Part 1.
TEXAS BOARD OF ARCHITECTURAL EXAMINERS
Chapter 1.
ARCHITECTS
Subchapter G. COMPLIANCE AND ENFORCEMENT
22 TAC §1.125
The Texas Board of Architectural Examiners proposes an amendment
to Chapter 1, Subchapter G, §1.125 concerning who is authorized to employ
the title "architect" and use the word "architect" or various constructions
thereof to describe his or her services. The amendment sets forth the titles
that may or may not be used by persons not registered as architects in the
State of Texas.
Cathy L. Hendricks, Executive Director, has determined that there will
be no fiscal implications for state or local government for the first five
years the section as proposed is in effect.
Ms. Hendricks has also determined that for each year of the first five
years the section as proposed is in effect, the public benefits anticipated
as a result of the proposed amendment will be that individuals not yet registered
to practice architecture will be restrained from misleading the public by
using titles that include the word "architect" or any construction thereof
to describe themselves or the work they do.
There are no anticipated economic costs to persons who are required to
comply with the section as proposed.
Comments may be submitted to Cathy L. Hendricks, ASID/IIDA, Executive Director,
Texas Board of Architectural Examiners, P.O. Box 12337, Austin, Texas, 78711-2337.
The amendment is proposed under Section 3(b) of the Architects'
Registration Law, Article 249a, Vernon's Texas Civil Statutes, which provides
the Texas Board of Architectural Examiners with authority to promulgate rules
necessary to the proper administration of the Act.
This proposed amendment does not affect any other statutes.
§1.125.Titles.
(a)
Persons holding Certificates of Registration for Architecture
issued by
the
[
(b)
No other person, firm, partnership, corporation, or groups
of persons may employ the title "architect" or constructions of the word
"architect"
[
(c)
The title "intern architect" may not be
used.
(d)
A person must be enrolled in the Board
approved Intern Development Program (IDP) in order to use the title "architect
intern."
(e)
The Board may take action against any
person who uses the title "intern architect" or "architectural intern" improperly.
The Board may deny the registration application of any applicant who has used
the title "intern architect" or "architectural intern" improperly.
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 March 14, 2000.
TRD-200001917
Cathy L. Hendricks, ASID/IIDA
Executive Director
Texas Board of Architectural Examiners
Proposed date of adoption: May 18, 2000
For further information, please call: (512) 305-8535
22 TAC §1.211
The Texas Board of Architectural Examiners proposes an amendment
to Chapter 1, Subchapter K, §1.211 concerning when the services of a
registered architect are required. The section sets forth the conditions under
which an architect is required to prepare plans, specifications, addenda,
change orders, and supplementary instructions for privately owned, new or
altered buildings constructed in the State of Texas. The amendment does not
change the purpose or specifics of the rule but simply replaces cumbersome
language in order to clarify the meaning of the rule.
Cathy L. Hendricks, Executive Director, has determined there will be no
fiscal implications for state or local government for the first five years
the section as proposed is in effect.
Ms. Hendricks has also determined that for each year of the first five
years the section as proposed is in effect, the public benefits anticipated
as a result of the proposed change will be that the legal rights and obligations
of persons affected by the section will be clearer. The agency anticipates
no effect on small business. There are no anticipated economic costs to persons
who are required to comply with the section as proposed.
Comments may be submitted to Cathy L. Hendricks, ASID/IIDA, Executive Director,
Texas Board of Architectural Examiners, P.O. Box 12337, Austin, Texas, 78711-2337.
The amendment is proposed under Section 3(b) of the Architects'
Registration Law, Article 249a, Vernon's Texas Civil Statutes, which provides
the Texas Board of Architectural Examiners with authority to promulgate rules
necessary to the proper administration of the Act.
This proposed amendment does not affect any other statutes.
§1.211.Privately Owned Buildings.
Construction Documents
[
[
buildings used primarily for
farm, ranch, or agricultural purposes;]
[
single family or duplex
family dwellings of any height or building area;]
[
multifamily dwellings
which do not exceed 16 living units per building, or two stories in height,
including basements, lofts, and mezzanines;]
[
buildings used for other
than institutional residential purposes which do not exceed two stories in
height, including basements and mezzanines, or 20,000 square feet of gross
building area.]
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 March 14, 2000.
TRD-200001918
Cathy L. Hendricks, ASID/IIDA
Executive Director
Texas State Board of Architectural Examiners
Proposed date of adoption: May 18, 2000
For further information, please call: (512) 305-8535
22 TAC §1.212
The Texas Board of Architectural Examiners proposes an amendment
to Chapter 1, Subchapter K, §1.212 concerning when the services of a
registered architect are required. The section sets forth the conditions under
which an architect is required to prepare plans, specifications, addenda,
change orders, and supplementary instructions for publicly owned, new or altered
buildings constructed in the State of Texas. The amendment adds to the list
of publicly owned buildings that require the services of a registered architect
any project that includes alterations or additions to existing buildings owned
by any public entity where the total construction cost when construction commenced
exceeded $50,000 and the alteration or addition requires the removal, relocation,
or addition of any walls or partitions or the alteration or addition of an
exit. The amendment is intended to clarify an existing statutory provision
which previously was not addressed in the rules.
Cathy L. Hendricks, Executive Director, has determined that there will
be no fiscal implications for state or local government for the first five
years the section as proposed is in effect.
Ms. Hendricks has also determined that for each year of the first five
years the section as proposed is in effect, the public benefits anticipated
as a result the proposed change will be that persons affected by the corresponding
statutory section will have a better understanding of their rights and their
obligations. The agency anticipates the effect on small business will be unchanged
because the proposed change merely clarifies an existing statutory provision.
The anticipated economic costs to persons who are required to comply with
the section as proposed are unchanged because the proposed change merely clarifies
an existing statutory provision.
Comments may be submitted to Cathy L. Hendricks, ASID/IIDA, Executive Director,
Texas Board of Architectural Examiners, P.O. Box 12337, Austin, Texas, 78711-2337.
The amendment is proposed under Section 3(b) of the Architects'
Registration Law, Article 249a, Vernon's Texas Civil Statutes, which provides
the Texas Board of Architectural Examiners with authority to promulgate rules
necessary to the proper administration of the Act.
This proposed amendment does not affect any other statutes.
§1.212.Publicly Owned Buildings.
(a)
Construction Documents
[
(1)
education
[
(2)
assembly: the use of a building for the gathering
together of [
(3)
office
occupancy
: the use of a building
for business [
(b)
Architectural Construction Documents for
any alteration or addition to an existing building owned by any public entity
where the total construction cost when construction commenced exceeds $50,000
and the alteration or addition requires the removal, relocation, or addition
of any walls or partitions or the alteration or addition of an exit shall
be prepared under the supervision of an architect if the building is intended
for any of the uses listed in subsection (a) of this section.
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 March 14, 2000.
TRD-200001919
Cathy L. Hendricks, ASID/IIDA
Executive Director
Texas State Board of Architectural Examiners
Proposed date of adoption: May 18, 2000
For further information, please call: (512) 305-8535
Subchapter B. REGISTRATION
22 TAC §5.31
The Texas Board of Architectural Examiners proposes a new
rule, §5.31 concerning requirements for individuals applying for registration
as an interior designer. The new section sets forth the requirements which
must be met before an individual may take the National Council for Interior
Design Qualification Examination in the State of Texas. The section sets forth
the education that an individual applying for interior design registration
must have obtained in order to qualify to take the National Council for Interior
Design Qualification Examination. The section provides that any individual
who began his or her interior design education or experience before September
1, 1999 shall be subject to the rules and regulations in effect at that time.
The section will ensure that all individuals applying for registration as
an interior designer in the State of Texas will have a specific level of education
that meets the requirements determined necessary by the Board to protect the
health, safety, and welfare of the citizens of the State of Texas.
Cathy L. Hendricks, Executive Director, has determined that for each year
of the first five years the section as proposed is in effect, it will have
a fiscal impact on units of state and local government because approved educational
programs are likely to experience increased enrollment levels and educational
programs that are not approved could experience decreased enrollment levels.
The dollar amount of such impact cannot be predicted at the present time because
data is not available to enable the agency to predict the actual fluctuations
of enrollment levels.
Ms. Hendricks has also determined that for each year of the first five
years the section as proposed is in effect, the public benefits anticipated
as a result of enforcing the section as proposed will be that persons newly
registered as interior designers in Texas will have satisfied a heightened
educational standard designed to better ensure that they are qualified to
practice interior design.
The new section, as proposed, is not likely to have a measurable effect
on small businesses. Persons who are required to comply with the section will
have to bear economic costs related to educational expenses. Such expenses
will vary according to each affected person's choice of an educational program.
Persons who are required to comply with the section also will have to complete
an internship-type program prior to examination, which will require an additional
two-year period of work prior to licensure. An internship currently is required
for licensure, but the proposed new section will increase the minimum period
of internship from one year to two years. The earning capacity of such individuals
may be impacted during the internship, but the agency does not anticipate
that any specific costs will be associated with the "internship" requirement.
Comments may be submitted to Cathy L. Hendricks, ASID/IIDA, Executive Director,
Texas Board of Architectural Examiners, P.O. Box 12337, Austin, Texas, 78711-2337.
The new rule is proposed under Section 5(d) of the Interior Designers'
Registration Law, Article 249e, Vernon's Texas Civil Statutes, which provides
the Texas Board of Architectural Examiners with authority to promulgate rules
necessary to the proper administration of the Act.
This proposed rule does not affect any other statutes.
§5.31.Eligibility.
(a)
In order to obtain interior design registration by examination
in Texas, an applicant shall demonstrate that the applicant has a combined
total of six years of approved interior design education and experience. For
purposes of this section, an applicant has "approved interior design education"
if:
(1)
The applicant graduated from a program that has been granted
professional status by the Foundation for Interior Design Research (FIDER);
(2)
The applicant has a baccalaureate degree in interior
design;
(3)
The applicant has:
(A)
A baccalaureate degree in a field other than interior design,
and
(B)
An associate's degree or a two- or three-year certificate
from an interior design program at an institution accredited by an agency
recognized by the Texas Higher Education Coordinating Board;
(4)
The applicant has:
(A)
A baccalaureate degree in a field other than interior design,
and
(B)
An associate's degree or a two- or three-year certificate
from a foreign interior design program approved or accredited by an agency
acceptable to the Board;
(5)
The applicant applied on or before August 31,
2010, and prior to that date, the applicant successfully completed:
(A)
At least six years of actual experience working under the
direct supervision of a registered interior designer or a registered architect,
(B)
An associate's degree in interior design from an institution
accredited by an agency recognized by the Texas Higher Education Coordinating
Board, and
(C)
Credit for the equivalent of at least 60 semester credit
hours toward any baccalaureate degree; or
(6)
The applicant applied on or before August 31,
2010, and prior to that date, the applicant successfully completed:
(A)
At least four years of actual experience working under
the direct supervision of a registered interior designer or a registered architect,
(B)
A FIDER accredited pre-professional assistant level program,
and
(C)
Credit for the equivalent of at least 60 semester credit
hours toward any baccalaureate degree.
(b)
If the applicant commences completion of the educational
requirements for registration after September 1, 2006, the applicant must
graduate from a program that has been granted professional status by FIDER.
(c)
For purposes of this section, the term "approved interior
design education" does not include continuing education courses.
(d)
For purposes of this section, an applicant shall be considered
to have "commenced" his/her interior design education upon enrollment in an
acceptable interior design education program.
(e)
The Board shall evaluate the education and experience required
by subsection (a) in accordance with the edition of the Table of Equivalents
for interior design in effect at the time the application is filed.
(f)
An applicant who enrolled in an acceptable interior design
education program before September 1, 1999, shall be subject to the rules
and regulations relating to educational and experiential requirements as they
existed on August 31, 1999.
(g)
An applicant who filed an application for registration
without examination prior to August 31, 1994, is subject to the rules and
regulations relating to educational and experiential requirements in effect
at the time the application was filed. Such applicant must complete the required
six years of experience on or before September 1, 2003, in order to be eligible
for registration without examination.
(h)
For purposes of this section, it is the applicant's responsibility
to demonstrate to the Board the requisite education and experience.
(i)
Pursuant to the provisions of §231.302 of the Texas
Family Code, each applicant shall submit his/her social security number on
forms prescribed by the Board. Such information shall be considered confidential
as stated in §231.302(e) of the Texas Family Code.
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 March 14, 2000.
TRD-200001920
Cathy L. Hendricks, ASID/IIDA
Executive Director
Texas Board of Architectural Examiners
Proposed date of adoption: May 18, 2000
For further information, please call: (512) 305-8535
Chapter 283.
LICENSING REQUIREMENTS FOR PHARMACISTS
22 TAC §283.5
The Texas State Board of Pharmacy proposes amendments to §283.5,
concerning Pharmacist-Intern Duties. The amendments, if adopted, will permit
and set the requirements for a pharmacist-intern to perform the duties of
a certified pharmacy technician.
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 increased training opportunities for pharmacist-interns.
There are no economic cost to entities required to comply with this section
or to small and large businesses, as defined by section 2006.002 of the Texas
Government Code.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The amendments are proposed under §§551.002, 554.051,
554.005, and 554.002 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 §554.005 as authorizing the agency to regulate the delivery
or distribution of prescription drugs as they relate to the practice of pharmacy
and to specify the minimum standards for the maintenance of prescription drug
records. The Board interprets §554.002 as authorizing the agency to set
the requirements for internship and to regulate the training, qualifications,
and employment of a pharmacist-intern.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code
§283.5.Pharmacist-Intern Duties.
(a)
(No change.)
(b)
When not under the direct supervision
of a preceptor pharmacist, a pharmacist-intern may function as a pharmacy
technician and perform all of the duties of a certified pharmacy technician
provided the pharmacist-intern:
(1)
is under the direct supervision of a pharmacist;
(2)
has completed the pharmacy's on-site technician training
program;
(3)
has completed a pharmacist training program in the
preparation of sterile pharmaceuticals if the pharmacist-intern is compounding
sterile pharmaceuticals; and
(4)
is counted as a certified pharmacy technician in the
ratio of pharmacy technicians to pharmacists.
(c)
[
(1)
present or identify himself/herself as a pharmacist;
(2)
sign or initial any document which is required to
be signed or initialed by a pharmacist unless a preceptor cosigns the document;
or
(3)
supervise supportive personnel.
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 March 16, 2000.
TRD-200001974
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 30, 2000
For further information, please call: (512) 305-8028
Subchapter A. ALL CLASSES OF PHARMACIES
22 TAC §291.7, §291.17
The Texas State Board of Pharmacy proposes amendments to §291.7,
concerning Change of Pharmacist Employment and §291.17, concerning Inventory
Requirements. The amendments, if adopted, will: (1) establish consistent procedures
for persons to follow when reporting a change of pharmacist-in-charge (PIC)
to the Texas State Board of Pharmacy; and (2) help ensure that the incoming
PIC is aware of the responsibilities of being a PIC of a pharmacy.
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 or local government as a result of enforcing or administering
the rules.
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 improved reporting of changes of the PIC of a
pharmacy. Since notification of a change of PIC is already required, there
are no economic cost to entities required to comply with the sections or to
small and large businesses, as defined by §2006.002 of the Texas Government
Code.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The amendments are proposed under §§554.002, 554.051,
and 562.106 of the Texas Pharmacy Act (Chapters 551-556, Texas Occupations
Code). The Board interprets §554.002 as authorizing the agency to regulate
the practice of pharmacy in Texas by enforcing the provisions of the Texas
Pharmacy Act relating to the conduct of a pharmacist practicing in this state.
The Board interprets §554.051 as authorizing the agency to adopt rules
for the proper administration and enforcement of the Act. The Board interprets §562.106
as requiring a pharmacy to report in writing to the Board, not later than
the 10th day after the date of a change of the person designated as the PIC
of a pharmacy.
The statutes affected by the rules: Chapters 551-566, Texas Occupations
Code
§291.7.Change of Pharmacist Employment.
(a)
(No change.)
(b)
Change of pharmacist-in-charge of a pharmacy.
(1)-(3)
(No change.)
(4)
The incoming pharmacist-in-charge shall be responsible
for the following actions:
(A)-(B)
(No change.)
(C)
notifying the board within 10 days in writing
on a
form provided by the board,
that a change of pharmacist-in-charge has
occurred. The notification shall include the following:
(i)-(iii)
(No change.)
(iv)
a statement
signed by the incoming pharmacist-in-charge
attesting that
:
(I)
an inventory has been conducted by the departing
and incoming pharmacists-in-charge; if the inventory was not taken by both
pharmacists, the statement shall provide an explanation
; and
[
(II)
the incoming pharmacist-in-charge has
read and understands the laws and rules relating to this class of pharmacy.
§291.17.Inventory Requirements.
(a)-(f)
(No change.)
(g)
Change of pharmacist-in-charge of a pharmacy.
(1)-(3)
(No change.)
(4)
The incoming pharmacist-in-charge shall be responsible
for the following actions:
(A)-(B)
(No change.)
(C)
notifying the board
within 10 days
in writing
on a form provided by the board,
that a change of pharmacist-in-charge
has occurred. The notification shall include the following:
(i)-(iii)
(No change.)
(iv)
a statement
signed by the incoming pharmacist-in-charge
attesting
that
:
(I)
an inventory has been conducted by the departing
and incoming pharmacists-in-charge; if the inventory was not taken by both
pharmacists, the statement shall provide an explanation
; and
[
(II)
the incoming pharmacist-in-charge has
read and understands the laws and rules relating to this class of pharmacy.
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 March 16, 2000.
TRD-200001971
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 30, 2000
For further information, please call: (512) 305-8028
22 TAC §§291.32, 291.33, 291.36
The Texas State Board of Pharmacy proposes amendments to §291.32,
concerning Personnel, §291.33, concerning Operational Standards, and §291.36,
concerning Class A Pharmacies Compounding Sterile Pharmaceuticals. The amendments,
if adopted, will: (1) clarify the duties which may be performed by pharmacy
technicians; (2) specify the requirements for a temporary absence of the pharmacist;
and (3) make changes resulting from a rule review of §291.36. Changes
as a result of the rule review of §291.36 include: (1) changes citations
as a result of the codification of the Texas Pharmacy Act by the 76th Legislature;
(2) allows the use of electronic signatures in certain circumstances; (3)
clarifies pharmaceutical care duties; (4) clarifies the definition of "state";
(5) makes provisions for dispensing Schedule II controlled substances issued
by out-of-state physicians; and (6) updates the requirements for transferring
prescriptions.
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 the establishment of clear guidelines for the use
of and supervision of properly trained pharmacy technicians. Changes as a
result of the rule review simply update requirements to reflect current requirements
for pharmacy practice. Both the automation and the rule review components
of these amendments permit the use of new technologies or practices which
were previously restricted. Since licensees are not mandated to use these
new technologies or practices, there is no additional fiscal impact for small
or large businesses or to other entities who are required to comply with this
section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The amendments are proposed under §§551.002, 554.051,
554.005, 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 §554.005 as authorizing the agency to regulate the delivery
or distribution of prescription drugs as they relate to the practice of pharmacy
and to specify the minimum standards for the maintenance of prescription drug
records. The Board interprets §554.053 as authorizing the agency to adopt
rules for the use and the duties of pharmacy technicians in a pharmacy.
The statutes affected by this rule: Chapters 551-566, Texas Occupations
Code
§291.32.Personnel
(a)
(No change.)
(b)
Pharmacists.
(1)
General.
(A)-(B)
(No change.)
(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
[
(ii)
(No change.)
(D)-(E)
(No change.)
(2)-(3)
(No change.)
(c)
Pharmacy technicians.
(1)
Qualifications.
(A)
General.
[
All pharmacy technicians shall:
(i)
[
(ii)
[
(iii)
[
[(ii)
For the purpose of this subsection,
pharmacy technicians are those persons who perform nonjudgmental technical
duties associated with the dispensing of a prescription drug order.]
(B)-(C)
(No change.)
(2)
Duties.
(A)
[
[
Pharmacy technicians may not perform any of
the duties listed in subsection (b)(2) of this section.
(B)
[
(i)
[
(ii)
[
(iii)
[
(C)
Pharmacy technicians may perform only
nonjudgmental technical duties associated with the preparation and distribution
of prescription drugs, including 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.
[(B)
Labeling.]
[(i)
A pharmacist may not delegate the act of affixing a label
to a prescription container unless the pharmacy technician has completed the
education and training requirements outlined in paragraphs (1) and (4) of
this subsection.]
[(ii)
Effective January 1, 2001, only certified pharmacy technicians
may affix a label to a prescription container.]
(3)-(5)
(No change.)
(d)
(No change.)
§291.33.Operational Standards
(a)
(No change.)
(b)
Environment.
(1)-(3)
(No change.)
(4)
Temporary absence of pharmacist.
(A)
If a pharmacy is staffed by a single pharmacist, the pharmacist
may leave the pharmacy for breaks and meal periods without closing the pharmacy
and removing pharmacy technicians from the pharmacy provided the following
conditions are met:
(i)
the pharmacist remains on-site and available for an emergency;
(ii)
the absence does not exceed 30 minutes at a time and a
total of 2 hours in a 24 hour period;
(iii)
the pharmacist reasonably believes that the security
of the pharmacy will be maintained in his or her absence. If in the professional
judgment of the pharmacist, for reasons of security or otherwise, the pharmacist
determines that the pharmacy should close during his or her absence, then
the pharmacist shall close the pharmacy and remove the pharmacy technicians
from the pharmacy during his or her absence; and
(iv)
a notice is posted which includes the following information:
(I)
the fact that pharmacist is on a break and the time the
pharmacist will return; and
(II)
the fact that certified pharmacy technicians may begin
processing of prescription drug orders or refills brought in during the pharmacist
absence but the prescription or refill may not be delivered to the patient
until the pharmacist returns and verifies the accuracy of the prescription.
(B)
During the time a pharmacist is absent from the pharmacy,
only certified pharmacy technicians who have completed the pharmacy's training
program may perform the following duties, provided a pharmacist verifies the
accuracy of all acts, tasks, and functions performed by the certified pharmacy
technicians prior to delivery of the prescription to the patient or the patient's
agent:
(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; and
(vi)
prepackaging and labeling prepackaged drugs.
(C)
Upon return to the pharmacy, the pharmacist shall:
(i)
conduct a drug regimen review as specified in subsection
(c)(2) of this section; and
(ii)
verify the accuracy of all acts, tasks, and functions
performed by the certified pharmacy technicians prior to delivery of the prescription
to the patient or the patient's agent.
(D)
An agent of the pharmacist may deliver a prescription drug
order to the patient or his or her agent provided a record of the delivery
is maintained containing the following information:
(i)
date of the delivery;
(ii)
unique identification number of the prescription drug
order;
(iii)
patient's name;
(iv)
patient's phone number or the phone number of the person
picking up the prescription; and
(v)
signature of the person picking up the prescription.
(E)
Any prescription delivered to a patient when a pharmacist
is not in the pharmacy must meet the requirements for a prescription delivered
to a patient as described in subsection (c)(1)(F) of this section.
(F)
During the times a pharmacist is absent from the pharmacy
a pharmacist intern shall be considered a certified pharmacy technician and
may perform only the duties of a certified pharmacy technician.
(G)
In pharmacies with two or more pharmacists on duty, the
pharmacists shall stagger their breaks and meal periods so that the pharmacy
is not left without a pharmacist on duty.
(c)
Prescription dispensing and delivery.
(1)
Patient counseling and provision of drug information.
(A)-(D)
(No change.)
(E)
In addition to the requirements of subparagraphs (A)-(D)
of this paragraph, if a prescription drug order is delivered to the patient
at the pharmacy, the following is applicable.
(i)
So that a patient will have access to information concerning
his or her prescription, a prescription may not be delivered to a patient
unless a pharmacist is in the pharmacy, except as provided in
subsection
(b)(4) of section.
[
[(ii)
An agent of the pharmacist may deliver
a prescription drug order to the patient or his or her agent during short
periods of time when a pharmacist is absent from the pharmacy, provided the
short periods of time do not exceed two hours, and provided a record of the
delivery is maintained containing the following information: ]
[(I)
date of the delivery; ]
[(II)
unique identification number of the prescription drug
order; ]
[(III)
patient's name; ]
[(IV)
patient's phone number or the phone number of the person
picking up the prescription; and]
[(V)
signature of the person picking up the prescription.]
[(iii)
Any prescription delivered to a patient
when a pharmacist is not in the pharmacy must meet the requirements described
in subparagraph (F) of this paragraph.]
(ii)
[
(F)-(G)
(No change.)
(2)-(4)
(No change.)
(d)-(j)
Equipment and supplies.
§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals
(a)
(No change.)
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
(No change.)
(2)
Act--The Texas Pharmacy Act,
Chapter 551-556,
Occupations Code,
[
(3)
Accurately as prescribed--Dispensing, delivering,
and/or distributing a prescription drug order:
(A)-(B)
(No change.)
(C)
with correct labeling (including directions for use) as
ordered by the practitioner. Provided, however, that nothing herein shall
prohibit pharmacist substitution if substitution is conducted in strict accordance
with applicable laws and rules, including
Chapters 562 and 563
[
(4)-(16)
(No change.)
(17)
Confidential record--Any health related record
that contains information that identifies an individual and that is
maintained by a pharmacy or pharmacist such as a patient medication record,
prescription drug order, or medication drug order.
(18)-(24)
(No change.)
(25)
Designated agent--
(A)
(No change.)
(B)
a licensed nurse, physician assistant, or pharmacist employed
in a health care facility to whom the practitioner communicates a prescription
drug order; [
(C)
an advanced practice nurse or physician assistant authorized
by a practitioner to carry out or sign a prescription drug order for dangerous
drugs under
Chapter 157 of the Medical Practice Act (Subtitle B, Occupations
Code); or
[
(D)
a person who is a licensed
vocational nurse or has an education equivalent to or greater than that required
for a licensed vocational nurse designated by the practitioner to communicate
prescriptions for an advanced practice nurse or physician assistant authorized
by the practitioner to sign prescription drug orders under Chapter 157 of
the Medical Practice Act (Subtitle B, Occupations Code).
(26)-(32)
(No change.)
(33)
Electronic signature--A unique security
code or other identifier which specifically identifies the person entering
information into a data processing system. A facility which utilizes electronic
signatures must:
(A)
maintain a permanent list of the unique security codes
assigned to persons authorized to use the data processing system; and
(B)
have an ongoing security program which is capable of identifying
misuse and/or unauthorized use of electronic signatures.
(34)
[
(35)
[
(36)
[
(37)
[
(38)
[
(A)
has not been dispensed to the patient in the same strength
and dosage form by this pharmacy within the last year;
(B)
is transferred from another pharmacy; and/or
(C)
is a discharge prescription drug order. (Note: furlough
prescription drug orders are not considered new prescription drug orders.)
(39)
[
(A)
original written prescription drug orders; or
(B)
original verbal or electronic prescription drug orders
reduced to writing either manually or electronically by the pharmacist.
(40)
[
(41)
[
(42)
[
(43)
[
(44)
[
(45)
[
(A)
participating in a pharmacy's technician training program;
or
(B)
a person currently enrolled in a technician training program
accredited by the American Society of Health-System Pharmacists provided:
(i)
the person is working 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;
(ii)
the person is under the direct supervision of and responsible
to a pharmacist; and
(iii)
the supervising pharmacist conducts in-process and final
checks.
(46)
[
(47)
[
(A)
a physician, dentist, podiatrist, veterinarian, or other
person licensed or registered to prescribe, distribute, administer, or dispense
a prescription drug or device in the course of professional practice in this
state;
(B)
a person licensed by another state in a health field in
which, under Texas law, licensees in this state may legally prescribe dangerous
drugs or a person practicing in another state and licensed by another state
as a physician, dentist, veterinarian, or podiatrist, having a current federal
Drug Enforcement Administration registration number, and who may legally prescribe
Schedule II, III, IV, or V controlled substances in such other state; or
(C)
a person licensed in the Dominion of Canada or the United
Mexican States in a health field in which, under the laws of this state, a
licensee may legally prescribe dangerous drugs;
(D)
does not include a person licensed under the Texas Pharmacy
Act.
(48)
[
(49)
[
(A)
a substance for which federal or state law requires a prescription
before it may be legally dispensed to the public;
(B)
a drug or device that under federal law is required, prior
to being dispensed or delivered, to be labeled with either of the following
statements:
(i)
"Caution: federal law prohibits dispensing without prescription";
or
(ii)
"Caution: federal law restricts this drug to use by or
on order of a licensed veterinarian"; or
(C)
a drug or device that is required by any applicable federal
or state law or regulation to be dispensed on prescription only or is restricted
to use by a practitioner only.
(50)
[
(A)
an order from a practitioner or a practitioner's designated
agent to a pharmacist for a drug or device to be dispensed; or
(B)
an order pursuant to the
Subtitle B, Chapter 157,
Occupations Code.
[
(51)
[
(52)
[
(53)
[
(54)
[
(55)
State--One of the 50
United States of America, a U.S. territory, or the District of Columbia.
(56)
[
(57)
[
(58)
[
(59)
[
(60)
[
(c)
Personnel.
(1)
(No change.)
(2)
Pharmacists.
(A)
General.
(i)-(ii)
(No change.)
(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
[
(II)
(No change.)
(iv)-(vi)
(No change.)
(B)
Duties. Duties which may only be performed by a pharmacist
are as follows:
(i)-(viii)
(No change.)
(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 [
(3)
Pharmacy technicians.
(A)
Qualifications.
(i)
General.
[
All pharmacy technicians shall:
(I)
[
(II)
[
(III)
[
[
For the purpose of this section,
pharmacy technicians are those persons who perform nonjudgmental technical
duties associated with the dispensing of a prescription drug order.]
(ii)-(iii)
(No change.)
(B)
Duties.
(i)
[
[
pharmacy technicians may not perform any of
the duties listed in paragraph (2)(B) of this subsection.
(ii)
[
(I)
[
(II)
[
(iii)
Pharmacy technicians may perform only
nonjudgmental technical duties associated with the preparation and distribution
of prescription drugs, including 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 subsection;
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, only certified pharmacy
technicians may compound sterile pharmaceuticals.
(X)
compounding non-sterile prescription drug
orders; and
(XI)
bulk compounding.
[(III)
A pharmacist may not delegate the act
of affixing a label to a prescription container unless the pharmacy technician
has completed the education and training requirements of subparagraphs (A)
and (D) of this paragraph.]
(ii)
(No change.)
(C)-(E)
(No change.)
(4)-(5)
(No change.)
(d)
Operational standards.
(1)
Licensing requirements.
(A)-(G)
(No change.)
(H)
A Class A pharmacy compounding sterile pharmaceuticals,
licensed under the provisions of the Act,
§560.051(a)(1),
[
(I)
(No change.)
(2)
Environment.
(A)
General requirements.
(i)-(vi)
(No change.)
(vii)
If prescription drug orders are delivered to the patient
at the pharmacy, [
(I)-(II)
(No change.)
(viii)
(No change.)
(B)-(C)
(No change.)
(D)
Temporary absence of pharmacist.
(i)
If a pharmacy is staffed by a single pharmacist, the pharmacist
may leave the pharmacy for breaks and meal periods without closing the pharmacy
and removing pharmacy technicians from the pharmacy provided the following
conditions are met:
(I)
the pharmacist remains on-site and available for an emergency;
(II)
the absence does not exceed 30 minutes at a time and a
total of 2 hours in a 24 hour period;
(III)
the pharmacist reasonably believes that the security
of the pharmacy will be maintained in his or her absence. If in the professional
judgment of the pharmacist, for reasons of security or otherwise, the pharmacist
determines that the pharmacy should close during his or her absence, then
the pharmacist shall close the pharmacy and remove the pharmacy technicians
from the pharmacy during his or her absence; and
(IV)
a notice is posted which includes the following information:
(-a-)
the fact that pharmacist is on a break and
the time the pharmacist will return; and
(-b-)
the fact that certified pharmacy technicians
may begin processing of prescription drug orders or refills brought in during
the pharmacist absence but the prescription or refill may not be delivered
to the patient until the pharmacist returns and verifies the accuracy of the
prescription.
(ii)
During the time a pharmacist is absent from
the pharmacy, only certified pharmacy technicians who have completed the pharmacy's
training program may perform the following duties, provided a pharmacist verifies
the accuracy of all acts, tasks, and functions performed by pharmacy technicians
prior to delivery of the prescription to the patient or the patient's agent:
(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; and
(VI)
prepackaging and labeling prepackaged drugs.
(iii)
Upon return to the pharmacy, the pharmacist
shall:
(I)
conduct a drug regimen review as specified in
paragraph (4)(A)(ii) of this subsection; and
(II)
verify the accuracy of all acts, tasks, and
functions performed by pharmacy technicians prior to delivery of the prescription
to the patient or the patient's agent.
(iv)
An agent of the pharmacist may deliver a prescription
drug order to the patient or his or her agent provided a record of the delivery
is maintained containing the following information:
(I)
date of the delivery;
(II)
unique identification number of the prescription
drug order;
(III)
patient's name;
(IV)
patient's phone number or the phone number
of the person picking up the prescription; and
(V)
signature of the person picking up the prescription.
(v)
Any prescription delivered to a patient when
a pharmacist is not in the pharmacy must meet the requirements for a prescription
delivered to a patient as described in paragraph (3)(A)(v) of this subsection.
(vi)
During the times a pharmacist is absent from
the pharmacy a pharmacist intern shall be considered a certified pharmacy
technician and may perform only the duties of a certified pharmacy technician.
(vii)
In pharmacies with two or more pharmacists
on duty, the pharmacists shall stagger their breaks and meal periods so that
the pharmacy is not left without a pharmacist on duty.
(3)
Prescription dispensing and delivery.
(A)
Patient counseling and provision of drug information.
(i)
(No change.)
(ii)
Such communication:
(I)-(III)
(No change.)
(IV)
[
(-a-)-(-c-)
(No change.)
(iii)-(iv)
(No change.)
(v)
In addition to the requirements of clauses (i)-(iv) of
this subparagraph, if a prescription drug order is delivered to the patient
at the pharmacy, the following is applicable.
(I)
So that a patient will have access to information concerning
his or her prescription, a prescription may not be delivered to a patient
unless a pharmacist is in the pharmacy, except as provided in
paragraph
(2)(D) of this subsection.
[
[(II)
An agent of the pharmacist may deliver
a prescription drug order to the patient or his or her agent during short
periods of time when a pharmacist is absent from the pharmacy, provided the
short periods of time do not exceed two hours, and provided a record of the
delivery is maintained containing the following information:]
[(-a-)
date of the delivery;]
[(-b-)
unique identification number of the prescription
drug order;]
[(-c-)
patient's name;]
[(-d-)
patient's phone number or the phone number of the
person picking up the prescription; and]
[(-e-)
signature of the person picking up the prescription.]
[(III)
Any prescription delivered to a patient
when a pharmacist is not in the pharmacy must meet the requirements described
in clause (vi) of this subparagraph.]
(II)
[
(vi)-(vii)
(No change.)
(B)
Prescription containers.
(i)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in an appropriate container as
specified on the manufacturer's
container.
[
[(I)
If a drug is susceptible to light, the
drug shall be dispensed in a light-resistant container.]
[(II)
If a drug is susceptible to moisture,
the drug shall be dispensed in a tight container.]
[(III)
The container should not interact physically
or chemically with the drug product placed in it so as to alter the strength,
quality, or purity of the drug beyond the official requirements.]
(ii)
(No change.)
(C)
Labeling.
(i)
At the time of delivery of the drug, the dispensing container
of a sterile pharmaceutical shall bear a label with at least the following
information:
(I)-(VII)
(No change.)
(VIII)
initials or identification code
[
(IX)-(XI)
(No change.)
(XII)
if the pharmacist has selected a generically equivalent
drug pursuant to the provisions of the Act,
Chapters 562 and 563,
[
(XIII)
the name of the advanced practice nurse or physician
assistant, if the prescription is carried out by an advanced practice nurse
or physician assistant in compliance with
Subtitle B, Chapter 157, Occupations
Code.
[
(ii)
(No change.)
(4)
Pharmaceutical care services.
(A)
(No change.)
(B)
Other pharmaceutical care services which may be provided
by pharmacists include, but are not limited to, the following:
(i)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practice Act[
(ii)
administering immunizations and vaccinations
under written protocol of a physician;
(iii)
[
(iv)
[
(v)
[
(5)
(No change.)
(6)
Library. A reference library shall be maintained which
includes the following in hard-copy or electronic format:
(A)
(No change.)
(B)
at least one current or updated reference from each of
the following categories:
(i)-(ii)
(No change.)
(iii)
a general information reference text, such as:
[
(I)-(V)
(No change.)
(iv)
(No change.)
(C)-(E)
(No change.)
(7)
(No change.)
(8)
Prepackaging of drugs and loading bulk drugs into
automated compounding or counting devices.
(A)
Prepackaging of drugs.
(i)-(ii)
(No change.)
(iii)
Records of prepackaging shall be maintained to show:
(I)-(VIII)
(No change.)
(IX)
name, initials,
signature,
or electronic signature
of the prepacker; and
(X)
signature
[
(iv)
(No change.)
(B)
Loading bulk drugs into automated compounding or counting
devices.
(i)-(ii)
(No change.)
(iii)
Records of loading bulk drugs into an automated compounding
or counting device shall be maintained to show:
(I)-(VI)
(No change.)
(VII)
name, initials,
signature,
or electronic signature
of the person loading the automated compounding or counting device; and
(VIII)
signature
[
(iv)
(No change.)
(9)
(No change.)
(e)
Records.
(1)
(No change.)
(2)
Prescriptions.
(A)
(No change.)
(B)
Written prescription drug orders.
(i)-(iii)
(No change.)
(iv)
Prescription drug orders written by practitioners in another
state.
(I)
(No change.)
(II)
Controlled substance prescription drug orders.
(-a-)
A pharmacist may dispense
prescription drug order for controlled substances in Schedule II issued by
a practitioner in another state provided:
(-1-)
the prescription is filled in compliance with
a written plan approved by the Director of the Texas Department of Public
Safety in consultation with the Board, which provides the manner in which
the dispensing pharmacy may fill a prescription for a Schedule II controlled
substance;
(-2-)
the prescription drug order is an original
written prescription issued by a person practicing in another state and licensed
by another state as a physician, dentist, veterinarian, or podiatrist, who
has a current federal Drug Enforcement Administration (DEA) registration number,
and who may legally prescribe Schedule II controlled substances in such other
state; and
(-3-)
the prescription drug order is not dispensed
more than six months from the initial date of issuance and may not be refilled.
(-b-)
A pharmacist may dispense prescription
drug orders for controlled substances in Schedule III, IV, or V issued by
a practitioner in another state provided:
(-1-)
[
(-2-)
[
(-3-)
[
(v)
(No change.)
(vi)
Prescription drug orders carried out or signed by an advanced
practice nurse or physician assistant.
(I)
A pharmacist may dispense a prescription drug order for
a dangerous drug which is carried out or signed by an advanced practice nurse
or physician assistant provided:
(-a-)
(No change.)
(-b-)
the advanced practice nurse or physician assistant
is practicing in accordance with
Subtitle B, Chapter 157, Occupations
Code.
[
(II)
Each practitioner shall designate in writing the name
of each advanced practice nurse or physician assistant authorized to carry
out or sign a prescription drug order pursuant to
Subtitle B, Chapter
157, Occupations Code.
[
(vii)
Prescription drug orders for Schedule II controlled substances.
No Schedule II controlled substance may be dispensed without a written prescription
drug order of a practitioner on
an official
[
(C)-(G)
(No change.)
(H)
Original prescription drug order records.
(i)-(ii)
(No change.)
(iii)
Original prescriptions shall be maintained in one of
the following formats:
(I)
(No change.)
(II)
within a patient medication record system provided that
original prescriptions for controlled substances are maintained separate from
original prescriptions for noncontrolled substances and
official
[
(iv)
Original prescription records other than
prescriptions
for Schedule II controlled substances
[
(I)-(III)
(No change.)
(I)
Prescription drug order information.
(i)
(No change.)
(ii)
All original prescriptions for dangerous drugs carried
out by an advanced practice nurse or physician assistant in accordance with
Subtitle B, Chapter 157, Occupations Code,
[
(I)
(No change.)
(II)
name, address,
and
telephone number[
(III)-(VIII)
(No change.)
(iii)-(iv)
(No change.)
(J)
(No change.)
(3)
Prescription drug order records maintained in
a manual system.
(A)
Original prescriptions. Original prescriptions shall be
maintained in three files as specified in paragraph
(2)(H)(iii)
[
(B)-(E)
(No change.)
(4)
Prescription drug order records maintained in
a data processing system.
(A)-(C)
(No change.)
(D)
Transfer of prescription drug order information. For the
purpose of refill or initial dispensing, the transfer of original prescription
drug order information is permissible between pharmacies, subject to the following
requirements.
(i)
The transfer of original prescription drug order information
for controlled substances listed in Schedules III, IV, or V is permissible
between pharmacies on a one-time basis
only. However, pharmacies electronically
sharing a real-time, on-line database may transfer up to the maximum refills
permitted by law and the prescriber's authorization
.
(ii)-(x)
(No change.)
(E)
Electronic transfer of prescription drug order information
between pharmacies. Pharmacies electronically accessing the same prescription
drug order records may electronically transfer prescription information if
the following requirements are met.
(i)
The original prescription is voided and the following
information is documented in the records of the transferring pharmacy;
[
(I)
the name, address, and if a
controlled substance, the DEA registration number of the pharmacy to which
such prescription is transferred;
(II)
the name of the pharmacist
or pharmacist intern receiving the prescription drug order information; and
(III)
the date of the transfer.
[(I)
the fact that the prescription drug order
was transferred; ]
[(II)
the unique identification number of
the prescription drug order transferred;]
[(III)
the name of the pharmacy to which it
was transferred; and]
[(IV)
the date and time of the transfer.]
[(ii)
A pharmacist in the transferring pharmacy
shall review the message and document the review by signing and dating a hard
copy of the message or a log book containing the information required on the
message as soon as practical, but in no event more than 72 hours from the
time of such transfer.]
(ii)
[
(F)
(No change.)
(5)-(10)
(No change.)
(11)
Confidentiality.
(A)
(No change.)
(B)
Confidential records are privileged and may be released
only to:
(i)
(No change.)
(ii)
a practitioner or another pharmacist
if, in the pharmacist's professional judgement, the release is necessary to
protect the patient's health and well being;
(iii)
the board or to a person or another
state or federal agency authorized by law to receive the confidential record;
(iv)
a law enforcement agency engaged in investigation
of a suspected violation of Chapter 481 or 483, Health and Safety Code, or
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C.
Section 801 et seq.);
(v)
a person employed by a state agency that
licenses a practitioner, if the person is performing the person's official
duties; or
[(ii)
practitioners and other pharmacists
when, in the pharmacist's professional judgment, such release is necessary
to protect the patient's health and well-being;]
[(iii)
other persons, the board, or other
state or federal agencies authorized by law to receive such information;]
[(iv)
a law enforcement agency engaged in
investigation of suspected violations of the Controlled Substances Act or
the Dangerous Drug Act;]
[(v)
a person employed by any state agency
which licenses a practitioner as defined in the Act if such person is engaged
in the performance of the person's official duties; or]
(vi)
(No change.)
(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 March 16, 2000.
TRD-200001972
Gay Dodson
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 30, 2000
For further information, please call: (512) 305-8028
22 TAC §§291.72-291.75
The Texas State Board of Pharmacy proposes amendments to §291.72,
concerning Definitions, §291.73, concerning Personnel, §291.74,
concerning Operational Standards, and §291.75, concerning Records. The
amendments, if adopted, will implement the recommendations of the Task Force
on Non-Residential Pharmacies and Pharmacy Automation as those recommendations
apply to Class C (Institutional) Pharmacies and make non-substantive housekeeping
changes due to the codification of the Texas Pharmacy Act by the 76th Legislature,
(1999).
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 or local government as a result of enforcing or administering
the rules.
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 protect the public through the effective control
and regulation of the use of automation in pharmacies and to update and clarify
currently existing rules. The automation component of the rules permits use
of new technology which previously was restricted. Since licensees are not
mandated to use the new technology, there is no additional fiscal impact for
small or large businesses or to other entities who are required to comply
with the sections.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The amendments are proposed under §§551.002, 554.051,
and 554.005 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 §554.005 as authorizing the agency to regulate the delivery
or distribution of prescription drugs as they relate to the practice of pharmacy
and to specify the minimum standards for the maintenance of prescription drug
records.
The statutes affected by the rules: Chapters 551-566, Texas Occupations
Code.
§291.72.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Accurately as prescribed--Distributing and/or delivering
a medication drug order:
(A)-(B)
(No change.)
(C)
with correct labeling [
(2)
Act--The Texas Pharmacy Act,
Chapters 551-566,
Occupations Code, as amended.
[
(3)-(5)
(No change.)
(6)
Automated compounding or counting device
[
(7)
Automated medication supply
system--a mechanical system that performs operations or activities relative
to the storage and distribution of medications for administration and which
collects, controls, and maintains all transaction information.
(8)
[
(9)
[
(10)
[
(11)
[
(A)
has completed the pharmacy technician training program
of the pharmacy;
(B)
has taken and passed the National Pharmacy Technician Certification
Exam or other examination approved during an open meeting by the Board; and
(C)
maintains a current certification with the Pharmacy Technician
Certification Board or any other entity providing an examination approved
by the Board.
(12)
[
(13)
[
(14)
[
(A)
as the result of a practitioner's prescription drug or
medication order or initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(B)
in anticipation of prescription drug or medication orders
based on routine, regularly observed prescribing patterns; or
(C)
for the purpose of, or as an incident to research, teaching,
or chemical analysis and not for sale or dispensing.
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(21)
[
(A)
"Caution: federal law prohibits dispensing without prescription";
or
(B)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(22)
[
(23)
[
(24)
[
(25)
[
(26)
[
(27)
[
(28)
[
(A)
An evaluation of medication orders and patient medication
records for:
(i)
known allergies;
(ii)
rational therapy--contraindications;
(iii)
reasonable dose and route of administration;
(iv)
reasonable directions for use;
(v)
duplication of therapy;
(vi)
drug-drug interactions;
(vii)
drug-food interactions;
(viii)
drug-disease interactions;
(ix)
adverse drug reactions; and
(x)
proper utilization, including overutilization or underutilization.
(B)
The drug regimen review may be conducted prior to administration
of the first dose (prospective) or after administration of the first dose
(retrospective).
(29)
[
(A)
maintain a permanent list of the unique security codes
assigned to persons authorized to use the data processing system; and
(B)
have an ongoing security program which is capable of identifying
misuse and/or unauthorized use of electronic signatures.
(30)
[
(31)
[
(32)
[
(33)
[
(34)
[
(35)
[
(36)
[
(37)
[
(38)
[
(39)
Medical Practice Act--The Texas
Medical Practice Act, Subtitle B, Occupations Code, as amended.
(40)
[
(41)
[
(42)
[
(43)
[
(44)
[
(45)
[
(46)
[
(47)
[
(A)
participating in a pharmacy's technician training program;
or
(B)
a person currently enrolled in a technician training program
accredited by the American Society of Health-System Pharmacists provided:
(i)
the person is working 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;
(ii)
the person is under the direct supervision of and responsible
to a pharmacist; and
(iii)
the supervising pharmacist conducts in-process and final
checks.
(48)
[
(49)
[
(A)
A substance for which federal or state law requires a prescription
before it may be legally dispensed to the public;
(B)
A drug or device that under federal law is required, prior
to being dispensed or delivered, to be labeled with either of the following
statements:
(i)
Caution: federal law prohibits dispensing without prescription;
or
(ii)
Caution: federal law restricts this drug to use by or
on order of a licensed veterinarian; or
(C)
A drug or device that is required by any applicable federal
or state law or regulation to be dispensed on prescription only or is restricted
to use by a practitioner only.
(50)
[
(A)
a written order from a practitioner or a verbal order from
a practitioner or his authorized agent to a pharmacist for a drug or device
to be dispensed; or
(B)
a written order or a verbal order pursuant to
Subtitle
B, Chapter 157, Occupations Code.
[
(51)
[
(52)
[
(53)
[
(54)
[
(55)
[
(56)
[
(57)
[
(58)
[
(59)
[
§291.73.Personnel.
(a)
(No change.)
(b)
Pharmacist-in-charge.
(1)
(No change.)
(2)
Responsibilities. The pharmacist-in-charge shall have
the responsibility for, at a minimum, the following:
(A)-(R)
(No change.)
(S)
assuring that a reasonable effort is made to obtain, record,
and maintain patient medication records; [
(T)
assuring the 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
; and
(U)
if the pharmacy uses an automated medication
supply system, shall be responsible for the following:
(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 medication supply
system, at least monthly, for expiration date, misbranding, physical integrity,
security, and accountability;
(iii)
assigning, discontinuing, or changing personnel access
to the automated medication supply system;
(iv)
ensuring that pharmacy technicians and licensed healthcare
professionals performing any services in connection with an automated medication
supply 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 medication supply system is
stocked accurately and an accountability record is maintained in accordance
with the written policies and procedures of operation.
(c)
(No change.)
(d)
Pharmacists.
(1)
(No change.)
(2)
Duties. Duties of the pharmacist-in-charge and all
other pharmacists shall include, but need not be limited to the following:
(A)-(C)
(No change.)
(D)
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
Subtitle
B, Chapter 157, Occupations Code;
[
(E)
(No change.)
(e)
Pharmacy technicians.
(1)
(No change.)
(2)
Duties.
(A)
General. Duties may include, but need not be limited to,
the following functions under the direct supervision of and responsible to
a pharmacist:
(i)-(iv)
(No change.)
(v)
entering medication order and drug distribution information
into a data processing system, provided judgmental decisions are not required
and a pharmacist checks the accuracy of the information entered into the system
prior to releasing the order or in compliance with the absence of pharmacist
requirements contained in §291.74(e) of this title (relating to Operational
Standards); [
(vi)
loading bulk unlabeled drugs into an
automated compounding
or counting device
[
(vii)
may be allowed access to
automated medication supply systems after proper training on the use of the
automated medication supply system and demonstration of comprehensive knowledge
of the written policies and procedures for its operation.
(B)
(No change.)
(3)-(5)
(No change.)
(f)-(g)
(No change.)
§291.74.Operational Standards.
(a)
Licensing requirements.
(1)
A Class C pharmacy shall register annually
or biennially
with the board on a pharmacy license application provided by the board,
following the procedures specified in §291.1 of this title (relating
to Pharmacy License Application).
(2)-(8)
(No change.)
(9)
A Class C pharmacy, licensed under the Act,
§560.051(a)(3),
[
(10)
(No change.)
(b)
Environment.
(1)
(No change.)
(2)
Special requirements for the compounding of sterile
pharmaceuticals in the institutional pharmacy.
(A)
If the institutional pharmacy compounds sterile pharmaceuticals,
the following is applicable.
(i)-(iii)
(No change.)
[
Automated compounding device(s).
If automated compounding device(s) are used, the pharmacy shall have a method
to calibrate and verify the accuracy of automated compounding devices used
in aseptic processing and document the calibration and verification on a routine
basis.]
(B)
(No change.)
(3)
(No change.)
(c)-(e)
(No change.)
(f)
Drugs.
(1)-(2)
(No change.)
(3)
Pre-packaging of drugs [
[
Pre-packaging of drugs].
(A)
[
(B)
[
(i)
[
(ii)
[
(iii)
[
(iv)
[
(C)
[
(i)
[
(ii)
[
(iii)
[
(iv)
[
(v)
[
(vi)
[
(viii)
[
(ix)
[
(x)
[
(D)
[
[(B)
Loading bulk or unlabeled drugs into
automated compounding or drug dispensing systems.]
[(i)
Automated compounding or drug dispensing systems may be
loaded with bulk or unlabeled drugs only by a pharmacist or by supportive
personnel under the direction and direct supervision of a pharmacist.]
[(ii)
The label of an automated compounding or drug dispensing
system container shall indicate the brand name and strength of the drug; or
if no brand name, then the generic name, strength, and name of the manufacturer
or distributor.]
[(iii)
Records of loading bulk or unlabeled drugs into an automated
compounding or drug dispensing system shall be maintained to show:]
[(I)
name of the drug, strength, and dosage form;]
[(II)
manufacturer or distributor;]
[(III)
manufacturer's lot number;]
[(IV)
expiration date;]
[(V)
quantity added to the automated drug compounding or dispensing
system; ]
[(VI)
date of loading;]
[(VII)
name, initials, or electronic signature of the person
loading the automated compounding or drug dispensing system; and]
[(VIII)
name, initials, or electronic signature of the responsible
pharmacist.]
[(iv)
The automated compounding or drug dispensing system shall
not be used until a pharmacist verifies that the system is properly loaded
and affixes his or her signature (first initial and last name or full signature)
or electronic signature to the record specified in clause (iii) of this subparagraph.]
(4)-(5)
(No change.)
(6)
Distribution.
(A)
Medication orders.
(i)-(iii)
(No change.)
(iv)
Institutional pharmacies shall be exempt from the labeling
provisions and patient notification requirements of
Section 556.006 and
556.009
[
(B)
Procedures.
(i)
(No change.)
(ii)
The written policies and procedures for the drug distribution
system shall include, but not be limited to, procedures regarding the following:
(I)-(XXVII)
(No change.)
(XXVIII)
use of
automated compounding or counting devices
[
(XXIX)-(XXXV)
(No change.)
(g)
Pharmaceutical care services.
(1)
(No change.)
(2)
Other pharmaceutical care services which may be provided
by pharmacists in the facility include, but are not limited to, the following:
(A)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practice Act[
(B)
administering immunizations and vaccinations
under written protocol of a physician;
(C)
[
(D)
[
(E)
[
(h)-(i)
(No change.)
(j)
Automated devices and systems.
(1)
Automated compounding or counting devices. If a pharmacy
uses automated compounding or counting devices:
(A)
the pharmacy shall have a method to calibrate and verify
the accuracy of the automated compounding or counting device and document
the calibration and verification on a routine basis;
(B)
the devices may be loaded with bulk or unlabeled drugs
only by a pharmacist or by pharmacy technicians under the direction and direct
supervision of a pharmacist;
(C)
the label of an automated compounding or counting device
container shall indicate the brand name and strength of the drug; or if no
brand name, then the generic name, strength, and name of the manufacturer
or distributor;
(D)
records of loading bulk or unlabeled drugs into an automated
compounding or counting device shall be maintained to show:
(i)
name of the drug, strength, and dosage form;
(ii)
manufacturer or distributor;
(iii)
manufacturer's lot number;
(iv)
expiration date;
(v)
date of loading;
(vi)
name, initials, or electronic signature of the person
loading the automated compounding or counting device; and
(vii)
signature or electronic signature of the responsible
pharmacist; and
(E)
the automated compounding or counting device shall not
be used until a pharmacist verifies that the system is properly loaded and
affixes his or her signature to the record specified in subparagraph (D) of
this paragraph.
(2)
Automated medication supply systems.
(A)
Authority to use automated medication supply systems. A
pharmacy may use an automated medication supply system to fill medication
orders provided that:
(i)
the pharmacist-in-charge is responsible for the supervision
of the operation of the system;
(ii)
the automated medication supply system has been tested
by the pharmacy and found to dispense accurately. The pharmacy shall make
the results of such testing available to the Board upon request; and
(iii)
the pharmacy will make the automated medication supply
system available for inspection by the board for the purpose of validating
the accuracy of the system.
(B)
Quality assurance program. A pharmacy which uses an automated
medication supply system to fill medication orders shall operate according
to a written program for quality assurance of the automated medication supply
system which:
(i)
requires continuous monitoring of the automated medication
supply system; and
(ii)
establishes mechanisms and procedures to test the accuracy
of the automated medication supply system at least every six months and whenever
any upgrade or change is made to the system and documents each such activity.
(C)
Policies and procedures of operation.
(i)
When an automated medication supply system is used to store
or distribute medications for administration pursuant to medication orders,
it shall be operated according to written policies and procedures of operation.
The policies and procedures of operation shall establish requirements for
operation of the automated medication supply system and shall describe policies
and procedures that:
(I)
include a description of the policies and procedures of
operation;
(II)
provide for a pharmacist's review and approval of each
original or new medication order filled through the use of the automated medication
supply system:
(-a-)
before the order is filled when a pharmacist is on duty
except for an emergency order;
(-b-)
retrospectively within 72 hours in a facility with
a full-time pharmacist when a pharmacist is not on duty at the time the order
is made; or
(-c-)
retrospectively within 7 days in a facility with
a part-time or consultant pharmacist when a pharmacist is not on duty at the
time the order is made;
(III)
provide for access to the automated medication supply
system for stocking and retrieval of medications which is limited to licensed
healthcare professionals or pharmacy technicians acting under the supervision
of a pharmacist;
(IV)
provide that all medication to be restocked in the automated
medication supply system has been checked by a pharmacist prior to restocking.
The actual restocking may be performed by a pharmacy technician after being
checked by a pharmacist;
(V)
provide for an accountability record to be maintained which
documents all transactions relative to stocking and removing medications from
the automated medication supply system;
(VI)
require a prospective or retrospective drug regimen review
is conducted as specified in subsection (g) of this section; and
(VII)
establish and make provisions for documentation of a
preventative maintenance program for the automated medication supply system.
(ii)
A pharmacy which uses an automated medication supply system
to fill medication orders shall, at least annually, review its written policies
and procedures, revise them if necessary, and document the review.
(D)
Recovery Plan. A pharmacy which uses an automated medication
supply system to store or distribute medications for administration pursuant
to medication orders shall maintain a written plan for recovery from a disaster
or any other situation which interrupts the ability of the automated medication
supply system to provide services necessary for the operation of the pharmacy.
The written plan for recovery shall include:
(i)
planning and preparation for maintaining pharmacy services
when an automated medication supply system is experiencing downtime;
(ii)
procedures for response when an automated medication supply
system is experiencing downtime;
(iii)
procedures for the maintenance and testing of the written
plan for recovery; and
(iv)
procedures for notification of the Board and other appropriate
agencies whenever an automated medication supply system experiences downtime
for more than two days of operation or a period of time which significantly
limits the pharmacy's ability to provide pharmacy services.
§291.75.Records.
(a)
(No change.)
(b)
Outpatient records.
(1)
(No change.)
(2)
Outpatient prescriptions, including, but not limited
to, furlough and discharge prescriptions, that are written by the practitioner
must be written on a form which meets the requirements of the Act,
§562.006
[
(3)
(No change.)
(c)
Inpatient records.
(1)-(5)
(No change.)
(6)
General requirements for records maintained in a data
processing system.
(A)-(C)
(No change.)
(D)
Change or discontinuance of a data processing system.
(i)
Records of distribution and return for all controlled substances,
[
(I)-(II)
(No change.)
(ii)-(iii)
(No change.)
(E)
(No change.)
(7)
Data processing system maintenance of records
for the distribution and return of all controlled substances, [
(A)
Each time a controlled substance, [
(B)-(D)
(No change.)
(8)-(9)
(No change.)
(d)-(e)
(No change.)
(f)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(1)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(A)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by Title 21, Code
of Federal Regulations,
§1304.04(a)
[
(B)-(C)
(No change.)
(2)-(4)
(No change.)
(g)
Confidentiality.
(1)
(No change.)
(2)
Confidential records are privileged and may be released
only to:
(A)
the patient or the patient's agent;
(B)
a practitioner or another pharmacist if,
in the pharmacist's professional judgement, the release is necessary to protect
the patient's health and well being;
(C)
the board or to a person or another state
or federal agency authorized by law to receive the confidential record;
(D)
a law enforcement agency engaged in investigation
of a suspected violation of Chapter 481 or 483, Health and Safety Code, or
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C.
Section 801 et seq.);
(E)
a person employed by a state agency that
licenses a practitioner, if the person is performing the person's official
duties; or
[(B)
practitioners and other pharmacists when,
in the pharmacist's professional judgment, such release is necessary to protect
the patient's health and well-being;]
[(C)
other persons, the board, or other state
or federal agencies authorized by law to receive such confidential records;]
[(D)
a law enforcement agency engaged in investigation
of suspected violations of the Controlled Substances Act or the Dangerous
Drug Act;]
[(E)
a person employed by any state agency
which licenses a practitioner as defined in this Act if such person is engaged
in the performance of the person's official duties; or]
(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 March 16, 2000.
TRD-200001973
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 30, 2000
For further information, please call: (512) 305-8028
Chapter 523.
CONTINUING PROFESSIONAL EDUCATION
Subchapter B. CONTINUING PROFESSIONAL EDUCATION STANDARDS
22 TAC §523.26
The Texas State Board of Public Accountancy (Board) proposes
an amendment to §523.26 concerning Program Time Credit Measurement.
The amendment to § 523.26 will allow hour-for-hour credit for courses
that have been approved by the Quality Assurance Service (QAS) of the National
Association of State Boards of Accountancy and will allow up to a maximum
of the average completion time for non-QAS approved self-study programs.
William Treacy, Executive Director of the Board, has determined that for
the first five-year period the proposed amendment will be in effect:
A. the additional estimated cost to the state expected as a result of enforcing
or administering the amendment will be zero because the proposed amendment
does not require the state to do anything.
B. the estimated reduction in costs to the state and to local governments
as a result of enforcing or administering the amendment will be zero because
the proposed amendment does not require the state or local government to do
anything.
C. the estimated loss or increase in revenue to the state as a result of
enforcing or administering the rule will be zero because the proposed amendment
does not require the state to do anything.
Mr. Treacy has determined that for the first five-year period the amendment
is in effect the public benefits expected as a result of adoption of the proposed
amendment will be that some self-study programs may apply for and be approved
by QAS, which results in more credit being granted to course participants,
which will encourage student participation in approved CPE courses.
The probable economic cost to persons required to comply with the amendment
will be zero because the proposed amendment does not require the state or
local government to do anything.
Mr. Treacy has determined that a Local Employment Impact Statement is not
required because the proposed amendment will not affect a local economy.
Mr. Treacy has determined that the proposed amendment will not have an
adverse economic effect on small businesses because the proposed amendment
does not require anyone to do anything.
The Board specifically invites comments from the public on the issues of
whether or not the proposed amendment will have an adverse economic effect
on small business; if the amendment is believed to have such an effect, then
how may the Board legally and feasibly reduce that effect considering the
purpose of the statute under which the amendment is to be adopted; and if
the amendment is believed to have such an effect, how the cost of compliance
for a small business compares with the cost of compliance for the largest
business affected by the amendment under any of the following standards: (a)
cost per employee; (b) cost for each hour of labor; or (c) cost for each $100
of sales. See Texas Government Code, §2006.002(c).
The Board request comments on the substance and effect of the proposed
amendment from any interested person. Comments must be received at the Board
no later than noon on April 24, 2000. Comments should be addressed to Amanda
G. Birrell, General Counsel, Texas State Board of Public Accountancy, 333
Guadalupe, Tower III, Suite 900, Austin, Texas 78701 or faxed to her attention
at (512) 305-7854.
The amendment is proposed under the Public Accountancy Act, Tex.
Occupations Code, §901.151 (Vernon 1999) which authorizes the Board to
adopt rules deemed necessary or advisable to effectuate the Act.
No other article, statute or code is affected by this proposed amendment.
§523.26. Program Time Credit Measurement.
(a) - (c)
(No change.)
(d)
Self-study programs should be pre-tested to determine
average completion time.
If the self-study course has been approved
by the Quality Assurance Service (QAS) of the National Association of State
Boards of Accountancy (NASBA), the credit allowed shall be hour-for-hour credit.
Otherwise, one
[
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 March 17, 2000.
TRD-200002025
William Treacy
Executive Director
Texas State Board of Public Accountancy
Earliest possible date of adoption: April 30, 2000
For further information, please call: (512) 305-7848
22 TAC §523.32
The Texas State Board of Public Accountancy (Board) proposes
an amendment to §523.32 concerning Ethics Course.
The amendment to §523.32 will remove self-study as an option for the
ethics course from out-of-state residents.
William Treacy, Executive Director of the Board, has determined that for
the first five-year period the proposed amendment will be in effect:
A. the additional estimated cost to the state expected as a result of enforcing
or administering the amendment will be zero because the proposed amendment
does not require anyone to do anything.
B. the estimated reduction in costs to the state and to local governments
as a result of enforcing or administering the amendment will be zero because
the proposed amendment does not require anyone to do anything.
C. the estimated loss or increase in revenue to the state as a result of
enforcing or administering the rule will be zero because the proposed amendment
does not require anyone to do anything.
Mr. Treacy has determined that for the first five-year period the amendment
is in effect the public benefits expected as a result of adoption of the proposed
amendment will be that out-of-state residents will have to take their ethics
courses by one of two formats that enhance the teaching/learning environment.
The probable economic cost to persons required to comply with the amendment
will be zero because the proposed amendment does not require anyone to do
anything.
Mr. Treacy has determined that a Local Employment Impact Statement is not
required because the proposed amendment will not affect a local economy.
Mr. Treacy has determined that the proposed amendment will not have an
adverse economic effect on small businesses because the proposed amendment
does not require anyone to do anything.
The Board specifically invites comments from the public on the issues of
whether or not the proposed amendment will have an adverse economic effect
on small business; if the amendment is believed to have such an effect, then
how may the Board legally and feasibly reduce that effect considering the
purpose of the statute under which the amendment is to be adopted; and if
the amendment is believed to have such an effect, how the cost of compliance
for a small business compares with the cost of compliance for the largest
business affected by the amendment under any of the following standards: (a)
cost per employee; (b) cost for each hour of labor; or (c) cost for each $100
of sales. See Texas Government Code, §2006.002(c).
The Board request comments on the substance and effect of the proposed
amendment from any interested person. Comments must be received at the Board
no later than noon on April 24, 2000. Comments should be addressed to Amanda
G. Birrell, General Counsel, Texas State Board of Public Accountancy, 333
Guadalupe, Tower III, Suite 900, Austin, Texas 78701 or faxed to her attention
at (512) 305-7854.
The amendment is proposed under the Public Accountancy Act, Tex.
Occupations Code, §901.151 (Vernon 1999) which authorizes the Board to
adopt rules deemed necessary or advisable to effectuate the Act.
No other article, statute or code is affected by this proposed amendment.
§523.32. Ethics Course.
(a)
General. Licensees certified or registered prior to January
1, 1995, are required to successfully complete within three years of January
1, 1995, a board-approved four-hour course of comprehensive study on the Rules
of Professional Conduct of the board. A person certified or registered on
or after January 1, 1995 and before September 1, 1999 shall report to the
board the successful completion of the four-hour course within three years
of the end of the initial license period. A minimum of two hours of instruction
on the board's Rules of Professional Conduct must be taken by and reported
on every third subsequent annual license notice.
(1)
(No change.)
(2)
A licensee granted retired, permanent disability,
or other exempt status is not required to complete the ethics course described
during
the licensee's
[
(b)
Course content and board approval. Before a provider of
continuing professional education can offer this course, the content of the
course must be submitted to the continuing professional education committee
of the board for approval. Course content shall be approved only after demonstrating,
either in a live instructor format[
(1) - (4)
(No change.)
(c) - (d)
(No change.)
(e)
Out-of state resident. A certificate or registration holder
who does not reside in the state of Texas may take the course in either a
live instructor format[
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 March 17, 2000.
TRD-200002026
William Treacy
Executive Director
Texas State Board of Public Accountancy
Earliest possible date of adoption: April 30, 2000
For further information, please call: (512) 305-7848
this
] Board are authorized to employ
the title "architect" and use the word
"architect,"
[
architect,
] or various constructions thereof, in describing or identifying services
they solicit, offer, or execute
[
he/she solicits, offers, or executes
].
architect
] to describe persons or services,
nor do such unregistered individuals or groups have authority to solicit,
offer, or execute architectural services in this state.
Subchapter K. PRACTICE; ARCHITECT REQUIRED
Architectural plans, specifications,
addenda, change orders, and supplementary instructions
] for all privately
owned, new, or altered buildings constructed in the State of Texas shall be
prepared under the supervision of an architect
unless the project is
excepted from this requirement pursuant to either Section 10 or Section 14
of the Act.
[
, except for the following:
]
(1)
(2)
(3)
(4)
Architectural
plans, specifications, addenda, change orders, and supplementary instructions
] for new buildings constructed
and owned by any public entity
where the total construction cost when construction commenced
[
by a political subdivision of the State of Texas or any other public entity
and whose total construction cost when originally begun
] exceeds $100,000
shall be prepared under the supervision of an architect
, unless the project
is excepted from this requirement pursuant to either Section 10 or Section
14 of the Act,
if the building is intended for any of the following
[
occupancy
] uses:
educational
]: the use
of a building [
by six or more people
] at any time for instructional
purposes;
50 or more
] persons for purposes such as civic, social,
or religious functions
or
[
,
] for recreation, food
or
drink consumption, or awaiting transportation;
office
], professional, or service type transactions
including normal accessory storage and the keeping of records and accounts.
Chapter 5.
INTERIOR DESIGNERS
Part 15.
TEXAS STATE BOARD OF PHARMACY
(b)
] A pharmacist-intern may not:
Chapter 291.
PHARMACIES
.
]
.
]
Subchapter B. COMMUNITY PHARMACY (CLASS A)
or
] functions performed by pharmacy technicians; and
(i)
]
(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.
General.
]
(i)
]
(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
[
conducts in-process and final checks;
]
(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
[
.
]
clause (ii) of this subparagraph.
]
(iv)
] A Class A pharmacy shall
make available for use by the public a current or updated edition of the United
States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient),
or another source of such information designed for the consumer.
Texas Civil Statutes, Article 4542a-1,
]
as amended.
§40
] of the Texas Pharmacy Act.
or
]
Medical Practice Act, Article 4495b, §3.06(d)(5)
or (6).
]
(33)
] Expiration date--The
date (and time, when applicable) beyond which a product should not be used.
(34)
] Full-time pharmacist--A
pharmacist who works in a pharmacy from 30 to 40 hours per week or if the
pharmacy is open less than 60 hours per week, one-half of the time the pharmacy
is open.
(35)
] Hard copy--A physical
document that is readable without the use of a special device (i.e., cathode
ray tube (CRT), microfiche reader, etc.).
(36)
] Medical Practice Act--The
Texas Medical Practice Act,
Subtitle B, Occupations Code,
[
Texas Civil Statutes, Article 4495b,
] as amended.
(37)
] New prescription drug
order--A prescription drug order that:
(38)
] Original prescription--The:
(39)
] Part-time pharmacist--A
pharmacist who works less than full-time.
(40)
] Patient counseling--Communication
by the pharmacist of information to the patient or patient's agent, in order
to improve therapy by ensuring proper use of drugs and devices.
(41)
] Pharmacist-in-charge--The
pharmacist designated on a pharmacy license as the pharmacist who has the
authority or responsibility for a pharmacy's compliance with laws and rules
pertaining to the practice of pharmacy.
(42)
] Pharmaceutical care--The
provision of drug therapy and other pharmaceutical services intended to assist
in the cure or prevention of a disease, elimination or reduction of a patient's
symptoms, or arresting or slowing of a disease process.
(43)
] Pharmacy technicians--Those
individuals utilized in pharmacies whose responsibility it shall be to provide
technical services that do not require professional judgment concerned with
the preparation and distribution of drugs under the direct supervision of
and responsible to a pharmacist. Pharmacy technician includes certified pharmacy
technicians, pharmacy technicians, and pharmacy technician trainees.
(44)
] Pharmacy technician
trainee--a pharmacy technician:
(45)
] Physician
assistant--A physician assistant recognized by the Texas State Board of Medical
Examiners as having the specialized education and training required under
Subtitle B, Chapter 157, Occupations Code,
[
the Medical Practice
Act, §3.06(d),
] and issued an identification number by the Texas
State Board of Medical Examiners.
(46)
] Practitioner--
(47)
] Prepackaging--The
act of repackaging and relabeling quantities of drug products from a manufacturer's
original commercial container into a prescription container for dispensing
by a pharmacist to the ultimate consumer.
(48)
] Prescription drug--
(49)
] Prescription drug
order--
Medical Practice Act, §3.06(d)(5) or (6).
]
(50)
] Process validation--Documented
evidence providing a high degree of assurance that a specific process will
consistently produce a product meeting its predetermined specifications and
quality attributes.
(51)
] Quality assurance--The
set of activities used to assure that the process used in the preparation
of sterile drug products lead to products that meet predetermined standards
of quality.
(52)
] Quality control--The
set of testing activities used to determine that the ingredients, components
(e.g., containers), and final sterile pharmaceuticals prepared meet predetermined
requirements with respect to identity, purity, non-pyrogenicity, and sterility.
(53)
] Sample--A prescription
drug which is not intended to be sold and is intended to promote the sale
of the drug.
(54)
] Sterile pharmaceutical--A
dosage form free from living micro-organisms.
(55)
] Texas Controlled Substances
Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter
481, as amended.
(56)
] Unit-dose packaging--The
ordered amount of drug in a dosage form ready for administration to a particular
patient, by the prescribed route at the prescribed time, and properly labeled
with name, strength, and expiration date of the drug.
(57)
] Unusable drugs--Drugs
or devices that are unusable for reasons such as they are adulterated, misbranded,
expired, defective, or recalled.
(58)
] Written protocol--A
physicians order, standing medical order, standing delegation order, or other
order or protocol as defined by rule of the Texas State Board of Medical Examiners
under the Texas Medical Practice Act [
(Texas Civil Statutes, Article
4495b)
].
or
] functions performed by pharmacy technicians; and
(Texas Civil Statutes, Article 4495b)
].
(I)
]
(-a-)
] have a high school or equivalent
degree, e.g., GED, or be currently enrolled in a program which awards such
a degree; and
(-b-)
] complete a structured didactic
and experiential training program, which provides instruction and experience
in the areas listed in subparagraph (D) of this paragraph.
(-c-)
] 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)
General.
]
(I)
]
(II)
] A pharmacist may delegate
to pharmacy technicians any nonjudgmental technical duty associated with the
preparation and distribution of prescription drugs provided:
(-a-)
] a pharmacist
verifies
the accuracy of all acts, tasks, and functions performed by pharmacy technicians;
and
[
conducts in-process and final checks;
] and
(-b-)
] pharmacy technicians are
under the direct supervision of and responsible to a pharmacist.
§29(b)(1),
] which also operates another type of pharmacy
which would otherwise be required to be licensed under the Act,
§560.051(a)(2),
[
§29(b)(2),
] concerning nuclear pharmacy (Class B),
is not required to secure a license for such other type of pharmacy; provided,
however, such licensee is required to comply with the provisions of
§291.51 of this title (relating to Purpose), §291.52 of this title
(relating to Definitions), §291.53 of this title (relating to Personnel), §291.54
of this title (relating to Operational Standards), and §291.55 of this
title (relating to Records), contained in Nuclear Pharmacy (Class B), to the
extent such sections are applicable to the operation of the pharmacy.
[
§291.51 of this title (relating to Definitions), §291.52 of
this title (relating to Personnel), §291.53 of this title (relating to
Operational Standards), and §291.54 of this title (relating to Records),
contained in Nuclear Pharmacy (Class B), to the extent such rules are applicable
to the operation of the pharmacy.
]
beginning January 1, 1995,
] the pharmacy shall
contain an area which is suitable for confidential patient counseling.
Beginning September 1, 1993, the communication
]
shall be reinforced with written information. The following is applicable
concerning this written information.
subclause (II) of this clause.
]
IV)
] A Class A pharmacy compounding
sterile pharmaceuticals that delivers prescriptions to patients or their agents
on-site shall make available for use by the public a current or updated edition
of the United States Pharmacopeia Dispensing Information, Volume II (Advice
to the Patient), or another source of such information, such as patient information
leaflets.
follows.
]
name
or initials
] of the person preparing the product and the pharmacist
who checked and released the final product;
§40,
] the statement "Substituted for Brand Prescribed" or
"Substituted for 'Brand Name'" where "Brand Name" is the actual name of the
brand name product prescribed; and
the Medical Practice Act, §3.06(d).
]
, §3.061
or §3.06(d)
];
(ii)
] managing patient compliance
programs;
(iii)
] providing preventative health
care services; and
(iv)
] providing case management
of patients who are being treated with high-risk or high-cost drugs, or who
are considered "high risk" due to their age, medical condition, family history,
or related concern.
general information:
]
name, initials,
] or electronic
signature of the responsible pharmacist.
name, initials,
] or
electronic signature of the responsible pharmacist.
(-a-)
] the prescription drug order
is an original written prescription issued by a person practicing in another
state and licensed by another state as a physician, dentist, veterinarian,
or podiatrist, who has a current federal Drug Enforcement Administration registration
number, and who may legally prescribe Schedule III, IV, or V controlled substances
in such other state;
(-b-)
] the prescription drug order
is not dispensed or refilled more than six months from the initial date of
issuance and may not be refilled more than five times; and
(-c-)
] if there are no refill
instructions on the original written prescription drug order (which shall
be interpreted as no refills authorized) or if all refills authorized on the
original written prescription drug order have been dispensed, a new written
prescription drug order is obtained from the prescribing practitioner prior
to dispensing any additional quantities of controlled substances.
the Medical Practice Act, §3.06(d).
]
the Medical Practice Act, §3.06(d).
] A list of the advanced practice nurses or physician assistants designated
by the practitioner must be maintained in the practitioner's usual place of
business. On request by a pharmacist, a practitioner shall furnish the pharmacist
with a copy of the written authorization for a specific advanced practice
nurse or physician assistant.
a triplicate
] prescription form as required by the Texas Controlled Substances Act, §481.075.
triplicate
] prescriptions for Schedule II controlled substances
are maintained separate from all other original prescriptions.
triplicate prescriptions
] may be stored on microfilm, microfiche, or other system which is capable
of producing a direct image of the original prescription record, e.g., digitalized
imaging system. If original prescription records are stored in a direct imaging
system, the following is applicable.
the Medical Practice
Act, §3.06(d),
] shall bear:
,
and original signature
] of the practitioner;
(2)(F)(iii)
] of this subsection.
The data processing system shall have a mechanism to send a message
to the transferring pharmacy containing the following information:
]
(iii)
] Pharmacies not owned by
the same person may electronically access the same prescription drug order
records, provided the owner or chief executive officer of each pharmacy signs
an agreement allowing access to such prescription drug order records.
Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)
(including directions for use)
] as ordered by the practitioner
and required by rule
. [
Provided, however, that nothing herein shall prohibit pharmacist substitution
if substitution is conducted in strict accordance with applicable laws and
rules, including the Texas Pharmacy Act, §40.
]
(Texas Civil Statutes, Article 4542a-1,
as amended).
]
Automated compounding or drug dispensing system
]--An automated
device that compounds, measures, counts and/or packages a specified quantity
of dosage units
of
[
for
] a designated drug product.
(7)
] Batch preparation/compounding--Compounding
of multiple sterile-product units, in a single discrete process, by the same
individual(s), carried out during one limited time period. Batch preparation
does not include the preparation of multiple sterile-product units pursuant
to medication orders.
(8)
] Biological safety cabinet--Containment
unit suitable for the preparation of low to moderate risk agents where there
is a need for protection of the product, personnel, and environment, according
to National Sanitation Foundation (NSF) Standard 49.
(9)
] Board--The State Board
of Pharmacy.
(10)
] Certified Pharmacy Technician--A
pharmacy technician who:
(11)
] Clean room--A room
in which the concentration of airborne particles is controlled and there are
one or more clean zones according to Federal Standard 209E et seq.
(12)
] Clean zone--A defined
space in which the concentration of airborne particles is controlled to meet
a specified airborne particulate cleanliness class.
(13)
] Compounding--The preparation,
mixing, assembling, packaging, or labeling of a drug or device:
(14)
] Confidential record--Any
health-related record
that contains information that identifies an individual
and that is
maintained by a pharmacy or pharmacist, such as a patient
medication record, prescription drug order, or medication drug order.
(15)
] Consultant pharmacist--A
pharmacist retained by a facility on a routine basis to consult with the facility
in areas that pertain to the practice of pharmacy.
(16)
] Controlled area--A controlled
area is the area designated for preparing sterile pharmaceuticals.
(17)
] Controlled substance--A
drug, immediate precursor, or other substance listed in Schedules I-V or Penalty
Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug,
immediate precursor, or other substance included in Schedules I-V of the Federal
Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public
Law 91-513).
(18)
] Critical areas--Any
area in the controlled area where products or containers are exposed to the
environment.
(19)
] Cytotoxic--A pharmaceutical
that has the capability of killing living cells.
(20)
] Dangerous drug--Any
drug or device that is not included in Penalty Groups 1-4 of the controlled
Substances Act and that is unsafe for self-medication or any drug or device
that bears or is required to bear the legend:
(21)
] Device--An instrument,
apparatus, implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including any component part or accessory,
that is required under federal or state law to be ordered or prescribed by
a practitioner.
(22)
] Direct copy--Electronic
copy or carbonized copy of a medication order, including a facsimile (FAX),
tele-autograph, or a copy transmitted between computers.
(23)
] Dispense--Preparing,
packaging, compounding, or labeling for delivery a prescription drug or device
in the course of professional practice to an ultimate user or his agent by
or pursuant to the lawful order of a practitioner.
(24)
] Distribute--The delivery
of a prescription drug or device other than by administering or dispensing.
(25)
] Distributing pharmacist--The
pharmacist who checks the medication order prior to distribution.
(26)
] Downtime--Period of
time during which a data processing system is not operable.
(27)
] Drug regimen review--
(28)
] Electronic signature--A
unique security code or other identifier which specifically identifies the
person entering information into a data processing system. A facility which
utilizes electronic signatures must:
(29)
] Expiration date--The
date (and time, when applicable) beyond which a product should not be used.
(30)
] Facility--Hospital or
other inpatient facility that is licensed under the Texas Hospital Licensing
Law, the Health and Safety Code, Chapter 241, or Texas Mental Health Code,
Chapter 6, Texas Civil Statutes, Article 5547-1 et seq., or that is maintained
or operated by the state.
(31)
] Floor stock--Prescription
drugs or devices not labeled for a specific patient and maintained at a nursing
station or other hospital department (excluding the pharmacy) for the purpose
of administration to a patient of the facility.
(32)
] Formulary--List of drugs
approved for use in the facility by the committee which performs the pharmacy
and therapeutics function for the facility.
(33)
] Full-time pharmacist--A
pharmacist who works in a pharmacy from 30 to 40 hours per week or if the
pharmacy is open less than 60 hours per week, one-half of the time the pharmacy
is open.
(34)
] Hard copy--A physical
document that is readable without the use of a special device (i.e., cathode
ray tube (CRT), microfiche reader, etc).
(35)
] Inpatient--A person
who is duly admitted to the hospital or who is receiving long term care services
or Medicare extended care services in a swing bed on the hospital premise
or an adjacent, readily accessible facility which is under the authority of
the hospital's governing body. For the purposes of this definition, the term
"long term care services" means those services received in a skilled nursing
facility which is a distinct part of the hospital and the distinct part is
not licensed separately or formally approved as a nursing home by the state,
even though it is designated or certified as a skilled nursing facility.
(36)
] Institutional pharmacy--Area
or areas in a facility where drugs are stored, bulk compounded, delivered,
compounded, dispensed, and distributed to other areas or departments of the
facility, or dispensed to an ultimate user or his or her agent.
(37)
] Investigational new
drug--New drug intended for investigational use by experts qualified to evaluate
the safety and effectiveness of the drug as authorized by the Food and Drug
Administration.
(38)
] Medication order--A
written order from a practitioner or a verbal order from a practitioner or
his authorized agent for administration of a drug or device.
(39)
] Part-time pharmacist--A
pharmacist either employed or under contract, who routinely works less than
full-time.
(40)
] Perpetual inventory--An
inventory which documents all receipts and distributions of a drug product,
such that an accurate, current balance of the amount of the drug product present
in the pharmacy is indicated.
(41)
] Pharmaceutical care--The
provision of drug therapy and other pharmaceutical services intended to assist
in the cure or prevention of a disease, elimination or reduction of a patient's
symptoms, or arresting or slowing of a disease process.
(42)
] Pharmacist-in-charge--Pharmacist
designated on a pharmacy license as the pharmacist who has the authority or
responsibility for a pharmacy's compliance with laws and rules pertaining
to the practice of pharmacy.
(43)
] Pharmacy and therapeutics
function--Committee of the medical staff in the facility which assists in
the formulation of broad professional policies regarding the evaluation, selection,
distribution, handling, use, and administration, and all other matters relating
to the use of drugs and devices in the facility.
(44)
] Pharmacy technician--Those
individuals utilized in pharmacies whose responsibility it shall be to provide
technical services that do not require professional judgment concerned with
the preparation and distribution of drugs under the direct supervision of
and responsible to a pharmacist. Pharmacy technician includes certified pharmacy
technicians, pharmacy technicians, and pharmacy technician trainees.
(45)
] Pharmacy technician
trainee--a pharmacy technician:
(46)
] Pre-packaging--The
act of re-packaging and re-labeling quantities of drug products from a manufacturer's
original container into unit-dose packaging or a multiple dose container for
distribution within the facility.
(47)
] Prescription drug--
(48)
] Prescription drug
order--
the Medical Practice Act, §3.06(d)(5)
or (6).
]
(49)
] Process validation--Documented
evidence providing a high degree of assurance that a specific process will
consistently produce a product meeting its predetermined specifications and
quality attributes.
(50)
] Quality assurance--The
set of activities used to assure that the process used in the preparation
of sterile drug products lead to products that meet predetermined standards
of quality.
(51)
] Quality control--The
set of testing activities used to determine that the ingredients, components
(e.g., containers), and final sterile pharmaceuticals prepared meet predetermined
requirements with respect to identity, purity, non-pyrogenicity, and sterility.
(52)
] Sample--A prescription
drug which is not intended to be sold and is intended to promote the sale
of the drug.
(53)
] Sterile pharmaceutical--A
dosage form free from living micro-organisms.
(54)
] Texas Controlled Substances
Act--The Texas Controlled Substances Act, the Health and Safety Code, Chapter
481, as amended.
(55)
] Unit-dose packaging--The
ordered amount of drug in a dosage form ready for administration to a particular
patient, by the prescribed route at the prescribed time, and properly labeled
with name, strength, and expiration date of the drug.
(56)
] Unusable drugs--Drugs
or devices that are unusable for reasons, such as they are adulterated, misbranded,
expired, defective, or recalled.
(57)
] Written protocol--A
physician's order, standing medical order, standing delegation order, or other
order or protocol as defined by rule of the Texas State Board of Medical Examiners
under the Texas Medical Practice Act
Subtitle B, Chapter 157, Occupations
Code.
[
(Texas Civil Statutes, Article 4495b).
]
and
]
(Texas Civil Statutes, Article
4495b);
]
and
]
automated compounding or drug dispensing system
] provided a pharmacist supervises, verifies that the system was properly
loaded prior to use, and affixes his or her signature (first initial and last
name or full signature) or electronic signature to the appropriate quality
control records
; and
§29(b)(3),
] which also operates
another type of pharmacy which would otherwise be required to be licensed
under the Act,
§560.051(a)(1)
[
§29(b)(1)
]
(Community Pharmacy (Class A)) or the Act,
§560.051(a)(2)
[
§29(b)(2)
] (Nuclear Pharmacy (Class B)), is not required
to secure a license for the such other type of pharmacy; provided, however,
such licensee is required to comply with the provisions of §291.31 of
this title (relating to Definitions), §291.32 of this title (relating
to Personnel), §291.33 of this title (relating to Operational Standards), §291.34
of this title (relating to Records), §291.35 of this title (relating
to Triplicate Prescription Records), and §291.36 of this title (relating
to Class A Pharmacies Compounding Sterile Pharmaceuticals), contained in Community
Pharmacy (Class A), or
§291.51 of this title (relating to Purpose), §291.52
of this title (relating to Definitions), §291.53 of this title (relating
to Personnel), §291.54 of this title (relating to Operational Standards),
and §291.55 of this title (relating to Records), contained in Nuclear
Pharmacy (Class B), to the extent such sections are applicable to the operation
of the pharmacy.
[
§291.51 of this title (relating to Definitions), §291.52
of this title (relating to Personnel), §291.53 of this title (relating
to Operational Standards), and §291.54 of this title (relating to Records),
contained in Nuclear Pharmacy (Class B), to the extent such rules are applicable
to the operation of the pharmacy.
]
(iv)
and loading bulk or unlabeled
drugs into automated compounding or drug dispensing systems.
]
(A)
(i)
] Drugs may be pre-packaged in
quantities suitable for internal distribution only by a pharmacist or by supportive
personnel under the direction and direct supervision of a pharmacist.
(ii)
] The label of a pre-packaged
unit shall indicate:
(I)
] brand name and strength of
the drug; or if no brand name, then the generic name, strength, and name of
the manufacturer or distributor;
(II)
] facility's unique lot number;
(III)
] expiration date based on
currently available literature; and
(IV)
] quantity of the drug, if
the quantity is greater than one.
(iii)
] Records of pre-packaging
shall be maintained to show:
(I)
] name of the drug, strength,
and dosage form;
(II)
] facility's unique lot number;
(III)
] manufacturer or distributor;
(IV)
] manufacturer's lot number;
(V)
] expiration date;
(VI)
] quantity per prepackaged
unit;
(vii
) [
(VII)
] number of prepackaged units;
(VIII)
] date packaged;
(IX)
] name, initials, or electronic
signature of the prepacker; and
(X)
] name, initials, or electronic
signature of the responsible pharmacist.
(iv)
] Stock packages, repackaged
units, and control records shall be quarantined together until checked/released
by the pharmacist.
subsections (e) and (g) of §40
] of the Act,
as respects drugs distributed pursuant to medication orders.
automated compounding or drug dispensing systems
];
, §3.061
or §3.06(d)
];
(B)
] managing patient compliance
programs;
(C)
] providing preventative health
care services; and
(D)
] providing case management of
patients who are being treated with high-risk or high-cost drugs, or who are
considered "high risk" due to their age, medical condition, family history,
or related concern.
§40(g)
]. Medication order forms or copies thereof
do not meet the requirements for outpatient forms.
and butorphanol (e.g., Stadol),
] nalbuphine (e.g., Nubain), tripelennamine
(e.g., PBZ) and carisoprodol (e.g., Soma). A pharmacy that changes or discontinues
use of a data processing system must:
and butorphanol
(e.g., Stadol),
] nalbuphine (e.g., Nubain), tripelennamine (e.g., PBZ),
and carisoprodol (e.g., Soma) to the pharmacy.
and/or butorphanol
(e.g., Stadol),
] nalbuphine (e.g., Nubain), tripelennamine (e.g., PBZ),
or carisoprodol (e.g., Soma) is distributed from or returned to the pharmacy,
a record of such distribution or return shall be entered into the data processing
system.
§1304(A)
],
and submits a copy of this written notification to the Texas State Board of
Pharmacy. Unless the registrant is informed by the divisional director of
the Drug Enforcement Administration that permission to keep central records
is denied, the pharmacy may maintain central records commencing 14 days after
receipt of notification by the divisional director.
Part 22.
TEXAS STATE BOARD OF PUBLIC ACCOUNTANCY
One
] half of the average completion time
is the
maximum
[
recommended
] credit to be allowed.
their
] exempt status. When the
exemption status is no longer applicable, the individual must complete the
ethics course as defined in §523.32(a) of this title (relating to Ethics
Course) and report it on the license notice.
,
] or a computer-based interactive
format as defined in §523.1(b)(5) of this title (relating to Continuing
Professional Education Purpose and Definitions) that the course contains the
underlying intent established in the following criteria.
,
]
or
a computer-based interactive
format
;
[
, a self-study format,
] or may write the board
to request an exemption.
Chapter 527.
QUALITY REVIEW