Proposed Rules Title 22

TITLE 22. EXAMINING BOARDS

PART 5. STATE BOARD OF DENTAL EXAMINERS

The State Board of Dental Examiners (Board) proposes this amendment to 22 TAC §101.6, concerning dental licensing for military service members, military veterans, and military spouses.

FISCAL NOTE: Casey Nichols, Executive Director, has determined that for the first five-year period the proposed rule is in effect, the proposed rule does not have foreseeable implications relating to cost or revenues of the state or local governments.

PUBLIC BENEFIT-COST NOTE: Casey Nichols has also determined that for the first five-year period the proposed rule is in effect, the public benefit anticipated as a result of this rule will be the protection of public safety and welfare.

LOCAL EMPLOYMENT IMPACT STATEMENT: Casey Nichols has also determined that the proposed rule does not affect local economies and employment.

SMALL AND MICRO-BUSINESS, RURAL COMMUNITY IMPACT STATEMENT: Casey Nichols has determined that no economic impact statement and regulatory flexibility analysis for small businesses, micro-businesses, and rural communities is necessary for this rule.

COST TO REGULATED PERSONS: This proposed rule does not impose a cost on a regulated person and, therefore, is not subject to Tex. Gov't. Code §2001.0045.

Comments on the proposed amendment may be submitted to Casey Nichols, Executive Director, 1801 Congress Avenue, Suite 8.600, Austin, Texas 78701, by fax to (512) 649-2482, or by email to official_rules_comments@tsbde.texas.gov for 30 days following the date that the proposed rule is published in the Texas Register. To be considered for purposes of this rulemaking, comments must be: (1) postmarked or shipped by the last day of the comment period; or (2) faxed or e-mailed by midnight on the last day of the comment period.

This proposed rule implements the amendment to Section 55.005(a) of the Texas Occupations Code as set out in S.B. 422 of the 88th Texas Legislature, Regular Session (2023).

§101.6.Dental Licensing for Military Service Members, Military Veterans, and Military Spouses.

(a) Definitions.

(1) "Active duty" means current full-time military service in the armed forces of the United States or active duty military service as a member of the Texas military forces, as defined by §471.001, Government Code, or similar military service of another state.

(2) "Armed forces of the United States" means the army, navy, air force, coast guard, or marine corps of the United States or a reserve unit of one of those branches of the armed forces.

(3) "Military service member" means a person who is on active duty.

(4) "Military spouse" means a person who is married to a military service member.

(5) "Military veteran" means a person who has served on active duty and who was discharged or released from active duty.

(b) A licensee is exempt from any penalty or increased fee imposed by the Board for failing to renew the license in a timely manner if the individual establishes to the satisfaction of Board staff that the individual failed to renew the license in a timely manner because the individual was serving as a military service member.

(1) any continuing education requirements; and

(2) any other requirement related to the renewal of the military service member's license.

(d) Alternative Licensing.

(1) A military service member, military veteran, or military spouse applicant may demonstrate competency by alternative methods in order to meet the requirements for obtaining a dental license issued by the Board if the applicant:

(A) holds a current license issued by another jurisdiction that has licensing requirements that are substantially equivalent to the licensing requirements in this state; or

(B) within the five years preceding the application date held the license in this state.

(2) For purposes of this section, the standard method of demonstrating competency is the specific examination, education, and or/experience required to obtain a dental license. In lieu of the standard method(s) of demonstrating competency for a dental license and based on the applicant's circumstances, the alternative methods for demonstrating competency may include any combination of the following as determined by the Board:

(A) education;

(B) continuing education;

(D) letters of good standing;

(E) letters of recommendation;

(F) work experience; or

(G) other methods required by the Executive Director.

(3) The executive director may waive any prerequisite to obtaining a license for an applicant described in paragraph (1) of this subsection after reviewing the applicant's credentials.

(e) The Board shall give credit to an applicant who is a military service member or military veteran for any verified military service, training, or education toward the licensing requirements, other than an examination requirement, including, but not limited to, education, training, certification, or a course in basic life support. The Board may not give credit if the applicant holds a restricted license issued by another jurisdiction or has an unacceptable criminal history according to Texas Occupations Code, Chapter 53 (relating to Consequences of Criminal Conviction) or §101.8 of this title (relating to Persons with Criminal Backgrounds).

(f) The Board has 30 days from the date a military service member, military veteran, or military spouse submits an application for alternative licensing to process the application and issue a license to an applicant who qualifies for the license. [~~The Board shall process an application from a military service member, military veteran, or military spouse as soon as practicable after receiving the application.~~]

(g) All applicants shall submit an application and proof of any relevant requirements on a form and in a manner prescribed by the Board.

(h) All applicants shall submit fingerprints for the retrieval of criminal history record information.

(i) All fees associated with a license application shall be waived for an applicant who is:

(1) a military service member or military veteran whose military service, training, or education substantially meets all of the requirements for the license; or

(2) a military service member, military veteran, or military spouse who holds a current license issued by another jurisdiction that has licensing requirements that are substantially equivalent to the requirements for licensure in this state.

(j) Licenses granted under this chapter have the terms established by §101.5 of this title (related to Staggered Dental Registrations), or a term of 12 months from the date the license is issued, whichever term is longer. The Board shall notify the licensee in writing or by electronic means of the requirements for renewal.

(k) This section establishes requirements and procedures authorized or required by Texas Occupations Code, Chapter 55, and does not modify or alter rights that may be provided under federal law.

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 March 8, 2024.

TRD-202401074

Lauren Studdard

General Counsel

State Board of Dental Examiners

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8910

22 TAC §101.14

The State Board of Dental Examiners (Board) proposes this amendment to 22 TAC §101.14, concerning exemption from licensure for certain military service members and military spouses.

The purpose of the proposal is to implement Senate Bill (S.B.) 422, 88th Legislature, Regular Session (2023), which amended Texas Occupations Code Chapter 55, Licensing of Military Service Members, Military Veterans, and Military Spouses. Specifically, the proposed amendment includes "military service members" in the title and makes the rule applicable to military service members in addition to military spouses. The proposed amendment also adds a requirement that the Board verify the licensure and issue an authorization to practice recognizing the licensure within 30 days of the date a military service member or military spouse submits the information required by the rule. The proposed amendment further provides that, in the event of a divorce or similar event that affects a person's status as a military spouse, the spouse may continue to engage in the business or occupation until the third anniversary of the date the spouse received the authorization to practice. Additionally, the amendment includes language to specify that this rule does not modify or alter rights that may be provided under federal law, and corrects clerical errors.

LOCAL EMPLOYMENT IMPACT STATEMENT: Casey Nichols has also determined that the proposed rule does not affect local economies and employment.

COST TO REGULATED PERSONS: This proposed rule does not impose a cost on a regulated person and, therefore, is not subject to Tex. Gov't. Code §2001.0045.

This proposed rule implements the amendments to Chapter 55, Texas Occupations Code as set out in S.B. 422 of the 88th Texas Legislature, Regular Session (2023).

§101.14.Exemption from Licensure for Certain Military Service Members and Military Spouses.

(a) The executive director of the Texas State Board of Dental Examiners must authorize a qualified military service member or military spouse to practice dentistry in Texas without obtaining a license in accordance with §55.0041(a), Texas Occupations Code. This authorization to practice is valid during the time the military service member or, with respect to a military spouse, the military service member to whom the military spouse is married is stationed at a military installation in Texas, but is not to exceed three years.

(b) In order to receive authorization to practice the military service member or military spouse must:

(1) hold an active license to practice dentistry in another state, territory, Canadian province, or country that:

(A) has licensing requirements that are determined by the board to be substantially equivalent to the requirements for licensure [~~certification~~] in Texas; and

(B) is not subject to any restriction, disciplinary order, probation, or investigation;

(2) notify the board of the military service member or military spouse's intent to practice in Texas on a form prescribed by the board; and

(3) submit proof of the military service member or military spouse's residency in this state, a copy of the military service member or military spouse's military identification card, and proof of the military service member's status as an active duty military service member as defined by §437.001(1), Texas Government Code (relating to Definitions). To establish residency, the military service member or military spouse must submit:

(A) a copy of the permanent change of station order for the military service member or military service member to whom the military spouse is married;

(B) a Texas address; and

(c) While authorized to practice dentistry in Texas, the military service member or military spouse shall comply with all other laws and regulations applicable to the practice of dentistry in Texas.

(d) The board has 30 days from the date a military service member or military spouse submits the information required by subsection (b) of this section to: [Once the board receives the form containing notice of a military spouse's intent to practice in Texas, the board will verify whether the military spouse's dental license in another state, territory, Canadian province, or country is active and in good standing. Additionally, the board will determine whether the licensing requirements in that jurisdiction are substantially equivalent to the requirements for licensure in Texas.]

(1) verify that the member or spouse is active and in good standing in a jurisdiction that has licensing requirements that are substantially equivalent to the requirements for licensure in Texas; and

(2) issue an authorization recognizing the licensure as the equivalent license in this state.

(e) In the event of a divorce or similar event that affects a person's status as a military spouse, the spouse may continue to engage in the business or occupation under the authority of this section until the third anniversary of the date the spouse received the authorization described by subsection (d) of this section. A similar event includes the death of the military service member or the military service member's discharge from the military.

(f) This section establishes requirements and procedures authorized or required by Texas Occupations Code, Chapter 55, and does not modify or alter rights that may be provided under federal law.

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 March 8, 2024.

TRD-202401073

Lauren Studdard

General Counsel

State Board of Dental Examiners

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8910

CHAPTER 102. FEES

22 TAC §102.1

The State Board of Dental Examiners (Board) proposes this amendment to 22 TAC §102.1, concerning fees.

The proposed amendment implements Section 257.002(c)-(c-1) of the Texas Occupations Code by requiring licensees whose license is expired for 90 days or less to pay a renewal fee that is equal to 1½ times the normally required renewal fee, and whose license is expired for more than 90 days but less than one year to pay a renewal fee that is equal to two times the normally required renewal fee.

The proposed amendment requires dental hygienists to pay a fee to apply for a local infiltration anesthesia certificate in accordance with Sections 258.001 and 262.002 of the Texas Occupations Code, and 22 TAC §115.10.

The proposed amendment requires registered dental assistants to pay a fee to reactivate a retired registration, and to reinstate a cancelled registration, in accordance with 22 TAC §114.8 and §114.13.

The proposed amendment changes the Texas Online fee to implement the Fiscal Year 2024 Texas.gov Fee Schedule. The updated fees were lower resulting in an overall smaller fee.

The proposed amendment changes the National Practitioner Data Bank (NPDB) fee to implement the NPDB's increased continuous query fee from $2.00 to $2.50.

LOCAL EMPLOYMENT IMPACT STATEMENT: Casey Nichols has also determined that the proposed rule does not affect local economies and employment.

GOVERNMENT GROWTH IMPACT STATEMENT: The Board has determined that for the first five-year period the proposed rule is in effect, the following government growth effects apply: (1) the proposed rule does not create or eliminate a government program; (2) implementation of the proposed rule does not require the creation or elimination of employee positions; (3) the implementation of the proposed rule does not require an increase or decrease in future appropriations; (4) the proposed rule does require an increase in fees paid to the agency; (5) the proposed rule does not create a new regulation; (6) the proposed rule does not expand an existing regulation; (7) the proposed rule does not increase or decrease the number of individuals subject to it; and (8) the proposed rule does not positively or adversely affect the state's economy.

COST TO REGULATED PERSONS: The Board finds that the provisions of Texas Government Code Section 2001.0045(b) do not apply to the proposal because the estimated costs associated with the proposal decreases licensees' costs for compliance with the rule, implements statutory requirements, and are necessary to protect the health, safety, and welfare of the people of Texas, as provided in Section 2001.045(c)(2)(B), (6) and (9).

Comments on the proposed rule may be submitted to Casey Nichols, Executive Director, 1801 Congress Avenue, Suite 8.600, Austin, Texas 78701, by fax to (512) 649-2482, or by email to official_rules_comments@tsbde.texas.gov for 30 days following the date that the proposed rule is published in the Texas Register. To be considered for purposes of this rulemaking, comments must be: (1) postmarked or shipped by the last day of the comment period; or (2) faxed or e-mailed by midnight on the last day of the comment period.

This rule is proposed under Texas Occupations Code §254.001(a), which gives the Board authority to adopt rules necessary to perform its duties and ensure compliance with state laws relating to the practice of dentistry to protect the public health and safety, and Texas Occupations Code §254.004, which directs the Board to establish reasonable and necessary fees sufficient to cover the cost of administering the Board's duties.

No statutes are affected by this proposed rule.

Legal counsel for the Board has reviewed the proposed rule and has found it to be within the Board's authority to adopt.

§102.1.Fees.

(a) Effective May 23, 2024 [~~November 3, 2023~~], the Board has established the following reasonable and necessary fees for the administration of its function. Upon initial licensure or registration, and at each renewal, the fees provided in subsections (b) - (d) of this section shall be due and payable to the Board.

Figure: 22 TAC §102.1(a) (.pdf)

~~[Figure: 22 TAC §102.1(a)]~~

(b) - (f) (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 March 8, 2024.

TRD-202401069

Lauren Studdard

General Counsel

State Board of Dental Examiners

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8910

CHAPTER 103. DENTAL HYGIENE LICENSURE

22 TAC §103.10

The State Board of Dental Examiners (Board) proposes this amendment to 22 TAC §103.10, concerning exemption from licensure for certain military service members and military spouses.

LOCAL EMPLOYMENT IMPACT STATEMENT: Casey Nichols has also determined that the proposed rule does not affect local economies and employment.

COST TO REGULATED PERSONS: This proposed rule does not impose a cost on a regulated person and, therefore, is not subject to Tex. Gov't. Code §2001.0045.

This proposed rule implements the amendments to Chapter 55, Texas Occupations Code as set out in S.B. 422 of the 88th Texas Legislature, Regular Session (2023).

§103.10.Exemption from Licensure for Certain Military Service Members and Military Spouses.

(a) The executive director of the Texas State Board of Dental Examiners must authorize a qualified military service member or military spouse to practice as a dental hygienist [~~dentistry~~] in Texas without obtaining a license in accordance with §55.0041(a), Texas Occupations Code. This authorization to practice is valid during the time the military service member or, with respect to a military spouse, the military service member to whom the military spouse is married is stationed at a military installation in Texas, but is not to exceed three years.

(b) In order to receive authorization to practice the military service member or military spouse must:

(1) hold an active dental hygienist license in another state, territory, Canadian province, or country that:

(A) has licensing requirements that are determined by the board to be substantially equivalent to the requirements for licensure [~~certification~~] in Texas; and

(B) is not subject to any restriction, disciplinary order, probation, or investigation;

(2) notify the board of the military service member or military spouse's intent to practice in Texas on a form prescribed by the board; and

(A) a copy of the permanent change of station order for the military service member or military service member to whom the military spouse is married;

(B) a Texas address; and

(c) While authorized to practice as a dental hygienist in Texas, the military service member or military spouse shall comply with all other laws and regulations applicable to the practice of dentistry in Texas.

(1) verify that the member or spouse is active and in good standing in a jurisdiction that has licensing requirements that are substantially equivalent to the requirements for licensure in Texas; and

(2) issue an authorization recognizing the licensure as the equivalent license in this state.

(f) This section establishes requirements and procedures authorized or required by Texas Occupations Code, Chapter 55, and does not modify or alter rights that may be provided under federal law.

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 March 8, 2024.

TRD-202401071

Lauren Studdard

General Counsel

State Board of Dental Examiners

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8910

CHAPTER 114. EXTENSION OF DUTIES OF AUXILIARY PERSONNEL--DENTAL ASSISTANTS

22 TAC §114.5

The State Board of Dental Examiners (Board) proposes this amendment to 22 TAC §114.5, concerning coronal polishing requirements for dental assistants.

The intent of the amendment is (1) to make it easier for dental assistants who have completed their training at a CODA-accredited program to begin coronal polishing without having to wait on gaining one year of work experience, and (2) to reduce the work experience requirement from two years to one year for dental assistants who did not graduate from a CODA-accredited program. Accordingly, the proposed amendment removes the work experience requirement for a dental assistant who graduated from a CODA-accredited program, and requires one-year work experience for a dental assistant who has not graduated from a CODA-accredited program before the dental assistant can apply to a CODA-accredited program to obtain coronal polishing education.

LOCAL EMPLOYMENT IMPACT STATEMENT: Casey Nichols has also determined that the proposed rule does not affect local economies and employment.

COST TO REGULATED PERSONS: This proposed rule does not impose a cost on a regulated person and, therefore, is not subject to Tex. Gov't. Code §2001.0045.

No statutes are affected by this proposed rule.

§114.5.Coronal Polishing.

(a) "Coronal polishing" means the removal of plaque and extrinsic stain from exposed natural and restored tooth surfaces using an appropriate rotary instrument with rubber cup or brush and polishing agent. This includes the use of a toothbrush.

(b) A Texas-licensed dentist may delegate coronal polishing to a dental assistant, if the dental assistant:

(1) works under the direct supervision of the licensed dentist; and [~~has~~]

(2) meets the education requirements in subsection (c) of this section.

~~[(2) at least two years experience as a dental assistant; and either]~~

[(A) completed a minimum of eight (8) hours of clinical and didactic education in coronal polishing taken through a dental school, dental hygiene school, or dental assisting program accredited by the Commission on Dental Accreditation of the American Dental Association and approved by the Board. The education must include courses on:]

~~[(i) oral anatomy and tooth morphology relating to retention of plaque and stain;]~~

~~[(ii) indications, contraindications, and complications of coronal polishing;]~~

~~[(iii) principles of coronal polishing, including armamentarium, operator and patient positioning, technique, and polishing agents;]~~

~~[(iv) infection control procedures;]~~

~~[(v) polishing coronal surfaces of teeth; and]~~

~~[(vi) jurisprudence relating to coronal polishing; or]~~

~~[(B) has either:]~~

[(i) graduated from a dental assisting program accredited by the Commission on Dental Accreditation of the American Dental Association and approved by the board that includes specific didactic course work and clinical training in coronal polishing; or]

~~[(ii) received certification of completion of requirements specified by the Dental Assisting National Board and approved by the Board.]~~

(1) graduated from a dental assisting program accredited by the Commission on Dental Accreditation of the American Dental Association (CODA) that includes specific didactic course work and clinical training in coronal polishing; or

(2) completed a minimum of eight (8) hours of clinical and didactic education in coronal polishing taken through a dental school, dental hygiene school, or dental assisting program accredited by CODA. A dental assistant must have at least one-year experience as a dental assistant before applying to a CODA program to obtain coronal polishing education. The education must include courses on:

(A) oral anatomy and tooth morphology relating to retention of plaque and stain;

(B) indications, contraindications, and complications of coronal polishing;

(C) principles of coronal polishing, including armamentarium, operator and patient positioning, technique, and polishing agents;

(D) infection control procedures;

(E) polishing coronal surfaces of teeth; and

(F) jurisprudence relating to coronal polishing.

(d) [~~(c)~~] The delegated duty of polishing by a dental assistant may not be billed as a prophylaxis.

(e) [~~(d)~~] Coronal polishing must be in accordance with the minimum standard of care and limited to the dental assistant's scope of practice.

(f) [~~(e)~~ ] The dental assistant must comply with the Dental Practice Act and Board Rules in the act of coronal polishing. Pursuant to §258.003 of the Dental Practice Act, the delegating dentist is responsible for all dental acts delegated to a dental assistant, including coronal polishing.

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 March 8, 2024.

TRD-202401070

Lauren Studdard

General Counsel

State Board of Dental Examiners

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8910

22 TAC §114.7

The State Board of Dental Examiners (Board) proposes this amendment to 22 TAC §114.7, concerning exemption from licensure for certain military service members and military spouses.

The purpose of the proposal is to implement Senate Bill (S.B.) 422, 88th Legislature, Regular Session (2023), which amended Texas Occupations Code Chapter 55, Licensing of Military Service Members, Military Veterans, and Military Spouses. Specifically, the proposed amendment includes "military service members" in the title and makes the rule applicable to military service members in addition to military spouses. The proposed amendment also adds a requirement that the Board verify the registration and issue an authorization to practice recognizing the registration within 30 days of the date a military service member or military spouse submits the information required by the rule. The proposed amendment further provides that, in the event of a divorce or similar event that affects a person's status as a military spouse, the spouse may continue to engage in the business or occupation until the third anniversary of the date the spouse received the authorization to practice. Additionally, the amendment includes language to specify that this rule does not modify or alter rights that may be provided under federal law, and corrects clerical errors.

LOCAL EMPLOYMENT IMPACT STATEMENT: Casey Nichols has also determined that the proposed rule does not affect local economies and employment.

COST TO REGULATED PERSONS: This proposed rule does not impose a cost on a regulated person and, therefore, is not subject to Tex. Gov't. Code §2001.0045.

This proposed rule implements the amendments to Chapter 55, Texas Occupations Code as set out in S.B. 422 of the 88th Texas Legislature, Regular Session (2023).

§114.7.Exemption from Licensure for Certain Military Service Members and Military Spouses.

(a) The executive director of the Texas State Board of Dental Examiners must authorize a qualified military service member or military spouse to perform delegated permitted duties as a dental assistant in Texas without obtaining a registration in accordance with §55.0041(a), Texas Occupations Code. This authorization to perform delegated permitted duties is valid during the time the military service member or, with respect to a military spouse, the military service member to whom the military spouse is married is stationed at a military installation in Texas, but is not to exceed three years.

(b) In order to receive authorization to perform delegated permitted duties the military service member or military spouse must:

(1) hold an active registration to perform delegated permitted duties as a dental assistant in another state, territory, Canadian province, or country that:

(A) has registration requirements that are determined by the board to be substantially equivalent to the requirements for registration in Texas; and

(B) is not subject to any restriction, disciplinary order, probation, or investigation;

(2) notify the board of the military service member or military spouse's intent to perform delegated permitted duties in Texas on a form prescribed by the board; and

(c) While authorized to perform delegated permitted duties as a dental assistant in Texas, the military service member or military spouse shall comply with all other laws and regulations applicable to the practice of dentistry in Texas.

(d) The board has 30 days from the date a military service member or military spouse submits the information required by subsection (b) of this section to: [Once the board receives the form containing notice of a military spouse's intent to perform delegated permitted duties in Texas, the board shall verify whether the military spouse's dental assistant registration in another state, territory, Canadian province, or country is active and in good standing. Additionally, the board shall determine whether the registration requirements in that jurisdiction are substantially equivalent to the requirements for registration in Texas.]

(1) verify that the member or spouse is active and in good standing in a jurisdiction that has registration requirements that are substantially equivalent to the registration requirements in Texas; and

(2) issue an authorization recognizing the registration as the equivalent registration in this state.

(f) This section establishes requirements and procedures authorized or required by Texas Occupations Code, Chapter 55, and does not modify or alter rights that may be provided under federal law.

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 March 8, 2024.

TRD-202401072

Lauren Studdard

General Counsel

State Board of Dental Examiners

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8910

CHAPTER 115. EXTENSION OF DUTIES OF AUXILIARY PERSONNEL--DENTAL HYGIENE

22 TAC §115.10

The State Board of Dental Examiners (Board) proposes new rule 22 TAC §115.10, concerning the administration of local infiltration anesthesia by a dental hygienist. The proposed new rule pertains to the certification and standards for the administration of a local anesthetic agent by a dental hygienist as set out in House Bill 3824 of the 88th Texas Legislature, Regular Session (2023), and codified at Sections 258.001 and 262.002 of the Texas Occupations Code.

This rule was initially proposed at the November 3, 2023 Board meeting and published in the December 15, 2023, issue of the Texas Register. During the public comment period, the Board received stakeholder comments requesting to clarify what "direct supervision" means in subsection (b)(1), and requesting to lower the amount of continuing education hours a dental hygienist is required to take in accordance with subsection (f)(1). As a result of the stakeholder comments, the Board decided to make the following changes to the rule: to add subsection (a)(2) to define what direct supervision means, which mirrors the definition found in 22 TAC §110.1(7) and the language in Section 258.001(5)(B); and, to lower the required amount of continuing education hours from 6 hours to 2 hours every two years. Additionally, the Board voted to have the continuing education requirement be in addition to any additional courses required for licensure. As a result of these changes, the Board voted to re-propose this rule at its February 16, 2024 meeting.

LOCAL EMPLOYMENT IMPACT STATEMENT: Casey Nichols has also determined that the proposed rule does not affect local economies and employment.

GOVERNMENT GROWTH IMPACT STATEMENT: The Board has determined that for the first five-year period the proposed rule is in effect, the following government growth effects apply: (1) the proposed rule does not create or eliminate a government program; (2) implementation of the proposed rule may require the creation of an additional employee position. The Board may need to hire an additional full-time license and permit specialist to process applications for certificates issued pursuant to this proposal; (3) the implementation of the proposed rule may require an increase in future appropriations if the agency needs to hire an additional full-time license and permit specialist; (4) the proposed rule does require an increase in fees paid to the agency for the initial certification fee; (5) the proposed rule does create a new regulation; (6) the proposed rule does not expand an existing regulation; (7) the proposed rule does increase the number of individuals subject to the rule's applicability by including dental hygienists who were not previously approved to administer local infiltration anesthesia; and (8) the proposed rule does not positively or adversely affect the state's economy.

COST TO REGULATED PERSONS: The Board finds that the provisions of Texas Government Code Section 2001.0045(b) do not apply to the proposal because the estimated costs associated with the proposal implement statutory requirements and are necessary to protect the health, safety, and welfare of the people of Texas, as provided in Section 2001.045(c)(6) and (9).

Comments on the proposed rule may be submitted to Casey Nichols, Executive Director, 1801 Congress Avenue, Suite 8.600, Austin, Texas 78701, by fax to (512) 649-2482, or by email to official_rules_comments@tsbde.texas.gov for 30 days following the date that the proposed rule is published in the Texas Register. To be considered for purposes of this rulemaking, comments must be: (1) postmarked or shipped by the last day of the comment period; or (2) faxed or e-mailed by midnight on the last day of the comment period.

This rule is proposed under Texas Occupations Code §254.001(a), which gives the Board authority to adopt rules necessary to perform its duties and ensure compliance with state laws relating to the practice of dentistry to protect the public health and safety; and Texas Occupations Code §254.004, which give the Board authority to establish reasonable and necessary fees.

This proposed rule implements the amendments to Sections 258.001 and 262.002 of the Texas Occupations Code as set out in House Bill 3824 of the 88th Texas Legislature, Regular Session (2023).

§115.10.Administration of Local Infiltration Anesthesia.

(a) Definitions.

(1) "Local infiltration anesthesia" means the deposition of a local anesthetic solution meant for the elimination of the sensation of pain by local injection of a drug near the terminal nerve endings of teeth and supporting tissues.

(2) "Direct supervision" means the delegating dentist is physically present in the facility where the procedure is occurring and is continuously aware of the patient's physical status and well-being.

(b) General Provisions.

(1) A Texas-licensed dentist may delegate the administration of local infiltration anesthesia to a licensed dental hygienist, if the dental hygienist works under the direct supervision of the licensed dentist.

(2) The dental hygienist must hold a current local infiltration anesthesia certificate in accordance with the requirements of this section.

(1) Administration of local infiltration anesthesia must be in accordance with the minimum standard of care and limited to a procedure the dental hygienist is authorized to perform on a patient who must be:

(A) at least 18 years of age; and

(B) not sedated, or is sedated using only nitrous oxide-oxygen inhalation.

(2) Informed consent must be obtained in accordance with §108.7 and §108.8 of this title (relating to Minimum Standard of Care, General; and Records of the Dentist respectively). In addition, the informed consent must include the risks and complications with the administration of local anesthesia and vasoconstrictors, and the delegating dentist and provider of local infiltration anesthesia must be clearly disclosed.

(d) Requirements for Initial Certification. To receive a dental hygiene local infiltration anesthesia certificate from the Board, a dental hygienist must:

(1) apply on an application form approved by the Board;

(2) pay an application fee set by Board rule;

(3) submit proof to the Board of the successful completion of a current course in Basic Life Support (BLS) for Healthcare Providers;

(4) submit proof to the Board that he or she has fulfilled at least one of the following qualifications:

(A) completed a minimum of 12 hours of clinical and 20 hours of didactic education in the administration of local infiltration anesthesia taken in a classroom setting at an educational institution accredited by the Commission on Dental Accreditation of the American Dental Association (CODA). The education must fulfill the requirements in subsection (e) of this section;

(B) during the preceding year of initial application, was authorized to administer a local anesthetic agent by:

(i) a branch of the United States armed forces; or

(ii) another state with clinical and didactic requirements substantially equivalent to the requirements of a course as described under subparagraph (A) of this paragraph, and have practiced for a minimum of three out of five years immediately preceding application to the Board; or

(C) successful completion of a CODA-accredited dental hygiene program that fulfills the requirements of subparagraph (A) of this paragraph.

(5) have passed a Board-approved certification examination relating to the administration of a local anesthetic agent as described in subsection (e)(4) of this section. A "Board-approved certification examination" means an examination provided by a CODA-accredited course.

(e) Education and Examination Requirements.

(1) The education program must be overseen by a Texas-licensed dentist who is a member of the CODA-accredited education institution and who has experience teaching the administration of local infiltration anesthesia.

(2) Didactic component. The program must include at least 20 hours of didactic instruction relating to the administration of local infiltration anesthesia in the practice of dental hygiene. Such education may be completed using an on-demand video course and must include:

(A) Texas State Board of Dental Examiners laws and regulations;

(B) physiology and neurophysiology;

(D) adult respiratory and circulatory physiology and related anatomy;

(E) emergency procedures;

(F) recognition and management of local complications associated with local anesthetic injections;

(G) recognition and management of systemic local anesthetic toxicity related to the administration of local anesthetics;

(H) medical history and evaluation procedures;

(I) considerations for medically complex patients;

(J) behavior context and dental patient management;

(K) definitions and descriptions of physiological and psychological aspects of anxiety and pain;

(L) pharmacology of agents used in local anesthetics and vasoconstrictors, including drug interactions and incompatibilities;

(M) indications and contraindications for use of local anesthetic and vasoconstrictors;

(N) recommended dosages of local anesthetic and vasoconstrictors;

(O) patient monitoring through observation, with particular attention to vital signs and reflexes related to consciousness;

(P) selection and preparation of the armamentaria and record keeping for administrating local anesthetic agents via infiltration;

(Q) safety and infection control procedures with regard to local infiltration anesthetic techniques and proper disposal of sharps; and

(R) post-operative care and instructions to patients.

(3) Clinical component. The program must include at least 12 hours of clinical instruction relating to the administration of local infiltration anesthesia in the practice of dental hygiene. Such education must include:

(A) selection and preparation of the armamentaria for administering local anesthetic agents;

(B) demonstration of proper infection control techniques regarding local anesthetic agents and proper disposal of sharps;

(C) demonstration of proper evaluation of the patient's health status, taking and assessing vital signs and monitoring the patient's physical status while under the effects of local anesthetic;

(D) demonstration of the proper techniques for the administration of local infiltration anesthesia on a live patient or hands-on simulation:

(i) basic technique;

(ii) aspiration;

(iii) slow rate of injection; and

(iv) minimum effective dosage; and

(E) clinical experience demonstrating the successful use of local infiltration anesthesia on a minimum of 5 live patient experiences appropriate for dental hygiene treatment. At a minimum, each student must demonstrate clinical competency in 4 different quadrants that includes at least 3 teeth. A hands-on simulation competency component must be demonstrated prior to treating the live patients. The live patient or hands-on simulation clinical experiences required must be performed under the direct supervision of a Texas-licensed dentist associated with the course.

(4) Examination.

(A) Each student must pass a competency examination on the material covered in the didactic section of the training course with a minimum passing score of 75% before continuing to the clinical section of the course. Students who do not pass the didactic competency examination may be offered remediation before the start of the clinical experience.

(B) Each student must pass a clinical competency examination including a demonstration of satisfactorily performing local anesthetic infiltration injections.

(f) Continuing Education.

(1) A dental hygienist with a local infiltration anesthesia certificate must complete no less than 2 hours of continuing education every two years in the administration of, or medical emergencies associated with, local anesthesia specific to the procedures to be performed by the dental hygienist administering the local anesthesia. The continuing education requirement under this subsection shall be in addition to any additional courses required for licensure.

(2) The continuing education must be provided by an educational course provider recognized by the Board.

(3) Dental hygienists must maintain documentation of the satisfactory completion of the required continuing education courses.

(g) Ineligibility. Applicants of an administration of local infiltration certificate are ineligible if they are in violation of a Board order at the time of application.

(h) A dental hygienist must submit a written report to the Board as provided below:

(1) The death of a dental patient which may have occurred as a consequence of the receipt of local infiltration anesthesia from the reporting hygienist must be reported within 72 hours of the death, or such time as the hygienist becomes aware or reasonably should have become aware of the death.

(2) The hospitalization of a dental patient, as a possible consequence of receiving local infiltration anesthesia from the reporting hygienist, must be reported within 30 days of the hospitalization or such time as the hygienist becomes aware of or reasonably should have become aware of the hospitalization. For purposes of this subsection, "hospitalization" shall be defined as an examination at a hospital or emergency medical facility that results in an in-patient admission for the purpose(s) of treatment and/or monitoring.

(3) In the evaluation of sedation/anesthesia morbidity or mortality, the Board shall consider the standard of care necessary to be that applicable to the patient's state of consciousness during the procedure.

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 March 8, 2024.

TRD-202401068

Lauren Studdard

General Counsel

State Board of Dental Examiners

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8910

PART 15. TEXAS STATE BOARD OF PHARMACY

CHAPTER 291. PHARMACIES

SUBCHAPTER A. ALL CLASSES OF PHARMACIES

22 TAC §291.12

The Texas State Board of Pharmacy proposes a new rule §291.12, concerning Delivery of Prescription Drugs. The new rule, if adopted, specifies requirements for the delivery of prescription drugs to a patient or patient's agent.

Daniel Carroll, Pharm.D., 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. Dr. Carroll 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 proposed rule will be to improve the health, safety, and welfare of patients by ensuring the safety and efficacy of prescription drugs that are delivered to a patient or patient's agent by Class A, Class A-S, Class E, and Class E-S pharmacies. For each year of the first five-year period the proposed rule §291.12 will be in effect, the probable economic cost to persons required to comply with the rule is $0.28 to $13.87 per package.

Economic Impact Statement

The Texas State Board of Pharmacy (Board) anticipates a possible adverse economic impact on some small or micro-businesses (pharmacies) or rural communities by the adoption of proposed rule §291.12. The economic cost to an individual will be the same as the economic cost to a business, if the individual chooses to pay the delivery-related expenses for the business. As of January 19, 2024, there are 3,936 Class A, Class A-S, Class E, and Class E-S pharmacies that offer home delivery services, as indicated by the pharmacies on Board licensing forms. The Board estimates that 381 rural communities in Texas have a Class A, Class A-S, Class E, or Class E-S pharmacy that offers home delivery services.

The economic impact of the proposed new rule on a particular pharmacy would be dependent on the volume of prescription dispensations the pharmacy delivers by common carrier or by pharmacy employee or same-day courier service. Additionally, the economic impact would be dependent on the types of drugs dispensed by the pharmacy as certain types of drugs are more likely to require strict temperature control. In total, the estimated cost would be $0.28 to $13.87 per package. The estimated cost of tamper evident packaging is $0.07 to $0.25 per package. The estimated cost of a temperature tag is $1.82 per package. The estimated cost of a time temperature strip is $1.20 per package. The estimated cost of insulated packaging is $2.04 to $5.60 per package. The estimated cost of an ice gel pack is $0.21 to $2.00 per package. The estimated cost of notification of delivery is $0.00 to $3.00 per package.

Alternative methods of achieved the purpose of proposed rule §291.12 were considered by the Board based on public comments received concerning two prior drafts of the proposed rule. The Board previously published for public comment proposed new rule §291.12 during its May 2, 2023, meeting. The proposed rule was published in the June 16, 2023, issue of the Texas Register (48 TexReg 3037). The Board received 12 written public comments concerning the proposed rule. Additionally, the Board received five oral public comments at the August 1, 2023, Board meeting. After reviewing and considering the comments, the Board directed Board staff to redraft the rule to address the concerns expressed in the comments. The amended rule draft was presented at the November 7, 2023, Board meeting and an additional oral comment was made concerning the potential rule proposal. After discussing the amended rule draft, the Board directed Board staff to redraft the rule to address the additional concerns expressed by Board members and the public. The amended rule draft was then presented at the February 6, 2024, Board meeting and two oral comments were made concerning the potential rule. The Board made additional changes to the rule proposal to address concerns expressed by Board members and the public. The updated rule proposal reflects the least restrictive methods of ensuring the safety and efficacy of prescription drugs delivered by common carrier or by pharmacy employee or same-day courier service.

Regulatory Flexibility Analysis

The Texas State Board of Pharmacy (Board) anticipates a possible adverse economic impact on some small or micro-businesses (pharmacies) or rural communities as a result of proposed rule §291.12. Alternative methods of achieved the purpose of proposed rule §291.12 were considered by the Board based on public comments received following a previous proposal of the rule. The Board previously published for public comment proposed new rule §291.12 during its May 2, 2023, meeting. The proposed rule was published in the June 16, 2023, issue of the Texas Register (48 TexReg 3037). The Board received 12 written public comments concerning the proposed rule. Additionally, the Board received five oral public comments at the August 1, 2023, Board meeting. After reviewing and considering the comments, the Board directed Board staff to redraft the rule to address the concerns expressed in the comments. The amended rule draft was presented at the November 7, 2023, Board meeting and an additional oral comment was made concerning the potential rule proposal. After discussing the amended rule draft, the Board again directed Board staff to redraft the rule to address the concerns expressed by Board members and the public. The amended rule draft was then presented at the February 6, 2024, Board meeting and two oral comments were made concerning the potential rule. The Board made additional changes to the rule proposal to address concerns expressed by Board members and the public. The updated rule proposal reflects the least restrictive methods of ensuring the safety and efficacy of prescription drugs delivered by common carrier or by pharmacy employee or same-day courier service. The Board finds that alternative regulatory methods would not be consistent with the health, safety, and environmental and economic welfare of the state.

For each year of the first five years the proposed rule will be in effect, Dr. Carroll 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 create a new regulation concerning the delivery of prescription drugs;

(6) The proposed rule does not limit or expand 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 would have a de minimis impact on this state's economy.

Written comments on the proposed rule may be submitted to Eamon D. Briggs, Deputy General Counsel, Texas State Board of Pharmacy, 1801 Congress Avenue, Suite 13.100, Austin, Texas 78701-1319, FAX (512) 305-8061. Comments must be received by 5:00 p.m., April 30, 2024.

The new rule is proposed under §§551.002 and 554.051 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 statutes affected by the proposed rule: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§291.12.Delivery of Prescription Drugs.

(a) Applicability. This section applies to the delivery of prescription drugs by a pharmacy licensed by the board as a Class A, Class A-S, Class E, or Class E-S pharmacy.

(b) Delivery by common carrier. A pharmacy may deliver prescription drugs by use of a common carrier (e.g., U.S. Mail) as provided in §291.9 of this title (relating to Prescription Pick Up Locations) on request of the patient or patient's agent. For purposes of this section, common carrier means a person or entity who holds out to the general public a willingness to provide transportation of property from place to place for compensation in the normal course of business, with the exception of a same-day courier service.

(1) Standards. The pharmacy shall ensure that all prescription drugs are delivered to the patient or patient's agent in accordance with nationally recognized standards, such as those of the manufacturer or the United States Pharmacopeia.

(2) Packaging. The pharmacy shall ensure that prescription drugs are packaged in commercially available tamper evident packaging.

(3) Temperature. The pharmacy shall ensure that any prescription drug delivered by common carrier is packaged in a manner that maintains a temperature range appropriate for the drug. This may include, without limitation, use of temperature tags, time temperature strips, insulated packaging, gel ice packs, or a combination of these as necessary.

(4) Irregularity in delivery. The pharmacy shall provide a method by which a patient or patient's agent can notify the pharmacy as to any irregularity in the delivery of the patient's prescription, to include but not be limited to:

(A) timeliness of delivery;

(B) condition of the prescription drug upon delivery; and

(5) Refusal to deliver. The pharmacy shall refuse to deliver by common carrier a prescription drug which in the professional opinion of the dispensing pharmacist may be clinically compromised by delivery by common carrier.

(c) Delivery by pharmacy employee or same-day courier service. A pharmacy may deliver prescription drugs by means of its employee or a same-day courier service as provided in §291.9 of this title on request of the patient or patient's agent.

(1) Standards. The pharmacy is responsible for any problems in the delivery of the prescription drug.

(2) Temperature. The prescription drug shall be maintained within the temperature range allowed by the United States Pharmacopeia or recommended by the manufacturer until the delivery has been received by the patient or patient's agent.

(d) All deliveries. A pharmacy that delivers prescription drugs by common carrier or by pharmacy employee or same-day courier service shall also comply with the following:

(1) Counseling information. The pharmacy shall comply with the requirements of §291.33(c)(1)(F) of this title (relating to Operational Standards).

(2) Notification of delivery. The pharmacy shall notify the patient or patient's agent of the delivery of a prescription drug.

(3) Compromised delivery. If a pharmacist determines a prescription drug is in any compromised during delivery, the pharmacy shall replace the drug or arrange for the drug to be replaced, either by promptly delivering a replacement to the patient or by promptly contacting the prescriber to arrange for the drug to be dispensed to the patient by a pharmacy of the patient's or patient's agent's choice.

(4) Records. The pharmacy shall maintain records for two years on the following events:

(A) when a prescription drug was sent and delivered to the patient or patient's agent; and

(B) patient complaints regarding compromised deliveries.

(5) Controlled substances. A pharmacy shall comply with all state and federal laws and rules relating to the delivery of controlled substances.

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 March 11, 2024.

TRD-202401114

Daniel Carroll, Pharm.D.

Executive Director

Texas State Board of Pharmacy

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8033

SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES

22 TAC §291.131

The Texas State Board of Pharmacy proposes amendments to §291.131, concerning Pharmacies Compounding Non-Sterile Preparations. The amendments, if adopted, update the personnel, environment, labeling, compounding process, quality assurance, and recordkeeping requirements for pharmacies compounding non-sterile preparations.

Daniel Carroll, Pharm.D., 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. Dr. Carroll 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 the safety and efficacy of compounded non-sterile preparations for patients, improve the health, safety, and welfare of patients by ensuring that Class A, Class C, and Class E pharmacies engaged in non-sterile compounding operate in a safe and sanitary environment, and provide clearer regulatory language. For each year of the first five-year period the rule will be in effect, the probable economic cost to persons required to comply with the amendments is $200. If a pharmacy engages in activities that require the purchase of a containment primary engineering control, the estimated cost of the device is $5,000 to $14,000.

Economic Impact Statement

The Texas State Board of Pharmacy (Board) anticipates a possible adverse economic impact on some small or micro-businesses (pharmacies) or rural communities as a result of the proposed amendments to §291.131. The Board is unable to estimate the number of small or micro-businesses subject to the proposed amendments. As of January 19, 2024, there are 4,487 Class A, Class C, and Class E pharmacies that perform non-sterile compounding, as indicated by the pharmacies on Board licensing forms. The Board estimates that 407 rural communities in Texas have a Class A, Class C, or Class E pharmacy that performs non-sterile compounding.

The economic impact of the proposed amendments on a particular pharmacy would be dependent on that pharmacy's current environment and the policies and procedures the pharmacy previously had in place for compounding non-sterile preparations. The estimated cost of certifying a containment primary engineering control is $200. If a pharmacy engages in activities that require the purchase of a containment primary engineering control, the estimated cost of the device is $5,000 to $14,000 depending on the size and quality of the unit. The estimated cost of the new beyond-use date requirements is dependent on the pharmacy's current practices. A shortened beyond-use date may require the compound to be made more frequently or discarded more often. Additional testing costs may be incurred to prove that a specific compounded preparation can exceed a new beyond-use date standard.

The Board established a Compounding Rules Advisory Group, comprised of a Sterile Subcommittee and a Non-Sterile Subcommittee, to review the recently issued revisions to United States Pharmacopeia General Chapter <795> Pharmaceutical Compounding- Nonsterile Preparations and United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding- Sterile Preparations, and the proposed amendments are based on the recommendations of the Non-Sterile Subcommittee. The proposed amendments were presented at the February 6, 2024, Board meeting and three oral public comments were made concerning the amendments. The Board made changes to the proposed amendments to address concerns expressed by Board members and the public. Alternative methods of achieving the purpose of the proposed amendments were considered by the Non-Sterile Subcommittee and the proposed amendments reflect the Non-Sterile Subcommittee's recommendation of the least restrictive methods of ensuring the safety and efficacy of non-sterile compounded preparations.

Regulatory Flexibility Analysis

The Texas State Board of Pharmacy (Board) anticipates a possible adverse economic impact on some small or micro-businesses (pharmacies) or rural communities as a result of the proposed amendments to §291.131. The Board established a Compounding Rules Advisory Group, comprised of a Sterile Subcommittee and a Non-Sterile Subcommittee, to review the recently issued revisions to United States Pharmacopeia General Chapter <795> Pharmaceutical Compounding- Nonsterile Preparations and United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding- Sterile Preparations, and the proposed amendments are based on the recommendations of the Non-Sterile Subcommittee. The Non-Sterile Subcommittee reviewed the new provisions of USP <795>, discussed whether any of the new provisions needed to be adopted in §291.131 to ensure patient safety in Texas, and considered various methods of achieving this purpose. The Non-Sterile Subcommittee discussed these changes during its meetings held on June 28, 2023, August 28, 2023, and September 26, 2023 meetings. The Non-Sterile Committee considered different options and levels of personnel training, environmental requirements, compounding processes, labeling requirements, quality assurance, and recordkeeping in determining recommendations for the least restrictive methods of ensuring the safety and efficacy of compounded non-sterile preparations. In reviewing the new provisions of USP <795>, the Non-Sterile Subcommittee recommended limiting or not adopting several of the new provisions, including annually re-demonstrating competency, daily temperature monitoring, and minimum frequencies for cleaning surfaces. The proposed amendments were presented at the February 6, 2024, Board meeting and three oral public comments were made concerning the amendments. The Board made changes to the proposed amendments to address concerns expressed by Board members and the public. The Board finds that alternative regulatory methods would not be consistent with the health, safety, and environmental and economic welfare of the state.

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

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

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

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

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

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

(6) The proposed amendments do expand an existing regulation by adding new operational standards for Class A, Class C, and Class E, pharmacies engaged in non-sterile compounding;

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

(8) The proposed amendments would have a de minimis impact on this state's economy.

Written comments on the amendments may be submitted to Eamon D. Briggs, Deputy General Counsel, Texas State Board of Pharmacy, 1801 Congress Avenue, Suite 13.100, Austin, Texas 78701-1319, FAX (512) 305-8061. Comments must be received by 5:00 p.m., April 30, 2024.

The amendments are proposed under §§551.002 and 554.051 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 statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§291.131.Pharmacies Compounding Non-Sterile Preparations.

(a) Purpose. Pharmacies compounding non-sterile preparations, prepackaging pharmaceutical products, and distributing those products shall comply with all requirements for their specific license classification and this section. The purpose of this section is to provide standards for the:

(1) compounding of non-sterile preparations pursuant to a prescription or medication order for a patient from a practitioner in Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies;

(2) compounding, dispensing, and delivery of a reasonable quantity of a compounded non-sterile preparation in a Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacy to a practitioner's office for office use by the practitioner;

(3) compounding and distribution of compounded non-sterile preparations by a Class A (Community) pharmacy for a Class C (Institutional) pharmacy; and

(4) compounding of non-sterile preparations by a Class C (Institutional) pharmacy and the distribution of the compounded preparations to other Class C (Institutional) pharmacies under common ownership.

(b) Definitions. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Active pharmaceutical ingredient--Any substance intended to be used in the compounding of a preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals or affecting the structure and function of the body.

(2) [~~(1)~~] Beyond-use date--The date or time after which the compounded non-sterile preparation shall not be stored or transported or begin to be administered to a patient. The beyond-use date is determined from the date or time when the preparation was compounded.

(3) [~~(2)~~] Cleaning--The process of removing soil (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products.

(4) [~~(3)~~] Component--Any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation.

(5) [~~(4)~~] Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device:

(A) as the result of a practitioner's prescription drug or medication order, based on the practitioner-patient-pharmacist relationship in the course of professional practice;

(B) for administration to a patient by a practitioner as the result of a practitioner's initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;

(C) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or

(D) for or as an incident to research, teaching, or chemical analysis and not for sale or dispensing, except as allowed under §562.154 or Chapter 563 of the Occupations Code.

(6) Containment primary engineering control--A ventilated device designed and operated to minimize worker and environmental exposures to hazardous drugs by controlling emissions of airborne contaminants through the full or partial enclosure of a potential contaminant source, the use of airflow capture velocities to trap and remove airborne contaminants near their point of generation, the use of air pressure relationships that define the direction of airflow into the cabinet, and the use of high-efficiency particulate air (HEPA) filtration on all potentially contaminated exhaust streams. Examples of containment primary engineering control include containment ventilated enclosures, biological safety cabinets, and compounding aseptic containment isolators.

(7) Controlled room temperature--The temperature maintained thermostatically that encompasses the usual and customary working environment of 20 - 25 degrees C (68 - 77 degrees F).

(8) Designated person(s)--One or more individuals assigned by the pharmacist-in-charge or the pharmacist-in-charge's designee to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of compounded non-sterile preparations.

(9) [~~(5)~~] Hot water--The temperature of water from the pharmacy's sink maintained at a minimum of 41 degrees C (105 degrees F) [~~105 degrees F (41 degrees C)~~].

(10) [~~(6)~~] Reasonable quantity--An amount of a compounded drug that:

(A) does not exceed the amount a practitioner anticipates may be used in the practitioner's office or facility before the beyond use date of the drug;

(B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and

(C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.

(11) Refrigerator--A cold place in which the temperature is controlled between 2 - 8 degrees C (36 - 46 degrees F).

(12) [~~(7)~~] Sanitizing--A process for reducing on inanimate surfaces the number of all forms of microbial life including fungi, viruses, and bacteria using an appropriate agent.

(13) [~~(8)~~] SOPs--Standard operating procedures.

(14) [~~(9)~~] USP/NF--The current edition of the United States Pharmacopeia/National Formulary.

(15) Water activity--A measure of the fraction of total water that is unbound and freely available to participate in chemical, biochemical, or physiochemical reactions or provide an environment that can support microbial growth.

(c) Personnel. All personnel who compound or have direct oversight of compounding non-sterile preparations shall be initially trained and qualified by demonstrating knowledge and competency in the areas outlined in paragraph (5)(C) of this subsection.

(1) Pharmacist-in-charge. In addition to the responsibilities for the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning non-sterile compounding:

(A) determining that all personnel involved in non-sterile compounding possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised;

(B) determining that all personnel involved in non-sterile compounding obtain continuing education appropriate for the type of compounding done by the personnel;

(D) maintaining an appropriate environment in areas where non-sterile compounding occurs; and

(E) assuring that effective quality control procedures are developed and followed.

(2) Designated person(s). The pharmacist-in-charge or the pharmacist-in-charge's designee shall designate one or more individuals to be responsible and accountable for the performance and operation of the facility and personnel for the preparation of compounded non-sterile preparations. The designated person(s) shall be identified in the facility's SOPs. If the compounding facility has only one person responsible for all compounding in the facility, then that person is the designated person.

(3) [~~(2)~~] Pharmacists. Special requirements for non-sterile compounding.

(A) All pharmacists engaged in compounding shall:

(i) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; and

(ii) obtain continuing education appropriate for the type of compounding undertaken or supervised [~~done~~] by the pharmacist.

(B) A pharmacist shall inspect and approve all components, including consideration of all physical and chemical properties of the components, drug product containers, closures, labeling, and any other materials involved in the compounding process.

(C) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to ensure that errors have not occurred in the compounding process.

(D) A pharmacist is responsible for the proper maintenance, cleanliness, and use of all equipment used in the compounding process.

(4) [~~(3)~~] Pharmacy technicians and pharmacy technician trainees. All pharmacy technicians and pharmacy technician trainees engaged in non-sterile compounding shall:

(A) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken;

(B) obtain continuing education appropriate for the type of compounding done by the pharmacy technician or pharmacy technician trainee; and

(5) [~~(4)~~] Training.

(A) All training activities shall be documented and covered by appropriate SOPs as outlined in subsection (d)(8)(A) of this section.

(B) All personnel involved in non-sterile compounding shall be well trained and must participate in continuing relevant training programs.

(i) hand hygiene;

(ii) garbing;

(iii) cleaning and sanitizing;

(iv) handling and transporting components and compounded non-sterile preparations;

(v) measuring and mixing;

(vi) proper use of equipment and devices selected to compound non-sterile preparations; and

(vii) documentation of the compounding process (e.g., Master Formulation Records and Compounding Records).

(d) Operational Standards.

(1) General requirements.

(A) Non-sterile drug preparations may be compounded in licensed pharmacies:

(i) upon presentation of a practitioner's prescription drug or medication order based on a valid pharmacist/patient/prescriber relationship;

(ii) in anticipation of future prescription drug or medication orders based on routine, regularly observed prescribing patterns; or

(iii) in reasonable quantities for office use by a practitioner and for use by a veterinarian.

(B) Non-sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time.

(i) The pharmacist's professional judgment shall be based on the criteria used to determine a beyond-use date outlined in paragraph (5)(C) of this subsection.

(ii) Documentation of the criteria used to determine the stability for the anticipated shelf time must be maintained and be available for inspection.

(iii) Any preparation compounded in anticipation of future prescription drug or medication orders shall be labeled. Such label shall contain:

(I) name and strength of the compounded preparation or list of the active ingredients and strengths;

(II) facility's lot number;

(III) beyond-use date as determined by the pharmacist using appropriate documented criteria as outlined in paragraph (5)(C) of this subsection; and

(IV) quantity or amount in the container.

(C) Commercially available products may be compounded for dispensing to individual patients provided the following conditions are met:

(i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient's needs;

(ii) the pharmacy maintains documentation that the product is not reasonably available due to a drug shortage or unavailability from the manufacturer; and

(iii) the prescribing practitioner has requested that the drug be compounded as described in subparagraph (D) of this paragraph.

(D) A pharmacy may not compound preparations that are essentially copies of commercially available products (e.g., the preparation is dispensed in a strength that is only slightly different from a commercially available product) unless the prescribing practitioner specifically orders the strength or dosage form and specifies why the patient needs the particular strength or dosage form of the preparation. The prescribing practitioner shall provide documentation of a patient specific medical need and the preparation produces a clinically significant therapeutic response (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The methodology for documenting unavailability includes maintaining a copy of the wholesaler's notification showing back-ordered, discontinued, or out-of-stock items. This documentation must be available in hard-copy or electronic format for inspection by the board.

(E) A pharmacy may enter into an agreement to compound and dispense prescription/medication orders for another pharmacy provided the pharmacy complies with the provisions of §291.125 of this title (relating to Centralized Prescription Dispensing).

(F) Compounding pharmacies/pharmacists may advertise and promote the fact that they provide non-sterile prescription compounding services, which may include specific drug products and classes of drugs.

(G) A pharmacy may not compound veterinary preparations for use in food producing animals except in accordance with federal guidelines.

(H) A pharmacist may add flavoring to a prescription at the request of a patient, the patient's agent, or the prescriber. The pharmacist shall label the flavored prescription with a beyond-use-date that shall be no longer than fourteen days if stored in a refrigerator unless otherwise documented. Documentation of beyond-use-dates longer than fourteen days shall be maintained by the pharmacy electronically or manually and made available to agents of the board on request. A pharmacist may not add flavoring to an over-the-counter product at the request of a patient or patient's agent unless the pharmacist obtains a prescription for the over-the-counter product from the patient's practitioner.

(2) Library. In addition to the library requirements of the pharmacy's specific license classification, a pharmacy shall maintain a current copy, in hard-copy or electronic format, of Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations.

(3) Environment.

(A) Pharmacies engaging in compounding shall have a designated and adequate area for the safe and orderly compounding of non-sterile preparations, including the placement of equipment and materials.

(B) Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of a drug compounding operation.

(C) A sink with hot and cold running water, exclusive of rest room facilities, shall be accessible to the compounding areas and be maintained in a sanitary condition. Supplies necessary for adequate washing shall be accessible in the immediate area of the sink and include:

(i) soap or detergent; and

(ii) air-driers or single-use towels.

(D) Appropriate measures shall be used to prevent cross-contamination between compounding non-sterile preparations with different components [~~If drug products which require special precautions to prevent contamination, such as penicillin, are involved in a compounding operation, appropriate measures~~], including dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its use for the preparation of other drug products[~~, must be used in order to prevent cross-contamination~~].

(E) Cleaning and sanitizing of surfaces in the non-sterile compounding area(s) shall occur on a regular basis as defined in appropriate SOPs as outlined in paragraph (8)(A) of this subsection.

(4) Equipment and Supplies.[ ~~The pharmacy shall:~~]

(A) If [if] the pharmacy engages in compounding non-sterile preparations that require weighing a component of the preparation, the pharmacy shall have a Class A prescription balance, or analytical balance and weights which shall be calibrated and have the accuracy of the balance verified by the pharmacy at least every 12 months as specified in the pharmacy's SOPs. The pharmacy shall document the calibration and verification.[~~; and~~]

(B) The pharmacy shall have equipment and utensils necessary for the proper compounding of prescription drug or medication orders. Such equipment and utensils used in the compounding process shall be:

(i) of appropriate design and capacity, and be operated within designed operational limits;

(ii) of suitable composition so that surfaces that contact components, in-process material, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the desired result;

(iii) cleaned and sanitized immediately prior to and after each use; and

(iv) routinely inspected, calibrated (if necessary), or checked to ensure proper performance.

(C) Weighing, measuring, or otherwise manipulating components that could generate airborne chemical particles (e.g., active pharmaceutical ingredients, added substances, and conventionally manufactured products) shall be evaluated to determine if these activities must be performed in a containment primary engineering control to reduce the potential exposure to personnel or contamination of the facility or compounded non-sterile preparations. The process evaluation shall be carried out in accordance with the facility's SOPs, and the assessment shall be documented.

(D) If a containment ventilated enclosure or biological safety cabinet is used, it shall be certified at least every 12 months or according to manufacturer specifications.

(5) Labeling. In addition to the labeling requirements of the pharmacy's specific license classification, the label dispensed or distributed pursuant to a prescription drug or medication order shall contain the following.

(A) The generic name(s) or the official name(s) of the principal active ingredient(s) of the compounded preparation.

(B) A statement that the preparation has been compounded by the pharmacy. (An auxiliary label may be used on the container to meet this requirement).

(C) A beyond-use date after which the compounded preparation should not be used. The beyond-use date shall be determined as outlined in Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations including the following:

(i) The pharmacist shall consider:

(I) physical and chemical properties of active ingredients;

(II) use of preservatives and/or stabilizing agents;

(III) dosage form;

(IV) storage containers and conditions; and

(V) scientific, laboratory, or reference data from a peer reviewed source and retained in the pharmacy. The reference data should follow the same preparation instructions for combining components [~~raw materials~~] and packaged in a container with similar properties.

(ii) In the absence of stability information applicable for a specific drug or preparation, the following maximum beyond-use dates are to be used when the compounded preparation is packaged in tight, light-resistant containers [~~and stored at controlled room temperatures~~].

(I) Aqueous dosage forms. An aqueous preparation is one that has a water activity equal to or greater than 0.6 (e.g., emulsions, gels, creams, solutions, sprays, or suspensions). [Nonaqueous liquids and solid formulations (Where the manufactured drug product is the source of active ingredient): 25% of the time remaining until the product's expiration date or 6 months, whichever is earlier.]

(-a-) Nonpreserved aqueous dosage forms: Not later than 14 days when stored in a refrigerator.

(-b-) Preserved aqueous dosage forms: Not later than 35 days when stored at controlled room temperature or in a refrigerator.

(II) Nonaqueous dosage forms. A nonaqueous dosage form is one that has a water activity less than 0.6. [~~Water-containing formulations (Prepared from ingredients in solid form): Not later than 14 days when refrigerated between 2 - 8 degrees Celsius (36 - 46 degrees Fahrenheit).~~]

(-a-) Nonaqueous oral liquids: Not later than 90 days when stored at controlled room temperature or in a refrigerator.

(-b-) Other nonaqueous dosage forms: Not later than 180 days when stored at controlled room temperature or refrigerator. Other nonaqueous dosage forms that have a water activity of less than 0.6 (e.g., capsules, tablets, granules, powders, nonaqueous topicals, suppositories, and troches or lozenges).

~~[(III) All other formulations: Intended duration of therapy or 30 days, whichever is earlier.]~~

(iii) Compounded non-sterile preparations requiring shorter beyond-use dates. The beyond-use dates in subclauses (I) and (II) of clause (ii) are the beyond-use dates for compounded nonsterile preparations in the absence of specific stability information. However, the designated person(s) shall still perform due diligence to determine if there is existing stability data that would require a shorter beyond-use date.

(I) The beyond-use date of the compounded non-sterile preparation shall not exceed the shortest remaining expiration date of any of the commercially available starting components.

(II) For compounded non-sterile preparations prepared from one or more compounded components, the beyond-use date generally shall not exceed the shortest beyond-use date of any of the individual compounded components. However, there may be acceptable instances when the beyond-use date of the final compounded non-sterile preparation exceeds the beyond-use date assigned to compounded components (e.g., pH-altering solutions). If the assigned beyond-use date of the final compounded non-sterile preparation exceeds the beyond-use date of the compounded components, the physical, chemical, and microbiological quality of the final compounded non-sterile preparation shall not be negatively impacted.

(iv) [~~(iii)~~] Extending beyond-use dates for compounded non-sterile preparations. Beyond-use date limits may be exceeded when supported by valid scientific stability information for the specific compounded preparation.

(I) Compounded non-sterile preparations with a USP/NF monograph. When compounding from a USP/NF compounded preparation monograph for the compounded non-sterile preparation, the beyond-use date shall not exceed the beyond-use date specified in the monograph.

(II) Compounded non-sterile preparations with stability information. If there is a stability study using a stability-indicating analytical method for the active pharmaceutical ingredient(s), compounded non-sterile preparation formulation, and material of composition of the container closure that will be used, then the beyond-use date indicated by the study may be used in lieu of the beyond-use date specified in subclauses (I) and (II) of clause (ii) for aqueous and nonaqueous dosage forms, up to a maximum of 180 days.

(III) If the beyond-use date of the compounded non-sterile preparation is extended beyond the beyond-use date specified in subclauses (I) and (II) of clause (ii), an aqueous compounded non-sterile preparation must pass antimicrobial effectiveness testing.

(-a-) The designated person(s) may rely on antimicrobial effectiveness testing that is conducted, or contracted for, once for each formulation in the particular container closure system, including materials of composition or the container closure system, in which it will be packaged.

(-b-) Alternatively, the designated person(s) may rely on antimicrobial effectiveness testing results provided by an FDA-registered facility or published in peer-reviewed literature as long as the compounded non-sterile preparation formulation, including any preservative, and container closure materials of composition are the same as those tested, unless a bracketing study is performed.

(-c-) When a bracketing study is performed, antimicrobial effectiveness testing may be performed on a low concentration and on a high concentration of the active ingredient in the formulation to establish preservative effectiveness across various strengths of the same formulation (e.g. bracketing). The concentration of all other ingredients, including preservatives, must fall within the bracketed range.

(6) Written drug information. Written information about the compounded preparation or its major active ingredient(s) shall be given to the patient at the time of dispensing. A statement which indicates that the preparation was compounded by the pharmacy must be included in this written information. If there is no written information available, the patient should be advised that the drug has been compounded and how to contact a pharmacist, and if appropriate the prescriber, concerning the drug.

(7) Drugs, components, and materials used in non-sterile compounding.

(A) Drugs used in non-sterile compounding shall be USP/NF grade substances manufactured in an FDA-registered facility.

(B) If USP/NF grade substances are not available, or when food, cosmetics, or other substances are or must be used, the substance shall be of a chemical grade in one of the following categories:

(i) Chemically Pure (CP);

(ii) Analytical Reagent (AR); or

(iii) American Chemical Society (ACS); or

(iv) Food Chemical Codex; or

(C) If a drug, component, or material is not purchased from an FDA-registered facility, the pharmacist shall establish purity and stability by obtaining a Certificate of Analysis from the supplier and the pharmacist shall compare the monograph of drugs in a similar class to the Certificate of Analysis.

(D) A manufactured drug product may be a source of active ingredient. Only manufactured drugs from containers labeled with a batch control number and a future expiration date are acceptable as a potential source of active ingredients. When compounding with manufactured drug products, the pharmacist must consider all ingredients present in the drug product relative to the intended use of the compounded preparation.

(E) All components shall be stored in properly labeled containers in a clean, dry area, under proper temperatures.

(F) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug product beyond the desired result.

(G) Components, drug product containers, and closures shall be rotated so that the oldest stock is used first.

(H) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug product.

(I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal Food and Drug Administration list of drug products withdrawn or removed from the market for safety reasons.

(8) Compounding process.

(A) All significant procedures performed in the compounding area shall be covered by written SOPs designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process. At a minimum, SOPs shall be developed for:

(i) the facility;

(ii) equipment;

(iii) personnel;

(iv) preparation evaluation;

(v) quality assurance;

(vi) preparation recall;

(vii) packaging; [~~and~~]

(viii) storage of compounded preparations;[.]

(ix) hand hygiene and garbing; and

(x) cleaning and sanitizing.

(B) Any compounded preparation with an official monograph in the USP/NF shall be compounded, labeled, and packaged in conformity with the USP/NF monograph for the drug.

(C) Any person with a communicable [~~an apparent~~] illness or open lesion that may adversely affect the safety or quality of a drug product being compounded shall report these conditions to the designated person(s). The designated person(s) shall determine whether the person must be excluded from compounding areas until the person's conditions have resolved [~~be excluded from direct contact with components, drug product containers, closures, any materials involved in the compounding process, and drug products until the condition is corrected~~].

(D) Personnel engaged in the compounding of drug preparations shall perform proper hand hygiene prior to engaging in compounding activities. Proper hand hygiene shall be defined in appropriate SOPs as outlined in subparagraph (A) of this paragraph and appropriate for prevention of preparation and facility contamination.

(E) Garbing requirements and the frequency of changing garb shall be determined by the pharmacy and documented in appropriate SOPs as outlined in subparagraph (A) of this paragraph. The garbing requirements under the pharmacy's SOPs must be appropriate for the type of compounding performed. Gloves shall be worn for the prevention of preparation and facility contamination.

(F) At each step of the compounding process, the pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate to conform to the formula being prepared.

(9) Quality Assurance.

(A) Initial formula validation. Prior to routine compounding of a non-sterile preparation, a pharmacy shall conduct an evaluation that shows that the pharmacy is capable of compounding a product that contains the stated amount of active ingredient(s).

(B) Finished preparation checks. The prescription drug and medication orders, written compounding procedure, preparation records, and expended materials used to make compounded non-sterile preparations shall be inspected for accuracy of correct identities and amounts of ingredients, packaging, labeling, and expected physical appearance and properties before the non-sterile preparations are dispensed.

(10) Quality Control.

(A) The pharmacy shall follow established quality control procedures to monitor the quality of compounded drug preparations for uniformity and consistency such as capsule weight variations, adequacy of mixing, clarity, or pH of solutions. When developing these procedures, pharmacy personnel shall consider the provisions of Chapter 795, concerning Pharmacy Compounding Non-Sterile Preparations, Chapter 1075, concerning Good Compounding Practices, and Chapter 1160, concerning Pharmaceutical Calculations in Prescription Compounding contained in the current USP/NF. Such procedures shall be documented and be available for inspection.

(B) Compounding procedures that are routinely performed, including batch compounding, shall be completed and verified according to written procedures. The act of verification of a compounding procedure involves checking to ensure that calculations, weighing and measuring, order of mixing, and compounding techniques were appropriate and accurately performed.

(C) Unless otherwise indicated or appropriate, compounded preparations are to be prepared to ensure that each preparation shall contain not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated and labeled quantity of active ingredient per unit weight or volume and not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated weight or volume per unit of the preparation.

(e) Records.

(1) Maintenance of records. Every record required by this section shall be:

(A) kept by the pharmacy and be available, for at least two years, 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 an electronic format. 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.

(C) Documentation of the performance of quality control procedures is not required if the compounding process is done pursuant to a patient specific order and involves the mixing of two or more commercially available oral liquids or commercially available preparations when the final product is intended for external use.

(2) Master Formulation Record and Compounding Record [~~records~~].

(A) Master Formulation Record. A master formulation record shall be developed and approved by a pharmacist for all compounded preparations. Once approved, a duplicate of the master formulation record shall be used as the compound record each time the compound is prepared and on which all documentation for that compound occurs. The master formulation record shall contain at a minimum:

(i) the formula;

(ii) the components;

(iii) the compounding directions;

(iv) evaluation and testing requirements;

(v) specific equipment used during preparation;

(vi) storage requirements;

(vii) a reference to the location of the following documentation which may be maintained with other records, such as quality control records:

(I) the criteria used to determine the beyond-use date; and

(II) documentation of performance of quality control procedures, including, but not limited to, expected physical appearance of the final product.

[(A) Compounding pursuant to patient specific prescription drug or medication orders. Compounding records for all compounded preparations shall be maintained by the pharmacy electronically or manually as part of the prescription drug or medication order, formula record, formula book, or compounding log and shall include:]

~~[(i) the date of preparation;]~~

[(ii) a complete formula, including methodology and necessary equipment which includes the brand name(s) of the raw materials, or if no brand name, the generic name(s) and name(s) of the manufacturer(s) of the raw materials and the quantities of each;]

~~[(iii) signature or initials of the pharmacist or pharmacy technician or pharmacy technician trainee performing the compounding;]~~

[(iv) signature or initials of the pharmacist responsible for supervising pharmacy technicians or pharmacy technician trainees and conducting in-process and final checks of compounded preparations if pharmacy technicians or pharmacy technician trainees perform the compounding function;]

~~[(v) the quantity in units of finished preparations or amount of raw materials;]~~

~~[(vi) the container used and the number of units prepared;]~~

~~[(vii) a reference to the location of the following documentation which may be maintained with other records, such as quality control records:]~~

~~[(I) the criteria used to determine the beyond-use date; and]~~

[(II) documentation of performance of quality control procedures. Documentation of the performance of quality control procedures is not required if the compounding process is done pursuant to a patient specific order and involves the mixing of two or more commercially available oral liquids or commercially available preparations when the final product is intended for external use.]

(B) Compounding Record. The record for each preparation shall document the following:

(i) identity of all components and their corresponding amounts, concentrations, or volumes;

(ii) lot number and expiration date of each component;

(iii) component manufacturer/distributor or suitable identifying number;

(iv) container specifications;

(v) unique lot or control number;

(vi) beyond use date;

(vii) date of preparation;

(viii) name, initials, or electronic signature of the person(s) involved in the preparation;

(ix) name, initials, or electronic signature of the responsible pharmacist;

(x) finished preparation evaluation and testing specifications, if applicable; and

(xi) comparison of actual yield to anticipated or theoretical yield, when appropriate.

~~[(B) Compounding records when batch compounding or compounding in anticipation of future prescription drug or medication orders.]~~

[(i) Master work sheet. A master work sheet shall be developed and approved by a pharmacist for preparations prepared in batch. Once approved, a duplicate of the master work sheet shall be used as the preparation work sheet from which each batch is prepared and on which all documentation for that batch occurs. The master work sheet shall contain at a minimum:]

~~[(I) the formula;]~~

~~[(II) the components;]~~

~~[(III) the compounding directions;]~~

~~[(IV) a sample label;]~~

~~[(V) evaluation and testing requirements;]~~

~~[(VI) specific equipment used during preparation;]~~

~~[(VII) storage requirements;]~~

~~[(VIII) a reference to the location of the following documentation which may be maintained with other records, such as quality control records:]~~

~~[(-a-) the criteria used to determine the beyond-use date; and]~~

~~[(-b-) documentation of performance of quality control procedures.]~~

~~[(ii) Preparation work sheet. The preparation work sheet for each batch of preparations shall document the following:]~~

~~[(I) identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes;]~~

~~[(II) lot number and expiration date of each component;]~~

~~[(III) component manufacturer/distributor or suitable identifying number;]~~

~~[(IV) container specifications;]~~

~~[(V) unique lot or control number assigned to batch;]~~

~~[(VI) beyond use date of batch preparations;]~~

~~[(VII) date of preparation;]~~

~~[(VIII) name, initials, or electronic signature of the person(s) involved in the preparation;]~~

~~[(IX) name, initials, or electronic signature of the responsible pharmacist;]~~

~~[(X) finished preparation evaluation and testing specifications, if applicable; and]~~

~~[(XI) comparison of actual yield to anticipated or theoretical yield, when appropriate.]~~

(f) Office Use Compounding and Distribution of Compounded Preparations to Class C Pharmacies or Veterinarians in Accordance With §563.054 of the Act.

(1) General.

(A) A pharmacy may dispense and deliver a reasonable quantity of a compounded preparation to a practitioner for office use by the practitioner in accordance with this subsection.

(B) A Class A pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile compounded preparations to a Class C pharmacy.

(C) A Class C pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile compounded preparations that the Class C pharmacy has compounded for other Class C pharmacies under common ownership.

(D) To dispense and deliver a compounded preparation under this subsection, a pharmacy must:

(i) verify the source of the raw materials to be used in a compounded drug;

(ii) comply with applicable United States Pharmacopoeia guidelines, including the testing requirements, and the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191);

(iii) enter into a written agreement with a practitioner for the practitioner's office use of a compounded preparation;

(iv) comply with all applicable competency and accrediting standards as determined by the board; and

(v) comply with the provisions of this subsection.

(2) Written Agreement. A pharmacy that provides non-sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall:

(A) address acceptable standards of practice for a compounding pharmacy and a practitioner and receiving pharmacy that enter into the agreement including a statement that the compounded preparations may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except as authorized by §563.054 of the Act;

(B) state that the practitioner or receiving pharmacy should include on a separate log or in a patient's chart, medication order, or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient; and

(C) describe the scope of services to be performed by the pharmacy and practitioner or receiving pharmacy, including a statement of the process for:

(i) a patient to report an adverse reaction or submit a complaint; and

(ii) the pharmacy to recall batches of compounded preparations.

(3) Recordkeeping.

(A) Maintenance of Records.

(i) Records of orders and distribution of non-sterile compounded preparations to a practitioner for office use or to a Class C pharmacy for administration to a patient shall:

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

(II) maintained separately from the records of products dispensed pursuant to a prescription or medication order; and

(III) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy or its representative. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format. Failure to provide the records set out in this subsection, either on site or within 72 hours for whatever reason, constitutes prima facie evidence of failure to keep and maintain records.

(ii) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

(B) Orders. The pharmacy shall maintain a record of all non-sterile compounded preparations ordered by a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information:

(i) date of the order;

(ii) name, address, and phone number of the practitioner who ordered the preparation and, if applicable, the name, address, and phone number of the Class C pharmacy ordering the preparation; and

(iii) name, strength, and quantity of the preparation ordered.

(C) Distributions. The pharmacy shall maintain a record of all non-sterile compounded preparations distributed pursuant to an order to a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information:

(i) date the preparation was compounded;

(ii) date the preparation was distributed;

(iii) name, strength, and quantity in each container of the preparation;

(iv) pharmacy's lot number;

(v) quantity of containers shipped; and

(vi) name, address, and phone number of the practitioner or Class C pharmacy to whom the preparation is distributed.

(D) Audit Trail.

(i) The pharmacy shall store the order and distribution records of preparations for all non-sterile compounded preparations ordered by and or distributed to a practitioner for office use or by a Class C pharmacy for administration to a patient in such a manner as to be able to provide an audit trail for all orders and distributions of any of the following during a specified time period.

(I) any strength and dosage form of a preparation (by either brand or generic name or both);

(II) any ingredient;

(III) any lot number;

(IV) any practitioner;

(V) any facility; and

(VI) any pharmacy, if applicable.

(ii) The audit trail shall contain the following information:

(I) date of order and date of the distribution;

(II) practitioner's name, address, and name of the Class C pharmacy, if applicable;

(III) name, strength, and quantity of the preparation in each container of the preparation;

(IV) name and quantity of each active ingredient;

(V) quantity of containers distributed; and

(VI) pharmacy's lot number;

(4) Labeling. The pharmacy shall affix a label to the preparation containing the following information:

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

(B) the statement: "For Institutional or Office Use Only--Not for Resale"; or if the preparation is distributed to a veterinarian the statement: "Compounded Preparation";

(D) pharmacy's lot number;

(E) beyond-use date as determined by the pharmacist using appropriate documented criteria;

(F) quantity or amount in the container;

(G) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and

(H) device-specific instructions, where appropriate.

(g) Recall Procedures.

(1) The pharmacy shall have written procedures for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to, the requirements as specified in paragraph (3) of this subsection.

(2) The pharmacy shall immediately initiate a recall of any non-sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.

(3) In the event of a recall, the pharmacist-in-charge shall ensure that:

(A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;

(B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;

(D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;

(E) the preparation is quarantined; and

(F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.

(4) If a pharmacy fails to initiate a recall, the board may require a pharmacy to initiate a recall if there is potential for or confirmed harm to a patient.

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 March 11, 2024.

TRD-202401115

Daniel Carroll, Pharm.D.

Executive Director

Texas State Board of Pharmacy

Earliest possible date of adoption: April 21, 2024

For further information, please call: (512) 305-8033