25 TAC §§229.172, 229.176, 229.177
New §229.172 is proposed under the Health and Safety
Code, §438.042, which requires the department to adopt necessary regulations
pursuant to the enforcement of Chapter 438; and §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. New §229.176 is proposed under the Health
and Safety Code, §438.102, which requires the department to adopt necessary
regulations pursuant to the enforcement of Chapter 438; and §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. New §229.177 is proposed under the Health
and Safety Code, §437.0076, which provides the department with the statutory
authority to adopt necessary regulations pursuant to the enforcement of Chapter
437; and §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.
New §229.172 affects the Health and Safety Code, Chapters 438, and
12; and implements the Government Code §2001.039, as passed by the 76th
Legislature. The proposed new §229.176 affects the Health and Safety
Code, Chapter 438, and Chapter 12; and the proposed new §229.177 affects
the Health and Safety Code, Chapter 437, and Chapter 12.
§229.172.Accreditation of Certified Food Management Programs.
(a)
Purpose. This section is intended to provide the framework
for accrediting manager level food safety programs in accordance with the
Texas Health and Safety Code (HSC), Chapter 438, Subchapter D. A uniform standard
governing the accreditation of food safety programs enhances the recognition
of reciprocity among regulatory agencies and reduces the expense of duplicate
education incurred when food establishment managers work in multiple regulatory
jurisdictions. Education of the food establishment manager provides more qualified
personnel, thereby reducing the risk of foodborne illness outbreaks caused
by improper food preparation and handling techniques.
(b)
Definitions. The following words and terms when used in
this section shall have the following meanings unless the context clearly
indicates otherwise.
(1)
Accredited -- A program approved by the department that
meets the standards set forth in this section.
(2)
Alternative training methods - Training other than classroom,
including but not limited to distance learning, comp-uterized training programs,
and correspondence courses.
(3)
Certificate -- The documentation issued by the department
or an organization that administers a department approved examination verifying
that an individual has complied with the requirements of this section.
(4)
Certification -- The process whereby a certificate is issued.
(5)
Certified food manager -- A person who has demonstrated
that they have the knowledge, skills and abilities required to protect the
public from foodborne illness by means of successfully completing a food safety
examination as described in this section.
(6)
Certified food management program -- A program accredited
by the department that provides food safety education for food establishment
managers and administers an approved examination for certification or recertification
purposes.
(A)
Certification program -- A program whose course work consists
of a minimum of 14 hours of instruction on food safety topics which may include
traditional or alternative methods of training, including distance education,
and at least a one-hour proctored department approved examination.
(B)
Recertification program -- A program whose course work
consists of six hours of instruction on food safety topics, which may include
traditional or alternative methods of training, including distance education,
and a department approved proctored examination.
(7)
Certified food management program instructor -- An individual
whose educational background and work experience meet the requirements for
approval as a certified food management instructor as described in this section.
(8)
Certified food management program licensee -- The individual,
corporation or company that is licensed by the department to operate certified
food management programs.
(9)
Certified food management program sponsor -- An individual
designated in writing to the department, by the licensee, as the person responsible
for administrative management of the program.
(10)
Conference for Food Protection -- An independent national
voluntary nonprofit organization to promote food safety and consumer protection.
(11)
Continuing education -- Documented professional education
or activities that provide for the continued proficiency of a certified food
management program instructor.
(12)
Department -- The Texas Department of Health.
(13)
Examination administrator -- An individual or individuals
who are designated in writing to the department, by the licensee, who is responsible
for administering food manager certification examinations.
(14)
Food -- A raw, cooked, or processed edible substance,
ice, beverage or ingredient used or intended for use or for sale in whole
or in part for human consumption, or chewing gum.
(15)
Food establishment -- An operation that stores, prepares,
packages, serves, or otherwise provides food for human consumption such as:
a food service establishment; retail food store; satellite or catered feeding
location; catering operation, if the operation provides food directly to a
consumer or to a conveyance used to transport people; market; remote catered
operations; conveyance used to transport people; institution or food bank
that relinquishes possession of food to a consumer directly or indirectly
through a delivery service such as home delivery of grocery orders or restaurant
takeout orders, or delivery service that is provided by common carriers.
(A)
The term includes: an element of the operation such as
a transportation vehicle or a central preparation facility that supplies a
vending location or satellite feeding location, unless the vending or feeding
location is permitted by the regulatory authority; a restaurant; a grocery
store; an operation that is conducted in a mobile, roadside, stationary, temporary,
or permanent facility or location; group residence; outfitter operations;
bed and breakfast extended and bed and breakfast food establishments where
consumption is on or of the premises; and regardless of whether there is a
charge for the food.
(B)
The term does not include: an establishment that offers
only prepackaged foods that are not potentially hazardous; a produce stand
that only offers whole, uncut fresh fruits and vegetables; a food processing
plant; a kitchen in a private home if only food that is not potentially hazardous
is prepared for sale or service at a function, such as a religious or charitable
organization's bake sale; a bed and breakfast limited facility as defined
in §229.162(4)(A) of this title; or a private home.
(16)
Law -- Applicable local, state and federal statutes, regulations
and ordinances.
(17)
Person -- An association, corporation, individual, partnership
or other legal entity, government or governmental subdivision or agency.
(18)
Proctor -- The examination administrator or a person who
is designated to assist the examination administrator.
(19)
Psychometric -- Scientific measurement or quantification
of human qualities, traits or behaviors.
(20)
Reciprocity -- Acceptance by state and local regulatory
authorities of a Department approved food manager certificate.
(21)
Regulatory authority -- The state or local enforcement
body or authorized representative having jurisdiction over the food establishment.
(22)
Secure -- Access limited to the certified food manager
licensee or examination administrator.
(23)
Single entity -- A corporation that educates only its
own employees.
(24)
Traceable means -- A method of mailing documents, which
can be tracked in the event of loss or delay.
(c)
Certified food manager.
(1)
Certified food manager responsibilities. Responsibilities
of a certified food manager include:
(A)
identifying hazards in the day-to-day operation of a food
establishment that provides food for human consumption;
(B)
developing or implementing specific policies, procedures
or standards aimed at preventing foodborne illness;
(C)
coordinating training, supervising or directing food preparation
activities, and taking corrective action as needed to protect the health of
the consumer;
(D)
training the food establishment employees on the principles
of food safety; and
(E)
conducting in-house self-inspections of daily operations
on a periodic basis to ensure that policies and procedures concerning food
safety are being followed.
(2)
Certification by training and food safety examination.
To be certified, a food manager must complete an accredited certification
or recertification program and pass an examination that has been administered
through a department accredited food management program.
(3)
Certificate reciprocity. Department issued food management
certificates shall be recognized statewide by regulatory authorities as the
only valid proof of successful completion of a department accredited food
management course.
(4)
Certificate availability. The original food manager certificate
shall be conspicuously posted at each food establishment.
(d)
Licensing of certified food management program licensee.
The department shall issue a license of accreditation to each certified food
management program licensee who has demonstrated compliance with this section.
A license issued under these rules will expire one year from the date of issuance.
This license is not transferable on change of ownership, or site location.
(1)
Application. A person wishing to apply for a certification
or recertification certified food management program license shall submit
an application to the department.
(2)
Certified food management program license fee. The license
application shall include the appropriate non-refundable fee.
(3)
Examination security agreement. The licensee shall submit
a signed security agreement for each examination administrator using a department
examination.
(4)
Certified food management program sponsor. The licensee
may designate a program sponsor as the person responsible for the administrative
management of the program.
(5)
Certified food management program instructor. A list of
all department certified food management program instructors who plan to teach
an accredited certification or recertification course shall be provided to
the department. An instructor application, along with other necessary documentation
must be submitted for all non-certified instructors.
(6)
Training methods. Training methods shall be designated
on the application. Documentation must be provided to the department verifying
that the time required to complete an alternative training program is equivalent
to 14 hours of training for certification and six hours for recertification.
(7)
Certification examination. Department approved examination(s)
utilized by the certified food protection management programs shall be designated
on the application.
(e)
Licensing of single entity certified food management programs.
In addition to the licensing requirements as specified in subsection (d) of
this section, a corporation wishing to use a single entity option, which defers
course length and topic requirements as specified HSC, §438.043(a), shall
submit to the department:
(1)
a copy of the course guide; and
(2)
an outline of each topic and sub-topics.
(f)
Responsibilities of a certified food management program
licensee.
(1)
Compliance with certified food management program law and
rules. The licensee is responsible for compliance with applicable certified
food management program law and rules.
(2)
Payment of fees. All fees shall be non-refundable and paid
as specified in subsection (p) of this section.
(3)
Change of ownership. A new licensing application, to include
non-refundable fee(s) as described in this section, shall be submitted prior
to a change of license ownership.
(4)
Certified food management program course content. All food
management programs must be taught utilizing the course content established
in the Conference for Food Protection's Standards for Accreditation of Food
Protection Manager Certification Programs, and must meet the training and
time requirements in subsection (d)(6) of this section.
(5)
Change of program sponsor. The licensee shall notify the
department in writing of the name of the new program sponsor.
(6)
Change of examination administrator. The licensee shall
submit a signed security agreement for each new examination administrator
prior to administering the department examination. New examination administrators
must receive instruction on administrative responsibilities for examination
security and processing.
(7)
Change of certified food management instructor. The licensee
shall ensure that only a department certified food management instructor serves
as the instructor for the food management program. All new instructors must
complete the application for new instructors that must be submitted by the
licensee to the department with the applicable documentation. All new instructors
must receive instruction on the applicable law and rules and administrative
responsibilities.
(8)
Mailing of answer sheets. The licensee shall ensure that
the answer sheets used for computerized grading shall be mailed to the department
by traceable means. The completed answer sheets must be received by the department
within seven working days of the examination date.
(g)
Requirements for certification of certified food management
program instructors. The instructors for all food management programs shall
be department certified prior to teaching a class. Instructors meeting the
qualifications will be approved for a five-year period. The application form
shall be submitted to the department through the accredited certified food
management program licensee.
(1)
New food management instructors. A completed application
for new instructors must be submitted to the department with the following
documentation:
(A)
the completed and signed application form;
(B)
a copy of a valid food management certificate; and
(C)
verification of education or experience in food safety
documented by one of the following:
(i)
an associate or higher college degree from an accredited
institution in a major related to food safety or environmental health, evidenced
by a copy of the candidate's diploma or transcript;
(ii)
five years of food establishment work experience verified
in an attached resume; or
(iii)
one year of regulatory inspection experience verified
in an attached resume.
(2)
Nationally accredited program instructors. Nationally accredited
program instructors who have met the minimum standards as set forth by this
section shall be given reciprocity when instructing and administering a Conference
for Food Protection accredited examination.
(h)
Responsibilities of certified food management program instructors.
(1)
Compliance with certified food management program law and
rules. All certified instructors are responsible for compliance with applicable
certified food management program law and rules.
(2)
Training requirements. All certified instructors are responsible
for instructing the course content as specified in subsection (f)(4) of this
section, and meeting the training time requirements as specified in subsection
(d)(6) of this section.
(3)
Examination administrator. Instructors serving as the examination
administrator must complete an examination security agreement prior to administering
a department examination.
(i)
Requirements for the renewal of certified food management
program instructor certification. In order for an instructor to renew their
instructor certification, they must comply with the requirements of this subsection.
(1)
Instructor certification renewal. At least 60 days prior
to the certificate expiration date, the department will mail instructors a
renewal notice. In order for certification to be renewed, the instructor must
return the completed renewal notice to the department prior to the expiration
date along with required documentation.
(2)
Continuing education requirements. An instructor must earn
a minimum of 12 contact hours of continuing education credits before expiration
of their certification.
(3)
Accepted continuing education topics. Continuing education
topics may include areas in food safety or instruction enhancement.
(4)
Verification of continuing education. The following may
be used for continuing education:
(A)
a certificate of completion for a course or seminar with
the participant's name, course name, date and number of contact hours earned;
(B)
a college transcript with course description;
(C)
a copy of a published professional research paper authored
by the instructor that indicates the journal name and publication date;
(D)
a signed and dated letter on official letterhead from an
employer detailing the instructor's participation in company workshops or
programs; or
(E)
other documentation of attendance as approved by the department.
(5)
Expiration of instructor certificate. Instructor certification
expires upon the expiration date on the certificate. In order to be recertified,
the instructor must submit a new food management instructor application.
(j)
Responsibilities of the examination administrators.
(1)
Compliance with certified food management program laws
and rules. The examination administrator is responsible for compliance with
the certified food management program laws and rules applicable to examination
administration.
(2)
Examination security agreement. An examination administrator
must complete a security agreement and submit to the department through the
certified food management program licensee. The department may not issue examinations
to an examination administrator who does not have a signed security agreement
on file with the department.
(3)
Examination security. The examination administrator shall
provide examination security at the examination site. All security measures
shall be met and maintained at all times during examination storage, administration
and issuance as described in this section.
(4)
Mailing answer sheets. Answer sheets used for computerized
grading shall be mailed to the department by traceable means. The completed
answer sheets must be received at the department within seven working days
of the examination date.
(5)
Examination results. Candidates shall be informed of the
process for receiving their certificate upon passing the examination. Candidates
shall be informed of the reexamination process, in the event of examination
failure.
(6)
Replacement process for candidate certificate. Candidates
shall be informed of the process for replacing lost or damaged certificates.
(k)
Certified food manager certificates.
(1)
Certificate issuance. Certified food manager certificates
for candidates who complete an accredited program and pass the department
examination will be mailed directly to the candidate at the address provided
on the computerized grading sheet.
(2)
Certificate period. A certified food manager certificate
shall be valid for five years from the date of examination. All certificates
issued prior to the effective date of these rules will expire on the expiration
date as stated on the certificate.
(3)
Certificate renewal. Renewal shall be achieved by completing
a recertification program and passing a department approved examination. A
renewal certificate shall be valid for five years from date of issuance.
(4)
Certificate replacement. An individual requesting a certified
food manager certificate replacement must submit a written request to the
department with the appropriate non-refundable fee. Replacement certificates
will bear the same expiration date as the original certificate.
(5)
Expired certificates. Certified food managers whose certification
has expired shall complete an accredited certification course and pass the
final examination.
(6)
Certification through single entity corporations. Candidates
from accredited single entity corporations will receive food management certificates
as described in this section, except that the food management certificate
shall:
(A)
clearly indicate that the certificate is for the single
entity only;
(B)
be recognized by regulatory authorities for only that single
entity; and
(C)
not receive reciprocity or recertification.
(l)
Department examination criteria. The department examination
shall meet accepted psychometric standards for reliability, validity and passing
score. The department certification examination shall consist of 75 statistically
valid questions to be administered at one time following the required training
which precedes the examination. The department recertification examination
shall consist of 50 statistically valid questions to be administered at one
time following the required training which precedes the examination.
(m)
National examination criteria. National food manager examinations
recognized by the Conference for Food Protection shall be considered department
approved examinations. Examination administrators for national examinations
must implement and maintain all of the administrative procedures as outlined
in the Conference for Food Protection Standards for Accreditation of Food
Protection Manager Certification Programs.
(n)
Site requirements for administration of the department
examination and national examinations. Examination sites utilizing the department
examination or a national examination must comply with all legal requirements
for safety, health, and accessibility for all qualified candidates. Accommodations,
lighting, space, comfort, and workspace for taking the examination must allow
all candidates to perform at their highest level of competency. Requirements
at each site include but are not limited to:
(1)
accessibility in accordance with the requirements of the
Americans with Disabilities Act must be available for all qualified examinees;
(2)
sufficient spacing between each examinee in the area in
which the actual testing is conducted, or other appropriate and effective
methods, to preclude any examinee from viewing another candidate's examinations;
(3)
acoustics that allow each examinee to hear instructions
clearly, using an electronic audio system if necessary;
(4)
adequate lighting at each examinee's work space for reading
fine print; and
(5)
appropriate ventilation and temperature for the health
and comfort of examinees.
(o)
Examination administration. Examination administrators
shall implement and maintain the following examination administration procedures
for a program utilizing the department examination.
(1)
Security procedures shall be in place which protect the
examination from compromise at all times. The examinations shall be stored
and administered under secure conditions and shall be inventoried prior to
and immediately following each administration of an examination. The examination
may not be duplicated. Candidates shall have access to the examination only
during examination administration.
(2)
There shall be one proctor for every 35 candidates taking
the examination. Proctors shall, by picture identification, confirm the accurate
identity of each candidate. The examination administrator shall train and
supervise the activities of any proctor(s).
(3)
A candidate who speaks English as a second language may
use a translation dictionary to translate English into their native language.
(4)
An employee or a non-biased volunteer translator may be
used as a translator of languages other than English to administer the examination
orally. Translators shall be pre-approved by the examination administrator,
and shall not compromise the integrity of the examination or the examination
results of the candidate.
(5)
Each candidate's examination results and personal information
shall be held confidential. Such information may be made available only to
the examinee and to persons designated in writing by the examinee in a dated
document containing the examinee's original signature. The signed document
must specify the name(s) of specific individuals the information may be released
to and the exact information which may be provided. The department shall only
release information in writing and only to appropriately designated and identified
person(s).
(6)
All completed answer sheets for the department examinations
shall:
(A)
be mailed by traceable means, and received by the department
within seven working days of the examination date for grading and processing;
(B)
be submitted in a condition acceptable for immediate scanning.
Forms requiring extensive correction shall be returned to the examination
administrator ungraded; and
(7)
Only the department shall grade the department examination.
(p)
Required fees. All fees are payable to the Texas Department
of Health and are non- refundable. Fees must be submitted with the appropriate
form that relates to the fee category.
(1)
Certified food manager program license fee. A program fee
shall be $300 per year for each certification or recertification program.
(2)
Candidate fee. A candidate fee for those taking a department
approved examination shall be $17. If the candidate fails the department examination,
another candidate fee must be submitted to retake the examination.
(3)
Replacement certificate. A replacement certificate fee
for the department examination shall be $10.
(4)
Late fee. Certified food manager licensees submitting a
renewal application to the department after the expiration date shall pay
an additional $100 as a late fee.
(q)
Department examination related to late fees. Department
examinations will not be provided to any licensee that is over 30 days delinquent
in renewing a certified food management program license.
(r)
Certified food management program registry. The department
shall maintain a program registry of all accredited certification and recertification
programs. The registry shall be made available on the department website.
(s)
Department audits. Examination and classroom audits shall
be conducted to assess program compliance. Audits may be based on analysis
of data compiled by the department.
(t)
Denial, suspension and revocation of program accreditation.
An accredited food manager program license may be denied, suspended or revoked
for the following reasons:
(1)
an average quarterly candidate failure rate in any one
quarter of 25% or higher on examinations;
(2)
a licensee, examination administrator or proctor breaches
the security agreement;
(3)
a licensee is delinquent in payment of fees as described
in this section; or
(4)
violation of the provisions of this section.
(u)
Denial, suspension and revocation procedures. Denial, suspension
and revocation procedures under this section shall be conducted in accordance
with the Administrative Procedure Act, Government Code, Chapter 2001.
§229.176.Certification of Food Managers.
(a)
Purpose. This section is intended to provide the framework
of certification programs for food managers in accordance with Texas Health
and Safety Code (HSC), Chapter 438, Subchapter G. Certification of Food Managers
supports demonstration of food safety knowledge, thereby reducing the risk
of foodborne illness outbreaks caused by improper food preparation and handling
techniques.
(b)
Definitions. The following words and terms when used in
this section shall have the following meanings unless the context clearly
indicates otherwise:
(1)
Certificate -- The documentation issued by the department
or an organization that administers a department approved examination verifying
that an individual has complied with the requirements of this section.
(2)
Certification -- The process whereby a certificate is issued.
(3)
Certified food manager -- A person who has demonstrated
that he/she has the knowledge, skills and abilities required to protect the
public from foodborne illness by means of successfully completing a food safety
examination as described in this section.
(4)
Certified food manager licensee -- The individual, corporation,
or company that is licensed by the department to administer a department approved
examination for food manager certification and who complies with the examination
site requirements.
(5)
Certified food manager examination -- A department approved
examination for food manager certification.
(6)
Conference for Food Protection -- An independent national
voluntary nonprofit organization promoting food safety and consumer protection.
(7)
Department -- The Texas Department of Health.
(8)
Examination administrator -- an individual designated in
writing to the department by the licensee who is responsible for administering
food manager certification examinations.
(9)
Examination site -- The physical location at which the
department approved examination is administered.
(10)
Food -- A raw, cooked, or processed edible substance,
ice, beverage, or ingredient used or intended for use or for sale in whole
or in part for human consumption, or chewing gum.
(11)
Food establishment -- An operation that stores, prepares,
packages, serves, or otherwise provides food for human consumption such as:
a food service establishment; retail food store; satellite or catered feeding
location; catering operation, if the operation provides food directly to a
consumer or to a conveyance used to transport people; market; remote catered
operations; conveyance used to transport people; institution or food bank
that relinquishes possession of food to a consumer directly or indirectly
through a delivery service such as home delivery of grocery orders or restaurant
takeout orders, or delivery service that is provided by common carriers.
(A)
The term includes: an element of the operation such as
a transportation vehicle or a central preparation facility that supplies a
vending location or satellite feeding location, unless the vending or feeding
location is permitted by the regulatory authority; a restaurant; a grocery
store; an operation that is conducted in a mobile, roadside, stationary, temporary,
or permanent facility or location; group residence; outfitter operations;
bed and breakfast extended and bed and breakfast food establishments where
consumption is on or off the premises; and regardless of whether there is
a charge for the food.
(B)
The term does not include: an establishment that offers
only prepackaged foods that are not potentially hazardous; a produce stand
that only offers whole, uncut fresh fruits and vegetables; a food processing
plant; a kitchen in a private home if only food that is not potentially hazardous
is prepared for sale or service at a function, such as a religious or charitable
organization's bake sale; a bed and breakfast limited facility as defined
in §229.162(4)(A) of this title.
(12)
Law -- Applicable local, state and federal statutes, regulations
and ordinances.
(13)
Nonprofit organization -- A civic or fraternal organization,
charity, lodge, association, proprietorship or corporation possessing a 501(C)
exemption under the Internal Revenue Code; or religious organizations meeting
the definition of "church" under the Internal Revenue Code, §170(b)(1)(A)(I).
(14)
Person -- An association, corporation, partnership, individual
or other legal entity, government or governmental subdivision or agency.
(15)
Personal validation question -- A question designed to
establish the identity of the candidate taking a certified food manager examination
by requiring an answer related to the candidate's personal information such
as a driver's license number, address, date of birth, or other similar information
that is unique to the candidate.
(16)
Proctor -- The examination administrator or a person who
is designated to assist the examination administrator.
(17)
Psychometric -- Scientific measurement or quantification
of human qualities, traits or behaviors.
(18)
Reciprocity -- Acceptance by state and local regulatory
authorities of a department approved food manager certificate.
(19)
Regulatory authority -- The state or local enforcement
body or authorized representative having jurisdiction over the food establishment.
(20)
Secure -- Access limited to the licensee or examination
administrator.
(21)
Traceable means -- A method of mailing documents that
can be tracked in the event of loss or delay.
(c)
Certified food manager.
(1)
Certified food manager responsibilities. Responsibilities
of a certified food manager include:
(A)
identifying hazards in the day-to-day operation of a food
establishment that provides food for human consumption;
(B)
developing or implementing specific policies, procedures
or standards aimed at preventing foodborne illness;
(C)
coordinating training, supervising or directing food preparation
activities and taking corrective action as needed to protect the health of
the consumer;
(D)
training the food establishment employees on the principles
of food safety; and
(E)
conducting in-house self-inspection of daily operations
on a periodic basis to ensure that policies and procedures concerning food
safety are being followed.
(2)
Certification by a food safety examination. To be certified,
a food manager must pass a department approved examination or a national examination
recognized by the Conference for Food Protection.
(3)
Certificate reciprocity. A certificate issued to an individual
who successfully completes a department approved examination shall be accepted
as meeting the training and examination requirements under HSC, §438.046(b).
(4)
Certificate availability. The original food manager certificate
shall be conspicuously posted at each food establishment.
(d)
Licensing of certified food manager licensee. The department
shall issue a license to certified food manager licensees meeting the requirements
of this subsection. A license issued under these rules shall expire one year
from the date of issuance. A license is not transferable on change of ownership,
or change of site location.
(1)
Application. Persons wishing to apply for a certified food
manager license shall submit an application to the department.
(2)
Certified food manager licensee fee. The license application
shall include the appropriate non-refundable fee as specified in subsection
(o)(1) of this section.
(3)
Examination security agreement. The licensee shall submit
a signed security agreement for each examination administrator using a department
examination.
(4)
Certification examination. Department approved examination(s)
utilized by the certified food manager licensee shall be designated on the
application.
(5)
Number of examination sites utilized. The license application
shall indicate the number of examination sites to be utilized under the certified
food manager license.
(e)
Responsibilities of certified food manager licensee.
(1)
Compliance with food manager laws and rules. The licensee
is responsible for compliance with applicable food manager laws and rules.
(2)
Payment of fees. All fees shall be non-refundable and paid
as specified in subsection (o) of this section.
(3)
Change of ownership or site location. A new licensing application
package, to include non-refundable fee(s) as described in this section, shall
be submitted prior to a change of licensee ownership or site location.
(4)
Change of the examination administrator. The licensee shall
submit a signed security agreement by a new examination administrator prior
to administering the department examination.
(5)
Examination administration. The licensee shall directly
administer the department approved examination.
(f)
Responsibilities of department examination administrators.
(1)
Compliance with food manager laws and rules. The examination
administrator is responsible for compliance with the food manager laws and
rules applicable to examination administration.
(2)
Examination security agreement. An examination administrator
must complete, sign and date a security agreement and submit it to the department
through the certified food manager licensee. The department may not issue
examinations to examination administrators who do not have a signed security
agreement on file with the department.
(3)
Examination security. The examination administrator shall
provide examination security at the examination site. All security measures
specified in this section shall be met and maintained at all times during
examination storage, administration and issuance.
(4)
Mailing answer sheets. Answer sheets used for computerized
grading shall be mailed to the department by traceable means. The completed
answer sheets must be received at the department within seven working days
of the examination date.
(5)
Examination results. Candidates shall be informed of the
process for receiving their certificate upon passing the examination. Candidates
shall be informed of the reexamination process, in the event of examination
failure.
(6)
Replacement process for candidate certificate. Candidates
shall be informed of the process for replacing lost or damaged certificates.
(g)
Responsibilities for Internet examination providers.
(1)
Compliance with food manager laws and rules. Internet examination
providers are responsible for compliance with food manager laws and rules
applicable to examination administration.
(2)
Examination Security Agreement. Internet examination providers
must submit the department security agreement signed by the certified food
manager licensee.
(3)
Examination Security. Candidates taking Internet examinations
shall be advised on the application that outside training materials or assistance
shall not be used during administration of the examination and that appropriate
measures must be taken to assure that the examination is not compromised.
(h)
Certified food manager certificates.
(1)
General certificate issuance. Certificates shall be issued
by the department or the organization that administers a department approved
examination. Certificates issued after successful passage of a department
approved examination shall be deemed to meet the requirements for food manager
certification.
(2)
Department certificate issuance. Certified food manager
certificates for candidates who pass the department's examination will be
mailed directly to the candidate at the address provided on the computerized
grading sheets.
(3)
Certificate period. A certified food manager certificate
shall be valid for five years from the date of examination. All certificates
issued prior to the effective date of these rules will expire on the expiration
date as stated on the certificate.
(4)
Certificate renewal. Renewal shall be achieved by passing
an examination approved by the department. A renewal certificate shall be
valid for five years from the date of issuance.
(5)
Department certificate replacement. An individual requesting
a certified food manager certificate replacement must submit a written request
to the department with the appropriate non-refundable fee. Replacement certificates
will bear the same expiration date as the original certificate.
(i)
Department examination criteria. The department examination
shall meet accepted psychometric standards for reliability, validity and passing
score. The department examination shall consist of 75 statistically valid
questions to be administered at one time following any voluntary training
which may precede the examination.
(j)
National examination criteria. National food manager examinations
recognized by the Conference for Food Protection shall be considered department
approved examinations. Examination administrators for national examinations
must implement and maintain all of the administrative procedures as outlined
in the Conference for Food Protection Standards for Accreditation of Food
Protection Manager Certification Programs.
(k)
Internet examination criteria. Documentation that Internet
examination questions meet accepted psychometric standards for reliability,
validity, and passing score shall be submitted to the department. Each candidate
shall receive a unique form of the examination with regard to question sequence.
Internet examinations shall consist of 75 statistically valid questions that
are administered at one time following any voluntary training that may precede
the examination.
(l)
Site requirements for administration of the department
examination and national examinations. Examination sites utilizing the department
examination or a national examination must comply with all legal requirements
for safety, health, and accessibility for all qualified candidates. Accommodations,
lighting, space, comfort, and workspace for taking the examination must allow
all candidates to perform at their highest level of competency. Requirements
at each site include but are not limited to:
(1)
accessibility in accordance with the requirements of the
Americans with Disabilities Act must be available for all qualified examinees;
(2)
sufficient spacing between each examinee in the area where
the actual examination is conducted, or other appropriate and effective methods,
to preclude any examinee from viewing other candidates' examinations;
(3)
acoustics that allow each examinee to hear instructions
clearly, using an electronic audio system if necessary;
(4)
adequate lighting at each examinee's workspace for reading
fine print; and
(5)
appropriate ventilation and temperature for the health
and comfort of examinees.
(m)
Department examination administration. Examination administrators
shall implement and maintain the following examination administration procedures
for a program utilizing the department examination:
(1)
Security procedures shall be in place, which protect the
examination from compromise at all times. The examinations shall be stored
and administered under secure conditions and shall be inventoried prior to
and immediately following each administration of an examination. The examination
may not be duplicated. Candidates shall have access to the examination only
during examination administration;
(2)
There shall be one proctor for every 35 candidates taking
the examination. Proctors shall, by picture identification, confirm the accurate
identity of each candidate. The examination administrator shall train and
supervise the activities of any proctor(s);
(3)
A candidate who speaks English as a second language may
use a translation dictionary to translate English into their native language;
(4)
An employee or a non-biased volunteer translator may be
used as a translator of languages other than English to administer the examination
orally. Translators shall be pre-approved by the examination administrator,
and shall not compromise the integrity of the examination nor the examination
results of the candidate;
(5)
Each candidate's examination results and personal information
shall be held confidential. Such information may be made available only to
the examinee and to persons designated in writing by the examinee in a dated
document containing the examinee's original signature. The signed document
must specify the name(s) of specific individuals the information may be released
to and the exact information which may be provided. The department shall only
release information in writing and only to appropriately designated and identified
person(s);
(6)
All completed answer sheets for the department examinations
shall:
(A)
be mailed by traceable means, and received by the department
within seven working days of the examination date for grading and processing;
(B)
be submitted in a condition acceptable for immediate scanning.
Forms requiring extensive correction shall be returned to the examination
administrator ungraded; and
(7)
Only the department shall grade the department examination.
(n)
Internet examination administration.
(1)
Registration requirements for Internet examinations. The
licensee shall register the candidates and require the candidates to:
(A)
verify their identity;
(B)
provide responses to ten personal validation questions;
and
(C)
maintain examination security.
(2)
Licensee examination disclosure information. The licensee
shall inform the candidate that:
(A)
reference materials shall not be used during the examination;
(B)
the candidate shall not receive assistance from anyone
during the examination; and
(C)
examination questions may not be replicated in any fashion.
(3)
Personal validation questions. The licensee shall verify
a candidate's identity throughout the examination. The personal validation
process must include the following elements:
(A)
a minimum of five personal validation questions selected
from the ten questions provided during registration shall be incorporated
at various times during the examination;
(B)
the personal validation questions must be randomly generated
with respect to time and order;
(C)
the same personal validation questions shall not be asked
more than once during the same examination; and
(D)
the examination session shall cease and the candidate shall
be automatically exited from the examination if a candidate answers a personal
validation question incorrectly.
(4)
System support. The licensee of an approved Internet examination
must include the following system capabilities and security measures:
(A)
capability to browse or review previously completed examination
questions;
(B)
capability to navigate logically and systematically through
the examination;
(C)
technical support personnel for Internet examination issues;
(D)
security of personal candidate information in transit and
at rest;
(E)
a back-up and disaster recovery system capability; and
(F)
assurance that examination data is maintained in a secure
and safe environment and readily available to the department.
(5)
Reporting requirements for non-proctored Internet examination
administrators. Internet examination administrators who administer examinations
in non-proctored locations shall submit a semi-annual report to enable the
department to evaluate examination security and system performance. The report
shall include:
(A)
statistical data to enable measurement of central tendency,
ranges of examination scores, standard deviation, standard error of measurement,
and examination cut score;
(B)
the number of personal validation questions used; and
(C)
the number of examinations discontinued due to incorrect
responses to personal validation questions.
(6)
Time allotment for non-proctored Internet examination providers.
Time allotted for administration of non-proctored examinations shall not exceed
90 minutes.
(o)
Required fees. All fees are payable to the Texas Department
of Health and are non- refundable. Fees must be submitted with the appropriate
form that relates to the fee category. Fees shall be:
(1)
Certified food manager licensee fee. Certified food manager
licensee fees shall be based on the number of sites at which the certified
food manager licensee administers the examinations based on the following
scale:
(A)
one site - $200;
(B)
two to ten sites - $500; or
(C)
over ten sites - $1,000.
(2)
Candidate fee. A candidate fee for those taking the department
examination shall be $17. If the candidate fails the department examination,
another candidate fee must be submitted to retake the examination.
(3)
Replacement certificate fee. A replacement certificate
fee for the department examination shall be $10.
(4)
Late fee. A certified food manager licensee submitting
a renewal application to the department after the expiration date shall pay
an additional $100 as a late fee.
(p)
Department examination related to late fees. Department
examinations will not be provided to any licensee that is over 30 days delinquent
in renewing a license.
(q)
Certified food manager licensee registry. The department
shall maintain a registry of all licensed certified food manager licensees.
The registry shall be made available on the department website.
(r)
Department audits. Audits of certified food manager licensees
shall be conducted to assess compliance with these rules. Audits may be based
on analysis of data compiled by the department.
(s)
Denial, suspension and revocation of certified food manager
license. A certified food manager license may be denied, suspended or revoked
for the following reasons:
(1)
a licensee, examination administrator, or proctor breaches
the security agreement;
(2)
a licensee is delinquent in payment of fees as described
in this section; or
(3)
violation of the provisions of this section.
(t)
Denial, suspension and revocation procedures. Denial, suspension
and revocation procedures under this section shall be conducted in accordance
with the Administrative Procedure Act, Government Code, Chapter 2001.
§229.177.Certification of Food Managers in Areas Under Texas Department of Health Permitting Jurisdiction.
(a)
Purpose. The purpose of this section is to implement a
food manager certification requirement as authorized in the Texas Health and
Safety Code (HSC), Chapter 437, §437.0076(b). Certification of food managers
after testing on food safety principles reduces the risk of foodborne illness
outbreaks caused by improper food preparation and handling techniques.
(b)
Food manager certification required. One certified food
manager must be employed by each food establishment permitted under HSC, §437.0055.
Certification must be obtained by passing a department approved examination
at an approved examination site, and meeting all requirements in HSC, Chapter
438, Subchapter G, and §229.176 of this title (relating to Certification
of Food Managers).
(c)
Food manager certification exemptions. The following food
establishments are exempt from the requirements in subsection (b) of this
section:
(1)
establishments that handle only prepackaged food and do
not package food as exempted in HSC, §437.0076(c);
(2)
child care facilities as exempted by HSC, §437.0076(f);
(3)
establishments that do not prepare or handle exposed potentially
hazardous foods as defined §229.162(66) of this title; or
(4)
nonprofit organizations as defined in §229.371(9)
of this title (relating to Permitting Retail Food Establishments).
(d)
Responsibilities of a certified food manager. Responsibilities
of a certified food manager include:
(1)
identifying hazards in the day-to-day operation of a food
establishment that provide food for human consumption;
(2)
developing or implementing specific policies, procedures
or standards to prevent foodborne illness;
(3)
supervising or directing food preparation activities and
ensuring appropriate corrective actions are taken as needed to protect the
health of the consumer;
(4)
training the food establishment employees on the principles
of food safety; and
(5)
performing in-house self-inspections of daily operations
on a periodic basis to ensure that policies and procedures concerning food
safety are being followed.
(e)
Certificate reciprocity. A certificate issued to an individual
who successfully completes a department approved examination shall be accepted
as meeting the training and testing requirements under HSC, §438.046(b).
(f)
Certificate posting. The original food manager certificate
shall be posted in a location in the food establishment that is conspicuous
to consumers.
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 February 25, 2002.
TRD-200201156
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 7, 2002
For further information, please call: (512) 458-7236
Subchapter O. LICENSING OF WHOLESALE DISTRIBUTORS OF DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
25 TAC §§229.251 - 229.255
The Texas Department of Health (department) proposes amendments
to §§229.251 - 229.255, concerning the licensing of wholesale distributors
of drugs - including good manufacturing practices.
Specifically, the sections cover licensing fees and procedures; minimum
standards for licensure; refusal, revocation, or suspension of license; and
provisions for the Wholesale Drug Distributors Advisory Committee. Amended §229.251
will alphabetize the defined terms to make them consistent with other division
rules. Amended §229.252 will clarify licensing fees for out-of-state
wholesale drug distributors. Amended §229.253 will clarify that drug
distributors will have to be in compliance with the Texas Controlled Substances
Act, Health and Safety Code, Chapter 481, and will implement Title 21, Code
of Federal Regulations (CFR), Part 203, titled "Prescription Drug Marketing."
The new language is pursuant to recent amendments to the Federal Prescription
Drug Marketing Act of 1987 and the Prescription Drug Amendments of 1992, which
were enacted to protect the public against drug diversion by establishing
procedures, requirements, and minimum standards for distribution of prescription
drugs and prescription drug samples. Amended §229.254 will clarify language
for consistency with other programs within the Drugs and Medical Devices Division.
Amended §229.255 will update the language of the section to be consistent
with other sections of the rule.
Government Code, §2001.039 requires each state agency to review and
consider for readoption each rule adopted by that agency pursuant to Government
Code, Chapter 2001 (Administrative Procedure Act). The current rules have
been reviewed and the department has determined that reasons for adopting
the sections continue to exist; however, the rules need revisions as described
in this preamble.
The department published a Notice of Intention to Review §§229.251
- 229.255 in the
Texas Register
on November
30, 2001 (26 TexReg 9933). No comments were received as a result of the publication
of the notice.
Cynthia T. Culmo, R.Ph., Director, Drugs and Medical Devices Division,
has determined that for the first five-year period the sections are in effect,
there will be no fiscal implications to state or local government as a result
of enforcing or administering the sections as proposed because the licensing
requirements are not being substantially changed.
Ms. Culmo has also determined that for each year of the first five years
the sections as proposed are in effect, the public benefit will be clarification
of licensing of wholesale distributors of drugs - including good manufacturing
practices. There will be no adverse economic effect on micro-businesses and/or
small businesses and persons who may be required to comply with these sections
as proposed. The finding of no adverse economic effect on micro-businesses
and/or small businesses is based on the intent of the proposed sections to
clarify existing licensing requirements and the determination that no changes
to existing licensure fee schedules will occur. There will be no impact on
local employment.
Comments on the proposed amendments may be submitted to John L. Gower,
Drugs and Medical Devices Division, Texas Department of Health, 1100 West
49th Street, Austin, Texas 78756, (512) 719-0237, e-mail address: John.Gower@tdh.state.tx.us.
Comments will be accepted for 30 days from the date of publication of this
proposal in the
Texas Register
.
The amendments are proposed under the Health and Safety Code, §431.241,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 431; and §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 amendments affect the Health and Safety Code, Chapter 431 and Chapter
12.
§229.251.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
(No change.)
(2)
Flea market - A location at
which two or more booths or similar spaces are rented or otherwise made available
temporarily and at which persons offer tangible personal property for sale.
(3)
[
(2)
] Manufacturer - A person who
manufactures, prepares, propagates, compounds, processes, packages, repackages,
or changes the container, wrapper, or labeling of any drug package.
(4)
[
(3)
] Place of business - Each location
at which drugs are distributed at wholesale as defined in the Health and Safety
Code, Chapter 431.
(5)
[
(4)
] Wholesale distribution - Distribution
to a person other than a consumer or patient, including, but not limited to
distribution to any person by a manufacturer, repacker, own label distributor,
jobber, or wholesaler.
[
(5)
Flea market - A location at
which booths or similar spaces are rented or otherwise made available temporarily
to two or more persons and at which the persons offer tangible personal property
for sale.]
§229.252.Licensing Fee and Procedures.
(a)
License fee.
(1)
All wholesale distributors of drugs who are not manufacturers
of drugs in Texas shall obtain a license annually with the Texas Department
of Health (department). Except as provided for in paragraph (2) of this subsection,
wholesale distributors of drugs who are not manufacturers of drugs in Texas
shall pay a
non-refundable
licensing fee for each place of business
operated as follows:
(A) - (D)
(No change.)
[
(E)
$750 per out-of-state wholesale
distributor, unless an audited statement is provided which demonstrates gross
annual drug sales of less than $20 million which would require a licensing
fee of $500; and]
(E)
[
(F)
] $0.00 per wholesale distributor
engaged in the distribution of an over-the-counter drug by a charitable organization,
as described in the Internal Revenue Code of 1986, §501(c)(3), to a nonprofit
affiliate of the organization to the extent otherwise permitted by law.
(2)
A wholesale distributor of drugs who is not a manufacturer
of drugs, who is required to be licensed under this section and who is also
required to be licensed as a device distributor under §229.439(a)(1)
of this title (relating to Licensure Fees) or as a [
wholesale
]
food
wholesaler
[
distributor
] under §229.182(a)(3)
of this title (relating to Licensing Fee and Procedures) shall pay a combined
non-refundable licensing
[
licensure
] fee for each place of
business. The
licensing
[
licensure
] fee shall be based
on the combined gross annual sales of these regulated products (foods, drugs,
and/or devices) as follows:
(A) - (E)
(No change.)
(3)
All wholesale distributors of drugs who are manufacturers
of drugs in Texas shall obtain a license annually with the department and
shall pay a
non-refundable
licensing fee for each place of business
operated as follows:
(A) - (C)
(No change.)
(4)
All out-of-state wholesale
distributors of drugs who distribute drugs into the State of Texas must pay
an annual non-refundable license fee as follows:
(A)
$750 per out-of-state wholesale drug distributor;
or
(B)
$500 per out-of-state wholesale drug distributor
with gross annual sales of $20 million or less, provided an outside audited
statement demonstrating gross annual sales are less than $20 million is provided
to the department.
(5)
[
(4)
] If the United States Food and
Drug Administration (FDA) determines, with respect to a product that is a
combination of a drug and a device, that the primary mode of action of the
product is as a drug, a person who engages in wholesale distribution of the
product is subject to
licensing
[
licensure
] as described
in this section.
(6)
For the purpose of collecting
licensing fees under this section, a person that distributes both its own
manufactured drugs and drugs it does not manufacture must obtain only a wholesale
distributor of drugs (manufacturing) license. However, when calculating the
amount of the licensing fee, the manufacturer must include the total for all
drugs manufactured and distributed from the place of business. In addition,
drug warehousing locations operated by a drug distributor, including locations
from which drugs are held for limited periods of time for distribution, and
which are totally separate from any manufacturing location, must be individually
licensed as drug distributors.
(7)
A firm that has more than one
business location may request a one-time prorating of fees when applying for
a license for each new location. Upon approval by the department, the expiration
date of the license for the new location will be the same as the expiration
date of the firm's other licensed locations.
(b)
(No change.)
(c)
License statement. The wholesale distributors' licensing
statement shall be signed and verified by the owner, partner, president, or
corporate designee [
(copy of Resolution must accompany application)
],
shall be made on the department furnished license form, and shall contain
the following information:
(1) - (6)
(No change.)
(d) - (e)
(No change.)
(f)
Issuance of license. The department may license a wholesale
distributor of drugs who meets the requirements of this section and §229.253
of this title (relating to Minimum Standards for Licensing).
(1)
The initial license shall be valid for one year from the
start
date of
the regulated business activity
[
issuance
] which becomes the anniversary date.
(2)
(No change.)
(g) - (i)
(No change.)
§229.253.Minimum Standards for Licensing [ Licensure ].
(a) - (b)
(No change.)
(c)
Requirements for wholesale prescription drug distributors.
(1) - (3)
(No change.)
(4)
Legend drugs
and controlled substances
. A wholesale
drug distributor may not possess, sell, or transfer drugs whose labels bear
the legend "Caution: Federal law prohibits dispensing without a prescription"
or "Rx Only" unless that person is authorized to possess, sell or transfer
such drugs in compliance with the Texas Food, Drug, and Cosmetic Act, Health
and Safety Code, Chapter 431, Subchapter I;
the Texas Controlled Substance
Act, Health and Safety Code, Chapter 481;
and the Texas Dangerous Drug
Act, Health and Safety Code, Chapter 483.
(d) - (f)
(No change.)
(g)
Drugs general, drug advertising, specific requirements
for special drugs, official names and established names, and labeling and
packaging requirements for controlled substances.
(1)
The department adopts by reference and will enforce Title
21, Code of Federal Regulations:
(A) - (B)
(No change.)
(C)
Part 203, §§203.1
- 203.60, titled "Prescription Drug Marketing";
(D)
[
(C)
] Part 250, §§250.10
- 250.250, titled "Special Requirements For Specific Human Drugs";
(E)
[
(D)
] Part 299, §§299.3
- 299.5, titled "Drugs; Official Names and Established Names"; and
(F)
[
(E)
] Part 1302, §§1302.01
- 1302.08, titled "Labeling and Packaging Requirements For Controlled Substances."
(2)
(No change.)
(h) - (p)
(No change.)
§229.254.Refusal, Revocation, or Suspension of License.
(a)
After an opportunity for a
hearing, the commissioner may refuse an application for a license or may refuse
to license a wholesale distributor of drugs, or may revoke or suspend the
license if the commissioner determines after providing an opportunity for
hearing that the applicant or licensee:
(1)
has been convicted of a felony or misdemeanor
that involves moral turpitude, including but not limited to the illegal use,
sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates,
amphetamines, desoxyephedrine, their compounds or derivatives, or any other
dangerous or habit-forming drugs;
(2)
is an association, partnership, or corporation
and any officer or management employee, partner, or any officer or director
of the corporation has been convicted of a felony or misdemeanor that involves
moral turpitude, including but not limited to the illegal use, sale, or transportation
of intoxicating liquors, narcotic drugs, barbiturates, amphetamines; desoxyephedrine,
their compounds or derivatives, or any other dangerous or habit-forming drugs;
(3)
has violated any provisions of the Texas, Food,
Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 or these sections;
(4)
has failed to pay a license fee or an annual
renewal fee for a license;
(5)
has obtained or attempted to obtain a license
by fraud or deception;
(6)
has violated the Health and Safety Code, §431.021(1)(3),
concerning the counterfeiting of a drug or the sale or holding for sale of
a counterfeit drug;
(7)
has violated the Health and Safety Code, Chapter
481 (Texas Controlled Substance Act), or the Health and Safety Code, Chapter
483 (Dangerous Drug Act); or
(8)
has violated the rules of the director of the
Department of Public Safety, including responsibility for a significant discrepancy
in the records that state law requires the applicant or licensee to maintain.
[
(a)
Basis. The Texas Department
of Health (department) may, after providing opportunity for hearing, refuse
to license a wholesale distributor of drugs, or may revoke or suspend the
license for violations of the requirements in §§229.251 - 229.253
of this title (relating to Definitions, Licensing Fee and Procedures, and
Minimum Standards for Licensing) or for any of the reasons described in the
Texas Health and Safety Code, Chapter 431.]
(b)
[
Hearings.
] Any hearings for the refusal, revocation,
or suspension of a license are governed by the department's formal hearing
procedures in Chapter 1 of this title (relating to Texas Board of Health)
and the Administrative Procedure Act, Government Code, Chapter 2001.
(c)
If the department suspends
a license, the suspension shall remain in effect until the department determines
that the reason for the suspension no longer exists. If the suspension overlaps
a renewal date, the suspended license holder shall comply with the renewal
procedures in §229.252(g) of this title (relating to Licensing Fee and
Procedures); however, the department may choose not to renew the license until
the department determines that the reason for suspension no longer exists.
(d)
If the department revokes or
does not renew a license, a person may reapply for a license by complying
with the requirements and procedures in §229.252(a) and (c) of this title
at the time of reapplication. The department may refuse to issue a license
if the reason for revocation or non-renewal continues to exist.
§229.255.Wholesale Drug Distributors Advisory Committee.
(a) - (b)
(No change.)
(c)
Purpose. The purpose of the committee is to provide advice
to the board in the area of
licensing
[
licensure
] of
wholesale drug distributors.
(d) - (p)
(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 February 22, 2002.
TRD-200201084
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 7, 2002
For further information, please call: (512) 458-7236