Part 15. TEXAS STATE BOARD OF PHARMACY

Chapter 281. ADMINISTRATIVE PRACTICE AND PROCEDURES

Subchapter C. DISCIPLINARY GUIDELINES

22 TAC §281.63, §281.64

The Texas State Board of Pharmacy proposes amendments to §281.63, concerning Considerations for Criminal Offenses and §281.64, concerning Sanctions for Applicants with Criminal Offenses. The amendments, if adopted, clarify that the crime of driving while intoxicated is considered to be directly related to the duties and responsibilities of licensees and registrants, and clarify that the sanction guidelines apply to licensees and registrants including applicants. In addition, the amendments, if adopted, change the title of §281.64 from Sanctions for Applicants with Criminal Offenses to Sanctions for Criminal Offenses.

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

Ms. Dodson has determined that, for each year of the first five-year period the amendments will be in effect, the public benefit anticipated as a result of enforcing the amendments will ensure that individuals licensed or registered to work in a pharmacy are qualified and ensure the public's safety. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the amendments as proposed.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., April 30, 2008.

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

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

§281.63.Considerations for Criminal Offenses.

(a) - (h) (No change.)

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

(1) - (3) (No change.)

(4) a misdemeanor or felony offense under the Texas Penal Code involving:

(A) - (P) (No change.)

(Q) driving while intoxicated;

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

(S) [(R)] mail fraud; or

(T) [(S)] any criminal offense which requires the individual to register with the Department of Public Safety as a sex offender under Chapter 62, Code of Criminal Procedure.

(5) - (7) (No change.)

§281.64.Sanctions for [ Applicants with ] Criminal Offenses.

(a) The guidelines for disciplinary sanctions apply to criminal convictions and to deferred adjudication community supervisions or deferred dispositions, as authorized by the Act, [ for applicants] for all types of licensees and registrants including applicants for such licenses and registrations [ licenses and registrations ] issued by the board. The board considers criminal behavior to be highly relevant to an individual's fitness to engage in pharmacy practice. The "date of disposition," when referring to the number of years used to calculate the application of disciplinary sanctions, refers to the date a conviction, a deferred adjudication, or a deferred disposition is entered by the court. The use of the term "currently on probation" is construed to refer to individuals [applicants ] currently serving community supervision or any other type of probationary term imposed by an order of a court for a conviction, deferred adjudication, or deferred disposition.

(b) (No change.)

(c) The board has determined that the nature and seriousness of certain crimes outweigh other factors to be considered in §281.63(g) and necessitate the disciplinary action listed below. The following sanctions apply to individuals [applicants] with the criminal offenses as described below:

(1) (No change.)

(2) Felony offenses:

(A) Drug-related offenses, such as those listed in Chapter 481 or 483, Health and Safety Code:

(i) Offenses involving manufacture, delivery, or possession with intent to deliver, fraud, or theft of drugs:

(I) Currently on probation--denial or revocation;

(II) 0-5 years since date of disposition--denial or revocation;

(III) 6-10 years since date of disposition--denial or revocation;

(IV) 11-20 years since date of disposition--denial orrevocation;

(V) (No change.)

(ii) Offenses involving possession of drugs:

(I) Currently on probation--denial or revocation;

(II) - (V) (No change.)

(B) Offenses involving sexual contact or violent acts, or offenses considered to be felonies of the first degree under the Texas Penal Code:

(i) Currently on probation--denial or revocation;

(ii) 0-5 years since date of disposition--denial or revocation;

(iii) 6-10 years since date of disposition--denial or revocation;

(iv) - (v) (No change.)

(C) Other felony offenses:

(i) Currently on probation--denial or revocation;

(ii) - (iv) (No change.)

(3) Misdemeanor offenses:

(A) Drug-related offenses, such as those listed in Chapter 481 or 483, Health and Safety Code:

(i) Offenses involving manufacture, delivery, or possession with intent to deliver, fraud, or theft of drugs:

(I) Currently on probation--denial or revocation;

(II) - (III) (No change.)

(ii) (No change.)

(B) (No change.)

(C) Other misdemeanor offenses involving moral turpitude: 0-5 years since date of disposition--reprimand.

[(i) 0-5 years since date of disposition--2 years probation;]

[(ii) 6-10 years since date of disposition--reprimand;]

(d) When an individual [applicant] has multiple criminal offenses or other violations, the board shall consider imposing additional more severe types of disciplinary sanctions, as deemed necessary.

(e) An individual [applicant] who suffers from an impairment as described by §565.001(a)(4) or (7) or §568.003(a)(5), may provide mitigating information including treatment, counseling, and monitoring in order to mitigate the sanctions imposed.

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

Filed with the Office of the Secretary of State on March 6, 2008.

TRD-200801345

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: April 20, 2008

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

22 TAC §§283.1, 283.2, 283.4 - 283.6

The Texas State Board of Pharmacy proposes amendments to §283.1, concerning Purpose, §283.2, concerning Definitions, §283.4, concerning Internship Requirements, §283.5, concerning Pharmacist-Intern Duties, and §283.6, concerning Preceptor Requirements. The amendments, if adopted, implement recommendations from the Task Force on Internship Requirements. The amendments, if adopted, update definitions and add a new definition for an intern-trainee; update the goals and objectives to be consistent with new guidelines set forth by the Accreditation Council for Pharmacy Education; outline the requirements for individuals applying to the Board as an intern-trainee; authorize the executive director to extend the terms of an extended internship if the administration of the NAPLEX and/or Texas Jurisprudence Examinations is delayed; clarify the duties that may be performed by an intern-trainee working under a pharmacist preceptor serving as an instructor for a Texas college/school-based internship program; define the ratios of preceptors to pharmacist-interns; and rename §283.6 to Preceptor Requirements and Ratio of Preceptors of Pharmacist-Interns.

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

Ms. Dodson has determined that, for each year of the first five-year period the amendments will be in effect, the public benefit anticipated as a result of enforcing the amendments will ensure that individuals registered with the Board as pharmacist-interns are properly supervised and are qualified to work in a pharmacy. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the amendments as proposed.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 p.m., April 30, 2008.

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

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

§283.1.Purpose.

The purpose of this chapter is to provide a comprehensive, coherent regulatory scheme for the licensing of individuals [ those] wishing to engage in the practice of pharmacy in this state. The provisions of this chapter govern in conjunction with the Texas Pharmacy Act (Chapters 551 - 566, and 568 - 569, Occupations Code, as amended) the method for the issuance of a certificate to act as a pharmacist in Texas. This chapter also provides a framework for any board-approved internship program.

§283.2.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) ACPE-- Accreditation Council for Pharmacy Education. [ The American Council on Pharmaceutical Education.]

(2) - (7) (No change.)

(8) Direct supervision--A pharmacist preceptor or healthcare professional preceptor is physically present and on-site at the licensed location of the pharmacy where the pharmacist-intern is performing pharmacist-intern duties.

(9) [(8)] Extended-intern--An intern, registered with the board, who has:

(A) applied to the board for licensure by examination and has successfully passed the NAPLEX and Texas Pharmacy Jurisprudence Examination but lacks the required number of hours of internship for licensure; or

(B) applied to the board to take the NAPLEX and Texas Jurisprudence Examinations within three calendar months after graduation and has either:

(i) graduated and received a professional degree from a college/school of pharmacy the professional degree program of which has been accredited by ACPE and approved by the board; or

(ii) completed all of the requirements for graduation and for receipt of a professional degree from a college/school of pharmacy the professional degree program of which has been accredited by ACPE and approved by the board; or

(C) applied to the board to take the NAPLEX and Texas Jurisprudence Examinations within three calendar months after obtaining full certification from the Foreign Pharmacy Graduate Equivalency Commission; or

(D) applied to the Board for re-issuance of a pharmacist license which has been expired for more than two years but less than ten years and has successfully passed the Texas Pharmacy Jurisprudence examination, but lacks the required number of hours of internship or continuing education required for licensure; or

(E) been ordered by the Board to complete an internship.

(10) [(9)] Foreign pharmacy graduate--A pharmacist whose [undergraduate ] pharmacy degree was conferred by a pharmacy school whose professional degree program has not been accredited by ACPE and approved by the board. [outside the United States by a pharmacy school listed in the World Directory of Schools of Pharmacy published by the World Health Organization. The United States, as used here, includes the 50 states, the District of Columbia, and Puerto Rico.]

(11) [(10)] FPGEC--The Foreign Pharmacy Graduate Equivalency Commission.

(12) [(11)] FPGEE--The Foreign Pharmacy Graduate Equivalency Examination, given by FPGEC.

(13) [(12)] Healthcare Professional--An individual licensed as:

(A) a physician in Texas or another state; or

(B) a pharmacist in a state other than Texas but not licensed in Texas. [in another state but who is not licensed in Texas.]

(14) [(13)] Healthcare Professional Preceptor--A healthcare professional serving as an instructor for a Texas college/school-based internship program who is recognized by a Texas college/school of pharmacy to supervise and be responsible for the activities and functions of a student-intern or intern-trainee [pharmacist-intern] in the internship program.

(15) Intern-trainee--A pharmacist intern, registered with the board, who is enrolled in the first year of the professional sequence of a Texas college/school of pharmacy and who may only work in a site assigned by a Texas college/school of pharmacy.

(16) [(14)] Internship--A practical experience program that is approved by the board.

(17) [(15)] MPJE--Multistate Pharmacy Jurisprudence Examination.

(18) [(16)] NABP--The National Association of Boards of Pharmacy.

(19) [(17)] NAPLEX--The North American Pharmacy Licensing Examination, or its predecessor, the National Association of Boards of Pharmacy Licensing Examination.

(20) [(18)] Pharm D--A doctorate in pharmacy.

(21) [(19)] Pharmaceutical care--The provision of drug therapy and other pharmaceutical services defined in the rules of the board and intended to assist in the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process.

(22) [(20)] Pharmacist-intern-- An intern-trainee, a student-intern, or an extended-intern who is participating in a board approved internship program. [An undergraduate student enrolled in the professional sequence of a college of pharmacy who has successfully completed the first professional year and a minimum of 30 credit hours of work towards a professional degree in pharmacy and is participating in a board-approved internship program or an extended-intern participating in a board-approved internship program.]

(23) [(21)] Pharmacist Preceptor--A pharmacist licensed in Texas to practice pharmacy who meets the requirements under board rules and is recognized by the board to supervise and be responsible for the activities and functions of a pharmacist-intern in an [the] internship program.

(24) Preceptor--A pharmacist preceptor or a healthcare professional preceptor.

(25) [(22)] Professional degree--A baccalaureate in pharmacy (BS) or a doctorate [doctor] of pharmacy (Pharm D) degree.

(26) [(23)] State--One of the 50 United States of America, the District of Columbia, and Puerto Rico.

(27) [(24)] Student-intern--A pharmacist-intern, registered with the board who is enrolled in the professional sequence of a college/school of pharmacy, [ and] has completed the first professional year and obtained a minimum of 30 credit hours of work towards a professional degree in pharmacy, and is participating in a board-approved internship program.

(28) [(25)] Texas Pharmacy Jurisprudence Exam or Texas Drug and Pharmacy Jurisprudence Examination--A licensing exam developed or approved by the Board which evaluates an applicant's knowledge of the drug and pharmacy requirements to practice pharmacy legally in the state of Texas.

§283.4.Internship Requirements.

(a) Goals and competency objectives of internship.

(1) The goal of internship is for the pharmacist-intern to attain the knowledge, skills, and abilities to safely, efficiently, and effectively provide pharmacist-delivered patient care to a diverse patient population [pharmaceutical care to individual patients] and practice pharmacy under the laws and regulations of the State of Texas.

(2) The following competency objectives are necessary to accomplish the goal of internship in paragraph (1) of this subsection.

(A) Provides drug products. The pharmacist-intern shall demonstrate [acquire] competence in determining the appropriateness of prescription drug orders and medication orders; evaluating and selecting products; and assuring the accuracy of the product/prescription dispensing process.

(B) Communicates with patients and/or patients' agents [ their care givers] about prescription drugs. The pharmacist-intern shall demonstrate [acquire] competence in interviewing and counseling patients, and/or the patients' agents [their care givers], on drug usage, dosage, packaging, routes of administration, intended drug use, and storage; discussing drug cautions, adverse [side] effects, and patient conditions; explaining policies on fees and services; relating to patients in a professional manner; and interacting to confirm patient understanding.

(C) Communicates with patients and/or patients' agents [ their care givers] about nonprescription products, devices, dietary supplements, diet, nutrition, traditional nondrug therapies, complementary and alternative therapies, and diagnostic aids. The pharmacist-intern shall demonstrate [ acquire] competence in interviewing and counseling patients and/or patients' agents [their care givers] on conditions, [and] intended drug use, and adverse effects; assisting in and recommending drug selection; triaging and assessing the need for treatment or referral, including referral for a patient seeking pharmacist-guided self-care; [ referring patients to other health professionals; ] providing information on medical/surgical [and home health-care ] devices and home diagnostic products; and providing poison control treatment information and referral.

(D) Communicates with healthcare [health] professionals and patients and/or patients' agents. [ the public.] The pharmacist-intern shall demonstrate [ acquire] competence in obtaining and providing accurate and concise information in a professional manner and using appropriate oral, written, and nonverbal language.

(E) Practices as a member of the patient's interdisciplinary healthcare team. [Collaborates with physicians, other health-care professionals, patients and/or their care givers to develop a therapeutic plan which will include monitoring and evaluating drug therapy.] The pharmacist-intern shall demonstrate [acquire] competence in collaborating with physicians, other healthcare professionals, patients, and/or patients' agents [their care givers] to formulate a therapeutic plan. The pharmacist-intern shall demonstrate [acquire] competence in establishing and interpreting data-bases, identifying drug-related problems and recommending appropriate pharmacotherapy specific to patient needs, monitoring and evaluating patient outcomes, and devising follow-up plans.

(F) Maintains professional-ethical standards. The pharmacist-intern is required to comply with laws and regulations pertaining to pharmacy practice; [to learn] to apply [good ] professional judgment; to exhibit reliability and credibility in dealing with others; to deal professionally and ethically with colleagues and patients; to demonstrate sensitivity and empathy for patients/care givers; and to maintain confidentiality.

(G) Compounds. The pharmacist-intern shall demonstrate [acquire ] competence in using acceptable professional procedures; selecting appropriate equipment and containers; appropriately preparing compounded non-sterile and sterile preparations; [ dosage forms;] and documenting calculations and procedures. Pharmacist-interns engaged in compounding non-sterile preparations shall meet the training requirements for pharmacists specified in §291.131 of this title (relating to Pharmacies Compounding Non-sterile Preparations). Pharmacist-interns engaged in compounding sterile preparations shall meet the training requirements for pharmacists specified in §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations).

(H) Retrieves and evaluates drug information. The pharmacist-intern shall demonstrate [acquire] competence in retrieving, evaluating, managing, and using the best available clinical and scientific publications for answering a drug-related request in a timely fashion and assessing, evaluating, and applying evidence based information to promote optimal health care. The pharmacist-intern shall perform investigations on relevant topics in order to promote inquiry and problem-solving with dissemination of findings to the healthcare community and/or the public. [selecting best available resources for answering a drug-related request in a timely fashion and in interpreting the information obtained and judging its relevance.]

(I) Manages general pharmacy operations. The pharmacist-intern shall develop a general understanding of planning, personnel and fiscal management, leadership skills, and policy development. [ and policy-making.] The pharmacist-intern shall have an understanding of drug security, storage and control procedures and the regulatory requirements associated with these procedures, and maintaining quality assurance and performance improvement. The pharmacist-intern shall observe [learn to notice ] and document discrepancies and irregularities, keep accurate records and document actions. The pharmacist-intern shall attend meetings requiring pharmacy representation.

(J) Participates in public health, community service or professional activities. [Understands the necessity of participating in public health and professional activities.] The pharmacist-intern shall develop basic knowledge and skills needed to become an effective healthcare [health] educator and a responsible participant in civic and professional organizations. [active participant in public health programs and professional organizations.]

(K) Demonstrates scientific inquiry. The pharmacist-intern shall develop skills to expand and/or refine knowledge in the areas of pharmaceutical and medical sciences or pharmaceutical services. This may include data analysis of scientific, clinical, sociological, and/or economic impacts of pharmaceuticals (including investigational drugs), pharmaceutical care, and patient behaviors, with dissemination of findings to the scientific community and/or the public.

[(K) Conducts research. The pharmacist-intern may develop research skills to expand and/or refine knowledge in the areas of pharmaceutical sciences or pharmaceutical services. This includes data collection and analysis of scientific, clinical, sociological, and/or economic impacts of pharmaceuticals (including investigational drugs), pharmaceutical care, and patient behaviors, with dissemination of findings to the scientific community and the public.]

(b) Hours requirement.

(1) The board requires 1,500 hours of internship for licensure. These hours may be obtained through one or [of ] more of the following methods:

(A) - (C) (No change.)

(2) - (3) (No change.)

(c) College-/School-Based [Student] Internship Programs.

(1) Internship experience acquired by student-interns.

(A) An individual may be designated a student-intern provided he/she meets all of the following requirements:

(i) has made application to the board;

(ii) is enrolled in the professional sequence of a college/school of pharmacy whose professional degree program has been accredited by ACPE and approved by the board;

(iii) has successfully completed the first professional year and obtained a minimum of 30 credit hours of work towards a professional degree in pharmacy; and

(iv) has met all requirements necessary in order for the board to access the criminal history records information, including submitting fingerprint information and being responsible for all associated costs.

(B) The terms of the student internship shall be as follows.

(i) The student internship shall be gained concurrent with college attendance, which may include:

(I) partial semester breaks such as spring breaks;

(II) between semester breaks; and

(III) whole semester breaks provided the student-intern attended the college/school in the immediate preceding semester and is scheduled with the college/school to attend in the immediate subsequent semester.

(ii) The student internship shall obtained in pharmacies licensed by the board, federal government pharmacies, or in a board-approved program.

(iii) The student internship shall be in the presence of and under the supervision of a healthcare professional preceptor or a pharmacist preceptor.

(C) None of the internship hours acquired outside of a school-based program may be substituted for any of the hours required in a Texas college/school of pharmacy internship program.

(2) Expiration date for student-intern designation.

(A) The student-internship expires:

(i) if the student-intern voluntarily or involuntarily ceases enrollment, including suspension, in a college/school of pharmacy whose professional degree program has been accredited by ACPE and approved by the board;

(ii) the student-intern fails the NAPLEX and/or Texas Jurisprudence Examinations specified in this section; or

(iii) the student-intern fails to take the NAPLEX and/or Texas Jurisprudence Examinations within three calendar months after graduation.

(B) The executive director of the board, in his/her discretion may extend the term of the student internship if administration of the NAPLEX or Texas Jurisprudence Examinations is suspended or delayed.

(3) [(1)] Texas colleges/schools of pharmacy internship programs.

(A) The board shall review for approval Texas colleges/schools of pharmacy internship programs [on or before September 1 ] of each fiscal year. The purpose of the board review will be to determine if such internship programs demonstrate that the competency objectives listed in subsection (a) of this section are [capable of] being met by each student-intern completing the internship. The board reserves the right to set conditions relating to the approval of such programs.

(B) The Texas colleges/schools of pharmacy shall determine [through examinations ] that each student-intern completing the college/school internship program demonstrates through assessment [meets ] the competency objectives listed in subsection (a) of this section.

(C) Internship experience shall be gained under a preceptor. [:]

[(i) a pharmacist licensed by the board and approved as a preceptor by the board;]

[(ii) a pharmacist licensed in a state other than Texas when working in a federal facility and serving as an instructor for a Texas college-based internship program; or]

[(iii) a healthcare professional preceptor.]

(D) All internship experience shall be approved by the board and shall occur in sites and under conditions which teach one or more of the competency objectives listed in subsection (a) of this section.

(E) Prior to taking the licensure examination any applicant participating in a Texas college/school-based internship shall complete the requirements of such internship.

(F) Intern-trainees and student-interns [ Pharmacist-interns] completing a board-approved Texas college /school-based structured internship shall be credited the number of hours actually obtained and reported by the college. [will be awarded 1,500 hours of internship experience, or the number of hours actually obtained if greater than 1,500.] No credit shall be awarded for didactic experience.

(G) No more than 600 [300] hours of the required 1,500 hours may be obtained under a healthcare professional preceptor except when a pharmacist-intern is working in a federal government pharmacy. [preceptor that is a healthcare professional].

(H) Individuals enrolled in the professional sequence of a Texas college/school of pharmacy whose professional degree program has been accredited by ACPE and approved by the board may be designated as a intern-trainee provided he/she meets all of the following requirements:

(i) has made application to the board;

(ii) is enrolled in the professional sequence of a college/school of pharmacy whose professional degree program has been accredited by ACPE and approved by the board; and

(iii) has met all requirements necessary in order for the board to access the criminal history records information, including submitting fingerprint information and being responsible for all associated costs. Such internship shall remain in effect during the time the intern-trainee is enrolled in the first year of the professional sequence and shall expire upon completion of the first year of the professional sequence or upon separation from the professional sequence.

[(2) Internship experience acquired by student-interns not in a Texas College of Pharmacy Internship Program].

[(A) A person may be designated a student-intern provided he/she meets all of the following requirements:]

[(i) has made application to the board;]

[(ii) is enrolled in the professional sequence of a college of pharmacy whose professional degree program has been accredited by ACPE and approved by the board;]

[(iii) has successfully completed the first professional year and a minimum of 30 credit hours of work towards a professional degree in pharmacy; and]

[(iv) has met all requirements necessary in order for the Board to access the criminal history records information, including submitting fingerprint information and being responsible for all associated costs.]

[(B) The terms of the student internship shall be as follows.]

[(i) The internship shall be gained concurrent with college attendance, which may include:]

[(I) partial semester breaks such as spring breaks;]

[(II) between semesters; and]

[(III) whole semester breaks provided the student-intern attended the college in the immediate preceding semester and is scheduled with the college to attend in the immediate subsequent semester.]

[(ii) The student internship shall be board-approved and gained in a pharmacy licensed by the board, or a federal government pharmacy participating in a board-approved internship program.]

[(iii) The student internship shall be in the presence of and under the direct supervision of a board-approved preceptor who is licensed by the board.]

[(C) None of the internship hours acquired may be substituted for any of the hours required in the Texas college of pharmacy internship program.]

[(3) Expiration date for student-intern designation. The student-internship remains in effect until the earlier of the following occurs:]

[(A) the student-intern voluntarily or involuntarily ceases enrollment in a college of pharmacy whose professional degree program has been accredited by ACPE and approved by the board;]

[(B) the failure of the student-intern to take the NAPLEX and Texas Jurisprudence Examinations within three calendar months after graduation;]

[(C) upon receipt of the results of the NAPLEX and Texas Jurisprudence Examinations specified in this section.]

(d) Extended-internship program.

(1) A person may be designated an extended-intern provided he/she has made application to the board and met one of the following requirements:

(A) passed NAPLEX and the Texas Pharmacy Jurisprudence Examination but lacks the required number of internship hours for licensure;

(B) applied to the board to take the NAPLEX and Texas Jurisprudence Examinations within three calendar months after graduation and has:

(i) graduated and received a professional degree from a college /school of pharmacy the professional degree program of which has been accredited by ACPE and approved by the board; or

(ii) completed all of the requirements for graduation and receipt of a professional degree from a college/school of pharmacy the professional degree program of which has been accredited by ACPE and approved by the board; or

(C) - (E) (No change.)

(2) (No change.)

(3) The terms of the extended-internship shall be as follows.

(A) (No change.)

(B) The extended-internship shall be in the presence of and under the direct supervision of a pharmacist preceptor. [ board-approved preceptor who is licensed by the board.]

(4) The extended internship remains in effect for two years. However, the internship expires immediately upon [ until the earlier of the following occurs]:

(A) the failure of the extended-intern to take the NAPLEX and Texas Jurisprudence Examinations within three calendar months after graduation or Foreign Pharmacy Graduate Equivalency Commission (FPGEC) certification; or

(B) the failure of the extended-intern to pass the NAPLEX and Texas Jurisprudence Examinations specified in this section . [; or]

[(C) the failure of the extended-intern to complete the requirements for licensure within two years after passing the required examination(s).]

(5) The executive director of the board, in his/her discretion may extend the term of the extended internship if administration of the NAPLEX and/or Texas Jurisprudence Examinations is suspended or delayed.

(6) [(5)] An applicant for licensure who has completed less than 500 hours of internship at the time of application shall complete the remainder of the 1,500 hours of internship and have the preceptor certify that the applicant has met the objectives listed in subsection (a) of this section.

(e) Pharmacist-intern identification.

(1) The board shall provide the pharmacist-intern written documentation of [his or her ] designation as a pharmacist-intern. This written documentation serves as identification and authorization to perform the duties of a pharmacist-intern as described in §283.5 of this title (relating to Pharmacist-Intern Duties).

(2) - (3) (No change.)

(f) (No change.)

§283.5.Pharmacist-Intern Duties.

(a) A student-intern or an extended-intern [ pharmacist-intern] participating in a board-approved internship program may perform any duty of a pharmacist provided the duties are delegated by and [he or she is ] under the supervision of:

(1) - (2) (No change.)

(b) A pharmacist preceptor serving as an instructor for a Texas college/school-based internship program, may delegate the following duties to an intern-trainee working in a site assigned by a Texas college/school of pharmacy board approved program provided the intern-trainee is under the direct supervision of the pharmacist preceptor:

(1) initiating and receiving refill authorization requests;

(2) entering prescription data into a data processing system;

(3) taking a stock bottle from the shelf for a prescription;

(4) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids, and placing them in the prescription container);

(5) affixing prescription labels and auxiliary labels to the prescription container;

(6) reconstituting medication;

(7) prepackaging and labeling prepackaged drugs;

(8) loading bulk unlabeled drugs into an automated dispensing system provided a pharmacist verifies that the system is properly loaded prior to use;

(9) bulk compounding;

(10) compounding non-sterile preparations provided the intern-trainee has completed the training required for pharmacists in §291.131 of this title (relating to Pharmacist Compounding Non-sterile Preparations);

(11) compounding sterile preparations provided the intern-trainee has completed the training required for pharmacists in §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations); and

(12) administering immunizations provided the intern-trainee has completed the training required for pharmacists in §295.15 of this title (relating to Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of a Physician).

[(b) When working in a Texas college of pharmacy internship program, supervision of a pharmacist-intern shall be:]

[(1) direct supervision when the pharmacist-intern is engaged in functions associated with the preparation and delivery of prescription or medication drug orders; and]

[(2) general supervision when the pharmacist-intern is engaged in functions not associated with the preparation and delivery of prescription or medication drug orders.]

(c) When not under the supervision of a pharmacist preceptor [ preceptor pharmacist], a pharmacist-intern may function as a pharmacy technician and perform all of the duties of a [registered] pharmacy technician without registering as a pharmacy technician provided the pharmacist-intern:

(1) - (3) (No change.)

(4) has completed the training required for pharmacists in §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations); and [has completed a pharmacist training program in the preparation of sterile pharmaceuticals if the pharmacist-intern is compounding sterile pharmaceuticals; and]

(5) (No change.)

(d) A pharmacist-intern may not:

(1) - (2) (No change.)

(3) independently supervise pharmacy technicians or pharmacy technician trainees.

§283.6.Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns.

(a) Preceptor requirements.

(1) [(a)] Preceptors shall be:

(A) [(1)] a pharmacist whose license to practice pharmacy in Texas is current and not on inactive status with the board; or

[(2) a pharmacist licensed in a state other than Texas when working in a federal facility and serving as an instructor for a Texas college-based internship program; or]

(B) [(3)] a healthcare professional preceptor. [who is recognized by a Texas college of pharmacy.]

(2) [(b)] A pharmacist preceptor shall publicly display the pharmacist preceptor certificate with his/her license to practice pharmacy and the license renewal certificate.

(3) [(c)] To be recognized as a pharmacist preceptor, a pharmacist must:

(A) [(1)] have at least:

(i) [(A)] one year of experience as a licensed pharmacist in the type of internship practice setting; or

(ii) [(B)] six months of residency training if the pharmacy resident is in a program accredited by the American Society of Health-System Pharmacists;

(B) [(2)] have completed:

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

(I) [(i)] developed by a Texas college /school of pharmacy; or

(II) [(ii)] approved by:

(-a-) [(I)] a committee comprised of the Texas colleges/schools of pharmacy; or

(-b-) [(II)] the board; or

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

(I) [(i)] developed by a Texas college/school of pharmacy; or

(II) [(ii)] approved by:

(-a-) [(I)] a committee comprised of the Texas colleges/schools of pharmacy; or

(-b-) [(II)] the board; and

(C) [(3)] meet the requirements of subsection (c) [(e)] of this section.

(b) Ratio of preceptors to pharmacist-interns.

(1) A preceptor may supervise only one pharmacist-intern at any given time (1:1 ratio) except as provided in paragraph (2) of this subsection.

(2) The following is applicable to Texas college/school of pharmacy internship program only.

(A) Supervision of a pharmacist-intern shall be;

(i) direct supervision when the student-intern or intern-trainee is engaged in functions associated with the preparation and delivery of prescription or medication drug orders; and

(ii) general supervision when the student-intern or intern-trainee is engaged in functions not associated with the preparation and delivery of prescription or medication drug orders.

(B) There is no ratio requirement for preceptors supervising intern-trainees and student-interns as a part of a Texas college/school of pharmacy when the intern-trainees and student-interns are not engaging in dispensing activities, patient counseling, or any activities requiring independent judgement.

(C) A preceptor for a Texas college/school of pharmacy internship program may supervise one intern-trainee and one student-intern at any given time.

(D) Texas college/schools of pharmacy may request a different preceptor to pharmacist-intern ratio during the board's annual review and approval of their college/school based, structured internship program. Any such ratio shall apply only to the internship experience acquired as a part of the college/school based, structured internship program.

(E) In an emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for preceptors, the executive director of the board, in his/her discretion, may allow a preceptor in a Texas college/school of pharmacy internship program to supervise up to two interns. The executive director shall notify the Texas colleges/schools of pharmacy of the length of time a preceptor may supervise up to two interns.

[(d) A preceptor may supervise only one pharmacist-intern at any given time. Texas Colleges of Pharmacy may request a different preceptor to pharmacist-intern ratio during the board's annual review and approval of their college based, structured internship program. Any such ratio shall apply only to the internship experience acquired as a part of the college based, structured internship program. In an emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for preceptors, the executive director of the board, in his/her discretion, may allow a preceptor in a Texas College of Pharmacy internship program to supervise up to two interns. The executive director shall notify the Texas Colleges of Pharmacy of the length of time a preceptor may supervise up to two interns.]

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

(1) the type and gravity of the offense for which the pharmacist's license was disciplined;

(2) the length of time since the action that caused the order;

(3) the length of time the pharmacist has previously served as a preceptor;

(4) the availability of other preceptors in the area;

(5) the reason(s) the pharmacist believes he/she should serve as a preceptor;

(6) a letter of recommendation from a Texas college/school of pharmacy [College of Pharmacy ] if the pharmacist will be serving as a pharmacist preceptor for a Texas college/schoolof pharmacy [ College of Pharmacy]; and

(7) any other factor presented by the pharmacist demonstrating good cause why the pharmacist should be allowed to act as a pharmacist preceptor.

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

Filed with the Office of the Secretary of State on March 6, 2008.

TRD-200801346

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: April 20, 2008

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

Subchapter B. COMMUNITY PHARMACY (CLASS A)

22 TAC §§291.31 - 291.34

The Texas State Board of Pharmacy proposes amendments to §291.31, concerning Definition, §291.32, concerning Personnel, §291.33, concerning Operational Standards, and §291.34, concerning Records. The amendments, if adopted, incorporate recommendations made by the Task Force on Pharmacy Security in Community (Class A) Pharmacies; clarify the definition of the prescription department; clarify the responsibilities of the owner to include establishing polices and procedures for the security of the prescription department; outline the security requirements for Class A pharmacies; clarify the temporary absence requirements for pharmacists; require the pharmacy to document the identity of each pharmacist involved in a specific portion of the dispensing process if the pharmacy's data processing system is capable of recording such information; and require the pharmacy to document the identity of the pharmacist responsible for providing verbal counseling on a new prescription.

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

Ms. Dodson has determined that, for each year of the first five-year period the amendments will be in effect, the public benefit anticipated as a result of enforcing the amendments will be to ensure the security of Class A pharmacies and will be to prohibit the diversion of prescription drugs from Class A pharmacies; ensure that pharmacists are accountable for the specific portion of the dispensing process that the individual performs; and ensure that pharmacists are accountable for providing verbal counseling on new prescriptions.

Ms. Dodson has determined the following fiscal impact for small businesses. Of the approximate 4,410 Community (Class A) pharmacies actively licensed in Texas, between 100 - 2,000 pharmacies may be considered a small business as defined in the in the Texas Government Code §2006.001(2). This number is based on the number of pharmacies licensed as independent pharmacies which would most likely include pharmacies with less than 100 employees. Pharmacies will be required to install a basic alarm system with off-site monitoring and perimeter and motion sensors. The agency has determined that the cost of systems varies based on selected features and physical size of the prescription department but estimates that the minimum economic impact to these pharmacies will be approximately $1,000 or less per year. This cost includes the installation of a system and monthly monitoring fees. Many pharmacies, including small businesses, already have some type of basic alarm system already in place so there will be no additional costs to these pharmacies.

Pharmacies will also be required to secure the prescription department with floor to ceiling walls; walls, partitions, or barriers at least 9 feet 6 inches high; electronically monitored motion detectors; or pull down sliders if the prescription department is closed when the rest of the facility is closed. This provision becomes only applies to new pharmcies licensed after June 1, 2009, or pharmacies that move to a new location. The Board can not predict the number of pharmacies that this provision may effect in the future, and since there are several options available for pharmacies to comply the Board is not able to determine a cost to comply.

Pharmacies that determine to maintain the required record of the counseling pharmacist on the data processing system will be required to update the computer system, if the computer system does not already store this information. The Board is unable to determine the cost because of the numerous vendors pharmacies use for computer systems and the undetermined programming cost for this change. However, the pharmacies have the alternative to record this information on the hard-copy prescription which does not have an associated cost.

Government Code, §2006.002, as amended by House Bill 3430, 80th Legislative Session, 2007, requires that before adopting a rule that may have an adverse economic effect on small businesses, a state agency must prepare an Economic Impact Statement that assesses the potential impact of a proposed rule on small businesses, as provided above, and a Regulatory Flexibility Analysis that considers alternative methods of achieving the purpose of a rule. As provided in guidelines established by the Office of the Attorney General, an agency is not required to consider alternatives that, while possibly minimizing adverse impacts on small businesses, would not be protective of the health, safety and environmental and economic welfare of the state. The Board considers the amendments to §291.33 imperative to protect the health, safety, and welfare of the citizens of Texas and did not consider alternatives for complying with the proposed amendments. In addition, the costs of a basic alarm system as required to comply with the proposed amendments are nominal with respect to the cost of operating a pharmacy.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 p.m., April 30, 2008.

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

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

§291.31.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) - (36) (No change.)

(37) Prescription department--the area of a pharmacy that contains prescription drugs.

(38) [(37)] Prescription drug--

(A) a substance for which federal or state law requires a prescription before the substance may be legally dispensed to the public;

(B) a drug or device that under federal law is required, before being dispensed or delivered, to be labeled with the statement:

(i) "Caution: federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law; or

(ii) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian"; or

(C) a drug or device that is required by federal or state statute or regulation to be dispensed on prescription or that is restricted to use by a practitioner only.

(39) [(38)] Prescription drug order--

(A) a written order from a practitioner or a verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or

(B) a written order or a verbal order pursuant to Subtitle B, Chapter 157, Occupations Code.

(40) [(39)] Prospective drug use review--A review of the patient's drug therapy and prescription drug order or medication order prior to dispensing or distributing the drug.

(41) [(40)] State--One of the 50 United States of America, a U.S. territory, or the District of Columbia.

(42) [(41)] Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended.

(43) [(42)] Written protocol--A physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas Medical Board under the Texas Medical Practice Act.

§291.32.Personnel.

(a) (No change.)

(b) Owner. The owner of a Class A pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:

(1) (No change.)

(2) establishment of polices and procedures for the security of the prescription department including the [and ] maintenance of effective controls against the theft or diversion of prescription drugs;

(3) - (5) (No change.)

(c) Pharmacists.

(1) General.

(A) - (E) (No change.)

(F) A dispensing pharmacist shall be responsible for and ensure that the drug is dispensed and delivered safely, and accurately as prescribed, unless the pharmacy's data processing system can record the identity of each pharmacist involved in a specific portion of the dispensing processing, in which case each pharmacist involved in the dispensing process shall be responsible for and ensure that the portion of the process the pharmacist is performing results in the safe and accurate dispensing and delivery of the drug as prescribed . [In addition, if multiple pharmacists participate in the dispensing process, each pharmacist shall ensure the safety and accuracy of the portion of the process the pharmacist is performing.] The dispensing process shall include, but not be limited to, drug regimen review and verification of accurate prescription data entry, including data entry of prescriptions placed on hold, packaging, preparation, compounding and labeling, and performance of the final check of the dispensed prescription.

(2) - (3) (No change.)

(d) - (e) (No change.)

§291.33.Operational Standards.

(a) (No change.)

(b) Environment.

(1) (No change.)

(2) Security.

(A) (No change.)

(B) The prescription department shall be locked by key, combination or other mechanical or electronic means to prohibit unauthorized access when a pharmacist is not on-site except as provided in subparagraphs (C) and (D) of this paragraph and paragraph (3) of this subsection. The following is applicable:

(i) If the prescription department is closed at any time when the rest of the facility is open, the prescription department must be physically or electronically secured. The security may be accomplished by means such as floor to ceiling walls; walls, partitions, or barriers at least 9 feet 6 inches high; electronically monitored motion detectors; or pull down sliders. Pharmacies licensed prior to June 1, 2009, shall be exempt from this provision unless the pharmacy changes location.

(ii) Effective, June 1, 2009, the pharmacy's key, combination, or other mechanical or electronic means of locking the pharmacy may not be duplicated without the authorization of the pharmacist-in-charge or owner.

(iii) Effective, June 1, 2009, at a minimum, the pharmacy must have a basic alarm system with off-site monitoring and perimeter and motion sensors. The pharmacy may have additional security by video surveillance camera systems.

(C) Prior to authorizing individuals to enter the prescription department, the pharmacist-in-charge or owner may designate persons who may enter the prescription department to perform functions, other than dispensing functions or prescription processing, documented by the pharmacist-in-charge including access to the prescription department by other pharmacists, pharmacy personnel and other individuals. The pharmacy must maintain written documentation of authorized individuals other than individuals employed by the pharmacy who accessed the prescription department when a pharmacist is not on-site.

(D) Only persons designated in writing by the pharmacist-in-charge may unlock the prescription department except in emergency situations. An additional key to the prescription department may be maintained in a secure location outside the prescription department for use during an emergency or as designated by the pharmacist-in-charge for entry by another pharmacist.

(E) Written policies and procedures for the pharmacy's security shall be developed and implemented by the pharmacist-in-charge and/or the owner of the pharmacy. Such polices and procedures may include quarterly audits of controlled substances commonly abused or diverted; perpetual inventories for the comparison of the receipt, dispensing, and distribution of controlled substances; monthly reports from the pharmacy's wholesaler(s) of controlled substances purchased by the pharmacy; opening and closing procedures; product storage and placement; and central management oversight.

[(B) The prescription department shall be locked by key or combination so as to prevent access when a pharmacist is not on-site. However, the pharmacist-in-charge may designate persons who may enter the pharmacy to perform functions designated by the pharmacist-in-charge (e.g., janitorial services).]

(3) Temporary absence of pharmacist.

(A) On-site supervision by pharmacist.

(i) If a pharmacy is staffed by only one pharmacist, the pharmacist may leave the prescription department for breaks and meal periods without closing the prescription department and removing pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department provided the following conditions are met:

(I) at least one pharmacy technician remains in the prescription department;

(II) the pharmacist remains on-site at the licensed location of the pharmacy and is immediately available;

(III) the absence does not exceed 30 minutes at a time and a total of one hour in a 12 hour period;

(IV) the pharmacist reasonably believes that the security of the prescription department will be maintained in his or her absence. If in the professional judgment of the pharmacist, the pharmacist determines that the prescription department should close during his or her absence, then the pharmacist shall close the prescription department and remove the pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department during his or her absence; and

(V) a notice is posted which includes the following information:

(-a-) the pharmacist is on a break and the time the pharmacist will return; and

(-b-) pharmacy technicians may begin the processing of prescription drug orders or refills brought in during the pharmacist's absence, but the prescription or refill may not be delivered to the patient or the patient's agent until the pharmacist verifies the accuracy of the prescription.

(ii) During the time a pharmacist is absent from the prescription department, only pharmacy technicians who have completed the pharmacy's training program may perform the following duties, provided a pharmacist verifies the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent:

(I) initiating and receiving refill authorization requests;

(II) entering prescription data into a data processing system;

(III) taking a stock bottle from the shelf for a prescription;

(IV) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container);

(V) affixing prescription labels and auxiliary labels to the prescription container; and

(VI) prepackaging and labeling prepackaged drugs.

(iii) Upon return to the prescription department, the pharmacist shall:

(I) conduct a drug regimen review as specified in subsection (c)(2) of this section; and

(II) verify the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent.

(iv) An agent of the pharmacist may deliver a previously verified prescription to the patient or his or her agent provided a record of the delivery is maintained containing the following information:

(I) date of the delivery;

(II) unique identification number of the prescription drug order;

(III) patient's name;

(IV) patient's phone number or the phone number of the person picking up the prescription; and

(V) signature of the person picking up the prescription.

(v) Any prescription delivered to a patient when a pharmacist is not in the prescription department must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.

(vi) During the times a pharmacist is absent from the prescription department a pharmacist intern shall be considered a registered pharmacy technician and may perform only the duties of a registered pharmacy technician.

(vii) In pharmacies with two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the prescription department is not left without a pharmacist on duty.

(B) Pharmacist is off-site.

(i) The prescription department must be secured with procedures for entry during the time that a pharmacy is not under the continuous on-site supervision of a pharmacist and the pharmacy is not open for pharmacy services.

(ii) Pharmacy technicians and pharmacy technician trainees may not perform any duties of a pharmacy technician or pharmacy technician trainee during the time that the a pharmacist is off-site.

(iii) An agent of the pharmacist may deliver a previously verified prescription to a patient or patient's agent during short periods of time when a pharmacist is off-site, provided the following conditions are met:

(I) short periods of time may not exceed two consecutive hours in a 24 hour period;

(II) a notice is posted which includes the following information:

(-a-) the pharmacist is off-site and not present in the pharmacy;

(-b-) no new prescriptions may be prepared at the pharmacy but previously verified prescriptions may be delivered to the patient or the patient's agent; and

(-c-) the date/time when the pharmacist will return.

(III) the pharmacy must maintain documentation of the absences of the pharmacist(s); and

(IV) the prescription department is locked and secured to prohibit unauthorized entry.

(iv) During the time a pharmacist is absent from the prescription department and is off-site, a record of prescriptions delivered must be maintained and contain the following information:

(I) date and time of the delivery;

(II) unique identification number of the prescription drug order;

(III) patient's name;

(IV) patient's phone number or the phone number of the person picking up the prescription; and

(V) signature of the person picking up the prescription.

(v) Any prescription delivered to a patient when a pharmacist is not on-site at the pharmacy must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.

[(A) If a pharmacy is staffed by a single pharmacist, the pharmacist may leave the prescription department for breaks and meal periods without closing the prescription department and removing pharmacy technicians and other pharmacy personnel from the prescription department provided the following conditions are met:]

[(i) at least one registered pharmacy technician remains in the prescription department;]

[(ii) the pharmacist remains on-site at the licensed location of the pharmacy and available for an emergency;]

[(iii) the absence does not exceed 30 minutes at a time and a total of one hour in a 12 hour period;]

[(iv) the pharmacist reasonably believes that the security of the prescription department will be maintained in his or her absence. If in the professional judgment of the pharmacist, the pharmacist determines that the prescription department should close during his or her absence, then the pharmacist shall close the prescription department and remove the pharmacy technicians or other pharmacy personnel from the prescription department during his or her absence; and]

[(v) a notice is posted which includes the following information:]

[(I) the fact that pharmacist is on a break and the time the pharmacist will return; and]

[(II) the fact that pharmacy technicians may begin the processing of prescription drug orders or refills brought in during the pharmacist absence but the prescription or refill may not be delivered to the patient or the patient's agent until the pharmacist returns and verifies the accuracy of the prescription.]

[(B) During the time a pharmacist is absent from the prescription department, only pharmacy technicians who have completed the pharmacy's training program may perform the following duties, provided a pharmacist verifies the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent:]

[(i) initiating and receiving refill authorization requests;]

[(ii) entering prescription data into a data processing system;]

[(iii) taking a stock bottle from the shelf for a prescription;]

[(iv) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container);]

[(v) affixing prescription labels and auxiliary labels to the prescription container provided the pharmacy technician:]

[(I) has completed the training requirements outlined in §297.6 of this title (relating to Pharmacy Technician Training); and]

[(II) is registered as a pharmacy technician within the provisions of §297.3 of this title (relating to Registration Requirements); and]

[(vi) prepackaging and labeling prepackaged drugs.]

[(C) Upon return to the prescription department, the pharmacist shall:]

[(i) conduct a drug regimen review as specified in subsection (c)(2) of this section; and]

[(ii) verify the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent.]

[(D) An agent of the pharmacist may deliver a prescription drug order to the patient or his or her agent provided a record of the delivery is maintained containing the following information:]

[(i) date of the delivery;]

[(ii) unique identification number of the prescription drug order;]

[(iii) patient's name;]

[(iv) patient's phone number or the phone number of the person picking up the prescription; and]

[(v) signature of the person picking up the prescription.]

[(E) Any prescription delivered to a patient when a pharmacist is not in the prescription department must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.]

[(F) During the times a pharmacist is absent from the prescription department a pharmacist intern shall be considered a registered pharmacy technician and may perform only the duties of a registered pharmacy technician.]

[(G) In pharmacies with two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the prescription department is not left without a pharmacist on duty.]

(c) Prescription dispensing and delivery.

(1) Patient counseling and provision of drug information.

(A) (No change.)

(B) Such communication:

(i) - (ii) (No change.)

(iii) shall be communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication; [ and]

(iv) effective, June 1, 2009, shall be documented by recording the initials or identification code of the pharmacist providing the counseling in the prescription dispensing record on either the original hard-copy prescription or in the pharmacy's data processing system; and

(v) [(iv)] shall be reinforced with written information relevant to the prescription and provided to the patient or patient's agent. The following is applicable concerning this written information.

(I) Written information must be in plain language designed for the consumer[, such as the USP DI patient information leaflets, ] and printed in easily readable font size.

(II) When a compounded product is dispensed, information shall be provided for the major active ingredient(s), if available.

(III) For new drug entities, if no written information is initially available, the pharmacist is not required to provide information until such information is available, provided:

(-a-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available;

(-b-) the pharmacist documents the fact that no written information was provided; and

(-c-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent.

(C) - (D) (No change.)

(E) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient at the pharmacy, the following is applicable.

(i) So that a patient will have access to information concerning his or her prescription, a prescription may not be delivered to a patient unless a pharmacist is in the pharmacy, except as provided in subsection (b)(3) of this section. [or clause (ii) of this subparagraph.]

[(ii) An agent of the pharmacist may deliver a prescription drug order to the patient or his or her agent during short periods of time when a pharmacist is absent from the pharmacy, provided the short periods of time do not exceed two hours in a 24 hour period, and provided a record of the delivery is maintained containing the following information:]

[(I) date of the delivery;]

[(II) unique identification number of the prescription drug order;]

[(III) patient's name;]

[(IV) patient's phone number or the phone number of the person picking up the prescription; and]

[(V) signature of the person picking up the prescription.]

(ii) [(iii)] Any prescription delivered to a patient when a pharmacist is not in the pharmacy must meet the requirements described in subparagraph (F) of this paragraph.

(iii) [(iv)] A Class A pharmacy shall make available for use by the public a current or updated edition of the United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient), or another source of such information designed for the consumer.

(F) - (I) (No change.)

(2) - (7) (No change.)

(d) - (i) (No change.)

§291.34.Records.

(a) (No change.)

(b) Prescriptions.

(1) - (5) (No change.)

(6) Prescription drug order information.

(A) - (C) (No change.)

(D) At the time of dispensing, a pharmacist is responsible for documenting the following information on either the original hard-copy prescription or in the pharmacy's data processing system:

(i) - (iv) (No change.)

(v) date of dispensing, if different from the date of issuance; [and]

(vi) brand name or manufacturer of the drug product actually dispensed, if the drug was prescribed by generic name or if a drug product other than the one prescribed was dispensed pursuant to the provisions of the Act, Chapters 562 and 563; and [.]

(vii) effective June 1, 2009, for each new prescription the initials or identification code of the pharmacist responsible for providing counseling.

(7) Refills.

(A) - (D) (No change.)

(E) If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a [A ] pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:

(i) (No change.)

[(ii) either:]

[(I) a natural or manmade disaster has occurred which prohibits the pharmacist from being able to contact the practitioner; or]

[(II) the pharmacist is unable to contact the practitioner after a reasonable effort;]

(ii) [(iii)] the quantity of prescription drug dispensed does not exceed a 72-hour supply;

(iii) [(iv)] the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;

(iv) [(v)] the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;

(v) [(vi)] the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;

(vi) [(vii)] the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and

(vii) [(viii)] if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:

(I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;

(II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;

(III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) [and (ii)] of this subparagraph; and

(IV) the pharmacist complies with the requirements of clauses (ii) - (vi) [(iii) - (v)] of this subparagraph.

(F) If a natural or manmade disaster has occurred that prohibits the pharmacist from being able to contact the practitioner, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:

(i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;

(ii) the quantity of prescription drug dispensed does not exceed a 30-day supply;

(iii) the governor has declared a state of disaster;

(iv) the board, through the executive director, has notified pharmacies that pharmacists may dispense up to a 30-day supply of prescription drugs;

(v) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;

(vi) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;

(vii) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;

(viii) the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and

(ix) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:

(I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;

(II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;

(III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and

(IV) the pharmacist complies with the requirements of clauses (ii) - (viii) of this subparagraph.

(c) - (j) (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.

Filed with the Office of the Secretary of State on March 6, 2008.

TRD-200801347

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: April 20, 2008

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

22 TAC §291.104

The Texas State Board of Pharmacy proposes amendments to §291.104, concerning Operational Standards. The amendments, if adopted, clarify the labeling requirements for Class E pharmacies shipping prescriptions to Texas residents.

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

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will ensure that out-of-state pharmacies shipping prescriptions to Texas residents include information on a prescription label to adequately identify the pharmacy. Ms. Dodson has determined that of the approximate 450 Class E pharmacies, less than 100 pharmacies may be considered a small business as defined in the Texas Government Code §2006.001(2). Although pharmacies are required to include certain information on prescription labels, there may be an economic impact to pharmacies if new labels are required to be printed or if there are programming costs associated with making changes to print the required information on the prescription label. It is difficult for the Board to determine these costs since these pharmacies are not located in Texas and there are numerous computer systems used by pharmacies. There is no fiscal impact for individuals which are required to comply with the amended section.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 pm, April 30, 2008.

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

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

§291.104.Operational Standards.

(a) (No change.)

(b) Prescription dispensing and delivery.

(1) General.

(A) All prescription drugs and/or devices shall be dispensed and delivered safely and accurately as prescribed.

(B) The pharmacy shall maintain adequate storage or shipment containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of packaging material and devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process.

(C) The pharmacy shall utilize a delivery system which is designed to assure that the drugs are delivered to the appropriate patient.

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

(E) Prior to dispensing a prescription, pharmacists shall determine, in the exercise of sound professional judgment, that the prescription is a valid prescription. A pharmacist may not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued on the basis of an Internet-based or telephonic consultation without a valid patient-practitioner relationship.

(F) Subparagraph (E) of this paragraph does not prohibit a pharmacist from dispensing a prescription when a valid patient-practitioner relationship is not present in an emergency situation (e.g. a practitioner taking calls for the patient's regular practitioner).

(2) Drug regimen review.

(A) For the purpose of promoting therapeutic appropriateness, a pharmacist shall prior to or at the time of dispensing a prescription drug order, review the patient's medication record. Such review shall at a minimum identify clinically significant:

(i) inappropriate drug utilization;

(ii) therapeutic duplication;

(iii) drug-disease contraindications;

(iv) drug-drug interactions;

(v) incorrect drug dosage or duration of drug treatment;

(vi) drug-allergy interactions; and

(vii) clinical abuse/misuse.

(B) Upon identifying any clinically significant conditions, situations, or items listed in subparagraph (A) of this paragraph, the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner. The pharmacist shall document such occurrences.

(3) Patient counseling and provision of drug information.

(A) To optimize drug therapy, a pharmacist shall communicate to the patient or the patient's agent, information about the prescription drug or device which in the exercise of the pharmacist's professional judgment the pharmacist deems significant, such as the following:

(i) the name and description of the drug or device;

(ii) dosage form, dosage, route of administration, and duration of drug therapy;

(iii) special directions and precautions for preparation, administration, and use by the patient;

(iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(v) techniques for self monitoring of drug therapy;

(vi) proper storage;

(vii) refill information; and

(viii) action to be taken in the event of a missed dose.

(B) Such communication:

(i) shall be provided with each new prescription drug order;

(ii) shall be provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent;

(iii) shall be communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication; and

(iv) shall be reinforced with written information. The following is applicable concerning this written information:

(I) Written information designed for the consumer, such as the USP DI patient information leaflets, shall be provided.

(II) When a compounded product is dispensed, information shall be provided for the major active ingredient(s), if available.

(III) For new drug entities, if no written information is initially available, the pharmacist is not required to provide information until such information is available, provided:

(-a-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available.

(-b-) the pharmacist documents the fact that no written information was provided; and

(-c-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent.

(C) Only a pharmacist may orally provide drug information to a patient or patient's agent and answer questions concerning prescription drugs. Non-pharmacist personnel may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist.

(D) If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist.

(E) The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."

(F) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., nursing homes).

(G) Upon delivery of a refill prescription, a pharmacist shall ensure that the patient or patient's agent is offered information about the refilled prescription and that a pharmacist is available to discuss the patient's prescription and provide information.

(H) Nothing in this subparagraph shall be construed as requiring a pharmacist to provide consultation when a patient or patient's agent refuses such consultation. The pharmacist shall document such refusal for consultation.

(4) Labeling. Unless compliance would violate the pharmacy or drug laws or rules in the state in which the pharmacy is located, at the time of delivery of the drug, the dispensing container shall bear a label with at least the following information:

(A) name, address, and phone number of the pharmacy;

(B) unique identification number of the prescription;

(C) date the prescription is dispensed;

(D) initials or an identification code of the dispensing pharmacist;

(E) name of the prescribing practitioner;

(F) name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner;

(G) instructions for use;

(H) quantity dispensed;

(I) appropriate ancillary instructions such as storage instructions or cautionary statements such as warnings of potential harmful effects of combining the drug product with any product containing alcohol;

(J) if the prescription is for a Schedules II - IV controlled substance, the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed";

(K) if the pharmacist has selected a generically equivalent drug, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed;

(L) the name of the advanced practice nurse or physician assistant, if the prescription is carried out or signed by an advanced practice nurse or physician assistant; and

(M) the name and strength of the actual drug product dispensed, unless otherwise directed by the prescribing practitioner.

(i) The name shall be either:

(I) the brand name; or

(II) if no brand name, then the generic name and name of the manufacturer or distributor of such generic drug. (The name of the manufacturer or distributor may be reduced to an abbreviation or initials, provided the abbreviation or initials are sufficient to identify the manufacturer or distributor. For combination drug products or non-sterile compounded drug products having no brand name, the principal active ingredients shall be indicated on the label.)

(ii) Except as provided in subparagraph (K) of this paragraph, the brand name of the prescribed drug shall not appear on the prescription container label unless it is the drug product actually dispensed.

(c) - (f) (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.

Filed with the Office of the Secretary of State on March 6, 2008.

TRD-200801348

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: April 20, 2008

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

22 TAC §297.7

The Texas State Board of Pharmacy proposes amendments to §297.7 concerning Exemption from Pharmacy Technician Certification Requirements. The amendments, if adopted, clarify that pharmacy technicians that are exempted from the certification requirements are required to register with the Board and are not exempted from registration requirements.

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

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will ensure that individuals exempted from technician certification requirements are registered with the Board and are qualified to work in a pharmacy. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., April 30, 2008.

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

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

§297.7.Exemption from Pharmacy Technician Certification Requirements.

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

(c) Rural county exempt pharmacy technicians. Rural county exempt pharmacy technicians are pharmacy technicians working in counties with a population of 50,000 or less and meet the following requirements.

(1) Eligibility. An individual may petition the board for an exemption from the certification requirements established by §568.002 of the Act (relating to Pharmacy Technician Registration Required) if the individual works in a county with a population of 50,000 or less.

(2) Petition process.

(A) An individual shall petition the board for the exemption. The petition shall contain the following:

(i) name of the individual;

(ii) name, address, and license number of the pharmacy where the individual is employed;

(iii) name of the county in which the pharmacy is located and the most recent official population estimate for the county from the Texas State Data Center;

(iv) a notarized statement signed by the individual stating:

(I) the reason(s) the individual is asking for the exemption, including reason(s) the individual has not taken and passed the National Pharmacy Technician Certification Exam or other examination approved by the board; and

(II) that the information provided in the petition is true and correct; and

(v) a notarized statement signed by the pharmacist-in-charge of the pharmacy the individual is currently working, stating that the:

(I) pharmacist-in-charge supports the individual's petition for exemption;

(II) individual has completed the pharmacy technician training program at the pharmacy; and

(III) pharmacist-in-charge has personally worked with and observed that the individual is competent to perform the duties of a pharmacy technician.

(B) Each petition shall be considered on an individual basis. In determining whether to grant the exemption, the board shall consider the information contained in the petition and additional information including the following:

(i) the accuracy and completeness of the petition;

(ii) reason(s) the individual is asking for the exemption;

(iii) the population of the county;

(iv) the number of pharmacies located in the county and adjacent counties and the number of pharmacy technicians working in these pharmacies;

(v) unemployment rate in the county and adjacent counties; and

(vi) the following information concerning the pharmacy where the individual is currently working:

(I) the degree of compliance on previous compliance inspections; and

(II) history of disciplinary action by the board or other regulatory agencies against the licenses held by the pharmacy or pharmacists working at the pharmacy.

(C) After review of the petition, the individual and the pharmacist-in-charge of the pharmacy where the individual is working shall be notified in writing of approval or denial of the petition.

[(i) If the petition is approved, the individual shall be sent an exemption certificate, which shall be displayed at the pharmacy where the pharmacy technician is working.]

[(ii) In lieu of the exemption, the board may grant the individual up to an additional 12 months to take and pass the National Pharmacy Technician Certification Exam or other examination approved by the board. During this additional time, the individual shall be designated a pharmacy technician trainee.]

(D) If the petition is approved, the individual shall register with the board as a pharmacy technician.

(3) Limitations.

(A) The exemption granted under this section may only be used at the pharmacy noted in the petition and may not be transferred to another pharmacy. If the pharmacy technician ceases employment at the pharmacy or changes employment, the exemption is canceled.

(B) If the population of the county exceeds 50,000, the board shall cancel the exemption. The pharmacy technician and the pharmacist-in-charge of the pharmacy shall be notified when an exemption is canceled.

(C) If the exemption granted under subparagraphs (A) or (B) of this paragraph is cancelled, the pharmacy technician's registration is void and the registration certificate must be surrendered to 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.

Filed with the Office of the Secretary of State on March 6, 2008.

TRD-200801349

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: April 20, 2008

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

22 TAC §309.3

The Texas State Board of Pharmacy proposes amendments to §309.3 concerning Generic Substitution. The amendments, if adopted, will implement S.B. 625 passed by the 80th Texas Legislature requiring a joint committee comprised of equal number of members from the Texas State Board of Pharmacy (TSBP) and the Texas Medical Board to make a recommendation to TSBP on whether to include a drug on the list of narrow therapeutic index (NTI) drugs as required by §562.0142. The Joint Committee met on November 19, 2007, to consider adding certain immunosuppressant drugs to the NTI list. The Joint Committee met on January 14, 2008, to consider adding certain epileptic drugs to the NTI list. The Joint Committee recommended on both occasions that no drugs be added to the NTI list. In addition, the amendments, if adopted, will rename Chapter 309 to Substitution of Drug Products.

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

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

Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., April 30, 2005.

The amendments are proposed under §§551.002, 554.051, and 562.0141 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.014 as authorizing the Board in consultation with the Texas Medical Board, to establish by a rule a list of NTI drugs.

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

§309.3.Generic Substitution.

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

(c) Dispensing directive.

(1) Written prescriptions.

(A) A practitioner may prohibit the substitution of a generically equivalent drug product for a brand name drug product by writing across the face of the written prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."

(B) The dispensing directive shall:

(i) be in a format that protects confidentiality as required by the Health Insurance Portability and Accountability Act of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent amendments; and

(ii) comply with federal and state law, including rules, with regard to formatting and security requirements.

(C) The dispensing directive specified in this paragraph may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.

(D) A [After, June 1, 2002, a] practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.

[(E) A written prescription drug order issued prior to June 1, 2002, but presented for dispensing on or after June 1, 2002, shall follow the substitution instructions on the prescription.]

(2) - (4) (No change.)

(d) (No change.)

(e) Refills.

(1) Original substitution instructions. All refills shall follow the original substitution instructions unless otherwise indicated by the practitioner or practitioner's agent.

[(A) All refills, shall follow the original substitution instructions, unless otherwise indicated by the practitioner or practitioner's agent.]

[(B) Prescriptions issued prior to June 1, 2002, on the two-line form shall follow the substitution instructions on the form.]

(2) Narrow therapeutic index drugs.

(A) The board and the Texas Medical Board shall establish a joint committee to recommend to the board a list of narrow therapeutic index drugs and the rules, if any, by which this paragraph applies to those drugs. The committee must consist of an equal number of members from each board. The committee members shall select a member of the committee to serve as presiding officer for a one year term. The presiding officer may not represent the same board as the presiding officer's predecessor.

(B) [(A)] The board, on the recommendation of the joint committee, [in consultation with the Texas State Board of Medical Examiners,] has determined that no drugs shall be included on a list of narrow therapeutic index drugs as defined in §562.013, Occupations Code.

(i) The board has specified in §309.7 of this title (relating to dispensing responsibilities) that for drugs listed in the publication, pharmacist shall use as a basis for determining generic equivalency, Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication. For drugs listed in the publications, pharmacists may only substitute products that are rated therapeutically equivalent in the Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements.

(ii) Practitioners may prohibit substitution through a dispensing directive in compliance with subsection (c) of this section.

(C) [(B)] The board shall reconsider the contents of the list if: [the Federal Food and Drug Administration determines a new equivalence classification which indicates that certain drug products are equivalent but special notification to the patient and practitioner is required when substituting these products.]

(i) the Federal Food and Drug Administration determines a new equivalence classification which indicates that certain drug products are equivalent but special notification to the patient and practitioner is required when substituting these products; or

(ii) any interested person petitions the board to reconsider the list. If the board receives a petition to include a drug on the list, the joint committee specified in subparagraph (A) of this paragraph shall review the request and make a recommendation to 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.

Filed with the Office of the Secretary of State on March 6, 2008.

TRD-200801350

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: April 20, 2008

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

Chapter 535. GENERAL PROVISIONS

Subchapter F. EDUCATION, EXPERIENCE, EDUCATIONAL PROGRAMS, TIME PERIODS AND TYPE OF LICENSE

22 TAC §535.62

The Texas Real Estate Commission (TREC) proposes an amendment to §535.62, concerning Acceptable Courses of Study.

The amendment to §535.62 changes the requirements for acceptability of correspondence courses offered to meet core education requirements for a real estate salesperson or broker license under the Real Estate License Act, Texas Occupations Code, Chapter 1101. Currently correspondence courses must be offered by an accredited college or university. Under the proposed amendment, TREC would continue to accept correspondence courses offered by accredited colleges and universities, but correspondence courses approved by the commission and offered by schools accredited by the commission and acceptable correspondence courses approved by a real estate regulatory agency of another state could be used to meet education requirements for a real estate salesperson or broker license under the Real Estate License Act.

Karen Alexander, Staff Services Director, has determined that for the first five-year period the amendments are in effect there will be no significant fiscal implications for the state or for units of local government as a result of enforcing or administering the amendments. There is no anticipated impact on local or state employment as a result of implementing the amendments. There will not be an adverse economic impact on small businesses and micro-businesses as a result of implementing the amendment. The economic cost to persons who are required to comply with the proposed section will be the fee associated with becoming accredited by TREC if the person is not already a TREC accredited school, currently $400.

The proposed amendments contain provisions for licensed proprietary schools to continue operating in the same manner as currently established with the additional ability to offer correspondence courses. Further, businesses that have existing relationships with colleges and universities are not precluded from maintaining the relationship, but they will also be able to independently offer approved correspondence courses if the businesses become accredited or licensed with TREC.

Ms. Alexander also has determined that for each year of the first five years the amendments as proposed are in effect the public benefit anticipated as a result of enforcing the amendments will be that existing TREC education providers will be able to independently offer correspondence courses that applicants and licensees may use for education credit.

Comments on the proposal may be submitted to Loretta R. DeHay, General Counsel, Texas Real Estate Commission, P.O. Box 12188, Austin, Texas 78711-2188.

The amendments are proposed under Texas Occupations Code, §1101.151, which authorizes the Texas Real Estate Commission to make and enforce all rules and regulations necessary for the performance of its duties and to establish standards of conduct and ethics for its licensees in keeping with the purpose and intent of the Act to insure compliance with the provisions of the Act.

The statutes affected by this proposal are Texas Occupations Code, Chapters 1101 and 1102. No other statute, code or article is affected by the proposed amendments.

§535.62.Acceptable Courses of Study.

(a) - (c) (No change.)

(d) A core real estate course also must meet each of the following requirements to be accepted.

(1) - (4) (No change.)

(5) For a correspondence course[, the course must have been offered by an accredited college or university, and students receiving credit for the course must pass either]:

(A) the course must have been offered by:

(i) an accredited college or university:

(ii) a school accredited by the commission; or

(iii) a real estate regulatory agency of another state.

(B) Students receiving credit for the course must pass either:

(i) a proctored final examination administered under controlled conditions to positively identified students and graded by the instructor or, if the examination is being graded mechanically or by use of a computer, by the provider, using answer keys approved by the instructor or provider; or

(ii) an examination by use of a computer under conditions that satisfy the commission that the examinee is the same person who seeks course credit.

[(A) a proctored final examination administered under controlled conditions to positively identified students and graded by the instructor or, if the examination is being graded mechanically or by use of a computer, by the provider, using answer keys approved by the instructor or provider; or]

[(B) an examination by use of a computer under conditions that satisfy the commission that the examinee is the same person who seeks course credit.]

(6) - (9) (No change.)

(e) - (f) (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.

Filed with the Office of the Secretary of State on March 3, 2008.

TRD-200801273

Loretta R. DeHay

Assistant Administrator and General Counsel

Texas Real Estate Commission

Earliest possible date of adoption: April 20, 2008

For further information, please call: (512) 465-3900

22 TAC §535.71

The Texas Real Estate Commission (TREC) proposes amendments to §535.71, concerning Mandatory Continuing Education: Approval of Providers, Courses and Instructors.

The amendments to §535.71 change the requirements for approval of correspondence courses offered to meet mandatory continuing education (MCE) requirements for a real estate salesperson or broker license under the Real Estate License Act, Texas Occupations Code, Chapter 1101. Currently correspondence courses must be offered by an accredited college or university. TREC would continue to accept correspondence courses offered by accredited colleges and universities, but correspondence courses approved by the commission and offered by a school accredited by the commission and acceptable correspondence courses approved by a real estate regulatory agency of another state could be used to meet mandatory continuing education requirements for a real estate salesperson or broker license under the Real Estate License Act.

Karen Alexander, Staff Services Director, has determined that for the first five-year period the amendments are in effect there will be no significant fiscal implications for the state or for units of local government as a result of enforcing or administering the amendments. There is no anticipated impact on local or state employment as a result of implementing the amendments. There will not be an adverse economic impact on small businesses and micro-businesses as a result of implementing the amendments.

The economic cost to persons who are required to comply with the proposed section will be the fees associated with becoming a TREC MCE provider if the person is not already a TREC provider. The proposed amendment contains provisions for MCE providers to continue operating in the same manner as currently established with the additional ability to offer correspondence courses. Further, businesses that have existing relationships with colleges and universities are not precluded from maintaining the relationship, but they will also be able to independently offer approved correspondence courses if the businesses become a TREC MCE provider.

Ms. Alexander also has determined that for each year of the first five years the amendments as proposed are in effect the public benefit anticipated as a result of enforcing the amendments will be that existing TREC MCE providers will be able to independently offer correspondence courses that applicants and licensees may use for MCE credit.

Comments on the proposal may be submitted to Loretta R. DeHay, General Counsel, Texas Real Estate Commission, P.O. Box 12188, Austin, Texas 78711-2188.

The amendments are proposed under Texas Occupations Code, §1101.151, which authorizes the Texas Real Estate Commission to make and enforce all rules and regulations necessary for the performance of its duties and to establish standards of conduct and ethics for its licensees in keeping with the purpose and intent of the Act to insure compliance with the provisions of the Act.

The statutes affected by this proposal are Texas Occupations Code, Chapters 1101 and 1102. No other statute, code or article is affected by the proposed amendments.

§535.71.Mandatory Continuing Education: Approval of Providers, Courses and Instructors.

(a) - (w) (No change.)

(x) Correspondence courses for elective credit. An MCE provider may register an MCE elective course by correspondence with the commission if the course is subject to the following conditions:

[(1) the course must be offered by a college or university accredited by a regional accrediting association, such as the Commission on Colleges of the Southern Association of Colleges and Schools, or its equivalent, which offers correspondence courses, whether credit or noncredit, in other disciplines;]

(1) [(2)] the content of the course must satisfy the requirements of the Act, §1101.455, and these sections; and

(2) [(3)] the course does not include a request for required legal course credit.

(y) (No change.)

(z) Correspondence courses for required legal credit. The commission may approve a provider to offer an MCE required legal ethics course by correspondence subject to the following conditions:

[(1) the course must be offered by a college or university accredited by a regional accrediting association, such as the Commission on Colleges of the Southern Association of Colleges and Schools, or its equivalent, which offers correspondence courses, whether credit or noncredit, in other disciplines;]

(1) [(2)] the content of the course must satisfy the requirements of the Act, §1101.455 and these sections, and must be substantially similar to the legal courses disseminated and updated by the Commission;

(2) [(3)] students receiving MCE credit for the course must pass either:

(A) a proctored final examination administered under controlled conditions to positively identified students, at a location and by an official approved by the commission and graded by the instructor or, if the examination is being graded mechanically or by use of a computer, by the provider, using answer keys approved by the instructor or provider; or

(B) an examination by use of a computer under conditions that satisfy the commission that the examinee is the same person who seeks MCE credit; and

(3) [(4)] written course work required of students must be graded by an approved instructor or the provider's coordinator or director, who is available to answer students' questions or provide assistance as necessary, using answer keys approved by the instructor or provider.

(aa) - (hh) (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.

Filed with the Office of the Secretary of State on March 3, 2008.

TRD-200801274

Loretta R. DeHay

Assistant Administrator and General Counsel

Texas Real Estate Commission

Earliest possible date of adoption: April 20, 2008

For further information, please call: (512) 465-3900

22 TAC §535.92, §535.95

The Texas Real Estate Commission (TREC) proposes amendments to §535.92, concerning Renewal: Time for Filing; Satisfaction of Mandatory Continuing Education (MCE) Requirements and §535.95, concerning Miscellaneous Provisions Concerning License or Registration Renewals.

The amendments to §535.92(f) change the procedure for licensees who choose to pay an MCE deferral fee under §1101.457, Texas Occupations Code to defer MCE requirements for an additional 60 days after the date the license is renewed. If a licensee fails to timely pay the deferral fee or fails to complete the MCE requirements within the 60-day period, the license will be placed on inactive status. To reactivate the license, the licensee must pay an additional $250 fee, pay the original $200 deferral fee, complete the MCE requirements, certify that the licensee has not engaged in real estate brokerage activity, and pay the appropriate change fee.

The amendments to §535.92(h) change the requirements for approval of correspondence courses offered to meet MCE requirements for a real estate salesperson or broker license under the Real Estate License Act, Texas Occupations Code, Chapter 1101. Currently correspondence courses must be offered by an accredited college or university. TREC would continue to accept correspondence courses offered by accredited colleges and universities, but correspondence courses approved by the commission and offered by a school accredited by the commission and acceptable correspondence courses approved by a real estate regulatory agency of another state could be used to meet mandatory continuing education requirements for a real estate salesperson or broker license under the Real Estate License Act.

The amendments to §535.95 are proposed to clarify recent amendments to the Real Estate License Act (the Act), Texas Occupations Code, Chapter 1101, enacted by House Bill 1530, 80th Legislative Session, Regular Session, regarding fingerprinting requirements. The amendments would clarify fingerprinting requirements in cases where a licensee renews a license, has been fingerprinted, and the fingerprints have been rejected by the DPS or the FBI. The proposed amendments to §535.95 amend the text of the title of the section and authorize the commission to renew a salesperson or broker license on active status if the licensee has provided at least one set of fingerprints to the Department of Public Safety (DPS), the fingerprints were rejected by the DPS or the Federal Bureau of Investigation (FBI), and the licensee has met all other requirements for renewal of the license including paying a renewal fee and completing or properly deferring MCE (MCE) requirements. In some cases the DPS or the FBI requires that the licensee, at no additional cost, submit additional data or more fingerprints if the first set of fingerprints were rejected for technical reasons. The proposed rule authorizes the commission to issue the license in such cases if the licensee has otherwise complied with all other renewal requirements, and requires the commission to notify the licensee that the licensee needs to contact the DPS to submit additional fingerprints. The proposed rule authorizes the commission to take disciplinary action against a licensee for failing to provide the requested data in a timely manner.

Karen Alexander, Staff Services Director, has determined that for the first five-year period the amendments to §535.92(f) are in effect there will be fiscal implications for the state, but not for units of local government as a result of enforcing or administering the sections. The Enforcement Division currently assesses administrative penalties against approximately 120 licensees per year for failing to timely complete MCE under §1101.456, Texas Government Code. If the trend continues the fiscal impact will be approximately ten licensees a month paying the $250 late reporting fee in lieu of administrative penalties producing $5,000 additional revenue for fiscal year 2008, $30,000 for 2009, $30,000 for 2010, $30,000 for 2011, $30,000 and $30,000 for 2012.

Ms. Alexander has determined that for the first five-year period the amendments to §535.92(g) and §535.95 are in effect there will be no significant fiscal implications for the state or for units of local government as a result of enforcing or administering the sections. There is no anticipated impact on local or state employment as a result of implementing any of the amendments. There is no anticipated adverse impact on small businesses and micro-businesses.

There is no anticipated economic cost to persons who are required to comply with the proposed amendments to §535.92(f). The proposed amendment to §535.92(f) merely changes the procedure so that rather than paying an administrative penalty, the licensee will pay a late reporting fee to reactivate his or her license. The economic cost to persons who are required to comply with the proposed amendments to §535.92(g) will be the fees associated with becoming a TREC MCE provider if the person is not already a TREC MCE provider. There is no anticipated economic cost to persons who are required to comply with the proposed amendments to §535.95.

Ms. Alexander also has determined that for each year of the first five years the amendments to §535.92(f) are in effect the public benefit anticipated as a result of enforcing the amendment will be fewer cases referred to enforcement for persons who fail to comply with the late MCE requirements as such licenses will automatically go on inactive status if the licensee fails to timely comply. For each year of the first five years the amendments to §535.92(g) are in effect the public benefit anticipated as a result of enforcing the amendment will be that existing TREC MCE providers will be able to independently offer correspondence courses that applicants and licensees may use for MCE credit. For each year of the first five years the amendments to §535.95 are in effect the public benefit anticipated as a result of enforcing the amendment will be clarification of fingerprinting requirements in cases where there have been technical difficulties obtaining the fingerprint so that the license may be issued if the licensee has otherwise met all other requirements for renewal of the license.

Comments on the proposal may be submitted to Loretta R. DeHay, General Counsel, Texas Real Estate Commission, P.O. Box 12188, Austin, Texas 78711-2188.

The amendments are proposed under Texas Occupations Code, §1101.151, which authorizes the Texas Real Estate Commission to make and enforce all rules and regulations necessary for the performance of its duties and to establish standards of conduct and ethics for its licensees in keeping with the purpose and intent of the Act to insure compliance with the provisions of the Act.

The statutes affected by this proposal are Texas Occupations Code, Chapters 1101 and 1102, and Senate Bill 914 and House Bill 1530, 80th Legislature, Regular Session. No other statute, code or article is affected by the proposed amendments.

§535.92.Renewal: Time for Filing; Satisfaction of Mandatory Continuing Education Requirements.

(a) - (e) (No change.)

(f) Notwithstanding any provisions of the Act to the contrary, when a licensee in an active status files a timely application to renew a current license and has satisfied all requirements other than the completion of applicable MCE requirements, the commission shall renew the current license in an active status. [and notify the licensee in writing that if the licensee has not completed the required number of hours of MCE courses prior to the expiration date of the current license, the licensee must pay an additional fee of $200 and complete the required number of hours of MCE courses within 60 days after the effective date of the new license. For the purpose of this section, a renewed license is effective the day following the expiration of the current license. If the licensee does not complete the required number of hours of MCE courses prior to the expiration date of the current license, the licensee shall complete the required number of hours of MCE courses and pay the additional fee within 60 days after the effective date of the new license. MCE courses completed after expiration of the current license under this provision may not be applied to the following renewal of the license. Original applications and return to active status are subject to MCE requirements imposed by the Act.]

(1) If the licensee has not completed MCE requirements prior to the expiration of the current license, the licensee must, within 60 days after the effective date of the new license, pay an additional MCE deferral fee of $200 AND complete the required number of MCE hours.

(2) If, within 15 days after the end of the 60 day period set out in paragraph (1) of this subsection, the commission has not been provided with evidence that the licensee has completed the required number of MCE hours and paid the MCE deferral fee of $200, the renewed license shall be placed on inactive status.

(3) In order to reactivate a license placed on inactive status under this subsection, the licensee must:

(A) provide the commission with evidence that the licensee has completed the required MCE hours;

(B) certify, on a form acceptable to the commission, that the licensee has not engaged in activity requiring a license at any time after the license became inactive;

(C) complete and submit a Request to Return to Active Status Form if a broker or a Salesperson Sponsorship Form if a salesperson and pay the appropriate fee;

(D) if the license was placed on inactive status because the licensee failed to timely pay the $200 MCE deferral fee required by paragraph (1) of this subsection, the licensee must, because the licensee received the benefits of the 60-day deferral, pay the $200 MCE deferral fee; and

(E) pay a late reporting fee of $250.

(4) For the purpose of this section, a renewed license is effective the day following the expiration of the current license. MCE courses completed after expiration of the current license under this provision may not be applied to the following renewal of the license.

(g) (No change.)

(h) A course taken by a Texas licensee to satisfy continuing education requirements of another state may be approved on an individual basis for MCE elective credit in this state upon the commission's determination that:

(1) (No change.)

(2) the course was approved for continuing education credit for a real estate license by the other state [and, if a correspondence course, was offered by an accredited college or university ];

(3) - (5) (No change.)

(i) - (m) (No change.)

§535.95.Miscellaneous Provisions Concerning License or Registration Renewals , Including Fingerprinting Requirements .

(a) - (d) (No change.)

(e) To provide for an orderly implementation of fingerprinting requirements and minimize disruption of licensure, the commission may issue a renewal license on active status if the licensee has provided at least one set of fingerprints to the Department of Public Safety (DPS), the fingerprints were rejected by the DPS or the Federal Bureau of Investigation FBI, and the licensee has otherwise complied with all other renewal requirements. If it is subsequently determined that the DPS or the FBI requires additional data from the licensee to complete a criminal history record check, the commission shall so notify the licensee. The commission may take disciplinary action against a licensee for failing to provide the requested data within a reasonable time, as specified in the notice.

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

Filed with the Office of the Secretary of State on March 3, 2008.

TRD-200801275

Loretta R. DeHay

Assistant Administrator and General Counsel

Texas Real Estate Commission

Earliest possible date of adoption: April 20, 2008

For further information, please call: (512) 465-3900

22 TAC §535.101

The Texas Real Estate Commission (TREC) proposes amendments to §535.101, concerning Fees.

The proposed amendments add a fee charged by the Federal Bureau of Investigation for a national criminal history check in connection with a license renewal. The fee is variable, but is currently set at $19.25. The amendments also propose a late reporting fee of $250 for licensees who fail to timely comply with the requirements of 22 TAC §535.92(f). Under §1101.457, Texas Occupations Code, a licensee may pay a $200 MCE deferral fee to defer MCE requirements for an additional 60 days after the date the license is renewed. If a licensee fails to timely pay the deferral fee or fails to complete the MCE requirements within the 60-day period, the license will be placed on inactive status under proposed amendments to 22 TAC §535.92(f). To reactivate the license, the licensee must pay the $250 late reporting fee, pay the original $200 deferral fee, complete the MCE requirements, certify that the licensee has not engaged in real estate brokerage activity, and pay the appropriate change fee.

Karen Alexander, Staff Services Director, has determined that for the first five-year period new §535.101(b)(17) is in effect there will be fiscal implications for the state, but not to units of local government as a result of enforcing or administering §535.101(b)(17). The current fee that the Federal Bureau of Investigation charges for federal criminal history record checks is $19.95. Approximately 180 applicants may be required to pay the fee in Fiscal Year 2008 for total estimated revenue of $3,465. For Fiscal Year 2009, approximately 1,080 applicants, and 14,400 Salesperson Annual Education renewal licensees are estimated to be required to pay the fee for total estimated revenue of $301,455. For each of the three years after (2010 - 2012), approximately 1,080 applicants, and 21,600 Salesperson Annual Education renewal licensees are estimated to be required to pay the fee for a total estimated revenue of $436,590 per year. This estimate does not include estimated revenue for 2-year license renewals as implementation of those costs will not begin until 2010.

Ms. Alexander has determined that there is no anticipated impact on local or state employment as a result of implementing the amendments. However, there is an anticipated impact on small businesses and micro-businesses. The Commission has approximately 150,000 real estate brokers and salespersons licensed in Texas. It is estimated that nearly all of these entities are small businesses and many of them are micro-businesses. The projected economic impact of this rule amendment on these small businesses will be slightly negative due to a required fee, currently set at $19.25 by the Federal Bureau of Investigation to conduct a national criminal history record check. Under §2006.002, Texas Government Code, an agency is required to consider alternative regulatory methods only if the alternative methods would be consistent with the health, safety and environmental and economic welfare of the state. TREC has developed this proposed rule in accordance with a legislative mandate. Consequently, any variance from the legislative mandate would not be consistent with the health, safety, and environmental and economic welfare of the state, and no alternative regulatory methods have been considered.

Ms. Alexander has determined that for the first five-year period new §535.101(b)(18) is in effect there will be fiscal implications for the state, but not for units of local government as a result of enforcing or administering the sections. The Enforcement Division currently assesses administrative penalties against approximately 120 licensees per year for failing to timely complete MCE under §1101.456, Texas Government Code. If the trend continues the fiscal impact will be ten licensees per month paying the $250 late reporting fee in lieu of administrative penalties producing $5,000 additional revenue per fiscal year for 2008, $30,000 for 2009, $30,000 for 2010, $30,000 for 2011, and $30,000 for 2012. There are no anticipated fiscal implications for units of local government. There is no anticipated impact on small businesses, micro businesses or local or state employment as a result of implementing the sections.

There is no anticipated impact on local or state employment as a result of implementing new §535.101(b)(18). There is no anticipated adverse impact on small businesses and micro-businesses. There is no anticipated economic cost to persons who are required to comply with the proposed rule. The proposed new §535.101(b)(18) merely changes the procedure so that rather than paying an administrative penalty, a licensee who fails to timely comply with the late MCE requirements will pay a late reporting fee to reactivate his or her license.

Ms. Alexander also has determined that for each year of the first five years new §535.101(b)(17) is in effect the public benefit anticipated as a result of enforcing the amendment is that a national criminal history check will be conducted on every renewal of a real estate salesperson and broker license. For each year of the first five years new §535.101(b)(18) is in effect the public benefit anticipated as a result of enforcing the amendment will be fewer cases referred to enforcement for persons who fail to comply with the late MCE requirements as such licenses will automatically go on inactive status if the licensee fails to timely comply.

Comments on the proposal may be submitted to Loretta R. DeHay, General Counsel, Texas Real Estate Commission, P.O. Box 12188, Austin, Texas 78711-2188.

The amendments are proposed under Texas Occupations Code, §1101.151, which authorizes the Texas Real Estate Commission to adopt and enforce rules necessary to administer Chapter 1101; and to establish standards of conduct and ethics for its licensees to fulfill the purposes of Chapter 1101 and ensure compliance with Chapter 1101.

The statute affected by this proposal is Texas Occupations Code, Chapter 1101. No other statute, code or article is affected by the proposed amendments.

§535.101.Fees.

(a) (No change.)

(b) The commission shall charge and collect the following fees:

(1) - (14) (No change.)

(15) a fee of $45 for the annual late renewal of a real estate salesperson or broker license for a person whose license has been expired 90 days or less; [and]

(16) a fee of $60 for the annual late renewal of a real estate salesperson or broker license for a person whose license has been expired more than 90 days but less than one year; [ .]

(17) the fee charged by the Federal Bureau of Investigation for a national criminal history check in connection with a license renewal; and

(18) a late reporting fee of $250 to reactivate a license under §535.92(f) of this chapter.

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

Filed with the Office of the Secretary of State on March 3, 2008.

TRD-200801276

Loretta R. DeHay

Assistant Administrator and General Counsel

Texas Real Estate Commission

Earliest possible date of adoption: April 20, 2008

For further information, please call: (512) 465-3900

22 TAC §535.212

The Texas Real Estate Commission (TREC) proposes amendments to §535.212, concerning Education and Experience Requirements for an Inspector License.

The amendments to §535.212 changes the requirements for acceptability of correspondence courses offered to meet core and continuing education requirements for a real estate and professional home inspector license under Texas Occupations Code, Chapter 1102. Currently correspondence courses must be offered by an accredited college or university. Under the proposed amendments, TREC would continue to accept correspondence courses offered by accredited colleges and universities, but correspondence courses approved by the commission and offered by schools accredited by the commission and acceptable correspondence courses approved by a real estate regulatory agency of another state could be used to meet core and continuing education requirements for a home inspector license in Texas.

Karen Alexander, Staff Services Director, has determined that for the first five-year period the amendments are in effect there will be no significant fiscal implications for the state or for units of local government as a result of enforcing or administering the amendments. There is no anticipated impact on local or state employment as a result of implementing the amendments. There will not be an adverse economic impact on small businesses and micro-businesses as a result of implementing the amendments.

The economic cost to persons who are required to comply with the proposed amendments will be the fees associated with becoming accredited by TREC if the person is not already a TREC accredited proprietary school or MCE provider. The proposed amendments contain provisions for licensed proprietary schools and Mandatory Continuing Education (MCE) providers to continue operating in the same manner as currently established with the additional ability to offer correspondence courses. Further, businesses that have existing relationships with colleges and universities are not precluded from maintaining the relationship, but they will also be able to independently offer approved correspondence courses if the businesses become accredited or licensed with TREC.

Ms. Alexander also has determined that for each year of the first five years the amendments as proposed are in effect the public benefit anticipated as a result of enforcing the amendments will be that existing TREC education providers will be able to independently offer correspondence courses that applicants and licensees may use for education credit.

Comments on the proposal may be submitted to Loretta R. DeHay, General Counsel, Texas Real Estate Commission, P.O. Box 12188, Austin, Texas 78711-2188.

The amendments are proposed under Texas Occupations Code, §1101.151, which authorizes the Texas Real Estate Commission to make and enforce all rules and regulations necessary for the performance of its duties and to establish standards of conduct and ethics for its licensees in keeping with the purpose and intent of the Act to insure compliance with the provisions of the Act.

The statutes affected by this proposal are Texas Occupations Code, Chapters 1101 and 1102, and Senate Bill 914 and House Bill 1530, 80th Legislature, Regular Session. No other statute, code or article is affected by the proposed amendments.

§535.212.Education and Experience Requirements for an Inspector License.

(a) Education requirements.

(1) - (2) (No change.)

(3) Except as provided to the contrary by this section, the review and acceptance of correspondence courses or courses offered by alternative delivery systems such as computers will be conducted in the manner prescribed by §535.62 of this title (relating to Acceptable Courses of Study). [ Correspondence courses are acceptable only if offered by an accredited college or university.]

(4) - (9) (No change.)

(b) (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.

Filed with the Office of the Secretary of State on March 3, 2008.

TRD-200801277

Loretta R. DeHay

Assistant Administrator and General Counsel

Texas Real Estate Commission

Earliest possible date of adoption: April 20, 2008

For further information, please call: (512) 465-3900

22 TAC §§543.2, 543.4, 543.10

The Texas Real Estate Commission (TREC) proposes amendments to §543.2, concerning Amendments; §543.4, concerning Forms; and §543.10, concerning Escrow Requirements.

The amendments change the notice requirements for developers to notify TREC of a change in the amount of a surety bond under §221.063(a) of the Texas Timeshare Act. Currently, a developer is required to file an amendment to a registration if there is a change of more than 20% in the amount of an original surety bond. The amendment would delete that requirement to amend the registration, but a developer would be required to notify the commission of any increase or decrease in the original surety bond as provided for in §221.063(a) of the Texas Timeshare Act.

The amendment to §543.4 would adopt by reference an amended Application for Abbreviated Registration of a Timeshare Plan, Form TSR 3-2 to make the form consistent with the text in the Application to Register a Timeshare Plan, Form TSR 1-4.

Loretta R. DeHay, General Counsel, has determined that for the first five-year period the amendments are in effect there will be no fiscal implications for the state or for units of local government as a result of enforcing or administering the amendments. There is no anticipated impact on local or state employment as a result of implementing the amendments. There is no anticipated impact on small businesses and micro-businesses as a result of implementing the proposed amendments. There is no anticipated economic cost to persons who are required to comply with the proposed amendments.

Ms. DeHay also has determined that for each year of the first five years the amendments as proposed are in effect the public benefit anticipated as a result of enforcing the amendments will be more efficiency and cost savings in reporting required information to TREC.

Comments on the proposal may be submitted to Loretta R. DeHay, General Counsel, Texas Real Estate Commission, P.O. Box 12188, Austin, Texas 78711-2188.

The amendments are proposed under the Texas Government Code, §221.024, which authorizes the Texas Real Estate Commission to prescribe and publish forms and adopt rules necessary to carry out the provisions of the Texas Timeshare Act.

The statute which is affected by this proposal is Texas Property Code, Chapter 221. No other statute, code or article is affected by the proposed amendments.

§543.2.Amendments.

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

(c) "Material" includes, but is not limited to:

(1) - (6) (No change.)

[(7) a change of more than 20% in the amount of an original surety bond;]

(7) [(8)] if applicable, an increase of more than 20% in an original alternative assurance as defined by Section 221.063(a) of the Texas Timeshare Act;

(8) [(9)] a change to a substantive provision of the escrow agreement between the escrow agent and the developer;

(9) [(10)] a change of management company; or

(10) (11)] a change to a substantive provision of the management agreement.

(d) - (g) (No change.)

§543.4.Forms.

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

(c) The Texas Real Estate Commission adopts by reference Application for Abbreviated Registration of a Timeshare Plan, Form TSR 3-2 [1], approved by the commission in 2008 [2006 ]. This document is published by and available from the Texas Real Estate Commission, P.O. Box 12188, Austin, Texas 78711-2188, www.trec.state.tx.us.

(d) - (j) (No change.)

§543.10.Escrow Requirements.

(a) For purposes of Section 221.063(a) of the Texas Timeshare Act, the alternative financial assurance from another state or jurisdiction must be for the same timeshare plan as the timeshare plan being registered or registration being amended.

(b) A timeshare developer shall, within 10 days of the change, provide the commission with written notice of any increase or decrease in the original surety bond as provided for in Section 221.063(a) of the Texas Timeshare Act.

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

Filed with the Office of the Secretary of State on March 3, 2008.

TRD-200801278

Loretta R. DeHay

Assistant Administrator and General Counsel

Texas Real Estate Commission

Earliest possible date of adoption: April 20, 2008

For further information, please call: (512) 465-3900