TITLE 22. EXAMINING BOARDS

PART 9. TEXAS MEDICAL BOARD

CHAPTER 186. RESPIRATORY CARE PRACTITIONERS

22 TAC §§186.2, 186.4, 186.6 - 186.8, 186.10, 186.13, 186.17, 186.28

The Texas Medical Board (Board) proposes amendments to Chapter 186, §186.2, relating to Definitions; §186.4, concerning Procedural Rules and Qualifications for Certificate Applicants; §186.6, concerning Biennial Renewal of Certificate; §186.7, concerning Temporary Permit; §186.8, concerning Inactive Certificate; §186.10, concerning Continuing Education Requirements; §186.13, concerning Identification Requirements; §186.17, concerning Grounds for Denial of Certification and for Disciplinary Action; and §186.28, concerning Retired Certificate.

The amendment to §186.2 adds paragraph (41), which establishes a definition for Voluntary Charity Care.

The amendment to §186.4 adds a reference to §175.1 of this title (relating to Application and Administrative Fees). Additionally, the amendment to §186.4 adds military service members and military veterans to the alternative certification procedures established under subsection (g).

The amendment to §186.6 adds references to §175.2 of this title (relating to Registration and Renewal Fees), and §175.3 of this title (relating to Penalties). The amendments also change a reference to "registration" to "renewal" to reflect accurate terminology.

The amendment to §186.7 adds language to subsection (a)(1) clarifying that temporary permits are issued to certain applicants who have signed an agreed order or remedial plan that is pending board approval. The amendments also add a reference to §175.1 of this title (relating to Application and Administration Fees). Finally, the amendments clarify that subsection (c) only applies to those applicants with active practice issues.

The amendment to §186.8 adds language clarifying that inactive certificate holders must renew their inactive certificates every year and may not practice while in an inactive status. These amendments leave in place language stating that inactive certificate holders are excused from paying renewal fees.

The amendment to §186.10 adds a new requirement for ethic continuing education. Additionally, the amendments add non-traditional continuing education credit for teachers and instructors at an accredited respiratory care educational program and for certain examinations taken for credentialing and re-credentialing purposes. Finally, the amendments clarify that if an initial credentialing examination is counted towards fulfillment of continuing education requirements, the same examination taken later for re-credentialing purposes may only be applied towards fulfillment of continuing education requirements once every three (3) renewal periods.

The amendment to §186.13 adds subsection (b) requiring respiratory care practitioners with a temporary permit to hold themselves out as a temporary respiratory care practitioner or TRCP.

The amendment to §186.17 adds language clarifying that Chapter 53 of the Texas Occupations Code guides the analysis for denial of certification and disciplinary action based on criminal history. Additionally, the amendments delete language that did not comport with Chapter 53 of the Occupations Code.

The amendments to §186.28 add language clarifying that retired certificate holders who wish to provide voluntary charity care must get approval from the board before providing such care. Additionally, the amendments add a reference to §186.2(41) of this title (relating to Definitions), which defines Voluntary Charity Care.

Scott Freshour, 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 this proposal will be to establish a definition for Voluntary Charity Care, as used in §186.28, relating to Retired Certificate; to clarify where fees are listed in board rules and to clarify that alternative certification procedures apply to military service members and veterans; to clarify where fees are listed in board rules and to clarify what fees are applicable; to clarify the requirements for temporary permits and to which applicants the requirements apply; to ensure that inactive certificate holders understand the requirements for inactive certificates; to ensure that respiratory care practitioners have worthwhile and useful continuing education requirements to ensure public safety and protection; to ensure that the public knows who is providing care and what type of credential that respiratory care practitioner holds; to ensure that an applicant or certificate holder who has a criminal history is analyzed by the board in accordance with the proper law and to ensure that retired certificate holders understand how and when they can provide care.

Mr. Freshour has also determined that for the first five-year period the sections are in effect there will be no effect to individuals required to comply with the rules as proposed. There will be no effect on small businesses, micro businesses, or rural communities.

Pursuant to Government Code §2001.0221, the agency provides the following Government Growth Impact Statement for the proposed rules. For each year of the first five years the proposed amendments will be in effect, the agency has determined the following:

(1) The proposed rules do not create or eliminate a government program.

(2) Implementation of the proposed rules does not require the creation of new employee positions or the elimination of existing employee positions.

(3) Implementation of the proposed rules does not require an increase or decrease in future legislative appropriations to the agency.

(4) The proposed rules do not require an increase or decrease in fees paid to the agency.

(5) The proposed rules do not create a new regulation.

(6) The proposed rules do not limit or repeal an existing regulation. The proposed rules on continuing education expand existing regulation, in that additional continuing education credit is proposed to be accepted by the board.

(7) The proposed rules do not increase or decrease the number of individuals subject to the rule's applicability.

(8) The proposed rules do not positively or adversely affect this state's economy.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or e-mailed 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, §205.101, which provides authority for the Board to recommend rules to establish licensing and other fees and recommend rules necessary to administer and enforce this chapter. Amendments to §186.10 are proposed under the authority of the Texas Occupations Code Annotated §604.154, which provides authority for the board to establish uniform continuing education requirements. Additionally, amendments to §186.17 are proposed under the authority of the Texas Occupations Code Annotated, §604.058, which requires the board to adopt rules as necessary to comply with Chapter 53 of the Occupations Code.

§186.2.Definitions.

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

(1) - (40) (No change.)

(41) Voluntary Charity Care--Respiratory care provided for no compensation to indigent populations, in medically underserved areas, or for a disaster relief organization. As used in this definition, compensation means direct or indirect payment of anything of monetary value, except payment or reimbursement of reasonable, necessary, and actual travel and related costs.

§186.4.Procedural Rules and Qualifications for Certificate Applicants.

(a) Except as otherwise provided in this section, an individual applying for a respiratory care practitioner certificate issued by the advisory board must:

(1) (No change.)

(2) pay the appropriate application fee as prescribed by the advisory board and as set forth in §175.1 of this title (relating to Application and Administrative Fees);

(3) - (14) (No change.)

(b) - (f) (No change.)

(g) Alternative Certification Procedure for Military Service Members, Military Veterans, and Military Spouses [spouse]:

(1) An applicant who is a military service member, military veteran, or military [the] spouse, as defined in §186.2 of this chapter (relating to Definitions), [of a member of the armed forces of the United States assigned to a military unit headquartered in Texas] may be eligible for alternative demonstrations of competency for certain Texas state-certification requirements. Unless specifically allowed in this subsection, an applicant must meet the requirements for certification as specified in this chapter.

(2) To be eligible, an applicant must be a military service member, military veteran, or military [the] spouse [of a person serving on active duty as a member of the armed forces of the United States] and meet one of the following requirements:

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

(3) - (4) (No change.)

(h) - (i) (No change.)

§186.6.Biennial Renewal of Certificate.

(a) Respiratory care practitioners issued a certificate under the Act shall register biennially and pay a fee. A respiratory care practitioner may, on notification from the advisory board, renew an unexpired certificate by submitting the required form and documents (including fingerprints if required as required by §604.1523 of the Act) and by paying the required renewal fee, as set forth in §175.2 of this title (relating to Registration and Renewal Fees), to the advisory board on or before the expiration date of the certificate. The renewal fee shall be prorated in accordance with §604.151 of the Act. The fee shall accompany the required form which legibly sets forth the certificate holder's name, mailing address, business address, and other necessary information prescribed by the advisory board.

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

(d) If the renewal fee and completed application form are not received on or before the expiration date of the certificate, the fees set forth in §175.3 [Chapter 175] of this title (relating to [Fees and] Penalties) shall apply.

(e) - (i) (No change.)

(j) Expired Biennial Certificates.

(1) If a respiratory care practitioner's certificate has been expired for less than one year, the respiratory care practitioner may obtain a new certificate by submitting to the advisory board a completed application, the renewal [registration] fee, as defined in §175.2 [chapter 175] of this title, and the penalty fee, as defined in §175.3 [175] of this title (relating to Penalties).

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

(k) (No change.)

§186.7.Temporary Permit.

(a) The advisory board, or its designee, shall issue a temporary permit to an applicant who:

(1) meets all the qualifications for a respiratory care practitioner certificate under the Act and has signed an Agreed Order or Remedial Plan but is waiting for the next scheduled meeting of the advisory board for the Agreed Order or Remedial Plan to be approved by the advisory board and the certificate to be issued;

(2) seeks to temporarily substitute for a certified respiratory care practitioner during the practitioner's absence, if the applicant:

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

(C) pays the appropriate fee prescribed by the advisory board as set forth in §175.1 of this title (relating to Application and Administrative Fees);

(3) - (4) (No change.)

(b) (No change.)

(c) In order to be determined eligible for a temporary permit to remedy active practice issues under subsection (a)(4) of this section, applicant must:

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

(d) (No change.)

§186.8.Inactive Certificate.

(a) A respiratory care practitioner may have a certificate placed on inactive status by applying to the advisory board. A respiratory care practitioner with an inactive certificate must renew the inactive certificate each year, but is excused from paying renewal fees on the certificate. During the time the certificate is inactive, the certificate holder [and] may not practice as a respiratory care practitioner in Texas.

(b) - (f) (No change.)

§186.10.Continuing Education Requirements.

(a) General. Each respiratory care practitioner is required to complete 24 contact hours of approved continuing education (CE) every two (2) years as a condition of renewal of a certificate. At least 12 contact hours must be in traditional courses. The remainder of contact hours may be in non-traditional courses or from passage of examinations detailed in subsection (b)(3) of this section. At least 2 contact hours must be in ethics. These ethics hours may be completed via traditional courses or non-traditional courses.

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

(b) Types of acceptable continuing education. Continuing education must be in skills relevant to the practice of respiratory care and must have a direct benefit to patients and clients and shall be acceptable if the experience falls in one or more of the following categories:

(1) (No change.)

(2) Non-traditional CE.

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

(C) A respiratory care practitioner who teaches or instructs a course in a respiratory care educational program accredited by the Commission on Accreditation for Respiratory Care or other accrediting body approved by the board shall be credited one (1) contact hour in non-traditional CE for each contact hour actually taught. CE credit will be given only once per renewal period for teaching a particular course.

(3) Passage of an official credentialing or proctored self-evaluation examination, as follows:

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

(C) NBRC Neonatal/Pediatric Respiratory Care Specialist (NPS) examination (credentialing or re-credentialing) - 10 contact hours;

(D) NBRC Adult Critical Care Specialist (ACCS) examination (credentialing or re-credentialing) - 10 contact hours;

(E) NBRC Sleep Disorder Specialist (SDS) examination (credentialing or re-credentialing) - 10 contact hours;

(F) NBRC Certified Pulmonary Function Technologist (CPFT) examination or NBRC Registered Pulmonary Function Technologist (RPFT) examination (credentialing or re-credentialing) - 10 contact hours;

(G) Board of Registered Polysomnographic Technologists (BRPT) registration examination (credentialing or re-credentialing) - 10 contact hours;

(H) National Asthma Educator Certification Board (NAECB) Certified Asthma Educator (AE-C) examination (credentialing or re-credentialing) - 10 contact hours;

(I) [(H)] Advanced [Initial course in advanced] cardiac life-support (ACLS), pediatric advanced life-support (PALS), neonatal advanced life-support (NALS) or neonatal resuscitation program (NRP), basic trauma life-support, or pre-hospital trauma life-support (credentialing or re-credentialing) - 8 contact hours;

(J) [(I)] Examinations listed in subparagraphs (A) - (I) [(H)] of this paragraph may be counted only once for credit. If an initial credentialing examination is counted towards fulfillment of CE requirements, the same examination taken later for re-credentialing purposes may only be applied towards fulfillment of CE requirements once every three (3) renewal periods.

(c) - (g) (No change.)

§186.13.Identification Requirements.

(a) A respiratory care practitioner certified by the advisory board shall keep the respiratory care practitioner's Texas certificate available for inspection at the respiratory care practitioner's primary place of business and shall, when engaged in professional activities, wear a name tag identifying the respiratory care practitioner as a respiratory care practitioner.

(b) A respiratory care practitioner holding a temporary permit issued under §186.7 of this chapter (relating to Temporary Permits) shall hold themselves out as a temporary respiratory care practitioner or TRCP.

§186.17.Grounds for Denial of Certification and for Disciplinary Action.

The advisory board may refuse to issue a certificate to any person and may, following notice of hearing and a hearing as provided for in the APA, take disciplinary action against any respiratory care practitioner who:

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

(4) is convicted of a crime [felony], or has received [imposition of] deferred adjudication or pre-trial diversion for a crime, in accordance with Chapter 53 of the Texas Occupations Code;

(5) - (21) (No change.)

§186.28.Retired Certificate.

The registration fee shall not apply to retired respiratory care practitioners.

(1) (No change.)

(2) The following restrictions shall apply to respiratory care practitioners whose licenses are on official retired status:

(A) the respiratory care practitioner must not engage in clinical activities or practice respiratory care in any state, other than providing only voluntary charity care, as defined by §186.2(41) of this title (relating to Definitions), after approval by the advisory board;

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

(3) - (7) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 18, 2017.

TRD-201705243

Scott Freshour

Executive Director

Texas Medical Board

Earliest possible date of adoption: January 28, 2018

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


CHAPTER 194. MEDICAL RADIOLOGIC TECHNOLOGY

SUBCHAPTER A. CERTIFICATE HOLDERS, NON-CERTIFIED TECHNICIANS, AND OTHER AUTHORIZED INDIVIDUALS OR ENTITIES

The Texas Medical Radiologic Technology Board proposes amendments to §§194.3, 194.5, 194.6, 194.7, 194.16, and 194.17, and proposes the repeal of §194.14, concerning Medical Radiologic Technology.

The amendment to §194.3, concerning Meetings and Committees, deletes subsection (f) and language providing that the board may at a regular or special meeting remove the secretary from office upon a majority vote, with other amendments re-lettering the remaining subsections. Language related to licensure and disciplinary committee functions is revised to clarify that the committees do not draft rules, but rather review draft language prepared by staff. Amendments further add a new paragraph (4) to subsection (f), setting forth new rules related to the creation of a new Education Committee. The proposed committee's functions include recommending rules to the full board regarding education and training requirements certification as a radiologic technologist or registration as a non-certified technician (NCT), continuing education requirements for renewal of a Texas MRT certificate or NCT registration, and standards for the approval or rescinding approval of radiologic technologist certificate education program curricular and instructors.

The amendments to §194.5, concerning Applicability of Chapter; Exemptions, delete language referring to §194.14 of this title (relating to Alternate Training Requirements for Podiatric Medical Assistants), reflecting the proposed repeal of §194.14, which is also proposed elsewhere in this issue of the Texas Register.

The amendments to §194.6, concerning Procedural Rules and Minimum Eligibility Requirements for Applicants for a Certificate or Placement on the Board's Non-Certified Technician General Registry, amend language so that an applicant is not deemed per se ineligible for a certificate or registration, based upon action taken against another license issued by a licensing authority in this or another state that is subject to probation or other disciplinary action not involving revocation or suspension. The board will continue to have the authority to deny a certificate or placement on the general registry based upon all such action, regardless if it is an action not involving revocation or suspension, but the amendments will allow the board more discretion in certain cases. The amendments further delete language under subsection (c)(8) and move it to a new paragraph (2), maintaining the board's discretion to consider the nature of any final disciplinary action, other than suspension or revocation, when determining whether to issue the certificate or other authorization. Amendments are further proposed to subsection (f)(3) and subsection (i), with language referring to §194.14 of this title, being deleted, to reflect the proposed repeal of §194.14. Amendments are proposed to subsection (j) so that clarifying language is added to make it clearer that non-certified technicians must comply with the active practice requirements under the rules in order to show eligibility for placement on the general registry. Amendments are proposed to subsection (l) and make corrections to typographical errors.

The amendment to §194.7, concerning Biennial Renewal of Certificate of Placement on the Board's General Registry for Non-Certified Technicians Generally, deletes language to subsection (c), related to continuing education requirements, so that the minimum requirements for formal hours no longer require live, instructor-led hours. The amendments will result in more efficiency while maintaining rigorous requirements ensuring current competency, by aligning the rules with the requirements set forth by the American Registry of Radiologic Technologists, which lack a live instruction requirement. Amendments are further made to subsection (c)(5), and make corrections to typographical errors.

Section 194.14, concerning Alternate Training Requirements for Podiatric Medical Assistants, is proposed for repeal. The repeal of such rules will comport with S.B. 674, which amended Texas Occupations Code, Chapter 601, and eliminated dual registration for non-certified technicians by certain state licensing boards, including the Podiatry Board. The MRT Board will maintain a single set of minimum training requirements in order to obtain eligibility for placement on a general registry for non-certified technicians (NCT).

The amendment to §194.16, concerning Hardship Exemptions, amends language in order to comport with S.B. 674, which amended Texas Occupations Code, §601.203, so that in order to show that an applicant faces a hardship in hiring a certificate holder or NCT due to an inability to attract and retain medical radiologic technologists, the applicant must also show evidence that the location for which the hardship exemption is sought must be located in a county with a population of less than 50,000. Amendments are further proposed to delete subsection (b)(4)(B)(vi), so that the use of only a hand-held fluoroscope with a maximum operating capability of 65 kilovolts and 1 milliampere, or similar type of x-ray unit for upper extremities only, with the radiation produced by the radiographic equipment representing a minimal threat to the patient and the operator of the equipment, no longer qualifies for a hardship exemption. The basis for the repeal is that the use of such equipment should be performed by individuals who have completed minimum training and obtained registration as a NCT or certification as a MRT or LMRT.

The amendment to §194.17, concerning Dangerous or Hazardous Procedures, removes language referring to §194.14 of this title, reflecting the proposed repeal of §194.14.

Scott Freshour, 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 this proposal will be to eliminate unnecessary duplication of language in the rules, comport with amendments to Texas Occupations Code, Chapter 601, made by SB 674 (85th Leg. R.S.); provide the board with more discretion to consider qualified applicants who have a history of minor disciplinary action and have had no compliance problems with completing the terms of the action; and align continuing education requirements with ARRT's requirements, thereby increasing efficiency for individuals subject to the rules, while maintaining minimum requirements necessary to ensure current and ongoing competency.

Pursuant to Texas Government Code §2001.0221, the agency provides the following Government Growth Impact Statement for the proposed rules. For each year of the first five years the proposed rules will be in effect, the agency has determined the following:

(1) The proposed rules do not create or eliminate a government program;

(2) Implementation of the proposed rules does not require the creation of new employee positions or the elimination of existing employee positions;

(3) Implementation of the proposed rules does not require an increase or decrease in future legislative appropriations to the agency;

(4) The proposed rules do not require an increase or decrease in fees paid to the agency;

(5) The proposed rules create a new regulation;

(6) The proposed rules limit or repeal an existing regulation;

(7) The proposed rules decrease the number of individuals subject to the rule's applicability; and

(8) The proposed rules do not positively or adversely affect this state's economy.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the sections as proposed 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 or rural communities.

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

22 TAC §§194.3, 194.5 - 194.7, 194.16, 194.17

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §601.058, which provides authority for the Board to recommend rules to establish licensing and other fees and recommend rules necessary to administer and enforce this chapter. The amendments are further authorized under S.B. 674 (85th Legislature, R.S.).

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

§194.3.Meetings and Committees.

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

[(f) The board, at a regular meeting or special meeting, upon majority vote of the members present, may remove the secretary from office.]

(f) [(g)] The following are standing and permanent committees of the board. Each committee, with the exception of the Executive Committee, shall consist of at least one board member who is a licensed physician, one board member who is a licensed medical radiologic technologist, and one public board member. In the event that a committee does not have a representative of one or more of these groups, the presiding officer shall appoint additional members as necessary to maintain this composition. The Executive Committee shall include the presiding officer, secretary, and other members as named by the presiding officer. The presiding officer shall name the chair and assign the members of the other committees. The responsibilities and authority of these committees shall include those duties and powers as defined in paragraphs (1) - (4) [(3)] of this subsection and such other responsibilities and authority which the board may from time to time delegate to these committees.

(1) Licensure Committee.

(A) Review [Draft and review] proposed rules regarding licensure, and make recommendations to the board regarding changes or implementation of such rules.

(B) Review [Draft and review] proposed rules pertaining to the overall licensure process, and make recommendations to the board regarding changes or implementation of such rules.

(C) Receive and review applications for licensure in the event the eligibility for licensure of an applicant is in question.

(D) Present the results of reviews of applications for licensure, and make recommendations to the board regarding licensure of applicants whose eligibility is in question.

(E) Make recommendations to the board regarding matters brought to the attention of the Licensure Committee.

(F) Oversee and make recommendations to the board regarding any aspect of the examination process including the approval of an appropriate licensure examination and the administration of such an examination and documentation and verification of records from all applicants for licensure.

(2) Disciplinary Committee.

(A) Review [Draft and review] proposed rules regarding the enforcement of the Act.

(B) Oversee the disciplinary process and give guidance to the board and staff regarding methods to improve the disciplinary process and more effectively enforce the Act.

(C) Monitor the effectiveness, appropriateness, and timeliness of the disciplinary process.

(D) Make recommendations regarding resolution and disposition of specific cases and approve, adopt, modify, or reject recommendations from staff or representatives of the board regarding actions to be taken on pending cases. Approve dismissals of complaints and closure of investigations.

(E) Make recommendations to the board and staff regarding policies, priorities, budget, and any other matters related to the disciplinary process and enforcement of the Act.

(F) Make recommendations to the board regarding matters brought to the attention of the Disciplinary Committee.

(3) Executive Committee.

(A) Ensure records are maintained of all committee actions.

(B) Review requests from the public to appear before the board and provide opportunities for the public to speak regarding issues related to the regulation of the practice of radiologic technology.

(C) Review inquiries regarding policy or administrative procedure.

(D) Delegate tasks to other committees.

(E) Take action on a matter of urgency that may arise between board meetings. Such matters shall be presented to the board at the next board meeting.

(F) Assist the Medical Board in the organization, preparation, and delivery of information and testimony to the Legislators and committees of the Legislature.

(G) Formulate and make recommendations to the board regarding future board goals and objectives and the establishment of priorities and methods for their accomplishment.

(H) Study and make recommendations to the board regarding the role and responsibility of the board officers and committees.

(I) Review staff reports regarding finances and the budget.

(J) Make recommendations to the board regarding matters brought to the attention of the Executive Committee.

(4) Education Committee.

(A) Review and make recommendations to the board regarding changes or implementation of rules concerning the following areas:

(i) educational and training requirements for certification as a medical radiologic technologist or registration as a non-certified technician in Texas;

(ii) standards for the approval or rescinding approval of medical radiologic technologist or non-certified technician education program curricula and instructors;

(iii) continuing education requirements for renewal of a Texas medical radiologic technologist certificate or NCT registration;

(B) Assist with problems relating to education program or program instructor issues which may arise within the purview of the board; and

(C) Make recommendations to the board regarding matters brought to the attention of the Education Committee.

(g) [(h)] Meetings of the board and of its committees are open to the public unless such meetings are conducted in executive session pursuant to the Open Meetings Act or the Act. In order that board meetings may be conducted safely, efficiently, and with decorum, attendees may not engage in disruptive activity that interferes with board proceedings. The public shall remain within those areas of the board offices and board meeting room designated as open to the public. Members of the public shall not address or question board members during meetings unless recognized by the board's presiding officer pursuant to a published agenda item.

(h) [(i)] Journalists have the same right of access as other members of the public to board meetings conducted in open session and are subject to the same rules. Observers of a board meeting may not disrupt the meeting or disturb its participants. Observers may make audio or visual recordings of such proceedings conducted in open session, as long as the recording activities do not disrupt the meeting. Observers who make audio or visual records are subject to the following limitations: upon request made by the board's presiding officer, camera operators must periodically extinguish artificial lights to allow excessive heat to dissipate; camera operators may not assemble or disassemble equipment while the board is in session and conducting business; persons seeking to position microphones for recording board proceedings may not disrupt the meeting or disturb participants. Journalists may conduct interviews in the reception area of the agency's offices or, at the discretion of the board's presiding officer, in the meeting room after recess or adjournment. No interview may be conducted in the hallways of the agency's offices. The board's presiding officer may exclude from a meeting any person who, after being duly warned, persists in conduct contrary to the requirements and limitations described in this subsection and subsection (g) [(h)] of this section.

(i) [(j)] The assistant presiding officer of the board shall assume the duties of the presiding officer in the event of the presiding officer's absence or incapacity.

(j) [(k)] In the event of the absence or temporary incapacity of the presiding officer, and the assistant presiding officer, the members of the board may elect another member to act as the presiding officer of a board meeting, or may elect an interim acting presiding officer for the duration of the absences or incapacity or until another presiding officer is appointed by the governor.

(k) [(l)] Upon the death, resignation, removal or permanent incapacity of the presiding officer or the assistant presiding officer, the board shall elect an assistant presiding officer from its membership to fill the vacant position. The board may elect an interim acting presiding officer until another presiding officer is appointed by the governor. Such an election shall be conducted as soon as practicable at a regular or special meeting of the board.

(l) [(m)] Committee minutes shall be approved by the full board with a quorum of the committee members present to vote on approval of the minutes.

§194.5.Applicability of Chapter; Exemptions.

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

(c) This chapter does not prohibit the performance of a radiologic procedure which has not been identified as dangerous or hazardous under §194.17 of this chapter (relating to Dangerous or Hazardous Procedures) by the following:

(1) a person who has successfully completed a training program for non-certified technicians (NCT), in accordance with §194.13 of this chapter (relating to Mandatory Training Programs for Non-Certified Technicians)[, §194.14 of this chapter (relating to Alternate Training for Podiatric Medical Assistants),] and §194.15 of this chapter (relating to Bone Densitometry Training) and who performs the procedure under the instruction or direction of a practitioner if the person and the practitioner are in compliance with rules adopted under the Act, §§601.251 - 601.254, by the Texas Board of Chiropractic Examiners, Texas Medical Board, Texas Physician Assistants Board, Texas Board of Nursing or Texas State Board of Podiatric Medical Examiners;

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

§194.6.Procedural Rules and Minimum Eligibility Requirements for Applicants for a Certificate or Placement on the Board's Non-Certified Technician General Registry.

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

(c) General Requirements.

(1) Except as otherwise required in this section, an applicant for temporary or regular certification as a MRT or LMRT, or registration as a NCT must:

(A) [(1)] graduate from high school or its equivalent as determined by the Texas Education Agency;

(B) [(2)] attain at least 18 years of age;

(C) [(3)] submit an application on a form prescribed by the board;

(D) [(4)] pay the required application fee, as set forth under Chapter 175 of this title (relating to Fees and Penalties);

(E) [(5)] provide a complete and legible set of fingerprints, on a form prescribed by the board, to the board or to the Department of Public Safety for the purpose of obtaining criminal history record information from the Department of Public Safety and the Federal Bureau of Investigation;

(F) [(6)] certify that the applicant is mentally and physically able to perform radiologic procedures;

(G) [(7)] not have a license, certification, or registration in this state or from any other licensing authority or certifying professional organization that is currently revoked[,] or suspended;[, or subject to probation or other disciplinary action;]

(H) [(8)] not have proceedings that have been instituted against the applicant for the restriction, cancellation, suspension, or revocation of certificate, license, or authority to perform radiologic procedures in the state, a Canadian province, or the uniformed service of the United States in which it was issued; [unless the board takes that fact into consideration in determining whether to issue the certificate;]

(I) [(9)] not have pending any prosecution against applicant in any state, federal, or international court for any offense that under the laws of this state is a felony, or an offense that is a misdemeanor [that involves a crime] of moral turpitude;

(J) [(10)] be of good professional character as defined under §194.2 of this chapter (relating to Definitions);

(K) [(11)] submit to the board any other information the board considers necessary to evaluate the applicant's qualifications; and

(L) [(12)] meet any other requirement established by rules adopted by the board.

(2) The board retains the discretion to consider the nature of any final disciplinary action, other than suspension or revocation, when determining whether to issue the certificate or other authorization.

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

(f) Documentation. The following documentation shall be submitted as a part of the certification application process:

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

(3) Training Program Certification. For applicants who are graduates of a program accepted by the board for certification under §194.12 or [of this chapter,] §194.13 of this chapter, [or §194.14 of this chapter,] each applicant must have a certificate of successful completion of an educational program submitted directly from a program accepted by the board for certification, on a form provided by the board.

(4) - (8) (No change.)

(g) - (h) (No change.)

(i) All applicants must provide sufficient documentation to the board that the applicant has, on a full-time basis, actively practiced, been a student at an acceptable approved program under §194.12 [of this chapter,] or §194.13 [of this chapter or §194.14] of this chapter or been on the active teaching faculty of an acceptable approved program under §194.12 or §194.13 of this chapter, within one of the last two years preceding receipt of an application for certification or registration. The term "full-time basis," for purposes of this section, shall mean at least 20 hours per week for 40 weeks duration during a given year.

(j) Applicants who are unable to demonstrate active practice on a full time basis may, in the discretion of the board, be eligible for an unrestricted [certificate] or [a] restricted certificate or placement on the non-certified technician registry, subject to one or more of the following conditions or restrictions as set forth in paragraphs (1) - (5) of this subsection:

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

(k) (No change.)

(l) Alternative Procedures for Military Service Members, Military Veterans, and Military Spouses.

(1) An applicant who is a military service member, military veteran, or military spouse may be eligible for alternative demonstrations of competency for certain requirements related to an application for certification or placement on the board's Non-Certified Technician [NCT] General Registry. Unless specifically allowed in this subsection, an applicant must meet the requirements for certification as a medical radiologic technologist, limited medical radiologic technologist, or placement on the board's Non-Certified Technician General Registry as specified in this chapter.

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

(5) Alternative Demonstrations of Competency Allowed. Applicants qualifying under paragraphs (1) and (2) of this subsection:

(A) in demonstrating compliance with subsection(i) [(h)] of this section must only provide sufficient documentation to the board that the applicant has, on a full-time basis, actively practiced, been a student at an approved program, or has been on the active teaching faculty of an approved program, within one of the last three [two] years preceding receipt of an application for certification;

(B) notwithstanding the one year expiration in subsection (k)(1) of this section, are allowed an additional six months to complete the application prior to it becoming inactive; and

(C) notwithstanding the 20 day deadline in subsection (k)(6) of this section, may be considered for certification up to five days prior to the board meeting.

(m) - (o) (No change.)

§194.7.Biennial Renewal of Certificate or Placement on the Board's General Registry for Non-Certified Technicians Generally.

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

(c) Continuing education requirements.

(1) Generally.

(A) (No change.)

(B) LMRT. As a prerequisite to the biennial registration of a limited certificate, a minimum of 18 hours of continuing education acceptable to the board must be completed during each biennial renewal period. The hours completed must be in the topics of general radiation health and safety or related to the categories of limited certificate held. The continuing education must be completed in the following categories:

(i) At least nine hours of the required number of hours must be satisfied by attendance and participation in formal[, instructor-led] courses that are designated for Category A or A+ credits of continuing education evaluated by an organization recognized by ARRT as a Recognized Continuing Education Evaluation Mechanism (RCEEM) or RCEEM+ during the biennial renewal period.

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

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

(E) NCTs. As a prerequisite to the biennial registration of a general registration permit, the individual must complete a minimum of 12 hours of continuing education during each biennial renewal period. The continuing education must be completed in the following categories:

(i) At least six hours of the required number of hours must be satisfied by attendance and participation in formal[, instructor-led courses] that are designated for Category A or A+ credits of continuing education evaluated by an organization recognized by ARRT as a Recognized Continuing Education Evaluation Mechanism (RCEEM) or RCEEM+ during the biennial renewal period.

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

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

(5) Exemptions.

(A) A [certificate] holder of a certificate or registration as a non-certified technician may request in writing an exemption for the following reasons, subject to the approval of the certification committee of the board:

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

(B) An exception under paragraph (5) [(6)] of this subsection may not exceed one registration period, but may be renewed biennially, subject to the approval of the board.

(6) - (10) (No change.)

(d) - (l) (No change.)

§194.16.Hardship Exemptions.

(a) General. This section sets forth the requirements related to §601.203 of the Act.

(1) A hospital, federally qualified health center (FQHC) as defined by 42 U.S.C. §1396d, or practitioner may apply to the board for a hardship exemption from employing an MRT, LMRT, or NCT.

(2) The following conditions are considered to be a hardship for the purposes of paragraph (1) of this subsection:

(A) the applicant reports an inability to attract and retain medical radiologic technologists and the location for which the hardship exemption is sought is in a county with a population of less than 50,000;

(B) the applicant is located more than 200 miles from a school of medical radiologic technology or non-certified technician education program approved in accordance with §194.12 of this chapter (relating to Standards for the Approval of Certificate Program Curricula and Instructors) or §194.13 of this chapter (relating to Mandatory Training Programs for Non-Certified Technicians);

(C) the nearest school of medical radiologic technology approved in accordance with §194.12 or §194.13 of this chapter has a waiting list of applicants due to a lack of faculty or space;

(D) the applicant's need for graduates in medical radiologic technology exceeds the number of graduates from the nearest school of medical radiologic technology approved in accordance with §194.12 or §194.13 of this chapter; or

(E) emergency conditions have occurred during the 90 days prior to making application for the hardship exemption.

(3) [(2)] The applicant must demonstrate a hardship in employing an MRT, LMRT, or NCT, and must provide information indicating that the individuals who will perform radiologic procedures meet the minimum requirements as described in subsection (b)(5) of this section.

(4) [(3)] The applicant shall not allow the individual(s) named in the application to perform a radiologic procedure until the board grants a hardship exemption.

(5) [(4)] A hardship exemption granted by the board does not constitute licensure, certification, registration, or authorization to perform a dangerous or hazardous radiologic procedure or mammography.

(6) [(5)] No more than seven individuals will be allowed to perform radiologic procedures under the hardship exemption, if granted.

(b) Required application materials.

(1) The applicant must apply for a hardship on the forms prescribed by the board and must be accompanied by the appropriate fee, as provided under chapter 175 of this title (relating to Fees and Penalties). The date of application shall be the date the application and application fee is postmarked. If there is no visible postmark, or if the application is hand-delivered, the application date shall be the date the board receives the application.

(2) The application must be accompanied by documentation clearly indicating that the applicant is a licensed hospital, FQHC, or practitioner. A copy of the current hospital license, certificate of qualification issued to the FQHC, or current license of the practitioner shall be acceptable documentation.

(3) If the application is from a hospital or FQHC, the administrator or chief executive officer of the hospital or FQHC must sign the application form. If the applicant is a practitioner, the practitioner must sign the application form.

(4) The applicant must meet the following requirements:

(A) Each individuals named in the application as hired or employed to perform radiologic procedures under the hardship exemption must:

(i) graduate from high school or its equivalent as determined by the Texas Education Agency;

(ii) attain at least 18 years of age;

(iii) provide a complete and legible set of fingerprints, on a form prescribed by the board, to the board or to the Department of Public Safety for the purpose of obtaining criminal history record information from the Department of Public Safety and the Federal Bureau of Investigation;

(iv) be mentally and physically able to perform radiologic procedures; and

(v) be of good professional character as defined under §194.2 of this chapter (relating to Definitions).

(B) The applicant must meet one or more of the following requirements:

(i) if the applicant is unable to attract or retain an MRT or LMRT, a sworn affidavit providing the physical address of the applicant hospital, FQHC, or practice location of the practitioner, and describing the reasons the applicant is unable to attract and retain an MRT or LMRT at a comparable salary for the area, the applicant's attempts to attract and retain an MRT or LMRT, evidence of recruiting efforts during the 30-day period prior to application for the hardship exemption. The applicant must also provide[, and] copies of advertisements to hire an MRT or LMRT;

(ii) if the applicant is located more than 200 highway miles from the nearest school of medical radiologic technology approved in accordance with §194.12 [of this chapter (relating to Standards for the Approval of Certificate Program Curricula and Instructors) ] or §194.13 of this chapter [(relating to Mandatory Training Programs for Non-Certified Technicians)], a sworn affidavit describing in narrative form the physical address of the nearest school of medical radiologic technology; the physical address of the applicant hospital, FQHC, or primary practice location of the practitioner; and the actual distance in highway miles between the school and the applicant hospital, FQHC, or practitioner's primary practice. The applicant shall include a map of the area clearly indicating the locations of each entity;

(iii) if the nearest school of medical radiologic technology approved in accordance with §194.12 and §194.13 of this chapter has a waiting list of school applicants due to a lack of faculty or space, a sworn affidavit from the applicant indicating that admissions to the school are pending because of a lack of faculty or space;

(iv) if the applicant's need for graduates in medical radiologic technology exceeds the number of graduates from the nearest school of medical radiologic technology approved in accordance with §194.12 of this chapter, a sworn affidavit from the applicant indicating that the number of graduates from the nearest school does not meet the applicant's needs for radiologic technologists; or

(v) if emergency conditions have occurred during the 90 days prior to making application for the hardship exemption, a sworn affidavit from the applicant describing the emergency conditions, the hardship(s) the emergency conditions have created and how long the hardship(s) is anticipated to continue. For the purposes of this subparagraph, emergency conditions may include a disaster, epidemic, or other catastrophic event.[;]

[(vi) if the applicant uses only a hand-held fluoroscope with a maximum operating capability of 65 kilovolts and 1 milliampere, or a similar type of x-ray unit for imaging upper extremities only, at the location indicated on the application form and the applicant believes that the radiation produced by the radiographic equipment represents a minimal threat to the patient and the operator of the equipment, the following is required to be submitted:]

[(I) a copy of the current certificate of registration for radiation machine issued by DSHS; and]

[(II) a sworn affidavit describing the equipment used; the types of radiographs performed; the training completed by the operator of the equipment within the 24-month period prior to application or reapplication for a hardship exemption; the date(s) the training was completed by the operator; the radiation safety measures taken for the patient, operator and others; the level or amount of supervision provided by an MRT or a practitioner(s) to the operator while performing the radiographic procedure; and the equipment manufacturer's specifications for the diagnostic radiographic equipment utilized at the location indicated on the application form, including the maximum operating capability.]

(5) All application materials and information are subject to verification by the board.

(6) The board shall send a written notice listing the additional materials required to an applicant whose application is incomplete. An application not completed within 30 days after the date of the written notice shall be invalid unless the applicant has advised the board of a valid reason for the delay.

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

§194.17.Dangerous or Hazardous Procedures.

(a) General. This section identifies radiologic procedures which are dangerous or hazardous and may only be performed by a practitioner, medical radiologic technologist (MRT) or limited medical radiologic technologist (LMRT). A person trained under §194.13 of this chapter (relating to Mandatory Training Programs for Non-Certified Technicians) [or §194.14 of this chapter (relating to Alternate Training Requirements for Podiatric Medical Assistants)] is not an MRT, LMRT or otherwise certified under the Act and shall not perform a dangerous or hazardous procedure identified in this section unless expressly permitted by this section.

(b) - (h) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 18, 2017.

TRD-201705244

Scott Freshour

Executive Director

Texas Medical Board

Earliest possible date of adoption: January 28, 2018

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


22 TAC §194.14

The repeal is proposed under the authority of the Texas Occupations Code Annotated, §601.058, which provides authority for the Board to recommend rules to establish licensing and other fees and recommend rules necessary to administer and enforce this chapter. The amendments are further authorized under S.B. 674 (85th Legislature, R.S.).

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

§194.14.Alternate Training Requirements for Podiatric Medical Assistants.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 18, 2017.

TRD-201705245

Scott Freshour

Executive Director

Texas Medical Board

Earliest possible date of adoption: January 28, 2018

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


PART 15. TEXAS STATE BOARD OF PHARMACY

CHAPTER 283. LICENSING REQUIREMENTS FOR PHARMACISTS

22 TAC §283.3

The Texas State Board of Pharmacy proposes amendments to §283.3, concerning Educational and Age Requirements. The amendments, if adopted, clarify the requirements for pharmacist licensure by removing a reference to good moral character.

Allison Vordenbaumen Benz, R.Ph., M.S., 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. Benz 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 amendments will be clarification of requirements for pharmacist licensure. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment.

For each year of the first five years the proposed amendments will be in effect, Ms. Benz has determined the following:

(1) The proposed rules do not create or eliminate a government program;

(2) Implementation of the proposed rules do not require the creation of new employee positions or the elimination of existing employee positions;

(3) Implementation of the proposed rules do not require an increase or decrease in the future legislative appropriations to the agency;

(4) The proposed rules do not require an increase or decrease in fees paid to the agency;

(5) The proposed rules do not create a new regulation;

(6) The proposed rules do not expand or limit an existing regulation;

(7) The proposed rules do not increase or decrease the number of individuals subject to the rules' applicability; and

(8) The proposed rules do not positively or adversely affect this state's economy.

Written comments on the amendments may be submitted to Megan G. Holloway, Staff Attorney, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-500, Austin, Texas, 78701, FAX (512) 305-6778. Comments must be received by 5:00 p.m., January 26, 2018.

The amendments are proposed under §§551.002, 554.051, and 562.1011 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.1011 as authorizing the agency to adopt rules for prospective and retrospective drug use review for new medication orders.

The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§283.3.Educational and Age Requirements.

An applicant for licensure as a pharmacist shall [be of good moral character,] provide satisfactory evidence that the age of 18 years has been obtained and shall meet one of the following requirements:

(1) have graduated and received a professional degree from a college of pharmacy; or

(2) have graduated from a foreign college of pharmacy and obtained full certification from the FPGEC.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 15, 2017.

TRD-201705195

Allison Vordenbaumen Benz, R.Ph., M.S.

Executive Director

Texas State Board of Pharmacy

Earliest possible date of adoption: January 28, 2018

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


CHAPTER 291. PHARMACIES

SUBCHAPTER H. OTHER CLASSES OF PHARMACY

22 TAC §291.153

The Texas State Board of Pharmacy proposes amendments to §291.153, concerning Central Prescription Drug or Medication Order Processing Pharmacy (Class G). The amendments, if adopted, remove a reference to drug therapy management as a pharmacist duty in a Class G pharmacy setting and correct grammatical errors.

Allison Vordenbaumen Benz, R.Ph., M.S., 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 rule.

Ms. Benz 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 amendments will be correctly indicating pharmacist duties in a Class G pharmacy setting and providing grammatically correct regulations. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment.

For each year of the first five years the proposed amendment will be in effect, Ms. Benz has determined the following:

(1) The proposed rule does not create or eliminate a government program;

(2) Implementation of the proposed rule does not require the creation of new employee positions or the elimination of existing employee positions;

(3) Implementation of the proposed rule does not require an increase or decrease in the future legislative appropriations to the agency;

(4) The proposed rule does not require an increase or decrease in fees paid to the agency;

(5) The proposed rule does not create a new regulation;

(6) The proposed rule does not expand or limit an existing regulation;

(7) The proposed rule does not increase or decrease the number of individuals subject to the rule's applicability; and

(8) The proposed rule does not positively or adversely affect this state's economy.

Written comments on the amendments may be submitted to Megan G. Holloway, Staff Attorney, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-500, Austin, Texas 78701, FAX (512) 305-6778. Comments must be received by 5:00 p.m., January 26, 2018.

The amendments are proposed under §§551.002, 554.051, and 562.1011 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.1011 as authorizing the agency to adopt rules for prospective and retrospective drug use review for new medication orders.

The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§291.153.Central Prescription Drug or Medication Order Processing Pharmacy (Class G)

(a) Purpose.

(1) The purpose of this section is to provide standards for a centralized prescription drug or medication order processing pharmacy.

(2) Any facility established for the primary purpose of processing prescription drug or medication drug orders shall be licensed as a Class G pharmacy under the Act. A Class G pharmacy shall not store bulk drugs, or dispense a prescription drug order. Nothing in this subsection shall prohibit an individual pharmacist employee who is licensed in Texas from remotely accessing the pharmacy's electronic data base from a location other than a licensed pharmacy in order to process prescription or medication drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records, and the Texas-licensed pharmacist does not engage in the receiving of written prescription or medication orders or the maintenance of prescription or medication drug orders at the non-licensed remote location.

(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act.

(1) Centralized prescription drug or medication order processing--The processing of a prescription drug or medication orders by a Class G pharmacy on behalf of another pharmacy, a health care provider, or a payor. Centralized prescription drug or medication order processing does not include the dispensing of a prescription drug but includes any of the following:

(A) receiving, interpreting, or clarifying prescription drug or medication drug orders;

(B) data entering and transferring of prescription drug or medication order information;

(C) performing drug regimen review;

(D) obtaining refill and substitution authorizations;

(E) verifying accurate prescription data entry;

(F) interpreting clinical data for prior authorization for dispensing;

(G) performing therapeutic interventions; and

(H) providing drug information concerning a patient's prescription.

(2) Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or, if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open.

(c) Personnel.

(1) Pharmacist-in-charge.

(A) General. Each Class G pharmacy shall have one pharmacist-in-charge who is employed on a full-time basis, who may be the pharmacist-in-charge for only one such pharmacy.

(B) Responsibilities. The pharmacist-in-charge shall have responsibility for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge. The pharmacist-in-charge may advise the owner on administrative or operational concerns. The pharmacist-in-charge shall have responsibility for, at a minimum, the following:

(i) educating [education] and training [of] pharmacy technicians and pharmacy technician trainees;

(ii) maintaining records of all transactions of the Class G pharmacy required by applicable state and federal laws and sections;

(iii) adhering [adherence] to policies and procedures regarding the maintenance of records in a data processing system such that the data processing system is in compliance with Class G pharmacy requirements; and

(iv) legally operating [legal operation of] the pharmacy, including meeting all inspection and other requirements of all state and federal laws or sections governing the practice of pharmacy.

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

(A) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and

(B) establishing [establishment of] policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.

(3) Pharmacists.

(A) General.

(i) The pharmacist-in-charge shall be assisted by sufficient number of additional licensed pharmacists as may be required to operate the Class G pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.

(ii) All pharmacists shall assist the pharmacist-in-charge in meeting his or her responsibilities.

(iii) Pharmacists are solely responsible for the direct supervision of pharmacy technicians and pharmacy technician trainees and for designating and delegating duties, other than those listed in subparagraph (B) of this paragraph, to pharmacy technicians and pharmacy technician trainees. Each pharmacist shall be responsible for any delegated act performed by pharmacy technicians and pharmacy technician trainees under his or her supervision.

(iv) Pharmacists shall directly supervise pharmacy technicians and pharmacy technician trainees who are entering prescription data into the pharmacy's data processing system by one of the following methods.

(I) Physically present supervision. A pharmacist shall be physically present to directly supervise a pharmacy technician or pharmacy technician trainee who is entering prescription order or medication order data into the data processing system. Each prescription or medication order entered into the data processing system shall be verified at the time of data entry.

(II) Electronic supervision. A pharmacist may electronically supervise a pharmacy technician or pharmacy technician trainee who is entering prescription order or medication order data into the data processing system provided the pharmacist:

(-a-) is on-site, in the pharmacy where the technician/trainee is located;

(-b-) has immediate access to any original document containing prescription or medication order information or other information related to the dispensing of the prescription or medication order. Such access may be through imaging technology provided the pharmacist has the ability to review the original, hardcopy documents if needed for clarification; and

(-c-) verifies the accuracy of the data entered information prior to the release of the information to the system for storage.

(III) Electronic verification of data entry by pharmacy technicians or pharmacy technician trainees. A pharmacist may electronically verify the data entry of prescription information into a data processing system provided:

(-a-) a pharmacist is on-site in the pharmacy where the pharmacy technicians/trainees are located;

(-b-) the pharmacist electronically conducting the verification is either a:

(-1-) Texas licensed pharmacist; or

(-2-) pharmacist employed by a Class E pharmacy that has the same owner as the Class G pharmacy where the pharmacy technicians/trainees are located or that has entered into a written contract or agreement with the Class G pharmacy, which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations;

(-c-) the pharmacy establishes controls to protect the privacy and security of confidential records; and

(-d-) the pharmacy keeps permanent records of prescriptions electronically verified for a period of two years.

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

(B) Duties. Duties which may only be performed by a pharmacist are as follows:

(i) receiving oral prescription drug or medication orders and reducing these orders to writing, either manually or electronically;

(ii) interpreting prescription drug or medication orders;

(iii) selecting drug products;

(iv) verifying the data entry of the prescription drug or medication order information at the time of data entry prior to the release of the information to a Class A, Class C, or Class E pharmacy for dispensing;

(v) communicating to the patient or patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant, as specified in §291.33(c) of this title (relating to Operational Standards);

(vi) communicating to the patient or the patient's agent on his or her request information concerning any prescription drugs dispensed to the patient by the pharmacy;

(vii) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records; and

(viii) interpreting patient medication records and performing drug regimen reviews.[; and]

[(ix) performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act.]

(4) Pharmacy Technicians and Pharmacy Technician Trainees.

(A) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).

(B) Duties.

(i) Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in paragraph (3)(B) of this subsection.

(ii) A pharmacist may delegate to pharmacy technicians and pharmacy technician trainees any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:

(I) a pharmacist verifies the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees;

(II) pharmacy technicians and pharmacy technician trainees are under the direct supervision of and responsible to a pharmacist; and

(iii) Pharmacy technicians and pharmacy technician trainees may perform only nonjudgmental technical duties associated with the preparation of prescription drugs, as follows:

(I) initiating and receiving refill authorization requests; and

(II) entering prescription or medication order data into a data processing system.

(C) Ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees. A Class G pharmacy may have a ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees of 1:8 provided:

(i) at least seven 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.

(5) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows.

(A) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician, or a certified pharmacy technician, if the technician maintains current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the board.

(B) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.

(C) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist intern.

(D) Pharmacists. All pharmacists shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist.

(d) Operational Standards.

(1) General requirements.

(A) A Class A, Class C, or Class E Pharmacy may outsource prescription drug or medication order processing to a Class G pharmacy provided the pharmacies:

(i) have:

(I) the same owner; or

(II) entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and

(ii) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to perform a non-dispensing function.

(B) A Class G pharmacy shall comply with the provisions applicable to the class of pharmacy contained in either §§291.31 - 291.35 of this title (relating to Definitions, Personnel, Operational Standards, Records, and Official Prescription Requirements in Class A (Community) Pharmacies), or §§291.72 - 291.75 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class C (Institutional) Pharmacy), or §§291.102 - 291.105 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class E (Non-Resident) Pharmacy) to the extent applicable for the specific processing activity and this section including:

(i) duties which must be performed by a pharmacist; and

(ii) supervision requirements for pharmacy technicians and pharmacy technician trainees.

(2) Licensing requirements.

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

(B) A Class G pharmacy which changes ownership shall notify the board within 10 days of the change of ownership and apply for a new and separate license as specified in §291.3 of this title (relating to Required Notifications).

(C) A Class G pharmacy which changes location and/or name shall notify the board of the change within 10 days and file for an amended license as specified in §291.3 of this title.

(D) A Class G pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within 10 days of the change, following the procedures in §291.3 of this title.

(E) A Class G 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).

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

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

(3) Environment.

(A) General requirements.

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

(ii) The pharmacy shall be properly lighted and ventilated.

(B) Security.

(i) Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drug records.

(ii) Pharmacies shall employ appropriate measures to ensure that security of prescription drug records is maintained at all times to prohibit unauthorized access.

(4) Policy and Procedures. A policy and procedure manual shall be maintained by the Class G pharmacy and be available for inspection. The manual shall:

(A) outline the responsibilities of each of the pharmacies;

(B) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription drug or medication order processing; and

(C) include policies and procedures for:

(i) protecting the confidentiality and integrity of patient information;

(ii) maintaining [maintenance of] appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any processing;

(iii) complying with federal and state laws and regulations;

(iv) operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and

(v) annually reviewing the written policies and procedures and documenting such review.

(e) Records.

(1) every record required to be kept under the provisions of this section shall be:

(A) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and

(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.

(2) The pharmacy shall maintain appropriate records which identify, by prescription drug or medication order, the name(s), initials, or identification code(s) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performs a processing function for a prescription drug or medication order. Such records may be maintained:

(A) separately by each pharmacy and pharmacist; or

(B) in a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy and pharmacist.

(3) In addition, the pharmacy shall comply with the record keeping requirements applicable to the class of pharmacy to the extent applicable for the specific processing activity and this section.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 15, 2017.

TRD-201705196

Allison Vordenbaumen Benz, R.Ph., M.S.

Executive Director

Texas State Board of Pharmacy

Earliest possible date of adoption: January 28, 2018

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


CHAPTER 295. PHARMACISTS

22 TAC §295.2

The Texas State Board of Pharmacy proposes amendments to §295.2, concerning Change of Employment. The amendments, if adopted, add a definition of the term employment.

Allison Vordenbaumen Benz, R.Ph., M.S., 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 rule.

Ms. Benz 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 amendments will be clarification of requirements for pharmacist licensure. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment.

For each year of the first five years the proposed amendments will be in effect, Ms. Benz has determined the following:

(1) The proposed rules do not create or eliminate a government program;

(2) Implementation of the proposed rules do not require the creation of new employee positions or the elimination of existing employee positions;

(3) Implementation of the proposed rules do not require an increase or decrease in the future legislative appropriations to the agency;

(4) The proposed rules do not require an increase or decrease in fees paid to the agency;

(5) The proposed rules do not create a new regulation;

(6) The proposed rules do not expand or limit an existing regulation;

(7) The proposed rules do not increase or decrease the number of individuals subject to the rules' applicability; and

(8) The proposed rules do not positively or adversely affect this state's economy.

Written comments on the amendments may be submitted to Megan G. Holloway, Staff Attorney, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-500, Austin, Texas 78701, FAX (512) 305-6778. Comments must be received by 5:00 p.m., January 26, 2018.

The amendments are proposed under §§551.002, 554.051, and 562.1011, of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.1011 as authorizing the agency to adopt rules for prospective and retrospective drug use review for new medication orders.

The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§295.2.Change of Employment.

(a) A pharmacist shall report in writing to the board within 10 days of a change of employment and be responsible for seeing that his or her name is removed from the pharmacy license of last employment and added to the pharmacy license of new employment.

(b) For the purposes of this section, the term "employment" means the pharmacy at which the pharmacist engages in work on a regular and routine basis, whether remunerative or not, including the practice of pharmacy, administrative or managerial duties, supervisory tasks, or direct or indirect contractual services for pay. The term does not include an isolated case of practicing pharmacy on a temporary basis in order to relieve another pharmacist, unless such isolated cases become regular and routine.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 15, 2017.

TRD-201705197

Allison Vordenbaumen Benz, R.Ph., M.S.

Executive Director

Texas State Board of Pharmacy

Earliest possible date of adoption: January 28, 2018

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, add a requirement of one hour of continuing education on opioid abuse for pharmacist license renewal.

Allison Vordenbaumen Benz, R.Ph., M.S., 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 rule.

Ms. Benz 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 amendments will be increased awareness and education on opioid abuse amongst the pharmacist community. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment.

For each year of the first five years the proposed amendment will be in effect, Ms. Benz has determined the following:

(1) The proposed rule does not create or eliminate a government program;

(2) Implementation of the proposed rule does not require the creation of new employee positions or the elimination of existing employee positions;

(3) Implementation of the proposed rule does not require an increase or decrease in the future legislative appropriations to the agency;

(4) The proposed rule does not require an increase or decrease in fees paid to the agency;

(5) The proposed rule does not create a new regulation;

(6) The proposed rule does not expand or limit an existing regulation;

(7) The proposed rule does not increase or decrease the number of individuals subject to the rule's applicability; and

(8) The proposed rule does not positively or adversely affect this state's economy.

Written comments on the amendments may be submitted to Megan G. Holloway, Staff Attorney, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-500, Austin, Texas 78701, FAX (512) 305-6778. Comments must be received by 5:00 p.m., January 26, 2018.

The amendments are proposed under §§551.002, 554.051, and 562.1011 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.1011 as authorizing the agency to adopt rules for prospective and retrospective drug use review for new medication orders.

The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§295.8.Continuing Education Requirements.

(a) Authority and purpose.

(1) Authority. In accordance with §559.053 of the Texas Pharmacy Act, (Chapters 551 - 566, and 568 - 569, Occupations Code), all pharmacists must complete and report 30 contact hours (3.0 CEUs) of approved continuing education obtained during the previous license period in order to renew their license to practice pharmacy.

(2) Purpose. The board recognizes that the fundamental purpose of continuing education is to maintain and enhance the professional competency of pharmacists licensed to practice in Texas, for the protection of the health and welfare of the citizens of Texas.

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

(1) ACPE--Accreditation Council for Pharmacy Education.

(2) Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Occupations Code.

(3) Approved programs--Live programs, home study, and other mediated instruction delivered by an approved provider or a program specified by the board and listed as an approved program in subsection (e) of this section.

(4) Approved provider--An individual, institution, organization, association, corporation, or agency that is approved by the board.

(5) Board--The Texas State Board of Pharmacy.

(6) Certificate of completion--A certificate or other official document presented to a participant upon the successful completion of an approved continuing education program.

(7) Contact hour--A unit of measure of educational credit which is equivalent to approximately 60 minutes of participation in an organized learning experience.

(8) Continuing education unit (CEU)--A unit of measure of education credit which is equivalent to 10 contact hours (i.e., one CEU = 10 contact hours).

(9) CPE Monitor--A collaborative service from the National Association of Boards of Pharmacy and ACPE that provides an electronic system for pharmacists to track their completed CPE credits.

(10) Credit hour--A unit of measurement for continuing education equal to 15 contact hours.

(11) Enduring Materials (Home Study)--Activities that are printed, recorded or computer assisted instructional materials that do not provide for direct interaction between faculty and participants.

(12) Initial license period--The time period between the date of issuance of a pharmacist's license and the next expiration date following the initial 30 day expiration date.

(13) License period--The time period between consecutive expiration dates of a license.

(14) Live programs--Activities that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences, workshops, etc.

(15) Standardized pharmacy examination--The North American Pharmacy Licensing Examination (NAPLEX).

(c) Methods for obtaining continuing education. A pharmacist may satisfy the continuing education requirements by either:

(1) successfully completing the number of continuing education hours necessary to renew a license as specified in subsection (a)(1) of this section;

(2) successfully completing during the preceding license period, one credit hour for each year of their license period, which is a part of the professional degree program in a college of pharmacy the professional degree program of which has been accredited by ACPE; or

(3) taking and passing the standardized pharmacy examination (NAPLEX) during the preceding license period, which shall be equivalent to the number of continuing education hours necessary to renew a license as specified in subsection (a)(1) of this section.

(d) Reporting Requirements.

(1) Renewal of a pharmacist license. To renew a license to practice pharmacy, a pharmacist must report on the renewal application completion of at least thirty contact hours (3.0 CEUs) of continuing education. The following is applicable to the reporting of continuing education contact hours.

(A) For renewals received after January 1, 2015, at least one contact hour (0.1 CEU) specified in paragraph (1) of this subsection shall be related to Texas pharmacy laws or rules.

(B) For renewals received after January 1, 2019, at least one contact hour (0.1 CEU) specified in paragraph (1) of this subsection shall be related to opioid abuse.

(C) [(B)] Any continuing education requirements which are imposed upon a pharmacist as a part of a board order or agreed board order shall be in addition to the requirements of this section.

(2) Failure to report completion of required continuing education. The following is applicable if a pharmacist fails to report completion of the required continuing education.

(A) The license of a pharmacist who fails to report completion of the required number of continuing education contact hours shall not be renewed and the pharmacist shall not be issued a renewal certificate for the license period until such time as the pharmacist successfully completes the required continuing education and reports the completion to the board.

(B) A pharmacist who practices pharmacy without a current renewal certificate is subject to all penalties of practicing pharmacy without a license including the delinquent fees specified in the Act, §559.003.

(3) Extension of time for reporting. A pharmacist who has had a physical disability, illness, or other extenuating circumstances which prohibits the pharmacist from obtaining continuing education credit during the preceding license period may be granted an extension of time to complete the continued education requirement. The following is applicable for this extension:

(A) The pharmacist shall submit a petition to the board with his/her license renewal application which contains:

(i) the name, address, and license number of the pharmacist;

(ii) a statement of the reason for the request for extension;

(iii) if the reason for the request for extension is health related, a statement from the attending physician(s) treating the pharmacist which includes the nature of the physical disability or illness and the dates the pharmacist was incapacitated; and

(iv) if the reason for the request for the extension is for other extenuating circumstances, a detailed explanation of the extenuating circumstances and if because of military deployment, documentation of the dates of the deployment.

(B) After review and approval of the petition, a pharmacist may be granted an extension of time to comply with the continuing education requirement which shall not exceed one license renewal period.

(C) An extension of time to complete continuing education credit does not relieve a pharmacist from the continuing education requirement during the current license period.

(D) If a petition for extension to the reporting period for continuing education is denied, the pharmacist shall:

(i) have 60 days to complete and report completion of the required continuing education requirements; and

(ii) be subject to the requirements of paragraph (2) of this subsection relating to failure to report completion of the required continuing education if the required continuing education is not completed and reported within the required 60-day time period.

(4) Exemptions from reporting requirements.

(A) All pharmacists licensed in Texas shall be exempt from the continuing education requirements during their initial license period.

(B) Pharmacists who are not actively practicing pharmacy shall be granted an exemption to the reporting requirements for continuing education provided the pharmacists submit a completed renewal application for each license period which states that they are not practicing pharmacy. Upon submission of the completed renewal application, the pharmacist shall be issued a renewal certificate which states that pharmacist is inactive. Pharmacists who wish to return to the practice of pharmacy after being exempted from the continuing education requirements as specified in this subparagraph must:

(i) notify the board of their intent to actively practice pharmacy;

(ii) pay the fee as specified in §295.9 of this title (relating to Inactive License); and

(iii) provide copies of completion certificates from approved continuing education programs as specified in subsection (e) of this section for 30 contact hours (3.0 CEUs). Approved continuing education earned within two years prior to the licensee applying for the return to active status may be applied toward the continuing education requirement for reactivation of the license but may not be counted toward subsequent renewal of the license.

(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 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 a license period.

(C) Proof of completion of an ACPE course shall contain the following information:

(i) name of the participant;

(ii) title and completion date of the program;

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

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

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

(vi) either:

(I) a dated certifying signature of the approved provider and the official ACPE logo; or

(II) the CPE Monitor logo.

(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 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 a license period.

(3) Basic cardiopulmonary resuscitation (CPR) courses which lead to CPR certification by the American Red Cross or the American Heart Association or its equivalent 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 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 or its equivalent.

(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 or its equivalent 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 or its equivalent.

(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 or its equivalent 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 or its equivalent.

(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 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) 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.

(9) Pharmacists shall receive credit toward their continuing education requirements for programs or courses approved by other state boards of pharmacy as follows:

(A) Pharmacists shall receive credit for the number of hours for the program or course as specified by the other state board of pharmacy.

(B) Proof of attendance at a program or course approved by another state board of pharmacy shall be a certificate or other documentation that indicates:

(i) name of the participant;

(ii) title and completion date of the program;

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

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

(v) a dated certifying signature of the provider; and

(vi) documentation that the program is approved by the other state board of pharmacy.

(10) 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.

(11) 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.

(12) 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.

(13) Programs approved by the American Medical Association (AMA) as Category 1 Continuing Medical Education (CME) and accredited by the Accreditation Council for Continuing Medical Education subject to the following conditions.

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

(B) Pharmacists who present approved CME 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 a license period.

(C) Proof of completion of a CME course shall contain the following information:

(i) name of the participant;

(ii) title and completion date of the program;

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

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

(v) a dated certifying signature of the approved provider.

(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. Such records may be maintained in hard copy or electronic format.

(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 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 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.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 15, 2017.

TRD-201705198

Allison Vordenbaumen Benz, R.Ph., M.S.

Executive Director

Texas State Board of Pharmacy

Earliest possible date of adoption: January 28, 2018

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


CHAPTER 297. PHARMACY TECHNICIANS AND PHARMACY TECHNICIAN TRAINEES

22 TAC §297.3

The Texas State Board of Pharmacy proposes amendments to §297.3, concerning Registration Requirements. The amendments, if adopted, create a schedule for the renewal of an expired pharmacy technician registration to be consistent with §568.004 of the Texas Pharmacy Act.

Allison Vordenbaumen Benz, R.Ph., M.S., 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 rule.

Ms. Benz 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 amendments will be to ensure consistency between statute and regulations. There is no anticipated impact on rural communities or local or state employment. The economic 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. The economic effect to individuals whose registration has expired for 90 days or less will be a decrease of one-half times the renewal fee. There will be no economic effect on individuals whose registration has expired for more than 90 days.

For each year of the first five years the proposed amendment will be in effect, Ms. Benz has determined the following:

(1) The proposed rule does not create or eliminate a government program;

(2) Implementation of the proposed rule does not require the creation of new employee positions or the elimination of existing employee positions;

(3) Implementation of the proposed rule does not require an increase or decrease in the future legislative appropriations to the agency;

(4) The proposed rule does not require an increase in fees paid to the agency. However, the proposed rule does require a decrease in fees paid to the agency for individuals whose registration has expired for 90 days or less, as specified in §568.004 of the Texas Pharmacy Act;

(5) The proposed rule does not create a new regulation;

(6) The proposed rule does not expand or limit an existing regulation;

(7) The proposed rule does not increase or decrease the number of individuals subject to the rule's applicability; and

(8) The proposed rule does not positively or adversely affect this state's economy.

Written comments on the amendments may be submitted to Megan G. Holloway, Staff Attorney, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-500, Austin, Texas 78701, FAX (512) 305-6778. Comments must be received by 5 p.m., January 26, 2018.

The amendments are proposed under §§551.002, 554.051, and 562.1011 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.1011 as authorizing the agency to adopt rules for prospective and retrospective drug use review for new medication orders.

The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§297.3.Registration Requirements.

(a) General.

(1) Individuals who are not registered with the Board may not be employed as or perform the duties of a pharmacy technician or pharmacy technician trainee.

(2) Individuals who have previously applied and registered as a pharmacy technician, regardless of the pharmacy technician's current registration status, may not register as a pharmacy technician trainee.

(3) Individuals who apply and are qualified for both a pharmacy technician trainee registration and a pharmacy technician registration concurrently will not be considered for a pharmacy technician trainee registration.

(b) Registration for pharmacy technician trainees. An individual may register as a pharmacy technician trainee only once and the registration may not be renewed.

(1) Each applicant for pharmacy technician trainee registration shall:

(A) have a high school or equivalent diploma (e.g., GED), or be working to achieve a high school or equivalent diploma. For the purposes of this subparagraph, an applicant for registration may be working to achieve a high school or equivalent diploma for no more than two years;

(B) complete the Texas application for registration that includes the following information:

(i) name;

(ii) addresses, phone numbers, date of birth, and social security number; and

(iii) any other information requested on the application.

(C) meet all requirements necessary in order for the Board to access the criminal history record information, including submitting fingerprint information and paying the required fees.

(2) Once an applicant has successfully completed all requirements of registration, and the board has determined there are no grounds to refuse registration, the applicant will be notified of registration as a pharmacy technician trainee and of his or her pharmacy technician trainee registration number.

(3) Pharmacy technician trainee registrations expire two years from the date of registration or upon issuance of registration as a registered pharmacy technician, whichever is earlier.

(c) Initial registration for pharmacy technicians.

(1) Each applicant for pharmacy technician registration shall:

(A) have a high school or equivalent diploma (e.g., GED), or be working to achieve a high school or equivalent diploma. For the purpose of this clause, an applicant for registration may be working to achieve a high school or equivalent diploma for no more than two years; and

(B) either have:

(i) taken and passed a pharmacy technician certification examination approved by the board and have a current certification certificate; or

(ii) been granted an exemption from certification by the board as specified in §297.7 of this title (relating to Exemption from Pharmacy Technician Certification Requirements); and

(C) complete the Texas application for registration that includes the following information:

(i) name;

(ii) addresses, phone numbers, date of birth, and social security number; and

(iii) any other information requested on the application.

(D) meet all requirements necessary in order for the Board to access the criminal history record information, including submitting fingerprint information and paying the required fees; and

(E) pay the registration fee specified in §297.4 of this title (relating to Fees).

(2) Once an applicant has successfully completed all requirements of registration, and the board has determined there are no grounds to refuse registration, the applicant will be notified of registration as a registered pharmacy technician and of his or her pharmacy technician registration number. If the pharmacy technician applicant was registered as a pharmacy technician trainee at the time the pharmacy technician registration is issued, the pharmacy technician trainee registration expires.

(d) Renewal.

(1) All applicants for renewal of a pharmacy technician registration shall:

(A) complete the Texas application for registration that includes the following information:

(i) name;

(ii) addresses, phone numbers, date of birth, and social security number;

(iii) meet all requirements necessary in order for the Board to access the criminal history record information, including submitting fingerprint information and being responsible for all associated costs; and

(iv) any other information requested on the application.

(B) pay the renewal fee specified in §297.4 of this title; and

(C) complete 20 contact hours of continuing education per renewal period as specified in §297.8 of this title (relating to Continuing Education).

(2) A pharmacy technician registration expires on the last day of the assigned expiration month.

(3) As specified in §568.004 of the Act, if [If] the completed application and renewal fee are not received in the board's office on or before the last day of the assigned expiration month, the person's pharmacy technician registration shall expire. An expired registration shall be renewed according to the following schedule. [A person shall not practice as a pharmacy technician with an expired registration.]

(A) If a pharmacy technician registration has expired for 90 days or less, the person may become registered by making application and paying to the board a renewal fee that is equal to one and one-half times the renewal fee for the registration as specified in §297.4 of this title (relating to Fees).

(B) If a pharmacy technician registration has been expired for more than 90 days but less than one year, the person may become registered by making application and paying to the board a renewal fee that is equal to two times the renewal fee for the registration as specified in §297.4 of this title.

[(4)] [If a pharmacy technician registration has expired, the person may renew the registration by paying to the board the renewal fee and a delinquent fee that is equal to the renewal fee as specified in §297.4 of this title.]

(C) [(5)] If a pharmacy technician registration has expired for more than one year, the pharmacy technician may not renew the registration and must complete the requirements for initial registration as specified in subsection (c) of this section.

(4) [(6)] After review, the board may determine that paragraph (3)(C) [(5)] of this subsection does not apply if the registrant is the subject of a pending investigation or disciplinary action.

(e) An individual may use the title "Registered Pharmacy Technician" or "Ph.T.R." if the individual is registered as a pharmacy technician in this state.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 15, 2017.

TRD-201705199

Allison Vordenbaumen Benz, R.Ph., M.S.

Executive Director

Texas State Board of Pharmacy

Earliest possible date of adoption: January 28, 2018

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