PART 9. TEXAS MEDICAL BOARD

CHAPTER 185. PHYSICIAN ASSISTANTS

22 TAC §§185.4, 185.6, 185.13, 185.16, 185.19, 185.23, 185.26

The Texas Medical Board (Board) proposes amendments to Chapter 185, §§185.4, 185.6, 185.13, 185.16, 185.19, 185.23, and 185.26, concerning Physician Assistants.

The amendment to §185.4, relating to Procedural Rules for Licensure Applicants, deletes expired language that grandfathered licensure applicants who applied before 2008 from having to comply with certain examination requirements, explains that applicants for relicensure who have already taken the jurisprudence exam (JP) are not required to retake the exam, and makes presentation of state licensure verification a discretionary requirement rather than mandatory for each applicant.

The amendment to §185.6, relating to Annual Renewal of License, allows physician assistants to obtain six hours of continuing medical education (CME) per year by serving as an expert panel reviewer for the Board and deletes language relating to a 30-day grace period after expiration of license to conform with §204.156, Texas Occupations Code.

The amendment to §185.13, relating to Notification of Intent to Practice and Supervise, provides that if a primary supervising physician of a physician assistant is not able to supervise for more than 30 days, then a new primary supervising physician must provide supervision.

The amendment to §185.16, relating to Employment Guidelines, clarifies at what academic institutions a physician may supervise a physician assistant for the purpose of providing medical services in preventive medicine, disease management, health and wellness education or similar services.

The amendment to §185.19, relating to Employment Guidelines, references §§187.75 - 185.82 of this title for the purpose of imposing administrative penalties on physician assistants for certain violations of the Physician Assistants (PA) Act.

The amendment to §185.23, relating to Third Party Reports to the Board, corrects rule citations in the Professional Liability Claims Report.

The amendment to §185.26, relating to Voluntary Surrender of Physician Assistant License, updates the language to correctly reflect the title of Chapter 196 of Title 22 of the Texas Administrative Code.

Elsewhere in this issue of the Texas Register, the Board contemporaneously proposes the rule review for Chapter 185.

Nancy Leshikar, Interim General Counsel for the Board, has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing §185.4 will be to ease some of the requirements for licensure applicants without lowering the standards to become a physician assistant. The public benefit anticipated as a result of enforcing §185.6 will be to encourage physician assistants in good standing with the Board to serve as expert panel reviewers on standard of care cases. The public benefit anticipated as a result of enforcing §185.13 will be to ensure that physician assistants are adequately supervised by a physician. The public benefit anticipated as a result of enforcing §185.16 will be to clarify the rule regarding applicability. The public benefit anticipated as a result of enforcing §185.19 will be to clarify when administrative penalties may be assessed for violations of the PA Act. The public benefit anticipated as a result of enforcing §185.23 will be to provide accurate rules for licensees to follow. The public benefit anticipated as a result of enforcing §185.26 will be to have accurate rules for licensees to follow.

Ms. Leshikar has also determined that for the first five-year period the sections are in effect there will be no fiscal implication to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the rules as proposed. There will be no effect on small or micro businesses.

Comments on the proposals may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018, or e-mail comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §204.101, which provides authority for the Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of physician assistants in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§185.4.Procedural Rules for Licensure Applicants.

(a) Except as otherwise provided in this section, an individual shall be licensed by the board before the individual may function as a physician assistant. A license shall be granted to an applicant who:

(1) - (9) (No change.)

(10) must pass [for applicants who apply for a license on or after January 1, 2007, passes] the national licensing examination required for NCCPA certification within no more than six attempts; and[.]

(11) must pass the [for applicants who apply for a license on or after September 1, 2007, passes a] jurisprudence examination ("JP exam"), which shall be conducted on the licensing requirements and other laws, rules, or regulations applicable to the physician assistant profession in this state. The jurisprudence examination shall be developed and administered as follows:

(A) The staff of the Medical Board shall prepare questions for the JP exam and provide a facility by which applicants can take the examination.

(B) Applicants must pass the JP exam with a score of 75 or better within three attempts.

(C) An examinee shall not be permitted to bring medical books, compends, notes, medical journals, calculators or other help into the examination room, nor be allowed to communicate by word or sign with another examinee while the examination is in progress without permission of the presiding examiner, nor be allowed to leave the examination room except when so permitted by the presiding examiner.

(D) Irregularities during an examination such as giving or obtaining unauthorized information or aid as evidenced by observation or subsequent statistical analysis of answer sheets, shall be sufficient cause to terminate an applicant's participation in an examination, invalidate the applicant's examination results, or take other appropriate action.

(E) An applicant who is unable to pass the JP exam within three attempts must appear before a committee of the board to address the applicant's inability to pass the examination and to re-evaluate the applicant's eligibility for licensure. It is at the discretion of the committee to allow an applicant additional attempts to take the JP exam.

(F) A person who has passed the JP Exam shall not be required to retake the Exam for relicensure, except as a specific requirement of the board as part of an agreed order.

(b) The following documentation shall be submitted as a part of the licensure process:

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

(4) Verification from other states. On request of board staff, an applicant must have any state, in which he or she has ever been licensed as any type of healthcare provider regardless of the current status of the license, submit to the board a letter verifying the status of the license and a description of any sanctions or pending disciplinary matters. The information must be sent directly from the state licensing entities. [Each applicant for licensure who is licensed, registered, or certified in another state must have that state submit directly to the board, on a form provided by the board, that the physician assistant's license, registration, or certification is current and in full force and that the license, registration, or certification has not been restricted, canceled, suspended, or revoked. The other state shall also include a description of any sanctions imposed by or disciplinary matters pending in the state.]

[(5) State License Registration. Each applicant, if licensed, registered, or certified in another state as a physician assistant, must submit a copy of the license registration certificate to the board. The license, registration, or certificate number and the date of expiration must be visible on the copy.]

(5) [(6)] Arrest Records. If an applicant has ever been arrested, a copy of the arrest and arrest disposition needs to be requested from the arresting authority and that authority must submit copies directly to the board.

(6) [(7)] Malpractice. If an applicant has ever been named in a malpractice claim filed with any liability carrier or if an applicant has ever been named in a malpractice suit, the applicant must:

(A) have each liability carrier complete a form furnished by this board regarding each claim filed against the applicant's insurance;

(B) for each claim that becomes a malpractice suit, have the attorney representing the applicant in each suit submit a letter directly to the board explaining the allegation, dates of the allegation, and current status of the suit. If the suit has been closed, the attorney must state the disposition of the suit, and if any money was paid, the amount of the settlement. The letter shall be accompanied by supporting documentation including court records if applicable. If such letter is not available, the applicant will be required to furnish a notarized affidavit explaining why this letter cannot be provided; and

(C) provide a statement, composed by the applicant, explaining the circumstances pertaining to patient care in defense of the allegations.

(7) [(8)] Additional Documentation. Additional documentation as is deemed necessary to facilitate the investigation of any application for licensure must be submitted.

(c) - (e) (No change.)

§185.6.Annual Renewal of License.

(a) (No change.)

(b) The following documentation shall be submitted as part of the renewal process:

(1) Continuing Medical Education. As a prerequisite to the annual registration of a physician assistant's license, 40 hours of continuing medical education (CME) are required to be completed in the following categories:

(A) at least one-half of the hours are to be from formal courses that are designated for Category I credit by a CME sponsor approved by the American Academy of Physician Assistants.

(B) The remaining hours may be from Category II composed of informal self-study, attendance at hospital lectures, grand rounds, case conferences, or by providing volunteer medical services at a site serving a medically underserved population, other than at a site that is the primary practice site of the license holder, and shall be recorded in a manner that can be easily transmitted to the board upon request.

(C) A physician assistant shall receive one credit of continuing medical education for each hour of time spent up to 6 hours per year, as required by subparagraph (A) of this paragraph based on participation in a program sponsored by the board and approved for CME credit for the evaluation of a physician assistant's competency or practice monitoring.

(2) - (8) (No change.)

(c) - (h) (No change.)

(i) Expired Annual Registration Permits.

(1) If a physician assistant's registration permit has been expired for less than one year, the physician assistant may obtain a new permit by submitting to the board a completed permit application, the registration fee, as defined in §175.2(2) of this title (relating to Registration and Renewal Fees) and the penalty fee, as defined in §175.3(2) of this title (relating to Penalties). [ If a physician assistant's registration permit has expired, the physician assistant may register for a new permit without monetary penalty during the first 30 days following expiration. If a physician assistant's permit has been expired for longer than 30 days, but less than 91, the physician may obtain a new permit by submitting to the board a completed permit application, the registration fee, and the penalty fee, as defined in §175.3(2) of this title.]

[(2) If a physician assistant's registration permit has been expired for longer than 90 days but less than one year, the physician assistant may obtain a new permit by submitting a completed permit application, the registration fee, and a penalty fee as defined in §175.3(2) of this title.]

(2) [(3)] If a physician assistant's registration permit has been expired for one year or longer, the physician assistant's license is automatically canceled, unless an investigation is pending, and the physician assistant may not obtain a new permit.

(3) A person whose license has expired may not engage in activities that require a license until the licensed has been renewed.

[(4)] Practicing as a physician assistant after a physician assistant's permit has expired [the expiration of the 30-day grace period] under subsection (a) of this section without obtaining a new registration permit for the current registration period has the same effect as, and is subject to all penalties of, practicing as a physician assistant without a license. The Board interprets §204.156 of the Act to provide the exclusive sanction that may be imposed by the board for practicing medicine after the expiration of the permit.

§185.13.Notification of Intent to Practice and Supervise.

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

(d) If a supervising physician will be unavailable to supervise the physician assistant as required by this section, arrangements shall be made for an alternate physician to provide that supervision. The alternate physician providing that supervision shall affirm in writing and document through a log where the physician assistant is located, that he or she is familiar with the protocols or standing delegation orders in use, and is accountable for adequately supervising care provided pursuant to those protocols or standing delegation orders. The log shall be kept with the protocols or standing orders. The log shall contain dates of the alternate physician supervision and be signed by the alternate physician acknowledging this responsibility. The physician assistant is responsible for verifying that the alternate physician is a licensed Texas physician holding an unrestricted and active license. Alternate physicians may not collectively provide supervision for more than a 30-day period. If the primary supervising physician cannot return to supervising the physician assistant after 30 days, a new primary supervising physician must provide supervision.

§185.16.Employment Guidelines.

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

(d) A physician who provides medical services in preventive medicine, disease management, health and wellness education, or similar services in an accredited academic/teaching institution listed in paragraphs (1) - (3) [(10)] of this subsection, or its affiliates, may be denoted as the supervising physician for more than five physician assistants in that institution or its affiliates, provided the supervising physician determines that the physician assistants are properly trained to deliver the services, that the services are of such a nature that they may be safely and competently delivered by the supervised physician assistants, and the proper paperwork has been filed with the Medical Board. The supervision of physician assistants must comply with all institutional rules and there must be accurate and timely internal institutional records, which are available upon request within 24 hours to the Medical Board, which list the name and license number of the physician who is specifically assigned to actively supervise each physician assistant at one of the following institutions:

(1) a school of medicine in this state accredited by the Liaison Committee on Medical Education or the American Osteopathic Association of Professional Education;

(2) the University of Texas Health Science Center at Tyler; or

(3) the University of Texas M.D. Anderson Cancer Center.

[(1) University of Texas Medical Branch at Galveston;]

[(2) University of Texas Southwestern Medical Center at Dallas;]

[(3) University of Texas Health Science Center at Houston;]

[(4) University of Texas Health Science Center at San Antonio;]

[(5) University of Texas Health Center at Tyler;]

[(6) University of Texas M.D. Anderson Cancer Center;]

[(7) Texas A&M University College of Medicine;]

[(8) Texas Tech University School of Medicine;]

[(9) Baylor College of Medicine; or]

[(10) University of North Texas Health Science Center at Fort Worth.]

(e) - (f) (No change.)

§185.19.Administrative Penalties.

(a) Pursuant to §204.351 of the Act, the board by order may impose an administrative penalty, in accordance with §§187.75 - 187.82 of this title (relating to the Imposition of Administrative Penalty), against a person licensed or regulated under the Act who violates the Act or a rule or order adopted under the Act. The imposition of such a penalty shall be consistent with the requirements of the Act. [The board by order may impose an administrative penalty, subject to the provisions of the APA, against a person licensed or regulated under the Act who violates the Act or a rule or order adopted under the Act.]

(b) - (c) (No change.)

§185.23.Third Party Reports to the Board.

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

(d) Reporting Professional Liability Claims.

(1) - (8) (No change.)

(9) Reporting Form. The reporting form shall be as follows:

Figure: 22 TAC §185.23(d)(9) (.pdf)

(10) (No change.)

(e) (No change.)

§185.26.Voluntary Relinquishment or Surrender of Physician Assistant License.

Pursuant to §204.315 of the Act, the Board may accept the voluntary relinquishment or surrender of a physician assistant license. Chapter 196 of this title (relating to Voluntary Relinquishment or Surrender of a Medical License [ Voluntary Surrender of a Medical License ]) shall govern the voluntary relinquishment or surrender of a physician assistant license in a similar manner as that chapter applies to a medical license. Section 185.4 of this title (relating to Procedural Rules for Licensure Applicants) shall govern reapplication after a voluntary relinquishment or surrender.

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 May 29, 2009.

TRD-200902078

Mari Robinson, J.D.

Interim Executive Director

Texas Medical Board

Earliest possible date of adoption: July 12, 2009

For further information, please call: (512) 305-7016

CHAPTER 291. PHARMACIES

SUBCHAPTER A. ALL CLASSES OF PHARMACIES

22 TAC §291.6

The Texas State Board of Pharmacy proposes amendments to §291.6 concerning Pharmacy License Fees. The amendments to §291.6, if adopted, will raise pharmacy license fees based on increased expense.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the amendments are in effect, there will be fiscal implications for state government as a result of enforcing or administering the proposal as follows:

Revenue Increase

FY2010 = $300,298

FY2011 = $332,840

FY2012 = $332,840

FY2013 = $332,840

FY2014 = $332,840

There are no anticipated fiscal implications for local government.

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 amended rule will be assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission. The effect on large, small or micro-businesses (pharmacies) required to comply with the amended rule will be an increase of $106 for an initial registration and an increase of $106 for the renewal of a registration.

The economic cost to an individual will be the same as the economic cost to a business, if the individual chooses to pay the business registration fee.

Comments on the proposed new rules, amendments and repeals 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., July 31, 2009.

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.

§291.6.Pharmacy License Fees.

(a) Initial License Fee.

(1) The fee for an initial license shall be $491 [$385 ] for a two year registration and for processing the application and issuance of the pharmacy license as authorized by the Act §554.006.

(2) In addition, the following fees shall be collected:

(A) $15 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act §564.051;

(B) $10 surcharge to fund TexasOnline as authorized by Chapter 2054, Subchapter I, Government Code; and

(C) $5 surcharge to fund the Office of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations Code.

(3) New pharmacy licenses shall be assigned an expiration date and initial registration fee shall be prorated based on the assigned expiration date.

(b) Biennial License Renewal. The Texas State Board of Pharmacy shall require biennial renewal of all pharmacy licenses provided under the Act §561.002.

(c) Renewal Fee.

(1) The fee for biennial renewal of a pharmacy license shall be $491 [$385] for processing the application and issuance of the pharmacy license as authorized by the Act §554.006;

(2) In addition, the following fees shall be collected:

(A) $15 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act §564.051;

(B) $10 surcharge to fund TexasOnline as authorized by Chapter 2054, Subchapter I, Government Code; and

(C) $2 surcharge to fund the Office of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations Code.

(d) Duplicate or Amended Certificates. The fee for issuance of an amended pharmacy license renewal certificate shall be $20.

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

Filed with the Office of the Secretary of State on June 1, 2009.

TRD-200902102

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 12, 2009

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

22 TAC §291.32

The Texas State Board of Pharmacy proposes amendments to §291.32 concerning Personnel. The amendments, if adopted, allow Class A pharmacies that dispense no more than 20 prescription drugs to have a 1:5 ratio of pharmacists to pharmacy technicians/pharmacy technician trainees. The amendments, if adopted, eliminate the requirement for such pharmacies to be primarily involved in non-sterile compounding.

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 to expand the number of pharmacies with a limited scope of practice to have more technicians being supervised by pharmacists to provide increased services to the patients. 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 p.m., July 31, 2009.

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.

§291.32.Personnel.

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

(d) Pharmacy Technicians and Pharmacy Technician Trainees.

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

(3) Ratio of pharmacist to pharmacy technicians and pharmacy technician trainees.

(A) Except as provided in subparagraph (B) of this paragraph, the ratio of pharmacists to pharmacy technicians and pharmacy technician trainees may be 1:3, provided at least one of the three is a pharmacy technician. The ratio of pharmacists to pharmacy technician trainees may not exceed 1:2.

(B) As specified in §568.006 of the Act, a Class A pharmacy [ that primarily compounds non-sterile pharmaceuticals ] may have a ratio of pharmacists to pharmacy technicians/pharmacy technician trainees of 1:5 provided:

(i) the Class A pharmacy:

(I) dispenses no more than 20 different prescription drugs; and

(II) does not produce sterile preparations including intravenous or intramuscular drugs on-site; and

(ii) the following conditions are met:

(I) at least four are pharmacy technicians and not pharmacy technician trainees; and

(II) The pharmacy has written policies and procedures regarding the supervision of pharmacy technicians and pharmacy technician trainees, including requirements that the pharmacy technicians and pharmacy technician trainees included in a 1:5 ratio may be involved only in one process at a time. For example, a technician/trainee who is compounding non-sterile preparations or who is involved in the preparation of prescription drug orders may not also call physicians for authorization of refills.

(e) (No change.)

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

Filed with the Office of the Secretary of State on June 1, 2009.

TRD-200902103

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 12, 2009

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

22 TAC §§291.72 - 291.76

The Texas State Board of Pharmacy proposes amendments to §291.72 concerning Definitions, §291.73 concerning Personnel, §291.74 concerning Operational Standards, §291.75 concerning Records, and §291.76 concerning Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center. The amendments, if adopted, incorporate recommendations made by the Task Force on Class C Pharmacy Rules as follows: clarify the definition of an inpatient and change all references from inpatient to patient; allow for a quarterly inspection of automated medication supply systems provided certain monitoring and security features are present; delete the need for in-process checking of prepacking and labeling of unit and multi-dose packages by pharmacy technicians, but keep the final check by pharmacists; change the word typewriter to data processing system and printer; add electronic receiving of medication orders; define labeling requirements for discharge prescriptions; allow pharmacy technicians to re-stock automated medication supply cabinets provided a pharmacist conducts checking, provided machine readable product identifier information is used in the final verification; delete tripelennamine (PBZ) from drugs considered as controlled substances; replace reference to supportive personnel with pharmacy technician and pharmacy technician trainee; delete requirements that dangerous drugs be supplied to discharged emergency room patients on a telephone call by physician. The amendments, if adopted, also incorporate staff recommendations to update/correct references to other rules and update the rules to be consistent with other sections of the rules.

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

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 to ensure the safety and welfare of patients receiving medications from Class C pharmacies. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the rules.

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., July 31, 2009.

The amendments are proposed under §551.002, and §554.051, of the Texas Pharmacy Act (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.

§291.72.Definitions.

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

(1) - (11) (No change.)

(12) Direct copy--Electronic copy or carbonized copy of a medication order, including a facsimile (FAX) or digital image[, tele-autograph, or a copy transmitted between computers ].

(13) - (19) (No change.)

(20) Facility--

(A) a hospital or other patient [in-patient ] facility that is licensed under Chapter 241 or 577, Health and Safety Code;

(B) a hospice patient [in-patient] facility that is licensed under Chapter 142, Health and Safety Code;

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

(21) - (23) (No change.)

(24) Hard copy--A physical document that is readable without the use of a special device (i.e., data processing system, computer, etc.) [cathode ray tube (CRT), microfiche reader, etc)].

(25) (No change.)

[(26) Inpatient--A person who is duly admitted to the licensed hospital or other hospital or facility maintained or operated by the state, or who is receiving long term care services or Medicare extended care services in a swing bed on the hospital premise or an adjacent, readily accessible facility which is under the authority of the hospital's governing body. For the purposes of this definition, the term "long term care services" means those services received in a skilled nursing facility which is a distinct part of the hospital and the distinct part is not licensed separately or formally approved as a nursing home by the state, even though it is designated or certified as a skilled nursing facility. An inpatient includes a person confined in any correctional institution operated by the state of Texas.]

(26) [(27)] Institutional pharmacy--Area or areas in a facility where drugs are stored, bulk compounded, delivered, compounded, dispensed, and distributed to other areas or departments of the facility, or dispensed to an ultimate user or his or her agent.

(27) [(28)] Investigational new drug--New drug intended for investigational use by experts qualified to evaluate the safety and effectiveness of the drug as authorized by the Food and Drug Administration.

(28) [(29)] Medical Practice Act--The Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.

(29) [(30)] Medication order--A written order from a practitioner or a verbal order from a practitioner or his authorized agent for administration of a drug or device.

(30) [(31)] Part-time pharmacist--A pharmacist either employed or under contract, who routinely works less than full-time.

(31) Patient--A person who is receiving services at the facility (including patients receiving ambulatory procedures and patients conditionally admitted as observation patients), or who is receiving long term care services or Medicare extended care services in a swing bed on the hospital premise or an adjacent, readily accessible facility that is under the authority of the hospital's governing body. For the purposes of this definition, the term "long term care services" means those services received in a skilled nursing facility which is a distinct part of the hospital and the distinct part is not licensed separately or formally approved as a nursing home by the state, even though it is designated or certified as a skilled nursing facility. A patient includes a person confined in any correctional institution operated by the state of Texas.

(32) - (37) (No change.)

(38) Pre-packaging--The act of re-packaging and re-labeling quantities of drug products from a manufacturer's original container into unit-dose packaging or a multiple dose container for distribution within the facility except as specified in §291.74(f)(3)(B) of this title (relating to Operational Standards).

(39) - (40) (No change.)

(41) Quality assurance--The set of activities used to assure that the process used in the preparation of sterile drug preparations [products] lead to preparations [products ] that meet predetermined standards of quality.

(42) Quality control--The set of testing activities used to determine that the ingredients, components (e.g., containers), and final sterile preparations [pharmaceuticals] prepared meet predetermined requirements with respect to identity, purity, non-pyrogenicity, and sterility.

(43) - (48) (No change.)

§291.73.Personnel.

(a) Requirements for pharmacist services.

(1) A Class C pharmacy in a facility licensed for 101 beds or more shall be under the continuous on-site supervision of a pharmacist during the time it is open for pharmacy services; provided, however, that pharmacy technicians and pharmacy technician trainees may distribute prepackaged and prelabeled drugs from a drug storage area of the facility e.g., a surgery suite, [satellite pharmacy] in the absence of physical [on-site] supervision of a pharmacist, under the following conditions:

(A) - (B) (No change.)

(2) A Class C pharmacy in a facility licensed for 100 beds or less shall have the services of a pharmacist at least on a part-time or consulting basis according to the needs of the facility except that a pharmacist shall be on-site at least once every seven days.

(3) (No change.)

(b) Pharmacist-in-charge.

(1) General.

(A) Each institutional pharmacy in a facility with 101 beds or more shall have one full-time pharmacist-in-charge, who may be pharmacist-in-charge for only one such pharmacy except as specified in subparagraph (C) of this paragraph.

(B) - (E) (No change.)

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

(A) - (B) (No change.)

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

(D) [(C)] providing written guidelines and approval of the procedure to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile preparations is not performed under direct pharmacy supervision;

(E) [(D)] participating in the development of a formulary for the facility, subject to approval of the appropriate committee of the facility;

(F) [(E)] developing a system to assure that drugs to be administered to atients [ inpatients] are distributed pursuant to an original or direct copy of the practitioner's medication order;

(G) [(F)] developing a system for the filling and labeling of all containers from which drugs are to be distributed or dispensed;

(H) [(G)] assuring that the pharmacy maintains and makes available a sufficient inventory of antidotes and other emergency drugs as well as current antidote information, telephone numbers of regional poison control center and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the facility;

(I) [(H)] maintaining records of all transactions of the institutional pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials including pharmaceuticals, components used in the compounding of preparations [pharmaceuticals], and participate in policy decisions regarding prescription drug delivery devices;

(J) [(I)] participating in those aspects of the facility's patient care evaluation program which relate to pharmaceutical utilization and effectiveness;

(K) [(J)] participating in teaching and/or research programs in the facility;

(L) [(K)] implementing the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the facility;

(M) [(L)] providing effective and efficient messenger or delivery service to connect the institutional pharmacy with appropriate areas of the facility on a regular basis throughout the normal workday of the facility;

(N) [(M)] developing a system for the labeling, storage, and distribution of investigational new drugs, including access to related drug information for healthcare personnel [maintenance of information] in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational new drugs;

(O) [(N)] assuring that records in a data processing system are maintained such that the data processing system is in compliance with Class C (Institutional) pharmacy requirements;

(P) [(O)] assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;

(Q) [(P)] assuring the legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy; and

(R) [(Q)] if the pharmacy uses an automated medication supply system, shall be responsible for the following:

(i) reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;

(ii) inspecting medications in the automated medication supply system, at least monthly, for expiration date, misbranding, physical integrity, security, and accountability; except that inspection of medications in the automated medication supply system may be performed quarterly if:

(I) the facility uses automated medication supply systems that monitors expiration dates of prescription drugs; and

(II) security of the system is checked at regularly defined intervals (e.g., daily or weekly);

(iii) assigning, discontinuing, or changing personnel access to the automated medication supply system;

(iv) ensuring that pharmacy technicians, pharmacy technician trainees, and licensed healthcare professionals performing any services in connection with an automated medication supply system have been properly trained on the use of the system and can demonstrate comprehensive knowledge of the written policies and procedures for operation of the system; and

(v) ensuring that the automated medication supply system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.

(c) (No change.)

(d) Pharmacists.

(1) (No change.)

(2) Duties. Duties of the pharmacist-in-charge and all other pharmacists shall include, but need not be limited to the following:

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

(E) accepting the responsibility for:

(i) distributing prescription drugs and devices with drug components pursuant to medication orders;

(ii) compounding and labeling of prescription drugs and devices with drug components;

(iii) proper and safe storage of prescription drugs and devices with drug components; and

(iv) maintaining proper records for prescription drugs and devices with drug components.

(3) (No change.)

(e) Pharmacy technicians and pharmacy technician trainees.

(1) (No change.)

(2) Duties. Duties may include, but need not be limited to, the following functions under the supervision of and responsible to a pharmacist:

(A) Facilities licensed for 101 beds or more. The following functions must be performed under the physically present supervision of a pharmacist:

(i) pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts a final check [in-process and final checks] and affixes his or her name, initials [signature (first initial and last name or full signature)] or electronic signature to the appropriate quality control records prior to distribution;

(ii) preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation prior to distribution;

(iii) bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution;

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

(vi) loading [bulk] unlabeled drugs into an automated compounding or counting device provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her name, initials [signature (first initial and last name or full signature)] or electronic signature to the appropriate quality control records;

(vii) - (viii) (No change.)

(ix) compounding sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(I) (No change.)

(II) are supervised by a pharmacist who has completed the training specified in §291.133 of this title, and who conducts in-process and final checks, and affixes his or her name, initials , or electronic signature to the label or if batch prepared, to the appropriate quality control records. (The name, initials , or electronic signature are not required on the label if it is maintained in a permanent record of the pharmacy.)

(B) Facilities licensed for 100 beds or less.

(i) Physically present supervision. The following functions must be performed under the physically present supervision of a pharmacist:

(I) pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts a final check [in-process and final checks] and affixes his or her name, initials [signature (first initial and last name or full signature)] or electronic signature to the appropriate quality control records prior to distribution;

(II) bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution;

(III) loading [bulk] unlabeled drugs into an automated compounding or counting device provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her name, initials, [signature (first initial and last name or full signature)] or electronic signature to the appropriate quality control records; and

(IV) compounding medium-risk and high-risk sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(-a-) (No change.)

(-b-) are supervised by a pharmacist who has completed the training specified in §291.133 of this title and who conducts in-process and final checks, and affixes his or her name, initials , or electronic signature to the label or if batch prepared, to the appropriate quality control records. (The name, initials , initials or electronic signature are not required on the label if it is maintained in a permanent record of the pharmacy.)

(ii) Electronic supervision or physically present supervision. The following functions may be performed under the electronic supervision or physically present supervision of a pharmacist:

(I) preparing, packaging, or labeling prescription drugs pursuant to medication orders, provided a pharmacist checks the preparation prior to distribution;

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

(VI) compounding low-risk sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(-a-) (No change.)

(-b-) are supervised by a pharmacist who has completed the training specified in §291.133 of this title, and who conducts in-process and final checks, and affixes his or her name, initials , or electronic signature to the label or if batch prepared, to the appropriate quality control records. (The name, initials , or electronic signature are not required on the label if it is maintained in a permanent record of the pharmacy.)

(3) (No change.)

(f) - (g) (No change.)

§291.74.Operational Standards.

(a) Licensing requirements.

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

(6) A Class C pharmacy shall notify the board in writing within 10 days of closing, following the procedures in §291.5 of this title (relating to Closing a Pharmacy [Closed Pharmacies]).

(7) - (9) (No change.)

(10) A Class C (Institutional) pharmacy engaged in the compounding of non-sterile preparations [ non-sterile compounding of drug products for inpatients of the hospital] shall comply with the provisions of §291.131 of this title (relating to Pharmacies Compounding Non-sterile Preparations);

(11) A Class C (Institutional) pharmacy engaged in the compounding of sterile preparations [pharmaceuticals] shall comply with the provisions of §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations).

(12) (No change.)

(13) A Class C (Institutional) pharmacy engaged in centralized prescription dispensing and/or prescription drug or medication order processing shall comply with the provisions of §291.123 of this title (relating to Central [Centralized] Prescription Drug or Medication Order Processing) and/or §291.125 of this title (relating to Centralized Prescription Dispensing).

(b) Environment.

(1) General requirements.

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

(E) The temperature of the institutional pharmacy shall be maintained within a range compatible with the proper storage of drugs. The temperature of the refrigerator and/or freezer shall be maintained within a range compatible with the proper storage of drugs [requiring refrigeration].

(F) - (G) (No change.)

(2) (No change.)

(c) Equipment and supplies. Institutional pharmacies distributing medication orders shall have the following equipment:

(1) data processing system including a printer [ typewriter] or comparable equipment; and

(2) refrigerator and/or freezer and a system or device (e.g., thermometer) to monitor the temperature [and humidity] to ensure that proper storage requirements are met.

(d) (No change.)

(e) Absence of a pharmacist.

(1) Medication orders.

(A) In facilities with a full-time pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacy is closed, the following is applicable.

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

(v) The pharmacist shall verify the withdrawal of drugs from the pharmacy and perform a drug regimen review as specified in subsection (g)(1)(B) of this section as soon as practical, but in no event more than 72 hours from the time of such withdrawal.

(B) In facilities with a part-time or consultant pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacist is not on duty, or when the pharmacy is closed, the following is applicable.

(i) - (iii) (No change.)

(iv) The pharmacist shall verify the withdrawal of drugs from the pharmacy and perform a drug regimen review as specified in subsection (g)(1)(B) of this section after a reasonable interval, but in no event may such interval exceed seven days.

(2) Floor stock. In facilities using a floor stock method of drug distribution, the following is applicable.

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

(D) The pharmacist shall verify the withdrawal of drugs from the pharmacy after a reasonable interval, but in no event may such interval exceed seven days.

(f) Drugs.

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

(4) Sterile preparations [pharmaceuticals] prepared in a location other than the pharmacy. A distinctive supplementary label shall be affixed to the container of any admixture. The label shall bear at a minimum:

(A) patient's name and location, if not immediately administered;

(B) - (E) (No change.)

(5) Distribution.

(A) Medication orders.

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

(iii) Pharmacy technicians and pharmacy technician trainees [Supportive personnel] may not receive verbal medication orders.

(iv) (No change.)

(B) Procedures.

(i) (No change.)

(ii) The written policies and procedures for the drug distribution system shall include, but not be limited to, procedures regarding the following:

(I) - (XXIV) (No change.)

(XXV) routine distribution of patient [inpatient ] medication;

(XXVI) preparation and distribution of sterile preparations [pharmaceuticals];

(XXVII) - (XXIX) (No change.)

(XXX) drug administration to include infusion devices and[,] drug delivery systems[ , and first dose monitoring];

(XXXI) - (XXXV) (No change.)

(6) Discharge Prescriptions. Discharge prescriptions must be dispensed and labeled in accordance with §291.33 of this title (relating to Occupational Standards) except that certain medications packaged in unit-of-use containers, such as metered-dose inhalers, insulin pens, topical creams or ointments, or ophthalmic or otic preparation that are administered to the patient during the time the patient was a patient in the hospital, may be provided to the patient upon discharge provided the pharmacy receives a discharge order and the product bears a label containing the following information:

(A) name of the patient;

(B) name and strength of the medication;

(C) name of the prescribing or attending practitioner;

(D) directions for use;

(E) duration of therapy (if applicable); and

(F) name and telephone number of the pharmacy.

(g) (No change.)

(h) Emergency rooms.

(1) (No change.)

(2) When a pharmacist is not on duty in the facility, the following is applicable for supplying prescription drugs to be taken home by the patient for self-administration from the emergency room. If the patient has been admitted to the emergency room and assessed by a practitioner at the hospital, the following procedures shall be observed in supplying prescription drugs from the emergency room.

[(A) If the patient has been admitted to the emergency room and assessed by a practitioner at the hospital, the following procedures shall be observed in supplying prescription drugs from the emergency room.]

(A) [(i)] Dangerous drugs and/or controlled substances may only be supplied in accordance with the system of control and accountability for dangerous drugs and/or controlled substances administered or supplied from the emergency room; such system shall be developed and supervised by the pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge.

(B) [(ii)] Only dangerous drugs and/or controlled substances listed on the emergency room drug list may be supplied; such list shall be developed by the pharmacist-in-charge and the facility's emergency department committee (or like group or person responsible for policy in that department) and shall consist of dangerous drugs and/or controlled substances of the nature and type to meet the immediate needs of emergency room patients.

(C) [(iii)] Dangerous drugs and/or controlled substances may only be supplied in prepackaged quantities not to exceed a 72-hour supply in suitable containers and appropriately prelabeled (including necessary auxiliary labels) by the institutional pharmacy.

(D) [(iv)] At the time of delivery of the dangerous drugs and/or controlled substances, the practitioner or licensed nurse under the supervision of a practitioner shall appropriately complete the label with at least the following information:

(i) [(I)] name, address, and phone number of the facility;

(ii) [(II)] date supplied;

(iii) [(III)] name of practitioner;

(iv) [(IV)] name of patient;

(v) [(V)] directions for use;

(vi) [(VI)] brand name and strength of the dangerous drug or controlled substance; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug or controlled substance;

(vii) [(VII)] quantity supplied; and

(viii) [(VIII)] unique identification number.

(E) [(v)] The practitioner, or a licensed nurse under the supervision of the practitioner, shall give the appropriately labeled, prepackaged drug to the patient and explain the correct use of the drug.

(F) [(vi)] A perpetual record of dangerous drugs and/or controlled substances supplied from the emergency room shall be maintained in the emergency room. Such record shall include the following:

(i) [(I)] date supplied;

(ii) [(II)] practitioner's name;

(iii) [(III)] patient's name;

(iv) [(IV)] brand name and strength of the dangerous drug or controlled substance; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug or controlled substance;

(v) [(V)] quantity supplied; and

(vi) [(VI)] unique identification number.

(G) [(vii)] The pharmacist-in-charge, or staff pharmacist designated by the pharmacist-in-charge, shall verify the correctness of this record at least once every seven days.

[(B) If the patient has been admitted to the emergency room of a hospital and a practitioner telephones an order for a dangerous drug to be supplied, the following is applicable.]

[(i) Dangerous drugs may only be supplied to patients of hospitals after the normal business hours of local pharmacies and when pharmacy services are not reasonably available to the patient.]

[(ii) The practitioner shall cosign any order for a dangerous drug which is telephoned to the hospital emergency room within 72 hours.]

[(iii) The practitioner shall have a previous patient/physician relationship with the patient admitted to the emergency room.]

[(iv) The dangerous drugs may only be supplied in accordance with the system of control and accountability for drugs administered or supplied from the emergency room; such system shall be developed and supervised by the pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge.]

[(v) Only dangerous drugs listed on the emergency room drug list may be supplied; such list shall be developed by the pharmacist-in-charge and the facility's emergency department committee (or like group or person responsible for policy in that department) and shall consist of dangerous drugs of the nature and type to meet the immediate needs of emergency room patients.]

[(vi) The dangerous drugs may only be supplied in prepackaged quantities not to exceed a 72-hour supply in suitable containers and appropriately prelabeled (including necessary auxiliary labels) by the institutional pharmacy.]

[(vii) At any time of delivery of the dangerous drugs, a licensed nurse shall complete the label with at least the following information:]

[(I) name, address, and phone number of the facility;]

[(II) date supplied;]

[(III) name of the practitioner;]

[(IV) name of the patient;]

[(V) directions for use;]

[(VI) brand name and strength of the dangerous drug; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug;]

[(VII) quantity supplied; and]

[(VIII) unique identification number.]

[(viii) A licensed nurse shall give the appropriately labeled, prepackaged dangerous drug to the patient and explain the correct use of the drug.]

[(ix) A perpetual record of dangerous drugs supplied from the emergency room shall be maintained in the emergency room. Such record shall include the following:]

[(I) date supplied;]

[(II) practitioner's name;]

[(III) patient's name;]

[(IV) brand name and strength of the dangerous drug; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug;]

[(V) quantity supplied; and]

[(VI) unique identification number.]

[(x) The pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge shall verify the correctness of this record at least once every seven days.]

[(C) Prior to implementing the procedures for supplying dangerous drugs to emergency room patients of a hospital on the telephone order of a practitioner, as specified in subparagraph (B) of this paragraph, the hospital shall notify the board of its intent to implement this policy. Such notification shall be signed by the hospital administrator, medical director, and pharmacist-in-charge and contain the following information:]

[(i) the hours the hospital pharmacy is open for pharmacy services; and]

[(ii) documentation of the lack of pharmacy services after normal business hours of the hospital pharmacy.]

(i) (No change.)

(j) Automated devices and systems.

(1) Automated compounding or counting devices. If a pharmacy uses automated compounding or counting devices:

(A) (No change.)

(B) the devices may be loaded with [bulk or] unlabeled drugs only by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist;

(C) (No change.)

(D) records of loading [bulk or] unlabeled drugs into an automated compounding or counting device shall be maintained to show:

(i) - (vii) (No change.)

(E) (No change.)

(2) Automated medication supply systems.

(A) - (B) (No change.)

(C) Policies and procedures of operation.

(i) When an automated medication supply system is used to store or distribute medications for administration pursuant to medication orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall establish requirements for operation of the automated medication supply system and shall describe policies and procedures that:

(I) (No change.)

(II) provide for a pharmacist's review and approval of each original or new medication order prior to withdrawal from [filled through the use of ] the automated medication supply system:

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

(III) - VII)

(ii) (No change.)

(D) Automated medication supply systems used for storage and recordkeeping of medications located outside of the pharmacy department (e.g., Pyxis). A pharmacy technician or pharmacy technician trainee may re-stock an automated medication supply system located outside of the pharmacy department with prescription drugs other than IV admixtures provided:

(i) prior to distribution of the prescription drugs a pharmacist verifies that the prescription drugs pulled to stock the automated supply system match the list of prescription drugs generated by the automated medication supply system;

(ii) the prescription drugs to re-stock the system are labeled with a machine readable product identifier, such as a barcode;

(iii) any previous manipulation of the product such as repackaging or extemporaneous compounding has been checked by a pharmacist; and

(iv) quality assurance audits are conducted according to established policies and procedures to ensure accuracy of the process.

(E) [(D)] Recovery Plan. A pharmacy which uses an automated medication supply system to store or distribute medications for administration pursuant to medication orders shall maintain a written plan for recovery from a disaster or any other situation which interrupts the ability of the automated medication supply system to provide services necessary for the operation of the pharmacy. The written plan for recovery shall include:

(i) planning and preparation for maintaining pharmacy services when an automated medication supply system is experiencing downtime;

(ii) procedures for response when an automated medication supply system is experiencing downtime;

(iii) procedures for the maintenance and testing of the written plan for recovery; and

(iv) procedures for notification of the Board and other appropriate agencies whenever an automated medication supply system experiences downtime for more than two days of operation or a period of time which significantly limits the pharmacy's ability to provide pharmacy services.

(3) Verification of medication orders prepared by the pharmacy department through the use of an automated medication supply system. A pharmacist must check drugs prepared pursuant to medication orders to ensure that the drug is prepared for distribution accurately as prescribed. This paragraph does not apply to automated medication supply systems used for storage and recordkeeping of medications located outside of the pharmacy department.

(A) This check shall be considered accomplished if:

(i) (No change.)

(ii) the following checks are conducted by a pharmacist:

(I) if the automated medication supply system contains unlabeled [ bulk] stock drugs, a pharmacist verifies that those drugs have been accurately stocked; and

(II) (No change.)

(B) If the final check is accomplished as specified in subparagraph (A)(ii) of this paragraph, the following additional requirements must be met.

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

(iii) The automated medication supply system documents and maintains:

(I) (No change.)

(II) the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician or pharmacy technician trainee who performs any other portion of the medication order preparation process.

(iv) (No change.)

(4) (No change.)

§291.75.Records.

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

(c) Patient [Inpatient] records.

(1) (No change.)

(2) Patient medication records (PMR). A patient medication record shall be maintained for each patient [inpatient] of the facility. The PMR shall contain at a minimum the following information.

(A) - (B) (No change.)

(3) (No change.)

(4) Schedule II controlled substances records. Records of controlled substances listed in Schedule II shall be maintained as follows.

(A) - (B) (No change.)

(C) Distribution records for controlled substances listed in Schedule II shall bear the following information:

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

(v) name, initials, [signature (first initial and last name or full signature)] or electronic signature of the individual administering the controlled substance;

(vi) - (vii) (No change.)

(5) Floor stock records.

(A) Distribution records for Schedule II - V controlled substances floor stock shall include the following information:

(i) - (v) (No change.)

(vi) name, initials, [signature (first initial and last name or full signature)] or electronic signature of the individual administering drug;

(vii) - (viii) (No change.)

(B) - (C) (No change.)

(6) General requirements for records maintained in a data processing system.

(A) - (B) (No change.)

(C) Change or discontinuance of a data processing system.

(i) Records of distribution and return for all controlled substances, nalbuphine (e.g., Nubain)[ , tripelennamine (e.g., PBZ) ] and carisoprodol (e.g., Soma). A pharmacy that changes or discontinues use of a data processing system must:

(I) - (II) (No change.)

(ii) - (iii) (No change.)

(D) (No change.)

(7) Data processing system maintenance of records for the distribution and return of all controlled substances, nalbuphine (e.g., Nubain)[, tripelennamine (e.g., PBZ), ] and carisoprodol (e.g., Soma) to the pharmacy.

(A) Each time a controlled substance, nalbuphine (e.g., Nubain)[, tripelennamine (e.g., PBZ),] or carisoprodol (e.g., Soma) is distributed from or returned to the pharmacy, a record of such distribution or return shall be entered into the data processing system.

(B) The data processing system shall have the capacity to produce a hard copy printout of an audit trail of drug distribution and return for any strength and dosage form of a drug (by either brand or generic name or both) during a specified time period. This printout shall contain the following information:

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

(v) if not immediately retrievable via electronic image [CRT display], the following shall also be included on the printout:

(I) - (II) (No change.)

(C) An audit trail printout for each strength and dosage form of these drugs distributed during the preceding month shall be produced at least monthly and shall be maintained in a separate file at the facility unless the pharmacy complies with subparagraph (D) of this section. The information on this printout shall be sorted by drug name and list all distributions/returns for that drug chronologically.

(D) (No change.)

(8) - (9) (No change.)

(d) - (f) (No change.)

§291.76.Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center.

(a) (No change.)

(b) Definitions. The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

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

(7) Direct copy--Electronic copy or carbonized copy of a medication order including a facsimile (FAX) or digital image[, tele-autograph, or a copy transmitted between computers ].

(8) - (13) (No change.)

(14) Hard copy--A physical document that is readable without the use of a special device (i.e., data processing system, computer, etc. [ cathode ray tube (CRT), microfiche reader, etc.]).

(15) - (25) (No change.)

(c) Personnel.

(1) Pharmacist-in-charge.

(A) (No change.)

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

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

(iii) distribution of drugs to be administered to patients [inpatients ] pursuant to an original or direct copy of the practitioner's medication order;

(iv) (No change.)

(v) maintaining and making available a sufficient inventory of antidotes and other emergency drugs, both in the pharmacy and patient [inpatient ] care areas, as well as current antidote information, telephone numbers of regional poison control center and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the ASC;

(vi) - (xiii) (No change.)

(2) (No change.)

(3) Pharmacists.

(A) General.

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

(iii) All pharmacists shall be responsible for any delegated act performed by pharmacy technicians or pharmacy technician trainees under his or her supervision.

(iv) (No change.)

(B) - (C) (No change.)

(4) Pharmacy technicians and pharmacy technician trainees.

(A) (No change.)

(B) Duties. Duties may include, but need not be limited to, the following functions, under the direct supervision of a pharmacist:

(i) prepacking and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts a final check [in-process and final checks ] and affixes his or her name, initials, [signature or ] electronic signature to the appropriate quality control records prior to distribution;

(ii) (No change.)

(iii) compounding non-sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees have completed the training specified in §291.131 of this title;

(iv) compounding sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(I) have completed the training specified in §291.133 of this title; and

(II) are supervised by a pharmacist who has completed the sterile preparations training specified in §291.133 of this title, conducts in-process and final checks, and affixes his or her name, initials, or electronic signature to the label or if batch prepared to the appropriate quality control records. (The name, initials, or electronic signature are not required on the label if it is maintained in a permanent record of the pharmacy.)

[(iii) compounding non-sterile and sterile preparations pursuant to medication orders;]

[(I) have completed the training specified in §291.26 of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals); and]

[(II) are supervised by a pharmacist who has completed the sterile products training specified in §291.26 of this title, conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy.)]

(v) [(iv)] bulk compounding, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution;

(vi) [(v)] distributing routine orders for stock supplies to patient care areas;

(vii) [(vi)] entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order or in compliance with the absence of pharmacist requirements contained in subsection (d)(6)(E) and (F) of this section;

(viii) [(vii)] maintaining inventories of drug supplies;

(ix) [(viii)] maintaining pharmacy records; and

(x) [(ix)] loading bulk unlabeled drugs into an automated drug dispensing system provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her name, initials or [ signature] or electronic signature to the appropriate quality control records.

(C) Procedures.

(i) (No change.)

(ii) Pharmacy technicians and pharmacy technician trainees shall handle prescription drug orders in the same manner as pharmacy technicians or pharmacy technician trainees working in a Class A pharmacy.

(D) Special requirements for compounding.

(i) (No change.)

(ii) Sterile Preparations. All pharmacy technicians and pharmacy technician trainees engaged in compounding sterile preparations shall meet the training requirements specified in §291.133 [§291.131] of this title.

(5) - (6) (No change.)

(d) Operational standards.

(1) Licensing requirements.

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

(F) An ASC pharmacy shall notify the board in writing within 10 days of closing, following the procedures in §291.5 of this title (relating to Closing a Pharmacy [Closed Pharmacies]).

(G) - (I) (No change.)

(J) An ASC pharmacy engaged in the compounding of non-sterile preparations [non-sterile compounding of drug products for inpatients of the hospital] shall comply with the provisions of §291.131 of this title.

(K) An ASC pharmacy engaged in the compounding of sterile preparations [pharmaceuticals] shall comply with the provisions of §291.133 of this title.

(L) - (M) (No change.)

(2) (No change.)

(3) Equipment and supplies. Ambulatory surgical centers supplying drugs for postoperative use shall have the following equipment and supplies:

(A) data processing system including a printer [ typewriter] or comparable equipment; and

(B) - (C) (No change.)

(4) Library. A reference library shall be maintained that [ which] includes the following in hard-copy or electronic format and that pharmacy personnel shall be capable of accessing at all times:

(A) - (F) (No change.)

(5) Drugs.

(A) Procurement, preparation, and storage.

(i) - (iii) (No change.)

(iv) All drugs shall be stored at the proper temperatures, as defined in the USP/NF and in §291.15 of this title (relating to Storage of Drugs) [by the following terms].

[(I) Room temperature--temperature maintained between 15 degrees Celsius (59 degrees Fahrenheit) and 30 degrees Celsius (86 degrees Fahrenheit).]

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

[(III) Refrigerate--temperature that is thermostatically maintained between 2 degrees Celsius (36 degrees Fahrenheit) and 8 degrees Celsius (46 degrees Fahrenheit).]

[(IV) Freeze--temperature that is thermostatically maintained between minus 20 degrees Celsius (minus 4 degrees Fahrenheit) and minus 10 degrees Celsius (14 degrees Fahrenheit).]

(v) - (vi) (No change.)

(B) - (C) (No change.)

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

(e) Records.

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

(3) Patient [Inpatient] records.

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

(F) General requirements for records maintained in a data processing system are as follows.

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

(iii) Change or discontinuance of a data processing system.

(I) Records of distribution and return for all controlled substances, nalbuphine (Nubain), and carisoprodol (Soma) [ tripelennamine (PBZ)]. A pharmacy that changes or discontinues use of a data processing system must:

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

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

(iv) (No change.)

(G) Data processing system maintenance of records for the distribution and return of all controlled substances, nalbuphine (Nubain), or carisoprodol (Soma) [tripelennamine (PBZ)] to the pharmacy.

(i) Each time a controlled substance, nalbuphine (Nubain), or carisoprodol (Soma) [tripelennamine (PBZ)] is distributed from or returned to the pharmacy, a record of such distribution or return shall be entered into the data processing system.

(ii) The data processing system shall have the capacity to produce a hard-copy printout of an audit trail of drug distribution and return for any strength and dosage form of a drug (by either brand or generic name or both) during a specified time period. This printout shall contain the following information:

(I) - (IV) (No change.)

(V) if not immediately retrievable via electronic image [CRT display], the following shall also be included on the printout:

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

(iii) - (iv) (No change.)

(H) - (I) (No change.)

(4) - (6) (No change.)

[(7) Confidentiality.]

[(A) A pharmacist shall provide adequate security of prescription drug orders, medication orders, and patient medication records to prevent indiscriminate or unauthorized access to confidential health information.]

[(B) Confidential records are privileged and may be released only to:]

[(i) the patient or the patient's agent;]

[(ii) a practitioner or another pharmacist if, in the pharmacist's professional judgement, the release is necessary to protect the patient's health and well being;]

[(iii) the board or to a person or another state or federal agency authorized by law to receive the confidential record;]

[(iv) a law enforcement agency engaged in investigation of a suspected violation of Chapter 481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.);]

[(v) a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties; or]

[(vi) an insurance carrier or other third party payor authorized by a patient to receive such information.]

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

Filed with the Office of the Secretary of State on June 1, 2009.

TRD-200902108

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 12, 2009

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

22 TAC §295.5

The Texas State Board of Pharmacy proposes amendments to §295.5 concerning Pharmacist License or Renewal Fees. The proposed amendments to §295.5, if adopted, will raise pharmacist license fees based on increased expenses.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the amendments are in effect, there will be fiscal implications for state government as a result of enforcing or administering the amended rule as follows:

Revenue Increase

FY2010 = $1,127,098

FY2011 = $1,425,806

FY2012 = $1,425,806

FY2013 = $1,425,806

FY2014 = $1,425,806

There are no anticipated fiscal implications for local government.

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 amended rule will be assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission. The effect on large, small or micro-businesses (pharmacies) will be the same as the economic cost to an individual, if the pharmacy chooses to pay the fee for the individual.

Economic cost to persons who are required to comply with the amended rule will be an increase of $106 for an initial registration and an increase of $106 for the renewal of a registration.

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., July 31, 2009.

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.

§295.5.Pharmacist License or Renewal Fees.

(a) (No change.)

(b) Initial License Fee.

(1) The fee for the initial license shall be $320 [$214 ] for a two year registration and for processing the application and issuance of the pharmacist license as authorized by the Act, §554.006.

(2) In addition, the following fees shall be collected:

(A) $13 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051;

(B) $10 surcharge to fund TexasOnline as authorized by Chapter 2054, Subchapter I, Government Code; and

(C) $5 surcharge to fund the Office of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations Code.

(3) New pharmacist licenses shall be assigned an expiration date and initial fee shall be prorated based on the assigned expiration date.

(c) Renewal Fee.

(1) The fee for biennial renewal of a pharmacist license shall be $320 [$214] for processing the application and issuance of the pharmacist license as authorized by the Act, §554.006.

(2) In addition, the following fees shall be collected:

(A) $13 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051;

(B) $10 surcharge to fund TexasOnline as authorized by Chapter 2054, Subchapter I, Government Code; and

(C) $2 surcharge to fund the Office of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations Code.

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

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

Filed with the Office of the Secretary of State on June 1, 2009.

TRD-200902104

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 12, 2009

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

22 TAC §295.8

The Texas State Board of Pharmacy proposes amendments to §295.8 concerning Continuing Education Requirements. The amendments, if adopted, clarify that, for pharmacists, the ACPE number must indicate that the program is for pharmacists by the designation of the letter P, allow pharmacists to complete the same program once per licensure period, clarify the pediatric advanced life support certification is also approved for continuing education credit, allow pharmacists to receive 3 hours of continuing education credit for certification by the Board of Pharmaceutical Specialty, and allow pharmacists to receive credit for attending a program provided by the Texas State Board of Pharmacy or a course offered by the Texas State Board of Pharmacy.

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 to ensure pharmacists receive appropriate and approved continuing education. 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 p.m., July 31, 2009.

The amendments are proposed under §551.002, §554.051, and §559.052 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 §559.052 as authorizing the agency to adopt rules for the approval of continuing education programs.

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

§295.8.Continuing Education Requirements.

(a) (No change.)

(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

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

(6) Certificate of completion--A certificate or other official document presented to a participant upon the successful completion of a continuing education program. Certificates presented by an ACPE approved provider must contain the following information:

(A) name of the participant;

(B) title and date of the program;

(C) name of the approved provider sponsoring or cosponsoring the program;

(D) number of contact hours and/or CEUs awarded;

(E) the assigned ACPE universal program number with a "P" designation indicating that the CE is targeted to pharmacists;

(F) a dated certifying signature of the approved provider; and

(G) the official ACPE logo.

(7) - (14) (No change.)

(c) - (d) (No change.)

(e) Approved Programs.

(1) Any program presented by an ACPE approved provider subject to the following conditions.

(A) Pharmacists may receive credit for the completion of the same ACPE course only once during [each year of] a license period.

(B) Pharmacists who present approved ACPE continuing education programs may receive credit for the time expended during the actual presentation of the program. Pharmacists may receive credit for the same presentation only once during [ each year of] a license period.

(C) Proof of completion of an ACPE course shall be a certificate of completion as defined by subsection (b)(6) of this section.

(2) Courses which are part of a professional degree program or an advanced pharmacy degree program offered by a college of pharmacy which has a professional degree program accredited by ACPE.

(A) Pharmacists may receive credit for the completion of the same course only once during [each year of ] a license period.

(B) Pharmacists who teach these courses may receive credit towards their continuing education, but such credit may be received only once for teaching the same course during [each year of] a license period.

(3) Basic cardiopulmonary resuscitation (CPR) courses which lead to CPR certification by the American Red Cross or the American Heart Association shall be recognized as approved programs. Pharmacists may receive credit for one contact hour (0.1 CEU) towards their continuing education requirement for completion of a CPR course only once during [each year of] a license period. Proof of completion of a CPR course shall be the certificate issued by the American Red Cross or the American Heart Association.

(4) Advanced cardiovascular life support courses (ACLS) or pediatric advanced life support (PALS) courses which lead to initial ACLS or PALS certification by the American Heart Association shall be recognized as approved programs. Pharmacists may receive credit for twelve contact hours (1.2 CEUs) towards their continuing education requirement for completion of an ACLS or PALS course only once during a license period. Proof of completion of an ACLS or PALS course shall be the certificate issued by the American Heart Association.

(5) Advanced cardiovascular life support courses (ACLS) or pediatric advanced life support (PALS) courses which lead to ACLS or PALS recertification by the American Heart Association shall be recognized as approved programs. Pharmacists may receive credit for four contact hours (0.4 CEUs) towards their continuing education requirement for completion of an ACLS or PALS recertification course only once during a license period. Proof of completion of an ACLS or PALS recertification course shall be the certificate issued by the American Heart Association.

(6) Attendance at Texas State Board of Pharmacy Board Meetings shall be recognized for continuing education credit as follows.

(A) Pharmacists shall receive credit for three contact hours (0.3 CEUs) towards their continuing education requirement for attending a full, public board business meeting in its entirety.

(B) A maximum of six contact hours (0.6 CEUs) are allowed for attendance at a board meeting during a [within a pharmacist's biennial] license period.

(C) Proof of attendance for a complete board meeting shall be a certificate issued by the Texas State Board of Pharmacy.

(7) Participation in a Texas State Board of Pharmacy appointed Task Force shall be recognized for continuing education credit as follows.

(A) Pharmacists shall receive credit for three contact hours (0.3 CEUs) towards their continuing education requirement for participating in a Texas State Board of Pharmacy appointed Task Force.

(B) Proof of participation for a Task Force shall be a certificate issued by the Texas State Board of Pharmacy.

(8) Completion of an Institute for Safe Medication Practices' (ISMP) Medication Safety Self Assessment for hospital pharmacies or for community/ambulatory pharmacies shall be recognized for continuing education credit as follows.

(A) Pharmacists shall receive credit for three contact hours (0.3 CEUs) towards their continuing education requirement for completion of an ISMP Medication Safety Self Assessment.

(B) Proof of completion of an ISMP Medication Safety Self Assessment shall be:

(i) a continuing education certificate provided by an ACPE approved provider for completion of an assessment; or

(ii) a document from ISMP showing completion of an assessment.

(9) Pharmacists shall receive credit for three contact hours (0.3 CEUs) toward their continuing education requirements for taking and successfully passing the initial Geriatric Pharmacy Practice certification examination administered by the Commission for Certification in Geriatric Pharmacy. Proof of successfully passing the examination shall be a certificate issued by the Commission for Certification in Geriatric Pharmacy.

(10) Pharmacist shall receive credit for three contact hours (0.3 CEUs) toward their continuing education requirements for taking and successfully passing an initial Board of Pharmaceutical Specialties certification examination administered by the Board of Pharmaceutical Specialties. Proof of successfully passing the examination shall be a certificate issued by the Board of Pharmaceutical Specialties.

(11) Attendance at programs presented by the Texas State Board of Pharmacy or courses offered by the Texas State Board of Pharmacy as follows:

(A) Pharmacists shall receive credit for the number of hours for the program or course as stated by the Texas State Board of Pharmacy.

(B) Proof of attendance at a program presented by the Texas State Board of Pharmacy or completion of a course offered by the Texas State Board of Pharmacy shall be a certificate issued by the Texas State Board of Pharmacy.

(12) [(10)] Upon demonstrated need the board may establish criteria to approve programs presented by non-ACPE approved providers.

(f) Retention of continuing education records and audit of records by the board.

(1) Retention of records. Pharmacists are required to maintain certificates of completion of approved continuing education for three years from the date of reporting the contact hours on a license renewal application.

(2) Audit of records by the board. The board shall audit the records of pharmacists for verification of reported continuing education credit. The following is applicable for such audits.

(A) Upon written request, a pharmacist shall provide to the board documentation of proof [ copies of certificates of completion ] for all continuing education contact hours reported during a specified license period(s). Failure to provide all requested records during the specified time period constitutes prima facie evidence of failure to keep and maintain records and shall subject the pharmacist to disciplinary action by the board.

(B) Credit for continuing education contact hours shall only be allowed for approved programs for which the pharmacist submits documentation of proof [ copies of certificates of completion] reflecting that the hours were completed during the specified license period(s). Any other reported hours shall be disallowed. A pharmacist who has received credit for continuing education contact hours disallowed during an audit shall be subject to disciplinary action.

(C) A pharmacist who submits false or fraudulent records to the board shall be subject to disciplinary action by the board.

(g) (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 June 1, 2009.

TRD-200902105

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 12, 2009

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

22 TAC §297.4

The Texas State Board of Pharmacy proposes amendments to §297.4 concerning Fees. The proposed amendments to §297.4 will raise pharmacy technician registration fees based on increased expenses.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the amendments are in effect, there will be fiscal implications for state government as a result of enforcing or administering the amended rule as follows:

Revenue Increase

FY2010 = $1,013,552

FY2011 = $1,216,290

FY2012 = $1,216,290

FY2013 = $1,216,290

FY2014 = $1,216,290

There are no anticipated fiscal implications for local government.

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 amended rule will be assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission. The effect on large, small or micro-businesses (pharmacies) will be the same as the economic cost to an individual, if the pharmacy chooses to pay the individual fee.

Economic cost to persons who are required to comply with the amended rule will be an increase of $61 for a pharmacy technician trainee registration, an increase of $112 for an initial pharmacy technician registration and an increase of $109 for the renewal of a pharmacy technician registration.

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., July 31, 2009.

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.

§297.4.Fees.

(a) Pharmacy technician trainee. The fee for registration shall be $61 and is composed of the following fees: [There shall be no fee for registration as a pharmacy technician trainee.]

(1) $53 for processing the application and issuance of the pharmacy technician trainee registration as authorized by the Act, §568.005;

(2) a $3 surcharge to fund TexasOnline as authorized by Chapter 2054, Subchapter I, Government Code; and

(3) $5 surcharge to fund the Office of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations Code.

(b) Pharmacy technician.

(1) Biennial Registration. The board shall require biennial renewal of all pharmacy technician registrations provided under Chapter 568 of the Act.

(2) Initial Registration Fee.

(A) The fee for initial registration shall be $112 [$59 ] for a two year registration and is composed of the following fees:

(i) $104 [$51] for processing the application and issuance of the pharmacy technician registration as authorized by the Act, §568.005;

(ii) a $3 surcharge to fund TexasOnline as authorized by Chapter 2054, Subchapter I, Government Code; and

(iii) $5 surcharge to fund the Office of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations Code.

(B) The initial registration fee shall be prorated based on the assigned expiration date.

(3) Renewal Fee. The fee for biennial renewal of a pharmacy technician registration shall be $109 [$56] and is composed of the following:

(A) $104 [$51] for processing the application and issuance of the pharmacy technician registration as authorized by the Act, §568.005;

(B) a $3 surcharge to fund TexasOnline as authorized by Chapter 2054, Subchapter I, Government Code; and

(C) $2 surcharge to fund the Office of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations Code.

(c) (No change.)

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

Filed with the Office of the Secretary of State on June 1, 2009.

TRD-200902106

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 12, 2009

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

22 TAC §303.1, §303.2

The Texas State Board of Pharmacy proposes amendments to §303.1 concerning Destruction of Dispensed Drugs and §303.2 concerning Disposal of Stock Prescription Drugs. The amendments, if adopted, clarify that only dangerous drugs that have been previously dispensed to a patient may be accepted by a pharmacy and destroyed based on DEA requirements and the amendments, if adopted, remove references to tripelennamine which is no longer available.

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 to ensure pharmacists destroy drugs in accordance with federal regulations. 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 p.m., July 31, 2009.

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.

§303.1.Destruction of Dispensed Drugs.

(a) Drugs dispensed to patients in health care facilities or institutions.

(1) Destruction by the consultant pharmacist. The consultant pharmacist, if in good standing with the Texas State Board of Pharmacy, is authorized to destroy dangerous drugs and controlled substances dispensed to patients in health care facilities or institutions, providing the following conditions are met.

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

(E) The actual destruction of the drugs is witnessed by one of the following:

(i) a commissioned peace officer;

(ii) an agent of the Texas State Board of Pharmacy;

(iii) an agent of the Texas Health and Human Services Commission [Department of Human Services], authorized by the Texas State Board of Pharmacy to destroy drugs;

(iv) an agent of the Texas Department of State Health Services [Health], authorized by the Texas State Board of Pharmacy to destroy drugs; or

(v) any two individuals working in the following capacities at the facility:

(I) facility administrator;

(II) director of nursing;

(III) acting director of nursing; or

(IV) licensed nurse.

(F) (No change.)

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

(b) Dangerous drugs returned to a pharmacy. A pharmacist may accept and destroy dangerous drugs that have been previously dispensed to a patient and returned to a pharmacy by the patient or an agent of the patient. However, a pharmacist may not accept controlled substance that have been previously dispensed to a patient. The following procedures shall be followed in destroying dangerous drugs.

(1) The dangerous drugs shall be destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements.

(2) Documentation shall be maintained that includes the following information:

(A) name and address of the dispensing pharmacy;

(B) unique identification number assigned to the prescription, if available;

(C) name and strength of the dangerous drug; and

(D) signature of the pharmacist.

[(b) Drugs returned to a pharmacy. A pharmacist, licensed by the board, is authorized to destroy dangerous drugs and controlled substances which have been previously dispensed to a patient and returned to a pharmacy by the patient or an agent of the patient. The following procedures shall be followed in destroying these drugs.]

[(1) Dangerous drugs other than tripelennamine (e.g., PBZ),nalbuphine (e.g., Nubain), and carisoprodol (e.g., Soma).]

[(A) The dangerous drugs shall be destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements.]

[(B) Documentation shall be maintained which includes the following information:]

[(i) name and address of the dispensing pharmacy;]

[(ii) unique identification number assigned to the prescription, if available;]

[(iii) name and strength of the dangerous drug; and]

[(iv) signature of the pharmacist.]

[(2) Controlled substances and tripelennamine (e.g., PBZ), nalbuphine (e.g., Nubain), and carisoprodol (e.g., Soma).]

[(A) Controlled substances and triplennamine (PBZ), nalbuphine (Nubain), and carisoprodol (e.g., Soma) shall be destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements.]

[(B) The destruction shall be witnessed by one of the following individuals:]

[(i) the patient or patient's agent;]

[(ii) another licensed pharmacist;]

[(iii) a commissioned peace officer; or]

[(iv) an agent of the Texas State Board of Pharmacy, Texas Department of Public Safety, or Drug Enforcement Agency.]

[(C) Documentation shall be maintained which includes the following information:]

[(i) date of destruction;]

[(ii) name and address of the dispensing pharmacy;]

[(iii) unique identification number assigned to the prescription if available;]

[(iv) name of the patient;]

[(v) name, strength, and quantity of the drug; and]

[(vi) signature of the pharmacist who destroyed the drugs and signature of the witness to the destruction.]

§303.2.Disposal of Stock Prescription Drugs.

(a) (No change.)

(b) Disposal of stock dangerous drugs. A pharmacist, licensed by the board, is authorized to destroy stock dangerous drugs owned by a licensed pharmacy if such dangerous drugs are destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements. However, the following procedures shall be followed in destroying any brand or dosage form of [tripelennamine (e.g., PBZ),] nalbuphine (e.g., Nubain), and carisoprodol (e.g., Soma):

(1) the dangerous drugs are inventoried; and

(2) the destruction is witnessed by another licensed pharmacist or a commissioned peace officer.

(c) (No change.)

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

Filed with the Office of the Secretary of State on June 1, 2009.

TRD-200902107

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 12, 2009

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

CHAPTER 511. ELIGIBILITY

SUBCHAPTER C. EDUCATIONAL REQUIREMENTS

22 TAC §511.58

The Texas State Board of Public Accountancy (Board) proposes an amendment to §511.58, concerning Definitions of Related Business Subjects.

The amendment to §511.58 attempts to insure that individuals teaching college level ethics courses not have a history of having been disciplined by the Board or other state or federal licensing agencies.

William Treacy, Executive Director of the Board, has determined that for the first five-year period the proposed amendment will be in effect:

A. the additional estimated cost to the state expected as a result of enforcing or administering the amendment will be none.

B. the estimated reduction in costs to the state and to local governments as a result of enforcing or administering the amendment will be none.

C. the estimated loss or increase in revenue to the state as a result of enforcing or administering the amendment will be none.

Mr. Treacy has determined that for the first five-year period the amendment is in effect the public benefit expected as a result of adoption of the proposed amendment will be a licensee better educated in ethics which will inure to the benefit of the public.

The probable economic cost to persons required to comply with the amendment will be insignificant.

Mr. Treacy has determined that a Local Employment Impact Statement is not required because the proposed amendment will not affect a local economy.

Mr. Treacy has determined that the proposed amendment will not have a significant adverse economic effect on small businesses because the amendment is not expected to affect a significant number of small businesses.

Mr. Treacy has determined that an Economic Impact Statement and a Regulatory Flexibility Analysis are not required because the proposed amendment will not adversely affect small or micro businesses.

The Board requests comments on the substance and effect of the proposed rule from any interested person. Comments must be received at the Board no later than noon on July 12, 2009. Comments should be addressed to J. Randel (Jerry) Hill, General Counsel, Texas State Board of Public Accountancy, 333 Guadalupe, Tower 3, Suite 900, Austin, Texas 78701 or faxed to his attention at (512) 305-7854.

The Board specifically invites comments from the public on the issues of whether or not the proposed amendment will have an adverse economic effect on small businesses; if the proposed rule is believed to have an adverse effect on small businesses, estimate the number of small businesses believed to be impacted by the rule, describe and estimate the economic impact of the rule on small businesses, offer alternative methods of achieving the purpose of the rule; then explain how the Board may legally and feasibly reduce that adverse effect on small businesses considering the purpose of the statute under which the proposed rule is to be adopted; finally describe how the health, safety, environmental and economic welfare of the state will be impacted by the various proposed methods. See Texas Government Code, §2006.002(c).

The amendment is proposed under the Public Accountancy Act ("Act"), Texas Occupations Code, §901.151 which authorizes the Board to adopt rules deemed necessary or advisable to effectuate the Act.

No other article, statute or code is affected by this proposed amendment.

§511.58.Definitions of Related Business Subjects.

(a) An individual who holds a baccalaureate degree from a recognized educational institution as defined by board rule, §511.52 of this title (relating to Recognized Colleges and Universities) may take related business courses offered at an accredited community college, provided they are recognized as upper level courses for a 4-year BBA degree from an institution recognized by the board.

(b) The board will accept not fewer than 24 semester credit hours of upper level courses (for the purposes of this subsection, economics and statistics at any college level will count as upper division courses) as related business subjects (without repeat), taken at a recognized educational institution shown on official transcripts or accepted by a recognized educational institution for purposes of obtaining a baccalaureate degree or its equivalent, in the following areas. Not more than 6 credit semester hours taken in any subject area may be used to meet the minimum hour requirement.

(1) business law, including study of the Uniform Commercial Code;

(2) economics;

(3) management;

(4) marketing;

(5) business communications;

(6) statistics and quantitative methods;

(7) finance;

(8) information systems or technology; and

(9) other areas related to accounting.

(c) In addition to the 24 hours required in subsection (b) of this section, the board requires that 3 passing semester hours be earned as a result of taking a course in ethics. The course must be taken at a recognized educational institution and should provide students with a framework of ethical reasoning, professional values and attitudes for exercising professional skepticism and other behavior that is in the best interest of the public and profession. The ethics program should provide a foundation for ethical reasoning and include the core values of integrity, objectivity and independence taught by an instructor who has not been disciplined by the board for a violation of the board's rules of professional conduct unless waived by the board.

(d) The board requires that a minimum of 2 semester credit hours in accounting communications or business communications be completed. The semester hours may be obtained through a discrete course or offered through an integrated approach. If the course content is offered through integration, the university must advise the board of the course(s) that contain the accounting communications or business communications content.

(e) Credit for hours taken at recognized colleges and universities using the quarter system shall be counted as 2/3 of a semester hour for each hour of credit received under the quarter system.

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 May 28, 2009.

TRD-200902063

J. Randel (Jerry) Hill

General Counsel

Texas State Board of Public Accountancy

Earliest possible date of adoption: July 12, 2009

For further information, please call: (512) 305-7842

SUBCHAPTER B. CONTINUING PROFESSIONAL EDUCATION RULES FOR INDIVIDUALS

22 TAC §523.120

The Texas State Board of Public Accountancy (Board) proposes an amendment to §523.120, concerning Standards for CPE Reporting.

The amendment to §523.120 will modify the rule to reflect that the certificate is evidence of the completion of the course.

William Treacy, Executive Director of the Board, has determined that for the first five-year period the proposed amendment will be in effect:

A. the additional estimated cost to the state expected as a result of enforcing or administering the amendment will be none.

B. the estimated reduction in costs to the state and to local governments as a result of enforcing or administering the amendment will be none.

C. the estimated loss or increase in revenue to the state as a result of enforcing or administering the amendment will be none.

Mr. Treacy has determined that for the first five-year period the amendment is in effect the public benefits expected as a result of adoption of the proposed amendment will be a better understanding of what constitutes evidence of course completion.

The probable economic cost to persons required to comply with the amendment will be none.

Mr. Treacy has determined that a Local Employment Impact Statement is not required because the proposed amendment will not affect a local economy.

Mr. Treacy has determined that the proposed amendment will not have an adverse economic effect on small businesses because the amendment does not impose any duties or obligations upon small businesses.

Mr. Treacy has determined that an Economic Impact Statement and a Regulatory Flexibility Analysis are not required because the proposed amendment will not adversely affect small or micro businesses.

The Board requests comments on the substance and effect of the proposed rule from any interested person. Comments must be received at the Board no later than noon on July 12, 2009. Comments should be addressed to J. Randel (Jerry) Hill, General Counsel, Texas State Board of Public Accountancy, 333 Guadalupe, Tower 3, Suite 900, Austin, Texas 78701 or faxed to his attention at (512) 305-7854.

The Board specifically invites comments from the public on the issues of whether or not the proposed amendment will have an adverse economic effect on small businesses; if the proposed rule is believed to have an adverse effect on small businesses, estimate the number of small businesses believed to be impacted by the rule, describe and estimate the economic impact of the rule on small businesses, offer alternative methods of achieving the purpose of the rule; then explain how the Board may legally and feasibly reduce that adverse effect on small businesses considering the purpose of the statute under which the proposed rule is to be adopted; finally describe how the health, safety, environmental and economic welfare of the state will be impacted by the various proposed methods. See Texas Government Code, §2006.002(c).

The amendment is proposed under the Public Accountancy Act ("Act"), Texas Occupations Code, §901.151 which authorizes the Board to adopt rules deemed necessary or advisable to effectuate the Act.

No other article, statute or code is affected by this proposed amendment.

§523.120.Standards for CPE Reporting.

(a) Participants in group or self-study programs must document their participation, including:

(1) sponsor name and identification number;

(2) title or description of content, or both;

(3) date(s);

(4) location; and

(5) number of credit hours.

(b) These standards are designed to encourage participants to document their attendance at group programs or participation in self-study programs. Evidence of completion is [would normally be] the certificate supplied by the sponsor. Documentation [by the licensee] must be retained by the licensee for the three most recent full reporting periods.

(c) Credit hours earned from sources other than registered sponsors, or membership on designated committees should be claimed at the time the license renewal is submitted on the appropriate form "Claiming Credit from a Non-Registered Sponsor" justifying the reason the CPE credit hours are being claimed.

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 May 28, 2009.

TRD-200902064

J. Randel (Jerry) Hill

General Counsel

Texas State Board of Public Accountancy

Earliest possible date of adoption: July 12, 2009

For further information, please call: (512) 305-7842

22 TAC §523.132

The Texas State Board of Public Accountancy (Board) proposes an amendment to §523.132, concerning Board Contracted Ethics Instructors.

The amendment to §523.132 will permit someone disciplined by the board to teach ethics courses upon requesting and receiving a waiver from the limitation.

William Treacy, Executive Director of the Board, has determined that for the first five-year period the proposed amendment will be in effect:

A. the additional estimated cost to the state expected as a result of enforcing or administering the amendment will be none.

B. the estimated reduction in costs to the state and to local governments as a result of enforcing or administering the amendment will be none.

C. the estimated loss or increase in revenue to the state as a result of enforcing or administering the amendment will be none.

Mr. Treacy has determined that for the first five-year period the amendment is in effect the public benefits expected as a result of adoption of the proposed amendment will be a better protected public by permitting qualified instructors to educate licensees in ethics.

The probable economic cost to persons required to comply with the amendment will be insignificant.

Mr. Treacy has determined that a Local Employment Impact Statement is not required because the proposed amendment will not affect a local economy.

Mr. Treacy has determined that the proposed amendment will not have an adverse economic effect on small businesses because the amendment does not impose any duties or obligations upon small businesses.

Mr. Treacy has determined that an Economic Impact Statement and a Regulatory Flexibility Analysis are not required because the proposed amendment will not adversely affect small or micro businesses.

The Board requests comments on the substance and effect of the proposed rule from any interested person. Comments must be received at the Board no later than noon on July 12, 2009. Comments should be addressed to J. Randel (Jerry) Hill, General Counsel, Texas State Board of Public Accountancy, 333 Guadalupe, Tower 3, Suite 900, Austin, Texas 78701 or faxed to his attention at (512) 305-7854.

The Board specifically invites comments from the public on the issues of whether or not the proposed amendment will have an adverse economic effect on small businesses; if the proposed rule is believed to have an adverse effect on small businesses, estimate the number of small businesses believed to be impacted by the rule, describe and estimate the economic impact of the rule on small businesses, offer alternative methods of achieving the purpose of the rule; then explain how the Board may legally and feasibly reduce that adverse effect on small businesses considering the purpose of the statute under which the proposed rule is to be adopted; finally describe how the health, safety, environmental and economic welfare of the state will be impacted by the various proposed methods. See Texas Government Code, §2006.002(c).

The amendment is proposed under the Public Accountancy Act ("Act"), Texas Occupations Code, §901.151 which authorizes the Board to adopt rules deemed necessary or advisable to effectuate the Act.

No other article, statute or code is affected by this proposed amendment.

§523.132.Board Contracted Ethics Instructors.

(a) The board may contract with any instructor wishing to offer an ethics course approved by the board pursuant to §523.131 of this title (relating to Board Approval of Ethics Course Content) who can demonstrate that:

(1) the instructor is a certified public accountant licensed in Texas or that the instructor is team teaching with a certified public accountant licensed in Texas and has completed the board's ethics training program as required by the board;

(2) the instructor has never been disciplined for a violation of the board's Rules of Professional Conduct unless waived by the board; and

(3) the instructor is qualified to teach ethical reasoning because he has:

(A) experience in the study and teaching of ethical reasoning; and

(B) formal training in organizational or ethical behavior instruction.

(b) An instructor demonstrates that he is qualified to teach ethical reasoning upon proof that he has:

(1) at the time of application obtained education in ethics substantially equivalent to a minimum of 6 hours of credit from an accredited University, College or Community College, of which at least three hours must be in organizational ethics;

(2) teaching experience that is substantially equivalent to two or more full time semesters teaching experience at an accredited University, College or Community College;

(3) spent at least ten years performing accountancy related activities as a licensed CPA;

(4) no record of discipline for violation of the rules of professional conduct of the American Institute of Certified Public Accountants, the Texas Society of Certified Public Accountants or other national or state accountancy organization recognized by the board; and

(5) goals and interests consistent with the board's purpose of protecting the public interest pursuant to the provisions of the Act.

(c) The board may refuse to contract, refuse to renew a contract or cancel the contract of any instructor who has engaged in conduct rendering that instructor unsuitable for teaching ethics.

(d) An instructor must submit a current resume with the contract.

(e) Interpretive comments: To have goals and interests consistent with the board's purpose of protecting the public interest pursuant to the provisions of the Public Accountancy Act an instructor must refrain from using the instruction of an ethics course as a marketing tool for other products and services offered by the instructor. An instructor must be free from conflicts of interest with the board in both fact and appearance. Representation of a respondent or a complainant in a disciplinary proceeding pending before the board creates the appearance of a conflict of interest.

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 May 28, 2009.

TRD-200902067

J. Randel (Jerry) Hill

General Counsel

Texas State Board of Public Accountancy

Earliest possible date of adoption: July 12, 2009

For further information, please call: (512) 305-7842

22 TAC §523.143

The Texas State Board of Public Accountancy (Board) proposes an amendment to §523.143, concerning Sponsor's Record.

The amendment to §523.143 will require the sponsor of a continuing professional education program to provide and retain notice of the course and its promotional materials.

William Treacy, Executive Director of the Board, has determined that for the first five-year period the proposed amendment will be in effect:

A. the additional estimated cost to the state expected as a result of enforcing or administering the amendment will be none.

B. the estimated reduction in costs to the state and to local governments as a result of enforcing or administering the amendment will be none.

C. the estimated loss or increase in revenue to the state as a result of enforcing or administering the amendment will be none.

Mr. Treacy has determined that for the first five-year period the amendment is in effect the public benefits expected as a result of adoption of the proposed amendment will be to assure that the courses offered to the public will be clearly identified prior to enrollment.

The probable economic cost to persons required to comply with the amendment will be insignificant.

Mr. Treacy has determined that a Local Employment Impact Statement is not required because the proposed amendment will not affect a local economy.

Mr. Treacy has determined that the proposed amendment will not have an adverse economic effect on small businesses because the amendment does not impose any duties or obligations upon small businesses.

Mr. Treacy has determined that an Economic Impact Statement and a Regulatory Flexibility Analysis are not required because the proposed amendment will not adversely affect small or micro businesses.

The Board requests comments on the substance and effect of the proposed rule from any interested person. Comments must be received at the Board no later than noon on July 12, 2009. Comments should be addressed to J. Randel (Jerry) Hill, General Counsel, Texas State Board of Public Accountancy, 333 Guadalupe, Tower 3, Suite 900, Austin, Texas 78701 or faxed to his attention at (512) 305-7854.

The Board specifically invites comments from the public on the issues of whether or not the proposed amendment will have an adverse economic effect on small businesses; if the proposed rule is believed to have an adverse effect on small businesses, estimate the number of small businesses believed to be impacted by the rule, describe and estimate the economic impact of the rule on small businesses, offer alternative methods of achieving the purpose of the rule; then explain how the Board may legally and feasibly reduce that adverse effect on small businesses considering the purpose of the statute under which the proposed rule is to be adopted; finally describe how the health, safety, environmental and economic welfare of the state will be impacted by the various proposed methods. See Texas Government Code, §2006.002(c).

The amendment is proposed under the Public Accountancy Act ("Act"), Texas Occupations Code, §901.151 which authorizes the Board to adopt rules deemed necessary or advisable to effectuate the Act.

No other article, statute or code is affected by this proposed amendment.

§523.143.Sponsor's Record.

(a) In order to support the reports required of participants, the sponsor of group or self-study programs must retain the following records:

(1) record of participation, e.g., sign-in sheet reflecting the credit hours earned by each participant including those who arrive late or leave early;

(2) course program including recommended credit hours as required by §523.140(b) of this title (relating to Program Standards);

(3) documentation [advance notification] as required by §523.140(a) of this title including all [ and] promotional materials[, if any];

(4) date(s);

(5) location;

(6) instructor(s), including resume or biography; and

[(7) number of credit hours; and]

(7) [(8)] evaluation of program as directed in §523.141(b) of this title (relating to Evaluation).

(b) Documentation must be retained for three years from the date the program is completed. [To satisfy the detailed requirements of all jurisdictions, a retention period of three years from the date the program is completed is appropriate. The record of attendance should reflect the credit hours earned by each participant, including those who arrive late or leave early.]

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 May 28, 2009.

TRD-200902065

J. Randel (Jerry) Hill

General Counsel

Texas State Board of Public Accountancy

Earliest possible date of adoption: July 12, 2009

For further information, please call: (512) 305-7842

22 TAC §527.10

The Texas State Board of Public Accountancy (Board) proposes an amendment to §527.10, concerning Peer Review Report Committee.

The amendment to §527.10 will update the rule to reflect the new pass rating for firms.

William Treacy, Executive Director of the Board, has determined that for the first five-year period the proposed amendment will be in effect:

A. the additional estimated cost to the state expected as a result of enforcing or administering the amendment will be none.

B. the estimated reduction in costs to the state and to local governments as a result of enforcing or administering the amendment will be none.

C. the estimated loss or increase in revenue to the state as a result of enforcing or administering the amendment will be none.

Mr. Treacy has determined that for the first five-year period the amendment is in effect the public benefits expected as a result of adoption of the proposed amendment will be an understanding of an acceptable Peer Review rating.

The probable economic cost to persons required to comply with the amendment will be insignificant.

Mr. Treacy has determined that a Local Employment Impact Statement is not required because the proposed amendment will not affect a local economy.

Mr. Treacy has determined that the proposed amendment will not have an adverse economic effect on small businesses because the amendment does not impose any duties or obligations upon small businesses.

Mr. Treacy has determined that an Economic Impact Statement and a Regulatory Flexibility Analysis are not required because the proposed amendment will not adversely affect small or micro businesses.

The Board requests comments on the substance and effect of the proposed rule from any interested person. Comments must be received at the Board no later than noon on July 12, 2009. Comments should be addressed to J. Randel (Jerry) Hill, General Counsel, Texas State Board of Public Accountancy, 333 Guadalupe, Tower 3, Suite 900, Austin, Texas 78701 or faxed to his attention at (512) 305-7854.

The Board specifically invites comments from the public on the issues of whether or not the proposed amendment will have an adverse economic effect on small businesses; if the proposed rule is believed to have an adverse effect on small businesses, estimate the number of small businesses believed to be impacted by the rule, describe and estimate the economic impact of the rule on small businesses, offer alternative methods of achieving the purpose of the rule; then explain how the Board may legally and feasibly reduce that adverse effect on small businesses considering the purpose of the statute under which the proposed rule is to be adopted; finally describe how the health, safety, environmental and economic welfare of the state will be impacted by the various proposed methods. See Texas Government Code, §2006.002(c).

The amendment is proposed under the Public Accountancy Act ("Act"), Texas Occupations Code, §901.151 which authorizes the Board to adopt rules deemed necessary or advisable to effectuate the Act.

No other article, statute or code is affected by this proposed amendment.

§527.10.Peer Review Report Committee.

A peer review report committee (PRRC) is comprised of CPAs practicing public accountancy and formed by a sponsoring organization for the purpose of accepting peer review reports submitted by firms on peer review engagements.

(1) Each member of a PRRC must be active in the practice of public accountancy at a supervisory level in the accounting or auditing function while serving on the committee. The member's firm must be enrolled in an approved practice-monitoring program and have received a report with a rating of pass or an unmodified report on its most recently completed peer review. A majority of the committee members must satisfy the qualifications required of system peer review team captains as established and reported in the AICPA Standards for Performing and Reporting on Peer Reviews.

(2) Each member of a PRRC must be approved for appointment by the governing body of the sponsoring organization.

(3) In determining the size of a PRRC, the requirement for broad industry experience, and the likelihood of some members needing to recuse themselves during the consideration of some reviews as a result of the members' close association to the firm or because they performed the review, shall be considered.

(4) No more than one PRRC member may be from the same firm.

(5) The PRRC members' terms shall be staggered to provide for continuity.

(6) A PRRC member may not concurrently serve as:

(A) a member of any state's board of accountancy; or

(B) a member of any state's CPA society's ethics committee.

(7) A PRRC member may not participate in any discussion or have any vote with respect to a reviewed firm when the committee member lacks independence as defined in §501.70 of this title (relating to Independence) or has a conflict of interest. Examples of conflicts of interest include, but are not limited to:

(A) the member's firm has performed the most recent peer review of the reviewed firm's accounting and auditing practice;

(B) the member served on the review team, which performed the current or the immediately preceding review of the enrolled firm; or

(C) the member believes he cannot be impartial or objective.

(8) Each PRRC member must comply with the confidentiality requirements of §901.161 of the Act. The sponsoring organization may annually require its PRRC members to sign a statement acknowledging their appointments and the responsibilities and obligations of their appointments.

(9) A PRRC decision to accept a report must be made by not fewer than three members who satisfy the above criteria.

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 May 28, 2009.

TRD-200902066

J. Randel (Jerry) Hill

General Counsel

Texas State Board of Public Accountancy

Earliest possible date of adoption: July 12, 2009

For further information, please call: (512) 305-7842

CHAPTER 851. TEXAS BOARD OF PROFESSIONAL GEOSCIENTISTS LICENSING RULES

SUBCHAPTER A. LICENSING

22 TAC §851.30

The Texas Board of Professional Geoscientists (TBPG or Board) proposes an amendment to 22 TAC §851.30, regarding firm registration. The proposed amendment cleans up wording related to firm registration; clarifies exemptions for engineering firms; and allows the Board to issue certificates of registration on a non-annual basis. The proposed amendment also exempts from registration an engineering firm that performs service or work that is both engineering and geoscience as long as the geoscience work performed is incidental and specific to their work as an engineering firm.

Mr. Charles Horton, Interim Executive Director of TBPG, has determined that for the first five-year period the section is in effect there will be little or no fiscal impact for state or local government as a result of enforcing or administering the section.

Mr. Horton has also determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be enhancement of the professional practice of geoscientists by clarifying the requirements for registration as a Geoscience Firm. There will be little or no effect on small businesses. There will be no anticipated economic cost to persons who are required to comply with the proposed section.

Comments on this proposal may be submitted in writing to: Molly B. Roman, Administrative Coordinator, TBPG, P.O. Box 13225, Austin, Texas 78711, (512) 936-4405. Comments may also be submitted electronically to mroman@tbpg.state.tx.us or faxed to (512) 936-4409. Comments must be submitted no later than 30 days from the date the proposed amendments are posted in the Texas Register. All requests for a public hearing on the proposed section submitted under the Administrative Procedure Act must be received by Ms. Roman no more than 15 calendar days after notice of proposed amendments to this section have been published in the Texas Register.

This amendment is proposed under the Texas Occupations Code §1002.151, which authorizes the Board to adopt and enforce rules consistent with the Texas Geoscience Practice Act and necessary for the performance of its duties, and §1002.351, which authorizes the Board to regulate the public practice of geoscience by firms and corporations.

The proposed amendment implements the Texas Occupations Code, §1002.151 and §1002.351.

§851.30.Firm Registration.

(a) The Texas Board of Professional Geoscientists will [shall ] receive, evaluate, and process all applications for a certificate of registration issued under the authority of the Texas Geoscience Practice Act (Act). Unless an exemption applies, as outlined in §1002.252, registration as a Geoscience Firm is required from all firms offering to engage or engaging in the public practice of professional geoscience in Texas. [Applications for the certificate of registration shall be accepted and will be mandatory from all firms offering to engage or engaging in the practice of professional geoscience for the public in Texas that do not meet any exemptions in §1002.252.] As provided in §851.10(11), the term firm includes corporations, sole-proprietorships, partnerships and/or joint stock associations. For the purposes of this section, the term public includes but is not limited to political subdivisions of the state, business entities, and individuals. The Board has the authority under the Act to issue a [an annual] certificate of registration to applicants that, subsequent to review and evaluation, are found to have met all requirements of the Act and Board rules. The Board has the authority under the Act to deny a certificate of registration to any applicant found not to have met all requirements of the Act and Board rules. This section does not apply to an engineering firm that performs service or work that is both engineering and geoscience if the geoscience work performed is incidental and specific to their work as an engineering firm.

(b) - (h) (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 May 26, 2009.

TRD-200902026

Charles Horton

Interim Executive Director

Texas Board of Professional Geoscientists

Earliest possible date of adoption: July 12, 2009

For further information, please call: (512) 936-4405