Part XV.
Texas State Board of Pharmacy
Chapter 291.
Pharmacies
Subchapter E. Clinic Pharmacy (Class D)
22 TAC §291.93
The Texas State Board of Pharmacy adopts amendments to §291.93,
concerning Operational Standards for Class D (Clinic) Pharmacies with changes
to the proposed text as published in the December 25, 1998, issue of the
Adoption of this amendment: (1) clarifies some terms, updates titles for
library references, and corrects citations to Board rules; (2) eliminates
butorphanol (Stadol) from the list of prohibited drugs in a Class D pharmacy
since it is now a controlled substance and is now included in the prohibition
for controlled substances; (3) allows physician assistants to provide prepackaged
drugs to patients in the same manner that licensed nurses currently can, in
a Class D pharmacy with an expanded formulary; (4) allows partial directions
for use on the label of prepackaged drugs under certain conditions; and (5)
clarifies that petitions to the Board for expanded formularies or alternative
visitation schedules must contain notarized signatures.
No comments were received.
The amendment is adopted under sections 4, 16(a), and 17(b) of
the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes). The Board
interprets section 4 as authorizing the agency to adopt rules to protect the
public health, safety, and welfare through the effective control and regulation
of the practice of pharmacy. The Board interprets section 16(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets section 17(b) as authorizing the agency to adopt
rules to regulate the delivery or distribution of prescription drugs as they
relate to the practice of pharmacy.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.
§291.93.Operational Standards.
(a)-(b)
(No change.)
(c)
Equipment. Each clinic pharmacy shall maintain the following
equipment and supplies:
(1)-(2)
(No change.)
(3)
if the clinic pharmacy compounds prescription drug
orders, a properly maintained Class A prescription balance (with weights)
or equivalent analytical balance. It is the responsibility of the pharmacist-in-charge
to have such balance inspected at least every three years by the appropriate
authority as prescribed by local, state, or federal law or regulations.
(d)
Library. A reference library shall be maintained which
includes the following in hard copy or electronic format:
(1)
(No change.)
(2)
current copies of at least two of the following references:
(A)
Facts and Comparisons with current supplements;
(B)
AHFS Drug Information;
(C)
United States Pharmacopeia Dispensing Information (USPDI);
(D)
Physician's Desk Reference (PDR);
(E)
American Drug Index;
(F)
Hansten's and Horn's Drug Interactions Analysis and Management;
(G)
reference texts in any of the following subjects: toxicology,
pharmacology, or drug interactions; or
(H)
reference texts pertinent to the major function(s) of the
clinic.
(e)
Drugs and devices.
(1)
Formulary.
(A)-(B)
(No change.)
(C)
The formulary shall not contain the following drugs or
types of drugs:
(i)
Nalbuphine (Nubain);
(ii)
Propranolol or other beta adrenergic receptor blocking
agents;
(iii)
antipsychotics; and
(iv)
Schedule I-V controlled substances.
(D)
Clinics with a patient population which consists of at
least 80% indigent patients may petition the board to operate with a formulary
which includes types of drugs and/or devices, other than those listed in subparagraph
(B) of this paragraph based upon documented objectives of the clinic, under
the following conditions.
(i)
Such petition shall contain an affidavit with the notarized
signatures of the medical director, the pharmacist-in-charge, and the owner/chief
executive officer of the clinic, and include the following documentation:
(I)-(V)
(No change.)
(ii)
(No change.)
(iii)
The following additional requirements shall be satisfied.
(I)
Supportive personnel who are providing drugs shall be licensed
nurses or physician assistants.
(II)
The pharmacist-in-charge, consultant pharmacist, or staff
pharmacist shall make on-site visits to the clinic at least monthly.
(iv)
(No change.)
(2)-(3)
(No change.)
(4)
Prepackaging and labeling for provision.
(A)
Drugs may be prepackaged and labeled for provision in the
clinic pharmacy. Such prepackaging shall be performed by a pharmacist or supportive
personnel under the direct supervision of a pharmacist and shall be for the
internal use of the clinic.
(B)
Drugs must be prepackaged in suitable containers.
(C)
The label of the prepackaged unit shall bear:
(i)
the name and address of the clinic;
(ii)
directions for use, which may include incomplete directions
for use provided:
(I)
labeling with incomplete directions for use has been authorized
by the pharmacy and therapeutics committee;
(II)
precise requirements for completion of the directions
for use are developed by the pharmacy and therapeutics committee and maintained
in the pharmacy policy and procedure manual; and
(III)
the directions for use are completed by practitioners,
pharmacists, licensed nurses or physician assistants in accordance with the
precise requirements developed under subclause (II) of this clause;
(iii)
name and strength of the drug--if generic name, the name
of the manufacturer or distributor of the drug;
(iv)
quantity;
(v)
lot number and expiration date; and
(vi)
appropriate ancillary label(s).
(D)
Records of prepackaging shall be maintained according to
§291.94(c) of this title (relating to Records).
(5)
Labeling for provision of drugs and/or devices
in an original manufacturer's container.
(A)
(No change.)
(B)
Drugs and/or devices in an original manufacturer's container
may be labeled by:
(i)
(No change.)
(ii)
supportive personnel in a Class D pharmacy, provided the
drugs and/or devices and control records required by §291.94(d) of this
title (relating to Records) are quarantined together until checked and released
by a pharmacist.
(C)
Records of labeling for provision of drugs and/or devices
in an original manufacturer's container shall be maintained according to §
291.94(d) of this title (relating to Records).
(6)
Provision.
(A)-(E)
(No change.)
(F)
Such drugs and/or devices shall be labeled by a pharmacist
licensed by the board; however, when drugs and/or devices are provided under
the supervision of a physician according to standing delegation orders or
standing medical orders, supportive personnel may at the time of provision
print on the label the following information:
(i)
patient's name;
(ii)
any information necessary to complete the directions for
use in accordance with paragraph (4)(C)(ii) of this subsection;
(iii)
date of provision; and
(iv)
practitioner's name.
(G)
Records of provision shall be maintained according to §291.94(e)
of this title (relating to Records).
(H)
Controlled substances may not be provided or dispensed.
(7)
(No change.)
(f)-(g)
(No change.)
(h)
Supervision.
(1)
(No change.)
(2)
The pharmacist-in-charge, consultant pharmacist, or
staff pharmacist shall personally visit the clinic every three months to ensure
that the clinic is following set policies and procedures, provided, however,
that clinics who are operated by state or local governments and clinics who
are funded by public money may petition the board for an alternative visitation
schedule under the following conditions.
(A)
Such petition shall contain an affidavit with the notarized
signatures of the medical director, the pharmacist-in-charge, and the owner/chief
executive officer of the clinic, which states that the clinic has a current
policy and procedure manual on file, has adequate security to prevent diversion
of dangerous drugs, and is in compliance with all rules governing Class D
pharmacies.
(B)-(C)
(No change.)
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 March
5, 1999.
TRD-9901358
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 25, 1999
Proposal publication date: December 25, 1998
For further information, please call: (512) 305-8028
22 TAC §295.8
The Texas State Board of Pharmacy adopts an amendment to
§295.8, concerning Continuing Education Requirements without changes
to the proposed text in the December 25, 1998, issue of the
Texas Register
(23 TexReg 12998). The amendment adds another method
for pharmacists to obtain their annual continuing education requirement.
Adoption of the rule will permit course work completed as part of a professional
degree program in an accredited college of pharmacy to apply towards a pharmacist's
requirement for continuing education.
No comments were received.
The amendment is adopted under sections 4, 16(a), and 24A of
the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes). The Board
interprets section 4 as authorizing the agency to adopt rules to protect the
public health, safety, and welfare through the effective control and regulation
of the practice of pharmacy. The Board interprets section 16(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets section 24A as authorizing the agency to adopt
rules relating to the approval of continuing education programs.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.
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 March
5, 1999.
TRD-9901359
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 25, 1999
Proposal publication date: December 25, 1998
For further information, please call: (512) 305-8028
22 TAC §303.1, §303.2
The Texas State Board of Pharmacy adopts amendments to §303.1,
concerning Destruction of Dispensed Drugs, and §303.2, concerning Disposal
of Stock Prescription Drugs without changes to the proposed text in the December
25, 1998, issue of the
Texas Register
(23
TexReg 12999). The amendments come as a result of the review of Chapter 303
(§§303.1 - 303.3) concerning Destruction of Dangerous Drugs and
Controlled Substances, pursuant to the Appropriations Act, Section 167.
Adoption of this amendment: (1) modifies and clarifies the requirements
for drug destruction and disposal in compliance with DEA and other state and
federal requirements; (2) corrects citations; (3) makes changes due to the
scheduling of butorphanol (Stadol) as a controlled substance; and (4) establishes
that the preferred method of destruction and disposal is to transfer possession
of the drug to a properly registered disposal firm.
No comments were received.
The amendment is adopted under sections 4, 16(a), and 17(b) of
the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes). The Board
interprets section 4 as authorizing the agency to adopt rules to protect the
public health, safety, and welfare through the effective control and regulation
of the practice of pharmacy. The Board interprets section 16(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets section 17(b) as authorizing the agency to adopt
rules to regulate the delivery or distribution of prescription drugs as they
relate to the practice of pharmacy.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.
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 March
5, 1999.
TRD-9901357
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 25, 1999
Proposal publication date: December 25, 1998
For further information, please call: (512) 305-8028
Chapter 741.
Speech-Language Pathologists and Audiologists
The State Board of Examiners for Speech-Language Pathology and Audiology
(board) adopts amendments to §§741.2, 741.142, 741.162, 741.163,
741.164, 741.165, 741.181, and new 741.201, concerning speech-language pathology
and audiology. Section 741.2 is adopted with changes to the proposed text
as published in the September 25, 1998, issue of the
Texas Register
(23 TexReg 9682). Sections 741.142, 741.162, 741.163,
741.164, 741.165, 741.181 and new 741.201 are adopted without changes and
will not be republished. The amendment to §741.87, which was simultaneously
proposed, is withdrawn from consideration for permanent adoption.
The adopted amendments cover all definitions listed with numbers in new
The amendments to increase, combine or add various fees will cover the
cost of administering the program and issue licenses to applicants quicker.
The amendments to revise board forms and continuing education submission will
streamline the renewal process for licensees and allow the board office to
process requests for renewals promptly without hiring additional staff. The
remaining amendments clarify existing language concerning delegation of duties
to assistants and extended recheck. The new section establishes a schedule
of sanctions as required by Texas Civil Statutes, Article 4512j, §17(f).
These amendments and new section will insure continuing competency and effective
regulation of speech-language pathologists and audiologists.
The following comment was received concerning the proposed sections. Following
the comment is the board's response and any resulting changes.
Comment: One commenter was concerned that the proposed amendments extending
the 30-day trial period as set forth in §741.2(29) and §741.87(g)(1)
lacked clarity and did not fully consider the economic impact on dispensers
of hearing instruments.
Response: Based on these comments and questions raised by staff, the board
has withdrawn the amendment extending the 30-day trial period set forth in
§741.2(29) and §741.87(g)(1). The board may consider amending the
30-day trial period in the future. Therefore, the amendment to §741.87
which was simultaneously proposed, is withdrawn from consideration for permanent
adoption.
The commenter was Audiology Practices, Inc. The commenter was neither for
nor against the rules in their entirety; however, it expressed concerns, asked
questions, and made recommendations.
Subchapter A. Introduction
22 TAC §741.2
The amendment is adopted under Texas Civil Statutes, Article
4512j, §5 which provides the State Board of Examiners for Speech-Language
Pathology and Audiology with the authority to adopt rules necessary to administer
and enforce Article 4512j.
§741.2.Definitions.
The following words and terms when used in this chapter, shall have
the following meanings unless the context clearly indicates otherwise.
(1)
Act - The law relating to the licensing and regulation
of speech-language pathologists and audiologists, Texas Civil Statutes, Article
4512j.
(2)
Assistant in audiology - An individual who works under
the direct on-site supervision and direction of a licensed audiologist and
is licensed under §741.85 of this title (relating to Requirements for
an Assistant in Audiology License).
(3)
Assistant in speech-language pathology - An individual
who works under the direct, on-site supervision and direction of a licensed
speech-language pathologist and is licensed under §741.65 of this title
(relating to Requirements for an Assistant in Speech-Language Pathology License).
(4)
Audiologist - An individual who meets the requirements
of Subchapter H of this chapter (relating to Application Procedures) and holds
a valid license to practice audiology.
(5)
Board - The State Board of Examiners for Speech-Language
Pathology and Audiology.
(6)
Delegation - The supervisor of an assistant may assign
certain services to the assistant; however, the supervisor is ultimately responsible
for all services provided.
(7)
Department - The Texas Department of Health.
(8)
Ear specialist - A licensed physician who specializes
in diseases of the ear and is medically trained to identify the symptoms of
deafness in the context of the total health of the patient, and is qualified
by special training to diagnose and treat hearing loss. Such physicians are
also known as otolaryngologists, otologists, and otorhinolaryngologists.
(9)
Extended absence - More than two consecutive working
days for any single continuing education experience.
(10)
Extended recheck - Starting at 40 dB and going down
by 10 dB until no response is obtained or until 20 dB is reached and then
up by 5 dB until a response is obtained. The frequencies to be evaluated are
1,000, 2,000, and 4,000 hertz (Hz).
(11)
Health care professional - An individual required
to be licensed or registered by this Act or any person licensed, certified,
or registered by the state in a health-related profession.
(12)
Hearing instrument - A device designed for, offered
for the purpose of, or represented as aiding persons with or compensating
for impaired hearing.
(13)
Hearing screening - A manually administered individual
pure-tone air conduction screening with pass/fail results for the purpose
of rapidly identifying those persons with possible hearing impairment which
has the potential of interfering with communication.
(14)
Intern in audiology - An individual completing the
supervised professional experience as required by §741.81(12) of this
title (relating to Requirements for an Audiology License) and licensed under
§741.82 of this title (relating to Requirements for an Intern in Audiology
License).
(15)
Intern in speech-language pathology - An individual
completing the supervised professional experience as required by §741.61(12)
of this title (relating to Requirements for a Speech-Language Pathology License)
and licensed under §741.62 of this title (relating to Requirements for
an Intern in Speech-Language Pathology License).
(16)
License - The document required by the Act which
provides verification that an individual has met the requirements for qualification
and practice as set forth in the Act and as interpreted within this chapter.
(17)
Month - A calendar month.
(18)
Person - An individual, a corporation, partnership,
or other legal entity.
(19)
Practice of audiology - The application of nonmedical
principles, methods and procedures for the measurement, testing, appraisal,
prediction, consultation, counseling, habilitation, rehabilitation, or instruction
related to disorders of the auditory or vestibular systems for the purpose
of rendering or offering to render services or for participating in the planning,
directing or conducting of programs which are designed to modify communicative
disorders involving speech, language, auditory or vestibular function, or
other aberrant behavior relating to hearing loss. An audiologist may engage
in any tasks, procedures, acts, or practices that are necessary for the evaluation
of hearing, for training in the use of amplification including hearing instrument,
for the making of earmolds for hearing instrument, for the fitting, dispensing,
and sale of hearing instrument or for the management of cerumen. An audiologist
may participate in consultation regarding noise control and hearing conservation,
may provide evaluations of environment or equipment including calibration
of equipment used in testing auditory functioning and hearing conservation,
and may perform the basic speech and language screening tests and procedures
consistent with his or her training.
(20)
Practice of speech-language pathology - The application
of nonmedical principles, methods, and procedures for the measurement, testing,
evaluation, prediction, counseling, habilitation, rehabilitation, or instruction
related to the development and disorders of communication, including speech,
voice, language, oral pharyngeal function, or cognitive processes, for the
purpose of rendering or offering to render services or for participating in
the planning, directing or conducting of programs which are designed to modify
communicative disorders and conditions in individuals or groups of individuals.
Speech-language pathologists may perform basic audiometric screening tests
and aural rehabilitation or habilitation consistent with his or her training.
(21)
Provisional license - A nonrenewable license issued
to an applicant who meets the requirements of §741.64 of this title (relating
to Requirements for a Provisional Speech- Language Pathology License) or §741.84
of this title (relating to Requirements for a Provisional Audiology License).
(22)
Registrant - An individual issued a temporary certificate
of registration or a registration to fit and dispense hearing instruments.
(23)
Registration to fit and dispense hearing instruments
- A registration issued to an audiologist or intern in audiology licensed
under this Act who completed a form received from the board office that declared
his or her intent to fit and dispense hearing instruments as required by §741.87
of this title (relating to Requirements for Registration of Audiologists and
Interns in Audiology who Fit and Dispense Hearing Instruments).
(24)
Sale or purchase - Includes the sale, lease or rental
of a hearing instrument to a member of the consuming public who is a user
or prospective user of a hearing instrument.
(25)
Speech-language pathologist - An individual who meets
the requirements of Subchapter E of this chapter (relating to Requirements
for Licensure and Registration of Speech- Language Pathologists) and holds
a valid license to practice speech-language pathology.
(26)
Student in audiology - An individual pursuing a course
of study leading to a degree with an emphasis in audiology and who works within
the educational institution or one of its cooperating programs under the direct,
on-site supervision and direction of an audiologist licensed under the Act.
(27)
Student in speech-language pathology - An individual
pursuing a course of study leading to a degree with an emphasis in speech-language
pathology and who works within the educational institution or one of its cooperating
programs under the direct, on-site supervision and direction of a speech-language
pathologist licensed under the Act.
(28)
Temporary certificate of registration - A nonrenewable
document issued to an individual who meets all requirements for licensure
as required by §741.61 of this title (relating to Requirements for a
Speech-Language Pathology License) or §741.81 of this title (relating
to Requirements for an Audiology License) and is in the processing of taking
the examination as required by §741.122 of this title (relating to Administration).
(29)
Thirty-day trial period - The purchaser of a hearing
instrument has possession of an appropriately fitted hearing instrument for
a total of 30 days.
(30)
Used hearing instrument - A hearing instrument that
has been worn for any period of time by a user. However, a hearing instrument
shall not be considered "used" merely because it has been worn by a prospective
user as a part of a bona fide hearing instrument evaluation conducted to determine
whether to select that particular hearing instruments for that prospective
user, if such evaluation has been conducted in the presence of the dispenser
or a hearing instruments health professional selected by the dispenser to
assist the buyer in making such a determination.
(31)
Year - A calendar year.
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 March
8, 1999.
TRD-9901410
Jon K. Ashby, Ph.D.
Chairperson
State Board of Examiners for Speech-Language Pathology and Audiology
Effective date: March 28, 1999
Proposal publication date: September 25, 1998
For further information, please call: (512) 458-7236
22 TAC §741.142
The amendment is adopted under Texas Civil Statutes, Article
4512j, §5 which provides the State Board of Examiners for Speech-Language
Pathology and Audiology with the authority to adopt rules necessary to administer
and enforce Article 4512j.
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 March
8, 1999.
TRD-9901412
Jon K. Ashby, Ph.D.
Chairperson
State Board of Examiners for Speech-Language Pathology and Audiology
Effective date: March 28, 1999
Proposal publication date: September 25, 1998
For further information, please call: (512) 458-7236
22 TAC §§741.62-741.165
The amendments are adopted under Texas Civil Statutes, Article
4512j, §5 which provides the State Board of Examiners for Speech-Language
Pathology and Audiology with the authority to adopt rules necessary to administer
and enforce Article 4512j.
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 March
8, 1999.
TRD-9901413
Jon K. Ashby, Ph.D.
Chairperson
State Board of Examiners for Speech-Language Pathology and Audiology
Effective date: March 28, 1999
Proposal publication date: September 25, 1998
For further information, please call: (512) 458-7236
Chapter 295.
Pharmacies
Chapter 303.
Destruction of Dangerous Drugs and Controlled Substances
Part XXXII.
State Board of Examiners for Speech-Language Pathology and Audiology
Subchapter J. Licensing and Registration Procedures
Subchapter K. License and Registration Renewal
Subchapter L. Fees and Processing Procedures