The LBB report estimates that allowing generic substitution of products not listed in the Orange Book would reduce the state's expenditure for prescription drugs for Medicaid by at least $9.9 million in All Funds for the 2006-2007 biennium. According to the LBB report, approximately $3.9 million of this amount could be saved for the General Revenue Fund.

Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be allowing the substitution of products not listed in the Orange Book saving patients and the State of Texas money.

There is no fiscal impact for small or large businesses or to other entities who are required to comply with the sections.

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

§309.2.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act, §551.003 and Chapter 562.

(1) Act--The Texas Pharmacy Act, Occupations Code, Subtitle J, as amended.

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

(3) Electronic prescription drug order--A prescription drug order which is transmitted by an electronic device to the receiver (pharmacy). [ ~~Electronic prescription drug order includes computer to computer transmission, but does not include facsimile prescription drug orders.~~ ]

~~[ ~~(4)~~ Facsimile prescription drug order--A prescription drug order which is transmitted by an electronic device which sends an exact image to the receiver (pharmacy).]~~

(4) [ ~~(5)~~ ] Generically equivalent--A drug that is pharmaceutically equivalent and therapeutically equivalent to the drug prescribed.

(5) [ ~~(6)~~ ] Pharmaceutically equivalent--Drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical compendial or other applicable standards of strength, quality, and purity according to the United States Pharmacopoeia or another nationally recognized compendium.

(6) [ ~~(7)~~ ] Therapeutically equivalent--Pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity.

(7) [ ~~(8)~~ ] Original prescription--The:

(A) original written prescription drug orders; or

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

(8) [ ~~(9)~~ ] Practitioner--

(A) A person licensed or registered to prescribe, distribute, administer, or dispense a prescription drug or device in the course of professional practice in this state, including a physician, dentist, podiatrist, therapeutic optometrist, or veterinarian but excluding a person licensed under this subtitle;

(B) A person licensed by another state, Canada, or the United Mexican States in a health field in which, under the law of this state, a license holder in this state may legally prescribe a dangerous drug;

(C) A person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration registration number and who may legally prescribe a Schedule II, III, IV, or V controlled substance, as specified under Chapter 481, Health and Safety Code, in that other state; or

(D) An advanced practice nurse or physician assistant to whom a physician has delegated the authority to carry out or sign prescription drug orders under §§157.052, 157.053, 157.054, 157.0541, or 157.0542, Occupations Code.

§309.3.Generic Substitution.

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

(e) Refills.

(1) (No change.)

(2) Narrow therapeutic index drugs.

(A) The board, 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. [ The board has specified in §309.7 of this title (relating to dispensing responsibilities) that 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. ]

(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 [ ~~Pharmacists~~ ] may only substitute products that are rated therapeutically equivalent in the Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements.

(ii) (No change.)

(B) (No change.)

§309.7.Dispensing Responsibilities.

(a) The determination of the drug product to be substituted as authorized by the Subchapter A, Chapter 562 of the Act, is the professional responsibility of the pharmacist, and the pharmacist may not dispense any product that does not meet the requirements of the Subchapter A, Chapter 562 of the Act. As specified in Chapter 562 of the Act and §309.2 of this title (relating to definitions), a generically equivalent product is one that is pharmaceutically equivalent and therapeutically equivalent to the drug prescribed.

(b) Pharmacists shall use [ ~~utilize~~ ] as a basis for the determination of generic equivalency as defined in the Subchapter A, Chapter 562 of the Act, the following: [ Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication. ]

(1) For drugs listed in the publication, pharmacists shall use Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication, to determine generic equivalency. Pharmacists may only substitute products that are rated therapeutically equivalent in the Orange Book and have an "A" rating. "A" rated drug products include but are not limited to, those designated AA, AB, AN, AO, AP, or AT in the Orange Book.

(2) For drugs not listed in the Orange Book, pharmacists shall use their professional judgment to determine generic equivalency.

[ ~~(c)~~ Pharmacists may only substitute products that are rated therapeutically equivalent in the Orange Book and have an "A" rating. "A" rated drug products include but are not limited to, those designated AA, AB, AN, AO, AP, or AT in the Orange Book.]

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 February 18, 2005.

TRD-200500760

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: April 3, 2005

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

Part 39. TEXAS BOARD OF PROFESSIONAL GEOSCIENTISTS

Chapter 851. TEXAS BOARD OF PROFESSIONAL GEOSCIENTISTS LICENSING RULES

Subchapter A. LICENSING

22 TAC §851.32

The Texas Board of Professional Geoscientists (TBPG) proposes 22, Texas Administrative Code Chapter 851, §851.32, concerning continuing education. This newly proposed rule establishes both requirements and procedures related to the continuing education of licensed geoscientists in the State of Texas. Legislation enactment in 2001 of Senate Bill 405 required the Texas Board of Professional Geoscientists to adopt and implement a recommended timeline and criteria by which continuing education rules would be established that would enable licensed geoscientists to renew their licenses. The proposed rule provides language clarifying the agency's requirement of number of educational hours as well as acceptable courses applicable to continuing education. The need for this clarification is based on feedback from the geological community in the agency's initial year of operation.

Michael D. Hess, Executive Director of the Texas Board of Professional Geoscientists, has determined that for the first five years that this rule is in effect there will be no fiscal implication for state and local government as a result of enforcement and administration of this section.

Mr. Hess has also determined that for each year of the first five years that this section is in effect, the State of Texas can anticipate public benefit as a result of enforcement and enhancement of the professional practice of geology through the requirement of an increased level of education for the geoscience licensed population. There will not be an effect on small or micro businesses, however it is anticipated that there will be an economic cost to licensees in order to take the required educational courses.

Comments on the proposal may be submitted in writing to Michael D. Hess, Executive Director, P.O. Box 13225, Austin, Texas 78701, (512) 936-4401. Comments may also be submitted electronically to geoscience@tbpg.state.tx.us or faxed to (512) 936-4409. All comments must be received 30 days after publication of this rule in the Texas Register . All requests for a public hearing on the proposed section submitted under the Administrative Procedure Act must be received by the Executive Director not more than 15 calendar days after notice of a proposed new section has been published in the Texas Register .

The new section is proposed under the Texas Occupations Code, Chapter 1002, which authorizes the Board to adopt a mandated continuing education process and criteria by which all licensees will participate prior to their annual license renewal.

The proposed section implements the Texas Occupations Code, §1002.302.

§851.32.Continuing Education Program.

(a) Each license holder shall meet the Continuing Education Program (CEP) requirements for professional development as a condition for license renewal.

(b) Terms used in this section are defined as follows:

(1) Professional Development Hour (PDH)--A contact hour (clock hour) of CEP activity. PDH is the basic unit for CEP reporting.

(2) Continuing Education Unit (CEU)--Unit of credit customarily used for continuing education courses. One continuing education unit equals 10 hours of class in an approved continuing education course.

(3) College/Unit Semester/Quarter Hour--Credit for course in a discipline of geoscience or other related technical elective of the discipline.

(4) Course/Activity--Any qualifying course or activity with a clear purpose and objective which will maintain, improve, or expand the skills and knowledge relevant to the license holder's field of practice.

(d) A minimum of 1 PDH per renewal period must be in the area of professional ethics, roles and responsibilities of professional geoscientists, or review on-line of the Texas Geoscientist Practice Act and Board Rules.

(e) If a license holder exceeds the annual requirement in any renewal period, a maximum of 30 PDH units may be carried forward into the subsequent renewal periods.

(f) PDH units may be earned as follows:

(1) Successful completion or auditing of college credit courses.

(2) Successful completion of continuing education courses, either offered by a professional or trade organization, university or college, or offered in-house by a corporation, other business entity, professional or technical societies, associations, agencies, or organizations, or other group.

(3) Successful completion of correspondence, on-line, televised, videotaped, and other short courses/tutorials.

(4) Presenting or attending qualifying seminars, in-house courses, workshops, or professional or technical presentations made at meetings, conventions, or conferences sponsored by a corporation, other business entity, professional or technical societies, associations, agencies, or organizations, or other group.

(5) Teaching or instructing as listed in paragraphs (1) - (4) of this section.

(6) Authoring published papers, articles, books, or accepted licensing examination items.

(7) Active participation in professional or technical societies, associations, agencies, or organizations, including:

(A) Serving as an elected or appointed official;

(B) Serving on a committee of the organization;

(8) Patents Issued.

(9) Engaging in self-directed course work.

(10) Software Programs Published.

(g) All activities described in subsection (f) of this section shall be relevant to the practice of a discipline of geoscience and may include technical, ethical, or managerial content.

(h) The conversion of other units of credit to PDH units is as follows and subject to subsection (g) of this section

(1) 1 College or unit semester hour--15 PDH

(2) 1 College or unit quarter hour--10 PDH

(3) 1 Continuing Education Unit--10 PDH

(4) 1 Hour of professional development in course work, seminars, or professional or technical presentations made at meetings, conventions, or conferences--1 PDH

(5) 1 Hour of professional development through self-directed course study (Not to exceed 5 PDH)--1 PDH

(6) Each published paper or article--10 PDH and book--45 PDH

(7) Active participation, as defined in subsection (f)(7) of this section, in professional or technical society, association, agency, or organization (Not to exceed 5 PDH per year)--1 PDH

(8) Each patent issued--15 PDH

(9) Each software program published--15 PDH

(10) Teaching or instructing as described in subsection (f)(5) of this section--3 times the PDH credit earned.

(i) Determination of Credit

(1) The Board shall be the final authority with respect to whether a course or activity meets the requirements of these rules.

(2) The Board shall not pre-approve or endorse any CEP activities during the first two years after the effective date of this rule. It is the responsibility of each license holder to assure that all PDH credits claimed meet CEP requirements. However, a course provider may contact the Board for an opinion for whether or not a course or technical presentation would meet the CEP requirements. Two years after the effective date of this rule, pre-approval will be required.

(3) Credit for college or community college approved courses will be based upon course credit established by the college.

(4) Credit for qualifying seminars and workshops will be based on one PDH unit for each hour of attendance. Attendance at qualifying programs presented at professional and/or technical society meetings will earn PDH units for the actual time of each program.

(5) Credit for self-directed course work will be based on one PDH unit for each hour of study and is not to exceed 5 PDH per renewal period. Credit determination for self-directed course work is the responsibility of the license holder and subject to review as required by the board.

(6) Credit determination for activities described in subsection (h)(6) of this section is the responsibility of the license holder and subject to review as required by the board.

(7) Credit for activity described in subsection (h)(7) of this section requires that a license holder serve as an officer of the organization, actively participate in a committee of the organization, or perform other activities such as making or attending a presentation at a meeting or writing a paper presented at a meeting. PDH credits are not earned until the end of each year of service is completed.

(8) Teaching credit, as defined in subsection (f)(5) of this section, is valid for teaching a course or seminar for the first time only.

(j) The license holder is responsible for maintaining records to be used to support credits claimed. Records required include, but are not limited to:

(1) A log, on a form provided by TBPG, showing the type of activity claimed, sponsoring organization, location, duration, instructor's or speaker's name, and PDH credits earned; and

(2) Attendance verification records in the form of completion certificates, receipts, attendance roster, or other documents supporting evidence of attendance.

(k) The license holder must submit CEP certification on the log form provided by TBPG and a list of each activity, date, and hours claimed that satisfy the CEP requirement for that renewal year when audited. A percentage of the licenses will be randomly audited each year.

Figure: 22 TAC §851.32(k) (.pdf)

(l) CEP records for each license holder must be maintained for a period of three years by the license holder.

(m) CEP records for each license holder are subject to audit by the board or its authorized representative.

(1) Copies must be furnished, if requested, to the Board or its authorized representative for audit verification purposes.

(2) If upon auditing a license holder, the Board finds that the activities cited do not fall within the bounds of educational, technical, ethical, or professional management activities related to the practice of geoscience; the board may require the license holder to acquire additional PDH as needed to fulfill the minimum CEP requirements.

(n) A license holder may be exempt from the professional development educational requirements for one of the following reasons listed in paragraphs (1) - (5) of this subsection:

(1) New license holders by way of examination shall be exempt for their first renewal period.

(2) A license holder serving on active duty and deployed outside the United States, its possessions and territories, in or for the military service of the United States for a period of time exceeding one hundred twenty (120) consecutive days in a year shall be exempt from obtaining the professional development hours required during that year.

(3) A license holder employed outside the United States, its possessions and territories, actively engaged in the practice of geoscience for a period of time exceeding three hundred (300) consecutive days in a year shall be exempt from obtaining the professional development hours required during that year except for five (5) hours of self-directed course work.

(4) License holders who list their status as "Inactive" and who further certify that they are no longer receiving any remuneration from providing professional geoscience services in Texas shall be exempt from the professional development hours required.

(5) License holders experiencing long term physical disability or illness. may be exempt by applying for "inactive" status. Supporting documentation must be furnished to the board.

(o) A license holder may bring an inactive license to active status by obtaining all delinquent PDH units. However, if the total number required to become current exceeds 30 units, then 30 units shall be the maximum number required.

(p) Noncompliance:

(1) If a license holder does not certify that CEP requirements have been met for a renewal period, the license shall be considered expired and subject to late fees and penalties.

(2) A determination by audit that CEP requirements have been falsely reported shall be considered to be misconduct and will subject the license holder to disciplinary action.

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 February 16, 2005.

TRD-200500738

Michael D. Hess

Executive Director

Texas Board of Professional Geoscientists

Earliest possible date of adoption: April 3, 2005

For further information, please call: (512) 936-4400