Part 10.
TEXAS FUNERAL SERVICE COMMISSION
Chapter 201.
LICENSING AND ENFORCEMENT--PRACTICE AND PROCEDURE
22 TAC §201.16
The Texas Funeral Service Commission (Commission) proposes
amendments to §201.16, concerning the Memorandum of Understanding between
the Commission and the Texas Department of Health published at 25 Texas Administrative
Code §181.27.
Currently, §201.16 adopts by reference the Memorandum of Understanding
between the Commission and the Department, published in 25 Texas Administrative
Code, §181.27. This proposed amendment sets forth the full language of
the Memorandum of Understanding, and makes other non-substantive changes.
O.C. Robbins, Executive Director, Texas Funeral Service Commission, has
determined that for the first five-year period this section is in effect,
there will be no fiscal implications for state or local government as a result
of enforcing or administering the section. There will be no effect on small
businesses. There is no anticipated economic cost to persons who are required
to comply with the proposed section, beyond what is already required under
the existing rule.
Mr. Robbins has also determined that for the first five-year period this
section is in effect, the public benefit will be licensee and consumer awareness
of the Memorandum of Understanding between the Commission and the Department.
The Memorandum of Understanding sets forth each agency's responsibilities
for the referral, investigation and resolution of complaints affecting the
administration and enforcement of state laws relating to vital statistics
and the licensing of funeral directors, and embalmers.
Comments on the proposal may be submitted in writing for a 30 day period
to O.C. Robbins, Executive Director, Texas Funeral Service Commission, P.O.
Box 12217, Capitol Station, Austin, Texas 78711-1440, 512-479-5064 (fax) or
chet.robbins@tfsc.state.tx.us. The staff will be available on the third Thursday
of the 30 day period following publication to hold a public hearing for interested
parties wishing to make comments.
The amendment is proposed under §651.152 of the Texas Occupations
Code which authorizes the Commission to issue such rules and regulations as
may be necessary to effect the provision of this section.
No other statutes, articles or codes are affected by the proposed amendment.
§201.16.Memorandum of Understanding with the Texas Department of Health.
(a)
Purpose. The purpose of this section is
to implement Texas Civil Statutes, Article 4582b, now codified as Texas Occupations
Code, Chapter 651, 76th Legislature, 1999, and Health and Safety Code, Chapters
193 and 195. In an effort to better protect the public health, safety and
welfare, it is the legislative intent of the laws of the Texas Department
of Health (Department) and the Texas Funeral Service Commission (TFSC) to
adopt by rule a memorandum of understanding to facilitate cooperation between
the agencies by establishing joint procedures and describing the actual duties
of each agency for the referral, investigation, and resolution of complaints
affecting the administration and enforcement of state laws relating to vital
statistics and the licensing of funeral directors and funeral establishments.
[
(b)
Scope.
(1)
The Memorandum of Understanding (MOU) includes the respective
responsibilities of the Department and the TFSC in regulating any person or
entity under the Health and Safety Code, Chapters 193 and 195, concerning
the completion and filing of death records.
(2)
The Department and the TFSC will implement the cooperative
procedure described in this memorandum to refer complaints to the other agency
when that complaint falls within the other agency's jurisdiction or may have
an affect on the administration and enforcement of the law for which the other
agency is responsible.
(3)
The Department and the TFSC will implement the cooperative
procedure described in this MOU in order to notify the other agency of violations
of Health and Safety Code, Chapters 193 and 195; and Texas Occupations Code,
Chapter 651 by funeral directors and funeral establishments, and to assist
and encourage funeral directors, embalmers, and funeral establishments to
conform their activities relating to the completion and filing of death records.
(4)
The MOU does not limit the authority of either agency,
acting in its own capacity under state or federal law, to investigate complaints
that fall within that agency's statutory jurisdiction.
(c)
Definitions. The following words and terms,
when used in this section, shall have the following meanings, unless the context
clearly indicates otherwise.
(1)
Agency--Texas Department of Health or the Texas Funeral
Service Commission.
(2)
Death record--A report of death, death certificate, or
a burial-transit permit, and such other forms as the Department or the Texas
Board of Health determine to be necessary.
(3)
Department--The Texas Department of Health or any local
registrar.
(4)
Funeral Director--A person who for compensation engages
in or conducts, or who holds himself out as being engaged, for compensation,
in preparing, other than the embalming, for the burial or disposition of dead
human bodies, and maintaining or operating a funeral establishment for the
preparation and disposition, or for the care of dead human bodies.
(5)
Funeral establishment--A place of business used in the
care and preparation for burial or transportation of dead human bodies, or
any other place where one or more persons, either as sole owner, in co-partnership,
or through corporate status, represent themselves to be engaged in the business
of embalming and/or funeral directing, or is so engaged.
(6)
Local registrar--
(A)
The justice of the peace is a local registrar of births
and deaths in a justice of the peace precinct. However, the duty of registering
births and deaths may be transferred to the county clerk if the justice of
the peace and the county clerk agree in writing and the agreement is ratified
by the commissioners court.
(B)
The municipal clerk or secretary is the local registrar
of births and deaths in a municipality with a population of 2,500 or more.
(C)
If a local registrar fails or refuses to register each
birth and death in the district or neglects duties, the county judge or the
mayor, as appropriate, shall appoint a new local registrar and shall send
the name and mailing address of the appointee to the state registrar.
(7)
Person--
(A)
includes corporation, organization, government, or governmental
subdivision or agency, business trust, estate, trust, partnership, association,
and any other legal entity; or
(B)
includes individual, corporation, or association where
enforcement of Health and Safety Code, Chapter 195 is involved.
(8)
Physician--Any individual licensed by the Texas Board of
Medical Examiners to practice medicine in this state.
(d)
Delegation of responsibilities. The Department
and TFSC agree that the agencies shall have the following responsibilities.
(1)
The Department shall have primary responsibility for the
enforcement of the laws, rules, and policies governing the collection and
maintenance of a system of vital statistics, including the collection and
maintenance of death records for the State of Texas. Except as may be otherwise
provided by law, the Department shall:
(A)
design the format and prescribe the data to be entered
on all forms that constitute the death records of the state;
(B)
prescribe the rules and procedures to be followed by a
funeral director licensed by TFSC in executing his/her responsibility to secure
the required data and file the completed death record;
(C)
establish rules or policies to determine when a local registrar
may accept the filing of a death record by a funeral director or the funeral
director's designee and the purposes for which each record may be used, including
the filing and uses of a delayed death certificate; and
(D)
enforce the provisions of the Health & Safety Code
(Code), Chapter 193, in accordance with Chapter 195 of the Code relating to
criminal penalties for violations of laws relating to vital statistics. These
laws include Chapters 191, 192, and 193 of the Code and rules adopted thereunder.
If the state registrar knows or suspects that a funeral director or a funeral
establishment has violated the provisions of §195.003 or other provisions
of Title 3 of the Code, he or she shall report the violation to the appropriate
district or county attorney for prosecution.
(2)
The Texas Funeral Service Commission (TFSC) shall have
primary responsibility for the enforcement of the laws, rules, and policies
governing the licensing of funeral directors, embalmers, funeral and commercial
embalming establishments. Except as may be otherwise provided by law, the
TFSC has authority:
(A)
to inspect a funeral establishment for violations of Chapter
193 of the Code; and
(B)
before a hearing, assess an administrative penalty or after
a hearing in accordance with Texas Occupations Code Chapter 651, to reprimand,
revoke, suspend, or probate the suspension of a license, impose any combination
of the sanctions against a licensed funeral director or funeral establishment
if the licensee has violated Chapter 193 of the Code;
(3)
Referral, investigation, and resolution of complaint.
(A)
If the Department receives a complaint that alleges conduct
by a funeral director or a funeral establishment that constitutes possible
violations of Texas Occupations Code, Chapter 651, or the rules adopted by
TFSC under authority of Texas Occupations Code, Chapter 651, the Department
may refer the complaint to the TFSC for investigation and disposition; however,
if the complaint describes conduct by any person or entity licensed under
Texas Occupations Code, Chapter 651 that constitutes possible violations of
Chapters 193 and 195 of the Code, the Department shall retain jurisdiction
over the subject matter of the complaint, investigate the complaint, and if
valid, shall file a complaint with TFSC; or the Department or any local vital
statistics registrar may refer the complaint to TFSC for investigation and
adjudication.
(B)
If TFSC receives a complaint that alleges conduct by any
person that constitutes possible violations of Title 3 of the Code, TFSC shall
immediately notify the Department of the complaint for any appropriate action
by the Department.
(C)
If either agency receives a complaint that alleges facts
that constitute a violation of any other law, the complaint shall be referred
to the appropriate state administrative agency or state or local law enforcement
agency.
(D)
Each agency shall appoint at least one person to an interagency
team that will meet at least biannually and at that time review each unresolved
complaint that affects the agencies jointly.
(i)
If the complaint has not been referred for investigation
and resolution, the team will refer the complaint to the Department, TFSC,
or other appropriate state administrative or law enforcement agency, including
the State Board of Medical Examiners, or local law enforcement agency.
(ii)
If the Department and the TFSC determine that a complaint
has been incorrectly referred, they will refer the complaint appropriately.
(E)
To the extent allowed by law, each agency shall cooperate
and assist the other in the investigation and resolution of complaints. The
following actions may be taken where indicated in the other's enforcement
actions.
(i)
Either agency may request the assistance of the other in
the investigation of a complaint.
(ii)
Each agency may share information obtained during the
complaint investigation with the other agency when the subject matter of the
complaint affects both agencies.
(iii)
Any information obtained by the TFSC as a result of a
complaint investigation is not subject to public disclosure under the Government
Code, §552.101, by virtue of Texas Occupations Code, Chapter 651, §651.203,
until the case has reached its final disposition.
(iv)
Each agency shall make its personnel available to testify
in an administrative or judicial proceeding brought on behalf of the other
agency, when the personnel has knowledge of information that is material to
the subject matter of the proceeding.
(e)
Effective date. This section shall become
effective on August 1, 1994. The MOU may be amended at any time upon mutual
agreement of the agencies and the amendments are effective as to each agency
20 days after the adopted amendments are filed with the
Texas Register.
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 June 4, 2002.
TRD-200203463
O.C. "Chet" Robbins
Executive Director
Texas Funeral Service Commission
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 936-2466
Chapter 271.
EXAMINATIONS
22 TAC §§271.1, 271.2, 271.6
The Texas Optometry Board proposes amendments to Rules §§271.1,
271.2 and 271.6 in order to correct the legal citations to the Texas Optometry
Act. The new citations will be to the Act as codified in the Texas Occupations
Code. The Board also proposes to amend §271.6 to include the statutory
change in §351.254(c) of the Optometry Act that permits fourth year students
in good standing and in the last semester of optometry school to take the
state jurisprudence examination. These amendments are proposed as part of
the Board's rule review process.
Chris Kloeris, Executive Director of the Texas Optometry Board, has determined
that for the first five-year period the amendments are in effect, there will
be no fiscal implications for state and local governments as a result of enforcing
or administering the amendments.
Mr. Kloeris also has determined that for each of the first five years the
amendments are in effect, the public benefit anticipated as a result of enforcing
the amendments is that applicants for license can utilize the provisions of
the Optometry Act without confusion over contradictory language in the rule.
The public benefit will also include licensees, applicants, and the public
having access to the correct reference to the Texas Optometry Act. It has
also been determined that the amendments will not impose any additional costs
to the persons affected by the rule. No additional costs are foreseen for
small or micro business.
Comments on the proposal may be submitted to Chris Kloeris, Executive Director,
Texas Optometry Board, 333 Guadalupe Street, Suite 2-420, Austin, Texas 78701-3942.
The deadline for furnishing comments is thirty days after publication in the
The amendments are proposed under the Texas Optometry Act, Texas
Occupations Code, §351.151. The amendments affect §§351.151
and 351.254.
The Texas Optometry Board interprets §351.151 as authorizing the adoption
of procedural and substantive rules for the regulation of the optometric profession.
Section 351.254 authorizes certain fourth year students to take the examination.
§271.1.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 Texas Optometry Act,
Chapter 351, Texas Occupations
Code
[
(2)-(8)
(No change.)
§271.2.Applications
(a)-(d)
(No change.)
(e)
Any person furnishing false information in such application
shall be denied the right to take the examination, or if the applicant has
been licensed before it is made known to the board of the falseness of such
information, such license shall be subject to suspension, revocation, or cancellation
in accordance with the Act,
§351.501
[
(f)-(i)
(No change.)
§271.6.National Board Examination
(a)
The board determines that the written examination by the
National Board of Examiners in Optometry (NBEO) known as Part I and Part II
complies in all material respects with the written examination requirements
of the Act,
§351.255 and §351.256
[
(b)
The board determines that the practical examination known
as Part III by the National Board of Examiners in Optometry (NBEO) complies
in all material respects with the practical examination requirements of the
Act,
§351.255 and §351.256
[
(c)
All applicants must comply with the application process
and qualification criteria of the Act,
§351.254
[
(d)
(No change.)
(e)
In addition to the NBEO examinations referenced in subsections
(a) and (b) of this section, all applicants shall take and pass a written
jurisprudence examination given by the Texas Optometry Board in order to be
eligible for licensure. The board shall administer the jurisprudence written
examination at least on a quarterly schedule. The jurisprudence examination
can be administered in conjunction with Part III of the NBEO, provided the
applicant has graduated from an approved college of optometry and has completed
application with the board.
However, an applicant who meets the other
requirements of this section and §351.254 of the Act may take the examination
without having graduated, if the dean of a college of optometry that meets
the requirements of the board notifies the board in writing that the applicant
is enrolled in good standing in the college and is in the final semester before
graduation.
(f)
(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 June 5, 2002.
TRD-200203498
Chris Kloeris
Executive Director
Texas Optometry Board
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8500
Chapter 281.
ADMINISTRATIVE PRACTICE AND PROCEDURES
Subchapter A. GENERAL PROVISIONS
22 TAC §§281.2, 281.4, 281.14, 281.17
The Texas State Board of Pharmacy proposes amendments to §281.2,
concerning Definitions, §281.4, concerning Official Acts in Writing and
Open to the Public, §281.14, concerning Charges for Public Records, and §281.17,
concerning Historically Underutilized Businesses. The amendments, if adopted,
will correct and/or simplify citations referenced in the rules.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rules are in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rules. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rules will be in effect, the public benefit anticipated as a result of
enforcing the rules will be increased productivity due to accurately cross
referenced citations. There is no fiscal impact anticipated for small or large
businesses, or other entities required to comply with the rules.
Written comments on the proposed amendments may be submitted to Steve Morse,
R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by 5 p.m., August 1, 2002.
The amendments are proposed under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations Code). The
Board interprets §551.002 as authorizing the agency to protect the public
through the effective control and regulation of the practice of pharmacy.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act.
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§281.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise:
(1) - (25)
(No change.)
(26)
Texas
Public Information
[
§281.4.Official Acts in Writing and Open to the Public.
All official acts of the board shall be evidenced by a written record.
Such writings shall be open to the public in accordance with the Act and the
Texas
Public Information
[
§281.14.Charges for Public Records.
In accordance with Government Code, Chapter 552, the following specifies
the charges the agency will make for copies of public information.
(1)
(No change.)
(2)
Charges.
(A)
The charge for providing copies of public information shall
be determined in accordance with the rules promulgated by the
Texas Building
and Procurement
[
(B) - (E)
(No change.)
§281.17.Historically Underutilized Businesses
The Texas State Board of Pharmacy adopts by reference the rules promulgated
by the
Texas Building and Procurement
[
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 June 7, 2002.
TRD-200203549
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
22 TAC §§281.27, 281.33, 281.43, 281.45
The Texas State Board of Pharmacy proposes amendments to §281.27,
concerning Service of Documents on Parties, §281.33, concerning Discovery, §281.43,
concerning Public Attendance and Comment at Hearing; and §281.45, concerning
Evidence. The amendments, if adopted, will correct and/or simplify citations
referenced in the rules.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rules are in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rules. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rules will be in effect, the public benefit anticipated as a result of
enforcing the rules will be increased productivity due to accurately cross
referenced citations. There is no fiscal impact anticipated for small or large
businesses, or other entities required to comply with the rules.
Written comments on the proposed amendments may be submitted to Steve Morse,
R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by 5 p.m., August 1, 2002.
The amendments are proposed under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations Code). The
Board interprets §551.002 as authorizing the agency to protect the public
through the effective control and regulation of the practice of pharmacy.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act.
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§281.27.Service of Documents on Parties.
(a)
Service on all parties. Any person filing a document with
SOAH in a case shall, on the same date as the document is filed, provide a
copy to each party or the party's authorized representative by hand-delivery;
by regular, certified or registered mail; by electronic mail, upon agreement
of the parties; or by facsimile transmission; provided however, when a party
files a business record affidavit, pursuant to Texas Rules of [
(b) - (d)
(No change.)
§281.33.Discovery
(a)
(No change.)
(b)
Parties may obtain discovery regarding any matter not privileged
or exempted by the Texas Rules of Civil Procedure, Texas Rules of [
(c)
(No change.)
(d)
Parties may obtain discovery by the following methods:
oral or written depositions; written interrogatories to a party; requests
of a party for admission of facts and the genuineness or identity of documents;
requests and motions for production, examination, and copying of documents
and other tangible materials; and requests and motions for entry upon and
examination of real property.
(1)
Interrogatories. Unless the ALJ directs otherwise, each
party may serve no more than two sets of interrogatories to any other party.
The number of questions, including subsections, in a set of interrogatories
shall be limited so as not to require more than thirty answers.
(A) - (B)
(No change.)
(C)
Interrogatories may relate to any matters which can be
inquired into under the Texas Rules of Civil Procedure, [
(D)
Interrogatories may be served after a deposition has been
taken, and a deposition may be sought after interrogatories have been answered,
but the ALJ, on motion of the deposition witness or the party interrogated,
may make such protective order as justice may require. The provisions of the
Texas Rules of Civil Procedure, [
(E)
(No change.)
(2) - (4)
(No change.)
(e) - (f)
(No change.)
(g)
A responding party is under a continuing duty to reasonably
supplement its discovery responses under the circumstances specified in the
Texas Rules of Civil Procedure[
(h)
Objections to discovery requests shall be filed within
ten days after receipt.
(1)
(No change.)
(2)
If an objection is founded upon a claim of privilege or
exemption under Texas Rules of Civil Procedure [
(i) - (k)
(No change.)
§281.43.Public Attendance and Comment at Hearing.
(a) - (b)
(No change.)
(c)
When required by statute, members of the public shall be
allowed to make public comment addressing matters pertinent to the issues
in the case. Unless otherwise provided by law, public comment is not part
of the evidentiary record of the case unless sworn, subject to cross-examination,
offered by a party in accordance with the ALJ's orders and received in accordance
with the Texas Rules of [
§281.45.Evidence.
(a)
Relevancy of evidence. In a contested case, evidence that
is irrelevant, immaterial, or unduly repetitious, as those terms are defined
by the Texas Rules of [
(b) - (e)
(No change.)
(f)
Documentary Evidence.
(1)
(No change.)
(2)
An exhibit excluded from evidence will be considered withdrawn
by the offering party, and will be returned to the party, unless the party
makes an offer of proof in accordance with the Texas Rules of [
(g)
(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 June 7, 2002.
TRD-200203550
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes the repeal of §281.40,
concerning Participation by Telephone and simultaneously proposes new §281.40,
concerning Participation by Telephone. The new rule, if adopted, will update
the section to be consistent with rules adopted by the State Office of Administrative
Hearings (SOAH).
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the rule.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be consistency between the requirements of SOAH and
the Texas State Board of Pharmacy. There is no fiscal impact anticipated for
small or large businesses or other entities required to comply with the rule.
Written comments on the proposed new rule may be submitted to Steve Morse,
R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by 5 p.m., August 1, 2002.
22 TAC §281.40
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas State Board of Pharmacy or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations Code). The
Board interprets §551.002 as authorizing the agency to protect the public
through the effective control and regulation of the practice of pharmacy.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act.
The statutes affected by the repeal: Chapters 551 - 566, Texas Occupations
Code.
§281.40.Participation by Telephone.
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 June 7, 2002.
TRD-200203555
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
22 TAC §281.40
The new rule is proposed under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations Code). The
Board interprets §551.002 as authorizing the agency to protect the public
through the effective control and regulation of the practice of pharmacy.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act.
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§281.40.Participation by Telephone.
(a)
A party may request to appear by telephone or videoconferencing
or to present the testimony of a witness by such methods, upon timely motion
stating the reason(s) for the request and containing the pertinent telephone
number(s). A timely motion that is unopposed will be deemed granted without
the necessity of an order, unless denied by order of the judge.
(b)
The judge may conduct a prehearing conference by telephone
or videoconferencing upon adequate notice to the parties, even in the absence
of party motion.
(c)
All substantive and procedural rights apply to telephone
and videoconferencing rehearings and hearings, subject only to the limitations
of the physical arrangement.
(d)
Documentary evidence to be offered at a telephone or videoconferencing
prehearing conference or hearing shall be served on all parties and filed
with SOAH at least three days before the prehearing or hearing unless the
judge, by written order, amends the filing deadline.
(e)
For a telephone or videoconferencing hearing or prehearing
conference, the following may be considered a failure to appear and grounds
for default if the conditions exist for more than ten minutes after the scheduled
time for hearing or prehearing conference:
(1)
failure to answer the telephone or videoconference line;
(2)
failure to free the line for the proceeding; or
(3)
failure to be ready to proceed with the hearing or prehearing
conference as scheduled.
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 June 7, 2002.
TRD-200203556
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
Subchapter A. ALL CLASSES OF PHARMACIES
22 TAC §291.20
The Texas State Board of Pharmacy proposes amendments to §291.20,
concerning Remote Pharmacy Services. The amendments, if adopted, will (1)
add Assisted Living Centers to the list of facilities in which automated pharmacy
systems may be located; and (2) delete the requirement for the signature of
the medical director or other person responsible for the on-site operation
of the facility on renewal applications.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to: (1) increase the provision of pharmacy services
within certain facilities; and (2) provide an easier renewal process. Since
remote pharmacy services are not required, there is no fiscal impact anticipated
for small or large businesses or to other entities who are required to comply
with this section.
Written comments on the proposed amendments may be submitted to Steve Morse,
R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by 5 p.m., August 1, 2002.
The amendments are proposed under §§551.002, 554.051,
562.108, 562.109, and 562.110 of the Texas Pharmacy Act (Chapters 551 - 566,
Texas Occupations Code). The Board interprets §551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §554.051 as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets §562.108 as authorizing the agency to adopt
rules for Emergency Medication Kits. The Board interprets §562.109 as
authorizing the agency to adopt rules for Automated Pharmacy Systems. The
Board interprets §562.110 as authorizing the agency to adopt rules for
Telepharmacy Systems.
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§291.20.Remote Pharmacy Services.
(a)
Remote pharmacy services using automated pharmacy systems.
(1) - (2)
(No change.)
(3)
General requirements.
(A)
A provider pharmacy may provide remote pharmacy services
using an automated pharmacy system to a jail or prison operated by or for
the State of Texas, a jail or prison operated by local government or a healthcare
facility regulated under Chapter 142, 242,
247,
or 252, Health
and Safety Code provided drugs are administered by a licensed healthcare
professional working in the jail, prison, or healthcare facility.
(B) - (G)
(No change.)
(4)
Operational standards.
(A)
Application for permission to provide pharmacy services
using an automated pharmacy system.
(i)
A Class A or Class C Pharmacy shall make application to
the board to provide remote pharmacy services using an automated pharmacy
system. The application shall contain an affidavit with the notarized signatures
of the pharmacist-in-charge, and the medical director or the person responsible
for the on-site operation of the facility (e.g., administrator, chief operating
officer, owner, chief executive
officer
[
(I) - (III)
(No change.)
(IV)
documentation that the automated pharmacy system is located
where medications are administered by license healthcare professionals and
is:
(-a-)
a facility regulated under Chapter 142, 242,
247,
or 252, Health and Safety Code; or
(-b-)
a jail or prison, operated by the State of Texas or local
government.
(ii)
Such application shall be resubmitted every two years
in conjunction with the application for renewal of the provider pharmacy's
license. The renewal petition shall contain the documentation required in
clause (i) of this subparagraph
except the notarized signature of the
medical director or the person responsible for the on-site operation of the
facility (e.g., administrator, chief operating officer, owner, chief executive
officer) is not required
.
(iii)
(No change.)
(B) - (H)
(No change.)
(5)
(No change.)
(b)
Remote pharmacy services using emergency medication kits.
(1)-(3)
(No change.)
(4)
Operational standards.
(A)
Application for permission to provide pharmacy services
using an emergency medication kit.
(i)
A Class A or Class C Pharmacy shall make application to
the board to provide remote pharmacy services using an emergency medication
kit. The application shall contain an affidavit with the notarized signatures
of the pharmacist-in-charge, and the medical director or the person responsible
for the on-site operation of the facility (e.g., administrator, owner, chief
executive
officer
[
(I)-(IV)
(No change.)
(ii)
Such application shall be resubmitted every two years
in conjunction with the application for renewal of the provider pharmacy's
license. The renewal petition shall contain the documentation required in
clause (i) of this subparagraph
except the notarized signature of the
medical director or the person responsible for the on-site operation of the
facility (e.g., administrator, owner, chief executive officer, chief operating
officer) is not required
.
(iii)
(No change.)
(B)-(G)
(No change.)
(5)
(No change.)
(c)
Remote pharmacy services using telepharmacy systems.
(1)-(3)
(No change.)
(4)
Operational standards.
(A)
Application to provide pharmacy services using a telepharmacy
system.
(i)
A Class A or class C Pharmacy shall make application to
the board to provide remote pharmacy services using a telepharmacy system.
The application shall contain an affidavit with the notarized signatures
of pharmacist-in-charge, and the medical director or the person responsible
for the on-site operation of the facility (e.g., administrator, owner, chief
executive
officer
[
(I) - (V)
(No change.)
(ii)
Such application shall be resubmitted every two years
in conjunction with the renewal of the provider pharmacy's license. The renewal
application shall contain the documentation required in clause (i) of this
subparagraph
except the notarized signature of the medical director
or the person responsible for the on-site operation of the facility (e.g.,
administrator, owner, chief executive officer, chief operating officer) is
not required
.
(iii)
(No change.)
(B) - (F)
(No change.)
(5)
(No change.)
(d)
(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 June 7, 2002.
TRD-200203551
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
22 TAC §291.32, §291.36
The Texas State Board of Pharmacy proposes amendments to §291.32,
concerning Personnel, and §291.36, concerning Class A Pharmacies Compounding
Sterile Pharmaceuticals. The amendments, if adopted, will (1) permit a pharmacist
to be in-charge of two Class A pharmacies open at the same time under certain
conditions; and (2) separate responsibilities of the pharmacist-in-charge
and the owner of a Class A pharmacy license.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rules are in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rules. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rules will be in effect, the public benefit anticipated as a result of
enforcing the rules will be to: (1) improve the availability of pharmacists-in-charge;
and (2) separate the responsibilities of the pharmacist-in-charge and owner
of a pharmacy to increase individual accountability. There is no fiscal impact
anticipated for small or large businesses or to other entities who are required
to comply with the sections.
Written comments on the proposed amendments may be submitted to Steve Morse,
R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by 5 p.m., August 1, 2002.
The amendments are proposed under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations Code). The
Board interprets §551.002 as authorizing the agency to protect the public
through the effective control and regulation of the practice of pharmacy.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act.
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§291.32.Personnel.
(a)
Pharmacist-in-charge.
(1)
General.
(A)
Each Class A pharmacy shall have one pharmacist-in-charge
who is employed on a full-time basis, who may be the pharmacist-in-charge
for only one such pharmacy; provided, however, such pharmacist-in-charge may
be the pharmacist-in-charge of
:
(i)
more than one Class A pharmacy, if the additional
Class A pharmacies are not open to provide pharmacy services simultaneously
; or
(ii)
up to two Class A pharmacies open simultaneously
if the pharmacist-in- charge works at least 10 hours per week in each pharmacy.
(B)
The pharmacist-in-charge shall comply with the provisions
of §291.17 of this title (relating to Inventory Requirements).
(2)
Responsibilities.
The pharmacist-in-charge shall have
responsibility for the practice of pharmacy at the pharmacy for which he or
she is the pharmacist-in-charge. The pharmacist-in-charge may advise the owner
on administrative or operational concerns.
The pharmacist-in-charge
shall have responsibility for, at a minimum, the following:
[(A)
dispensing of drugs, including:]
[(i)
packaging, preparation, compounding, and labeling; and
]
[(ii)
ensuring that drugs are dispensed safely, and accurately
as prescribed;]
[(B)
delivery of drugs to the patient or the
patient's agent, including ensuring that drugs are delivered safely, and accurately
as prescribed;
[(C)
assuring that a pharmacist communicates
to the patient or the patient's agent information about the prescription drug
or device which in the exercise of the pharmacist's professional judgment,
the pharmacist deems significant as specified in §291.33(c) of this title
(relating to Operational Standards);]
[(D)
assuring that a pharmacist communicates
to the patient or the patient's agent on their request, information concerning
any prescription drugs dispensed to the patient by the pharmacy;]
[(E)
assuring that a reasonable effort is
made to obtain, record, and maintain patient medication records;]
(A)
[
(B)
[
(C)
[
(D)
[
(E)
[
(F)
[
(G)
[
(H)
[
(I)
[
(J)
[
(i)
reviewing and approving all policies and procedures for
system operation, safety, security, accuracy and access, patient confidentiality,
prevention of unauthorized access, and malfunction;
(ii)
inspecting medications in the automated pharmacy dispensing
system, at least monthly, for expiration date, misbranding, physical integrity,
security, and accountability;
(iii)
assigning, discontinuing, or changing personnel access
to the automated pharmacy dispensing system;
(iv)
ensuring that pharmacy technicians and licensed healthcare
professionals performing any services in connection with an automated pharmacy
dispensing system have been properly trained on the use of the system and
can demonstrate comprehensive knowledge of the written policies and procedures
for operation of the system; and
(v)
ensuring that the automated pharmacy dispensing system
is stocked accurately and an accountability record is maintained in accordance
with the written policies and procedures of operation.
(b)
Owner. The owner of a Class A pharmacy
shall have responsibility for all administrative and operational functions
of the pharmacy. The pharmacist-in-charge may advise the owner on administrative
and operational concerns. The owner shall have responsibility for, at a minimum,
the following, and if the owner is not a Texas licensed pharmacist, the owner
shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
(1)
establishment of policies for procurement of prescription
drugs and devices and other products dispensed from the Class A pharmacy;
(2)
establishment and maintenance of effective controls against
the theft or diversion of prescription drugs;
(3)
if the pharmacy uses an automated pharmacy dispensing system,
reviewing and approving all policies and procedures for system operation,
safety, security, accuracy and access, patient confidentiality, prevention
of unauthorized access, and malfunction; and
(4)
providing the pharmacy with the necessary equipment and
resources commensurate with its level and type of practice.
(c)
[
(1)
General.
(A)
The pharmacist-in-charge shall be assisted by sufficient
number of additional licensed pharmacists as may be required to operate the
Class A pharmacy competently, safely, and adequately to meet the needs of
the patients of the pharmacy.
(B)
All pharmacists shall assist the pharmacist-in-charge in
meeting his or her responsibilities in ordering, dispensing, and accounting
for prescription drugs.
(C)
Pharmacists are solely responsible for the direct supervision
of pharmacy technicians and for designating and delegating duties, other than
those listed in paragraph (2) of this subsection, to pharmacy technicians.
Each pharmacist:
(i)
shall verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians; and
(ii)
shall be responsible for any delegated act performed by
pharmacy technicians under his or her supervision.
(D)
All pharmacists while on duty, shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(E)
A dispensing pharmacist shall ensure that the drug is dispensed
and delivered safely, and accurately as prescribed. In addition, if multiple
pharmacists participate in the dispensing process, each pharmacist shall ensure
the safety and accuracy of the portion of the process the pharmacist is performing.
The dispensing process shall include, but not be limited to, drug regimen
review and verification of accurate prescription data entry,
packaging,
preparation, compounding and
labeling [
(2)
Duties. Duties which may only be performed by a pharmacist
are as follows:
(A)
receiving oral prescription drug orders and reducing these
orders to writing, either manually or electronically;
(B)
interpreting prescription drug orders;
(C)
selection of drug products;
(D)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the prescription has been dispensed
accurately as prescribed;
(E)
communicating to the patient or patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgement, the pharmacist deems significant, as specified in §291.33(c)
of this title;
(F)
communicating to the patient or the patient's agent on
his or her request information concerning any prescription drugs dispensed
to the patient by the pharmacy;
(G)
assuring that a reasonable effort is made to obtain, record,
and maintain patient medication records;
(H)
interpreting patient medication records and performing
drug regimen reviews; and
(I)
performing a specific act of drug therapy management for
a patient delegated to a pharmacist by a written protocol from a physician
licensed in this state in compliance with the Medical Practice Act.
(3)
Special requirements for nonsterile compounding.
(A)
All pharmacists engaged in compounding shall possess the
education, training, and proficiency necessary to properly and safely perform
compounding duties undertaken or supervised. Continuing education shall include
training in the art and science of compounding and the legal requirements
for compounding.
(B)
A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials involved
in the compounding process.
(C)
A pharmacist shall review all compounding records for accuracy
and conduct in-process and final checks to assure that errors have not occurred
in the compounding process.
(D)
A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(d)
[
(1)
Qualifications.
(A)
General. All pharmacy technicians shall:
(i)
have a high school or equivalent degree, e.g., GED, or
be currently enrolled in a program which awards such a degree; and
(ii)
complete a structured didactic and experiential training
program, which provides instruction and experience in the areas listed in
paragraph (4) of this subsection.
(iii)
Effective January 1, 2001, all pharmacy technicians must
have taken and passed the National Pharmacy Technician Certification Exam
or other examination approved during an open meeting by the Board or be a
pharmacy technician trainee.
(B)
Pharmacy Technician Trainee.
(i)
A person shall be designated as a pharmacy technician trainee
while participating in a pharmacy's technician training program in preparation
for the National Pharmacy Technician Certification Exam or other examination
approved during an open meeting by the Board.
(ii)
A person may be designated a pharmacy technician trainee
for no more than one year. A person may not be a technician trainee if they
fail to pass the certification exam within this one year training period.
This clause does not apply to a pharmacy technician trainee working in a pharmacy
as part of a training program accredited by the American Society of Health-System
Pharmacists or an individual enrolled in a health science technology education
program in a Texas high school.
(iii)
Individuals enrolled in a health science technology education
program in a Texas high school that is accredited by the Texas Education Agency,
may be designated as a pharmacy technician trainee for up to two years provided:
(I)
the work as a pharmacy technician is concurrent with enrollment
in a health science technology education program, which may include:
(-a-)
partial semester breaks such as spring breaks;
(-b-)
between semesters; and
(-c-)
whole semester breaks provided the individual was enrolled
in the health science technology education program in the immediate preceding
semester and is scheduled with the high school to attend in the immediate
subsequent semester;
(II)
the individual is under the direct supervision of and
responsible to a pharmacist; and
(III)
the supervising pharmacist verifies the accuracy of all
acts, tasks, or functions performed by the individual.
(C)
Certified Pharmacy Technicians.
(i)
All certified pharmacy technicians shall have taken and
passed the National Pharmacy Technician Certification Exam or other examination
approved during an open meeting by the Board and maintain a current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(ii)
A certified pharmacy technician shall publicly display
their current certification certificate in the technician's primary place
of practice and a copy of their current certification certificate in all other
pharmacies where the technician performs the duties of a technician.
(2)
Duties.
(A)
Pharmacy technicians may not perform any of the duties
listed in subsection (b)(2) of this section.
(B)
A pharmacist may delegate to pharmacy technicians any nonjudgmental
technical duty associated with the preparation and distribution of prescription
drugs provided:
(i)
a pharmacist verifies the accuracy of all acts, tasks,
and functions performed by pharmacy technicians;
(ii)
pharmacy technicians are under the direct supervision
of and responsible to a pharmacist; and
(iii)
effective September 1, 2000, only pharmacy technicians
who have been properly trained on the use of an automated pharmacy dispensing
system and can demonstrate comprehensive knowledge of the written policies
and procedures for the operation of the system may be allowed access to the
system; and
(C)
Pharmacy technicians may perform only nonjudgmental technical
duties associated with the preparation and distribution of prescription drugs,
including but not limited to the following:
(i)
initiating and receiving refill authorization requests;
(ii)
entering prescription data into a data processing system;
(iii)
taking a stock bottle from the shelf for a prescription;
(iv)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(v)
affixing prescription labels and auxiliary labels to the
prescription container provided:
(I)
the pharmacy technician has completed the education and
training requirements outlined in paragraphs (1) and (4) of this subsection;
and
(II)
effective January 1, 2001, only certified pharmacy technicians
may affix a label to a prescription container.
(vi)
reconstituting medications;
(vii)
prepackaging and labeling prepackaged drugs;
(viii)
loading bulk unlabeled drugs into an automated dispensing
system provided a pharmacist verifies that the system is properly loaded prior
to use;
(ix)
compounding non-sterile prescription drug orders; and
(x)
bulk compounding.
(3)
Ratio of pharmacist to pharmacy technicians.
(A)
The ratio of pharmacists to pharmacy technicians may not
exceed 1:2
(B)
The ratio of pharmacists to pharmacy technicians may be
1:3 provided that at least one of the three technicians is certified.
(4)
Training.
(A)
pharmacy technicians shall complete initial training as
outlined by the pharmacist-in-charge in a training manual. Such training:
(i)
shall include training and experience as outlined in paragraph
(5) of this subsection; and
(ii)
may not be transferred to another pharmacy unless:
(I)
the pharmacies are under common ownership and control and
have a common training program; and
(II)
the pharmacist-in-charge of each pharmacy in which the
pharmacy technician works certifies that the pharmacy technician is competent
to perform the duties assigned in that pharmacy.
(B)
A pharmacy technician shall be designated a pharmacy technician
trainee until completing the full training program. A pharmacy technician
trainee:
(i)
may perform all of the duties of a pharmacy technician
except affix a label to a prescription container;
(ii)
may be designated a pharmacy technician trainee for no
longer than one year except as specified in paragraph (1)(B) of this subsection;
and
(iii)
shall be counted in the pharmacist to pharmacy technician
ratio.
(C)
The pharmacist-in-charge shall assure the continuing competency
of pharmacy technicians through in-service education and training to supplement
initial training.
(D)
The pharmacist-in-charge shall document the completion
of the training program and certify the competency of pharmacy technicians
completing the training. A written record of initial and in-service training
of pharmacy technicians shall be maintained and contain the following information:
(i)
name of the person receiving the training;
(ii)
date(s) of the training;
(iii)
general description of the topics covered;
(iv)
a statement or statements that certifies that the pharmacy
technician is competent to perform the duties assigned;
(v)
name of the person supervising the training; and
(vi)
signature of the pharmacy technician and the pharmacist-in-charge
or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge
as responsible for training of pharmacy technicians.
(E)
A person who has previously completed training as a pharmacy
technician, or a licensed nurse or physician assistant is not required to
complete the entire training program if the person is able to show competency
through a documented assessment of competency. Such competency assessment
may be conducted by personnel designated by the pharmacist-in-charge, but
the final acceptance of competency must be approved by the pharmacist-in-charge.
(5)
Training program. Pharmacy technician training shall be
outlined in a training manual. Such training manual shall, at a minimum, contain
the following:
(A)
written procedures and guidelines for the use and supervision
of pharmacy technicians. Such procedures and guidelines shall:
(i)
specify the manner in which the pharmacist responsible
for the supervision of pharmacy technicians will supervise such personnel
and verify the accuracy and completeness of all acts, tasks, and functions
performed by such personnel; and
(ii)
specify duties which may and may not be performed by pharmacy
technicians; and
(B)
instruction in the following areas and any additional areas
appropriate to the duties of pharmacy technicians in the pharmacy:
(i)
Orientation;
(ii)
Job descriptions;
(iii)
Communication techniques;
(iv)
Laws and rules;
(v)
Security and safety;
(vi)
Prescription drugs:
(I)
Basic pharmaceutical nomenclature;
(II)
Dosage forms;
(vii)
Prescription drug orders:
(I)
Prescribers;
(II)
Directions for use;
(III)
Commonly-used abbreviations and symbols;
(IV)
Number of dosage units;
(V)
Strengths and systems of measurement;
(VI)
Routes of administration;
(VII)
Frequency of administration;
(VIII)
Interpreting directions for use;
(viii)
Prescription drug order preparation:
(I)
Creating or updating patient medication records;
(II)
Entering prescription drug order information into the
computer or typing the label in a manual system;
(III)
Selecting the correct stock bottle;
(IV)
Accurately counting or pouring the appropriate quantity
of drug product;
(V)
Selecting the proper container;
(VI)
Affixing the prescription label;
(VII)
Affixing auxiliary labels, if indicated; and
(VIII)
Preparing the finished product for inspection and final
check by pharmacists;
(ix)
Other functions;
(x)
Drug product prepackaging;
(xi)
Compounding of non-sterile pharmaceuticals;
(xii)
Written policy and guidelines for use of and supervision
of pharmacy technicians.
(e)
[
(1)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee, pharmacy technician, or a certified
pharmacy technician.
(2)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies him
or her as a pharmacist intern.
(3)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals.
(a) - (b)
(No change.)
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
General.
(i)
Each Class A pharmacy compounding sterile pharmaceuticals
shall have one pharmacist-in-charge who is employed on a full-time basis,
who may be the pharmacist-in- charge for only one such pharmacy; provided,
however, such pharmacist-in-charge may be the pharmacist-in-charge of
;
(I)
more than one Class A pharmacy, if the additional
Class A pharmacies are not open to provide pharmacy services simultaneously
; or
[
(II)
up to two Class A pharmacies open simultaneously
if the pharmacist-in-charge works at least 10 hours per week in each pharmacy.
(ii)
The pharmacist-in-charge shall comply with the provisions
of §291.17 of this title (relating to Inventory Requirements).
(B)
Responsibilities.
The pharmacist-in-charge shall have
responsibility for the practice of pharmacy at the pharmacy for which he
or she is the pharmacist-in- charge. The pharmacist-in-charge may advise
the owner on administrative and operational concerns.
The pharmacist-in-charge
shall have the responsibility for, at a minimum, the following:
[(i)
ensuring that drugs and/or devices are
dispensed and delivered safely and accurately as prescribed;]
[(ii)
that a pharmacist communicates to the
patient or the patient's agent information about the prescription drug or
device which in the exercise of the pharmacist's professional judgment, the
pharmacist deems significant as specified in subsection (d)(3) of this section;]
[(iii)
assuring that a pharmacist communicates
to the patient or the patient's agent on his or her request, information concerning
any prescription drugs dispensed to the patient by the pharmacy;]
[(iv)
assuring that a reasonable effort is
made to obtain, record, and maintain patient medication records;]
(i)
[
(ii)
[
(iii)
[
(iv)
[
(v)
[
(vi)
[
(vii)
[
(viii)
[
(ix)
[
(x)
[
(xi)
[
(xii)
[
(2)
Owner. The owner of a Class A pharmacy
shall have responsibility for all administrative and operational functions
of the pharmacy. The pharmacist-in-charge may advise the owner on administrative
and operational concerns. The owner shall have responsibility for, at a minimum,
the following, and if the owner is not a Texas licensed pharmacist, the owner
shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
(A)
establishment of policies for procurement of prescription
drugs and devices and other products dispensed from the Class A pharmacy;
(B)
establishment and maintenance of effective controls against
the theft or diversion of prescription drugs;
(C)
if the pharmacy uses an automated pharmacy dispensing system,
reviewing and approving all policies and procedures for system operation,
safety, security, accuracy and access, patient confidentiality, prevention
of unauthorized access, and malfunction; and
(D)
providing the pharmacy with the necessary equipment and
resources commensurate with its level and type of practice.
(3)
[
(A)
General.
(i)
The pharmacist-in-charge shall be assisted by sufficient
number of additional licensed pharmacists as may be required to operate the
pharmacy competently, safely, and adequately to meet the needs of the patients
of the pharmacy.
(ii)
All pharmacists shall assist the pharmacist-in-charge
in meeting his or her responsibilities in ordering, dispensing, and accounting
for prescription drugs.
(iii)
Pharmacists are solely responsible for the direct supervision
of pharmacy technicians and for designating and delegating duties, other than
those listed in subparagraph (B) of this paragraph, to pharmacy technicians.
Each pharmacist:
(I)
shall verify the accuracy of all acts, tasks, and functions
performed by pharmacy technicians; and
(II)
shall be responsible for any delegated act performed by
pharmacy technicians under his or her supervision.
(iv)
All pharmacists while on duty, shall be responsible for
complying with all state and federal laws or rules governing the practice
of pharmacy.
(v)
A pharmacist shall be accessible at all times to respond
to patients' and other health professionals' questions and needs. Such access
may be through a telephone which is answered 24 hours a day.
(vi)
A dispensing pharmacist shall ensure that the drug is
dispensed and delivered safely, and accurately as prescribed.
In addition,
if multiple pharmacists participate in the dispensing process, each pharmacist
shall ensure the safety and accuracy of the portion of the process the pharmacist
is performing. The dispensing process shall include, but not be limited to,
drug regimen review and verification of accurate prescription data entry,
packaging, preparation, compounding and labeling, and performance of the final
check of the dispensed prescription.
(B)
Duties. Duties which may only be performed by a pharmacist
are as follows:
(i)
receiving verbal prescription drug orders and reducing
these orders to writing, either manually or electronically;
(ii)
interpreting and evaluating prescription drug orders;
(iii)
selection of drug products;
(iv)
interpreting patient medication records and performing
drug regimen reviews;
(v)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the prescription has been dispensed
accurately as prescribed;
(vi)
communicating to the patient or patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgment, the pharmacist deems significant as specified in paragraph
(3) of this subsection;
(vii)
communicating to the patient or the patient's agent on
his or her request, information concerning any prescription drugs dispensed
to the patient by the pharmacy;
(viii)
assuring that a reasonable effort is made to obtain,
record, and maintain patient medication records; and
(ix)
performing a specific act of drug therapy management for
a patient delegated to a pharmacist by a written protocol from a physician
licensed in this state in compliance with the Medical Practice Act.
(4)
[
(A)
Qualifications.
(i)
General. All pharmacy technicians shall:
(I)
have a high school or equivalent degree, e.g., GED, or
be currently enrolled in a program which awards such a degree; and
(II)
complete a structured didactic and experiential training
program, which provides instruction and experience in the areas listed in
subparagraph (D) of this paragraph.
(III)
Effective January 1, 2001, all pharmacy technicians must
have taken and passed the National Pharmacy Technician Certification Exam
or other examination approved during an open meeting by the Board or be a
pharmacy technician trainee.
(ii)
Pharmacy Technician Trainee.
(I)
A person shall be designated as a pharmacy technician trainee
while participating in a pharmacy's technician training program in preparation
for the National Pharmacy Technician Certification Exam or other examination
approved during an open meeting by the Board.
(II)
A person may be designated a pharmacy technician trainee
for no more than one year. A person may not be a technician trainee if they
fail to pass the certification exam within this one year training period.
This subclause does not apply to a pharmacy technician trainee working in
a pharmacy as part of a training program accredited by the American Society
of Health-System Pharmacists or an individual enrolled in a health science
technology education program in a Texas high school.
(III)
Individuals enrolled in a health science technology education
program in a Texas high school that is accredited by the Texas Education Agency,
may be designated as a pharmacy technician trainee for up to two years provided:
(-a-)
the work as a pharmacy technician is concurrent with
enrollment in a health science technology education program, which may include:
(-1-)
partial semester breaks such as spring breaks;
(-2-)
between semesters; and
(-3-)
whole semester breaks provided the individual was enrolled
in the health science technology education program in the immediate preceding
semester and is scheduled with the high school to attend in the immediate
subsequent semester;
(-b-)
the individual is under the direct supervision of and
responsible to a pharmacist; and
(-c-)
the supervising pharmacist verifies the accuracy of all
acts, tasks, or functions performed by the individual.
(iii)
Certified Pharmacy Technicians.
(I)
All certified pharmacy technicians shall have taken and
passed the National Pharmacy Technician Certification Exam or other examination
approved during an open meeting by the Board and maintain a current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(II)
A certified pharmacy technician shall publicly display
their current certification certificate in the technician's primary place
of practice and a copy of their current certification certificate in all other
pharmacies where the technician performs the duties of a technician.
(B)
Duties.
(i)
pharmacy technicians may not perform any of the duties
listed in paragraph (2)(B) of this subsection.
(ii)
A pharmacist may delegate to pharmacy technicians any
nonjudgmental technical duty associated with the preparation and distribution
of prescription drugs provided:
(I)
a pharmacist verifies the accuracy of all acts, tasks,
and functions performed by pharmacy technicians; and
(II)
pharmacy technicians are under the direct supervision
of and responsible to a pharmacist.
(iii)
Pharmacy technicians may perform only nonjudgmental technical
duties associated with the preparation and distribution of prescription drugs,
including but not limited to the following.
(I)
initiating and receiving refill authorization requests;
(II)
entering prescription data into a data processing system;
(III)
taking a stock bottle from the shelf for a prescription;
(IV)
preparing and packaging prescription drug orders (i.e.,
counting tablets/capsules, measuring liquids and placing them in the prescription
container);
(V)
affixing prescription labels and auxiliary labels to the
prescription container provided:
(-a-)
the pharmacy technician has completed the education and
training requirements outlined in subparagraphs (A) and (D) of this paragraph;
and
(-b-)
effective January 1, 2001, only certified pharmacy technicians
may affix a label to a prescription container.
(VI)
reconstituting medications;
(VII)
prepackaging and labeling prepackaged drugs;
(VIII)
loading bulk unlabeled drugs into an automated dispensing
system provided a pharmacist verifies that the system is properly loaded prior
to use;
(IX)
compounding sterile pharmaceuticals provided:
(-a-)
the pharmacy technician has completed the education and
training specified in paragraph (4) of this subsection and the pharmacy technician
is supervised by a pharmacist who has completed the training specified in
paragraph (4) of this subsection; and
(-b-)
effective January 1, 2001, the pharmacy technicians:
(-1-)
are either certified pharmacy technicians or technician
trainees;
(-2-)
have completed the training specified in paragraph (4)
of this subsection; and
(-3-)
are supervised by a pharmacist who has completed the
training specified in paragraph (4) of this subsection, conducts in-process
and final checks, and affixes his or her initials to the appropriate quality
control records.
(X)
compounding non-sterile prescription drug orders; and
(XI)
bulk compounding.
(iv)
Certified pharmacy technicians. Effective January 1, 2001,
only certified pharmacy technicians may:
(I)
affix a label to a prescription container; and
(II)
compound sterile pharmaceuticals.
(C)
Ratio of pharmacist to pharmacy technicians.
(i)
The ratio of pharmacists to pharmacy technicians may not
exceed 1:2 provided that only one pharmacy technician may be engaged in the
compounding of sterile pharmaceuticals.
(ii)
The ratio of pharmacists to pharmacy technicians may be
1:3 provided that at least one of the three technicians is certified and only
one may be engaged in the compounding of sterile pharmaceuticals.
(D)
Training.
(i)
pharmacy technicians shall complete initial training as
outlined by the pharmacist-in-charge in a training manual which includes training
and experience as outlined in subparagraph (E) of this paragraph prior to
the regular performance of their duties. Such training:
(I)
shall include training and experience as outlined in subparagraph
(E) of this paragraph; and
(II)
may not be transferred to another pharmacy unless:
(-a-)
the pharmacies are under common ownership and control
and have a common training program; and
(-b-)
the pharmacist-in-charge of each pharmacy in which the
pharmacy technician works certifies that the pharmacy technician is competent
to perform the duties assigned in that pharmacy.
(ii)
A pharmacy technician shall be designated a pharmacy technician
trainee until completing the full training program. A pharmacy technician
trainee:
(I)
may perform all of the duties of a pharmacy technician
except affix a label to a prescription;
(II)
may be designated a pharmacy technician trainee for no
longer than one year except as specified in subparagraph (A)(ii) of this paragraph;
and
(III)
shall be counted in the pharmacist to pharmacy technician
ratio.
(iii)
The pharmacist-in-charge shall assure the continuing
competency of pharmacy technicians through-in-service education and training
to supplement initial training.
(iv)
The pharmacist-in-charge shall document the completion
of the training program and certify the competency of pharmacy technicians
completing the training. A written record of initial and in-service training
of pharmacy technicians shall be maintained and contain the following information:
(I)
name of the person receiving the training;
(II)
date(s) of the training;
(III)
general description of the topics covered;
(IV)
a statement or statements that certifies that the pharmacy
technician is competent to perform the duties assigned;
(V)
name of the person supervising the training; and
(VI)
signature of the pharmacy technician and the pharmacist-in-charge
or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge
as responsible for training of pharmacy technicians.
(v)
A person who has previously completed training as a pharmacy
technician, or a licensed nurse or physician assistant is not required to
complete the entire training program if the person is able to show competency
through a documented assessment of competency. Such competency assessment
may be conducted by personnel designated by the pharmacist-in-charge, but
the final acceptance of competency must be approved by the pharmacist-in-charge.
(E)
Training program. Pharmacy technicians training shall be
outlined in a training manual. Such training manual shall, at a minimum, contain
the following:
(i)
written procedures and guidelines for the use and supervision
of pharmacy technicians. Such procedures and guidelines shall:
(I)
specify the manner in which the pharmacist responsible
for the supervision of pharmacy technicians will supervise such personnel
and verify the accuracy and completeness of all acts, task and functions performed
by such personnel; and
(II)
specify duties which may and may not be performed by pharmacy
technicians; and
(ii)
instruction in the following areas and any additional
areas appropriate to the duties of pharmacy technicians in the pharmacy:
(I)
Orientation;
(II)
Job descriptions;
(III)
Communication techniques;
(IV)
Laws and rules;
(V)
Security and safety;
(VI)
Prescription drugs:
(-a-)
Basic pharmaceutical nomenclature;
(-b-)
Dosage forms;
(VII)
Prescription drug orders:
(-a-)
Prescribers;
(-b-)
Directions for use;
(-c-)
Commonly-used abbreviations and symbols;
(-d-)
Number of dosage units;
(-e-)
Strength and systems of measurement;
(-f-)
Route of administration;
(-g-)
Frequency of administration;
(-h-)
Interpreting directions for use;
(VIII)
Prescription drug order preparation:
(-a-)
Creating or updating patient medication records;
(-b-)
Entering prescription drug order information into the
computer or typing the label in a manual system;
(-c-)
Selecting the correct stock bottle;
(-d-)
Accurately counting or pouring the appropriate quantity
of drug product;
(-e-)
Selecting the proper container;
(-f-)
Affixing the prescription label;
(-g-)
Affixing auxiliary labels, if indicated; and
(-h-)
Preparing the finished product for inspection and final
check by pharmacists;
(IX)
Other functions;
(X)
Drug product prepackaging;
(XI)
Compounding of non-sterile pharmaceuticals;
(XII)
Written policy and guidelines for use of and supervision
of pharmacy technicians.
(5)
[
(A)
General.
(i)
All pharmacy personnel preparing sterile pharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge
and described in the policy and procedure or training manual. Such training
shall include instruction and experience in the following areas:
(I)
aseptic technique;
(II)
critical area contamination factors;
(III)
environmental monitoring;
(IV)
facilities;
(V)
equipment and supplies;
(VI)
sterile pharmaceutical calculations and terminology;
(VII)
sterile pharmaceutical compounding documentation;
(VIII)
quality assurance procedures;
(IX)
aseptic preparation procedures including proper gowning
and gloving technique;
(X)
handling of cytotoxic and hazardous drugs, if applicable;
and
(XI)
general conduct in the controlled area.
(ii)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile pharmaceuticals
shall be observed and evaluated as satisfactory through written or practical
tests and process validation and such evaluation documented.
(iii)
Although process validation may be incorporated into
the experiential portion of a training program, process validation must be
conducted at each pharmacy where an individual compounds sterile pharmaceuticals.
No product intended for patient use shall be compounded by an individual until
the on-site process validation test indicates that the individual can competently
perform aseptic procedures, except that a pharmacist may temporarily compound
sterile pharmaceuticals and supervise pharmacy technicians compounding sterile
pharmaceuticals without process validation provided the pharmacist:
(I)
has completed a recognized course in an accredited college
of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in this subparagraph; and
(II)
completes the on-site process validation within seven
days of commencing work at the pharmacy.
(iv)
Process validation procedures for assessing the preparation
of specific types of sterile pharmaceuticals shall be representative of all
types of manipulations, products, and batch sizes that personnel preparing
that type of pharmaceutical are likely to encounter.
(v)
The pharmacist-in-charge shall assure continuing competency
of pharmacy personnel through in-service education, training, and process
validation to supplement initial training. Personnel competency shall be evaluated:
(I)
during orientation and training prior to the regular performance
of those tasks;
(II)
whenever the quality assurance program yields an unacceptable
result;
(III)
whenever unacceptable techniques are observed; and
(IV)
at least on an annual basis.
(B)
Pharmacists.
(i)
All pharmacists who compound sterile pharmaceuticals or
supervise pharmacy technicians compounding sterile pharmaceuticals shall:
(I)
complete through a single course, a minimum of 20 hours
of instruction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training may be through:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 20 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(-b-)
completion of a recognized course in an accredited college
of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in subparagraph (A) of this paragraph; and
(II)
possess knowledge about:
(-a-)
aseptic processing;
(-b-)
quality control and quality assurance as related to environmental,
component, and end-product testing;
(-c-)
chemical, pharmaceutical, and clinical properties of
drugs;
(-d-)
container, equipment, and closure system selection; and
(-e-)
sterilization techniques.
(ii)
The required experiential portion of the training programs
specified in this subparagraph must be supervised by an individual who has
already completed training as specified in subparagraph (B) or (C) of this
paragraph.
(C)
Pharmacy technicians. In addition to the qualifications
and training outlined in paragraph (3) of this subsection, all pharmacy technicians
who compound sterile pharmaceuticals shall:
(i)
have a high school or equivalent education;
(ii)
either:
(I)
complete through a single course, a minimum of 40 hours
of instruction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training may be obtained through the:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 40 hours of instruction and
experience in the areas listed in subparagraph (A) of this paragraph. Such
training may not be transferred to another pharmacy unless the pharmacies
are under common ownership and control and use a common training program;
or
(-b-)
completion of a course sponsored by an ACPE approved
provider which provides 40 hours of instruction and experience in the areas
listed in subparagraph (A) of this paragraph; or
(II)
completion of a training program which is accredited by
the American Society of Health-System Pharmacists (formerly the American Society
of Hospital Pharmacists). Individuals enrolled in training programs accredited
by the American Society of Health-System Pharmacists may compound sterile
pharmaceuticals in a licensed pharmacy provided:
(-a-)
the compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component of the American
Society of Health-System Pharmacists training program;
(-b-)
the individual is under the direct supervision of and
responsible to a pharmacist who has completed training as specified in subparagraph
(B) of this paragraph; and
(-c-)
the supervising pharmacist conducts in-process and final
checks; and
(iii)
on January 1, 2001, discontinue preparation of sterile
pharmaceuticals if the technician has not taken and passed the National Pharmacy
Technician Certification Exam or other examination approved during an open
meeting by the Board. Such pharmacy technicians may continue to compound sterile
pharmaceuticals during the interim between the effective date of these rules
and January 1, 2001, if they maintain documentation of completion of the training
specified in clause (ii) of this subparagraph.
(iv)
acquire the required experiential portion of the training
programs specified in this subparagraph under the supervision of an individual
who has already completed training as specified in subparagraph (B) or (C)
of this paragraph.
(D)
Documentation of Training. A written record of initial
and in-service training and the results of written or practical testing and
process validation of pharmacy personnel shall be maintained and contain the
following information:
(i)
name of the person receiving the training or completing
the testing or process validation;
(ii)
date(s) of the training, testing, or process validation;
(iii)
general description of the topics covered in the training
or testing or of the process validated;
(iv)
name of the person supervising the training, testing,
or process validation; and
(v)
signature (first initial and last name or full signature)
of the person receiving the training or completing the testing or process
validation and the pharmacist-in-charge or other pharmacist employed by the
pharmacy and designated by the pharmacist-in-charge as responsible for training,
testing, or process validation of personnel.
(6)
[
(A)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee, pharmacy technician, or a certified
pharmacy technician.
(B)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies him
or her as a pharmacist intern.
(C)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
(d)-(f)
(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 June 7, 2002.
TRD-200203552
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
22 TAC §291.73
The Texas State Board of Pharmacy proposes amendments to §291.73,
concerning Personnel. The amendments, if adopted, will permit pharmacy technician
certification certificates to be maintained in a file at a Class C pharmacy
provided certain conditions are met.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to ease recordkeeping requirements for Class C
pharmacies and speed the inspection process. There is no fiscal impact anticipated
for small or large businesses or to other entities who are required to comply
with this section.
Written comments on the proposed amendments may be submitted to Steve Morse,
R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments
must be received by 5 p.m., August 1, 2002.
The amendments are proposed under §§551.002, 554.051,
and 554.053 of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations
Code). The Board interprets §551.002 as authorizing the agency to protect
the public through the effective control and regulation of the practice of
pharmacy. The Board interprets §554.051 as authorizing the agency to
adopt rules for the proper administration and enforcement of the Act. The
Board interprets §554.053 as authorizing the agency to adopt rules for
the use of pharmacy technicians in pharmacies.
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§291.73.Personnel.
(a) - (d)
(No change.)
(e)
Pharmacy technicians.
(1)
Qualifications.
(A) - (B)
(No change.)
(C)
Certified Pharmacy Technicians.
(i)
(No change.)
(ii)
A certified pharmacy technician shall publicly display
their current certification certificate in the technician's primary place
of practice and a copy of their current certification certificate in all other
pharmacies where the technician performs the duties of a technician
except as noted in clause (iii) of this subparagraph
.
(iii)
A certified pharmacy technician who
only works in the inpatient portion of a Class C pharmacy is not required
to publicly display their current certification certificate in the pharmacy,
provided the pharmacist-in-charge maintains on file for inspection by a Board
representative:
(I)
the technician's current certification certificate if the
pharmacy is the technician's primary place of practice; or
(II)
a copy of the technician's current certification certificate
if the pharmacy is not the technician's primary place of practice.
(2) - (5)
(No change.)
(f) - (g)
(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 June 7, 2002.
TRD-200203553
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
22 TAC §301.1
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas State Board of Pharmacy or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Texas State Board of Pharmacy proposes the repeal
of §301.1, concerning a Savings Clause. The repeal, if adopted, will
delete a section which has been determined, through the rule review process,
to no longer be necessary.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the repeal is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the repeal. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the repeal will be in effect, the public benefit anticipated as a result of
repealing the rule will be to delete an obsolete rule. There is no fiscal
impact anticipated for small or large businesses or to other entities as a
result of the repeal.
Written comments on the repeal may be submitted to Steve Morse, R.Ph.,
Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe
Street, Box 21, Austin, Texas, 78701-3942, FAX 512/305-8082. Comments must
be received by 5 p.m., August 1, 2002.
The repeal is proposed under §551.002, and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations Code). The
Board interprets §551.002 as authorizing the agency to protect the public
through the effective control and regulation of the practice of pharmacy.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act. The
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§301.1.Saving Clause.
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 June 7, 2002.
TRD-200203557
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
22 TAC §311.1
The Texas State Board of Pharmacy proposes amendments to §311.1,
concerning Procedures. The amendment, if adopted, will clarify responsible
parties.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to clarify responsibilities in the event of a complaint
against an employee of the agency. There is no fiscal impact anticipated for
small or large businesses or to other entities who are required to comply
with this section.
Written comments on the amendment may be submitted to Steve Morse, R.Ph.,
Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe
Street, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must
be received by 5 p.m., August 1, 2002.
The amendment is proposed under §551.002, and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566, Texas Occupations Code). The
Board interprets §551.002 as authorizing the agency to protect the public
through the effective control and regulation of the practice of pharmacy.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act. The
The statutes affected by this rule: Chapters 551 - 566, Texas Occupations
Code.
§311.1.Procedures.
(a) - (e)
(No change.)
(f)
Upon completing the review of the complaint and relevant
statements or documents, the executive director shall render a decision concerning
the complaint within 10 days and provide written notification of
the
[
(g)
Complaints alleging violations of the Board Code of Conduct
by the
executive director
[
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 June 7, 2002.
TRD-200203554
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 21, 2002
For further information, please call: (512) 305-8028
Chapter 535.
PROVISIONS OF THE REAL ESTATE LICENSE ACT
Subchapter G. MANDATORY CONTINUING EDUCATION
The Texas Funeral Service Commission adopts by reference the
joint memorandum of understanding with the Texas Department of Health published
at 25 Texas Administrative Code §181.27.
]
Part 14.
TEXAS OPTOMETRY BOARD
Texas Civil Statutes, Article 4552
].
4.04(a)(1)
].
§3.05 and §3.06
]. The passing score on each Part of the National Board written examination
is determined by the criterion-referenced standard setting approach, in which
the passing score is set at the scaled score of 300. The Texas Optometry Board
will accept scores from an NBEO written examination if Part I or II was satisfactorily
completed on or after January 1, 1984.
§3.05 and §3.06
]. The passing scores on Part III shall be determined by the NBEO. The
board will accept scores from an NBEO Part III examination if Part III was
satisfactorily completed on or after June of 1994.
§3.02
], as well as all applicable board rules.
Part 15.
TEXAS STATE BOARD OF PHARMACY
Open Records
] Act--Government Code, Chapter 552.
Open Records
] Act, Government
Code Chapter 552. Any hearing and any Board meeting shall be open to the public
in accordance with the Texas Open Meetings Act, Government Code, Chapter 551,
provided, however, that pursuant to §552.011, Texas Pharmacy Act, the
board may, in its discretion, conduct deliberations relative to licensee disciplinary
actions in a closed meeting. The board in a closed meeting may conduct disciplinary
hearings relating to a pharmacist or pharmacy student who is impaired because
of chemical abuse or mental or physical illness. At the conclusion of its
deliberations relative to licensee disciplinary action, the board shall vote
and announce its decision relative to the licensee in open session. All disciplinary
hearings before the State Office of Administrative Hearings shall be open
to the public, including those relating to a pharmacist or pharmacy student
who is impaired because of chemical abuse or mental or physical illness. Official
action of the board shall not be bound or prejudiced by any informal statement
or opinion made by any member of the board or the employees of the agency.
General Services
] Commission at 1 TAC §§111.61
- 111.70.
General Services
]
Commission, which are set forth in Subchapter B of 1 TAC §§111.11
- 111.24 regarding Historically Underutilized Business Certification Program.
Subchapter B. GENERAL PROCEDURES IN A CONTESTED CASE
Civil
] Evidence 902(10), or a transcript, the party may give notice of the
filing without the necessity of providing a copy to each party. By order,
the ALJ may exempt a party from serving other documents upon all parties.
Civil
] Evidence, or other rule or law, that is relevant to the subject matter
of the proceeding.
Rule 166b,
]
but the answers, subject to any objections as to admissibility, may be used
only against the party who answers or whose attorney answers the interrogatories.
A party may be required in the party's answers to identify each person whom
the party expects to call as an expert witness at the hearing, and to state
the subject matter about which the expert is to testify.
Rule 166b,
] are applicable for
the protection of the party from whom answers to interrogatories are sought
under this section.
, Rule 166b(6)
].
166b(3)
], the ALJ
may require the objecting party to provide an index that lists, for each document
claimed privileged or exempt from discovery: the date and title of the document;
the preparer or custodian of the information; to whom the document was sent
and from whom it was received; and the claimed privilege(s) or exemption(s).
A full a complete explanation of the claimed privilege or exemption shall
be provided. The index and explanations may be public documents if so determined
by the ALJ after review of the index and accompanying explanations. The documents
claimed to be privileged or exempted from discovery shall be provided to the
ALJ in camera by the deadline established by the ALJ.
Civil
] Evidence as made applicable by
the Administrative Procedure Act.
Civil
] Evidence, shall be excluded. However,
consistent with the APA, the rules of evidence as applied in a non-jury civil
case in district court govern contested case hearings conducted by SOAH, except
that evidence inadmissible under those rules may be admitted if it is necessary
to ascertain facts not reasonably susceptible of proof under those rules,
and provided is not precluded by statute.
Civil
] Evidence.
Subchapter B. GENERAL PROCEDURES IN A CONTESTED CASE
Chapter 291.
PHARMACIES
office
]), and
include the following:
office
], chief operating officer),
and include the following:
office
], chief operating officer),
and include the following:
Subchapter B. COMMUNITY PHARMACY (CLASS A)
]
(F)
] education and training of pharmacy
technicians;
(G)
]
supervising a system to
assure appropriate
[
establishment of policies for
] procurement
of prescription drugs and devices and other products dispensed from the Class
A pharmacy;
(H)
] disposal and distribution of
drugs from the Class A pharmacy;
(I)
] bulk compounding of drugs;
(J)
] storage of all materials, including
drugs, chemicals, and biologicals;
(K)
] maintaining records of all
transactions of the Class A pharmacy necessary to maintain accurate control
over and accountability for all pharmaceutical materials required by applicable
state and federal laws and sections;
(L)
]
supervising a system to
assure
[
establishment and
] maintenance of effective controls
against the theft or diversion of prescription drugs, and records for such
drugs;
(M)
]
assuring that
[
maintenance of
] records in a data processing system
are maintained
such that the data processing system is in compliance with Class A
(community) pharmacy requirements;
(N)
] legal operation of the pharmacy,
including meeting all inspection and other requirements of all state and federal
laws or sections governing the practice of pharmacy; and
(O)
] effective September 1, 2000,
if the pharmacy uses an automated pharmacy dispensing system, shall be responsible
for the following:
(b)
] Pharmacists.
and dispensing
], and
performance of the final check of the dispensed prescription.
(c)
] Pharmacy Technicians.
(d)
] Identification of pharmacy
personnel. All pharmacy personnel shall be identified as follows.
.
]
(v)
] developing a system to assure
that all pharmacy personnel responsible for compounding and/or supervising
the compounding of sterile pharmaceuticals within the pharmacy receive appropriate
education and training and competency evaluation;
(vi)
]
supervising a system
to assure appropriate
[
establishing policies for
] procurement
of drugs and devices and storage of all pharmaceutical materials including
pharmaceuticals, components used in the compounding of pharmaceuticals, and
drug delivery devices;
(vii)
] developing a system for
the disposal and distribution of drugs from the Class A pharmacy;
(viii)
] developing a system for
bulk compounding or batch preparation of drugs;
(ix)
] developing a system for the
compounding, sterility assurance, quality assurance and quality control of
sterile pharmaceuticals;
(x)
] participating in those aspects
of the patient care evaluation program relating to pharmaceutical material
utilization and effectiveness;
(xi)
] implementing the policies
and decisions relating to pharmaceutical services;
(xii)
] maintaining records of
all transactions of the Class A pharmacy necessary to maintain accurate control
over and accountability for all pharmaceutical materials required by applicable
state and federal laws and rules;
(xiii)
]
supervising a system
to assure
[
developing a system to assure the
] maintenance
of effective controls against the theft or diversion of prescription drugs,
and records for such drugs;
(xiv)
] assuring that records in
a data processing system are maintained such that the data processing system
is in compliance with this section;
(xv)
] assuring that the pharmacy
has a system to dispose of cytotoxic waste in a manner so as not to endanger
the public health; and
(xvi)
] legal operation of the
pharmacy, including meeting all inspection and other requirements of all state
and federal laws or rules governing the practice of pharmacy.
(2)
] Pharmacists.
(3)
] Pharmacy technicians.
(4)
] Special education, training,
and evaluation requirements for pharmacy personnel compounding or responsible
for the direct supervision of pharmacy personnel compounding sterile pharmaceuticals.
(5)
] Identification of pharmacy
personnel. Pharmacy personnel shall be identified as follows.
Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)
Chapter 301.
FRAUD, DECEIT, AND MISREPRESENTATION IN THE PRACTICE OF PHARMACY
Chapter 311.
CODE OF CONDUCT
his
] decision to the employee, his or her supervisor, and
board members within five days of rendering
the
[
his
]
decision. The executive director shall notify the complainant of the disposition
of the complaint. If the disposition of the complaint affects the employee's
employment status, the employee has the right to exercise the board's grievance
procedure.
executive director/secretary
]
shall be directed to the president of the board. The procedures set out in
this section shall be followed in disposing of such complaints; provided,
however, that for the purposes of this subsection, where the term
"executive
director"
[
"executive director-secretary'
] appears in the
procedures set out in this section, the term "president of the
board"
[
board'
] shall be substituted therefor.
Part 23.
TEXAS REAL ESTATE COMMISSION