TITLE health-services

Part I. Texas Department of Health

Chapter 1. Texas Board of Health

Subchapter I. Reimbursement Programs

25 TAC §1.111

(Editor's note: The text of the following section proposed for repeal will not be published. The section may be examined in the offices of the Texas Department of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas Department of Health (department) proposes the repeal of §1.111 because the law authorizing the State Legalization Impact Assistance Grant has been repealed and the grant is no longer funded.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, requires each state agency to review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Section 1.111 has been reviewed and the department has determined that the reasons for adopting the section no longer exist.

The Administrative Procedure Act, §2001.004(1), requires each state agency to adopt rules of practice stating the nature and requirements of all available formal and informal procedures. Section 2001.003(6)(B), defines the term "rule" to include the repeal of a prior rule. Section 1.111 fits within that definition. The department published a notice of intention to review this rule as required by Rider 167 in the Texas Register (23 TexReg 9075) on September 4, 1998. No comments were received by the department on this section.

Susan K. Steeg, General Counsel, has determined that for each year of the first five years the section will be repealed, there will be no fiscal implications to state or local government as a result of administering the section as proposed.

Ms. Steeg has determined that for each year of the first five years as a result of a repeal of this section, the public benefits anticipated will be the addition of health or allied health professionals to the list of professionals with whom the department may issue a grant or with whom the department may contract or otherwise engage. The method of selection of these health professionals or individuals who practice allied health professions will be beneficial in the quality of service or the cost of the service. There will be no effect on small businesses. There are no anticipated economic cost to persons because the repeal requires no compliance, and there is no anticipated impact on local employment.

Comments on the proposal may be submitted to Susan K. Steeg, General Counsel, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, 512/458-7236. Comments will be accepted for 30 days following publication of the proposal in the Texas Register .

The repeal is proposed under the Administrative Procedure Act, §2001.004, which requires state agencies to adopt rules of practice stating the nature and requirements of all available formal and informal procedures, §2001.003(6)(B) which provides that the repeal of a prior rule is a "rule", and the Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, and the commissioner of health.

The repeal affects the Health and Safety Code, Chapter 12, and the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature.

§1.111.State Legalization Impact Assistance Grant (SLIAG).

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900209

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236


Subchapter N. Personnel Policies and Procedures

25 TAC §1.171

(Editor's note: The text of the following section proposed for repeal will not be published. The section may be examined in the offices of the Texas Department of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas Department of Health (department) proposes a repeal of §1.171 concerning personnel policies & procedures for sick leave pooling for the department.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, requires each state agency to review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Section 1.171 has been reviewed and the department has determined that the reasons for adopting the section do not continue to exist. This rule is currently in a department policy manual utilized by the Bureau of Human Resources.

The department published a Notice of Intention to Review the section as required by Rider 167 in the Texas Register (23 TR 9077) on September 4, 1998. No comments were received by the department on this section.

Sharon Brewer, Bureau Chief, has determined that for each year of the first five years the section is repealed, there will be no fiscal implications to state or local government as a result of repealing the section as proposed.

Ms. Brewer has determined that for each year of the first five years the section is repealed, there will be no impact on the public or on department employees, no effect on small businesses, no anticipated economic costs to persons who are required to comply with the section as repealed and no anticipated impact on local employment as a result of repealing the section as proposed. Sick leave pooling is addressed in the department's personnel manual and that policy is easily accessible to the public and to department employees by request to the department's Human Resources Offices, by review of the department's personnel manual and/or by accessing the department's web site.

Comments on the proposal may be submitted to Sharon Brewer, Bureau Chief, Bureau of Human Resources, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, 512/458-7302. Comments will be accepted for 30 days following publication of the proposal in the Texas Register .

The repeal is proposed under the Health and Safety Code, §12.001 which provides the board with the authority to adopt rules for its procedures and the performance of each duty imposed by law on the board, the department, and the commissioner of health.

The repeal affects the Health and Safety Code, Chapter 12; and the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature.

§1.171.Sick Leave Pooling.

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900206

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236


Subchapter O. Procurement of Professional Services

25 TAC §1.181

The Texas Department of Health (department) proposes an amendment to §1.181 concerning grants and contracts for professional services.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, requires each state agency to review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Section 1.181 has been reviewed and the department has determined that the reasons for adopting the section continue to exist.

The Health and Safety Code, §12.0121 authorizes the department to award a grant or enter into a contract or otherwise engage an individual or group or association of individuals to perform professional health or allied health services. The department may make the award through one of two methods: (1) competition or (2) demonstrated competence and qualifications for the type of professional services to be performed when those services are related to the practice of a health or allied health profession and when the fees for the professional services are fair, reasonable, consistent with and not higher than usual and customary fees for the services.

The department published a notice of intention to review the section as required by Rider 167 in the Texas Register (23 TexReg 9075) on September 4, 1998. No comments were received by the department on this section.

Susan K. Steeg, General Counsel, has determined that for each year of the first five years the section is in effect there will be no fiscal implications to state or local government as a result of administering the section as proposed.

Ms. Steeg has determined that for each year of the first five years the section is in effect, the public benefits anticipated as a result of enforcing or administering this section will be the addition of health or allied health professionals to the list of professionals with whom the department may issue a grant or with whom the department may contract or otherwise engage. The method of selection of these health professionals or individuals who practice allied health professions will be beneficial in the quality of service or the cost of the service. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the section as proposed. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Susan K. Steeg, General Counsel, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, 512/458-7236. Comments will be accepted for 30 days following publication of the proposal in the Texas Register .

The amendment is proposed under Health and Safety Code, §12.0121 authorizing the department to contract for professional services, and the Health and Safety Code, §12.001, which provides the Board with the authority to adopt rules for its procedures and the performance of each duty imposed by law on the board, the department, and the commissioner of health.

The amendment affects the Health and Safety Code, Chapter 12 and the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature.

§1.181.Grants and Contracts for Professional Services.

(a)-(b)

(No change.)

(c)

Categories of providers. This subsection covers the categories of licensed, certified, registered, or otherwise authorized providers under state law to whom the department may award a grant for professional services or with whom the department may contract or otherwise engage to perform professional services. The categories of providers, as described by the scope of their practice, are listed as follows:

(1)-(2)

(No change.)

(3)

chemical dependency counseling;

(4)

[ (3) ] chiropractic services;

(5)

contact lens dispensing;

(6)

[ (4) ] dentistry;

(7)

marriage and family therapy;

(8)

[ (5) ] massage therapy;

(9)

medical radiologic technology;

(10)

[ (6) ] medicine;

(11)

[ (7) ] nursing;

(12)

[ (8) ] nutrition;

(13)

[ (9) ] optometry;

(14)

orthotist;

(15)

perfusionist;

(16)

[ (10) ] pharmacy;

(17)

[ (11) ] physical therapy;

(18)

podiatry;

(19)

[ (12) ] professional counseling;

(20)

professional medical physics;

(21)

prosthetics;

(22)

[ (13) ] psychology;

(23)

physician assistant;

[ (14)

radiographic technology;]

(24)

[ (15) ] respiratory therapy;

(25)

sex offender treatment;

(26)

[ (16) ] social work;

(27)

spectacle dispensing;

(28)

[ (17) ] speech-language pathology;

(29)

[ (18) ] emergency medical services;

(30)

[ (19) ] veterinary services;

(31)

[ (20) ] professional sanitarian services;

(32)

[ (21) ] hearing aid dispensers; [ and ]

(33)

[ (22) ] occupational therapy ; and [ . ]

(34)

any other category for which an individual is licensed, certified, registered or otherwise authorized by the state and who is acting within the scope of the individual's license, certification, registration, or other authorization in the practice of a health or allied health profession.

(d)-(e)

(No change.)

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900207

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236


Subchapter Q. Investigations of Abuse, Neglect, or Exploitation of Children or Elderly or Disabled Persons

25 TAC §§1.203-1.205, 1.207

The Texas Department of Health proposes amendments to §§1.203-1.205 and 1.207 concerning investigations of abuse, neglect, or exploitation of children or elderly or disabled persons.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 1.201, 1.202, and 1.206 have been reviewed and the department has determined that reasons for readopting these sections continue to exist.

The department published a notice of intention to review the rules as required by Rider 167 in the Texas Register (23 TexReg 9075) on September 4, 1998. No comments were received.

The proposed amendments implement Senate Bill 359 passed by the 75th Legislature, 1997, amending the Human Resources Code, Chapter 48, and the Family Code, Chapter 261, which authorizes the department to conduct investigations of abuse, neglect, or exploitation of children or elderly or disabled persons and to adopt rules relating to such investigations.

Specifically, the amended sections cover definitions; abuse, neglect, and exploitation defined; reports and investigations; and confidentiality of the investigative process and reports.

Section 1.203 defines words and terms used throughout the rules. The definitions are numbered in compliance with Texas Register format requirements (1 TAC §91.1, effective February 17, 1998). The definition of "facility" was amended to add youth camps to the list of facilities and to update the description of the hospitals operated by the department. The definition of "sexual abuse" was amended to correct the spelling of "nonconsensual."

Section 1.204 defines abuse, neglect and exploitation. A minor editorial change was made to subsection (a)(1)(H) to comply with Texas Register form and style requirements. New language was added to subsection (a)(1)(I) and (J) and subsection (a)(2)(A) and (B) to conform to changes to the Human Resources Code, Chapter 48 in accordance with Senate Bill 359.

Section 1.205 covers reports and investigations. New subsection (o) and new language in subsection (i)(1) were added to conform to changes to the Family Code, Chapter 261 in accordance with Senate Bill 359.

Section 1.207 covers confidentiality of investigative process and report. New subsections (h)-(j) were added to conform to changes to the Family Code, Chapter 261 in accordance with Senate Bill 359.

Susan K. Steeg, General Counsel has determined that for each year of the first five years the amendments are in effect, there will be no fiscal implications to state or local government as a result of enforcing or administering the amendments as proposed.

Ms. Steeg also has determined that for each year of the first five years the amendments are in effect, the public benefit anticipated as a result of enforcing or administering the amendments will be to ensure uniformity in investigations of abuse, neglect, or exploitation performed by the department and compliance with the laws relating to such investigations. There will be no effect on small businesses. There is no anticipated economic costs to persons who are required to comply with the amendments as proposed. There will be no impact on local employment.

Comments on the proposal may be submitted in writing to Susan K. Steeg, General Counsel, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199, 512/458-7236. Comments will be accepted for 30 days from the date of publication of the proposal in the Texas Register .

The amendments are proposed under the Health and Safety Code, §12.001 which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health; the Family Code, §261.401 which requires rules relating to the investigation of abuse or neglect of a child; and the Human Resources Code, §48.083 which requires rules relating to the investigation of abuse, neglect, or exploitation of an elderly or disabled person.

The amendments affect the Health and Safety Code, Chapter 12; the Human Resources Code, Chapter 48; the Family Code, Chapter 261; and the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature.

§1.203.Definitions.

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

(1)

Agent--An individual not employed by a facility but working under the auspices of the facility, such as a volunteer, student, or consultant.

(2)

Allegation--A report by a person believing or having knowledge that a child has been or may be abused or neglected in a facility or that an elderly or disabled person has been or may be abused, neglected or exploited in a facility.

(3)

Caretaker--An owner, operator, manager, employee, or agent of a facility in which a patient or client is located.

(4)

Child--A person under 18 years of age who is not and has not been married or who has not had the disabilities of minority removed for general purposes.

(5)

Client--A child, disabled person or elderly person receiving services in a facility.

(6)

Clinical issues--Issues relating to unsafe practice by a licensed health care professional or a violation of a state law or rule relating to the licensure or practice of a licensed health care professional.

(7)

Confirmed--A finding that an allegation of abuse, neglect, or exploitation is supported by the preponderance of the evidence.

(8)

Department--The Texas Department of Health.

(9)

Disabled person--A person with a mental, physical, or developmental disability that substantially impairs the person's ability to provide adequately for the person's care or protection and who is either 18 years of age or older or who is under 18 years of age and has the disabilities of minority removed.

(10)

Elderly person--A person 65 years of age or older.

(11)

Facility--A facility providing health care services which is operated, licensed, certified, or registered by the department. Such facilities include licensed general or special hospitals, licensed private psychiatric hospitals, licensed special care facilities, licensed abortion facilities, licensed ambulatory surgical centers, licensed birthing centers, licensed end stage renal disease facilities, the two [ state chest ] hospitals operated by the department, youth camps, and public health clinics operated by the department. This term includes any owner, operator, manager, employee, or agent of a facility.

(12)

Guardian--Anyone named as "guardian of the person" of a child, elderly person, or disabled person by a probate court order.

(13)

Inconclusive--A finding that an allegation of abuse, neglect, or exploitation leads to no conclusion or definite result due to a lack of witnesses or other relevant evidence.

(14)

Nonserious physical injury--Any injury determined not to be serious by the examining physician. Examples of nonserious injury may include superficial laceration, contusion, or abrasion.

(15)

Observable and material impairment--Discernable and substantial damage or deterioration.

(16)

Patient--A child, disabled person, or elderly person receiving health care services in a facility.

(17)

Perpetrator--The person who has committed an act of abuse or neglect of a child or abuse, neglect, or exploitation of an elderly or disabled person.

(18)

Perpetrator unknown--The term used to describe an incidence in which abuse, neglect, or exploitation is confirmed but positive identification of the responsible person can not be made and in which self injury has been eliminated as the cause.

(19)

Preponderance of evidence--The greater weight of evidence or evidence which is more credible and convincing to the mind.

(20)

Reporter--The person filing a report of abuse, neglect, or exploitation, either the:

(A)

victim of alleged abuse, neglect, or exploitation;

(B)

a third party filing a report on behalf of the alleged victim; or

(C)

both.

(21)

Serious physical injury--An injury determined to be serious by the examining physician. Examples of serious injury may include fracture; dislocation of any joint; internal injury; any contusion larger than two and one-half inches in diameter; concussion; second or third degree burns; first degree scald burns greater than the percentage of the body involved or involving hands, feet, face or genitals; or multiple lacerations, contusions or abrasions.

(22)

Sexual abuse--Any sexual activity, including any involuntary or nonconsensual [ nonconsenual ] sexual conduct that would constitute an offense under the Penal Code, §21.08 (indecent exposure) or Chapter 22 (assaulting offenses), involving a facility and a patient or client. Sexual activity includes but is not limited to kissing, hugging, stroking, or fondling with sexual intent; oral sex or sexual intercourse; and request, suggestion or encouragement for the performance of sex.

(23)

Substantial harm--Real and significant physical injury or damage to a child that includes, but is not limited to, bruises, cuts, welts, skull or other bone fractures, brain damage, subdural hematoma, internal injuries, burns, scalds, wounds, poisoning, human bites, concussions, and dislocations and sprains.

(24)

Substantial risk--Real and significant possibility or likelihood.

(25)

Unconfirmed--A finding that an allegation of abuse, neglect or exploitation is not supported by the preponderance of the evidence.

(26)

Unfounded--A finding that an allegation of abuse, neglect, or exploitation is spurious or patently without factual basis.

§1.204.Abuse, Neglect, and Exploitation Defined.

(a)

Abuse defined.

(1)

Abuse of a child includes the following acts or omissions by any person:

(A)-(F)

(No change.)

(G)

compelling or encouraging the child to engage in sexual conduct as defined by the Penal Code, §43.01 (This is met whether the child actually engages in sexual conduct or simply faces a substantial risk of doing so); [ or ]

(H)

causing, permitting, encouraging, engaging in, or allowing the photographing, filming, or depicting of the child if the person knew or should have known that the resulting photograph, film, or depiction of the child is obscene (as defined by the Penal Code) or pornographic (this [ . (This ] is met whether or not the child voluntarily participates[ . ]) ;

(I)

the current use by a person of a controlled substance as defined by the Health and Safety Code, Chapter 481, in a manner or to the extent that the use results in physical, mental, or emotional injury to a child; or

(J)

causing, expressly permitting, or encouraging a child to use a controlled substance as defined by the Health and Safety Code, Chapter 481.

(2)

Abuse of an elderly or disabled person means:

(A)

the negligent or wilful infliction of injury, unreasonable confinement, intimidation, or cruel punishment with resulting physical or emotional harm or pain by the person's caretaker, family member, or other individual who has an ongoing relationship with the person [ or mental anguish ]; or

(B)

sexual abuse by the persons, caretaker, family member, or other individual who has an ongoing relationship with the person .

(3)

(No change.)

(b)-(c)

(No change.)

§1.205.Reports and Investigations.

(a)-(h)

(No change.)

(i)

An investigation shall include:

(1)

an interview with the alleged victim, if appropriate . An interview with a child alleged to be a victim of physical abuse or sexual abuse shall be audiotaped or videotaped unless the department determines that good cause exists for not audiotaping or videotaping the interview. Good cause may include, but is not limited to, such considerations as the age of the child and the nature and seriousness of the allegations under investigation. Nothing in this paragraph shall be construed as prohibiting the department from audiotaping or videotaping an interview of a child on any case for which such audiotaping or videotaping is not required under this paragraph. The fact that the department failed to audiotape or videotape an interview is admissible at the trial of the offense that is the subject of the interview ;

(2)-(3)

(No change.)

(j)-(n)

(No change.)

(o)

The department shall make a reasonable effort to notify each parent and legal guardian, if one has been appointed, of the nature of the allegation, that the interview or examination was conducted, and of the disposition of the investigation.

(1)

When during an investigation of a report of suspected child abuse or neglect a representative of the department conducts an interview with or an examination of a child, the department shall make a reasonable effort before 24 hours after the time of the interview or examination to notify each parent of the child and the child's legal guardian of the nature of the allegation and of the fact that the interview or examination was conducted.

(2)

If a report of suspected child abuse or neglect is administratively closed by the department as a result of a preliminary investigation that did not include an interview or examination of the child, the department shall make a reasonable effort before the expiration of 24 hours after the time the investigation is closed to notify each parent and legal guardian of the disposition of the investigation.

(3)

The notice required by paragraphs (1) and (2) of this subsection is not required if the department determines that the notice is likely to endanger the safety of the child who is the subject of the report, the person who made the report, or any other person who participates in the investigation of the report.

(4)

The notice required by paragraphs (1) and (2) of this subsection may be delayed at the request of a law enforcement agency if notification during the required time would interfere with an ongoing criminal investigation.

§1.207.Confidentiality of Investigative Process and Report.

(a)-(g)

(No change.)

(h)

The completed investigative report regarding abuse, neglect, or exploitation of an elderly or disabled person shall be released to the subject of a report of abuse, neglect, or exploitation or to that person's legal representative upon request. Any information relating to the reporter's identity or any other individual whose safety or welfare may be endangered by the disclosure shall be blacked out or deidentified.

(i)

At the conclusion of an investigation in which the department determines that the person alleged to have abused or neglected a child did not commit abuse or neglect, the department shall notify the person of the person's right to request the department to remove information about the person's alleged role in the abuse or neglect report from the department's records.

(j)

On request under subsection (i) of this section by a person whom the department has determined did not commit abuse or neglect, the department shall remove information from the department's records concerning the person's alleged role in the abuse or neglect report.

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900242

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236


Chapter 3. Memorandums of Understanding with Other State Agencies

25 TAC §3.41

(Editor's note: The text of the following section proposed for repeal will not be published. The section may be examined in the offices of the Texas Department of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas Department of Health (department) proposes the repeal of §3.41 concerning the contract with the Texas Health Care Information Council (council). Specifically, the section defined terms commonly used in working with the council, specified contracting requirements between the department and the council, set forth parameters for data submission and collection by the department and the council, and established the authority of the department to inspect records of data sources and to levy penalties for nonreporting.

The Texas Legislature created the council through passage of its enabling legislation, Chapter 108 of the Health and Safety Code, in 1995. Section 108.008 (b)(2), as originally enacted, required the department to provide assistance to the council "in accordance with rules adopted by the board (Board of Health) after consulting with the council and set out in the contract with the council." Senate Bill 788, 75th Legislature, 1997, removed the wording from the law requiring the board to adopt rules. The department and the council currently have a memorandum of understanding in place as required by Senate Bill 788. The department and council will continue to have a contract although it will no longer be adopted by board rule.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, requires each state agency to review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Section 3.41 has been reviewed and the department has determined that the reasons for adopting the section no longer exist.

The department published a notice of intention to review the section proposed for repeal as required by Rider 167 in the Texas Register (23 TexReg 9077) on September 4, 1998. No comments were received by the department on these sections.

Ann Henry, Bureau of State Health Data and Policy Analysis, has determined that for each year of the first five years the repeal is in effect, there will be no fiscal implications for state or local governments as a result of the repeal.

Ms. Henry has also determined that for each year of the first five years the repeal is in effect, the public benefits anticipated are compliance with Senate Bill 788, 75th Legislature, 1997, and continuation of activities between the department and the council. Amendments to the current contract will be finalized more expeditiously since a corresponding rule change will not be required. There will be no effect on small businesses. There are no anticipated economic costs to persons as a result of this repeal. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Ann Henry, Bureau of State Health Data and Policy Analysis, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, 512/458-7261. Comments will be accepted for 30 days following publication of the proposal in the Texas Register .

The repeal is proposed under the Health and Safety Code, §12.001 which provides the Texas Board of Health (board) with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, and the commissioner of health.

The repeal affects the Health and Safety Code, Chapter 108; and the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature.

§3.41.Contract with the Texas Health Care Information Council.

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900204

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236


Chapter 37. Maternal and Child Health Services

Subchapter R. School Health Advisory Commission

25 TAC §37.350

The Texas Department of Health (department) proposes new §37.350 concerning the School Health Advisory Committee (committee). The committee provides assistance to the Texas Board of Health (board) and the department to establish a leadership role for the department in the support for and delivery of school health services.

In 1993, the Texas Legislature passed Senate Bill 383 (now codified in the Government Code, Chapter 2110) which requires that each state agency adopt rules to establish advisory committees. The rules must state the purpose of each committee, state the composition of the committee, describe the tasks of the committee, describe the manner in which the committee will report to the agency, and establish a date on which the committee will be automatically abolished unless the governing body of the agency affirmatively votes to continue the committee in existence.

The new section establishes the committee and provides procedures for its operation. Specifically, the section includes language to describe the purpose and tasks of the committee; to establish a review date of June 1, 2003, for the committee; to define the composition; and to establish requirements and procedures relating to terms of members, officers, meetings, attendance, staff support, parliamentary procedures, subcommittees, statements by members, reports to the board and reimbursement for expenses.

Kathleen Hamilton, Acting Chief, Bureau of Children's Health, has determined that for each year of the first five years the proposed section is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering this section.

Ms. Hamilton also has determined that for each year of the first five years the section is in effect, the public benefit anticipated as a result of enforcing the section will be better information and advice provided to the board and the department on the issues addressed by the advisory committee and clarification of the role and procedures of the committee. There will be no effect on small businesses. There are no economic costs to persons who are required to comply with the section as proposed. There will be no effect on local employment.

Comments may be submitted to Mary Jackson, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, 512/458-7700, mary.jackson@tdh.state.tx.us. Comments on the proposed section will be accepted for 30 days following publication in the Texas Register .

The new section is proposed under the Health and Safety Code, §11.016, which allows the board to establish advisory committees; the Government Code, Chapter 2110, which sets standards for the establishment of advisory committees by the agencies for which they function; and the Health and Safety Code, §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health.

The new section affects the Health and Safety Code, Chapter 11, and the Government Code, Chapter 2110.

§37.350.School Health Advisory Committee.

(a)

The committee. The School Health Advisory Committee (committee) shall be appointed under and governed by this section. The committee is established under the Health and Safety Code, §11.016, which allows the Board of Health (board) to establish advisory committees.

(b)

Applicable law. The committee is subject to the Government Code, Chapter 2110, concerning state agency advisory committees.

(c)

Purpose. The purpose of the committee is to provide assistance to the board to establish a leadership role for the Texas Department of Health (department) in the support for and delivery of school health services.

(d)

Tasks.

(1)

The committee shall advise the board concerning:

(A)

the development of a data collection model to compile basic information about school health services in the state; and

(B)

relevant issues based on the data collected to coordinate and improve school health services including health promotion.

(2)

The committee shall carry out any other tasks given to the committee by the board.

(e)

Review and duration. By June 1, 2003, the board will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date.

(f)

Composition. The committee shall be composed of 16 members appointed by the board as follows:

(1)

two physicians providing health services to school aged children;

(2)

two registered nurses or physician assistants providing school health services;

(3)

six consumer members including parents of school aged children and at least one parent of a special needs child;

(4)

two school administrators; and

(5)

four members representing organizations and/or agencies involved with the health of school children.

(g)

Terms of office. The term of office of each member shall be six years. Members shall serve after expiration of their term until a replacement is appointed.

(1)

Members shall be appointed for staggered terms so that the terms of a substantially equivalent number of members will expire on June 1 of each odd-numbered year beginning in 2001.

(2)

If a vacancy occurs, an individual shall be appointed to serve the unexpired portion of that term.

(h)

Officers. The chairman of the board shall appoint a presiding officer and an assistant presiding officer to begin serving on June 1 of each odd-numbered year.

(1)

Each officer shall serve until May 31 of each odd-numbered year. Each officer may holdover until his or her replacement is appointed by the chairman of the board.

(2)

The presiding officer shall preside at all committee meetings at which he or she is in attendance, call meetings in accordance with this section, appoint subcommittees of the committee as necessary, and cause proper reports to be made to the board. The presiding officer may serve as an ex-officio member of any subcommittee of the committee.

(3)

The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. If the office of the presiding officer becomes vacant, the assistant presiding officer will serve until a successor is appointed to complete the unexpired portion of the term of the office of presiding officer.

(4)

If the office of assistant presiding officer becomes vacant, it may be filled temporarily by vote of the committee until a successor is appointed by the chairman of the board.

(5)

A member shall serve no more than two consecutive terms as presiding officer and/or assistant presiding officer.

(6)

The committee may reference its officers by other terms, such as chairperson and vice-chairperson.

(i)

Meetings. The committee shall meet only as necessary to conduct committee business.

(1)

A meeting may be called by agreement of Texas Department of Health (department) staff and either the presiding officer or at least three members of the committee.

(2)

Department staff shall make meeting arrangements and shall contact committee members to determine availability for a meeting date and place.

(3)

The committee is not a "governmental body" as defined in the Open Meetings Act. However, in order to promote public participation, each meeting of the committee shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception that the provisions allowing executive sessions shall not apply.

(4)

Each member of the committee shall be informed of a committee meeting at least five working days before the meeting.

(5)

Nine members of the committee shall constitute a quorum for the purpose of transacting official business.

(6)

The committee is authorized to transact official business only when in a legally constituted meeting with a quorum present.

(7)

The agenda for each committee meeting shall include an item entitled public comment under which any person will be allowed to address the committee on matters relating to committee business. The presiding officer may establish procedures for public comment, including a time limit on each comment.

(j)

Attendance. Members shall attend committee meetings as scheduled. Members shall attend meetings of subcommittees to which the member is assigned.

(1)

A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting.

(2)

It is grounds for removal from the committee if a member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability, is absent for more than half of the committee and subcommittee meetings during a calendar year, or is absent from at least three consecutive committee meetings.

(3)

The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists.

(k)

Staff. Department staff shall provide administrative support for the committee.

(l)

Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.

(1)

Any committee action must be approved with a quorum present and by a majority vote of the members present.

(2)

Each member shall have one vote.

(3)

A member may not authorize another individual to represent the member by proxy.

(4)

The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.

(5)

Minutes of each committee meeting shall be taken by department staff.

(A)

A draft of the minutes approved by the presiding officer shall be provided to the board and each member of the committee within 30 days of each meeting.

(B)

After approval by the committee, the minutes shall be signed by the presiding officer.

(m)

Subcommittees. The committee may establish subcommittees as necessary to assist the committee in carrying out its duties.

(1)

The presiding officer shall appoint members of the committee to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer may also appoint nonmembers of the committee to serve on subcommittees.

(2)

Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the committee.

(3)

A subcommittee chairperson shall make regular reports to the committee at each of its meetings or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting.

(n)

Statement by members.

(1)

The board, the department, and the committee shall not be bound in any way by any statement or action on the part of any committee member except when a statement or action is in pursuit of specific instructions from the board, department, or committee.

(2)

The committee and its members may not participate in legislative activity in the name of the board, the department, or the committee except with approval through the department's legislative process. Committee members are not prohibited from representing themselves or other entities in the legislative process.

(o)

Reports to board. The committee shall file an annual written report with the board.

(1)

The report shall list the meeting dates of the committee and any subcommittees, the attendance records of its members, a brief description of actions taken by the committee, a description of how the committee has accomplished the tasks given to the committee by the board, the status of any rules which were recommended by the committee to the board, and anticipated activities of the committee for the next year.

(2)

The report shall identify the costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities.

(3)

The report shall cover the meetings and activities in the immediate preceding 12 months and shall be filed with the board each June. It shall be signed by the presiding officer and appropriate department staff.

(p)

Reimbursement for expenses. In accordance with the requirements set forth in the Government Code, Chapter 2110, a committee member may receive reimbursement for the member's expenses incurred for each day the member engages in official committee business if authorized by the General Appropriations Act or budget execution process.

(1)

No compensatory per diem shall be paid to committee members unless required by law.

(2)

A committee member who is an employee of a state agency, other than the department, may not receive reimbursement for expenses from the department.

(3)

A nonmember of the committee who is appointed to serve on a subcommittee may not receive reimbursement for expenses from the department.

(4)

Each member who is to be reimbursed for expenses shall submit to staff the member's receipts for expenses and any required official forms not later than 14 days after each committee meeting.

(5)

Requests for reimbursement of expenses shall be made on official state vouchers prepared by department staff.

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900208

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236


Chapter 97. Communicable Diseases

Subchapter B. Immunization Requirements in Texas Elementary and Secondary Schools and Institutions of Higher Education

25 TAC §§97.63, 97.65, 97.67, 97.74

The Texas Department of Health (department) proposes amendments to §§97.63, 97.65, 97.67, and 97.74 concerning immunization requirements for children and students in Texas child-care facilities, elementary and secondary schools and institutions of higher education. These amendments implement departmental initiatives to enhance childhood protection against hepatitis A, hepatitis B, and varicella (chickenpox) and incorporate recent recommendations of the Advisory Committee on Immunization Practices (ACIP) for the vaccination of health care workers by requiring varicella vaccination for higher education students in the health professions whose work involves direct patient contact. Hepatitis A vaccination will be required in 32 border counties for children and students 2 years old and older who were born on or after September 2, 1993. The existing requirement for hepatitis B vaccination throughout the state will be expanded to include a cohort of adolescents. A new requirement for varicella vaccine for children entering kindergarten in Fall, 1999, and all younger children attending child-care; for 12 year-olds without a reliable history of varicella disease; and for higher education students without a reliable history of varicella disease, who are pursuing health professions degrees.

Robert D. Crider, M.S., M.P.A., Director, Immunization Division, has determined that for the first five-year period that the sections will be in effect there will be fiscal implications to state and local government as a result of enforcing and administering the sections as proposed.

The total cost to state government of providing hepatitis A vaccine to the children and students in the 32 border-county region should approach $3.2 million. Federal funds (from the Vaccine for Children program and the 317 Grant program) administered by state government are expected to supply $2.9 million of the needed funding. Funds allocated from the state general revenue fund are expected to cover the remaining $300,000 in costs. The cost to state government of providing hepatitis B vaccine to the students affected by the hepatitis B requirement is expected to be $8.2 million per year. Federal funds administered by state government (from the Vaccine for Children program and the 317 Grant program) will cover approximately $7.6 million of the needed funding. The remaining cost, estimated to be $600,000, is expected to be paid out of state general revenues. The total cost to state government of immunizing the children and students affected by the varicella vaccination requirement will be approximately $19.5 million per year. Federal monies (from the Vaccine for Children program and the 317 Grant program) administered by state government are expected to provide roughly $18 million of the needed funding. State funds in the amount of $1.5 million are expected to pay for the remaining costs.

There will be increased costs to local health departments, primarily in increased operating expenses, e.g., labor and overhead, required to serve a larger number of children than the number currently receiving hepatitis A, hepatitis B, and varicella vaccines according to the recommended immunization schedule. These costs are estimated to be $9.3 million and may be partly offset by the collection of (sliding scale) clinic fees. Additional savings to local health departments are anticipated as the amount of indigent care provided for these diseases declines. Much of the cost of immunizing children against hepatitis A in the 32 border counties is already being expended in voluntary local vaccination programs. Similarly, many schools and local health departments have already implemented adolescent hepatitis B catch-up programs in their communities. In these areas, expenditures resulting from these new requirements will be smaller. Additional costs estimated at $847,000 will be incurred by child-care facilities, school districts, and private schools, which will be required to monitor their populations for compliance with the new requirements. Increased efforts made by these entities in monitoring compliance with these requirements should be offset by eliminating the expense of disease reporting, exclusions from attendance during periods of communicability, and (for public schools) the loss of federal funds based on average daily attendance.

Mr. Crider has also determined that for each year of the first five years that the sections are in effect the public benefits anticipated as a result of enforcing and administering the sections as proposed will emerge as fewer outbreaks of hepatitis A occur, fewer people develop chronic hepatitis B infection following acute infection, and parents and guardians experience less work disruption due to their children's varicella illness. These amendments are designed to enhance understanding of the requirements, which should simplify the work performed by the above entities as they monitor compliance. Health benefit plans will be affected by these proposed rules, which increase the number of vaccines and vaccinations for which they are required to provide first-dollar coverage. Health-care providers who administer uncompensated vaccination and private-pay parents will experience increased costs for vaccines and vaccine and administration. These visits are estimated to cost $90 on average. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Mr. Robert D. Crider, M.S., M.P.A., Director, Immunization Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7284, or (800) 252-9152. Comments will be accepted for 60 days following publication of this proposal in the Texas Register .

These amendments are proposed under Health and Safety Code §§81.023, which requires the Board of Health (board) to develop immunization requirements for children; Education Code §38.001, which allows the board to develop immunization requirements for admission to any elementary or secondary school; Education Code §51.933, which allows the board to develop immunization requirements for students at any institution of higher education who are pursuing a course of study in a health profession; Texas Human Resources Code, §42.043, which requires the department to make rules regarding the immunization of children admitted to day-care facilities; and Health and Safety Code §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department and the commissioner of health.

These sections affect Health and Safety Code §81.023; Texas Education Code, §38.001, §51.933; and Texas Human Resource Code §42.043.

§97.63.Required Immunizations.

(a)-(b)

(No change.)

(c)

The following immunizations are required in the respective age groupings. A child or student must meet all the immunization requirements specific to an age group upon first entering the age group.

(1)

Children less than five years of age: polio vaccine; diphtheria-tetanus- pertussis (DTP) or diphtheria-tetanus-acellular pertussis (DTaP) vaccine; measles, mumps, and rubella vaccine (MMR); [ and ] Haemophilus influenzae type b conjugate vaccine (HibCV) , hepatitis A, and varicella vaccine .

(A)-(D)

(No change.)

(E)

Children 12 months of age, but not yet 15 months of age (12 months through 14 months of age):

(i)-(ii)

(No change.)

(iii)

one dose of MMR vaccine is required. Only doses received on or after the first birthday will meet this requirement. Serologic confirmation of measles, mumps, or rubella immunity or serologic evidence of infection is acceptable in lieu of vaccination for that disease only. For further information see §97.67 of this title (relating to Verification of Immunity to Measles, Rubella, Mumps, [ or ] Hepatitis A, Hepatitis B[ . ] , or Varicella ; and

(iv)

(No change.).

(v)

one dose of varicella vaccine is required. This vaccine must have been received on or after the first birthday. A parent- or physician- validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity is acceptable in lieu of vaccine. For further information, see §97.67 of this title.

(F)

Children 15 months of age, but not yet 5 years of age (15 months through four years of age):

(i)-(iv)

(No change.)

(v)

one dose of varicella vaccine is required. This vaccine must have been received on or after the first birthday. A parent- or physician- validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity is acceptable in lieu of vaccine. For further information, see §97.67 of this title; and

(vi)

children subject to these requirements as described in §97.61 (relating to Children and Students Included in Requirements) must comply with the following requirement for hepatitis A vaccine if the facility, school or institution attended is located in any of the following counties: Brewster, Brooks, Cameron, Crockett, Culberson, Dimmitt, Duval, Edwards, El Paso, Frio, Hidalgo, Hudspeth, Jeff Davis, Jim Hogg, Kenedy, Kinney, La Salle, Maverick, McMullen, Pecos, Presidio, Real, Reeves, Starr, Sutton, Terrell, Uvalde, Val Verde, Webb, Willacy, Zapata, and Zavala. Serologic confirmation of immunity to hepatitis A or serologic evidence of infection is acceptable in lieu of vaccine. For further information, see §97.67 of this title. Doses of hepatitis A vaccine are required as follows:

(I)

children 2 years of age but not yet 3 years of age are required to show proof by 30 days past their second birthday of one dose of hepatitis A vaccine administered on or after their second birthday; and

(II)

children 3 years of age but not yet 5 years of age are required to have received two doses of hepatitis A vaccine administered on or after their second birthday.

(2)

Children and students five years of age or older.

(A)-(E)

(No change.)

(F)

Hepatitis B.

(i)

Effective August 1, 1998, children born on or after September 2, 1992, will be required to show proof of either:

(I)

[ (i) ] three doses of hepatitis B vaccine; or

(II)

[ (ii) ] serologic confirmation of immunity to hepatitis B or serologic evidence of infection. For further information see §97.67 of this title.

(ii)

Effective August 1, 1999, children born on or after September 2, 1987, but before September 2, 1992 will be required to show at the time of their 12th birthday, proof of either:

(I)

three doses of hepatitis B vaccine; or

(II)

serologic confirmation of immunity to hepatitis B or serologic evidence of infection. For further information see §97.67 of this title.

(G)

Varicella.

(i)

Effective August 1, 1999, children born on or after September 2, 1993, will be required to show proof of either:

(I)

one dose of varicella vaccine received on or after the first birthday; or

(II)

a parent- or physician-validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity. For further information, see §97.67 of this title.

(ii)

Effective August 1, 1999, children born on or after September 2, 1987, but before September 2, 1993, will be required to show at the time of their 12th birthday, proof of either:

(I)

one dose of varicella vaccine received on or after the first birthday; or

(II)

a parent- or physician-validated history of varicella illness (chickenpox) or serologic confirmation of varicella immunity. For further information, see §97.67 of this title.

(H)

Hepatitis A. Effective August 1, 1999, children subject to these requirements as described in §97.61 of this title must comply with the following requirement for hepatitis A vaccine if the facility, school or institution attended is located in any of the following counties: Brewster, Brooks, Cameron, Crockett, Culberson, Dimmitt, Duval, Edwards, El Paso, Frio, Hidalgo, Hudspeth, Jeff Davis, Jim Hogg, Kenedy, Kinney, La Salle, Maverick, McMullen, Pecos, Presidio, Real, Reeves, Starr, Sutton, Terrell, Uvalde, Val Verde, Webb, Willacy, Zapata, and Zavala. Serologic confirmation of immunity to hepatitis A or serologic evidence of infection is acceptable in lieu of vaccine. For further information, see §97.67 of this title. Children and students born on or after September 2, 1992, will be required to have received two doses of hepatitis A vaccine administered on or after their second birthday.

(3)

Students in institutions of higher education (colleges, universities, and other teaching facilities above the high school level).

(A)-(I)

(No change.)

(J)

Varicella. Beginning August 1, 1999, varicella vaccine is required of medical interns, residents, fellows, and students enrolled in health-related courses as defined in subparagraph (A) of this paragraph. One dose of vaccine is required for students who received this vaccine prior to 13 years of age; two doses are required for students who were not vaccinated before their thirteenth birthday. All doses of this vaccine must have been received on or after the first birthday. A history of varicella illness (chickenpox) validated by the student, the student's parent or the student's physician or serologic confirmation of varicella immunity is acceptable in lieu of vaccine. For further information, see §97.67 of this title.

§97.65.Pregnancy.

Requirements for polio, measles, rubella, [ and ] mumps , and varicella vaccines are waived during pregnancy. Pregnancy is not a medical contraindication for administration of tetanus/diphtheria toxoids.

§97.67.Verification of Immunity to Measles, Rubella, Mumps, [ or ] Hepatitis A, Hepatitis B[ . ] , or Varicella.

Section 97.63 of this title (relating to Required Immunizations) states that serologic confirmation of immunity to measles, rubella, mumps, hepatitis A, or hepatitis B are acceptable in lieu of vaccine against the serologically confirmed disease. If a child or student is unable to submit serological proof of immunity or serologic evidence of infection, then measles, rubella, mumps, or hepatitis B vaccine is required. Evidence of measles, rubella, mumps, or hepatitis B illnesses must consist of a laboratory report indicating confirmation of immunity or confirmation of infection. A copy of the report must be attached to the child's or student's immunization record, and the original should be returned to the child/student or the child's/student's parent or guardian. All histories of varicella illness must be supported by a written statement from a physician or the child's/student's parent or guardian containing wording such as: "This is to verify that (name of student) had varicella disease (chickenpox) on or about (date) and does not need varicella vaccine." or by serologic confirmation of varicella immunity. A copy of the statement or laboratory report must be attached to the child's/student's school immunization record and the original should be returned to the child/student or the child's/student's parent, or guardian. If a child or student is unable to submit such a statement or serologic evidence, varicella vaccine is required.

§97.74.Transfer of Records.

When a student transfers from one school or district to another, a copy of the immunization record, [ any measles or mumps illness statements from physicians, ] any laboratory reports or statement of prior illness accepted in lieu of vaccination as described in §97.67 of this title (relating to Verification of Immunity to Measles, Rubella, Mumps, Hepatitis A, Hepatitis B, or Varicella), any affidavits or statements of medical contraindications, any statements for religious exemption, and laboratory reports of immunity should be sent within 30 days to the receiving school. A record received from school officials of another district or state may be considered a validated record. Each school or institution of higher education shall cooperate in transferring students' immunization records between other schools and institutions of higher education. Specific approval from students, parents, or guardians is not required prior to making such record transfers.

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900203

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236


Chapter 229. Food and Drug

Subchapter X. Regulations to Set Standards for the Formulation, Sale and Distribution of Dietary Supplements Containing Ephedrine from Natural Ephedra Alkaloids and to Restrict the Sale and Distribution of Certain Drug Products Containing Ephedrine

25 TAC §§229.461-229.464

The Texas Department of Health (department) proposes new §§229.461 - 229.464, concerning the regulations to set standards for the formulation, sale and distribution of dietary supplements containing ephedrine from natural ephedra alkaloids and to restrict the sale and distribution of certain drug products containing ephedrine. Specifically, the sections cover standards for the formulation, sale, and distribution of dietary supplements containing ephedrine from natural ephedra alkaloids, product labels for dietary supplements containing ephedrine from natural ephedra alkaloids, advertising and promotional literature for dietary supplements containing ephedrine from natural ephedra alkaloids, and restrict the sale and distribution of certain drug products containing ephedrine. The proposed rules would assist consumers with understanding the possible side effects of taking dietary supplements containing ephedrine from natural ephedra alkaloids and would require over-the-counter drugs to follow specific formulations or to be available by prescription only.

Joseph L. Fuller, Associate Commissioner for Environmental and Consumer Health has determined that for the first five-year-period the sections are in effect there will be fiscal implications as a result of administering the sections as proposed. The effect on state government will be approximately $50,000 per year for enforcement of the over-the-counter drug restrictions. There are no costs for local government as a result of enforcing or administering the sections as proposed.

Mr. Fuller has also determined that for each year of the first five years the sections are in effect the public benefit will be a decrease in injuries resulting from the use, abuse, and misuse of ephedrine-containing dietary supplements and over-the counter drugs. There will be an economic impact for new labeling and advertising requirements and to meet the requirements of the good manufacturing practices. The anticipated economic costs to persons or small businesses who are required to comply with the sections as proposed will be as a result of the restrictions on over- the-counter drugs. The costs for complying cannot be determined, as each over-the-counter drug company will have to decide whether to reformulate its product to meet the exemptions or to become a prescription drug. There will be no effect on local employment.

Comments on the proposal may be submitted to Mr. Joseph L. Fuller, Associate Commissioner, Environmental and Consumer Health, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7541. Comments will be accepted for 60 days after publication of this proposal in the Texas Register . In addition, a public hearing on the proposed sections will held at 9:00 a.m. in the Texas Department of Health Board Room, Room M-739, 1100 West 49th Street, Austin, Texas, on February 25, 1999.

The new sections are proposed under Health and Safety Code, §431.021, which prohibits the introduction or delivery into commerce of any food or drug that is adulterated and prohibits the dissemination of any false advertisement; and §12.001, which provide the Texas Board of Health with authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the commissioner of health.

The new sections affect Texas Health and Safety Code, Chapter 431.

§229.461.Regulations to Restrict the Sale and Distribution of Dietary Supplements Containing Ephedrine.

The sale or distribution of any dietary supplement containing ephedrine group alkaloids is prohibited unless the product complies with the following requirements:

(1)

each serving has no more than 25 milligrams of ephedrine group alkaloids (the total of ephedrine, pseudoephedrine, norpseudoephedrine, norephedrine, methyl ephedrine, methyl- pseudo-ephedrine, and related alkaloids);

(2)

the product contains no chemically synthesized ephedrine group alkaloids;

(3)

the recommended daily intake, which shall be specified on the product label, does not exceed 100 milligrams of ephedrine group alkaloids; and

(4)

all products shall be analyzed in accordance with the methodology utilized by the U. S. Food and Drug Administration to ensure that they contain no more than 25 milligrams of ephedrine group alkaloids per serving.

§229.462.Product Labels for Dietary Supplements Containing Ephedrine.

(a)

The product label must state: "This product has (insert amount in product) milligrams concentrated ephedrine group alkaloids per serving in the form of herbal extracts."

(b)

The product label must use standardized nomenclature for the ephedrine ingredient such that the terms "ephedrine," "pseudoephedrine" or other ephedrine group alkaloid name is used when referring to the active ingredients in place of or in addition to the botanical name of the ephedrine group alkaloid.

(c)

The product label must state the amount in milligrams of caffeine alkaloids and other ingredients per serving that have a known stimulant effect (eg. yohimbine).

(d)

The product label must include a warning statement for the consumption of ephedrine group alkaloids that is conspicuously displayed on the label information panel in distinct contrast to other printing or graphics, and must be at least 1/16 inch type.

(e)

The warning on the product label must contain at a minimum the following information:

(1)

WARNING: Not for use by individuals under the age of 18. Do not use if pregnant or nursing. Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI)or any other prescription drug or over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products).

(2)

Exceeding recommended serving may cause serious adverse health effects.

(3)

Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms occur.

(4)

Certain individuals who consume caffeine with this product may experience side effects.

(f)

The product label must include a toll-free number to permit consumers to contact the company responsible for the manufacture of the product.

(g)

All labeling, except that affixed to the product container, and all promotional literature must include the following warning: "This product" (optional: may use any specific reference to product) "has ephedrine group alkaloids in the form of herbal extracts" (optional: from ma huang or other named herb) "and may not be appropriate for everyone. Read the label and follow directions."

§229.463.Advertising and Promotional Literature for Dietary Supplements Containing Ephedrine.

(a)

All advertising and promotional literature must be reviewed and approved by the company responsible for the manufacture of the ephedrine containing dietary supplement product.

(b)

Companies that engage in direct marketing of ephedrine containing dietary supplement products shall incorporate into contracts with distributors, franchisees, and/or independent contractors the following conditions:

(1)

no claims about the product which have not been approved in writing by the company may be made;

(2)

no medical claims may be made;

(3)

distributors, franchisees, and/or independent contractors are required to direct consumers to read the product label prior to purchase or consumption;

(4)

distributors, franchisees, and/or independent contractors are required to advise consumers under the care of a physician or with a chronic condition to consult with a physician prior to purchase of the product; and

(5)

distributors, franchisees, and/or independent contractors shall refer any person who makes a complaint about side effects to a licensed health care practitioner.

(c)

Companies that engage in direct marketing of ephedrine containing dietary supplement products shall effectively respond to distributors, franchisees, and/or independent contractors to prevent the distribution of unauthorized literature.

(d)

Distributors, franchisees, and/or independent contractors shall be trained by companies that engage in direct marketing of ephedrine containing dietary supplement products to refer medical questions to a physician and will not be permitted to give medical advice.

(e)

No claims shall be made for the indication of alteration of consciousness, euphoria, as a "legal" alternative for an illicit drug, or for any use of the product as a drug for the diagnosis, cure, mitigation, treatment, or prevention of any disease. To determine compliance with this requirement, the Texas Department of Health (department) may consider the following factors:

(1)

the product packaging;

(2)

the name and container labeling of the product; and

(3)

advertising and promotional materials created by the company responsible for the manufacture or distribution of the product.

(f)

Any company distributing an ephedrine containing dietary supplement product in Texas shall submit the product label to the Texas Poison Center Coordinating Committee, c/o Chief, Bureau of Epidemiology, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

§229.464.Regulations to Restrict the Sale and Distribution of Certain Drug Products Containing Ephedrine.

(a)

Drug products containing single ingredient ephedrine, its salts, optical isomers or salts of optical isomers, are dangerous drugs as defined in the Health and Safety Code, Chapter 483, relating to Dangerous Drugs.

(b)

Drug products that contain pseudoephedrine are exempt from the designation as dangerous drugs if the drug product is labeled in accordance with the U. S. Food and Drug Administration's final monograph.

(c)

Any drug product containing ephedrine, its salts, optical isomers or salts of optical isomers shall not be sold, distributed, introduced into commerce, manufactured, produced, packaged, exposed, offered, possessed or held for sale, dispensed or given away in this state except as dispensed upon the prescription of a licensed practitioner.

(d)

The following formulations are exempt from the designation as dangerous drugs under subsection (a) of this section, and the dispensing restrictions under subsection (c) of this section:

(1)

solid dosage forms that combine active ingredients must be in the following ranges for each recommended dose: ephedrine, its salts, optical isomers or salts of optical isomers not to exceed 12.5 milligrams (mg) combined with at least 200 mg guiafenesin; ephedrine, its salts, optical isomers or salts of optical isomers not to exceed 25 mg combined with at least 400 mg guiafenesin;

(2)

liquid oral dosage forms that combine active ingredients in the following ranges for each 5 milliliter (ml) dose: dextromethorphan HBr (not more than 10 mg), chlorpheniramine maleate (not more than 2 mg), ephedrine HCl (not more than 5 mg), phenylephrine (not more than 5 mg), ammonium chloride (not more than 40 mg), ipecac fluidextract (not more than 0.005 ml);

(3)

anorectal preparations containing less than 5.0% ephedrine;

(4)

nasal decongestant preparations containing 0.5% or less ephedrine; and

(5)

any ephedrine-containing drug product that is marketed pursuant to an approved new drug application under the Federal Food, Drug, and Cosmetic Act.

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

Filed with the Office of the Secretary of State on January 14, 1999.

TRD-9900210

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: February 28, 1999

For further information, please call: (512) 458-7236