TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 229. FOOD AND DRUG

Subchapter Y. REGULATIONS TO SET STANDARDS FOR THE FORMULATION, SALE, AND DISTRIBUTION OF DIETARY SUPPLEMENTS CONTAINING EPHEDRINE FROM NATURAL EPHEDRA [ EPHIDRA ] ALKALOIDS AND TO RESTRICT THE SALE AND DISTRIBUTION OF CERTAIN DRUG PRODUCTS CONTAINING EPHEDRINE

25 TAC §229.462

The Texas Department of Health (department) proposes an amendment to §229.462 concerning product labels for dietary supplements containing ephedrine; including a labeling requirement to prohibit the sale of dietary supplements containing ephedrine to persons 17 years of age or younger.

Section 229.462(f) will be amended to list the toll-free number used for the U.S. Food and Drug Administration MedWatch medical products reporting program. The purpose of the toll-free number is to permit consumers to report adverse effects of ephedrine containing products. The number is 1-800-332-1088 and will be required on all product labels after September 1, 2001.

New §229.462(h), after January 1, 2001, will require a warning statement to be on the product label or as an auxiliary label such as a sticker permanently affixed to the product container prohibiting the sale of dietary supplements containing ephedrine to persons 17 years of age or younger. This labeling is required by Senate Bill 656, Acts of the 76th Legislature (1999) as codified in Health and Safety Code §431.022(c).

Cynthia Culmo, R.Ph., Director, Drugs and Medical Devices Division, Bureau of Food and Drug Safety, 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 enforcing or administering the section as proposed.

Ms. Culmo has also 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 the proposed section will be that consumers of dietary supplements containing ephedrine will have free access to an adverse event reporting system. This system will aid regulators in tracking possible trends in product and consumer safety. Other benefits are that persons 17 years of age or younger will no longer have access to products that have been shown to be abused in a younger population. There are anticipated economic costs to persons or micro businesses or small businesses who are required to comply with the amendments as proposed. The effect on micro businesses or small businesses will be the requirement to relabel or add labeling to products that are currently marketed over-the-counter. The anticipated cost to persons or micro businesses or small businesses which are required to comply with the sections as proposed cannot be accurately estimated since the number of manufacturers, distributors and unit sales are not known. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Karen Tannert, R.Ph., Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, (512) 719-0237. Comments will be accepted for 60 days following publication of the proposal in the Texas Register . A public hearing to receive comments on this rule will be held on Wednesday, February 23, 2000, at 9:00 am in the Board Room, M739, Moreton Building, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756.

The amendment is proposed under Health and Safety Code, §431.241, which provides the department with the authority to adopt rules for the efficient enforcement of Chapter 431, the Texas Food, Drug, and Cosmetic Act; and §12.001, which provide the Texas Board of Health with the 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 amendment affects Health and Safety Code, Chapter 431.

§229.462.Product Labels for Dietary Supplements Containing Ephedrine.

(a)-(e)

(No change.)

(f)

After September 1, 2001, the [ The ] product label must include a toll-free number to permit consumers to report adverse effects [ to the department within 60 days of the date such number is published in the Texas Register ]. This toll-free number shall be 1-800-332-1088, which is the Food and Drug Administration's MedWatch medical product reporting program.

(g)

All labeling, except that affixed to the product container, all prerecorded or scripted radio and television advertising, 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 cause serious adverse health effects.[ " ] Read the label and follow directions."

(h)

After January 1, 2001, the product label must include a warning statement that indicates the sale to persons 17 years of age or younger is prohibited. This warning statement must be conspicuously displayed on the product label information panel or as an auxiliary label such as a sticker permanently affixed to the product container in distinct contrast to other printing or graphics, and must be at least 1/16 inch type.

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 18, 2000.

TRD-200000320

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: March 5, 2000

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


Part 2. TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION

Chapter 414. PROTECTION OF CONSUMERS AND CONSUMER RIGHTS

Subchapter A. CLIENT-IDENTIFYING INFORMATION

25 TAC §§414.3, 414.4, 414.7, 414.10, 414.11, 414.16

The Texas Department of Mental Health and Mental Retardation (TDMHMR) proposes amendments to §§414.3, 414.4, 414.7, 414.10, 414.11, and 414.16 of Chapter 414, Subchapter A, concerning client-identifying information.

The amendments would implement the provisions of the Texas Family Code, §153.3721 (added by the 76th Legislature, House Bill 2455), which provides a joint conservator the right to access the medical records of the child; the Texas Health and Safety Code, §614.017 (amended by the 76th Legislature, House Bill 3256), which defines "special needs offender" and describes the entities that may exchange client-identifying information of special needs offenders without consent for disclosure; the Texas Code of Criminal Procedure, §46.04 (added by the 76th Legislature, House Bill 245), which states that a person who files a motion under the article waives confidentiality of all mental health and medical records relevant to the person's competency; the Texas Insurance Code, Article 21.58A (amended by the 76th Legislature, Senate Bill 569), which restricts a utilization review agent from receiving or reviewing a professional's process or progress notes; the Texas Health and Safety Code, §611.004 (amended by the 76th Legislature, Senate Bill 1217), which clarifies to whom and for what purpose a professional may disclose confidential information relating a person detained in a correctional facility; and the Texas Health and Safety Code, §574.083 (amended by the 76th Legislature, Senate Bill 358), which allows the release of confidential information to law enforcement that relates to a court-committed client who is absent from a mental health facility.

Bill Campbell, Chief Financial Officer, has determined that for each year of the first five years the proposed amendments are in effect, enforcing or administering the rules does not have foreseeable implications relating to cost or revenue of the state or local governments because the proposed amendments do not include requirements that relate to cost or revenue of the state or local governments.

Karen Hale, Commissioner, has determined that, for each year of the first five years the proposed amendments are in effect, the public benefit expected is the compilation of relevant state and federal regulations regarding the disclosure of client-identifying information. The subchapter is organized and written so that its content is useful, understandable, and relevant to those who must comply with the regulations as well as to those who are the subject of the identifying information. It is anticipated that there would be no economic cost to persons required to comply with the proposed amendments because they do not impose economic requirements on such persons.

It is anticipated that the proposed amendments will not affect a local economy because the amendments do not include requirements that relate to a local economy.

It is anticipated that the proposed amendments will not have an adverse economic effect on small businesses or micro-businesses because the amendments do not include requirements that would economically affect small businesses or micro-businesses.

Written comments on the proposal may be sent to Linda Logan, director, Policy Development, Texas Department of Mental Health and Mental Retardation, P.O. Box 12668, Austin, Texas, 78711-2668, within 30 days of publication.

The amendments are proposed under the Texas Health and Safety Code, §532.015, which provides the Texas Board of Mental Health and Mental Retardation (board) with broad rulemaking authority; the Texas Health and Safety Code, §576.005, which mandates the confidentiality of records of a mental health facility that directly or indirectly identify a present, former, or proposed patient; and the Texas Health and Safety Code, §595.002, which requires the board to adopt rules that it considers necessary to facilitate compliance with Chapter 595.

The amendments would affect the Texas Health and Safety Code, §532.015, §576.005, and §595.002.

§414.3.Definitions.

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

(1)-(11)

(No change.)

(12)

Legally authorized representative--A legally authorized representative means:

(A)

a parent , [ or ] legal guardian , or conservator if the client is a minor, or a legal guardian if the client has been adjudicated incompetent to manage the client's personal affairs;

(B)

an agent of the patient authorized under the Advance Directives Act, Texas Health and Safety Code, Chapter 166 [ a durable power of attorney for health care ];

(C)-(E)

(No change.)

(13)-(16)

(No change.)

(17)

Special needs offender-- An individual for whom criminal charges are pending or who after conviction or adjudication is in custody or under any form of criminal justice supervision. [ A special needs offender is: ]

[(A)

a convicted felon with mental illness or mental retardation; or]

[(B)

an individual with mental illness or mental retardation placed on community supervision after a grant of deferred adjudication.]

(18)-(20)

(No change.)

§414.4.Statutes and Federal Regulations Governing Disclosure.

(a)

State statutory provisions governing disclosure of client-identifying information concerning clients receiving mental health and mental retardation services are contained primarily in §576.005 and Chapter 611 of the Texas Health and Safety Code.

(b)

(No change.)

(c)

Texas Human Resources Code, Chapter 48 [ §48.0385 ], establishes authority for the Texas Department of Protective and Regulatory Services (TDPRS) to have access to client records necessary to conduct investigations into allegations of abuse and neglect of persons served.

(d)-(h)

(No change.)

(i)

The Texas Code of Criminal Procedure, Article 46.04(j), waives confidentiality of all client-identifying information of a person challenging his or her competency under Article 46.04.

§414.7.When Consent for Disclosure is not Required: Clients Receiving MHMR Services.

(a)-(b)

(No change.)

(c)

When required in other than court proceedings. Client-identifying information may be disclosed without consent:

(1)-(3)

(No change.)

(4)

to persons, corporations, or governmental agencies involved in the paying or collecting of fees for mental or emotional health services provided by a professional . However, pursuant to the Texas Insurance Code, Article 21.58A(o), a utilization review agent may not receive or review a professional's process or progress notes ;

(5)-(11)

(No change.)

(12)

to designated persons or personnel of a correctional facility [ health care personnel of a penal or other custodial institution ] in which the client is detained if the disclosure is for the sole purpose of providing treatment and health care to the client in custody .

(d)

When used between facilities, local authorities , community centers , and contract providers. Client-identifying information may be disclosed without consent when it is used between department facilities, local authorities , community centers , and contract providers only if

(1)-(3)

(No change.)

(e)

(No change.)

(f)

When used for continuity of care of special needs offenders. In accordance with the Texas Health and Safety Code, §614.017, to provide continuity of care for a special needs offender (as defined), client-identifying information (i.e., identity ; [ , ] needs ; [ , ] treatment ; [ , ] social, criminal and vocational history ; [ , ] supervision status and compliance with conditions of supervision; and medical and mental health history) concerning the offender may be disclosed and received without consent among the following entities [ agencies, or a division within the following agencies, ] or a person with an agency relationship with one of the following entities [ a following agency, ] or a person who contracts with one or more of the following entities [ a following agency ]:

(1)

the institutional division of the Texas Department of Criminal Justice;

(2)

the pardons and paroles division of the Texas Department of Criminal Justice;

(3)

the community justice assistance division of the Texas Department of Criminal Justice;

(4)

the state jail division of the Texas Department of Criminal Justice;

(5)

the Texas Department of Mental Health and Mental Retardation;

(6)

the Texas Juvenile Probation Commission;

(7)

the Texas Youth Commission;

(8)

the Texas Rehabilitation Commission;

(9)

the Texas Education Agency;

(10)

the Criminal Justice Policy Council;

(11)

the Texas Commission on Alcohol and Drug Abuse;

(12)

the Commission on Jail Standards;

(13)

the Texas Department of Human Services;

(14)

the Texas Department on Aging;

(15)

the Texas School for the Blind and Visually Impaired;

(16)

the Texas Department of Health;

(17)

the Texas Commission for the Deaf and Hard of Hearing;

(18)

community supervision and corrections departments;

(19)

personal bond pretrial release offices established under Article 17.42, Code of Criminal Procedure;

(20)

local jails regulated by the Commission on Jail Standards; and

(21)

the office of the Texas Council on Offenders with Mental Impairments.

[(1)

Texas Department of Criminal Justice and its divisions, which are:]

[(A)

Community Justice Assistance Division;]

[(B)

Parole Division;]

[(C)

Institutional Division;]

[(D)

State Jail Division; and]

[(E)

the office of the Texas Council on Offenders with Mental Impairments;]

[(2)

a community supervision and corrections department;]

[(3)

Texas Department of Human Services;]

[(4)

Texas Department on Aging;]

[(5)

Texas Rehabilitation Commission;]

[(6)

Texas Department of Health;]

[(7)

Texas Commission for the Blind;]

[(8)

Texas Commission for the Deaf and Hard of Hearing;

[(9)

Texas Department of Mental Health and Mental Retardation; and]

[(10)

a local authority.]

(g)

When used to assist law enforcement in the return of a court-committed client who is absent from a mental health facility (as defined in the Texas Health and Safety Code, §571.003) or a facility. The facility administrator may release to a law enforcement official information about the client if the administrator determines that the information is needed to facilitate the return of the client to the mental health facility or the facility.

§414.10.Who Can Give Consent for Disclosure: Clients Receiving MHMR Services.

(a)

(No change.)

(b)

Minor clients.

(1)

If the client is a minor receiving mental retardation services, then the client does not have the capacity to consent to disclosure of client-identifying information. Only a parent, guardian of the person, managing conservator, joint managing conservator, or possessory conservator of the minor client can authorize and consent to disclosure of client-identifying information to any third party other than an attorney representing the client.

(2)

If the client is a minor under 16 years of age receiving mental health services, then the client does not have the capacity to consent to disclosure of client-identifying information. Only a parent, guardian of the person, managing conservator, joint managing conservator, or possessory conservator of the minor client can authorize and consent to disclosure of client-identifying information to a third party other than an attorney representing the client.

(3)

If the client is a competent minor at least 16 years of age but under 18 years of age receiving voluntary mental health services, then the client can unilaterally authorize and consent to disclosure of client-identifying information. The parent, managing conservator, joint managing conservator, or possessory conservator of such a minor client also can unilaterally authorize and consent to disclosure of client-identifying information.

(4)

If the client is a minor at least 16 years of age but under 18 years of age receiving court-ordered mental health services, then only a parent, guardian of the person, managing conservator, joint managing conservator, or possessory conservator can authorize and consent to disclosure of client-identifying information to a third party other than an attorney ad litem representing the client.

(5)

A joint managing conservator or possessory conservator has the right of access to medical, dental, and educational records of a minor to the same extent as the managing conservator. However, before releasing records to the [ possessory ] conservator, all references in the records to the place of residence of the managing conservator must be deleted.

(c)

(No change.)

§414.11.Who Can Give Consent for Disclosure: Clients Receiving Chemical Dependency Services.

(a)

(No change.)

(b)

Minor clients.

(1)-(2)

(No change.)

(3)

A joint managing conservator or possessory conservator has the right of access to medical, dental, and educational records of a minor to the same extent as the managing conservator. However, before releasing records to the [ possessory ] conservator, all references in the records to the place of residence of the managing conservator must be deleted.

(c)

(No change.)

§414.16.References.

Reference is made to the following state and federal statutes and rules of the department:

(1)

Texas Health and Safety Code, Chapters 166, 462, 574, 593, 595, 597, 611, and 614; §576.005; §595.005(c); §242.002(6); and §614.017;

(2)

Texas Human Resources Code, Chapter 48 [ §48.0385 ];

(3)-(5)

(No change.)

(6)

Code of Criminal Procedure, Article 42.12, Section 9 , and 46.04 ;

(7)-(9)

(No change.)

(10)

Texas Family Code, Chapter 264; [ and ]

(11)

Texas Rules of Civil Evidence, Rule 510(d) ; and

(12)

Texas Insurance Code, Article 21.58A(o).

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 21, 2000.

TRD-200000400

Charles Cooper

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Earliest possible date of adoption: March 5, 2000

For further information, please call: (512) 206-5216