Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 97.
COMMUNICABLE DISEASES
Subchapter I. IMMUNIZATION REQUIREMENTS FOR RESIDENTS OF TEXAS NURSING HOMES
25 TAC §97.201, §97.202
The Executive Commissioner of the Health and Human Services
Commission (commission), on behalf of the Department of State Health Services
(department), adopts amendments to §97.201 and §97.202, concerning
the immunizations nursing homes are required to offer in accordance with the
most recent recommendations of the Advisory Committee on Immunization Practices
(ACIP) and the requirement to document the receipt or refusal of the vaccinations,
without changes to the proposed text as published in the March 3, 2006, issue
of the
Texas Register
(31 TexReg 1409) and,
therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The amendments provide the ACIP recommendations as an immunization reference
for nursing homes, clarify language, and expand the mandatory time to provide
influenza vaccine for employees hired or residents admitted after November
30 of each year from "through February of each year" to "through March of
each year". This change will make these rules consistent with proposed Centers
for Medicare and Medicaid Services (CMS) nursing homes regulations and is
also in accordance with the most recent recommendation of the ACIP.
The department consulted with the Department of Aging and Disability Services,
CMS, Department of State Health Services Division for Regulatory Services,
ARC of Texas, Texas Association of Residential Care Communities, Texas Health
Care Association, Texas Organization of Residential Care Homes, Texas Advocates
for Nursing Homes, and the Texas Association of Area Agencies on Aging during
the rule process.
Government Code, §2001.039, 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 97.201
and 97.202 have been reviewed and the department has determined that reasons
for adopting the sections continue to exist because rules on this subject
are needed.
SECTION-BY-SECTION SUMMARY
A grammatical change was made to the amendment to §97.201, replacing
"which serve" with "serving". The amendment to §97.202 provides the ACIP
recommendations as an immunization reference for nursing homes, and expands
the mandatory time to provide influenza vaccine for employees hired or residents
admitted after November 30 of each year from "through February of each year"
to "through March of each year".
COMMENTS
The department, on behalf of the commission, did not receive any comments
regarding the proposed rules during the comment period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The amendments are authorized under Health and Safety Code, §81.021,
which requires the department to develop immunization requirements; and Government
Code, §531.0055, and Health and Safety Code, §1001.075, which authorize
the Executive Commissioner of the Health and Human Services Commission to
adopt rules and policies necessary for the operation and provision of health
and human services by the department and for the administration of Health
and Safety Code, Chapter 1001. The review of the rules implements Government
Code, §2001.039.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 30, 2006.
TRD-200602940
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 19, 2006
Proposal publication date: March 3, 2006
For further information, please call: (512) 458-7111 x6972
Subchapter B. LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE
25 TAC §§230.11 - 230.16
The Executive Commissioner of the Health and Human Services
Commission (commission), on behalf of the Department of State Health Services
(department), adopts new §§230.11 - 230.16, concerning limitations
on sales of products containing ephedrine, pseudoephedrine, and norpseudoephedrine.
New §230.11 and §230.15 are adopted with changes to the proposed
text as published in the February 24, 2006, issue of the
Texas Register
(31 TexReg 1170). New §§230.12 - 230.14, and
230.16 are adopted without changes to the proposed text and, therefore, will
not be republished.
BACKGROUND AND PURPOSE
The new sections are necessary to comply with Health and Safety Code (HSC),
Chapter 486, relating to the over-the-counter sales of ephedrine, pseudoephedrine,
and norpseudoephedrine. The new chapter requires the department to adopt rules
to implement and enforce the chapter. Under the chapter, any business establishment
(other than a pharmacy licensed by the Board of Pharmacy) that wishes to engage
in over-the-counter sales of products containing any quantity of ephedrine,
pseudoephedrine, or norpseudoephedrine must have a certificate of authority
(COA) from the department. In order to obtain a COA, a business must file
an application with the department; pay the required fee; and agree to comply
with the restrictions to access and record keeping requirements of these sections.
Compliance with these sections will be verified through audits and inspections.
SECTION-BY-SECTION SUMMARY
The name of Title 25, Texas Administrative Code, Chapter 230, was amended
to reflect the addition of new Subchapter B concerning the limitations on
sales of products containing ephedrine, pseudoephedrine, and norpseudoephedrine.
New §§230.11 - 230.16 set out the rules that limit the over-the-counter
sales of these regulated products. Section 230.11 defines the purpose and
definitions used in the rules. Section 230.12 sets out exemptions from obtaining
a certificate of authority (COA). Sections 230.13 and 230.14 explain the requirements
for a COA to engage in over-the-counter sales of these products, and provide
the minimum standards required to obtain and maintain the COA. Section 230.15
identifies the records that must be maintained for each transaction involving
the sale of these regulated products. Section 230.16 establishes the enforcement
actions that can be taken to ensure compliance with the rules.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed new rules during
the comment period, which the commission has reviewed and accepts. The department's
responses to the comments are discussed in the summary of comments.
Concerning proposed new §230.15(a)(2), a comment was submitted by
the National Association of Chain Drug Stores. The commenter was generally
in favor of the new rules but expressed concerns and made recommendations.
Comment: Concerning proposed new §230.15(a)(2), the commenter expressed
concern that requiring sales associates to record the Universal Product Code
(UPC) or Store Keeping Unit (SKU) would be an unnecessary and burdensome recordkeeping
requirement and alternatively suggested that sales associates should be required
to record the name of the product.
Response: The commission agrees with the comment and has revised the language
in §230.15(a)(2) and (3) accordingly.
The department staff on behalf of the commission provided comments and
the commission has reviewed and agrees to the following changes that will
result in clarification regarding any federal requirements that may apply
to persons selling pseudoephedrine, ephedrine, and phenylpropanolamine products.
In addition, the changes will result in clarification of the acceptable forms
of personal identification required to purchase these products.
Change: Concerning proposed new §230.11, relating to General Provisions,
clarifying language was added in new subsection (c) to reflect that persons
who sell or distribute ephedrine, pseudoephedrine, norpseudoephedrine or phenylpropanolamine
may be subject to additional federal statutes and regulations.
Change: Concerning proposed new §230.15(a)(1)(A), relating to Records,
a reference to "government" identification was removed in order to clarify
that other acceptable forms of personal identification are allowed for under
Health and Safety Code, Chapter 486.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The adopted new sections are authorized by Health and Safety Code, §12.0111,
which requires the department to charge fees for issuing or renewing a license; §12.0112,
which requires the term of each license issued to be two years; Health and
Safety Code, §486.003, which authorizes adoption of rules necessary for
the implementation and enforcement of Chapter 486; and Health and Safety Code, §486.004,
which requires that the department collect fees pertaining to the application
and issuance of the certificate of authority and enforcement of Chapter 486,
and the rules adopted under that chapter; and Government Code, §531.0055,
and Health and Safety Code, §1001.075, which authorizes the Executive
Commissioner of the Health and Human Services Commission to adopt rules and
policies necessary for the operation and provision of health and human services
by the department and for the administration of Health and Safety Code, Chapter
1001.
§230.11.General Provisions.
(a)
Purpose and applicability. The purpose of these sections
is to implement the duties of the Department of State Health Services (department)
under the Health and Safety Code (HSC), Chapter 486, relating to over-the-counter
sales of ephedrine, pseudoephedrine, and norpseudoephedrine.
(b)
Definitions. The following words and terms, when used in
this subchapter, shall have the following meanings, unless the context clearly
indicates otherwise. Unless otherwise specified, the terms have the meaning
assigned by HSC, Chapters 481 and 486, or their common use meaning.
(1)
Business establishment--A retail distributor such as a
grocery store; general merchandise store; drug store; or other entity or person,
other than a licensed pharmacy, that engages in direct sales to end-user consumers.
A distributor who engages in greater than 5% of gross annual sales of regulated
products to other than end-user consumers must obtain a license as a wholesaler
under HSC, Chapter 431, Subchapter I or Subchapter N.
(2)
Department--The Department of State Health Services.
(3)
Certificate of authority (COA)--A grant of authority to
engage in over-the-counter sales of regulated products, issued by the department
to a person under this subchapter.
(4)
Certificate of authority holder (COA holder)--A person
that has been issued a certificate of authority by the department to engage
in over-the-counter sales of regulated products.
(5)
Pharmacy--A person holding a current license to operate
a pharmacy issued by the Texas State Board of Pharmacy (Board of Pharmacy)
under Occupations Code, Chapter 560.
(6)
Record of sale--The paper or electronic documentation prepared
and maintained in compliance with §230.15 of this title (relating to
Records).
(7)
Regulated products--Any compound, mixture, or preparation
containing any detectable amount of ephedrine, pseudoephedrine, or norpseudoephedrine,
including its salts, optical isomers, and salts of optical isomers. The term
does not include any compound, mixture, or preparation that is in liquid,
liquid capsule, or liquid gel capsule form. A list of regulated products,
by name and universal product code (UPC) or stock-keeping unit (SKU) identifiers,
may be obtained from the Department of State Health Services, 1100 West 49th,
Austin, Texas 78756.
(8)
Over-the-counter sale--The sale of not more than two packages
or six grams of regulated products, in a single transaction to an individual.
(c)
Persons who sell or distribute ephedrine, pseudoephedrine,
norpseudoephedrine or phenylpropanolamine may be subject to additional federal
statutes and regulations adopted thereunder.
§230.15.Records.
(a)
Before completing a sale of a regulated product, an employee
with authority to access regulated products must:
(1)
require the person making the purchase to:
(A)
display a driver's license or other form of identification
containing the person's photograph and indicating that the person is 16 years
of age or older; and
(B)
sign for the purchase;
(2)
make a record of the sale, using a format approved or provided
by the department for this purpose, that includes the name of the person making
the purchase, the date of the purchase, the product name for the item purchased,
and the number of grams purchased; and
(3)
take reasonable measures to limit single sales transactions
to:
(A)
two packages of a regulated product; or
(B)
no more than 6 grams of ephedrine, pseudoephedrine, or
norpseuodoephedrine base.
(b)
The COA holder must maintain these records at the business
establishment for a minimum of two years from the date the record is made.
(c)
The COA holder must make the records available to the agent(s)
of the Department of State Health Services or the Department of Public Safety
upon request.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 30, 2006.
TRD-200602939
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: June 19, 2006
Proposal publication date: February 24, 2006
For further information, please call: (512) 458-7111 x6972
Chapter 801.
PROCEDURES AND BYLAWS
The Texas Council on Alzheimer's Disease and Related Disorders (council)
adopts the repeal of §§801.1 - 801.4 and new §801.1, concerning
the conduct of its meetings. New §801.1 is adopted with changes to the
proposed text as published in the March 3, 2006, issue of the
Texas Register
(31 TexReg 1415). The repealed §§801.1 - 801.4
are adopted without changes and, therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The repeals and new section are necessary to comply with the Health and
Safety Code, Chapter 101, §101.006, which requires the council to adopt
rules for the conduct of its meetings.
Government Code, §2001.039, 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 801.1
- 801.4 have been reviewed and the council has determined that reasons for
adopting the sections continue to exist because rules on this subject are
needed, and the restructuring of the rules better defines the Council's organization.
SECTION-BY-SECTION SUMMARY
In accordance with Health and Safety Code, Chapter 101, the repeal of §§801.1
- 801.4 and new §801.1 documents in the rules previously defined "procedures"
as "by-laws". The reorganization of the rules provides improved clarity in
redefining the council's officers and their duties, meetings, quorums, and
its voting membership.
COMMENTS
The council did not receive any comments regarding the proposed rules during
the comment period, but due to staff comments is making the following changes.
Change: Concerning §801.1(a), the phrase "by the" was added following
Chapter 101 for further clarification.
Change: Concerning §801.1(c)(6), the phrase "appointed by the Governor,
Lieutenant Governor and Speaker of the House" was added to the second sentence
in the paragraph concerning member appointment.
25 TAC §§801.1 - 801.4
STATUTORY AUTHORITY
The repeals are authorized by Health and Safety Code, Chapter 101, §101.006,
which requires the council to adopt rules for the conduct of its meetings.
Review of the sections implements Government Code, §2001.039.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 5, 2006.
TRD-200603036
Debbie Hanna
Chair
Texas Council on Alzheimer's Disease and Related Disorders
Effective date: June 25, 2006
Proposal publication date: March 3, 2006
For further information, please call: (512) 458-7111, x6972
Chapter 230.
SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS
Part 12.
TEXAS COUNCIL ON ALZHEIMER'S DISEASE AND RELATED DISORDERS
Chapter 801.
PROCEDURES