineering experience acquired after completion of the first degree used to meet the requirements of §131.91 of this title (relating to Educational Requirements for Applicants).

(1)-(2)

(No change.)

(3)

References must be provided to verify enough of the supplementary experience record to cover at least the minimum amount of time needed by the applicant for issuance of a license. Applicants applying under the Texas Engineering Practice Act (Act), §12(a)(1) shall provide references for at least four years of engineering experience; applicants applying under the Act, §12(a)(2) shall provide references for at least eight years of engineering experience. Applicants seeking a waiver from the Fundamentals of Engineering examination or the Principles and Practice of Engineering [ any ] examination requirement shall provide supplementary experience records and references for an additional eight years of experience beyond that listed in this subsection and shall conform to §131.71(b) of this title (relating to References) and §131.101(g) of this title (relating to Engineering Examinations Required for a License to Practice as a Professional Engineer).

(4)

(No change.)

(b)-(c)

(No change.)

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717187

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Education

22 TAC §131.91

The Texas Board of Professional Engineers proposes an amendment to §131.91, concerning education.

The amendment will provide clarification of the educational requirements necessary for licensure.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the section is in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be clarification of the educational requirements necessary for licensure.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendment is proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §12(a)(1) and (2) is affected by the proposed amendment.

§131.91. Educational Requirements for Applicants.

Applicants for a license shall have earned one of the following degrees or degree combinations listed in this section:

(1)

Accredited degrees, under the Texas Engineering Practice Act (the Act), §12(a)(1), as described in subparagraphs (A) and (B) of this paragraph:

(A)

(No change.)

(B)

a bachelor's degree in one of the mathematical, physical, or engineering sciences, plus a graduate degree in engineering, provided that:

(i)

the graduate degree is obtained from a college having an EAC/ABET accredited bachelor's degree in the same discipline; and [ or ]

(ii)

(No change.)

(2)

(No change.)

(3)

Other degree programs submitted to the board by the conferring institutions and approved by the board as meeting the requirements of paragraphs (1) or (2) of this section.

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717186

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Examinations

22 TAC §§131.101-131.104

The Texas Board of Professional Engineers proposes amendments to §§131.101-131.104, concerning examinations.

The amendments will provide clarification of the examination waiver requirements for applicants with Ph.D. degrees, clear and concise guidelines pertaining to examinations for record purposes, and the eligibility requirements for certification as an engineer-in-training.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the sections are in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the sections are in effect the public benefit anticipated as a result of enforcing the sections will be clarification of the examination waiver requirements for applicants with Ph.D. degrees, clear and concise guidelines pertaining to examinations for record purposes, and the eligibility requirements for certification as an engineer-in-training.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendments are proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §12 and §12.1 is affected by these proposed amendments.

§131.101. Engineering Examinations Required for a License to Practice as a Professional Engineer.

(a)-(e)

(No change.)

(f)

It is the intent of the board to utilize the examination as an integral part of the licensing process; all applicants are expected to have passed the examinations or to offer sufficient evidence of their qualifications in the absence of passage of the examinations. The board may waive one or both of the experience and knowledge examinations for applicants who do not pose a threat to the public health, safety, or welfare; request a waiver in writing at the time the application is filed; and meet one of the following requirements listed in paragraphs (1)-(3) of this subsection:

(1)-(2)

(No change.)

(3)

persons who have:

(A)

a Ph.D. degree in engineering from a recognized college or university that offers an EAC/ABET-approved undergraduate or master's degree program in a related branch of engineering or a Ph.D. degree in engineering or other related field of science or mathematics that is individually assessed and approved by the board during the evaluation process ; and

(B)

taught in an EAC/ABET program for at least six years, or have at least six years of experience consisting of an acceptable combination of other creditable engineering experience or EAC/ABET teaching experience. [ applied under the Act, 12(a)(1); and ]

[ (C)

taught in an EAC/ABET program for at least six years.]

(g)-(i)

(No change.)

§131.102. Examination for Record Purposes.

The board may administer examinations for record purposes. The Principles and Practice of Engineering examination may not be taken for record purposes unless an individual is licensed as a professional engineer or has been given permission by the board to take the examination.

[ (a)

The board may administer examinations for record purposes as a convenience to the public. The examinations will only be administered when, in the opinion of the board, sufficient funds, adequate space, and suitable proctors are available.

[ (b)

Examination sites, persons eligible to take the examinations, and any other criteria under which the examinations will be given will be determined for each examination date and may vary from one examination date to another.

[ (c)

The board will determine the conditions for giving each examination as soon as the available funds, examination sites, and acceptable proctors are available. In event the requirements in this section cannot be established 120 days prior to the examination date, the examination will not be given.

[ (d)

The Principles and Practice of Engineering examination may not be taken for record purposes unless an individual is registered as a professional engineer or has been given permission by the board to take the examination for registration purposes.]

§131.103. Engineer-in-Training.

Individuals who meet the requirements of the Texas Engineering Practice Act, 12.1, including successful passage of [ have an EAC/ABET-accredited engineering degree or a four-year degree in engineering or engineer-related science approved by the board and have successfully passed ] the Fundamentals of Engineering examination are eligible to apply for engineer-in-training certification.

§131.104. Engineer-in-Training Certificates.

A certificate as an engineer-in-training expires eight years from the date of issuance [ appearing thereon ]. This certification does not entitle an individual to practice as a professional engineer. The fee for engineer-in-training certification will be established by the board. To become enrolled as an engineer-in-training, a certificate may be issued to an eligible individual who requests [ is eligible, as described in 131.103 of this title (relating to Engineer-in-Training), shall apply to the board for ] the certificate and pays [ pay ] the established fee. Although the certificate has an expiration date, the records of the board will indicate that an individual has passed the Fundamentals of Engineering examination and these records will be maintained in the file indefinitely and will be made available as requested by the individual or another licensing jurisdiction. The certificate may be renewed [ one time at the request of the individual provided the request is accompanied by an explanation for the reason of the renewal and such request is approved by the board ].

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717185

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Board Review of Application

22 TAC §131.113

The Texas Board of Professional Engineers proposes an amendment to §131.113, concerning board review of application.

The amendment will provide clarification of the conditions under which the board will not reconsider applications for licensure.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the section is in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be clarification of the conditions under which the board will not reconsider applications for licensure.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendment is proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §12(a)(1) and (2) is affected by the proposed amendment.

§131.113.Reconsideration of Non-Approved Applications or Examination Waivers.

(a)

Reconsideration is not available to persons whose application is non-approved because of the failure to pass the Principles and Practice of Engineering examination, the failure to possess an acceptable education, the failure to claim the required creditable experience, or the failure of the applicant who is not licensed in another jurisdiction to establish Texas residency.

(b)-(c)

(No change.)

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717184

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Licensing

22 TAC §131.131

The Texas Board of Professional Engineers proposes an amendment to §131.131, concerning licensing.

The amendment will provide consistency with the terminology contained in Senate Bill 623 and will clarify language pertaining to regular and temporary licenses.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the section is in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be consistency with the terminology contained in Senate Bill 623 and clarification in the language pertaining to regular and temporary licenses.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendment is proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §15 is affected by the proposed amendment.

§131.131.Regular and Temporary Licenses.

Unless requested by the applicant or license holder, all [ All ] licenses issued by the board shall be considered regular licenses. Regular licenses [ and ] are fully renewable annually until such time as the board takes specific action to prevent [ such, a ] renewal or provision of the Texas Engineering Practice Act prevents renewal. If [ such, or ] the license holder requests that the license be temporary[ . When the license holder so requests ], the holder's regular license shall be converted to temporary status and may only be renewed twice. A temporary license holder shall be subject to all other rules and legal requirements to which a holder of a regular license is subject. The executive director shall [ also ] be authorized to convert a regular license to a temporary license at the time the regular license is issued provided a request for such has been received.

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717183

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Registration

22 TAC §§131.134-131.136

The Texas Board of Professional Engineers proposes amendments to §§131.134-131.136, concerning registration.

The amendments will provide consistency with the terminology contained in Senate Bill 623 and will clarify language pertaining to regular and temporary licenses.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the sections are in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the sections are in effect the public benefit anticipated as a result of enforcing the sections will be consistency with the terminology contained in Senate Bill 623 and clarification in the language pertaining to regular and temporary licenses.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendments are proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §15 is affected by the proposed amendments.

§131.134.Expirations and Renewals.

The [ certificate of registration is a ] license to practice engineering under the provisions of the Texas Engineering Practice Act (the Act) [ and ] must be renewed by the license holder [ registrant ] annually; otherwise, the [ such ] license shall become invalid until the date the board receives the license holder's [ registrant's ] renewal and penalty fee. Each license holder [ registrant ] shall advise the board in writing of each change of mailing address as it occurs. The board will mail a renewal notice to the last recorded address of each license holder [ registrant ] in compliance with the Act, §16(a). It is the sole responsibility of the license holder [ registrant ] to pay the required renewal fee together with any applicable penalty at the time of payment, regardless of whether the renewal notice is received. Stipulations with reference to expirations and renewals of licenses [ certificates of registration ] are set out in the Act, §16 and §16.1. The following will apply to renewals.

(1)-(5)

(No change.)

(6)

A license which has been expired for two years may not be renewed, but the former license holder [ registrant ] may apply for a new license [ certificate of registration ] as provided in the Act and applicable board rules.

(7)

In strict accordance with the provisions of the Texas Education Code, §57.491, pertaining to the loan default proceedings of the Texas Guaranteed Student Loan Corporation (TGSLC), if a license holder's [ licensee's ] name has been provided by the TGSLC as being in default of a loan, the board shall not renew the license of the license holder [ licensee ] on the second renewal date following such notification, unless the TGSLC certifies that the individual has entered into a repayment agreement with TGSLC, or is not in default on a loan. Such license holder [ licensee ] shall be provided an opportunity for a hearing, similar to that provided by §131.167 [ §131.137 ] of this title (relating to Disciplinary Actions), before any action concerning the nonrenewal of a license is taken under this paragraph. A defaulted loan shall not bar the board's issuance of an initial license if the applicant is otherwise qualified for licensure; however, the board shall not renew said license unless the TGSLC certifies the individual has satisfied the requirements of the Texas Education Code, §57.491.

§131.135.Replacement Certificates.

Only one license [ certificate of registration ] will be issued to each license holder [ registrant ]. A new license [ certificate of registration ] to replace any license [ certificate ] lost, destroyed, or mutilated, may be issued, subject to the rules of the board, on payment of the established fee[ , unless otherwise provided by law ] and verification of the status of the original license. A license holder [ registrant ] requesting a replacement license [ certificate ] under this section will, if possible, surrender to the board any remaining portions of his original license [ certificate ] and shall file with his request a sworn affidavit setting out the reasons for his request so that the board records will reflect the reason for issuance of a new license [ certificate ]. Replacement licenses [ certificates ] will reflect the assigned serial number of the license holder [ registrant ].

§131.136.New Design Certificates.

In the event the board [ by its own initiative or the requirements of law ] redesigns the license [ certificate of registration ] for professional engineers, a license holder [ registrant holding a valid certificate of the design existing prior to the date the new design is approved ] may obtain a license [ certificate ] of the new design upon payment of a fee to be established by the board. [ The registrant will not be required to surrender his original certificate to obtain a certificate of the new design. ]

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717182

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Professional Conduct and Ethics

22 TAC §131.151, §131.152

The Texas Board of Professional Engineers proposes amendments to §131.151 and §131.152, concerning professional conduct and ethics.

The amendments will provide clarification of what constitutes misconduct by an engineer and also conflicts of interest.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the sections are in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the sections are in effect the public benefit anticipated as a result of enforcing the sections will be clarification of what constitutes misconduct by an engineer and also conflicts of interest.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendments are proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §8 is affected by the proposed amendments.

§131.151.Engineers Shall Protect the Public.

(a)

(No change.)

(b)

Engineers shall not perform any engineering function which, when measured by generally accepted engineering standards or procedures, is reasonably likely to result in the endangerment of lives, health, safety, property, or welfare of the public. Any act or conduct which constitutes incompetence or gross negligence, or a criminal violation of law, constitutes misconduct and shall be censurable by the board.

(c)-(d)

(No change.)

§131.152.Engineers Shall Be Objective and Truthful.

(a)-(c)

(No change.)

(d)

A conflict of interest exists when an engineer accepts [ An engineer commits misconduct by accepting ] employment when a reasonable probability exists that the engineer's own financial, business, property, or personal interests may affect any professional judgment, decisions, or practices exercised on behalf of the client or employer. An engineer may accept such an employment only if all parties involved in the potential conflict of interest are fully informed in writing and the client or employer confirms the knowledge of the potential conflict in writing. An engineer in a conflict of interest employment shall maintain the interests of the client and other parties as provided by §131.154 of this title (relating to Engineers Shall Maintain Confidentiality of Clients) and other rules and statutes.

(e)

(No change.)

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717181

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Compliance and Enforcement

22 TAC §§131.162, 131.163, 131.166, 131.167

The Texas Board of Professional Engineers proposes amendments to §§131.162, 131.163, 131.166, and 131.167, concerning compliance and enforcement.

The amendments will clarify language pertaining to a firm's compliance with the TEPA, an engineer's compliance with the Act, and will provide correct examples of engineers' seals consistent with Senate Bill 623. The amendment to §131.167 provides clarification and corrects cross references to statute and rules.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the sections are in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the sections are in effect the public benefit anticipated as a result of enforcing the sections will be clarified language pertaining to a firm's compliance with the TEPA, an engineer's compliance with the Act and correct examples of engineers' seals consistent with Senate Bill 623.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The amendments are proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §§15, 17, 18, 22, 22C, and 23 is affected by the proposed amendments.

§131.162.Firm Compliance.

The board shall not consider any firm, partnership, association, corporation, or other business entity as being in compliance with the Texas Engineering Practice Act (Act), §17 and §18, unless a licensed professional engineer is a regular full-time employee of the firm, partnership, association, corporation or other business entity. The engineer shall provide to the board evidence of such employment upon its request. This section does not prohibit a licensed professional engineer from performing consulting engineering services on a part-time basis as an individual. An engineering firm shall provide that at least one full-time employee engineer directly supervises all engineering work performed in branch, remote, or project offices. [ Although this rule does not prohibit a licensed professional engineer from performing engineering services on a part-time basis, such part-time work for a firm does not allow that firm to offer engineering services or otherwise act in a manner not in conformance with the Act. Branch or remote offices shall have a full-time employee engineer directly supervising all engineering performed in that office. ]

§131.163.Engineer Compliance.

Any engineer who directly or indirectly enters into any contract, arrangement, plan, or scheme with any person, firm, partnership, association, or corporation or other business entity which in any manner results in a violation of §131.162 of this title (relating to Firm Compliance) shall be subject to legal and disciplinary actions available to the board. Engineers shall perform or directly supervise the engineering work of any subordinates as provided by §131.18 of this title (relating to Definitions). Under no circumstances shall engineers work in a part-time arrangement with a firm not otherwise in full compliance with §131.162 of this title in a manner that could enable such firm to offer or perform professional engineering services. [ Engineers who operate a part-time engineering business shall actively supervise the engineering work of any subordinates as that work occurs. ]

§131.166.Engineers' Seals.

(a)

The purpose of the engineer's seal is to assure the user of the engineering product that the work has been performed by the professional engineer named and to delineate the scope of the engineer's work. The engineer shall utilize the designation "P.E." or the titles set forth in the Texas Engineering Practice Act (Act), §1.3. Physical seals of two different sizes will be acceptable: a pocket seal (the size commercially designated as 1-5/8-inch seal) or desk seal (commercially designated as a two-inch seal) to be of the design shown in this subsection. Computer-generated seals may be of a reduced size provided that the engineer's name and number are clearly legible.

Figure: 22 TAC §131.166(a)

(b)-(n)

(No change.)

§131.167.Disciplinary Actions.

(a)-(g)

(No change.)

(h)

The following is a table of suggested sanctions the board may levy against license holders for specific infractions of the Act or rules; the minimum administrative penalty will be $100 per violation:

Figure: 22 TAC §131.167(h)

(i)

(No change.)

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717180

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Compliance and Enforcement

22 TAC §131.168

The Texas Board of Professional Engineers proposes new §131.168, concerning compliance and enforcement.

The new section will establish the investigative process and resulting action the board will follow to ensure due process when non-license holders or firms are found to have violated the Texas Engineering Practice Act, §8 and §22C.

John R. Speed, P.E., executive director, Texas Board of Professional Engineers, has determined that for the first five-year period the section is in effect there will no effect for state or local government.

Mr. Speed also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be the establishment of the investigative process and resulting action the board will follow to ensure due process when non-license holders or firms are found to have violated the Texas Engineering Practice Act, §8 and §22C.

Comments on the proposal may be submitted to John R. Speed, P.E., Executive Director, Texas Board of Professional Engineers, P.O. Drawer 18329, Austin, Texas 78760-8329.

The new section is proposed under Texas Civil Statutes, Article 3271, §8(a), which provide the Texas Board of Professional Engineers with the authority to promulgate rules in accordance with Senate Bill 623.

Texas Civil Statutes, Article 3271a, §8 and §22C is affected by the proposed new section.

§131.168.Actions Against Non-License Holders.

Under the authority and provisions of the Texas Engineering Practice Act, §8 and §22C, the board shall investigate complaints and take action against non-license holders or firms who are found to be censurable for a violation of the law. The following investigative process and resulting action listed in paragraphs (1)-(3) of this section will be followed by the board to ensure affected individuals and/or firms are afforded due process of law.

(1)

Upon receipt of a formal or staff initiated complaint, the information will be evaluated to determine if the evidence provides sufficient probable cause that a violation may have occurred.

(2)

If sufficient probable cause does not exist, an investigation will not be initiated.

(3)

If sufficient probable cause is found, then an investigation will be initiated by the board staff to determine if a violation of law has occurred. The board's investigative process will be as follows.

(A)

The individual or firm will be advised of the complaint and the specific section of the Act which appears to be violated. If the initial evidence is sufficiently strong, the executive director may offer the respondent a consent order that, if accepted, will be presented to the board for acceptance or rejection. The consent order shall include an administrative penalty not inconsistent with §131.167(i) of this title (relating to Disciplinary Actions) and a compliance requirement. The respondent shall be fully informed of the range of penalties allowed under criminal, civil and administrative proceedings.

(B)

The respondent will be afforded the opportunity to respond to the complaint to show that the actions which precipitated the complaint are not in violation of the Act, or to accept the consent order.

(C)

If, after evaluation of the respondent's response a violation appears evident, the respondent will be afforded the opportunity to resolve the allegations informally in the same manner prescribed for license holders in §131.167(e) of this title (relating to Disciplinary Actions).

(D)

Any board action under this paragraph which is not informally disposed by agreed or consent order, will be considered a contested case and will be handled in accordance with applicable law and board rules.

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717179

John R. Speed, P.E.

Executive Director

Texas Board of Professional Engineers

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 440-7723

Part XV. Texas State Board of Pharmacy

Chapter 291. Pharmacies

Nuclear Pharmacy (Class B)

22 TAC §§291.51-291.54

(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Texas Department of Pharmacy or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas State Board of of Pharmacy proposes repeal of §§291.51 - 291.54 and simultaneously proposes new §§291.51 - 291.55, concerning purpose, definitions, personnel, operational standards, and records in a Nuclear Pharmacy (Class B).

These rules, if adopted, will replace the current Nuclear Pharmacy (Class B) rules and specify the purpose, definitions, personnel, operational standards, and records for operation of a Nuclear Pharmacy (Class B). The rule are the result of recommendations to the Board of Pharmacy by a Task Force on Nuclear Pharmacy. This Task Force was established by the Board to review the current Class B (Nuclear) Pharmacy rules to identify and make recommendations for areas that need to be updated; make recommendations to incorporate appropriate requirements for the compounding of sterile pharmaceuticals; and make recommendations concerning areas of regulatory overlap between agencies, such as the Texas Department of Health - Bureau of Radiation Control and the Texas State Board of Pharmacy. The rules propose to update the rules to include appropriate requirements for the preparation of sterile radiopharmaceuticals; clarify the duties of a pharmacist and the responsibilities of the pharmacist-in-charge; specify training requirements for pharmacists and pharmacy technicians; establish education, training, and evaluation requirements for pharmacy personnel who compound or directly supervise the compounding of sterile radiopharmaceuticals; establish and/or update the requirements for licensing, environment, prescription dispensing and delivery, pharmaceutical care services, equipment, radiopharmaceutical and/or radioactive materials, loading bulk drugs into automated compounding devices, and sterile radiopharmaceuticals; and bring many of the recordkeeping provisions for a Community (Class A) Pharmacy Compounding Sterile Pharmaceuticals to the Nuclear Pharmacy (Class B) practice setting, such as permitting electronic radioactive prescription drug orders, radioactive prescription drug orders for certain drugs from practitioners not licensed in the state of Texas, contents of the various radioactive prescription drug orders, and other records required to be maintained by the pharmacy.

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

Ms. Dodson also 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 operation of a Class B (Nuclear Pharmacy.

An estimated $50.00 per year to meet the additional quality control and pharmacy technician training requirements. A one time $100.00 - $500.00 cost per pharmacist for sterile products training if not previously trained. The cost depends on whether the training course is an on-the-job program or an off-site program accredited by an ACPE approved provider including travel and lodging.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Compliance, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942.

The repeal is proposed under the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes): Section 4 which specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; Section 16(a) which gives the Board the authority to adopt rules for the proper administration and enforcement of the Act; Section 17(b)(3) which gives the Board the authority to specify minimum standards for drug storage, maintenance of prescription drug records and procedures for the delivery, dispensing in a suitable container appropriately labeled, providing of prescription drugs or devices within the practice of pharmacy.

The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.

§291.51. Definitions.

§291.52. Personnel.

§291.53. Operational Standards.

§291.54. Records.

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717052

Gay Dodson, R.Ph

Executive Director

Texas State Board of Pharmacy

Proposed date of adoption: February 10, 1998

For further information, please call: (512) 305-8026

22 TAC §§291.51-291.55

The new rule is proposed under the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes): Section 4 which specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; Section 16(a) which gives the Board the authority to adopt rules for the proper administration and enforcement of the Act; Section 17(b)(3) which gives the Board the authority to specify minimum standards for drug storage, maintenance of prescription drug records and procedures for the delivery, dispensing in a suitable container appropriately labeled, providing of prescription drugs or devices within the practice of pharmacy.

The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.

§291.51. Purpose.

The purpose of these sections is to provide standards for the preparation, labeling, and distribution of compounded radiopharmaceuticals by licensed nuclear pharmacies, pursuant to a radioactive prescription drug order.

§291.52. Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set forth in the Act, § 5.

Act

- The Texas Pharmacy Act, Texas Civil Statutes, Article 4542a-1, as amended.

Accurately as prescribed

-Dispensing, delivering, and/or distributing a prescription drug order or radioactive prescription drug order:

(A)

to the correct patient (or agent of the patient) for whom the drug or device was prescribed;

(B)

with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and

(C)

with correct labeling (including directions for use) as ordered by the practitioner. Provided, however, that nothing herein shall prohibit pharmacist substitution if substitution is conducted in strict accordance with applicable laws and rules, including §40 of the Texas Pharmacy Act.

Administer

-The direct application of a prescription drug and/or radiopharmaceutical, by injection, inhalation, ingestion, or any other means to the body of a patient by:

(A)

a practitioner, an authorized agent under his supervision, or other person authorized by law; or

(B)

the patient at the direction of a practitioner.

Airborne particulate cleanliness class

-The level of cleanliness specified by the maximum allowable number of particles per cubic foot of air as specified in Federal Standard 209E, et seq. For example:

(A)

Class 100 is an atmospheric environment which contains less than 100 particles no greater than 0.5 microns in diameter per cubic foot of air;

(B)

Class 10,000 is an atmospheric environment which contains less than 10,000 particles no greater than 0.5 microns in diameter per cubic foot of air; and

(C)

Class 100,000 is an atmospheric environment which contains less than 100,000 particles no greater than 0.5 microns in diameter per cubic foot of air.

Authentication of product history

-Identifying the purchasing source, the intermediate handling, and the ultimate disposition of any component of a radioactive drug. Authorized nuclear pharmacist A pharmacist who has completed the specialized training requirements specified by these rules for the preparation and distribution of radiopharmaceuticals. Authorized user Any individual named on a Texas radioactive material license, issued by the Texas Department of Health, Bureau of Radiation Control. Automated compounding or drug dispensing device An automated device that compounds, measures, counts, packages, and/or labels a specified quantity of dosage units for a designated drug product

Biological Safety Cabinet

-Containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

Board

-The Texas State Board of Pharmacy.

Class B pharmacy license or nuclear pharmacy license

-A license issued to a pharmacy dispensing or providing radioactive drugs or devices for administration to an ultimate user.

Clean room

-A room in which the concentration of airborne particles is controlled and there are one or more clean zones according to Federal Standard 209E, et. Seq.

Clean zone

-A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class.

Controlled area

-A controlled area is the area designated for preparing sterile radiopharmaceuticals.

Controlled substance

-A drug, immediate precursor, or other substance listed in Schedules I-V or Penalty Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug, immediate precursor, or other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).

Dangerous drug

-A device, drug, or radioactive drug that is unsafe for self medication and that is not included in Penalty Groups I through IV of Chapter 481 (Texas Controlled Substances Act). The term includes a device, drug, or radiopharmaceutical that bears or is required to bear the legend:

(A)

"Caution: Federal Law Prohibits Dispensing Without a Prescription;" or

(B)

"Caution: Federal Law Restricts This Drug To Be Used By or on the Order of a Licensed Veterinarian"

Data communication device

-An electronic device that receives electronic information from one source and transmits or routes it to another (e.g., bridge, router, switch, or gateway).

Deliver or delivery

-The actual, constructive, or attempted transfer of a prescription drug or device, radiopharmaceutical, or controlled substance from one person to another, whether or not for a consideration.

Designated agent

-

(A)

a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner, and for whom the practitioner assumes legal responsibility, who communicates radioactive prescription drug orders to a pharmacist; or

(B)

a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom the practitioner communicates a radioactive prescription drug order.

Device

-An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articles, including any component parts or accessory that is required under federal or state law to be ordered or prescribed by a practitioner.

Diagnostic prescription drug order

-A radioactive prescription drug order issued for a diagnostic purpose.

Dispense

-Preparing, packaging, compounding, or labeling for delivery a prescription drug or device, or a radiopharmaceutical in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.

Dispensing pharmacist

-The authorized nuclear pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.

Distribute

-The delivering of a prescription drug or device, or a radiopharmaceutical other than by administering or dispensing.

Electronic radioactive prescription drug order

-A radioactive prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).

Internal test assessment

-Validation of tests for quality control necessary to insure the integrity of the test.

Nuclear pharmacy technique

-The mechanical ability required to perform the nonjudgmental, technical aspects of preparing and dispensing radiopharmaceuticals.

Original prescription

-The:

(A)

original written radioactive prescription drug orders, or

(B)

original verbal or electronic radioactive prescription drug orders reduced to writing either manually or electronically by the pharmacist.

Pharmacist-in-charge

-The pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy.

Pharmacy technician/Supportive Personnel

-Those individuals utilized in pharmacies whose responsibility it shall be to provide technical services that do not require professional judgment concerned with the preparation and distribution of drugs or radiopharmaceuticals under the direct supervision of and responsible to a pharmacist.

Process validation

-Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

Radiopharmaceutical

-A prescription drug or device that exhibits spontaneous disintegration of unstable nuclei with the emission of a nuclear particle(s) or photon(s), including any nonradioactive reagent kit or nuclide generator that is intended to be used in preparation of any such substance.

Radioactive drug quality control

-The set of testing activities used to determine that the ingredients, components (e.g., containers), and final radiopharmaceutical prepared meets predetermined requirements with respect to identity, purity, non-pyrogenicity, and sterility and the interpretation of the resulting data in order to determine the feasibility for use in humans and animals including internal test assessment, authentication of product history, and the keeping of mandatory records.

Radioactive drug service

-The act of distributing radiopharmaceuticals; the participation in radiopharmaceutical selection and the performance of radiopharmaceutical drug reviews.

Radioactive prescription drug order

-An order from a practitioner or a practitioner's designated agent for a radiopharmaceutical to be dispensed.

Sterile radiopharmaceutical

-A dosage form of a radiopharmaceutical free from living micro-organisms.

Therapeutic prescription drug order

-A radioactive prescription drug order issued for a specific patient for a therapeutic purpose.

Ultimate user

-A person who has obtained and possesses a prescription drug or radiopharmaceutical for his or her own use or for the use of a member of his or her household.

§291.53. Personnel.

(a)

Pharmacists-in-Charge.

(1)

General.

(A)

Every nuclear pharmacy shall have an authorized nuclear pharmacist designated on the nuclear pharmacy license as the pharmacist-in-charge who shall be responsible for a nuclear pharmacy's compliance with laws and regulations, both state and federal, pertaining to the practice of nuclear pharmacy.

(B)

The nuclear pharmacy pharmacist-in-charge shall see that directives from the board are communicated to the owner(s), management, other pharmacists, and interns of the nuclear pharmacy.

(C)

An authorized nuclear pharmacist may be pharmacist-in-charge for no more than one nuclear pharmacy at any one given time.

(2)

Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following:

(A)

ensuring that radiopharmaceuticals are dispensed and delivered safely and accurately as prescribed;

(B)

developing a system to assure that all pharmacy personnel responsible for compounding and/or supervising the compounding of radiopharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation;

(C)

establishing policies for procurement of drugs and devices and storage of all pharmaceutical materials including radiopharmaceuticals, components used in the compounding of radiopharmaceuticals, and drug delivery devices;

(D)

developing a system for the disposal and distribution of drugs from the Class B pharmacy

(E)

developing a system for the compounding, sterility assurance, and quality control of sterile radiopharmaceuticals;

(F)

maintaining records of all transactions of the Class B pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials including radiopharmaceuticals, required by applicable state and federal laws and rules;

(G)

developing a system to assure the maintenance of effective controls against the theft or diversion of prescription drugs, and records for such drugs;

(H)

assuring that the pharmacy has a system to dispose of radioactive and cytotoxic waste in a manner so as not to endanger the public health; and

(I)

legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy.

(b)

Authorized nuclear pharmacists.

(1)

General.

(A)

The pharmacist-in-charge shall be assisted by a sufficient number of additional authorized nuclear pharmacists as may be required to operate the pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.

(B)

All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the direct supervision of an authorized nuclear pharmacist. General qualifications for an authorized nuclear pharmacist are the following. A pharmacist shall:

(i)

meet minimal standards of training and experience in the handling of radioactive materials in accordance with the requirements of the Texas Regulations for Control of Radiation of the Bureau of Radiation Control, Texas Department of Health;

(ii)

be a pharmacist licensed by the board to practice pharmacy in Texas; and

(iii)

submit to the board either:

(I)

written certification that he or she has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties; or

(II)

written certification signed by preceptor authorized nuclear pharmacist that he or she has achieved a level of competency sufficient to independently operate as an authorized nuclear pharmacist and has satisfactorily completed 700 hours in a structured educational program consisting of both:

(-a-)

200 hours of didactic training in a program accepted by the Bureau of Radiation Control, Texas Department of Health in the following areas:

(-1-)

radiation physics and instrumentation;

(-2-)

radiation protection;

(-3-)

mathematics pertaining to the use and measurement of radioactivity;

(-4-)

radiation biology; and

(-5-)

chemistry of radioactive material for medical use; and

(-b-)

500 hours of supervised experience in a nuclear pharmacy involving the following:

(-1-)

shipping, receiving, and performing related radiation surveys;

(-2-)

using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

(-3-)

calculating, assaying, and safely preparing dosages for patients or human research subjects;

(-4-)

using administrative controls to avoid mistakes in the administration of radioactive material; and

(-5-)

using procedures to prevent or minimize contamination and using proper decontamination procedures.

(C)

The board may issue a letter of notification that the evidence submitted by the pharmacist meets the requirements of subparagraph (B)(i)-(iii) of this paragraph and has been accepted by the board and that, based thereon, the pharmacist is recognized as an authorized nuclear pharmacist.

(D)

Authorized nuclear pharmacists are solely responsible for the direct supervision of pharmacy technicians and for delegating nuclear pharmacy techniques and additional duties, other than those listed in paragraph (2) of this subsection, to pharmacy technicians. Each authorized nuclear pharmacist:

(i)

shall verify the accuracy of all acts, tasks, or functions performed by pharmacy technicians; and

(ii)

shall be responsible for any delegated act performed by pharmacy technicians under his or her supervision.

(E)

All authorized nuclear pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.

(F)

The dispensing pharmacist shall ensure that the drug is dispensed and delivered safely and accurately as prescribed.

(2)

Duties. Duties which may only be performed by an authorized nuclear pharmacist are as follows:

(A)

receiving verbal therapeutic prescription drug orders and reducing these orders to writing, either manually or electronically;

(B)

receiving verbal, diagnostic prescription drug orders in instances where patient specificity is required for patient safety (e.g., radiolabeled blood products, radiolabeled antibiodies) and reducing these orders to writing, either manually or electronically;

(C)

interpreting and evaluating radioactive prescription drug orders;

(D)

selection of drug products; and

(E)

performing the final check of the dispensed prescription before delivery to the patient to ensure that the radioactive prescription drug order has been dispensed accurately as prescribed.

(c)

Pharmacy Technicians

(1)

General.

(A)

Pharmacy technicians in a nuclear pharmacy shall possess sufficient education and training to qualify such individual to perform assigned tasks including nuclear pharmacy techniques.

(B)

The pharmacist-in-charge shall document the training and certify the competency of pharmacy technicians completing the training. A written record of initial and in-service training of pharmacy technicians shall be maintained and contain the following information:

(i)

name of the person receiving the training;

(ii)

date(s) of the training;

(iii)

general description of the topics covered;

(iv)

a statement or statements that certifies that the pharmacy technician is competent to perform the duties assigned;

(v)

name of the person supervising the training; and

(vi)

signature of the pharmacy technician and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training of supportive personnel.

(2)

Duties. Pharmacy technicians may perform any nuclear pharmacy technique delegated by an authorized nuclear pharmacist which is associated with the preparation and distribution of radiopharmaceuticals other than those duties listed in subsection (b)(2) of this section provided:

(A)

an authorized nuclear pharmacist conducts in-process and final checks; and

(B)

pharmacy technicians are under the direct supervision of and responsible to an authorized nuclear pharmacist.

(3)

Ratio of authorized nuclear pharmacists to pharmacy technicians. The ratio of authorized nuclear pharmacists to pharmacy technicians shall be no greater than 1:2, provided that only one pharmacy technician may be engaged in the compounding of a sterile radiopharmaceutical.

(d)

Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile radiopharmaceuticals.

(1)

General.

(A)

All pharmacy personnel preparing sterile radiopharmaceuticals shall receive didactic and experiential training and competency evaluation through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge and described in the policy and procedure or training manual. Such training shall include instruction and experience in the following areas:

(i)

aseptic technique;

(ii)

critical area contamination factors;

(iii)

environmental monitoring;

(iv)

facilities;

(v)

equipment and supplies;

(vi)

sterile pharmaceutical and radiopharmaceutical calculations and terminology;

(vii)

sterile radiopharmaceutical compounding documentation;

(viii)

quality assurance procedures;

(ix)

aseptic preparation procedures including proper gowning and gloving technique;

(x)

handling of hazardous drugs, if applicable; and

(xi)

general conduct in the controlled area.

(B)

The aseptic technique of each person compounding or responsible for the direct supervision of personnel compounding sterile radiopharmaceuticals shall be observed, evaluated, and documented as satisfactory through written or practical tests and process validation.

(C)

Although process validation may be incorporated into the experiential portion of a training program, process validation must be conducted at each pharmacy where an individual compounds sterile radiopharmaceuticals. No product intended for patient use shall be compounded by an individual until the on-site process validation test indicates that the individual can competently perform aseptic procedures, except that an authorized nuclear pharmacist may temporarily compound sterile radiopharmaceuticals and supervise pharmacy technicians compounding sterile radiopharmaceuticals without process validation provided the authorized nuclear pharmacist:

(i)

has completed a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in this paragraph; and

(ii)

completes the on-site process validation within seven days of commencing work at the pharmacy.

(D)

Process validation procedures for assessing the preparation of specific types of sterile radiopharmaceuticals shall be representative of all types of manipulations, products, and batch sizes that personnel preparing that type of radioradiopharmaceutical are likely to encounter.

(E)

The pharmacist-in-charge shall assure continuing competency of pharmacy personnel through in-service education, training, and process validation to supplement initial training. Personnel competency shall be evaluated:

(i)

during orientation and training prior to the regular performance of those tasks;

(ii)

whenever the quality assurance program yields an unacceptable result;

(iii)

whenever unacceptable techniques are observed; and

(iv)

at least on an annual basis.

(2)

Pharmacists.

(A)

All pharmacists who compound sterile radiopharmaceuticals or supervise pharmacy technicians compounding sterile radiopharmaceuticals shall:

(i)

effective January 1, 2000, complete a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; and

(ii)

possess knowledge about:

(I)

aseptic processing;

(II)

quality control as related to environmental, component, and end-product testing;

(III)

chemical, pharmaceutical, and clinical properties of drugs;

(IV)

container, equipment, and closure system selection; and

(V)

sterilization techniques.

(B)

Pharmacists shall discontinue preparation of sterile radiopharmaceuticals if the training specified in subparagraph (A) of this paragraph is not completed by January 1, 2000.

(C)

The required experiential portion of the training programs specified in this paragraph must be supervised by an individual who has already completed training in the compounding of sterile pharmaceuticals.

(3)

Pharmacy technicians. In addition to the qualifications and training outlined in subsection (c) of this section, all pharmacy technicians who compound sterile radiopharmaceuticals shall:

(A)

have a high school or equivalent education;

(B)

complete through a single course, a structured on-the-job didactic and experiential training program at this pharmacy which provides 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program;

(C)

acquire the required experiential portion of the training programs specified in this paragraph under the supervision of an individual who has already completed training in the compounding of sterile pharmaceuticals.

(4)

Documentation of Training. A written record of initial and in-service training and the results of written or practical testing and process validation of pharmacy personnel shall be maintained and contain the following information:

(A)

name of the person receiving the training or completing the testing or process validation;

(B)

date(s) of the training, testing, or process validation;

(C)

general description of the topics covered in the training or testing or of the process validated;

(D)

name of the person supervising the training, testing, or process validation; and

(E)

signature (first initial and last name or full signature) of the person receiving the training or completing the testing or process validation and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or process validation of personnel.

§291.54. Operational Standards.

(a)

Licensing requirements.

(1)

It is unlawful for a person to provide radioactive drug services unless such provision is performed by a person licensed to act as an authorized nuclear pharmacist, as defined by the board, or is a person acting under the direct supervision of an authorized nuclear pharmacist acting in accordance with the Act and its rules, and the regulations of the Texas Department of Health, Bureau of Radiation Control. Subsection (a) of this section does not apply to:

(A)

a licensed practitioner or his or her designated agent for administration to his or her patient, provided no person may receive, possess, use, transfer, own, acquire, or dispose of radiopharmaceuticals except as authorized in a specific or a general license as provided in Texas Regulations for Control of Radiation, Part 41, Texas Department of Health, or the Act;

(B)

institutions and/or facilities with nuclear medicine services operated by practitioners and who are licensed by the Texas Department of Health, Bureau of Radiation Control, to prescribe, administer, and dispense radioactive materials (drugs and/or devices).

(2)

An applicant for a Class B pharmacy shall provide evidence to the board of the possession of a Texas Department of Health Radiation Control Number.

(3)

A Class B pharmacy shall register annually with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).

(4)

A Class B pharmacy which changes ownership shall notify the board within ten days of the change of ownership and apply for a new and separate license as specified in §291.4 of this title (relating to Change of Ownership).

(5)

A Class B pharmacy which changes location and/or name shall notify the board within ten days of the change and file for an amended license as specified in §291.2 of this title (relating to Change of Location and/or Name).

(6)

A Class B pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within ten days of the change, following the procedures in §291.3 of this title (relating to Change of Managing Officers).

(7)

A Class B pharmacy shall notify the board in writing within ten days of closing, following the procedures in §291.5 of this title (relating to Closed Pharmacies).

(8)

A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.

(9)

A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.

(10)

A Class B pharmacy, licensed under the provisions of the Act, §29(b)(2), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, §29(b)(1), concerning community pharmacy (Class A), is not required to secure a license for such other type of pharmacy; provided, however, such licensee is required to comply with the provisions of §291.31 of this title (relating to Definitions); §291.32 of this title (relating to Personnel); §291.33 of this title (relating to Operational Standards); §291.34 of this title (relating to Records); §291.35 of this title (relating to Triplicate Prescription Requirements); and §291.36 of this title (relating to Class A Pharmacies Dispensing Compounded Sterile Parenteral and/or Enteral Products), contained in Community Pharmacy (Class A), to the extent such rules are applicable to the operation of the pharmacy.

(11)

A Class B pharmacy engaged in nonsterile compounding of drug products shall comply with the provisions of §§291.31-291.34 of this title (relating to Definitions, Personnel, Operational Standards, and Records for Class A (Community) Pharmacies) to the extent such rules are applicable to nonsterile compounding of drug products.

(b)

Environment.

(1)

General requirements.

(A)

The pharmacy shall be enclosed and lockable.

(B)

The pharmacy shall have a designated controlled area for radiopharmaceuticals that is functionally separate from other areas of the facility. If non-sterile radiopharmaceuticals are dispensed, the controlled area for sterile radiopharmaceuticals shall be functionally separate from the controlled area for non- sterile radiopharmaceuticals.

(C)

The pharmacy shall have adequate space necessary for the storage, compounding, labeling, dispensing, and sterile preparation of drugs prepared in the pharmacy, and additional space, depending on the size and scope of pharmaceutical services.

(D)

The pharmacy shall be arranged in an orderly fashion and shall be kept clean. All required equipment shall be clean and in good operating condition.

(E)

A sink with hot and cold running water, exclusive of restroom facilities, designated primarily for use of admixtures, shall be available within the pharmacy area to all pharmacy personnel and shall be maintained in a sanitary condition at all times.

(F)

The pharmacy shall be properly lighted and ventilated.

(G)

The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of drugs; the temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration.

(H)

Animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.

(2)

Special requirements for the compounding of sterile radiopharmaceuticals. When the pharmacy compounds sterile radiopharmaceuticals, the following is applicable.

(A)

Aseptic environment control device(s). The pharmacy shall prepare sterile radiopharmaceuticals in an appropriate aseptic environmental control device(s) or area, such as a laminar air flow hood, biological safety cabinet, or clean room which is capable of maintaining at least Class 100 conditions during normal activity unless the use of such device will expose pharmacy personnel to unacceptable levels of nuclear radiation. The aseptic environmental control device(s) shall:

(i)

be certified by an independent contractor according to Federal Standard 209E, et seq, for operational efficiency at least every year or when it is relocated; and

(ii)

have pre-filters inspected periodically and replaced as needed, in accordance with written policies and procedures, and the inspection and/or replacement date documented.

(B)

Controlled area. The pharmacy shall have a designated controlled area for the compounding of sterile radiopharmaceuticals that is functionally separate from areas for the preparation of non-sterile pharmaceuticals and is constructed to minimize the opportunities for particulate and microbial contamination.

(C)

Automated compounding device(s). If automated compounding device(s) are used, the pharmacy shall have a method to calibrate and verify the accuracy of automated compounding devices used in aseptic processing and document the calibration and verification on a routine basis.

(3)

Security requirements.

(A)

All areas occupied by a pharmacy shall be capable of being locked by key or combination, so as to prevent access by unauthorized personnel when a pharmacist is not on-site.

(B)

The pharmacy may authorize personnel to gain access to that area of the pharmacy containing dispensed sterile radiopharmaceuticals, in the absence of the pharmacist, for the purpose of retrieving dispensed prescriptions to deliver to patients. If the pharmacy allows such after-hours access, the area containing the dispensed sterile radiopharmaceuticals shall be an enclosed and lockable area separate from the area containing undispensed prescription drugs. A list of the authorized personnel having such access shall be in the pharmacy's policy and procedure manual.

(C)

Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drugs, and records for such drugs.

(c)

Prescription dispensing and delivery.

(1)

Prescription containers (immediate inner containers).

(A)

A drug dispensed pursuant to a radioactive prescription drug order shall be dispensed in an appropriate immediate inner container as follows.

(i)

If a drug is susceptible to light, the drug shall be dispensed in a light-resistant container.

(ii)

If a drug is susceptible to moisture, the drug shall be dispensed in a tight container.

(iii)

The container should not interact physically or chemically with the drug product placed in it so as to alter the strength, quality, or purity of the drug beyond the official requirements.

(B)

Immediate inner prescription containers or closures shall not be re-used.

(2)

Delivery containers (outer containers).

(A)

Prescription containers may be placed in suitable containers for delivery which will transport the radiopharmaceutical safely in compliance with all applicable laws and regulations.

(B)

Delivery containers may be re-used provided they are maintained in a manner to prevent cross contamination.

(3)

Labeling.

(A)

The immediate inner container of a radiopharmaceutical shall be labeled with:

(i)

standard radiation symbol;

(ii)

the words "caution-radioactive material;"

(iii)

the name of the radiopharmaceutical; and

(iv)

the unique identification number of the prescription.

(B)

The outer container of a radiopharmaceutical shall be labeled with:

(i)

the name, address, and phone number of the pharmacy;

(ii)

the date dispensed;

(iii)

the directions for use, if applicable;

(iv)

the unique identification number of the prescription;

(v)

the name of the patient if known, or the statement, "for physician use" if the patient is unknown;

(vi)

the standard radiation symbol;

(vii)

the words "caution-radioactive material;"

(viii)

the name of the radiopharmaceutical;

(ix)

the amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different from the requested calibration date and time;

(x)

the name or initials of the person preparing the product and the authorized nuclear pharmacist who checked and released the final product unless documents are maintained in the pharmacy identifying these individuals for each prescription dispensed;

(xi)

if a liquid, the volume in milliliters;

(xii)

the requested calibration date and time; and

(xiii)

the expiration date and/or time.

(C)

The amount of radioactivity shall be determined by radiometric methods for each individual preparation immediately at the time of dispensing and calculations shall be made to determine the amount of activity that will be present at the requested calibration date and time, due to radioactive decay in the intervening period, and this activity and time shall be placed on the label per requirements set out in paragraph (2) of this subsection.

(d)

Pharmaceutical Care Services.

(1)

The following minimum level of pharmaceutical care services shall be provided whenever a therapeutic prescription drug order is dispensed and, when in the professional judgement of the pharmacist dispensing a diagnostic prescription drug order, the services are necessary to protect the patient's health while striving to produce positive patient outcomes. When it is determined that the following services are necessary, the dispensing pharmacist shall assure that efforts are made to gather the information necessary to properly perform the services.

(A)

Drug utilization review. A systematic ongoing process of drug utilization review shall be designed, followed, and documented to increase the probability of desired patient outcomes and decrease the probability of undesired outcomes from drug therapy with radiopharmaceuticals.

(B)

Drug regimen review.

(i)

For the purpose of promoting therapeutic appropriateness, an authorized nuclear pharmacist shall evaluate therapeutic prescription drug orders and patient medication history for:

(I)

known allergies;

(II)

rational therapy contraindications;

(III)

reasonable dose and route of administration;

(IV)

reasonable directions for use;

(V)

duplication of therapy;

(VI)

drug-drug interactions;

(VII)

drug-food interactions;

(VIII)

drug-disease interactions;

(IX)

adverse drug reactions;

(X)

proper utilization, including overutilization or underutilization; and

(XI)

clinical laboratory or clinical monitoring methods to monitor and evaluate drug effectiveness, side effects, toxicity, or adverse effects, and appropriateness to continued use of the drug in its current regimen.

(ii)

Upon identifying any clinically significant conditions, situations, or items listed in clause (i) of this subparagraph, the authorized nuclear pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner.

(2)

Other pharmaceutical care services which may be provided by authorized nuclear pharmacists include, but are not limited to, the following:

(A)

managing drug therapy as delegated by a practitioner as allowed under the provisions of the Medical Practice Act, § 3.061 or § 3.06(d);

(B)

managing patient compliance programs;

(C)

providing preventative health care services; and

(D)

providing case management of patients who are being treated with high-risk or high-cost drugs, or who are considered "high risk" due to their age, medical condition, family history, or related concern.

(e)

Equipment. The following minimum equipment is required in a nuclear pharmacy:

(1)

vertical laminar flow hood;

(2)

dose calibrator;

(3)

refrigerator;

(4)

Class A prescription balance, and accurate weights or balance of greater sensitivity if compounding occurs in the pharmacy which requires weighing;

(5)

scintillation analyzer;

(6)

microscope and hemocytometer;

(7)

adequate glassware, utensils, gloves, syringe shields and remote handling devices, and adequate equipment for product quality control;

(8)

adequate shielding material;

(9)

typewriter or comparable equipment;

(10)

radiation dosimeters for visitors and personnel and log entry book;

(11)

exhaust/fume hood with monitor, for storage and handling of all volatile radioactive drugs if applicable, to be determined by the Texas Radiation Control Bureau;

(12)

calculator; and

(13)

adequate radiation monitor(s).

(f)

Library. A nuclear pharmacy shall maintain a reference library which shall include the following in hard copy or electronic format:

(1)

United States Pharmacopoeia/National Formulary with supplements;

(2)

federal and state laws and regulations relating to Texas pharmacy;

(3)

Texas Regulations for Control of Radiation;

(4)

reference on the safe handling of radioactive materials;

(5)

a minimum of three texts dealing with nuclear medicine science;

(6)

reference on sterile product preparation; and

(7)

Code of Federal Regulations, Title 49, Parts 106-199, with recent amendments.

(g)

Radiopharmaceuticals and/or radioactive materials.

(1)

General requirements.

(A)

Radiopharmaceuticals may only be dispensed pursuant to a radioactive prescription drug order.

(B)

An authorized nuclear pharmacist may distribute radiopharmaceuticals to authorized users for patient use. A nuclear pharmacy may also furnish radiopharmaceuticals for departmental or physicians' use if such authorized users maintain a Texas radioactive materials license, and the radiopharmaceutical is labeled "for physician use," provided such distribution is documented in the control system.

(C)

An authorized nuclear pharmacist may transfer to authorized users radioactive materials not intended for drug use in accordance with Part 41 of the Texas Regulations for Control of Radiation, Texas Department of Health.

(D)

The transportation of radioactive materials from the nuclear pharmacy must be in accordance with current state and federal transportation regulations.

(2)

Procurement and storage.

(A)

The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff relative to such responsibility.

(B)

Prescription drugs and devices shall be stored within the prescription department or a locked storage area.

(C)

All drugs shall be stored at the proper temperature, as defined by the following terms.

(i)

Cold--Any temperature not exceeding 8 degrees Centigrade (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 degrees Centigrade (36 and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 and -10 degrees Centigrade (-4 and -14 degrees Fahrenheit).

(ii)

Cool--Any temperature between 8 and 15 degrees Centigrade (46 and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator unless otherwise specified in the labeling.

(iii)

Room temperature--The temperature prevailing in a working area. Controlled room temperature is a temperature thermostatically between 15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).

(iv)

Warm--Any temperature between 30 and 40 degrees Centigrade (86 and 104 degrees Fahrenheit).

(v)

Excessive heat--Temperature above 40 degrees Centigrade (104 degrees Fahrenheit).

(vi)

Protection from freezing where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.

(3)

Out-of-date and other unusable drugs or devices.

(A)

Any drug or device bearing an expiration date shall not be dispensed beyond the expiration date of the drug or device.

(B)

Outdated and other unusable drugs or devices shall be removed from dispensing stock and shall be quarantined together until such drugs or devices are disposed of properly.

(h)

Loading bulk drugs into automated compounding devices.

(1)

Automated compounding device may be loaded with bulk drugs only by an authorized nuclear pharmacist or by supportive personnel under the direction and direct supervision of an authorized pharmacist.

(2)

The label of an automated compounding device container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor.

(3)

Records of loading bulk drugs into an automated compounding device shall be maintained to show:

(A)

name of the drug, strength, and dosage form;

(B)

manufacturer or distributor;

(C)

manufacturer's lot number;

(D)

expiration date;

(E)

quantity added to the automated compounding device;

(F)

date of loading;

(G)

name, initials, or electronic signature of the person loading the automated compounding device; and

(H)

name, initials, or electronic signature of the responsible authorized nuclear pharmacist.

(4)

The automated compounding device shall not be used until an authorized nuclear pharmacist verifies that the system is properly loaded and affixes his or her signature or electronic signature to the record specified in paragraph 3 of this subsection.

(i)

Sterile radiopharmaceuticals.

(1)

Expiration date.

(A)

The expiration date assigned shall be based on:

(i)

established manufacturer's guidelines;

(ii)

published literature; or

(iii)

in-house or contracted stability studies.

(B)

The method for establishing expiration dates shall be documented.

(2)

Radioactive Drug Quality control. There shall be a documented, ongoing quality control program that monitors and evaluates personnel performance, equipment and facilities. Procedures shall be in place to assure that the pharmacy is capable of consistently preparing radiopharmaceuticals which are sterile and stable. Quality control procedures shall include, but are not limited to, the following:

(A)

recall procedures;

(B)

storage and dating;

(C)

documentation of appropriate functioning of refrigerator, freezer, and other equipment;

(D)

documentation of aseptic environmental control device(s) certification at least every year and the regular replacement of pre-filters as necessary;

(E)

a process to evaluate and confirm the quality of the prepared radiopharmaceutical; and

(F)

documentation of facility maintenance such as cleaning and environmental testing.

§291.55. Records.

(a)

Maintenance of records.

(1)

Every inventory or other record required to be kept under this section shall be kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative, and other authorized local, state, or federal law enforcement agencies.

(2)

Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy.

(3)

Records of controlled substances, other than original prescription drug orders, listed in Schedules III-V shall be maintained separately or readily retrievable from all other records of the pharmacy. For purposes of this subsection, "readily retrievable" means that the controlled substances shall be asterisked, red-lined, or in some other manner readily identifiable apart from all other items appearing on the record.

(4)

Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

(A)

the records maintained in the alternative system contain all of the information required on the manual record; and

(B)

the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

(b)

Prescriptions.

(1)

Professional responsibility. Pharmacists shall exercise sound professional judgment with respect to the accuracy and authenticity of any radioactive prescription drug order they dispense. If the pharmacist questions the accuracy or authenticity of a radioactive prescription drug order, he/she shall verify the order with the practitioner prior to dispensing.

(2)

Verbal radioactive prescription drug orders.

(A)

Only an authorized nuclear pharmacist or a pharmacist-intern under the direct supervision of an authorized nuclear pharmacist may receive from a practitioner or a practitioner's designated agent:

(i)

a verbal therapeutic prescription drug order; or

(ii)

a verbal diagnostic prescription drug order in instances where patient specificity is required for patient safety (e.g., radiolabeled blood products, radiolabeled antibodies).

(B)

A practitioner shall designate in writing the name of each agent authorized by the practitioner to communicate prescriptions verbally for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request.

(C)

If a radioactive prescription drug order is transmitted to an authorized nuclear pharmacist verbally, the pharmacist shall note any substitution instructions by the practitioner or practitioner's agent on the file copy of the prescription drug order. Such file copy may follow the two-line format indicated in paragraph (3)(B) of this subsection, or any other format that clearly indicates the substitution instructions.

(D)

A pharmacist may not dispense a verbal radioactive prescription drug order for a Schedule III, IV, or V controlled substance issued by a practitioner licensed in another state unless the practitioner is also registered under the Texas Controlled Substances Act.

(E)

A pharmacist may not dispense a verbal radioactive prescription drug order for a dangerous drug or a controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.

(3)

Written radioactive prescription drug orders.

(A)

Practitioner's signature. Written radioactive prescription drug orders shall be manually signed by the practitioner (electronically produced or rubber stamped signatures may not be used).

(i)

A practitioner may sign a radioactive prescription drug order in the same manner as he would sign a check or legal document, e.g., J.H. Smith or John H. Smith.

(ii)

The radioactive prescription drug order may not be signed by a practitioner's agent but may be prepared by an agent for the signature of a practitioner. However, the prescribing practitioner is responsible in case the radioactive prescription drug order does not conform in all essential respects to the law and regulations.

(B)

Required radioactive prescription drug order format.

(i)

A pharmacist may not dispense a written radioactive prescription drug order issued in Texas unless it is ordered on a form containing two signature lines of equal prominence, side by side, at the bottom of the form. Under either signature line shall be printed clearly the words "product selection permitted," and under the other signature line shall be printed clearly the words "dispense as written."

(ii)

The two signature line requirement does not apply to the following types of radioactive prescriptions drug orders:

(I)

radioactive prescription drug orders issued by a practitioner in a state other than Texas;

(II)

radioactive prescription drug orders for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; and

(III)

radioactive prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.

(C)

Preprinted radioactive prescription drug order forms. No radioactive prescription drug order form furnished to a practitioner shall contain a preprinted order for a radiopharmaceutical by brand name, generic name, or manufacturer.

(D)

Radioactive prescription drug orders written by practitioners in another state.

(i)

Dangerous drug prescription orders. A pharmacist may dispense a radioactive prescription drug order for dangerous drugs issued by practitioners in a state other than Texas in the same manner as radioactive prescription drug orders for dangerous drugs issued by practitioners in Texas are dispensed.

(ii)

Controlled substance prescription drug orders. A pharmacist may dispense radioactive prescription drug orders for controlled substances in Schedule III, IV, or V issued by a practitioner in another state provided:

(I)

the radioactive prescription drug order is an original written prescription issued by a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration registration number, and who may legally prescribe Schedule III, IV, or V controlled substances in such other state;

(II)

the radioactive prescription drug order is not dispensed or refilled more than six months from the initial date of issuance and may not be refilled more than five times; and

(III)

if there are no refill instructions on the original written radioactive prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original written radioactive prescription drug order have been dispensed, a new written radioactive prescription drug order is obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.

(E)

Radioactive prescription drug orders written by practitioners in the United Mexican States or the Dominion of Canada.

(i)

Controlled substance prescription drug orders. A pharmacist may not dispense a radioactive prescription drug order for a Schedule II, III, IV, or V controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States.

(ii)

Dangerous drug prescription drug orders. A pharmacist may dispense a radioactive prescription drug order for a dangerous drug issued by a person licensed in the Dominion of Canada or the United Mexican States as a physician, dentist, veterinarian, or podiatrist provided:

(I)

the radioactive prescription drug order is an original written prescription; and

(II)

if there are no refill instructions on the original written radioactive prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original written radioactive prescription drug order have been dispensed, a new written radioactive prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of dangerous drugs.

(vii)

Prescription drug orders for Schedule II controlled substances. No Schedule II controlled substance may be dispensed without a written prescription drug order of a practitioner on a triplicate prescription form as required by the Texas Controlled Substances Act, § 481.075.

(4)

Electronic radioactive prescription drug orders. For the purpose of this paragraph, electronic radioactive prescription drug orders shall be considered the same as verbal radioactive prescription drug orders.

(A)

An electronic radioactive prescription drug order may be transmitted by a practitioner or a practitioner's designated agent:

(i)

directly to a pharmacy; or

(ii)

through the use of a data communication device provided:

(I)

the prescription information is not altered during transmission; and

(II)

confidential patient information is not accessed or maintained by the operator of the data communication device unless the operator is authorized to receive the confidential information as specified in subsection (f) of this section.

(B)

A practitioner shall designate in writing the name of each agent authorized by the practitioner to electronically transmit prescriptions for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request.

(C)

A pharmacist may not dispense an electronic radioactive prescription drug order for a:

(i)

Schedule II controlled substance;

(ii)

Schedule III, IV, or V controlled substance issued by a practitioner licensed in another state unless the practitioner is also registered under the Texas Controlled Substances Act; or

(iii)

dangerous drug or controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.

(D)

The practitioner or practitioner's agent shall note any substitution instructions on the electronic radioactive prescription drug order. Such electronic radioactive prescription drug order may follow the two-line format indicated in paragraph (3)(B) of this subsection or any other format that clearly indicated the substitution instructions.

(5)

Authorization for generic substitution.

(A)

A pharmacist may dispense a generically equivalent drug product if:

(i)

the generic product cost the patient less than the prescribed drug product;

(ii)

the patient does not refuse the substitution; and

(iii)

the prescribing practitioner authorizes the substitution of a generically equivalent product; or

(iv)

the practitioner or practitioner's agent does not clearly indicate that the verbal or electronic prescription drug order shall be dispensed as ordered.

(B)

Practitioners shall indicate their dispensing instructions by signing on either the "Dispense as Written" or "Product Selection Permitted" line on the radioactive prescription drug order. If the practitioner's signature does not clearly indicate the radioactive prescription drug order shall be dispensed as written, the pharmacist may substitute a generically equivalent drug product.

(C)

A pharmacist may not substitute on radioactive prescription drug orders identified in paragraph (3)(D) and (E) of this subsection unless the practitioner has authorized substitution on the radioactive prescription drug order.

(D)

If the practitioner has not authorized substitution on the written radioactive prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:

(i)

the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original radioactive prescription drug order); or

(ii)

the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the radioactive prescription drug order was issued. The following is applicable concerning this documentation.

(I)

The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order.

(II)

The pharmacist shall note on the original radioactive prescription drug order the fact that documentation from such other state board of pharmacy is on file.

(III)

Such documentation shall be updated yearly.

(6)

Original prescription drug order records.

(A)

Original prescriptions shall be maintained by the pharmacy in numerical order and remain legible for a period of two years from the date of filling or the date of the last refill dispensed.

(B)

If an original prescription drug order is changed, such prescription order shall be invalid and of no further force and effect; if additional drugs are to be dispensed, a new prescription drug order with a new and separate number is required.

(C)

Original prescriptions shall be maintained in one of the following formats:

(i)

in three separate files as follows:

(I)

prescriptions for controlled substances listed in Schedule II;

(II)

prescriptions for controlled substances listed in Schedule III-V; and

(III)

prescriptions for dangerous drugs and nonprescription drugs; or

(ii)

within a patient medication record system provided that original prescriptions for controlled substances are maintained separate from original prescriptions for noncontrolled substances and triplicate prescriptions for Schedule II controlled substances are maintained separate from all other original prescriptions.

(D)

Original prescription records other than triplicate prescriptions may be stored on microfilm, microfiche, or other system which is capable of producing a direct image of the original prescription record, e.g., digitalized imaging system. If original prescription records are stored in a direct imaging system, the following is applicable.

(i)

The record of refills recorded on the original prescription must also be stored in this system.

(ii)

The original prescription records must be maintained in numerical order and as specified in subparagraph (C) of this paragraph.

(iii)

The pharmacy must provide immediate access to equipment necessary to render the records easily readable.

(7)

Prescription drug order information.

(A)

All original radioactive prescription drug orders shall bear:

(i)

name of the patient, if applicable at the time of the order;

(ii)

name of the institution;

(iii)

name, and if for a controlled substance, the address and DEA registration number of the practitioner

(iv)

name of the radiopharmaceutical;

(v)

amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different than the requested calibration date and time;

(vi)

date and time of calibration;

(vii)

if a liquid, the volume in milliliters;

(viii)

date of issuance; and

(ix)

if telephoned to the pharmacy by a designated agent, the full name of the designated agent.

(B)

All original electronic radioactive prescription drug orders shall bear:

(i)

name of the patient, if applicable at the time of the order;

(ii)

name of the institution;

(iii)

name, and if for a controlled substance, the address and DEA registration number of the practitioner

(iv)

name of the radiopharmaceutical;

(v)

amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different than the requested calibration date and time;

(vi)

date and time of calibration;

(vii)

if a liquid, the volume in milliliters;

(viii)

a statement which indicates that the prescription has been electronically transmitted (e.g., Faxed to or electronically transmitted to:);

(ix)

name, address, and electronic access number of the pharmacy to which the prescription was transmitted;

(x)

telephone number of the prescribing practitioner;

(xi)

date the prescription drug order was electronically transmitted to the pharmacy, if different from the date of issuance of the prescription;

(xii)

date of issuance; and

(xiii)

if telephoned to the pharmacy by a designated agent, the full name of the designated agent.

(C)

At the time of dispensing, a pharmacist is responsible for the addition of the following information to the original prescription:

(i)

unique identification number of the prescription drug order;

(ii)

initials or identification code of the person who compounded the sterile radiopharmaceutical and the pharmacist who checked and released the product;

(iii)

name, quantity, lot number, and expiration date of each product used in compounding the sterile radiopharmaceutical; and

(iv)

date of dispensing, if different from the date of issuance.

(8)

Refills. A radioactive prescription drug order must be filled from an original prescription which may not be refilled.

(c)

Policy and procedure manual.

(1)

All nuclear pharmacies shall maintain a policy and procedure manual. The nuclear pharmacy policy and procedure manual is a compilation of written policy and procedure statements.

(2)

A technical operations manual governing all nuclear pharmacy functions shall be prepared. It shall be continually revised to reflect changes in techniques, organizations, etc. All pharmacy personnel shall be familiar with the contents of the manual.

(3)

The nuclear pharmacy policies and procedures manual shall be prepared by the pharmacist-in-charge with input from the affected personnel and from other involved staff and committees to govern procurement, preparation, distribution, storage, disposal, and control of all drugs used and the need for policies and procedures relative to procurement of multisource items, inventory, investigational drugs, and new drug applications.

(d)

Other records. Other records to be maintained by a pharmacy:

(1)

a permanent log of the initials or identification codes which will identify each dispensing pharmacist by name (the initials or identification code shall be unique to ensure that each pharmacist can be identified, i.e., identical initials or identification codes shall not be used);

(2)

copy 3 of DEA order form (DEA 222) which has been properly dated, initialed, and filed, and all copies of each unaccepted or defective order form and any attached statements or other documents;

(3)

a hard copy of the power of attorney to sign DEA 222 order forms (if applicable);

(4)

suppliers' invoices of dangerous drugs and controlled substances; pharmacists or other responsible individuals shall verify that the controlled drugs listed on the invoices were actually received by clearly recording their initials and the actual date of receipt of the controlled substances;

(5)

suppliers' credit memos for controlled substances and dangerous drugs;

(6)

a hard copy of inventories required by §291.17 of this title (relating to Inventory Requirements);

(7)

hard-copy reports of surrender or destruction of controlled substances and/or dangerous drugs to an appropriate state or federal agency;

(8)

records of distribution of controlled substances and/or dangerous drugs to other pharmacies, practitioners, or registrants; and

(9)

a hard copy of any notification required by the Texas Pharmacy Act or these sections, including, but not limited to, the following:

(A)

reports of theft or significant loss of controlled substances to DEA, DPS, and the board;

(B)

notifications of a change in pharmacist-in-charge of a pharmacy; and

(C)

reports of a fire or other disaster which may affect the strength, purity, or labeling of drugs, medications, devices, or other materials used in the diagnosis or treatment of injury, illness, and disease.

(e)

Permission to maintain central records. Any pharmacy that uses a centralized recordkeeping system for invoices and financial data shall comply with the following procedures.

(1)

Controlled substance records. Invoices and financial data for controlled substances may be maintained at a central location provided the following conditions are met.

(A)

Prior to the initiation of central recordkeeping, the pharmacy submits written notification by registered or certified mail to the divisional director of the Drug Enforcement Administration as required by the Code of Federal Regulations, Title 21, § 1304.04(a), and submits a copy of this written notification to the Texas State Board of Pharmacy. Unless the registrant is informed by the divisional director of the Drug Enforcement Administration that permission to keep central records is denied, the pharmacy may maintain central records commencing 14 days after receipt of notification by the divisional director.

(B)

The pharmacy maintains a copy of the notification required in subparagraph (A) of this paragraph.

(C)

The records to be maintained at the central record location shall not include executed DEA order forms, prescription drug orders, or controlled substance inventories, which shall be maintained at the pharmacy.

(2)

Dangerous drug records. Invoices and financial data for dangerous drugs may be maintained at a central location.

(3)

Access to records. If the records are kept on microfilm, computer media, or in any form requiring special equipment to render the records easily readable, the pharmacy shall provide access to such equipment with the records.

(4)

Delivery of records. The pharmacy agrees to deliver all or any part of such records to the pharmacy location within two business days of written request of a board agent or any other authorized official.

(5)

Ownership of pharmacy records. For purposes of these sections, a pharmacy licensed under the Act is the only entity which may legally own and maintain prescription drug records.

(f)

Confidentiality.

(1)

A pharmacist shall provide adequate security of radioactive prescription drug order and patient medication records to prevent indiscriminate or unauthorized access to confidential health information. If radioactive prescription drug orders, requests for refill authorization, or other confidential health information are not transmitted directly between a pharmacy and a physician but are transmitted through a data communication device, confidential health information may not be accessed or maintained by the operator of the data communication device unless specifically authorized to obtain the confidential information by this subsection.

(2)

Confidential records are privileged and may be released only to:

(A)

the patient or the patient's agent;

(B)

practitioners and other pharmacists when, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well-being;

(C)

other persons, the board, or other state or federal agencies authorized by law to receive such information;

(D)

a law enforcement agency engaged in investigation of suspected violations of the Controlled Substances Act or the Dangerous Drug Act;

(E)

a person employed by any state agency which licenses a practitioner as defined in the Act if such person is engaged in the performance of the person's official duties; or

(F)

an insurance carrier or other third party payor authorized by a patient to receive such information.

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.

Issued in Austin, Texas, on December 22, 1997.

TRD-9717051

Gay Dodson, R.Ph

Executive Director

Texas State Board of Pharmacy

Proposed date of adoption: February 10, 1998

For further information, please call: (512) 305-8026

Part XXI. Texas State Board of Examiners of Psychologists

Chapter 461. General Rulings

22 TAC §461.19

The Texas State Board of Examiners of Psychologists proposes an amendment to §461.19, concerning Standardized Complaint Form. The amendment is being proposed in order to clarify and simplify the procedure used by the general public to file a complaint, including all necessary information.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee has also determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be to clarify and simplify the procedure used by the general public to file a complaint and include all necessary information. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

The amendment is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

The proposed amendment does not affect other statutes, articles, or codes.

§461.19. Standardized Complaint [ Grievance ] Form.

(a)

All complaints filed against a licensee [ and/or certificand ] regulated by the Board must be submitted to the Board in writing, on the Board approved standardized complaint form [ Grievance Form ]. The Board approved complaint form [ Grievance Form ] can be obtained free of charge from [ by writing or phoning ] the Board's office.

(b)

The Board shall make available to each person who files a complaint: the Board approved complaint form [ Grievance Form ], release of information forms , Rules and Regulations of the Board [ and the Board's complaint procedures ].

(c)

The complaint form [ Form ] must be physically delivered to the Board office to be considered filed. Fax transmittal does not constitute physical delivery.

(d)

All required release forms must be signed, witnessed and returned to the Board, along with the complaint form, before a complaint can be processed.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717157

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700

22 TAC §461.20

(Editor's note: The text of the following section proposed for repeal will not be published. The section may be examined in the offices of the Texas State Board of Examiners of Psychologists or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas State Board of Examiners of Psychologists proposes the repeal of §461.20, concerning Monitoring of Licensure or Certificate Holder. The rule is being repealed in order to make the rules more accessible and easily understood by licensees and the public by renumbering this rule as §461.30.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the repeal is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee also has determined that for each year of the first five years the repeal is in effect the public benefit anticipated as a result of enforcing the repeal will be to make the rules more accessible and easily understood by licensees and the general public by renumbering this rule as §461.30. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

The repeal is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

The proposed repeal does not affect other statutes, articles, or codes.

§461.20. Monitoring of Licensure or Certificate Holder.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717158

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700

The Texas State Board of Examiners of Psychologists proposes new §461.20, concerning Complaint Disposition. The new rule is being proposed in order to identify the steps taken by the Agency in processing, investigating and disposing of complaints in compliance with §25B of the Psychologists' Licensing Act.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee also has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be to expedite the complaint process, make more efficient use of the Board's resources and keep the public and licensees informed of the complaint process. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

The new rule is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

The proposed new rule does not affect other statutes, articles, or codes.

§461.20. Complaint Disposition.

(a)

Complaints shall be made in writing on the agency's complaint form.

(b)

A preliminary investigation shall be conducted to determine the identity of the person named or described in the complaint and to ensure that the complaint is complete. If the staff cannot determine the nature of the allegations, the complainant will be provided the opportunity to explain the allegations made in the complaint.

(c)

A review will be conducted after the preliminary investigation to determine if the complaint states an allegation which, if true, would constitute a violation of the Board's Act and rules.

(d)

Complaints that do not state a violation of the Board's Act or rules shall be returned to the complainant or, if the complaint alleges a violation of another agency's Act or rules, shall be referred to the appropriate agency.

(e)

Complaints that state a violation of the Board's Act and rules shall be investigated by an investigator assigned by the Manager of the Investigation Division.

(f)

Following completion of the investigation, an investigation report shall be drafted which includes a recommendation as to whether the investigation has produced sufficient evidence to establish probable cause that a violation of the Board's Act and rules has occurred.

(g)

The Investigation Division Manager, the Executive Director and counsel for the Board shall review the investigation report, evidence and the case file of the complaint to determine if there is sufficient evidence to demonstrate a violation of the Board's Act, rules, or a Board Order to recommend probable cause to the Board.

(h)

A complaint for which the staff determines probable cause shall be referred to a Disciplinary Review Panel of the Board for an informal conference. Counsel for the Board shall serve the Respondent with a Notice of Violations and Informal Settlement Conference which shall serve as notice of the Informal Settlement Conference and as notice of the violations for which the staff has recommended probable cause.

(i)

A complaint for which the staff determines that probable cause does not exist shall be referred to the Board for dismissal.

(j)

A complaint may be returned to the Investigation Division for further investigation at any time prior to the setting of a contested case before the State Office of Administrative Hearings or final disposition of a complaint by the Board.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717159

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700

22 TAC §461.21

The Texas State Board of Examiners of Psychologists proposes an amendment to §461.21, concerning Complaint Investigation. The amendment is being proposed in order to ensure that the Board's complaint process is in compliance with the statutory mandate of §25B of the Psychologists' Licensing Act.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee also has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be to ensure that the Board's complaint process is in compliance with the statutory mandate of §25B of the Psychologists' Licensing Act. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

The amendment is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

The proposed amendment does not affect other statutes, articles, or codes.

§461.21. Complaint Investigation [ and Disposition ].

(a)

The Board has established a priority rating system to distinguish between categories of complaints. The priority rating system is as follows:

(1)-(2)

(No change.)

(3)

cases involving current applicants for licensure [ as a psychological associate, certification as a psychologist, or licensure as a psychologist ];

(4)-(5)

(No change.)

(b)

The Investigation Division shall dispose of all complaints in a timely manner. A schedule shall be established for conducting each phase of a complaint that is under the control of the Board not later than the 30th day after the date the complaint is received by the Board. The schedule shall be kept in the information file of the complaint, and all parties shall be notified of the projected time requirements for pursuing the complaint. A change in the schedule must be noted in the complaint information file, and all parties to the complaint must be notified in writing not later than the seventh day after the date the change is made. [ To ensure that complaints are not dismissed without appropriate consideration, all complaints will be reviewed by the Complaints Review Committee outlined in §466.43 of this title (relating to Complaints Review Committee) ].

(c)

(No change.)

[ (d)

To ensure that a person who files a complaint shall be provided with an opportunity to explain the allegations made in the complaint, the complainant shall be notified and given an opportunity to appear before a committee of the Board. The complainant will be given the opportunity to address either the Disciplinary Review Panel or the Complaints Review Committee.]

(d)

[ (e) ] The services of a private investigator shall be retained only in the event that staff investigator positions are vacant or inadequate to provide essential investigative services. The services of a private investigative agency shall be obtained in accordance with the procurement procedures of the General Services Commission.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717160

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700

22 TAC §461.30

The Texas State Board of Examiners of Psychologists proposes new §461.30, concerning Monitoring of Licensees. The new rule is being proposed in order to make the rules more accessible and easily understood by licensees and the public.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee also has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be to clearly identify which division of the Board's office is responsible for the monitoring of licensees ordered to perform certain acts by the Board, thereby ensuring that those who are required to perform certain acts by the Board are providing the best services possible to the general public. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

The new rule is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

The proposed new section does not affect other statutes, articles, or codes.

§461.30. Monitoring of Licensees.

(a)

The Compliance Division is responsible for monitoring licensees who are ordered by the Board to perform certain acts. The Compliance Division ascertains that the licensee performs the required acts within the designated time period.

(b)

The Compliance Division is responsible for implementing the preventative approach of the Board to enforcement of the Act and the Rules of the Board by identifying and monitoring licensee who represent a risk to the public.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717161

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700

22 TAC §461.31

The Texas State Board of Examiners of Psychologists proposes §461.31, concerning Abolition Date for Psychological Associate Advisory Committee Set for September 1, 2005; Board Review of Psychological Associate Advisory Committee. The new rule is being proposed in order to ensure compliance with the statutory mandate of Texas Government Code, §§2110.001-2110.008 and the continued existence of the Psychological Associate Advisory Committee through the Sunset date set for the Agency.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee also has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be to ensure that the Psychological Associate Advisory Committee is not abolished by operation of law pursuant to Texas Government Code, §2110.008, and ensure for annual review as required by §2110.004. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

The new rule is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it and Texas Government Code, §2110.001-2110.008.

The proposed new section does not affect other statutes, articles, or codes.

§461.31. Abolition Date for Psychological Associate Advisory Committee Set for September 1, 2005; Board Review of Psychological Associate Advisory Committee.

The abolition date for the Psychological Associate Advisory Committee is hereby set for September 1, 2005. The Board shall annually review the Committee's work, the Committee's usefulness and the costs related to the Committee's existence, including the cost of agency staff time spent in support of the Committee's activities in conjunction with the Board's budgeting process.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717162

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700

Chapter 463. Applications

22 TAC §463.5

The Texas State Board of Examiners of Psychologists proposes an amendment to §463.5, concerning Application File Requirements. The amendment is being proposed in order to establish a temporary license for Licensed Specialists in School Psychology in compliance with §15A of the Psychologists' Licensing Act while ensuring that all such licensees meet minimal standards of competency and ensuring the protection of the public consumer of psychological services. An additional change is being made to bring paragraph (7) in compliance with Attorney General Letter Opinion 96-147.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee also has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be to ensure that the Board is in compliance with the mandate of §15A of the Psychologists' Licensing Act by creating a mechanism for temporary licensure of Licensed Specialist in School Psychology applicants who hold a substantially equivalent license in another jurisdiction, as well as ensuring compliance with the Psychologists' Licensing Act in general. There will be no effect on small businesses. The anticipated economic cost to persons who are required to comply with the rule as proposed will be in direct proportion to any cost incurred in obtaining required documentation.

Comments on the proposal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

This amendment is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

The proposed amendment does not affect other statutes, articles or codes.

§463.5. Application File Requirements.

An application file must be complete and contain whatever information or examination results the Board requires. An incomplete application remains in the active file for 90 days, at the end of which time, if still incomplete, it is void. If [ certification or ] licensure is sought again, a new application and filing fee must be submitted. No applicant can have more than one application as described in paragraphs (2), (3) and/or (5) of this section pending before the Board at one time. For any applicant against whom a complaint is filed with this Board, any final decision on the application will be held in abeyance until the Board has made a final determination on the complaint filed. If the complaint is not resolved within 180 days after an application has been held in abeyance, the Board shall review the complaint and make a determination as to whether to issue the license notwithstanding the complaint. In making the determination, the Board shall consider any relevant factor, including the potential for harm to the public if the license is granted, and the nature and severity of the allegations. The applicant will be permitted to take all required exams as scheduled but will not be [ certified or ] licensed until approved by the Board.

(1)-(6)

(No change.)

(7)

Licensure [ License/Certificate ] by Reciprocity. A completed application for [ certification or ] licensure by reciprocity with this Board must include, in addition to the requirements in paragraph (1) of this section:

(A)

If the applicant is providing psychological services in Texas before receiving licensure [ or certification ] by the Board, proof that the applicant is [ employed in an ] exempt from the Act pursuant to §22 [ agency ], or holds a temporary license [ or certificate, or is being supervised by a licensed psychologist in an acceptable setting which is appropriate for the education/experience background of the applicant ];

(B)-(G)

(No change.)

(8)

Temporary Licensure [ License/Certificate ] as a Licensed Psychologist, Provisionally Licensed Psychologist, Licensed Psychological Associate .

(A)

An application file must be complete and contain whatever information or examination results the Board requires. An incomplete application remains in the active file for 90 days at the end of which time, if still incomplete, it is void. If a temporary license [ or certificate ] is sought again, a new application and filing fee must be submitted. An application for permanent licensure must be on file with the Board.

(B)

A completed application for a temporary license [ or certificate ] must include, in addition to the requirements stated in paragraph (1) of this section for all applicants:

(i)-(ii)

(No change.)

[ (C)

For temporary licensure as a Licensed Specialist in School Psychology, proof that the individual has been certified as a National Certified School Psychologist, or official transcripts sent directly to the Board from all colleges/universities where applicant completed post-baccalaureate course work verifying the requirements set forth in Board Rule §463.32 of this title (relating to Licensed Specialist in School Psychology); and, if the applicant did not graduate from either a training program accredited by the National Association of School Psychologists or a training program in school psychology accredited by the American Psychological Association, proof of the internship.]

(9)

Temporary Licensure Requirements for an Applicant Seeking Permanent Licensure as a Licensed Specialist in School Psychology. [ Applications for grandparenting as a licensed specialist in school psychology must include the information required in Board Rule §463.32 of this title (relating to Licensed Specialist in School Psychology). ]

(A)

For purposes of §15A, Endorsement, of the Psychologists' Licensing Act, an applicant for temporary licensure as a licensed specialist in school psychology must establish that the requirements for licensing, certification, or registration in the jurisdiction in which the applicant is currently licensed "are substantially equal to those prescribed by this Act" by demonstrating that:

(i)

The jurisdiction requires:

(I)

a doctoral degree from a training program accredited in school psychology by the American Psychological Association or a graduate degree from a training program approved by the National Association of School Psychology (NASP) or a graduate degree in psychology from a regionally accredited institution and completion of at least sixty graduate credit hours that meet the training requirements set forth in §463.32(a) of this title (relating to Licensed Specialist in School Psychology, Requirements for Licensure); and

(II)

the licensee, certificand, or registrant has passed the National School Psychology Exam, at the cut-off score required for licensure in Texas, and;

(ii)

That the license, certificate or registration permits the holder to engage in the independent practice of psychology in a public school in that jurisdiction.

(B)

In addition to establishing that the jurisdiction in which the applicant is currently licensed, certified, or registered meets the criteria set forth in subparagraph (A) of this paragraph, an applicant for temporary licensure must also show:

(i)

The applicant holds a current valid National Certification of School Psychologists (NCSP) and the applicant is currently licensed, certified, or registered in good standing by a jurisdiction's regulatory authority to engage in the independent practice of psychology in a public school in that jurisdiction; or

(ii)

The applicant is licensed in good standing by a jurisdiction's psychology board as a school psychologist and that license permits the holder to engage in the independent practice of psychology in a public school in that jurisdiction.

(C)

A completed application for temporary licensure as an LSSP must contain, in addition to the requirements set forth for all applications in paragraph (1) of this section:

(i)

An application on file for permanent licensure as an LSSP; and

(ii)

The applicant's NCSP Exam score sent directly from the testing service; and

(iii)

All relevant transcripts that establish that the applicant has met the training requirements set forth in §463.32(a) of this title (relating to Licensed Specialist in School Psychology, Requirements for Licensure) sent directly from the university or college issuing the transcript; and

(iv)

Proof of licensure, certification, or registration in good standing as required by paragraph (8)(B)(ii) of this section sent directly from the jurisdiction that issued the credential; and

(v)

If applicable, proof of current NCSP credential in good standing sent directly from NASP.

(D)

An applicant for temporary licensure is responsible for providing the Board with the most current requirements from the jurisdiction in which the applicant is currently licensed, certified, or registered for purposes of establishing that the jurisdiction's requirements for licensure, certification, or registration are substantially equal to those prescribed by this Act as defined in this rule.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717163

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700

Chapter 466. Procedure

22 TAC §466.43

(Editor's note: The text of the following section proposed for repeal will not be published. The section may be examined in the offices of the Texas State Board of Examiners of Psychologists or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas State Board of Examiners of Psychologists proposes the repeal of §466.43, concerning Complaints Review Committee. The rule is being repealed in order to identify the steps taken by the Agency in processing, investigating and disposing of complaints in complaince with §25B of the Psychologists' Licensing Act.

Sherry L. Lee, Executive Director, has determined that for the first five-year period the repeal is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Lee also has determined that for each year of the first five years the repeal is in effect the public benefit anticipated as a result of enforcing the repeal will be to expedite the complaint process, make more efficient use of the Board's resources and keep the public and licensees informed of the complaint process. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the rule as proposed.

Comments on the repeal may be submitted to Janice C. Alvarez, Texas State Board of Examiners of Psychologists, 333 Guadalupe, Suite 2-450, Austin, Texas 78701, (512) 305-7700.

The repeal is proposed under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

The proposed repeal does not affect other statutes, articles, or codes.

§466.43. Complaints Review Committee.

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.

Issued in Austin, Texas, on December 19, 1997.

TRD-9717164

Sherry L. Lee

Executive Director

Texas State Board of Examiners of Psychologists

Earliest possible date of adoption: February 9, 1998

For further information, please call: (512) 305-7700