Part 11.
BOARD OF NURSE EXAMINERS
Chapter 211.
GENERAL PROVISIONS
22 TAC §§211.1 - 211.6
The Board of Nurse Examiners proposes the adoption of amendments
to §§211.1 - 211 .6, concerning General Provisions. Effective February
1, 2004, the Board of Nurse Examiners and Board of Vocational Nurse Examiners
were merged into one agency, Board of Nurse Examiners. House Bill 1483, passed
by the 78th Regular Legislative Session, was the legislative action that implemented
the consolidation. These proposed amendments implement HB 1483 and the make-up
and function of the new Board of Nurse Examiners. Any change in the rule language
merely tracks the statutory language or includes "licensed vocational nurses"
with "professional" or "registered nurses." In §211.1 and §211.4,
Texas Revised Statutes is removed or updated to the Texas Occupations Code.
Section 211.3 tracks the new language of Texas Occupations Code §301.054
relating to Terms.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed amendments are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed amendments.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed amendments are adopted, the public benefit
will be that the legislative intent of consolidating the boards and fiscal
austerity will be accomplished. There will be no effect on small businesses.
There is no anticipated economic cost to persons who are required to comply
with the proposed amendments.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed adoption of amendments to these sections is pursuant
to the authority of Texas Occupations Code §§301.151 and 301.152
which authorizes the Board of Nurse Examiners to adopt, enforce, and repeal
rules consistent with its legislative authority under the Nursing Practice
Act.
The adoption of the proposed amendments does implement §301.054 of
the Texas Occupations Code.
§211.1.Introduction.
(a)
Name. The entity is the Board of Nurse Examiners for the
State of Texas, hereafter referred to as the board. It is a decision-making
board appointed by the Governor of the State of Texas in compliance with
the
Texas
Occupations Code
[
(b)
Location. The administrative offices shall be located in
Austin, Texas.
(c)
Legal Authority. The board is established and functions
under the authority of Chapters 301, 303 and 304 of the Texas Occupations
Code.
(d)
Composition. The board shall be composed of those persons
appointed by the Governor with the advice and consent of the Senate.
(e)
Fiscal year. For all fiscal and administrative purposes,
the reporting year of the board shall be identical to that of the State of
Texas.
§211.2.Purpose and Functions.
(a)
Purpose. The purpose of the board is to protect and promote
the welfare of the people of Texas. This purpose supersedes the interest of
any individual, the nursing profession, or any special interest group. The
board fulfills its mission through two principle areas of responsibility:
(1)
regulation of the practice of professional
and vocational
nursing, and
(2)
accreditation of schools of nursing.
(b)
Functions. The board shall perform the following functions
as outlined in Texas Occupations Code
chapters
[
(1)
Establish standards of nursing practice and regulate the
practice of professional
and vocational
nursing.
(2)
Interpret the Nursing Practice Act and the Rules and Regulations
Relating to [
(3)
Receive complaints and investigate possible violations
of the Nursing Practice Act and rules and regulations.
(4)
Discipline violators through appropriate legal action to
enforce the Nursing Practice Act and rules and regulations.
(5)
Provide a mechanism for public comment with regard to the
rules and regulations and the Nursing Practice Act and review and modify the
rules and regulations when necessary and appropriate.
(6)
Examine and license qualified applicants to practice professional
and vocational
nursing and recognize qualified applicants to practice
advanced practice nursing in the state of Texas in a manner that ensures that
applicable standards are maintained and that practitioners are minimally competent.
(7)
Grant licensure by endorsement to
vocational and
registered
nurses and grant recognition of advanced practice nurses from other states
to ensure standards are maintained and applicable practices are consistent.
(8)
Recommend to legislature appropriate changes in the Nursing
Practice Act to ensure that the act is current and applicable to changing
needs and practices.
(9)
Establish standards for nursing education and accredit
or deny accreditation to schools of nursing and educational programs which
fail to meet or maintain the prescribed course of study or other applicable
standards to ensure that high levels of education are achieved.
(10)
Monitor the examination results of licensure applicants
to determine variances in the level of educational effectiveness.
(11)
Provide consultation and guidance to nurse education institutions
to facilitate self-study, evaluation, and the development of effective nurse
education programs.
(12)
Provide advice and counsel to the faculty of educational
programs, to staff of health agencies utilizing nursing services, and to practitioners
of nursing to continually improve professional service delivery.
(13)
Implement and manage all other programs and responsibilities
as authorized and mandated from time to time by the Texas Legislature.
§211.3.Organization and Structure.
(a)
General. In accordance with Texas Occupations Code
§§
[
(b)
Terms of office. The terms of board members shall be six
years in length and shall be staggered so that the terms of
as near to
[
(c)
Eligibility. Board member eligibility is governed by the
Texas Occupations Code
§§
[
(d)
Compensation. Each member of the board shall receive per
diem as provided by law for each day that the member engages in the business
of the board and will be reimbursed for travel expenses incurred in accordance
with the state of Texas and Board of Nurse Examiners' travel policies.
§211.4.Officers.
(a)
Selections and appointments. In accordance with
the
Texas
[
(b)
Duties of the officers.
(1)
The president shall:
(A)
preside at all meetings of the board;
(B)
represent the board in legislative matters and in meetings
with related groups;
(C)
appoint standing, ad hoc, and advisory committees;
(D)
perform such other duties as pertain to the office of the
president; and,
(E)
designate a member of the board to coordinate the annual
performance reviews of the executive director and evaluation of the board.
(2)
The vice president shall function in the absence of the
president and shall perform such other duties that are from time to time assigned
by the board. If the office of president becomes vacant, the vice president
will serve as president until another member is elected by the board or named
by the Governor.
§211.5.Meetings.
The board shall meet at least four times a year. It shall consider
such matters as may be necessary. Special meetings shall be called by the
president of the board or upon written request signed by three members of
the board in accordance with Texas Occupations Code
§
[
(1)
Agenda. An agenda shall be posted in accordance with the
Texas Government Code
chapter
[
(2)
Meetings of the board and of its committees are open to
the public unless such meetings are conducted in executive session pursuant
to state law.
(3)
Quorum. A majority of the members of the board, at least
three of whom shall be [
(4)
Voting. The board may act only by majority vote of a quorum
of members present and eligible to vote, with each eligible member entitled
to one vote. A member is not eligible to vote if a conflict of interest exists
as described in
§
211.8 of this title (relating to Conflict
of Interest). No proxy vote shall be allowed.
(5)
Presiding officer. In the absence of the president and
the vice president, a presiding officer shall be chosen by a majority of the
board members present.
(6)
Meeting held by tele-conference call. A meeting by the
Board of Nurse Examiners may be held by telephone conference call or video
conference call only as authorized by Texas Government Code
chapter
[
§211.6.Committees of the Board.
(a)
The following are standing and permanent committees of
the board, as established by the board in accordance with the Nursing Practice
Act. The responsibilities and authority of these committees include those
duties and powers as set forth including other responsibilities and charges
which the board may from time to time delegate to these committees.
(b)
Eligibility and Disciplinary Committee.
(1)
Members of the committee shall be appointed by the president
and shall consist of one consumer member and two nurse members. The President
shall have authority to substitute committee members when necessary to establish
a quorum due to absences of standing members.
(2)
The chair shall be named by the president.
(3)
Duties and powers. The disciplinary committee shall have
the authority to determine matters of eligibility for licensure and discipline
of licenses, including temporary suspension of a license, and administrative
and civil penalties.
(4)
Quorum. Two eligible voting members shall establish a quorum
of the Committee of which at least one member is a [
(5)
Tele-conference. A meeting by the Committee may be held
by telephone conference call or video conference call as authorized by Texas
Government Code
chapter
[
(c)
Education Liaison. The three board members representing
nursing educational programs shall serve as advisory to the staff on matters
pertaining to faculty waivers, proposed curriculum revisions and other issues
that may arise between regular board meetings. The recommendations of the
liaison members are presented to the board at the next regular meeting for
ratification.
(d)
Advanced Practice Liaison. Three members shall be designated
by the president to serve as advisory to the staff on matters pertaining to
advanced practitioner waivers and other issues that may arise between regular
board meetings. The recommendation of the liaison members are presented to
the board at the next regular meeting for ratification.
(e)
Other standing or ad hoc committees. The board may designate
other standing or ad hoc committees as deemed necessary. Such committees shall
have and exercise such authority as may be granted by the board.
(f)
Advisory Committees. The president may appoint, with the
authorization of the board, advisory committees for the performance of such
activities as may be appropriate or required by law.
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 12, 2004.
TRD-200401867
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
22 TAC §§213.1, 213.10, 213.13, 213.23, 213.26 - 213.32
The Board of Nurse Examiners proposes the adoption of amendments
to §§213.1, 213.10, 213.13, 213.23, and 213.26 - 213.32 concerning
Practice and Procedure. Effective February 1, 2004, the Board of Nurse Examiners
and the Board of Vocational Nurse Examiners were merged into one agency, Board
of Nurse Examiners. House Bill 1483, passed by the 78th Regular Legislative
Session, was the legislative action that implemented the consolidation. These
proposed amendments implement HB 1483 and the make-up and function of the
new Board of Nurse Examiners. Any change in the rule language merely tracks
the statutory language or includes "licensed vocational nurses" with "professional"
or "registered nurses" or the language deletes any specific nurse title to
a generic term of "nurse." The inclusion of licensed vocational nurses in
these amendments creates a consistent disciplinary process for all nurses.
A specific new requirement for licensed vocational nurses is now the requirement
placed on them by Texas Occupations Code Annotated §§301.252 and
301.257 requiring all nurses possess good professional character. Good professional
character is defined in §213.27. The process by which this is achieved
is through the Declaratory Order process. The Declaratory Order process is
outlined in §213.30. This requirement imposes an additional licensing
requirement on vocational nurses which did not exist prior to the consolidation
of the boards.
The administrative fines in §213.32 which are being proposed to be
applied to vocational nurses are more defined and broken into more specific
categories than the previous administrative fine rule applicable to vocational
nurses in 22 TAC §239.19. The fines also are comparatively similar in
the amounts imposed for similar violations.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed amendments are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed amendments.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed amendments are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. There will be no effect on
small businesses. The cost to those affected by these amendments is the additional
cost to licensed vocational nurses who are required to submit themselves to
the declaratory process. This additional process was imposed by statute, however,
and not by these proposed amendments.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed adoption of amendments to these sections is pursuant
to the authority of Texas Occupations Code §§301.151 and 301.152
which authorizes the Board of Nurse Examiners to adopt, enforce, and repeal
rules consistent with its legislative authority under the Nursing Practice
Act. The adoption of the proposed amendments does implement §§301.252
and 301.257 of the Texas Occupations Code.
§213.1.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise:
(1)-(12)
(No change.)
(13)
Declaratory order--An order, issued by the Board pursuant
to Texas Occupations Code Annotated § 301.257, determining the eligibility
of an individual for initial licensure as a registered
or vocational
nurse and setting forth both the basis for potential ineligibility
and the Board's determination of the disclosed eligibility issues.
(14)-(17)
(No change.)
(18)
Formal charges--Pleading of the staff publicly alleging
the reasons for disciplinary actions against a registered
or vocational
nurse created in accordance with Texas Occupations Code Annotated §
301.458.
(19)-(20)
(No change.)
(21)
Initial licensure--The original grant of permission to
practice [
(22)
License--Includes the whole or part of any Board permit,
certificate, approval, registration, or similar form of permission required
by law to practice professional
or vocational
nursing in the State
of Texas. For purposes of this subchapter, the term includes a multistate
licensure privilege.
(23)
Licensee--A person who has met all the requirements to
practice as a registered
or vocational
nurse pursuant to the Nursing
Practice Act and the Rules and Regulations relating to [
(24)
(No change.)
(25)
Minor Incident--Conduct in violation of the Nursing Practice
Act, which after a thorough evaluation of factors enumerated under §217.16
of this title (relating to Minor Incidents), indicates that the nurse's continuing
to practice professional
or vocational
nursing does not pose a
risk of harm to a client or other person and, therefore, does not need to
be reported to the Board or peer review committee.
(26)
Multistate Licensure Privilege-- See Texas Occupations
Code Annotated §304.001, article 1(h) (definition of Multistate Licensure
Privilege). For purposes of this subchapter, the multistate licensure privilege
means the privilege to practice as a professional
or vocational
nurse
in the state of Texas based on the current, official authority to practice
as a [
(27)-(38)
(No change.)
§213.10.Notice and Service.
(a)
(No change.)
(b)
Notice to a party holding a multistate licensure privilege
is effective and service is complete when sent by certified or registered
mail, return receipt requested, to the privilege holder's address of record
maintained with the home state [
(c)-(e)
(No change.)
§213.13.Complaint Investigation and Disposition.
(a)
Complaints shall be submitted to the Board in writing and
should contain at least the following information:
Nurse
[
(b)-(f)
(No change.)
§213.23.Decision of the Board.
(a)-(f)
(No change.)
(g)
A copy of the order shall be mailed to all parties and
to the party's last known employer as a [
(h)-(j)
(No change.)
§213.26.Reissuance of a License.
(a)
A person whose license to practice [
(b)-(d)
(No change.)
(e)
In considering reinstatement of a surrendered, suspended,
or revoked license, the Board will evaluate:
(1)-(4)
(No change.)
(5)
the petitioner's present qualification to practice [
§213.27.Good Professional Character.
(a)
(No change.)
(b)
Factors to be used in evaluating good professional character
in eligibility and disciplinary matters are:
(1)
(No change.)
(2)
A person who seeks to obtain or retain a license to practice
professional
or vocational
nursing shall provide evidence of good
professional character which, in the judgment of the Board, is sufficient
to insure that the individual can consistently act in the best interest of
patients/clients and the public in any practice setting. Such evidence shall
establish that the person:
(A)-(G)
(No change.)
(3)-(4)
(No change.)
(c)
(No change.)
(d)
The following provisions shall govern the determination
of present good professional character and fitness of a Petitioner, Applicant,
or Licensee who has been licensed to practice [
(1)
(No change.)
(2)
An individual disciplined for professional misconduct in
the course of practicing [
(3)-(4)
(No change.)
(e)
An individual who applies for initial licensure, reinstatement,
renewal, or endorsement to practice professional
or vocational
nursing
in Texas after the expiration of the three- year period in (c)(2) above and
subsection (f) of this rule, or after the completion of the disciplinary period
assessed or ineligibility period imposed by any jurisdiction under subsection
(d) above shall be required to prove, by a preponderance of the evidence:
(1)
that the best interest of the public and the profession,
as well as the ends of justice, would be served by his or her admission to
practice [
(2)
(No change.)
(f)
An individual who applies for initial licensure, reinstatement,
renewal, or endorsement to practice professional
or vocational
nursing
in Texas after a negative determination based on a felony conviction, felony
probation with or without an adjudication of guilt, or professional misconduct,
or voluntary surrender in lieu of disciplinary action and whose application
or petition is denied and not appealed is not eligible to file another petition
or application for licensure until after the expiration of three years from
the date of the Board's order denying the preceding petition for licensure.
§213.28.Licensure of Persons with Criminal Convictions.
(a)
This section sets out the considerations and criteria on
the eligibility of persons with criminal convictions to obtain a license as
a registered
or vocational
nurse or those already licensed who
renew their license. The Board may refuse to approve persons to take the licensure
examination, may refuse to issue or renew a license or certificate of registration,
or may refuse to issue a temporary permit to any individual that has been
convicted of a felony, a misdemeanor involving moral turpitude, or engaged
in conduct resulting in the revocation of probation imposed pursuant to such
a conviction.
(b)
The practice of nursing involves clients, their families,
significant others and the public in diverse settings. The registered
and vocational
nurse practices in an autonomous role with individuals
who are physically, emotionally and financially vulnerable. The nurse has
access to personal information about all aspects of a person's life, resources
and relationships. Therefore, criminal behavior whether violent or non-violent,
directed against persons, property or public order and decency is considered
by the Board as highly relevant to an individual's fitness to practice nursing.
(c)
In considering whether a criminal conviction renders the
individual ineligible for licensure or renewal of licensure as a registered
or vocational
nurse, the Board shall consider:
(1)
the knowing or intentional practice of [
(2)-(3)
(No change.)
(4)
the relationship of the crime to the purposes for requiring
a license to engage in [
(5)
(No change.)
(6)
the relationship of the crime to the ability, capacity,
or fitness required to perform the duties and discharge the responsibilities
of [
(7)-(8)
(No change.)
(d)-(f)
(No change.)
(g)
Behavior that would otherwise bar or impede licensure may
be deemed a "Youthful Indiscretion" as determined by an analysis of the behavior
using the factors set out in §213.27 of this title (relating to Good
Professional Character), subsections (a)-(e) of this section and at least
the following criteria:
(1)-(11)
(No change.)
(12)
evidence of current ability to practice [
(h)
With respect to a request to obtain a license from a person
who has a criminal history, the executive director is authorized to close
an eligibility file when the applicant has failed to respond to a request
for information or to a proposal for denial of eligibility within 60 days
thereof. [
§213.29.Criteria and Procedure Regarding Intemperate Use and Lack of Fitness in Eligibility and Disciplinary Matters.
(a)
A person desiring to obtain or retain a license to practice
professional
or vocational
nursing shall provide evidence of current
sobriety and fitness consistent with this rule.
(b)
Such person shall provide a sworn certificate to the Board
stating that he/she has read and understands the requirements for licensure
as a registered
or vocational
nurse and that he/she has not:
(1)
(No change.)
(2)
within the past five years, been diagnosed with, treated
or hospitalized for schizophrenia and/or other psychotic disorders, bi-polar
disorder, paranoid personality disorder, antisocial personality disorder or
borderline personality disorder. [
(c)
If a registered
or vocational
nurse is reported
to the Board for intemperate use, abuse of drugs or alcohol, or diagnosis
of or treatment for chemical dependency; or if a person is unable to sign
the certification in subsection (b) of this section, the following restrictions
and requirements apply:
(1)
(No change.)
(2)
Those persons who have become addicted to or treated for
alcohol or chemical dependency will not be eligible to obtain or retain a
license to practice as a [
(3)
Those persons who have become addicted to or treated for
alcohol or chemical dependency will not be eligible to obtain or retain an
unencumbered license to practice [
(4)
(No change.)
(d)-(i)
(No change.)
§213.30.Declaratory Order of Eligibility for Licensure.
(a)
A person enrolled or planning to enroll in an educational
nursing program that prepares a person for an initial license as a registered
or vocational
nurse or an applicant who seeks licensure by endorsement
pursuant to § 217.5 of this title (relating to Temporary License and
Endorsement) who has reason to believe that he or she may be ineligible for
licensure, may petition the Board for a declaratory order or apply for a license
by endorsement as to his or her eligibility.
(b)-(d)
(No change.)
(e)
If an applicant under §217.5 of this title has been
licensed to practice professional
or vocational
nursing in any
jurisdiction and has been disciplined, or allowed to surrender in lieu of
discipline, in that jurisdiction, the following provisions shall govern the
eligibility of the applicant under § 213.27 of this title (relating to
Good Professional Character).
(1)-(2)
(No change.)
(f)-(g)
(No change.)
§213.31.Cross-reference of Rights and Options Available to Licensees and Petitioners.
Licensees subject to disciplinary action and petitioners seeking a
determination of licensure eligibility have certain rights and options available
to them in connection with these mechanisms. For example, licensees or petitioners
have the right to request information in the Board's possession, including
information favorable to licensee or petitioner, and the option to be represented
by an attorney at their own expense. The following is a list of references
to provisions of the Nursing Practice Act (Texas Occupations Code Annotated
Chapter 301) and the Board's rules addressing these rights and options and
related matters. Persons with matters before the Board should familiarize
themselves with these provisions:
(1)-(17)
(No change.)
(18)
Section 217.11--Standards of [
(19)-(20)
(No change.)
§213.32.Schedule of Administrative Fine(s).
In disciplinary matters, the Board may assess a monetary penalty or
fine in the circumstances and amounts as described.
(1)
The following violations may be appropriate for disposition
by fine with or without educational stipulations:
(A)-(C)
(No change.)
(D)
aiding, abetting or permitting a [
(i)-(ii)
(No change.)
(E)-(O)
(No change.)
(2)-(4)
(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 12, 2004.
TRD-200401877
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
Chapter 231.
ADMINISTRATION
Subchapter A. DEFINITIONS
22 TAC §231.1
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Board of Vocational Nurse Examiners or in the Texas Register office, Room
245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code chapter 231 concerning Administration, and
specifically Subchapter A (Definitions), §231.1. The other two subchapters
are being proposed for repeal concurrently with this subchapter; General Practice
and Procedure (Subchapter B), and Board Rules (Subchapter C). Effective February
1, 2004, the Board of Nurse Examiners and the Board of Vocational Nurse Examiners
were merged into one agency, the Board of Nurse Examiners. The Board of Vocational
Nurse Examiners ceased to exist as an agency. House Bill 1483, passed by the
78th Regular Legislative Session, was the legislative action that implemented
the consolidation. These proposed repeals implement HB 1483 and the make-up
and function of the new Board of Nurse Examiners. Concurrent with these proposed
repeals are the proposed amendments to 22 Texas Administrative code chapter
211 (General Provisions) and chapter 213 (Practice and Procedure) which incorporate
Licensed Vocational Nurses into the Board of Nurse Examiners' procedural rules.
This proposed repeal is for the purpose of preventing conflicting rules.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeals are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed repeals.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeals are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeals will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of these
proposed repeals.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of this section is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act. The adoption
of the proposed repeals will not affect any existing statute.
§231.1.Definitions.
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 12, 2004.
TRD-200401881
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
22 TAC §§231.11 - 231.20, 231.22 - 231.27, 231.29 - 231.50
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Board of Vocational Nurse Examiners or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code chapter 231 concerning Administration, and
specifically Subchapter B (General Practice and Procedure), §§231.11
- 231.20, 231.22 - 231.27, 231.29 - 231.50. The other two subchapters are
being proposed for repeal concurrently with this subchapter: Definitions (Subchapter
A), and Board Rules (Subchapter C). Effective February 1, 2004, the Board
of Nurse Examiners and the Board of Vocational Nurse Examiners were merged
into one agency, the Board of Nurse Examiners. The Board of Vocational Nurse
Examiners ceased to exist as an agency. House Bill 1483, passed by the 78th
Regular Legislative Session, was the legislative action that implemented the
consolidation. These proposed repeals implement HB 1483 and the make-up and
function of the new Board of Nurse Examiners. Concurrent with these proposed
repeals are the proposed amendments to 22 Texas Administrative Code chapter
211 (General Provisions) and chapter 213 (Practice and Procedure) which incorporate
Licensed Vocational Nurses into the Board of Nurse Examiners' procedural rules.
This proposed repeal is for the purpose of preventing conflicting rules.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeals are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed repeals.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeals are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeals will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of these
proposed repeals.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of these sections is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act. The adoption
of the proposed repeals will not affect any existing statute.
§231.11.Headquarters of the Board.
§231.12.Organization of the Board.
§231.13.Philosophy of the Board.
§231.14.Objective of the Board.
§231.15.Functions of the Board.
§231.16.Officers of the Board.
§231.17.President of the Board.
§231.18.Vice President of the Board.
§231.19.Pro Tem President of the Board.
§231.20.Secretary-Treasurer of the Board.
§231.22.Vacancies in the Board.
§231.23.Reimbursement to Board Members for Meetings.
§231.24.Notice of Board Meetings.
§231.25.Board Meetings (Regular).
§231.26.Board Meetings (Special).
§231.27.Quorum of the Board.
§231.29.Agenda for Board Meeting.
§231.30.Order of Business.
§231.31.Parliamentary Authority.
§231.32.Record of Meeting.
§231.33.Fiscal Year.
§231.34.Auditing of Books.
§231.35.Seal of the Board.
§231.36.Executive Director.
§231.37.Director of Education.
§231.38.Associate Director (Directors) of Education.
§231.39.Blanket Position Bond.
§231.40.State Board Examination.
§231.41.Fees.
§231.42.Nursing Associations.
§231.43.Executive Secretary/Staff Service on Advisory Councils or Committee for Licensed Vocational Nurse Organization.
§231.44.Advertising.
§231.45.Salaries.
§231.46.Identifying Insignia.
§231.47.Source of Revenue.
§231.48.Bylaws.
§231.49.Overpayment.
§231.50.Charges for Providing Copies of Public Information.
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 12, 2004.
TRD-200401882
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
22 TAC §§231.61, 231.63, 231.64, 231.67, 231.69
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Board of Vocational Nurse Examiners or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code, Chapter 231 concerning Administration, and
specifically Subchapter C (Board Rules), §§231.61, 231.63, 231.64,
231.67, and 231.69. The other two subchapters are being proposed for repeal
concurrently with this subchapter: Definitions (Subchapter A), and General
Practice and Procedure (Subchapter B). Effective February 1, 2004, the Board
of Nurse Examiners and the Board of Vocational Nurse Examiners were merged
into one agency, the Board of Nurse Examiners. The Board of Vocational Nurse
Examiners ceased to exist as an agency. House Bill 1483, passed by the 78th
Regular Legislative Session, was the legislative action that implemented the
consolidation. These proposed repeals implement HB 1483 and the make-up and
function of the new Board of Nurse Examiners. Concurrent with these proposed
repeals are the proposed amendments to 22 Texas Administrative Code Chapter
211 (General Provisions) and Chapter 213 (Practice and Procedure) which incorporate
Licensed Vocational Nurses into the Board of Nurse Examiners' procedural rules.
This proposed repeal is for the purpose of preventing conflicting rules.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeals are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed repeals.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeals are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeals will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of these
proposed repeals.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of these sections is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act.
The adoption of the proposed repeals will not affect any existing statute.
§231.61.Purpose.
§231.63.Petition for Adoption of Rules.
§231.64.Petition Decision By Board.
§231.67.Public Information; Adoption of Rules; Availability of Rules and Orders.
§231.69.Rules Identification and 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 12, 2004.
TRD-200401883
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
Subchapter A. APPLICATION FOR LICENSURE
22 TAC §235.19
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Board of Vocational Nurse Examiners or in the Texas Register office, Room
245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code, Subchapter A, §235.19 (Licensure of
Persons With Criminal Convictions). Effective February 1, 2004, the Board
of Nurse Examiners and the Board of Vocational Nurse Examiners were merged
into one agency, the Board of Nurse Examiners. The Board of Vocational Nurse
Examiners ceased to exist as an agency. House Bill 1483, passed by the 78th
Regular Legislative Session, was the legislative action that implemented the
consolidation. These proposed repeals implement HB 1483 and the make-up and
function of the new Board of Nurse Examiners. Concurrent with these proposed
repeals are the proposed amendments to 22 Texas Administrative Code Chapter
211 (General Provisions) and Chapter 213 (Practice and Procedure) which incorporate
Licensed Vocational Nurses into the Board of Nurse Examiners' procedural rules.
This proposed repeal is for the purpose of preventing conflicting rules regarding
the effect of criminal convictions on the licensing process.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeal is adopted there will be no fiscal implications
for state or local government as a result of implementing the proposed repeal.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeal is adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeal will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of this proposed
repeal.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of this section is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act.
The adoption of the proposed repeal will not affect any existing statute.
§235.19.Licensure of Persons with Criminal Convictions.
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 12, 2004.
TRD-200401884
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
22 TAC §§235.21 - 235.25
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Board of Vocational Nurse Examiners or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code, Subchapter B (Board Review of Application), §§235.21
- 235.25. Effective February 1, 2004, the Board of Nurse Examiners and the
Board of Vocational Nurse Examiners were merged into one agency, the Board
of Nurse Examiners. The Board of Vocational Nurse Examiners ceased to exist
as an agency. House Bill 1483, passed by the 78th Regular Legislative Session,
was the legislative action that implemented the consolidation. These proposed
repeals implement HB 1483 and the make-up and function of the new Board of
Nurse Examiners. Concurrent with these proposed repeals are the proposed amendments
to 22 Texas Administrative Code Chapter 211 (General Provisions) and Chapter
213 (Practice and Procedure) which incorporate Licensed Vocational Nurses
into the Board of Nurse Examiners' procedural rules. This proposed repeal
is for the purpose of preventing conflicting rules regarding the determination
of a nurse's eligibility for licensure which is required to be done under
a declaration of eligibility under the new statutes.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeals are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed repeals.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeals are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeals will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of these
proposed repeals.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of these sections is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act.
The adoption of the proposed repeals will not affect any existing statute.
§235.21.Approved Applications.
§235.22.Application Not Approved.
§235.23.Rejected Application.
§235.24.Personal Appearance by Applicant.
§235.25.Scheduling Personal Appearance.
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 12, 2004.
TRD-200401885
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
Subchapter B. ENFORCEMENT
22 TAC §§239.12 - 239.15, 239.17 - 239.19
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Board of Vocational Nurse Examiners or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code, Subchapter B (Enforcement), §§239.12
- 239.15, 239.17 - 239.19. Effective February 1, 2004, the Board of Nurse
Examiners and the Board of Vocational Nurse Examiners were merged into one
agency, the Board of Nurse Examiners. The Board of Vocational Nurse Examiners
ceased to exist as an agency. House Bill 1483, passed by the 78th Regular
Legislative Session, was the legislative action that implemented the consolidation.
These proposed repeals implement HB 1483 and the make-up and function of the
new Board of Nurse Examiners. Concurrent with these proposed repeals are the
proposed amendments to 22 Texas Administrative Code Chapter 211 (General Provisions)
and Chapter 213 (Practice and Procedure) which incorporate Licensed Vocational
Nurses into the Board of Nurse Examiners' procedural rules. This proposed
repeal is for the purpose of preventing conflicting rules regarding the determination
of a nurse's eligibility for licensure when they have an issue involving criminal
convictions, mental fitness, or chemical dependency which are issues considered
in the declaration of eligibility process under 22 TAC §213.30. These
rules also address the disciplinary process which is in 22 TAC Chapter 213.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeals are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed repeal.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeals are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeal will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of this proposed
repeal.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of this section is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act.
The adoption of the proposed repeal will not affect any existing statute.
§239.12.Licensure of Persons with Criminal Convictions.
§239.13.Licensure of Persons with a History of Psychiatric Episodes.
§239.14.Licensure of Persons with a History of Substance Abuse.
§239.15.Licensure of Persons Who have Defaulted on Payments.
§239.17.Complaint Investigation and Disposition.
§239.18.Penalties and Sanctions.
§239.19.Schedule of Fines.
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 12, 2004.
TRD-200401886
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
22 TAC §§239.21 - 239.36
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Board of Vocational Nurse Examiners or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code, Subchapter C (Hearings Process), §§239.21
- 239.36. Effective February 1, 2004, the Board of Nurse Examiners and the
Board of Vocational Nurse Examiners were merged into one agency, the Board
of Nurse Examiners. The Board of Vocational Nurse Examiners ceased to exist
as an agency. House Bill 1483, passed by the 78th Regular Legislative Session,
was the legislative action that implemented the consolidation. These proposed
repeals implement HB 1483 and the make-up and function of the new Board of
Nurse Examiners. Concurrent with these proposed repeals are the proposed amendments
to 22 Texas Administrative Code Chapter 211 (General Provisions) and Chapter
213 (Practice and Procedure) which incorporate Licensed Vocational Nurses
into the Board of Nurse Examiners' procedural rules. This proposed repeal
is for the purpose of preventing conflicting rules regarding the hearings
process which is in 22 TAC Chapter 213.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeals are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed repeal.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeals are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeal will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of this proposed
repeal.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of this section is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act.
The adoption of the proposed repeal will not affect any existing statute.
§239.21.Subpoenas.
§239.22.Witness Fees and Expenses.
§239.23.Service of Notice.
§239.24.Hearings.
§239.25.Proposals for Decision.
§239.26.Filing of Exceptions, Briefs, and Replies.
§239.27.Oral Argument.
§239.28.Record of Hearing.
§239.29.Continuance.
§239.30.Entry of Appearance; Continuance.
§239.31.Failure to Attend Hearing; Default Judgment.
§239.32.Computation of Time.
§239.33.Probation.
§239.34.Records Retention Schedule.
§239.35.Release of Information.
§239.36.Temporary Suspensions.
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 12, 2004.
TRD-200401887
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
22 TAC §§239.41 - 239.51
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Board of Vocational Nurse Examiners or in the Texas Register office,
Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Board of Nurse Examiners proposes the repeal
of 22 Texas Administrative Code, Subchapter D (Informal Dispositions), §§239.41
- 239.51. Effective February 1, 2004, the Board of Nurse Examiners and the
Board of Vocational Nurse Examiners were merged into one agency, the Board
of Nurse Examiners. The Board of Vocational Nurse Examiners ceased to exist
as an agency. House Bill 1483, passed by the 78th Regular Legislative Session,
was the legislative action that implemented the consolidation. These proposed
repeals implement HB 1483 and the make-up and function of the new Board of
Nurse Examiners. Concurrent with these proposed repeals are the proposed amendments
to 22 Texas Administrative Code Chapter 211 (General Provisions) and Chapter
213 (Practice and Procedure) which incorporate Licensed Vocational Nurses
into the Board of Nurse Examiners' procedural rules. This proposed repeal
is for the purpose of preventing conflicting rules regarding informal dispositions
which are in 22 TAC Chapter 213.
Katherine Thomas, executive director, has determined that for the first
five-year period the proposed repeals are adopted there will be no fiscal
implications for state or local government as a result of implementing the
proposed repeal.
Katherine Thomas, executive director, has determined that for each year
of the first five years the proposed repeals are adopted, the public benefit
will be that all nurses will be subject to the same disciplinary and procedural
process which will be a more consistent process. The proposed repeal will
also prevent conflicting rules. There will be no effect on small businesses.
There is no anticipated cost to affected individuals as a result of this proposed
repeal.
Written comments on the proposal may be submitted to Katherine A. Thomas,
MN, RN, Executive Director, Board of Nurse Examiners, 333 Guadalupe, Suite
3-460, Austin, Texas 78701.
The proposed repeal of this section is pursuant to the authority
of Texas Occupations Code §§301.151 and 301.152 which authorizes
the Board of Nurse Examiners to adopt, enforce, and repeal rules consistent
with its legislative authority under the Nursing Practice Act.
The adoption of the proposed repeal will not affect any existing statute.
§239.41.Informal Conferences.
§239.42.Commencement of Disciplinary Actions.
§239.43.Notice of Complaint, Informal Conference, and Opportunity for a Hearing.
§239.44.Contents of the Notice of Complaint.
§239.45.Manner of Giving Notice.
§239.46.Answer to Notice of Complaint.
§239.47.Failure to Answer Notice of Complaint.
§239.48.Default Order.
§239.49.Record of Default.
§239.50.Opportunity to Show Compliance.
§239.51.Agreed Orders.
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 15, 2004.
TRD-200401888
Katherine Thomas
Executive Director
Board of Nurse Examiners
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-6823
Chapter 281.
ADMINISTRATIVE PRACTICE AND PROCEDURES
Subchapter A. GENERAL PROVISIONS
22 TAC §281.8
The Texas State Board of Pharmacy proposes amendments to §281.8,
concerning Grounds for Discipline for a Pharmacy License. The amendment, if
adopted, will clarify the activities which could result in disciplinary action
being taken against the holder of a pharmacy license.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be to clarify individuals who may not be employed
by a pharmacy or have access to prescription drugs and could result in disciplinary
action against the holder of a pharmacy license. There is no fiscal impact
anticipated for small or large businesses or to other entities who are required
to comply with this section.
Written comments on the amendment may be submitted to Allison Benz, R.Ph.,
M.S., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701, FAX 512/305-8082. Comments
must be received by 5 p.m., April 28, 2004.
The amendment is proposed under §§551.002, 554.051,
and 565.002 of the Texas Pharmacy Act (Chapters 551-566 and 568-569, 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 §565.002 as authorizing the agency to clarify
the activities which could result in disciplinary action being taken against
the holder of a pharmacy license.
The statutes affected by this rule: Chapters 551-566 and 568-569, Texas
Occupations Code.
§281.8.Grounds for Discipline for a Pharmacy License.
(a)
(No change.)
(b)
For the purposes of §565.002(3) of the Act, it is
grounds for discipline for a pharmacy license when:
(1)
during the time an individual's license to practice pharmacy,
which has been disciplined by the Board,
is revoked, canceled,
retired, surrendered,
or suspended, the pharmacy employs or allows such
individual access to prescription drugs;
(2) - (4)
(No change.)
(c)
(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 15, 2004.
TRD-200401921
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
Subchapter A. ALL CLASSES OF PHARMACIES
22 TAC §291.6
The Texas State Board of Pharmacy proposes amendments to §291.6,
concerning Pharmacy License Fees. The proposed amendment, if adopted, make
adjustments to the initial pharmacy licensing fee by decreasing the amount
charged by the Board to process an application from $351 to $341 and will
add a $10 fee to fund TexasOnline. The total initial licensing fee of $368
for a two-year registration is not changed.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be by assuring that the Texas State Board of Pharmacy
is adequately funded to carry out its mission, and assuring the funding of
TexasOnline. There is no fiscal impact anticipated for small or large businesses
or to other entities who are required to comply with this section.
Written comments on the amendment may be submitted to Allison Benz, R.Ph.,
M.S., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Box 21, Austin, Texas, 78701, FAX 512/305-8082. Comments
must be received by 5 p.m., April 28, 2004.
The amendments are proposed under §554.006 of the Texas
Pharmacy Act (Chapters 551-566, and 568-569, Texas Occupations Code). The
Board interprets §554.006 as authorizing the agency to establish reasonable
and necessary fees to produce sufficient revenue to cover the cost of administering
the Texas Pharmacy Act.
The statutes affected by this rule: Chapters 551-566, and 568-569, Texas
Occupations Code.
§291.6.Pharmacy License Fees.
(a)
Initial License Fee.
(1)
The fee for an initial license shall be $368 for a two
year registration and is composed of the following:
(A)
$341
[
(B)
$12 surcharge to fund a program to aid impaired pharmacists
and pharmacy students as authorized by the Act §564.051; [
(C)
$10 surcharge to fund TexasOnline as authorized
by Chapter 2054, Subchapter I, Government Code; and
(D)
[
(2)
(No change.)
(b) - (d)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on March 15, 2004.
TRD-200401922
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
22 TAC §291.25
The Texas State Board of Pharmacy (TSBP) proposes new §291.25,
concerning Pharmacies Compounding Non-sterile Pharmaceuticals. The new section,
if adopted, will outline operating standards for pharmacies that compound
non-sterile pharmaceuticals, implement the recommendations of the TSBP appointed
Task Force on Compounding (Task Force), and incorporate many of the provisions
included in the United States Pharmacopeia (USP) new General Chapter 795 (Pharmaceutical
Compounding Non- sterile Preparations).
The TSBP established the Task Force in August 2002. The Task Force was
composed of representatives from the pharmacy community appointed by the three
major pharmacy associations in Texas and pharmacists primarily involved in
compounding. The members of TSBP established the Task Force in response to
two issues. The first issue was the 2002 United States Supreme Court decision
which struck down the pharmacy compounding provisions of the federal Food,
Drug, and Cosmetic Act. This action left the federal law without any provisions
that allowed pharmacy compounding. In fact, if the federal law is read strictly,
all pharmacy compounding would be considered manufacturing. The second and
more important issue consisted of several incidences in other states in which
patient deaths had occurred after they had received injections of pharmaceuticals
that were compounded in pharmacies and were contaminated with bacteria.
The Task Force was charged with: (1) reviewing current federal and state
requirements for pharmacy compounding; (2) reviewing the current standards
of practice for pharmacy compounding; and (3) making recommendations to TSBP
regarding standards for compounding that will provide the necessary compounded
medications while protecting the health, safety, and welfare of the public.
The Task Force met two times and presented its recommendations to the Board
at the February 5, 2003 meeting.
At the February meeting, the members of TSBP directed staff to develop
draft rules based on the recommendations of the Task Force. The members of
TSBP reviewed the draft rules at the May 2003 meeting and directed staff to
continue to circulate the draft rules among the profession and incorporate
the recommendations from the profession. In August 2003, the members of TSBP
voted to publish the rules as proposed rules in the
Texas Register
. A public hearing on this first set of rules was held
on November 18, 2003. After receiving comments, the members of TSBP voted
to withdraw the first set of rules and directed staff to incorporate the majority
of the comments received at the public hearing and bring a new draft to the
February 2004 meeting. After reviewing the second set of draft rules at the
February 2004 meeting, the members of TSBP voted to publish the second set
of draft rules as proposed rules in the
Texas Register
.
The one major item not included in this second set of proposed rules is
a section that allows pharmacies to compound pharmaceuticals for physician
offices without a prescription for an individual patient. As pointed out in
the November 2003 public hearing, the Board does not have the authority to
set a percentage limit on the amount of compounded non-sterile pharmaceutical
that a pharmacy may sell to a physician's office without a prescription. In
fact, the Board believes that to adopt a rule that allowed a pharmacy to compound
non-sterile pharmaceuticals without a prescription for an individual patient
would be in violation of both the federal and state Food, Drug, and Cosmetic
Act. Specifically, the definition of manufacture in Section 431.002 of the
Health and Safety Code indicates that manufacturing does not include compounding
that is done within the practice of pharmacy and pursuant to a prescription
from a practitioner for a patient. Thus, the rules as published do not include
any provision for compounding for use in a physician office unless the pharmacy
has a prescription for a specific patient. However, the members of TSBP understand
that there are some instances in which compounding for physician office use
may be necessary. Therefore, the members of TSBP have instructed the staff
of TSBP to develop a policy that defines an appropriate level of enforcement
regarding this necessary physician office compounding.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be the establishment of standards for the safe compounding
of non-sterile pharmaceuticals by pharmacies. Ms. Dodson has also determined
that, for each year of the first five-year period the rule will be in effect,
an economic cost may exist for entities/persons required to comply with the
rule as described below.
There might be an adverse economic effect on micro, small, and large businesses
or to other entities/persons who are required to comply with this section.
Since the standards in these rules are almost exactly the same as those in
the previous rules, there is no anticipated cost to bring pharmacies into
compliance with the new provisions of these rules. However, because the previous
rules allowed a pharmacy to compound for physician office use without a prescription
(a provision considered to be in violation of state and federal law), pharmacies
that are compounding for physician offices without receiving a prescription
for a specific patient from the physician may experience loss of revenues.
The actual loss may vary greatly between pharmacies and TSBP cannot feasibly
calculate the loss, since TSBP does not have access to financial data from
pharmacies. It is reasonable to presume that the amount of compounding performed
by pharmacies for physician office use without a prescription should not change
significantly, because the same amount of the drugs would still be used by
physicians, but would now require a prescription to be generated prior to
dispensing of the compounded drug to the physician for administration in the
physician office.
Some pharmacies may disagree with this presumption, but with the absence
of financial data, TSBP has no method to confirm their assertions. If TSBP
assumes that a loss of revenue would occur, the loss of revenue to the pharmacy
could range from a few hundred to thousands of dollars, depending on the amount
of a pharmacy's business that would be lost which involves compounding for
physician office use. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between less than100
dollars per employee to several thousand dollars per employee. However, TSBP
does not maintain data to specifically segregate the pharmacies engaged in
non-sterile compounding, so TSBP cannot precisely determine the number of
pharmacies affected.
If an adverse economic effect exists for micro and small businesses based
on the requirements of the rule, including the prohibition in the rule against
compounding for physician office use without a prescription, TSBP is unable
to reduce that impact because doing so would be contrary to state and federal
law and would compromise the purposes of this rule which is intended to protect
the health and safety of the public.
A public hearing to receive comments on the proposed new rule will be held
at 9:00 a.m. on Tuesday, May 4, 2004, at the Health Professions Council Board
Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701. Persons
planning to present comments to the Board are asked to provide a written copy
of their comments prior to the hearing or bring 20 copies to the hearing.
Written comments on the new rule may be submitted to Allison Benz, R.Ph.,
M.S., Director of Professional Services, 333 Guadalupe Street, Suite 3-600,
Austin, Texas, 78701, FAX: 512/305-8082, E-mail: allison.benz@tsbp.state.tx.us.
Comments must be received by 5 p.m., April 28, 2004.
The new rule is proposed under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551-566 and 568-569,
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 §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets §554.051(b) as authorizing the agency to
adopt rules concerning the operation of a licensed pharmacy located in this
state applicable to a pharmacy licensed by the board that is located in another
state, if the board determines the rule is necessary to protect the health
and welfare of the citizens of this state.
The statutes affected by this rule: Chapters 551-566 and 568-569, Texas
Occupations Code.
§291.25.Pharmacies Compounding Non-Sterile Pharmaceuticals.
(a)
Purpose. The purpose of this section is to provide standards
for the compounding of non-sterile pharmaceuticals in Class A (Community),
Class B (Nuclear), Class C (Institutional) and Class E (Non-resident) pharmacies.
Pharmacies compounding non- sterile pharmaceuticals shall comply with the
requirements of this section in addition to all provisions for their specific
license classification.
(b)
Definitions. In addition to the definitions for specific
license classifications, the following words and terms, when used in this
section, shall have the following meanings, unless the context clearly indicates
otherwise.
(1)
Beyond-use date--The date after which a compounded preparation
should not be used and is determined from the date the preparation was compounded.
(2)
Component--Any ingredient intended for use in the compounding
of a drug product, including those that may not appear in such product.
(3)
Compounding--The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(A)
as the result of a practitioner's prescription drug or
medication order, or an 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.
(4)
Manufacturing--The production, preparation, propagation,
conversion, or processing of a drug or device, either directly or indirectly,
by extraction from substances of natural origin or independently by means
of chemical or biological synthesis and includes any packaging or repackaging
of the substances or labeling or relabeling of the container and the promotion
and marketing of such drugs or devices. Manufacturing also includes the preparation
and promotion of commercially available products from bulk compounds for resale
by pharmacies, practitioners, or other persons but does not include compounding.
(5)
SOPs--Standard operating procedures.
(6)
USP/NF--the current edition of the United States Pharmacopeia/National
Formulary
(c)
Personnel.
(1)
Pharmacist-in-charge. In addition to the responsibilities
for the specific class of pharmacy, the pharmacist-in-charge shall have the
responsibility for, at a minimum, the following concerning non-sterile compounding:
(A)
determining that all personnel involved in non-sterile
compounding possess the education, training, and proficiency necessary to
properly and safely perform compounding duties undertaken or supervised;
(B)
determining that all personnel involved in non-sterile
compounding obtain continuing education appropriate for the type of compounding
done by the personnel;
(C)
assuring that the equipment used in compounding is properly
maintained;
(D)
maintaining an appropriate environment in areas where non-sterile
compounding occurs; and
(E)
assuring that effective quality control procedures are
developed and followed.
(2)
Pharmacists. Special requirements for non-sterile compounding.
(A)
All pharmacists engaged in compounding shall:
(i)
possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken or supervised;
and
(ii)
obtain continuing education appropriate for the type of
compounding done by the pharmacist.
(B)
A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials involved
in the compounding process.
(C)
A pharmacist shall review all compounding records for accuracy
and conduct in-process and final checks to assure that errors have not occurred
in the compounding process.
(D)
A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(3)
Pharmacy technicians. All technicians engaged in compounding
shall:
(A)
possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken;
(B)
obtain continuing education appropriate for the type of
compounding done by the pharmacy technician: and
(C)
perform compounding duties under the direct supervision
of and responsible to a pharmacist.
(4)
Training.
(A)
All training activities shall be documented and covered
by appropriate SOPs as outlined in subsection (d)(7)(A) of this section.
(B)
All personnel involved in non-sterile compounding shall
be well trained and must participate in continuing relevant training programs.
(d)
Operational Standards.
(1)
General requirements.
(A)
Non-sterile drug products may be compounded in licensed
pharmacies:
(i)
upon presentation of a practitioner's prescription drug
or medication order based on a valid pharmacist/patient/prescriber relationship;
or
(ii)
in anticipation of future prescription drug or medication
orders based on routine, regularly observed prescribing patterns.
(B)
Non-sterile compounding in anticipation of future prescription
drug or medication orders must be based upon a history of receiving valid
prescriptions issued within an established pharmacist/patient/prescriber relationship,
provided that in the pharmacist's professional judgment the quantity prepared
is stable for the anticipated shelf time.
(i)
The pharmacist's professional judgment shall be based on
the criteria used to determine a beyond-use date outlined in paragraph (4)(C)
of this subsection.
(ii)
Documentation of the criteria used to determine the stability
for the anticipated shelf time must be maintained and be available for inspection.
(iii)
Any product compounded in anticipation of future prescription
drug or medication orders shall be labeled. Such label shall contain:
(I)
name and strength of the compounded medication or list
of the active ingredients and strengths;
(II)
facility's lot number;
(III)
beyond-use date as determined by the pharmacist using
appropriate documented criteria as outlined in clause (i) of this subparagraph;
and
(IV)
quantity or amount in the container.
(C)
Commercially available products may be compounded for dispensing
to individual patients provided the following conditions are met:
(i)
the commercial product is not reasonably available from
normal distribution channels in a timely manner to meet patient's needs; and
(ii)
the prescribing practitioner has requested that the drug
be compounded.
(D)
Preparations must be compounded only for dispensing by
the pharmacy where the products are compounded except that a pharmacy may
enter into an agreement to compound and dispense prescription/medication orders
for another pharmacy provided the pharmacy complies with the provisions of §291.37
of this title (relating to Centralized Prescription Dispensing). Compounded
preparations may not be distributed for resale, including distribution to
pharmacies under common ownership or control.
(E)
Compounding pharmacies/pharmacists may advertise and promote
the fact that they provide non-sterile prescription compounding services,
which may include specific drug products and classes of drugs.
(2)
Environment.
(A)
Pharmacies regularly engaging in compounding shall have
a designated and adequate area for the safe and orderly compounding of drug
products, including the placement of equipment and materials. Pharmacies involved
in occasional compounding shall prepare an area prior to each compounding
activity which is adequate for safe and orderly compounding.
(B)
Only personnel authorized by the responsible pharmacist
shall be in the immediate vicinity of a drug compounding operation.
(C)
A sink with hot and cold running water, exclusive of rest
room facilities, shall be accessible to the compounding areas and be maintained
in a sanitary condition. Supplies necessary for adequate washing shall be
accessible in the immediate area of the sink and include:
(i)
soap or detergent; and
(ii)
air-driers or single-use towels.
(D)
If drug products which require special precautions to prevent
contamination, such as penicillin, are involved in a compounding operation,
appropriate measures, including dedication of equipment for such operations
or the meticulous cleaning of contaminated equipment prior to its use for
the preparation of other drug products, must be used in order to prevent cross-contamination.
(3)
Equipment and Supplies. The pharmacy shall:
(A)
have a Class A prescription balance, or analytical balance
and weights which shall be properly maintained and subject to inspection at
least every three years by the Texas State Board of Pharmacy; and
(B)
have equipment and utensils necessary for the proper compounding
of prescription drug or medication orders. Such equipment and utensils used
in the compounding process shall be:
(i)
of appropriate design and capacity, and be operated within
designed operational limits;
(ii)
of suitable composition so that surfaces that contact
components, in-process material, or drug products shall not be reactive, additive,
or absorptive so as to alter the safety, identity, strength, quality, or purity
of the drug product beyond the desired result;
(iii)
cleaned and sanitized immediately prior to each use;
and
(iv)
routinely inspected, calibrated (if necessary), or checked
to ensure proper performance.
(4)
Labeling. In addition to the labeling requirements of the
pharmacy's specific license classification, the label dispensed or distributed
pursuant to a prescription drug or medication order shall contain the following.
(A)
The generic name(s) or the official name(s) of the principal
active ingredient(s) of the compounded preparation.
(B)
A statement that the preparation has been compounded by
the pharmacy. (An auxiliary label may be used on the container to meet this
requirement).
(C)
A beyond-use date after which the compounded preparation
should not be used. The beyond-use date shall be determined as outlined in
Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations
including the following.
(i)
The pharmacist shall consider:
(I)
physical and chemical properties of active ingredients;
(II)
use of preservatives and/or stabilizing agents;
(III)
dosage form;
(IV)
storage containers and conditions; and
(V)
scientific, laboratory, or reference data.
(ii)
In the absence of stability information applicable for
a specific drug or preparation, the following maximum beyond-use dates are
to be used when the compounded preparation is packaged in tight, light-resistant
containers and stored at controlled room temperatures.
(I)
Nonaqueous liquids and solid formulations (Where the manufactured
drug product is the source of active ingredient): 25% of the time remaining
until the product's expiration date or 6 months, whichever is earlier.
(II)
Water-containing formulations (Prepared from ingredients
in solid form): Not later than 14 days when refrigerated between 2 - 8 degrees
Celsius (36 - 46 degrees Fahrenheit)
(III)
All other formulations: Intended duration of therapy
or 30 days, whichever is earlier.
(iii)
Beyond-use date limits may be exceeded when supported
by valid scientific stability information for the specific compounded preparation.
(5)
Written drug information. Written information about the
compounded drug or its major active ingredient(s) shall be given to the patient
at the time of dispensing. A statement which indicates that the product was
compounded by the pharmacy must be included in this written information. If
there is no written information available, the patient should be advised in
writing that the drug has been compounded and how to contact a pharmacist,
and if appropriate the prescriber, concerning the drug.
(6)
Drugs, components, and materials used in non-sterile compounding.
(A)
Drugs used in non-sterile compounding shall preferably
be a USP/NF grade substances manufactured in an FDA-registered facility.
(B)
If USP/NF grade substances are not available, or when food,
cosmetics, or other substances are, or must be used, the substance shall be
of a chemical grade in one of the following categories:
(i)
Chemically Pure (CP);
(ii)
Analytical Reagent (AR); or
(iii)
American Chemical Society (ACS); or
(iv)
Food Chemical Codex; or
(C)
If a drug, component or material is not purchased from
a FDA- registered facility, the pharmacist shall establish purity and stability
by obtaining a Certificate of Analysis from the supplier.
(D)
A manufactured drug product may be a source of active ingredient.
Only manufactured drugs from containers labeled with a batch control number
and a future expiration date are acceptable as a potential source of active
ingredients. When compounding with manufactured drug products the pharmacist
must consider all ingredients present in the drug product relative to the
intended use of the compounded preparation.
(E)
All components shall be stored in properly labeled containers
in a clean, dry area, under proper temperatures.
(F)
Drug product containers and closures shall not be reactive,
additive, or absorptive so as to alter the safety, identity, strength, quality,
or purity of the compounded drug product beyond the desired result.
(G)
Components, drug product containers, and closures shall
be rotated so that the oldest stock is used first.
(H)
Container closure systems shall provide adequate protection
against foreseeable external factors in storage and use that can cause deterioration
or contamination of the compounded drug product.
(I)
A pharmacy may not compound a drug product which appears
on a federal Food and Drug Administration list of drug products withdrawn
or removed from the market for safety reasons.
(7)
Compounding process.
(A)
All significant procedures performed in the compounding
area shall be covered by written SOPs designed to ensure accountability, accuracy,
quality, safety, an uniformity in the compounding process. At a minimum, SOPs
shall be developed for:
(i)
the facility;
(ii)
equipment;
(iii)
personnel;
(iv)
actual compounding;
(v)
product evaluation;
(vi)
packaging; and
(vii)
storage of compounded preparations.
(B)
Any compounded preparation with an official monograph in
the USP/NF shall be compounded, labeled, and packaged in conformity with the
USP/NF monograph for the drug.
(C)
Any person with an apparent illness or open lesion that
may adversely affect the safety or quality of a drug product being compounded
shall be excluded from direct contact with components, drug product containers,
closures, any materials involved in the compounding process, and drug products
until the condition is corrected.
(D)
Personnel engaged in the compounding of drug products shall
wear clean clothing appropriate to the operation being performed. Protective
apparel, such as coats/jackets, aprons, hair nets, gowns, hand or arm coverings,
or masks shall be worn as necessary to protect personnel from chemical exposure
and drug products from contamination.
(E)
At each step of the compounding process, the pharmacist
shall assure that components used in compounding are accurately weighed, measured,
or subdivided as appropriate to conform to the formula being prepared.
(8)
Quality Control.
(A)
The pharmacy shall follow established quality control procedures
to monitor the output of compounded drug products for uniformity and consistency
such as capsule weight variations, adequacy of mixing, clarity, or pH of solutions.
When developing these procedures, pharmacy personnel shall consider the provisions
of Chapter 795, concerning Pharmacy Compounding Non-Sterile Preparations ,
Chapter 1075, concerning Good Compounding Practices, and Chapter 1160, concerning
Pharmaceutical Calculations in Prescription Compounding contained in the current
USP/NF. Such procedures shall be documented and be available for inspection.
(B)
Compounding procedures that are routinely performed, including
batch compounding, shall be completed and verified according to written procedures.
The act of verification of a compounding procedure involves checking to ensure
that calculations, weighing and measuring, order of mixing, and compounding
techniques were appropriate and accurately performed.
(C)
Unless otherwise indicated or appropriate, compounded preparations
are to be prepared to ensure that each preparation shall contain not less
than 90.0 percent and not more than 110.0 percent of the theoretically calculated
and labeled quantity of active ingredient per unit weight or volume and not
less than 90.0 percent and not more than 110.0 percent of the theoretically
calculated weight or volume per unit of the preparation.
(e)
Records.
(1)
Maintenance of records. Every record required by this section
shall be kept by the pharmacy for at least two years.
(2)
Compounding records.
(A)
Compounding records for all compounded preparations shall
be maintained by the pharmacy electronically or manually as part of the prescription
drug or medication order, formula record, formula book, or compounding log
and shall include:
(i)
the date of preparation;
(ii)
a complete formula, including methodology and necessary
equipment which includes the brand name(s) of the raw materials, or if no
brand name, the generic name(s) and name(s) of the manufacturer(s) of the
raw materials and the quantities of each;
(iii)
signature or initials of the pharmacist or pharmacy technician
performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising pharmacy technicians and other supportive personnel and conducting
in- process and final checks of compounded preparations if pharmacy technicians
perform the compounding function;
(v)
the quantity in units of finished products or amount of
raw materials;
(vi)
the container used and the number of units prepared;
(vii)
a reference to the location of the following documentation
which may be maintained with other records, such as quality control records:
(I)
the criteria used to determine the beyond-use date; and
(II)
documentation of performance of quality control procedures.
Documentation of the performance of quality control procedures is not required
if the compounding process is done pursuant to a patient specific order and
involves the mixing of two or more commercially available oral liquids or
commercially available preparations when the final product is intended for
external use.
(B)
Compounding records when batch compounding or compounding
in anticipation of future prescription drug or medication orders.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for formulations prepared in batch. Once approved,
a duplicate of the master work sheet shall be used as the preparation work
sheet from which each batch is prepared and on which all documentation for
that batch occurs. The master work sheet shall contain at a minimum:
(I)
the formula;
(II)
the components;
(III)
the compounding directions;
(IV)
a sample label;
(V)
evaluation and testing requirements;
(VI)
specific equipment used during preparation; and
(VII)
storage requirements.
(ii)
Preparation work sheet. The preparation work sheet for
each batch of preparations shall document the following:
(I)
identity of all solutions and ingredients and their corresponding
amounts, concentrations, or volumes;
(II)
lot number or each component;
(III)
component manufacturer/distributor or suitable identifying
number;
(IV)
container specifications (e.g., syringe, pump cassette);
(V)
unique lot or control number assigned to batch;
(VI)
beyond use date of batch-prepared products;
(VII)
date of preparation;
(VIII)
name, initials, or electronic signature of the person(s)
involved in the preparation;
(IX)
name, initials, or electronic signature of the responsible
pharmacist;
(X)
end-product evaluation and testing specifications, if applicable;
and
(XI)
comparison of actual yield to anticipated yield, when
appropriate.
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 15, 2004.
TRD-200401923
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
22 TAC §291.26
The Texas State Board of Pharmacy (TSBP) proposes new §291.26,
concerning Pharmacies Compounding Sterile Pharmaceuticals. The new section,
if adopted, will outline operating standards for pharmacies that compound
sterile pharmaceuticals, implement the recommendations of the TSBP appointed
Task Force on Compounding (Task Force), and incorporate many of the provisions
included in the United States Pharmacopeia (USP) new General Chapter 797 (Pharmaceutical
Compounding Sterile Preparations).
The TSBP established the Task Force in August 2002. The Task Force was
composed of representatives from the pharmacy community appointed by the three
major pharmacy associations in Texas and pharmacists primarily involved in
compounding. The members of TSBP established the Task Force in response to
two issues. The first issue was the 2002 United States Supreme Court decision
which struck down the pharmacy compounding provisions of the federal Food,
Drug, and Cosmetic Act. This action left the federal law without any provisions
that allowed pharmacy compounding. In fact, if the federal law is read strictly,
all pharmacy compounding would be considered manufacturing. The second and
more important issue consisted of several incidences in other states in which
patient deaths had occurred after they had received injections of pharmaceuticals
that were compounded in pharmacies and were contaminated with bacteria.
The Task Force was charged with: (1) reviewing current federal and state
requirements for pharmacy compounding; (2) reviewing the current standards
of practice for pharmacy compounding; and (3) making recommendations to TSBP
regarding standards for compounding that will provide the necessary compounded
medications while protecting the health, safety, and welfare of the public.
The Task Force met two times and presented its recommendations to the Board
at the February 5, 2003 meeting.
At the February meeting, the members of TSBP directed staff to develop
draft rules based on the recommendations of the Task Force. The members of
TSBP reviewed the draft rules at the May 2003 meeting and directed staff to
continue to circulate the draft rules among the profession and incorporate
the recommendations from the profession. In August 2003, the members of TSBP
voted to publish the rules as proposed rules in the
Texas Register
. A public hearing on this first set of rules was held
on November 18, 2003. After receiving comments, the members of TSBP voted
to withdraw the first set of rules and directed staff to incorporate the majority
of the comments received at the public hearing and bring a new draft to the
February 2004 meeting. After reviewing the second set of draft rules at the
February 2004 meeting, the members of TSBP voted to publish the second set
of draft rules as proposed rules in the
Texas Register
.
The one major item not included in this second set of proposed rules is
a section that allows pharmacies to compound pharmaceuticals for physician
offices without a prescription for an individual patient. As pointed out in
the November 2003 public hearing, the Board does not have the authority to
set a percentage limit on the amount of compounded sterile pharmaceuticals
that a pharmacy may sell to a physician's office without a prescription. In
fact, the Board believes that to adopt a rule that allowed a pharmacy to compound
sterile pharmaceuticals without a prescription for an individual patient would
be in violation of both the federal and state Food, Drug, and Cosmetic Act.
Specifically, the definition of manufacture in Section 431.002 of the Health
and Safety Code indicates that manufacturing does not include compounding
that is done within the practice of pharmacy and pursuant to a prescription
from a practitioner for a patient. Thus, the rules as published do not include
any provision for compounding for use in a physician office unless the pharmacy
has a prescription for a specific patient. However, the members of TSBP understand
that there are some instances in which compounding for physician office use
may be necessary. Therefore, the members of TSBP have instructed the staff
of TSBP to develop a policy that defines an appropriate level of enforcement
regarding this necessary physician office compounding.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be the establishment of standards for the safe compounding
of sterile pharmaceuticals by pharmacies. Ms. Dodson has also determined that,
for each year of the first five-year period the rule will be in effect, an
economic cost may exist for entities/persons required to comply with the rule
as described below.
There might be an adverse economic effect on micro, small, and large businesses
or to other entities/persons who are required to comply with this section.
Based on the significant variances in pharmacies' physical structure and layout,
it is difficult for TSBP to determine the actual cost to businesses required
to comply with this rule. These costs would involve bringing the sterile compounding
area of pharmacies into compliance with the new provisions of the rules and
in establishing an end product evaluation process. TSBP records indicate that
approximately 582 community pharmacies intended to provide sterile compounding
services to patients and approximately 92 hospital pharmacies intended to
compound sterile products for out-patients. However, TSBP cannot precisely
determine the number of pharmacies affected because TSBP records do not provide
additional information about the details of the pharmacies' compounding operations.
In addition, TSBP is unable to reduce these costs because to do so would compromise
the safety of sterile compounding practices.
Examples of new requirements under the rules are: (1) if the aseptic controlled
device is located within the controlled area, there must be six feet of separation
around the aseptic control device; (2) the controlled area must be accessible
without using hands; (3) when preparing high-risk pharmaceuticals, the controlled
area must maintain an environment of at least ISO Class 8 (Class 100,000);
(4) the pharmacy must establish end product evaluation procedures for all
products including high-risk preparations; and (5) the pharmacy must establish
a quality assurance program that meets the requirements of Chapter 797 of
the USP. The actual dollar amount for bringing the pharmacy into compliance
may vary greatly between pharmacies and could range from one hundred to several
tens of thousand dollars. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between one dollar
per employee to several thousand.
Pharmacies that are compounding for physician offices without receiving
a prescription for a specific patient from the physician may experience loss
of revenues. The actual loss may vary greatly between pharmacies and TSBP
cannot feasibly calculate the loss, since TSBP does not have access to financial
data from pharmacies. It is reasonable to presume that the amount of compounding
performed by pharmacies for physician office use without a prescription should
not change significantly, because the same amount of the drugs would still
be used by physicians, but would now require a prescription to be generated
prior to dispensing of the compounded drug to the physician for administration
in the physician office.
Some pharmacies may disagree with this presumption, but with the absence
of financial data, TSBP has no method to confirm their assertions. If TSBP
assumes that a loss of revenue would occur, the loss of revenue to the pharmacy
could range from a few hundred to thousands of dollars, depending on the amount
of a pharmacy's business that would be lost which involves compounding for
physician office use. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between less than
100 dollars per employee to several thousand.
Both state and federal law prohibit compounding without a prescription
for a specific patient. If pharmacies are compounding for physician office
use without a prescription, they are currently in violation of state and federal
law, such that the revenues generated therefrom are the result of an illegal
activity. If an adverse economic effect exists for micro and small businesses
based on the requirements of the rule, including the prohibition in the rule
against compounding for physician office use without a prescription, TSBP
is unable to reduce that impact because doing so would not be legal and feasible
considering the purpose of state and federal law concerning pharmacy compounding
and would compromise the purposes of this rule which is intended to protect
the health and safety of the public.
A public hearing to receive comments on the proposed new rule will be held
at 9:00 a.m. on Tuesday, May 4, 2004, at the Health Professions Council Board
Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701. Persons
planning to present comments to the Board are asked to provide a written copy
of their comments prior to the hearing or bring 20 copies to the hearing.
Written comments on the new rule may be submitted to Allison Benz, R.Ph.,
M.S., Director of Professional Services, 333 Guadalupe Street, Suite 3-600,
Austin, Texas, 78701, FAX: 512/305-8082, E-mail: allison.benz@tsbp.state.tx.us.
Comments must be received by 5 p.m., April 28, 2004.
The new rule is proposed under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551-566 and 568-569,
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 §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act. The Board interprets §554.051(b) as authorizing the agency to
adopt rules concerning the operation of a licensed pharmacy located in this
state applicable to a pharmacy licensed by the board that is located in another
state, if the board determines the rule is necessary to protect the health
and welfare of the citizens of this state.
The statutes affected by this rule: Texas Pharmacy Act, Chapters 551-566
and 568-569, Texas Occupations Code.
§291.26.Pharmacies Compounding Sterile Pharmaceuticals.
(a)
Purpose. The purpose of this section is to provide standards
for the compounding of sterile pharmaceuticals by all in Class A (Community),
Class B (Nuclear), Class C (Institutional) and Class E (Non-resident) pharmacies.
Pharmacies compounding sterile pharmaceuticals shall comply with all requirements
for their specific license classification and this section.
(b)
Definitions. In addition to the definitions for specific
license classifications, the following words and terms, when used in this
section, shall have the following meanings, unless the context clearly indicates
otherwise.
(1)
ACPE--Accreditation Council for Pharmacy Education.
(2)
Airborne particulate cleanliness class--The level of cleanliness
specified by the maximum allowable number of particles per cubic meter of
air as specified in the International Organization of Standardization (ISO)
Classification Air Cleanliness (ISO 14644-1). For example:
(A)
ISO Class 5 (formerly Class 100) is an atmospheric environment
which contains less than 3,520 particles 0.5 microns in diameter per cubic
meter of air (formerly stated as 100 particles 0.5 microns in diameter per
cubic foot of air);
(B)
ISO Class 7 (formerly Class 10,000) is an atmospheric environment
which contains less than 352,000 particles 0.5 microns in diameter per cubic
meter of air (formerly stated as 10,000 particles 0.5 microns in diameter
per cubic foot of air); and
(C)
ISO Class 8 (formerly Class 100,000) is an atmospheric
environment which contains less than 3,520,000 particles 0.5 microns in diameter
per cubic meter of air (formerly stated as 100,000 particles 0.5 microns in
diameter per cubic foot of air).
(3)
Ancillary supplies--Supplies necessary for the administration
of compounded sterile pharmaceuticals.
(4)
Aseptic preparation--The technique involving procedures
designed to preclude contamination of drugs, packaging, equipment, or supplies
by microorganisms during processing.
(5)
Automated compounding or counting device--An automated
device that compounds, measures, counts, and or packages a specified quantity
of dosage units for a designated drug product.
(6)
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/compounding
does not include the preparation of multiple sterile-product units pursuant
to patient specific medication orders.
(7)
Beyond-use date--The date after which a compounded preparation
should not be used and is determined from the date the preparation was compounded.
(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 the International
Organization of Standardization (ISO), Specifications for testing and monitoring
to prove continued compliance with ISO 14644-1 and/or ISO 14644-2.
(9)
Clean room--A room in which the concentration of airborne
particles is controlled and there are one or more clean zones according to
the International Organization of Standardization (ISO), Specifications for
testing and monitoring to prove continued compliance with ISO 14644-1 and/or
ISO 14644-2.
(10)
Clean zone--A defined space in which the concentration
of airborne particles is controlled to meet a specified airborne particulate
cleanliness class.
(11)
Component--Any ingredient intended for use in the compounding
of a drug product, including those that may not appear in such product.
(12)
Compounding--The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(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.
(13)
Controlled area--A controlled area is the area designated
for preparing sterile pharmaceuticals.
(14)
Critical site--Any opening providing a direct pathway
between a sterile product and the environment or any surface coming in direct
contact with the product and the environment.
(15)
Cytotoxic--A pharmaceutical that has the capability of
killing living cells.
(16)
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.
(17)
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.
(18)
SOPs--Standard operating procedures.
(19)
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.
(20)
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.
(21)
Sterile pharmaceutical--A dosage form free from living
micro-organisms.
(22)
USP/NF--The current edition of the United States Pharmacopeia/National
Formulary.
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
General. The pharmacy shall have a pharmacist-in-charge
in compliance with the specific license classification of the pharmacy.
(B)
Responsibilities. In addition to the responsibilities for
the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility
for, at a minimum, the following concerning sterile compounding:
(i)
developing a system to assure that all pharmacy personnel
responsible for compounding and/or supervising the compounding of sterile
pharmaceuticals within the pharmacy receive appropriate education and training
and competency evaluation;
(ii)
determining that all pharmacists involved in compounding
sterile pharmaceuticals obtain continuing education appropriate for the type
of compounding done by the pharmacist;
(iii)
supervising a system to assure appropriate procurement
of drugs and devices and storage of all pharmaceutical materials including
pharmaceuticals, components used in the compounding of pharmaceuticals, and
drug delivery devices;
(iv)
assuring that the equipment used in compounding is properly
maintained;
(v)
developing a system for the disposal and distribution of
drugs from the pharmacy;
(vi)
developing a system for bulk compounding or batch preparation
of drugs;
(vii)
developing a system for the compounding, sterility assurance,
quality assurance and quality control of sterile pharmaceuticals; and
(viii)
if applicable, assuring that the pharmacy has a system
to dispose of cytotoxic and/or biohazardous waste in a manner so as not to
endanger the public health.
(2)
Pharmacists. Special requirements for sterile compounding.
(A)
All pharmacists engaged in compounding shall:
(i)
possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken or supervised;
and
(ii)
obtain continuing education appropriate for the type of
compounding done by the pharmacist.
(B)
A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials involved
in the compounding process.
(C)
A pharmacist shall review all compounding records for accuracy
and conduct in-process and final checks to assure that errors have not occurred
in the compounding process.
(D)
A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(E)
A pharmacist shall be accessible at all times to respond
to patients' and other health professionals' questions and needs. Such access
may be through a telephone which is answered 24 hours a day.
(3)
Pharmacy technicians. Pharmacy technicians may compound
sterile pharmaceuticals provided the pharmacy technicians:
(A)
have completed the education and training specified in
paragraph (4) of this subsection; and
(B)
are supervised by a pharmacist who has completed the training
specified in paragraph (4) of this subsection, conducts in-process and final
checks, and affixes his or her initials to the appropriate quality control
records.
(4)
Special education, training, and evaluation requirements
for pharmacy personnel compounding or responsible for the direct supervision
of pharmacy personnel compounding sterile pharmaceuticals.
(A)
General.
(i)
All pharmacy personnel preparing sterile pharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge
and described in the policy and procedure or training manual. Such training
shall include instruction and experience in the following areas:
(I)
aseptic technique;
(II)
critical area contamination factors;
(III)
environmental monitoring;
(IV)
facilities;
(V)
equipment and supplies;
(VI)
sterile pharmaceutical calculations and terminology;
(VII)
sterile pharmaceutical compounding documentation;
(VIII)
quality assurance procedures;
(IX)
aseptic preparation procedures including proper gowning
and gloving technique;
(X)
handling of cytotoxic and hazardous drugs, if applicable;
and
(XI)
general conduct in the controlled area.
(ii)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile pharmaceuticals
shall be observed and evaluated as satisfactory through written or practical
tests and process validation and such evaluation documented.
(iii)
Although process validation may be incorporated into
the experiential portion of a training program, process validation must be
conducted at each pharmacy where an individual compounds sterile pharmaceuticals.
No product intended for patient use shall be compounded by an individual until
the on-site process validation test indicates that the individual can competently
perform aseptic procedures, except that a pharmacist may temporarily compound
sterile pharmaceuticals and supervise pharmacy technicians compounding sterile
pharmaceuticals without process validation provided the pharmacist:
(I)
has completed a recognized course in an accredited college
of pharmacy or a course sponsored by an ACPE approved provider which provides
20 hours of instruction and experience in the areas listed in this subparagraph;
and
(II)
completes the on-site process validation within seven
days of commencing work at the pharmacy.
(iv)
Process validation procedures for assessing the preparation
of specific types of sterile pharmaceuticals shall be representative of all
types of manipulations, products, risk levels, and batch sizes that personnel
preparing that type of pharmaceutical are likely to encounter.
(v)
The pharmacist-in-charge shall assure continuing competency
of pharmacy personnel through in-service education, training, and process
validation to supplement initial training. Personnel competency shall be evaluated:
(I)
during orientation and training prior to the regular performance
of those tasks;
(II)
whenever the quality assurance program yields an unacceptable
result;
(III)
whenever unacceptable techniques are observed; and
(IV)
at least on an annual basis.
(B)
Pharmacists.
(i)
All pharmacists who compound sterile pharmaceuticals or
supervise pharmacy technicians compounding sterile pharmaceuticals shall:
(I)
complete through a single course, a minimum of 20 hours
of instruction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training shall be completed at least every seven years and
may be obtained through:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 20 hours of instruction and
experience in the areas listed in paragraph (1) of this subsection. Such training
may not be transferred to another pharmacy unless the pharmacies are under
common ownership and control and use a common training program; or
(-b-)
completion of a recognized course in an accredited college
of pharmacy or a course sponsored by an ACPE approved provider which provides
20 hours of instruction and experience in the areas listed in subparagraph
(A) of this paragraph; and
(II)
every two years complete six hours of continuing education
related to sterile product compounding offered by a provider approved by ACPE.
(These hours may be applied towards the hours required for renewal of a license
to practice pharmacy.)
(III)
possess knowledge about:
(-a-)
aseptic processing;
(-b-)
quality control and quality assurance as related to environmental,
component, and end-product testing;
(-c-)
chemical, pharmaceutical, and clinical properties of
drugs;
(-d-)
container, equipment, and closure system selection; and
(-e-)
sterilization techniques.
(ii)
The required experiential portion of the training programs
specified in this subparagraph must be supervised by an individual who has
already completed training as specified in subparagraph (B) or (C) of this
paragraph.
(C)
Pharmacy technicians. In addition to qualifications for
specific license classifications all pharmacy technicians who compound sterile
pharmaceuticals shall:
(i)
have a high school or equivalent education;
(ii)
have initial training obtained either through completion
of:
(I)
a single course, a minimum of 40 hours of instruction and
experience in the areas listed in subparagraph (A) of this paragraph. Such
training may be obtained through:
(-a-)
completion of a structured on-the-job didactic and experiential
training program at this pharmacy which provides 40 hours of instruction and
experience in the areas listed in subparagraph (A) of this paragraph. Such
training may not be transferred to another pharmacy unless the pharmacies
are under common ownership and control and use a common training program;
or
(-b-)
completion of a course sponsored by an ACPE approved
provider which provides 40 hours of instruction and experience in the areas
listed in subparagraph (A) of this paragraph; or
(II)
a training program which is accredited by the American
Society of Health-System Pharmacists (formerly the American Society of Hospital
Pharmacists). Individuals enrolled in training programs accredited by the
American Society of Health-System Pharmacists may compound sterile pharmaceuticals
in a licensed pharmacy provided:
(-a-)
the compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component of the American
Society of Health-System Pharmacists training program;
(-b-)
the individual is under the direct supervision of and
responsible to a pharmacist who has completed training as specified in subparagraph
(B) of this paragraph; and
(-c-)
the supervising pharmacist conducts in- process and final
checks;
(iii)
acquire the required experiential portion of the training
programs specified in this subparagraph under the supervision of an individual
who has already completed training as specified in subparagraph (B) or (C)
of this paragraph; and
(iv)
every two years complete six hours of continuing education
related to sterile product compounding. (These hours may be applied towards
the hours required for renewal of a pharmacy technician's registration.)
(D)
Documentation of Training. A written record of initial
and in-service training and the results of written or practical testing and
process validation of pharmacy personnel shall be maintained and contain the
following information:
(i)
name of the person receiving the training or completing
the testing or process validation;
(ii)
date(s) of the training, testing, or process validation;
(iii)
general description of the topics covered in the training
or testing or of the process validated;
(iv)
name of the person supervising the training, testing,
or process validation; and
(v)
signature (first initial and last name or full signature)
of the person receiving the training or completing the testing or process
validation and the pharmacist-in-charge or other pharmacist employed by the
pharmacy and designated by the pharmacist-in-charge as responsible for training,
testing, or process validation of personnel.
(d)
Operational Standards.
(1)
General Requirements.
(A)
Sterile drug products may be compounded in licensed pharmacies:
(i)
upon presentation of a practitioner's prescription drug
or medication order based on a valid pharmacist/patient/prescriber relationship;
or
(ii)
in anticipation of future prescription drug or medication
orders based on routine, regularly observed prescribing patterns.
(B)
Sterile compounding in anticipation of future prescription
drug or medication orders must be based upon a history of receiving valid
prescriptions issued within an established pharmacist/patient/prescriber relationship,
provided that in the pharmacist's professional judgment the quantity prepared
is stable for the anticipated shelf time.
(i)
The pharmacist's professional judgment shall be based on
the criteria used to determine a beyond-use date outlined in paragraph (5)(C)
of this subsection.
(ii)
Documentation of the criteria used to determine the stability
for the anticipated shelf time must be maintained and be available for inspection.
(iii)
Any product compounded in anticipation of future prescription
drug or medication orders shall be labeled. Such label shall contain:
(I)
name and strength of the compounded medication or list
of the active ingredients and strengths;
(II)
facility's lot number;
(III)
beyond-use date as determined by the pharmacist using
appropriate documented criteria as outlined in clause (i) of this subparagraph;
(IV)
quantity or amount in the container;
(V)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic warning labels where appropriate;
and
(VI)
device-specific instructions, where appropriate.
(C)
Commercially available products may be compounded for dispensing
to individual patients provided the following conditions are met:
(i)
the commercial product is not reasonably available from
normal distribution channels in a timely manner to meet patient's needs; and
(ii)
the prescribing practitioner has requested that the drug
be compounded.
(D)
Pharmaceuticals must be compounded only for dispensing
by the pharmacy where the products are compounded except that a pharmacy may
enter into an agreement to compound and dispense prescription/medication orders
for another pharmacy provided the pharmacy complies with the provisions of §291.37
of this title (relating to Centralized Prescription Dispensing). Compounded
pharmaceuticals may not be distributed for resale, including distribution
to pharmacies under common ownership or control.
(E)
Compounding pharmacies/pharmacists may advertise and promote
the fact that they provide sterile prescription compounding services, which
may include specific drug products and classes of drugs.
(2)
Risk levels for compounded sterile pharmaceuticals. Risk
Levels for sterile compounded preparations shall be as outlined in USP/NF
Chapter 797 Pharmacy Compounding Sterile Preparations and as listed below.
(A)
Low-risk level compounded sterile pharmaceuticals.
(i)
Low-risk level compounded sterile pharmaceuticals are those
compounded under all of the following conditions.
(I)
The compounded sterile preparations are compounded with
aseptic manipulations entirely within ISO Class 5 or better air quality using
only sterile ingredients, products, components, and devices.
(II)
The compounding involves only transfer, measuring, and
mixing manipulations with closed or sealed packaging systems that are performed
promptly and attentively.
(III)
Manipulations are limited to aseptically opening ampuls,
penetrating sterile stoppers on vials with sterile needles and syringes, and
transferring sterile liquids in sterile syringes to sterile administration
devices and packages of other sterile products.
(IV)
For a low-risk preparation, in the absence of passing
a sterility test, the storage periods cannot exceed the following periods:
before administration, 48 hours at controlled room temperature, for not more
than 14 days if stored in cold temperatures, and for 45 days if stored in
a frozen state at minus 20 degrees Celsius or colder).
(ii)
Examples of low-risk compounding include the following.
(I)
Single transfers of sterile dosage forms from ampuls, bottles,
bags, and vials using sterile syringes with sterile needles, other administration
devices, and other sterile containers. The contents of ampuls require sterile
filtration to remove glass particles.
(II)
Manually measuring and mixing no more than three manufactured
products to compound drug admixtures and nutritional solutions.
(B)
Medium-risk level compounded sterile pharmaceuticals.
(i)
Medium-risk level compounded sterile pharmaceuticals are
those compounded aseptically under low-risk conditions and one or more of
the of the following conditions exists.
(I)
Multiple individual or small doses of sterile products
are combined or pooled to prepare a compounded sterile pharmaceutical that
will be administered either to multiple patients or to one patient on multiple
occasions.
(II)
The compounding process includes complex aseptic manipulations
other than the single-volume transfer.
(III)
The compounding process requires unusually long duration,
such as that required to complete the dissolution or homogenous mixing.
(IV)
The sterile compounded pharmaceutical's do not contain
broad-spectrum bacteriostatic substances, and they are administered over several
days.
(V)
For a medium-risk preparation, in the absence of passing
sterility test, the storage periods cannot exceed the following time periods:
before administration, the compounded sterile preparations are properly stored
and are exposed for not more than 30 hours at controlled room temperature
for not more than 7 days at a cold temperature, and for 45 days in solid frozen
state at minus 20 degrees or colder.
(ii)
Examples of medium-risk compounding include the following.
(I)
Compounding of total parenteral nutrition fluids using
a manual or automated device during which there are multiple injections, detachments,
and attachments of nutrient source products to the device or machine to deliver
all nutritional components to a final sterile container.
(II)
Filling of reservoirs of injection and infusion devices
with multiple sterile drug products and evacuations of air from those reservoirs
before the filled device is dispensed.
(III)
Filling of reservoirs of injection and infusion devices
with volumes of sterile drug solutions that will be administered over several
days at ambient temperatures between 25 and 40 degrees Celsius (77 and 104
degrees Fahrenheit).
(IV)
Transfer of volumes from multiple ampuls or vials into
a single, final sterile container or product.
(C)
High-risk level compounded sterile pharmaceuticals.
(i)
High-risk level compounded sterile pharmaceuticals are
those compounded under any of the following conditions.
(I)
Non-sterile ingredients, including manufactured products
are incorporated, or a non-sterile device is employed before terminal sterilization.
(II)
Sterile ingredients, components, devices, and mixtures
are exposed to air quality inferior to ISO Class 5. This includes storage
in environments inferior to ISO Class 5 of opened or partially used packages
of manufactured sterile products that lack antimicrobial preservatives.
(III)
Non-sterile preparations are exposed no more than 6 hours
before being sterilized.
(IV)
It is assumed, and not verified by examination of labeling
and documentation from suppliers or by direct determination, that the chemical
purity and content strength of ingredients meet their original or compendial
specifications in unopened or in opened packages of bulk ingredients.
(V)
For a high-risk preparation, in the absence of passing
sterility test, the storage periods cannot exceed the following time periods:
before administration, the compounded sterile preparations are properly stored
and are exposed for not more than 24 hours at controlled room temperature
for not more than 3 days at a cold temperature, and for 45 days in solid frozen
state at minus 20 degrees or colder.
(ii)
Examples of high-risk compounding include the following.
(I)
Dissolving non-sterile bulk drug and nutrient powders to
make solutions, which will be terminally sterilized.
(II)
Sterile ingredients, components, devices, and mixtures
are exposed to air quality inferior to ISO Class 5. This includes storage
in environments inferior to ISO Class 5 of opened or partially used packages
of manufactured sterile products that lack antimicrobial preservatives.
(III)
Measuring and mixing sterile ingredients in non-sterile
devices before sterilization is performed.
(IV)
Assuming, without appropriate evidence or direct determination,
that packages of bulk ingredients contain at least 95% by weight of their
active chemical moiety and have not been contaminated or adulterated between
uses.
(3)
Environment.
(A)
Special requirements for the compounding of sterile pharmaceuticals.
When the pharmacy compounds sterile pharmaceuticals, the following is applicable.
(i)
Controlled area.
(I)
Low and Medium Risk Preparations. The pharmacy shall have
a designated controlled area for the compounding of sterile pharmaceuticals
that is functionally separate from areas for the preparation of non-sterile
pharmaceuticals and is constructed to minimize the opportunities for particulate
and microbial contamination. This controlled area for the preparation of sterile
pharmaceuticals shall:
(-a-)
have a controlled environment that is aseptic or contains
an aseptic environmental control device(s). If the aseptic environmental control
device is located within the controlled area, the controlled area must extend
a minimum of six feet from the device and clearly marked to identify the separation
between the controlled and non-controlled area;
(-b-)
be clean, well lighted, and of sufficient size to support
sterile compounding activities;
(-c-)
be used only for the compounding of sterile pharmaceuticals;
(-d-)
be designed to avoid outside traffic and air flow;
(-e-)
be designed such that hand sanitizing and gowning occurs
outside the controlled area but is accessible without use of the hands of
the compounding personnel;
(-f-)
have non-porous and washable floors or floor covering
to enable regular disinfection;
(-g-)
be ventilated in a manner not interfering with aseptic
environmental control conditions;
(-h-)
have walls, ceilings, and fixtures, shelving, counters,
and cabinets that are smooth, impervious, free from cracks and crevices, and
nonshedding. (acoustical ceiling tiles that are coated with an acrylic paint
are acceptable);
(-i-)
have drugs and supplies stored on shelving areas above
the floor to permit adequate floor cleaning; and
(-j-)
contain only the appropriate compounding supplies and
not be used for bulk storage for supplies and materials. Objects that shed
particles may not be brought into the controlled area.
(II)
High-risk Preparations. In addition to the requirements
in subclause (I) of this clause, when high-risk preparations are compounded,
the aseptic environment control device(s) shall be located in a controlled
area that maintains at least an ISO Class 8 (formerly Class 100,000) environment.
(ii)
Aseptic environment control device(s). The pharmacy shall
prepare sterile pharmaceuticals in an appropriate aseptic environmental control
device(s) or area, such as a laminar air flow hood, biological safety cabinet,
clean room which is capable of maintaining at least ISO Class 5 (formerly
Class 100) conditions during normal activity, or other aseptic environmental
control devices that produce ISO Class 5 (formerly Class 100) environmental
conditions or better. The aseptic environmental control device(s) shall:
(I)
be certified by an independent contractor according to
the International Organization of Standardization (ISO) Classification of
Particulate Matter in Room Air (ISO 14644-1) for operational efficiency at
least every six months or when it is relocated; and
(II)
have pre-filters inspected periodically and replaced as
needed, in accordance with written policies and procedures, and the inspection
and/or replacement date documented.
(iii)
Automated compounding or counting device. If automated
compounding or counting devices are used, the pharmacy shall have a method
to calibrate and verify the accuracy of automated compounding or counting
devices used in aseptic processing and document the calibration and verification
on a routine basis.
(iv)
Cytotoxic drugs. In addition to the requirements specified
in clause (ii) of this subparagraph, if the product is also cytotoxic, the
following is applicable.
(I)
General.
(-a-)
All personnel involved in the compounding of cytotoxic
products shall wear appropriate protective apparel, such as masks, gloves,
and gowns or coveralls with tight cuffs.
(-b-)
Appropriate safety and containment techniques for compounding
cytotoxic drugs shall be used in conjunction with aseptic techniques required
for preparing sterile pharmaceuticals.
(-c-)
Disposal of cytotoxic waste shall comply with all applicable
local, state, and federal requirements.
(-d-)
Prepared doses of cytotoxic drugs must be dispensed,
labeled with proper precautions inside and outside, and distributed in a manner
to minimize patient contact with cytotoxic agents.
(II)
Aseptic environment control device(s).
(-a-)
Cytotoxic drugs must be prepared in a vertical flow biological
safety cabinet, or other aseptic environmental control devices that produce
ISO Class 5 (formerly Class 100) environmental conditions or better and provide
protection from cytotoxic products to personnel.
(-b-)
If the aseptic environment control device is also used
to prepare non-cytotoxic sterile pharmaceuticals, the device must be thoroughly
cleaned prior to its use to prepare non-cytotoxic sterile pharmaceuticals.
(B)
Security requirements. The pharmacy may authorize personnel
to gain access to that area of the pharmacy containing dispensed sterile pharmaceuticals,
in the absence of the pharmacist, for the purpose of retrieving dispensed
prescriptions to deliver to patients. If the pharmacy allows such after-hours
access, the area containing the dispensed sterile pharmaceuticals shall be
an enclosed and lockable area separate from the area containing undispensed
prescription drugs. A list of the authorized personnel having such access
shall be in the pharmacy's policy and procedure manual.
(C)
Storage requirements. All drugs shall be stored at the
proper temperature and conditions, as defined in the USP/NF. The most commonly
used definitions are as follows:
(i)
freezer--A place in which the temperature maintained thermostatically
between minus 25 degrees and minus 10 degrees Celsius (minus 13 degrees and
14 degrees Fahrenheit).
(ii)
cold--Any temperature not exceeding 8 degrees Celsius
(46 degrees Fahrenheit. A refrigerator is a cold place in which the temperature
maintained thermostatically between 2 degrees and 8 degrees Celsius (36 degrees
and 46 degrees Fahrenheit);
(iii)
cool--temperature between 8 degrees and 15 degrees Celsius
(46 degrees and 59 degrees Fahrenheit) which may, alternatively, be stored
in a refrigerator unless otherwise specified on the labeling; and
(iv)
controlled room temperature--temperature maintained thermostatically
between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit).
(4)
Equipment and supplies. Pharmacies compounding sterile
pharmaceuticals shall have the following equipment and supplies:
(A)
a system or device (i.e., thermometer) to monitor the temperature
and humidity to ensure that proper storage requirements are met, if sterile
pharmaceuticals are stored in the refrigerator;
(B)
a system or device to monitor the temperature and humidity
where bulk chemicals are stored;
(C)
if applicable, a Class A prescription balance, or analytical
balance and weights. Such balance shall be properly maintained and subject
to inspection at least every three years by the Texas State Board of Pharmacy;
(D)
have equipment and utensils necessary for the proper compounding
of prescription drug or medication orders. Such equipment and utensils used
in the compounding process shall be:
(i)
of appropriate design, appropriate capacity, and be operated
within designed operational limits;
(ii)
of suitable composition so that surfaces that contact
components, in-process material, or drug products shall not be reactive, additive,
or absorptive so as to alter the safety, identity, strength, quality, or purity
of the drug product beyond the desired result;
(iii)
cleaned and sanitized immediately prior to each use;
and
(iv)
routinely inspected, calibrated (if necessary), or checked
to ensure proper performance;
(E)
appropriate disposal containers for used needles, syringes,
etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic
agents, and/or biohazardous waste;
(F)
appropriate packaging or delivery containers to maintain
proper storage conditions for products;
(G)
infusion devices, if applicable; and
(H)
all necessary supplies, including:
(i)
disposable needles, syringes, and other supplies for aseptic
mixing;
(ii)
disinfectant cleaning solutions;
(iii)
hand washing agents with bactericidal action;
(iv)
disposable, lint free towels or wipes;
(v)
appropriate filters and filtration equipment;
(vi)
cytotoxic spill kits, if applicable; and
(vii)
masks, caps, coveralls or gowns with tight cuffs, shoe
covers, and gloves, as applicable.
(5)
Labeling. In addition to the labeling requirements for
the pharmacy's specific license classification, the label dispensed or distributed
pursuant to a prescription drug or medication order shall contain the following.
(A)
The generic name(s) or the official name(s) of the principal
active ingredient(s) of the compounded pharmaceutical.
(B)
A statement that the preparation has been compounded by
the pharmacy. (An auxiliary label may be used on the container to meet this
requirement).
(C)
A beyond-use date after which the compounded pharmaceutical
should not be used. The beyond-use date shall be determined as outlined in
Chapter 797 of the USP/NF concerning Pharmacy Compounding Sterile Preparations.
(D)
If the sterile pharmaceutical is compounded in a batch,
the following should also be included on the batch label.
(i)
unique lot number assigned to the batch;
(ii)
quantity;
(iii)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including cytotoxic warning labels where appropriate;
and
(iv)
device-specific instructions, where appropriate.
(6)
Written drug information. Written information about the
compounded drug or its major active ingredient(s) shall be given to the patient
at the time of dispensing. A statement which indicates that the product was
compounded by the pharmacy must be included in this written information. If
there is no written information available, the patient should be advised in
writing that the drug has been compounded and how to contact a pharmacist,
and if appropriate the prescriber, concerning the drug.
(7)
Pharmaceutical Care Services. In addition to the pharmaceutical
care requirements for the pharmacy's specific license classification, the
following requirements must be met.
(A)
Sterile pharmaceuticals compounded pursuant to prescription
drug orders (outpatients and long-term care facility patients).
(i)
Primary provider. There shall be a designated physician
primarily responsible for the patient's medical care. There shall be a clear
understanding between the physician, the patient, and the pharmacy of the
responsibilities of each in the areas of the delivery of care, and the monitoring
of the patient. This shall be documented in the patient medication record
(PMR).
(ii)
Patient training. The pharmacist-in-charge shall develop
policies that assure that the patient and/or patient's caregiver receives
information regarding drugs and their safe and appropriate use, including
instruction when applicable, regarding:
(I)
appropriate disposition of hazardous solutions and ancillary
supplies;
(II)
proper disposition of controlled substances in the home;
(III)
self-administration of drugs, where appropriate;
(IV)
emergency procedures, including how to contact an appropriate
individual in the event of problems or emergencies related to drug therapy;
and
(V)
if the patient or patient's caregiver prepares sterile
preparations in the home, the following additional information shall be provided:
(-a-)
safeguards against microbial contamination, including
aseptic techniques for compounding intravenous admixtures and aseptic techniques
for injecting additives to premixed intravenous solutions;
(-b-)
appropriate storage methods, including storage durations
for sterile pharmaceuticals and expirations of self-mixed solutions;
(-c-)
handling and disposition of premixed and self- mixed
intravenous admixtures; and
(-d-)
proper disposition of intravenous admixture compounding
supplies such as syringes, vials, ampules, and intravenous solution containers.
(iii)
Pharmacist-patient relationship. It is imperative that
a pharmacist-patient relationship be established and maintained throughout
the patient's course of therapy. This shall be documented in the patient's
medication record (PMR).
(iv)
Patient monitoring. The pharmacist-in-charge shall develop
policies to ensure that:
(I)
the patient's response to drug therapy is monitored and
conveyed to the appropriate health care provider; and
(II)
the first dose of any new drug therapy is administered
in the presence of an individual qualified to monitor for and respond to adverse
drug reactions.
(B)
Sterile pharmaceutical compounded pursuant to medication
orders (inpatients).
(i)
Education. The pharmacist-in-charge in cooperation with
appropriate multi-disciplinary staff of the facility shall develop policies
that assure that:
(I)
the patient and/or patient's caregiver receives information
regarding drugs and their safe and appropriate use; and
(II)
health care providers are provided with patient specific
drug information.
(ii)
Patient monitoring. The pharmacist-in-charge in cooperation
with appropriate multi-disciplinary staff of the facility shall develop policies
to ensure that the patient's response to drug therapy is monitored and conveyed
to the appropriate health care provider.
(8)
Drugs, components, and materials used in sterile compounding.
(A)
Drugs used in sterile compounding shall preferably be a
USP/NF grade substances manufactured in an FDA-registered facility.
(B)
If USP/NF grade substances are not available shall be of
a chemical grade in one of the following categories:
(i)
Chemically Pure (CP);
(ii)
Analytical Reagent (AR); or
(iii)
American Chemical Society (ACS); or
(iv)
Food Chemical Codex; or
(C)
If a drug, component or material is not purchased from
a FDA- registered facility, the pharmacist shall establish purity and stability
by obtaining a Certificate of Analysis from the supplier.
(D)
All components shall:
(i)
preferably be manufactured in an FDA-registered facility;
or
(ii)
in the professional judgment of the pharmacist, be of
high quality and obtained from acceptable and reliable alternative sources;
and
(iii)
stored in properly labeled containers in a clean, dry
area, under proper temperatures.
(E)
Drug product containers and closures shall not be reactive,
additive, or absorptive so as to alter the safety, identity, strength, quality,
or purity of the compounded drug product beyond the desired result.
(F)
Components, drug product containers, and closures shall
be rotated so that the oldest stock is used first.
(G)
Container closure systems shall provide adequate protection
against foreseeable external factors in storage and use that can cause deterioration
or contamination of the compounded drug product.
(H)
A pharmacy may not compound a drug product which appears
on a federal Food and Drug Administration list of drug products withdrawn
or removed from the market for safety reasons.
(9)
Compounding process.
(A)
All significant procedures performed in the compounding
area shall be covered by written SOPs designed to ensure accountability, accuracy,
quality, safety, and uniformity in the compounding process. At a minimum,
SOPs shall be developed for:
(i)
the facility;
(ii)
equipment;
(iii)
personnel;
(iv)
actual compounding;
(v)
product evaluation;
(vi)
packaging; and
(vii)
storage of compounded pharmaceuticals.
(B)
Any compounded formulation with an official monograph in
the USP/NF shall be compounded, labeled, and packaged in conformity with the
USP/NF monograph for the drug.
(C)
Any person with an apparent illness or open lesion that
may adversely affect the safety or quality of a drug product being compounded
shall be excluded from direct contact with components, drug product containers,
closures, any materials involved in the compounding process, and drug products
until the condition is corrected.
(D)
Personnel engaged in the compounding of drug products shall
wear clean clothing appropriate to the operation being performed. Protective
apparel, such as coats/jackets, aprons, hair nets, gowns, hand or arm coverings,
or masks shall be worn as necessary to protect personnel from chemical exposure
and drug products from contamination.
(E)
At each step of the compounding process, the pharmacist
shall assure that components used in compounding are accurately weighed, measured,
or subdivided as appropriate to conform to the formula being prepared.
(10)
Quality control.
(A)
Quality control procedures. The pharmacy shall follow established
quality control procedures to monitor the quality of compounded drug products
for conformity with the quality indicators established for the product. When
developing these procedures, pharmacy personnel shall consider the provisions
of Chapter 797, concerning Pharmaceutical Compounding Sterile Preparations,
Chapter 1075, concerning Good Compounding Practices, and Chapter 1160, concerning
Pharmaceutical Calculations in Prescription Compounding contained in the current
USP/NF. Such procedures shall be documented and be available for inspection.
(B)
End product evaluations.
(i)
The pharmacy shall conduct and document end product evaluations
appropriate for the preparation in accordance with written SOPs. End product
evaluations for non-batch compounded pharmaceuticals may be performed on random
samples. All batch compounded pharmaceuticals shall have end product evaluations.
(ii)
High-risk level compounded sterile pharmaceutical for
administration by injection into the vascular and central nervous systems
that are prepared in groups of more than 25 identical individual single-dose
packages (such as ampuls, bags, syringes, and vials), or in multiple dose
vials for administration to multiple patients, or are exposed longer than
12 hours at 2 - 8 degrees Celsius (36 - 46 degrees Fahrenheit) and longer
than six hours at warmer than 8 degrees Celsius (46 degrees Fahrenheit) before
they are sterilized shall be tested to ensure they are sterile and do not
contain excessive bacterial endotoxins as specified in Chapter 797 of the
USP/NF. If the preparation is a suspension, it should be tested to assure
it is not contaminated by fungus.
(e)
Records.
(1)
Maintenance of records. Every record required by this section
shall be kept by the pharmacy for at least two years.
(2)
Compounding records.
(A)
Compounding pursuant to patient specific prescription drug
or medication orders. Compounding records for all compounded pharmaceuticals
shall be maintained by the pharmacy electronically or manually as part of
the prescription drug or medication order, formula record, formula book, or
compounding log and shall include:
(i)
the date of preparation;
(ii)
a complete formula, including methodology and necessary
equipment which includes the brand name(s) of the raw materials, or if no
brand name, the generic name(s) or official name and name(s) of the manufacturer(s)
or distributor of the raw materials and the quantities of each;
(iii)
signature or initials of the pharmacist or pharmacy technician
performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising pharmacy technicians and other supportive personnel and conducting
in-process and finals checks of compounded pharmaceuticals if pharmacy technicians
perform the compounding function;
(v)
the quantity in units of finished products or amount of
raw materials;
(vi)
the container used and the number of units prepared; and
(vii)
a reference to the location of the following documentation
which may be maintained with other records, such as quality control records:
(I)
the criteria used to determine the beyond-use date; and
(II)
documentation of performance of quality control procedures.
(B)
Batch compounding or compounding in anticipation of future
prescription drug or medication orders.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for pharmaceuticals prepared in batch. Once approved,
a duplicate of the master work sheet shall be used as the preparation work
sheet from which each batch is prepared and on which all documentation for
that batch occurs. The master work sheet shall contain at a minimum:
(I)
the formula;
(II)
the components;
(III)
the compounding directions;
(IV)
a sample label;
(V)
evaluation and testing requirements;
(VI)
specific equipment used during preparation; and
(VII)
storage requirements.
(ii)
Preparation work sheet. The preparation work sheet for
each batch of pharmaceuticals shall document the following:
(I)
identity of all solutions and ingredients and their corresponding
amounts, concentrations, or volumes;
(II)
lot number for each component;
(III)
component manufacturer/distributer or suitable identifying
number;
(IV)
container specifications (e.g., syringe, pump cassette);
(V)
unique lot or control number assigned to batch;
(VI)
expiration date of batch-prepared products;
(VII)
date of preparation;
(VIII)
name, initials, or electronic signature of the person(s)
involved in the preparation;
(IX)
name, initials, or electronic signature of the responsible
pharmacist;
(X)
end-product evaluation and testing specifications, if applicable;
and
(XI)
comparison of actual yield to anticipated yield, when
appropriate.
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 15, 2004.
TRD-200401924
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
22 TAC §§291.31 - 291.34
The Texas State Board of Pharmacy (TSBP) proposes amendments
to §291.31 concerning Definitions, §291.32 concerning Personnel, §291.33
concerning Operational Standards, and §291.34 concerning Records in
a Class A (Community) Pharmacy. The amendments to §§291.31-291.33,
if adopted, will remove the current provisions relating to compounding of
non-sterile pharmaceuticals and reference new §291.25 which outline new
provisions for the compounding of non-sterile pharmaceuticals. New §291.25
is proposed elsewhere in this issue of the
Texas
Register
. New §291.25 outlines operating standards for pharmacies
that compound non-sterile and sterile pharmaceuticals, implements the recommendations
of the TSBP appointed Task Force on Compounding (Task Force), and incorporates
many of the provisions included in the United States Pharmacopeia (USP) new
General Chapter 795 (Pharmaceutical Compounding Non-sterile Preparations).
The amendments to §291.34, if adopted, will specify that only a pharmacist
may verify the receipt of controlled substances by a pharmacy; will require
written prescriptions which are electronically signed to be on security paper
to prevent alteration or copying; and will clarify electronically transmitted
confidential patient information must be in compliance with other state and
federal laws.
The TSBP established the Task Force in August 2002. The Task Force was
composed of representatives from the pharmacy community appointed by the
three major pharmacy associations in Texas and pharmacists primarily involved
in compounding. The members of TSBP established the Task Force in response
to two issues. The first issue was the 2002 United States Supreme Court decision
which struck down the pharmacy compounding provisions of the federal Food,
Drug, and Cosmetic Act. This action left the federal law without any provisions
that allowed pharmacy compounding. In fact, if the federal law is read strictly,
all pharmacy compounding would be considered manufacturing. The second and
more important issue consisted of several incidences in other states in which
patient deaths had occurred after they had received injections of pharmaceuticals
that were compounded in pharmacies and were contaminated with bacteria.
The Task Force was charged with: (1) reviewing current federal and state
requirements for pharmacy compounding; (2) reviewing the current standards
of practice for pharmacy compounding; and (3) making recommendations to TSBP
regarding standards for compounding that will provide the necessary compounded
medications while protecting the health, safety, and welfare of the public.
The Task Force met two times and presented its recommendations to the Board
at the February 5, 2003 meeting.
At the February meeting, the members of TSBP directed staff to develop
draft rules based on the recommendations of the Task Force. The members of
TSBP reviewed the draft rules at the May 2003 meeting and directed staff
to continue to circulate the draft rules among the profession and incorporate
the recommendations from the profession. In August 2003, the members of TSBP
voted to publish the rules as proposed rules in the
Texas Register
. A public hearing on this first set of rules was held
on November 18, 2003. After receiving comments, the members of TSBP voted
to withdraw the first set of rules and directed staff to incorporate the
majority of the comments received at the public hearing and bring a new draft
to the February 2004 meeting. After reviewing the second set of draft rules
at the February 2004 meeting, the members of TSBP voted to publish the second
set of draft rules as proposed rules in the
Texas
Register
.
The one major item not included in this second set of proposed rules is
a section that allows pharmacies to compound pharmaceuticals for physician
offices without a prescription for an individual patient. As pointed out
in the November 2003 public hearing, the Board does not have the authority
to set a percentage limit on the amount of compounded non-sterile pharmaceutical
that a pharmacy may sell to a physician's office without a prescription. In
fact, the Board believes that to adopt a rule that allowed a pharmacy to
compound non-sterile pharmaceuticals without a prescription for an individual
patient would be in violation of both the federal and state Food, Drug, and
Cosmetic Act. Specifically, the definition of manufacture in Section 431.002
of the Health and Safety Code indicates that manufacturing does not include
compounding that is done within the practice of pharmacy and pursuant to a
prescription from a practitioner for a patient. Thus, the rules as published
do not include any provision for compounding for use in a physician office
unless the pharmacy has a prescription for a specific patient. However, the
members of TSBP understand that there are some instances in which compounding
for physician office use may be necessary. Therefore, the members of TSBP
have instructed the staff of TSBP to develop a policy that defines an appropriate
level of enforcement regarding this necessary physician office compounding.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five- year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be the establishment of standards for the safe compounding
of non-sterile pharmaceuticals by pharmacies. Ms. Dodson has also determined
that, for each year of the first five-year period the rule will be in effect,
an economic cost may exist for entities/persons required to comply with the
rule as described below.
There might be an adverse economic effect on micro, small, and large businesses
or to other entities/persons who are required to comply with this section.
Since the standards in these rules are almost exactly the same as those in
the previous rules, there is no anticipated cost to bring pharmacies into
compliance with the new provisions of these rules. However, because the previous
rules allowed a pharmacy to compound for physician office use without a prescription
(a provision considered to be in violation of state and federal law), pharmacies
that are compounding for physician offices without receiving a prescription
for a specific patient from the physician may experience loss of revenues.
The actual loss may vary greatly between pharmacies and TSBP cannot feasibly
calculate the loss, since TSBP does not have access to financial data from
pharmacies. It is reasonable to presume that the amount of compounding performed
by pharmacies for physician office use without a prescription should not
change significantly, because the same amount of the drugs would still be
used by physicians, but would now require a prescription to be generated
prior to dispensing of the compounded drug to the physician for administration
in the physician office.
Some pharmacies may disagree with this presumption, but with the absence
of financial data, TSBP has no method to confirm their assertions. If TSBP
assumes that a loss of revenue would occur, the loss of revenue to the pharmacy
could range from a few hundred to thousands of dollars, depending on the
amount of a pharmacy's business that would be lost which involves compounding
for physician office use. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between less than
100 dollars per employee to several thousand dollars per employee. However,
TSBP does not maintain data to specifically segregate the pharmacies engaged
in non-sterile compounding, so TSBP cannot precisely determine the number
of pharmacies affected.
If an adverse economic effect exists for micro and small businesses based
on the requirements of the rule, including the prohibition in the rule against
compounding for physician office use without a prescription, TSBP is unable
to reduce that impact because doing so would be contrary to state and federal
law and would compromise the purposes of this rule which is intended to protect
the health and safety of the public.
There may also be a cost associated with the implementation of requiring
electronically signed prescriptions to be printed on tamper evident paper.
The cost to physicians is anticipated to be not more than $4.00 per prescription
pad (50 prescription blanks per pad).
A public hearing to receive comments on the proposed amendments will be
held at 9:00 a.m. on Tuesday, May 4, 2004, at the Health Professions Council
Board Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701.
Persons planning to present comments to the Board are asked to provide a
written copy of their comments prior to the hearing or bring 20 copies to
the hearing. Written comments on the amendments may be submitted to Allison
Benz, R.Ph., M.S., Director of Professional Services, 333 Guadalupe Street,
Suite 3-600, Austin, Texas, 78701, FAX: 512/305-8082, E-mail: allison.benz@tsbp.state.tx.us.
Comments must be received by 5 p.m., April 28, 2004.
The amendments are proposed under sections 551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551-566 and 568-569,
Texas Occupations Code). The Board interprets section 551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets section 551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets section 551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets section 554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets section 554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by this rule: Chapters 551-566 and 568-569, Texas
Occupations Code.
§291.31.Definitions.
The following words and terms, when used in this subchapter, shall
have the following meanings, unless the context clearly indicates otherwise.
(1) - (7)
(No change.)
[
[
[
[
[
(8)
[
(9)
[
(10)
[
(A)
is not included in Penalty Group 1, 2, 3, or 4, Chapter
481, Health and Safety Code, and is unsafe for self-medication; or
(B)
bears or is required to bear the legend:
(i)
"Caution: federal law prohibits dispensing without prescription"
or "Rx only" or another legend that complies with federal law; or
(ii)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(11)
[
(12)
[
(13)
[
(A)
a licensed nurse, physician assistant, pharmacist, or other
individual designated by a practitioner to communicate prescription drug
orders to a pharmacist;
(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).
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(A)
known allergies;
(B)
rational therapy-contraindications;
(C)
reasonable dose and route of administration;
(D)
reasonable directions for use;
(E)
duplication of therapy;
(F)
drug-drug interactions;
(G)
drug-food interactions;
(H)
drug-disease interactions;
(I)
adverse drug reactions; and
(J)
proper utilization, including overutilization or underutilization.
(19)
[
(20)
[
(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.
(21)
[
(22)
[
[
(23)
[
(24)
[
(25)
[
(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.)
(26)
[
(A)
original written prescription drug order; or
(B)
original verbal or electronic prescription drug order reduced
to writing either manually or electronically by the pharmacist.
(27)
[
(28)
[
(29)
[
(30)
[
(31)
[
(32)
[
(A)
participating in a pharmacy's technician training program;
or
(B)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health-System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(33)
[
(34)
[
(A)
a person licensed or registered to prescribe, distribute,
administer, or dispense a prescription drug or device in the course of professional
practice in this state, including a physician, dentist, podiatrist, or veterinarian
but excluding a person licensed under this subtitle;
(B)
a person licensed by another state, Canada, or the United
Mexican States in a health field in which, under the law of this state, a
license holder in this state may legally prescribe a dangerous drug;
(C)
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 a Schedule II, III, IV, or V controlled substance, as specified
under Chapter 481, Health and Safety Code, in that other state; or
(D)
an advanced practice nurse or physician assistant to whom
a physician has delegated the authority to carry out or sign prescription
drug orders under Section 157.0511, 157.052, 157.053, 157.054, 157.0541,
or 157.0542.
(35)
[
(36)
[
(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.
(37)
[
(38)
[
(39)
[
(40)
[
§291.32.Personnel.
(a)
Pharmacist-in-charge.
(1)
(No change.)
(2)
Responsibilities. The pharmacist-in-charge shall have responsibility
for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge.
The pharmacist-in-charge may advise the owner on administrative or operational
concerns. The pharmacist-in-charge shall have responsibility for, at a minimum,
the following:
(A) - (C)
(No change.)
[
(D)
[
(E)
[
(F)
[
(G)
[
(H)
[
(I)
[
(i)
consulting with the owner concerning and adherence to the
policies and procedures for system operation, safety, security, accuracy
and access, patient confidentiality, prevention of unauthorized access, and
malfunction;
(ii)
inspecting medications in the automated pharmacy dispensing
system, at least monthly, for expiration date, misbranding, physical integrity,
security, and accountability;
(iii)
assigning, discontinuing, or changing personnel access
to the automated pharmacy dispensing system;
(iv)
ensuring that pharmacy technicians and licensed healthcare
professionals performing any services in connection with an automated pharmacy
dispensing system have been properly trained on the use of the system and
can demonstrate comprehensive knowledge of the written policies and procedures
for operation of the system; and
(v)
ensuring that the automated pharmacy dispensing system
is stocked accurately and an accountability record is maintained in accordance
with the written policies and procedures of operation.
(b)
(No change.)
(c)
Pharmacists.
(1) - (2)
(No change.)
(3)
Special requirements for [
(A)
Non-Sterile Pharmaceuticals.
All pharmacists
engaged in compounding
non-sterile pharmaceuticals
shall
meet the training requirements specified in §291.25 of this title (relating
to Pharmacies Compounding Non-sterile Pharmaceuticals).
[
(B)
Sterile Pharmaceuticals. All pharmacists engaged in
compounding sterile pharmaceuticals shall meet the training requirements
specified in §291.26 of this title (relating to Pharmacies Compounding
Sterile Pharmaceuticals).
[
[
[
(d)
Pharmacy Technicians.
(1)
General.
(A) - (C)
(No change.)
(D)
Special requirements for compounding.
(i)
Non-Sterile Pharmaceuticals. All pharmacy technicians
engaged in compounding non-sterile pharmaceuticals shall meet the training
requirements specified in §291.25 of this title (relating to Pharmacies
Compounding Non- Sterile Pharmaceuticals).
(ii)
Sterile Pharmaceuticals. Pharmacy technicians
may compound sterile pharmaceuticals pursuant to medication orders provided
the pharmacy technicians:
(I)
have completed the training specified in §291.26
of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals);
and
(II)
are supervised by a pharmacist who has completed
the training specified in §291.26 of this title, conducts in-process
and final checks, and affixes his or her initials to the label or if batch
prepared, to the appropriate quality control records. (The initials are
not required on the label if it is maintained in a permanent record of the
pharmacy).
(2) - (3)
(No change.)
(e)
(No change.)
§291.33.Operational Standards.
(a)
Licensing requirements.
(1) - (8)
(No change.)
(9)
A Class A (community) pharmacy engaged in the compounding
of
non- sterile
[
(10)
A Class A (community) pharmacy
engaged in the compounding of sterile pharmaceuticals shall comply with the
provisions of §291.26 of this title (relating to Pharmacies Compounding
Sterile Pharmaceuticals).
(11)
[
(12)
[
(b)
Environment.
(1)
(No change.)
[
[
[
[
[
[
[
(2)
[
(A)
Each pharmacist while on duty shall be responsible for
the security of the prescription department, including provisions for effective
control against theft or diversion of prescription drugs, and records for
such drugs.
(B)
The prescription department shall be locked by key or combination
so as to prevent access when a pharmacist is not on-site. However, the pharmacist-in-charge
may designate persons who may enter the pharmacy to perform functions designated
by the pharmacist-in-charge (e.g., janitorial services).
(3)
[
(A)
If a pharmacy is staffed by a single pharmacist, the pharmacist
may leave the prescription department for breaks and meal periods without
closing the prescription department and removing pharmacy technicians and
other pharmacy personnel from the prescription department provided the following
conditions are met:
(i)
at least one registered pharmacy technician remains in
the prescription department;
(ii)
the pharmacist remains on-site at the licensed location
of the pharmacy and available for an emergency;
(iii)
the absence does not exceed 30 minutes at a time and
a total of one hour in a 12 hour period;
(iv)
the pharmacist reasonably believes that the security of
the prescription department will be maintained in his or her absence. If in
the professional judgment of the pharmacist, the pharmacist determines that
the prescription department should close during his or her absence, then the
pharmacist shall close the prescription department and remove the pharmacy
technicians or other pharmacy personnel from the prescription department during
his or her absence; and
(v)
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 pharmacy technicians may begin the 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 or the
patient's agent until the pharmacist returns and verifies the accuracy of
the prescription.
(B)
During the time a pharmacist is absent from the prescription
department, only 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 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 provided the pharmacy technician:
(I)
has completed the training requirements outlined in §297.6
of this title (relating to Pharmacy Technician Training); and
(II)
is registered as a pharmacy technician within the provisions
of §297.3 of this title (relating to Registration Requirements); and
(vi)
prepackaging and labeling prepackaged drugs.
(C)
Upon return to the prescription department, 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 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 prescription department 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 prescription
department a pharmacist intern shall be considered a registered pharmacy technician
and may perform only the duties of a registered pharmacy technician.
(G)
In pharmacies with two or more pharmacists on duty, the
pharmacists shall stagger their breaks and meal periods so that the prescription
department is not left without a pharmacist on duty.
(c)
(No change.)
(d)
Equipment and supplies.
[
(1)
[
(2)
[
(3)
[
(4)
[
(5)
[
(6)
[
[
[
[
[
[
[
[
(e)
(No change.)
(f)
Drugs.
(1) - (3)
(No change.)
[
[
[
[
[
[
[
[
[
[
[
[
(4)
[
(A)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986, or by a city, state or county government;
(B)
the pharmacy is a part of a health care entity which provides
health care primarily to indigent or low income patients at no or reduced
cost;
(C)
the samples are for dispensing or provision at no charge
to patients of such health care entity; and
(D)
the samples are possessed in compliance with the federal
Prescription Drug Marketing Act of 1986.
(g) - (h)
(No change.)
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
(i)
[
(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 pharmacy dispensing systems. This paragraph becomes
effective September 1, 2000.
(A)
Authority to use automated pharmacy dispensing systems.
A pharmacy may use an automated pharmacy dispensing system to fill prescription
drug orders provided that:
(i)
the pharmacist-in-charge is responsible for the supervision
of the operation of the system;
(ii)
the automated pharmacy dispensing 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 pharmacy dispensing
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
pharmacy dispensing system to fill prescription drug orders shall operate
according to a written program for quality assurance of the automated pharmacy
dispensing system which:
(i)
requires continuous monitoring of the automated pharmacy
dispensing system; and
(ii)
establishes mechanisms and procedures to test the accuracy
of the automated pharmacy dispensing 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 pharmacy dispensing system is used to
fill prescription drug 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 pharmacy dispensing
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, approval, and accountability
for the transmission of each original or new prescription drug order to the
automated pharmacy dispensing system before the transmission is made;
(III)
provide for access to the automated pharmacy dispensing
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)
require prior to use, that a pharmacist checks, verifies,
and documents that the automated pharmacy dispensing system has been accurately
filled each time the system is stocked;
(V)
provide for an accountability record to be maintained which
documents all transactions relative to stocking and removing medications from
the automated pharmacy dispensing system;
(VI)
require a prospective drug regimen review is conducted
as specified in subsection (c)(2) of this section; and
(VII)
establish and make provisions for documentation of a
preventative maintenance program for the automated pharmacy dispensing system.
(ii)
A pharmacy which uses an automated pharmacy dispensing
system to fill prescription drug 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 pharmacy
dispensing system to fill prescription drug orders shall maintain a written
plan for recovery from a disaster or any other situation which interrupts
the ability of the automated pharmacy dispensing 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 pharmacy dispensing system is experiencing downtime;
(ii)
procedures for response when an automated pharmacy dispensing
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, each patient
of the pharmacy, and other appropriate agencies whenever an automated pharmacy
dispensing 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.
(3)
Final check of prescriptions dispensed using an automated
pharmacy dispensing system. For the purpose of §§291.32(b)(2) of
this title, a pharmacist must perform the final check of all prescriptions
prior to delivery to the patient to ensure that the prescription is dispensed
accurately as prescribed.
(A)
This final check shall be considered accomplished if:
(i)
a check of the final product is conducted by a pharmacist
after the automated system has completed the prescription and prior to delivery
to the patient; or
(ii)
the following checks are conducted by a pharmacist:
(I)
if the automated pharmacy dispensing system contains bulk
stock drugs, a pharmacist verifies that those drugs have been accurately stocked
as specified in paragraph (2)(C)(i)(IV) of this subsection; and
(II)
a pharmacist checks the accuracy of the data entry of
each original or new prescription drug order entered into the automated pharmacy
dispensing system.
(B)
If the final check is accomplished as specified in subparagraph
(A)(ii) of this paragraph, the following additional requirements must be met.
(i)
The dispensing process must be fully automated from the
time the pharmacist releases the prescription to the automated system until
a completed, labeled prescription ready for delivery to the patient is produced.
(ii)
The pharmacy has conducted initial testing and has a continuous
quality assurance program which documents that the automated pharmacy dispensing
system dispenses accurately as specified in paragraph (2)(A) and (B) of this
subsection.
(iii)
The automated pharmacy dispensing system documents and
maintains:
(I)
the name(s), initials, or identification code(s) of each
pharmacist responsible for the checks outlined in subparagraph (A)(ii) of
this paragraph; and
(II)
the name(s), initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy technician who performs any other
portion of the dispensing process.
(iv)
The pharmacy establishes mechanisms and procedures to
test the accuracy of the automated pharmacy dispensing system at least every
month rather than every six months as specified in paragraph (2)(B) of this
subsection.
(4)
Automated checking device.
(A)
For the purpose of this subsection, an automated checking
device is a fully automated device which confirms, after dispensing but prior
to delivery to the patient, that the correct drug and strength has been labeled
with the correct label for the correct patient.
(B)
For the purpose of §291.32(b)(2) of this title, the
final check of a dispensed prescription shall be considered accomplished using
an automated checking device provided:
(i)
a check of the final product is conducted by a pharmacist
prior to delivery to the patient or the following checks are performed by
a pharmacist:
(I)
the prepackaged drug used to fill the order is checked
by a pharmacist who verifies that the drug is labeled and packaged accurately;
and
(II)
a pharmacist checks the accuracy of each original or new
prescription drug order.
(ii)
the prescription is dispensed, labeled, and made ready
for delivery to the patient in compliance with Class A (Community) Pharmacy
rules; and
(iii)
prior to delivery to the patient:
(I)
the automated checking device confirms that the correct
drug and strength has been labeled with the correct label for the correct
patient; and
(II)
a pharmacist performs all other duties required to ensure
that the prescription has been dispensed safely and accurately as prescribed.
(C)
If the final check is accomplished as specified in subparagraph
(B) of this paragraph, the following additional requirements must be met.
(i)
The pharmacy has conducted initial testing of the automated
checking device and has a continuous quality assurance program which documents
that the automated checking device accurately confirms that the correct drug
and strength has been labeled with the correct label for the correct patient.
(ii)
The pharmacy documents and maintains:
(I)
the name(s), initials, or identification code(s) of each
pharmacist responsible for the checks outlined in subparagraph (B)(i) of this
paragraph; and
(II)
the name(s) initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy technician who perform any other
portion of the dispensing process.
(iii)
The pharmacy establishes mechanisms and procedures to
test the accuracy of the automated checking device at least monthly.
§291.34.Records.
(a)
(No change.)
(b)
Prescriptions.
(1)
(No change.)
(2)
Written prescription drug orders.
(A)
Practitioner's signature.
(i)
Except as noted in clause (ii) of this subparagraph, written
prescription drug orders shall be:
(I)
manually signed by the practitioner; or
(II)
electronically signed by the practitioner using a system
which electronically replicates the practitioner's manual signature on the
written prescription, provided:
(-a-)
that security features of the system require
the practitioner to authorize each use
; and
(-b-)
the prescription is printed
on paper that is designed to prevent unauthorized copying of a completed
prescription and to prevent the erasure or modification of information written
on the prescription by the prescribing practitioner. (For example, the paper
contains security provisions against copying that result in some indication
on the copy that it is a copy and therefore render the prescription null and
void.)
(ii) - (v)
(No change.)
(B) - (E)
(No change.)
(3)
(No change.)
(4)
Electronic prescription drug orders. For the purpose of
this subsection, prescription drug orders shall be considered the same as
verbal prescription drug orders.
(A)
An electronic prescription drug order may be transmitted
by a practitioner or a practitioner's designated agent:
(i)
directly to a pharmacy; or
(ii)
through the use of a data communication device provided:
(I)
the
confidential
prescription information is
not altered during transmission; and
(II)
confidential patient information is not accessed or maintained
by the operator of the data communication device
other than for legal
purposes under federal and state law.
[
(B) - (C)
(No change.)
(5) - (7)
(No change.)
(c) - (g)
(No change.)
(h)
Other records. Other records to be maintained by a pharmacy:
(1) - (3)
(No change.)
(4)
suppliers' invoices of dangerous drugs and controlled substances;
a pharmacist
[
(5) - (10)
(No change.)
(i) - (k)
(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 15, 2004.
TRD-200401933
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
22 TAC §291.36
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas State Board of Pharmacy or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Texas State Board of Pharmacy (TSBP) proposes
the repeal of §291.36, concerning Class A Pharmacies Compounding Sterile
Pharmaceuticals. The repeal, if adopted, will eliminate a section of the rules
that is no longer necessary since the provisions of this section are incorporated
into new §291.26 which is proposed elsewhere in this issue of the
The TSBP established the Task Force in August 2002. The Task Force was
composed of representatives from the pharmacy community appointed by the three
major pharmacy associations in Texas and pharmacists primarily involved in
compounding. The members of TSBP established the Task Force in response to
two issues. The first issue was the 2002 United States Supreme Court decision
which struck down the pharmacy compounding provisions of the federal Food,
Drug, and Cosmetic Act. This action left the federal law without any provisions
that allowed pharmacy compounding. In fact, if the federal law is read strictly,
all pharmacy compounding would be considered manufacturing. The second and
more important issue consisted of several incidences in other states in which
patient deaths had occurred after they had received injections of pharmaceuticals
that were compounded in pharmacies and were contaminated with bacteria.
The Task Force was charged with: (1) reviewing current federal and state
requirements for pharmacy compounding; (2) reviewing the current standards
of practice for pharmacy compounding; and (3) making recommendations to TSBP
regarding standards for compounding that will provide the necessary compounded
medications while protecting the health, safety, and welfare of the public.
The Task Force met two times and presented its recommendations to the Board
at the February 5, 2003 meeting.
At the February meeting, the members of TSBP directed staff to develop
draft rules based on the recommendations of the Task Force. The members of
TSBP reviewed the draft rules at the May 2003 meeting and directed staff to
continue to circulate the draft rules among the profession and incorporate
the recommendations from the profession. In August 2003, the members of TSBP
voted to publish the rules as proposed rules in the
Texas Register
. A public hearing on this first set of rules was held
on November 18, 2003. After receiving comments, the members of TSBP voted
to withdraw the first set of rules and directed staff to incorporate the majority
of the comments received at the public hearing and bring a new draft to the
February 2004 meeting. After reviewing the second set of draft rules at the
February 2004 meeting, the members of TSBP voted to publish the second set
of draft rules as proposed rules in the
Texas Register
.
The one major item not included in this second set of proposed rules is
a section that allows pharmacies to compound pharmaceuticals for physician
offices without a prescription for an individual patient. As pointed out in
the November 2003 public hearing, the Board does not have the authority to
set a percentage limit on the amount of compounded sterile pharmaceuticals
that a pharmacy may sell to a physician's office without a prescription. In
fact, the Board believes that to adopt a rule that allowed a pharmacy to compound
sterile pharmaceuticals without a prescription for an individual patient would
be in violation of both the federal and state Food, Drug, and Cosmetic Act.
Specifically, the definition of manufacture in Section 431.002 of the Health
and Safety Code indicates that manufacturing does not include compounding
that is done within the practice of pharmacy and pursuant to a prescription
from a practitioner for a patient. Thus, the rules as published do not include
any provision for compounding for use in a physician office unless the pharmacy
has a prescription for a specific patient. However, the members of TSBP understand
that there are some instances in which compounding for physician office use
may be necessary. Therefore, the members of TSBP have instructed the staff
of TSBP to develop a policy that defines an appropriate level of enforcement
regarding this necessary physician office compounding.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the repeal is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be the establishment of standards for the safe compounding
of sterile pharmaceuticals by pharmacies. Ms. Dodson has also determined that,
for each year of the first five-year period the rule will be in effect, an
economic cost may exist for entities/persons required to comply with the rule
as described below.
There might be an adverse economic effect on micro, small, and large businesses
or to other entities/persons who are required to comply with this section.
Based on the significant variances in pharmacies' physical structure and layout,
it is difficult for TSBP to determine the actual cost to businesses required
to comply with this rule. These costs would involve bringing the sterile compounding
area of pharmacies into compliance with the new provisions of the rules and
in establishing an end product evaluation process. TSBP records indicate that
approximately 582 community pharmacies intended to provide sterile compounding
services to patients and approximately 92 hospital pharmacies intended to
compound sterile products for out-patients. However, TSBP cannot precisely
determine the number of pharmacies affected because TSBP records do not provide
additional information about the details of the pharmacies' compounding operations.
In addition, TSBP is unable to reduce these costs because to do so would compromise
the safety of sterile compounding practices.
Examples of new requirements under the rules are: (1) if the aseptic controlled
device is located within the controlled area, there must be six feet of separation
around the aseptic control device; (2) the controlled area must be accessible
without using hands; (3) when preparing high-risk pharmaceuticals, the controlled
area must maintain an environment of at least ISO Class 8 (Class 100,000);
(4) the pharmacy must establish end product evaluation procedures for all
products including high-risk preparations; and (5) the pharmacy must establish
a quality assurance program that meets the requirements of Chapter 797 of
the USP. The actual dollar amount for bringing the pharmacy into compliance
may vary greatly between pharmacies and could range from one hundred to several
tens of thousand dollars. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between one dollar
per employee to several thousand.
Pharmacies that are compounding for physician offices without receiving
a prescription for a specific patient from the physician may experience loss
of revenues. The actual loss may vary greatly between pharmacies and TSBP
cannot feasibly calculate the loss, since TSBP does not have access to financial
data from pharmacies. It is reasonable to presume that the amount of compounding
performed by pharmacies for physician office use without a prescription should
not change significantly, because the same amount of the drugs would still
be used by physicians, but would now require a prescription to be generated
prior to dispensing of the compounded drug to the physician for administration
in the physician office.
Some pharmacies may disagree with this presumption, but with the absence
of financial data, TSBP has no method to confirm their assertions. If TSBP
assumes that a loss of revenue would occur, the loss of revenue to the pharmacy
could range from a few hundred to thousands of dollars, depending on the amount
of a pharmacy's business that would be lost which involves compounding for
physician office use. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between less than
100 dollars per employee to several thousand.
Both state and federal law prohibit compounding without a prescription
for a specific patient. If pharmacies are compounding for physician office
use without a prescription, they are currently in violation of state and federal
law, such that the revenues generated therefrom are the result of an illegal
activity. If an adverse economic effect exists for micro and small businesses
based on the requirements of the rule, including the prohibition in the rule
against compounding for physician office use without a prescription, TSBP
is unable to reduce that impact because doing so would not be legal and feasible
considering the purpose of state and federal law concerning pharmacy compounding
and would compromise the purposes of this rule which is intended to protect
the health and safety of the public.
A public hearing to receive comments on the proposed repeal will be held
at 9:00 a.m. on Tuesday, May 4, 2004, at the Health Professions Council Board
Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701. Persons
planning to present comments to the Board are asked to provide a written copy
of their comments prior to the hearing or bring 20 copies to the hearing.
Written comments on the proposed repeal may be submitted to Allison Benz,
R.Ph., M.S., Director of Professional Services, 333 Guadalupe Street, Suite
3-600, Austin, Texas, 78701, FAX: 512/305-8082, E-mail: allison.benz@tsbp.state.tx.us.
Comments must be received by 5 p.m., April 28, 2004.
The repeal is proposed under §§551.002, 551.003, 554.001,
and 554.051 of the Texas Pharmacy Act (Chapters 551-566 and 568-569, 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 §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by the repeal: Chapters 551-566 and 568-569, Texas
Occupations Code.
§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals.
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 15, 2004.
TRD-200401925
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
22 TAC §§291.52 - 291.55
The Texas State Board of Pharmacy proposes amendments to §291.52
concerning Definitions, §291.53 concerning Personnel, §291.54 concerning
Operational Standards, and §291.55 concerning Records in a Class B (Nuclear)
Pharmacy. The amendments to §§291.52-291.54, if adopted, will amend
the current provisions relating to compounding of sterile pharmaceuticals
to match new §291.26 which outlines new provisions for the compounding
of sterile pharmaceuticals. New §291.26 is proposed elsewhere in this
issue of the Texas Register. New §291.26 outlines operating standards
for pharmacies that compound sterile pharmaceuticals, implements the recommendations
of the TSBP appointed Task Force on Compounding (Task Force), and incorporates
many of the provisions included in the United States Pharmacopeia (USP) new
General Chapter 797 (Pharmaceutical Compounding Sterile Preparations). The
amendments to §291.55, if adopted, will specify that only a pharmacist
may verify the receipt of controlled substances by a pharmacy, and will clarify
electronically transmitted confidential patient information must be in compliance
with other state and federal laws.
The TSBP established the Task Force in August 2002. The Task Force was
composed of representatives from the pharmacy community appointed by the three
major pharmacy associations in Texas and pharmacists primarily involved in
compounding. The members of TSBP established the Task Force in response to
two issues. The first issue was the 2002 United States Supreme Court decision
which struck down the pharmacy compounding provisions of the federal Food,
Drug, and Cosmetic Act. This action left the federal law without any provisions
that allowed pharmacy compounding. In fact, if the federal law is read strictly,
all pharmacy compounding would be considered manufacturing. The second and
more important issue consisted of several incidences in other states in which
patient deaths had occurred after they had received injections of pharmaceuticals
that were compounded in pharmacies and were contaminated with bacteria.
The Task Force was charged with: (1) reviewing current federal and state
requirements for pharmacy compounding; (2) reviewing the current standards
of practice for pharmacy compounding; and (3) making recommendations to TSBP
regarding standards for compounding that will provide the necessary compounded
medications while protecting the health, safety, and welfare of the public.
The Task Force met two times and presented its recommendations to the Board
at the February 5, 2003 meeting.
At the February meeting, the members of TSBP directed staff to develop
draft rules based on the recommendations of the Task Force. The members of
TSBP reviewed the draft rules at the May 2003 meeting and directed staff to
continue to circulate the draft rules among the profession and incorporate
the recommendations from the profession. In August 2003, the members of TSBP
voted to publish the rules as proposed rules in the Texas Register. A public
hearing on this first set of rules was held on November 18, 2003. After receiving
comments, the members of TSBP voted to withdraw the first set of rules and
directed staff to incorporate the majority of the comments received at the
public hearing and bring a new draft to the February 2004 meeting. After reviewing
the second set of draft rules at the February 2004 meeting, the members of
TSBP voted to publish the second set of draft rules as proposed rules in the
Texas Register.
The one major item not included in this second set of proposed rules is
a section that allows pharmacies to compound pharmaceuticals for physician
offices without a prescription for an individual patient. As pointed out in
the November 2003 public hearing, the Board does not have the authority to
set a percentage limit on the amount of compounded sterile pharmaceuticals
that a pharmacy may sell to a physician's office without a prescription. In
fact, the Board believes that to adopt a rule that allowed a pharmacy to compound
sterile pharmaceuticals without a prescription for an individual patient would
be in violation of both the federal and state Food, Drug, and Cosmetic Act.
Specifically, the definition of manufacture in Section 431.002 of the Health
and Safety Code indicates that manufacturing does not include compounding
that is done within the practice of pharmacy and pursuant to a prescription
from a practitioner for a patient. Thus, the rules as published do not include
any provision for compounding for use in a physician office unless the pharmacy
has a prescription for a specific patient. However, the members of TSBP understand
that there are some instances in which compounding for physician office use
may be necessary. Therefore, the members of TSBP have instructed the staff
of TSBP to develop a policy that defines an appropriate level of enforcement
regarding this necessary physician office compounding.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be the establishment of standards for the safe compounding
of sterile pharmaceuticals by pharmacies. Ms. Dodson has also determined that,
for each year of the first five-year period the rule will be in effect, an
economic cost may exist for entities/persons required to comply with the rule
as described below.
There might be an adverse economic effect on micro, small, and large businesses
or to other entities/persons who are required to comply with this section.
Based on the significant variances in pharmacies' physical structure and layout,
it is difficult for TSBP to determine the actual cost to businesses required
to comply with this rule. These costs would involve bringing the sterile compounding
area of pharmacies into compliance with the new provisions of the rules and
in establishing an end product evaluation process. TSBP records indicate that
approximately 582 community pharmacies intended to provide sterile compounding
services to patients and approximately 92 hospital pharmacies intended to
compound sterile products for out-patients. However, TSBP cannot precisely
determine the number of pharmacies affected because TSBP records do not provide
additional information about the details of the pharmacies' compounding operations.
In addition, TSBP is unable to reduce these costs because to do so would compromise
the safety of sterile compounding practices.
Examples of new requirements under the rules are: (1) if the aseptic controlled
device is located within the controlled area, there must be six feet of separation
around the aseptic control device; (2) the controlled area must be accessible
without using hands; (3) when preparing high-risk pharmaceuticals, the controlled
area must maintain an environment of at least ISO Class 8 (Class 100,000);
(4) the pharmacy must establish end product evaluation procedures for all
products including high-risk preparations; and (5) the pharmacy must establish
a quality assurance program that meets the requirements of Chapter 797 of
the USP. The actual dollar amount for bringing the pharmacy into compliance
may vary greatly between pharmacies and could range from one hundred to several
tens of thousand dollars. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between one dollar
per employee to several thousand.
Pharmacies that are compounding for physician offices without receiving
a prescription for a specific patient from the physician may experience loss
of revenues. The actual loss may vary greatly between pharmacies and TSBP
cannot feasibly calculate the loss, since TSBP does not have access to financial
data from pharmacies. It is reasonable to presume that the amount of compounding
performed by pharmacies for physician office use without a prescription should
not change significantly, because the same amount of the drugs would still
be used by physicians, but would now require a prescription to be generated
prior to dispensing of the compounded drug to the physician for administration
in the physician office.
Some pharmacies may disagree with this presumption, but with the absence
of financial data, TSBP has no method to confirm their assertions. If TSBP
assumes that a loss of revenue would occur, the loss of revenue to the pharmacy
could range from a few hundred to thousands of dollars, depending on the amount
of a pharmacy's business that would be lost which involves compounding for
physician office use. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between less than
100 dollars per employee to several thousand.
Both state and federal law prohibit compounding without a prescription
for a specific patient. If pharmacies are compounding for physician office
use without a prescription, they are currently in violation of state and federal
law, such that the revenues generated therefrom are the result of an illegal
activity. If an adverse economic effect exists for micro and small businesses
based on the requirements of the rule, including the prohibition in the rule
against compounding for physician office use without a prescription, TSBP
is unable to reduce that impact because doing so would not be legal and feasible
considering the purpose of state and federal law concerning pharmacy compounding
and would compromise the purposes of this rule which is intended to protect
the health and safety of the public.
A public hearing to receive comments on the proposed amendments will be
held at 9:00 a.m. on Tuesday, May 4, 2004, at the Health Professions Council
Board Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701.
Persons planning to present comments to the Board are asked to provide a written
copy of their comments prior to the hearing or bring 20 copies to the hearing.
Written comments on the amendments may be submitted to Allison Benz, R.Ph.,
M.S., Director of Professional Services, 333 Guadalupe Street, Suite 3-600,
Austin, Texas, 78701, FAX: 512/305-8082, E-mail: allison.benz@tsbp.state.tx.us.
Comments must be received by 5 p.m., April 28, 2004.
The amendments are proposed under §§551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551-566 and 568-569,
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 §551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets §551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets §554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by this rule: Chapters 551-566 and 568-569, Texas
Occupations Code.
§291.52.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise. Any
term not defined in this section shall have the definition set forth in the
Act, §551.003.
(1) - (2)
(No change.)
(3)
ACPE--Accreditation Council for Pharmacy
Education.
(4)
[
(A)
a practitioner, an authorized agent under his supervision,
or other person authorized by law; or
(B)
the patient at the direction of a practitioner.
(5)
[
(A)
Class 100
(ISO Class 5)
is an atmospheric environment
which contains less than 100 particles no greater than 0.5 microns in diameter
per cubic foot of air;
(B)
Class 10,000
(ISO Class 7)
is an atmospheric
environment which contains less than 10,000 particles no greater than 0.5
microns in diameter per cubic foot of air; and
(C)
Class 100,000
(ISO Class 8)
is an atmospheric
environment which contains less than 100,000 particles no greater than 0.5
microns in diameter per cubic foot of air.
(6)
Ancillary supplies--Supplies necessary
for the administration of compounded sterile pharmaceuticals.
(7)
Aseptic preparation--The technique involving
procedures designed to preclude contamination of drugs, packaging, equipment,
or supplies by microorganisms during processing.
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
[
(16)
[
(17)
Component--Any ingredient intended for
use in the compounding of a drug product, including those that may not appear
in such product.
(18)
Compounding--The preparation, mixing,
assembling, packaging, or labeling of a drug or device:
(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.
(19)
[
(20)
[
(21)
Critical site--Any opening providing
a direct pathway between a sterile product and the environment or any surface
coming in direct contact with the product and the environment.
(22)
[
(A)
is not included in Penalty Group 1, 2, 3, or 4, Chapter
481, Health and Safety Code, and is unsafe for self-medication; or
(B)
bears or is required to bear the legend:
(i)
"Caution: federal law prohibits dispensing without prescription"
or "Rx only" or another legend that complies with federal law; or
(ii)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(23)
[
(24)
[
(25)
[
(A)
a licensed nurse, physician assistant, pharmacist, or other
individual designated by a practitioner, and for whom the practitioner assumes
legal responsibility, who communicates radioactive prescription drug orders
to a pharmacist; or
(B)
a licensed nurse, physician assistant, or pharmacist employed
in a health care facility to whom the practitioner communicates a radioactive
prescription drug order.
(26)
[
(27)
[
(28)
[
(29)
[
(30)
[
(31)
[
(32)
[
(33)
[
(34)
[
(A)
original written radioactive prescription drug orders;
or
(B)
original verbal or electronic radioactive prescription
drug orders reduced to writing either manually or electronically by the pharmacist.
(35)
[
(36)
[
(37)
[
(A)
participating in a pharmacy's technician training program;
or
(B)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health-System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(38)
[
(39)
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.
(40)
[
(41)
[
(42)
[
(43)
[
(44)
[
(45)
[
(46)
[
§291.53.Personnel.
(a)
Pharmacists-in-Charge.
(1)
(No change.)
(2)
Responsibilities. The pharmacist-in-charge shall have the
responsibility for, at a minimum, the following:
(A) - (B)
(No change.)
(C)
determining that all pharmacists involved
in compounding sterile radiopharmaceuticals obtain continuing education appropriate
for the type of compounding done by the pharmacist;
(D)
[
(E)
assuring that the equipment used in compounding
is properly maintained;
(F)
[
(G)
developing a system for bulk compounding
or batch preparation of radiopharmaceuticals;
(H)
[
(I)
[
(J)
[
(K)
[
(L)
[
(b)
Authorized nuclear pharmacists.
(1)
(No change.)
(2)
Special requirements for sterile compounding.
(A)
All pharmacists engaged in compounding
shall:
(i)
possess the education, training, and proficiency
necessary to properly and safely perform compounding duties undertaken or
supervised; and
(ii)
obtain continuing education appropriate
for the type of compounding done by the pharmacist.
(B)
A pharmacist shall inspect and approve
all components, drug product containers, closures, labeling, and any other
materials involved in the compounding process.
(C)
A pharmacist shall review all compounding
records for accuracy and conduct in-process and final checks to assure that
errors have not occurred in the compounding process.
(D)
A pharmacist is responsible for the proper
maintenance, cleanliness, and use of all equipment used in the compounding
process.
(3)
[
(A)
receiving verbal therapeutic prescription drug orders and
reducing these orders to writing, either manually or electronically;
(B)
receiving verbal, diagnostic prescription drug orders in
instances where patient specificity is required for patient safety (e.g.,
radiolabeled blood products, radiolabeled antibiodies) and reducing these
orders to writing, either manually or electronically;
(C)
interpreting and evaluating radioactive prescription drug
orders;
(D)
selection of drug products; and
(E)
performing the final check of the dispensed prescription
before delivery to the patient to ensure that the radioactive prescription
drug order has been dispensed accurately as prescribed.
(c)
Pharmacy Technicians.
(1)
(No change.)
(2)
Special requirements for sterile compounding.
Pharmacy technicians may compound sterile pharmaceuticals provided the pharmacy
technicians:
(A)
have completed the education and training
specified in subsection (d) of this subsection; and
(B)
are supervised by a pharmacist who has
completed the training specified in subsection (d) of this subsection, conducts
in- process and final checks, and affixes his or her initials to the appropriate
quality control records.
(3)
[
(A)
General. Pharmacy technicians may perform any nuclear pharmacy
technique delegated by an authorized nuclear pharmacist which is associated
with the preparation and distribution of radiopharmaceuticals other than those
duties listed in subsection
(b)(3)
[
(i)
an authorized nuclear pharmacist conducts in-process and
final checks; and
(ii)
pharmacy technicians are under the direct supervision
of and responsible to an authorized nuclear pharmacist.
(B)
Labeling. Only registered pharmacy technicians may affix
a label to a prescription container.
(4)
[
(A)
The ratio of authorized nuclear pharmacists to pharmacy
technicians may not exceed 1:2, provided that only one pharmacy technician
may be engaged in the compounding of a sterile radiopharmaceutical.
(B)
The ratio of authorized nuclear pharmacists to pharmacy
technicians may be 1:3 provided that at least one of the three technicians
is a registered pharmacy technician and only one may be engaged in the compounding
of a sterile radiopharmaceutical.
(d)
Special education, training, and evaluation requirements
for pharmacy personnel compounding or responsible for the direct supervision
of pharmacy personnel compounding sterile radiopharmaceuticals.
(1)
General.
(A)
All pharmacy personnel preparing sterile radiopharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge
and described in the policy and procedure or training manual. Such training
shall include instruction and experience in the following areas:
(i)
aseptic technique;
(ii)
critical area contamination factors;
(iii)
environmental monitoring;
(iv)
facilities;
(v)
equipment and supplies;
(vi)
sterile pharmaceutical and radiopharmaceutical calculations
and terminology;
(vii)
sterile radiopharmaceutical compounding documentation;
(viii)
quality assurance procedures;
(ix)
aseptic preparation procedures including proper gowning
and gloving technique;
(x)
handling of hazardous drugs, if applicable; and
(xi)
general conduct in the controlled area.
(B)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile radiopharmaceuticals
shall be observed, evaluated, and documented as satisfactory through written
or practical tests and process validation.
(C)
Although process validation may be incorporated into the
experiential portion of a training program, process validation must be conducted
at each pharmacy where an individual compounds sterile radiopharmaceuticals.
No product intended for patient use shall be compounded by an individual until
the on-site process validation test indicates that the individual can competently
perform aseptic procedures, except that an authorized nuclear pharmacist may
temporarily compound sterile radiopharmaceuticals and supervise pharmacy technicians
compounding sterile radiopharmaceuticals without process validation provided
the authorized nuclear pharmacist:
(i)
has completed a recognized course in an accredited college
of pharmacy or a course sponsored by an
ACPE
[
(ii)
completes the on-site process validation within seven
days of commencing work at the pharmacy.
(D)
Process validation procedures for assessing the preparation
of specific types of sterile radiopharmaceuticals shall be representative
of all types of manipulations, products,
risk levels
and batch
sizes that personnel preparing that type of radioradiopharmaceutical are likely
to encounter.
(E)
The pharmacist-in-charge shall assure continuing competency
of pharmacy personnel through in-service education, training, and process
validation to supplement initial training. Personnel competency shall be evaluated:
(i)
during orientation and training prior to the regular performance
of those tasks;
(ii)
whenever the quality assurance program yields an unacceptable
result;
(iii)
whenever unacceptable techniques are observed; and
(iv)
at least on an annual basis.
(2)
Pharmacists.
(A)
All pharmacists who compound sterile radiopharmaceuticals
or supervise pharmacy technicians compounding sterile radiopharmaceuticals
shall:
(i)
[
(I)
completion of a structured on-the-job
didactic and experiential training program at this pharmacy which provides
20 hours of instruction and experience in the areas listed in paragraph (1)
of this subsection. Such training may not be transferred to another pharmacy
unless the pharmacies are under common ownership and control and use a common
training program; or
(II)
completion of a recognized course in
an accredited college of pharmacy or a course sponsored by an ACPE approved
provider which provides 20 hours of instruction and experience in the areas
listed in paragraph (1) of this subsection; and
(ii)
possess knowledge about:
(I)
aseptic processing;
(II)
quality control
and quality assurance
as related
to environmental, component, and end-product testing;
(III)
chemical, pharmaceutical, and clinical properties of
drugs;
(IV)
container, equipment, and closure system selection; and
(V)
sterilization techniques
; and
[.]
(iii)
every two years complete six hours of
continuing education related to sterile or nuclear product compounding offered
by a provider approved by ACPE. (These hours may be applied towards the hours
required for renewal of a license to practice pharmacy.)
[
(B)
[
(3)
Pharmacy technicians. In addition to the qualifications
and training outlined in subsection (c) of this section, all pharmacy technicians
who compound sterile radiopharmaceuticals shall:
(A)
(No change.)
(B)
have initial training obtained either
through completion of:
(i)
a single course, a minimum of 40 hours
of instruction and experience in the areas listed in paragraph (1) of this
subsection. Such training may be obtained through:
(I)
completion of a structured
on-the-job didactic and experiential training program at this pharmacy which
provides 40 hours of instruction and experience in the areas listed in paragraph
(1) of this subsection. Such training may not be transferred to another pharmacy
unless the pharmacies are under common ownership and control and use a common
training program; or
(II)
completion of a course sponsored by an
ACPE approved provider which provides 40 hours of instruction and experience
in the areas listed in paragraph (1) of this subsection; or
(ii)
a training program which is accredited
by the American Society of Health-System Pharmacists (formerly the American
Society of Hospital Pharmacists). Individuals enrolled in training programs
accredited by the American Society of Health-System Pharmacists may compound
sterile pharmaceuticals in a licensed pharmacy provided:
(I)
the compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component of the American
Society of Health-System Pharmacists training program;
(II)
the individual is under the direct supervision of and
responsible to a pharmacist who has completed training as specified in paragraph
(1) of this subsection; and
(III)
the supervising pharmacist conducts in-process and final
checks; and
(C)
repeat the training specified in subparagraph
(B) of this paragraph at least every seven years; and
(D)
acquire the required experiential portion
of the training programs specified in this subparagraph under the supervision
of an individual who has already completed training as specified in paragraph
(2) or (3) of this subsection.
(E)
every two years complete six hours of
continuing education related to sterile product compounding. (These hours
may be applied towards the hours required for renewal of a pharmacy technician's
registration.)
[
[
[
[
(4)
(No change.)
§291.54.Operational Standards.
(a)
Licensing requirements.
(1) - (9)
(No change.)
(10)
A Class B pharmacy, licensed under the provisions of the
Act, §560.051(a)(2), which also operates another type of pharmacy which
would otherwise be required to be licensed under the Act, §560.051(a)(1),
concerning community pharmacy (Class A), 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 §291.31 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);
and
§291.35 of this title (relating to
Official
[
(11)
A Class B pharmacy engaged in nonsterile compounding of
drug products shall comply with the provisions of
§291.25 of this
title (relating to Pharmacies Compounding Non-Sterile Pharmaceuticals)
[
(12)
A Class B pharmacy engaged in sterile
compounding of pharmaceutical drug products other than radiopharmaceuticals
shall comply with the provisions of §291.26 of this title (relating to
Pharmacies Compounding Sterile Pharmaceuticals).
(b)
Risk levels for compounded sterile pharmaceuticals.
Risk Levels for sterile compounded preparations shall be as outlined in USP/NF
Chapter 797 Pharmacy Compounding Sterile Preparations and as listed below.
(1)
Low-risk level compounded sterile pharmaceuticals.
(A)
Low-risk level compounded sterile pharmaceuticals
are those compounded under all of the following conditions.
(i)
The compounded sterile preparations are
compounded with aseptic manipulations entirely within ISO Class 5 or better
air quality using only sterile ingredients, products, components, and devices.
(ii)
The compounding involves only transfer,
measuring, and mixing manipulations with closed or sealed packaging systems
that are performed promptly and attentively.
(iii)
Manipulations are limited to aseptically
opening ampuls, penetrating sterile stoppers on vials with sterile needles
and syringes, and transferring sterile liquids in sterile syringes to sterile
administration devices and packages of other sterile products.
(iv)
For a low-risk preparation, in the absence
of passing a sterility test, the storage periods cannot exceed the following
periods: before administration, 48 hours at controlled room temperature, for
not more than 14 days if stored in cold temperatures, and for 45 days if stored
in a frozen state at minus 20 degrees Celsius or colder).
(B)
Examples of low-risk compounding include
the following.
(i)
Single transfers of sterile dosage forms
from ampuls, bottles, bags, and vials using sterile syringes with sterile
needles, other administration devices, and other sterile containers. The contents
of ampuls require sterile filtration to remove glass particles.
(ii)
Manually measuring and mixing no more
than three manufactured products to compound drug admixtures and nutritional
solutions.
(2)
Medium-risk level compounded sterile pharmaceuticals.
(A)
Medium-risk level compounded sterile pharmaceuticals
are those compounded aseptically under low-risk conditions and one or more
of the of the following conditions exists.
(i)
Multiple individual or small doses of
sterile products are combined or pooled to prepare a compounded sterile pharmaceutical
that will be administered either to multiple patients or to one patient on
multiple occasions.
(ii)
The compounding process includes complex
aseptic manipulations other than the single-volume transfer.
(iii)
The compounding process requires unusually
long duration, such as that required to complete the dissolution or homogenous
mixing.
(iv)
The sterile compounded pharmaceutical's
do not contain broad-spectrum bacteriostatic substances, and they are administered
over several days.
(v)
For a medium-risk preparation, in the
absence of passing sterility test, the storage periods cannot exceed the following
time periods: before administration, the compounded sterile preparations are
properly stored and are exposed for not more than 30 hours at controlled room
temperature for not more than 7 days at a cold temperature, and for 45 days
in solid frozen state at minus 20 degrees or colder.
(B)
Examples of medium-risk compounding include
the following.
(i)
Compounding of total parenteral nutrition
fluids using a manual or automated device during which there are multiple
injections, detachments, and attachments of nutrient source products to the
device or machine to deliver all nutritional components to a final sterile
container.
(ii)
Filling of reservoirs of injection and
infusion devices with multiple sterile drug products and evacuations of air
from those reservoirs before the filled device is dispensed.
(iii)
Filling of reservoirs of injection and
infusion devices with volumes of sterile drug solutions that will be administered
over several days at ambient temperatures between 25 and 40 degrees Celsius
(77 and 104 degrees Fahrenheit).
(iv)
Transfer of volumes from multiple ampuls
or vials into a single, final sterile container or product.
(3)
High-risk level compounded sterile pharmaceuticals.
(A)
High-risk level compounded sterile pharmaceuticals
are those compounded under any of the following conditions.
(i)
Non-sterile ingredients, including manufactured
products are incorporated, or a non-sterile device is employed before terminal
sterilization.
(ii)
Sterile ingredients, components, devices,
and mixtures are exposed to air quality inferior to ISO Class 5. This includes
storage in environments inferior to ISO Class 5 of opened or partially used
packages of manufactured sterile products that lack antimicrobial preservatives.
(iii)
Non-sterile preparations are exposed
no more than 6 hours before being sterilized.
(iv)
It is assumed, and not verified by examination
of labeling and documentation from suppliers or by direct determination, that
the chemical purity and content strength of ingredients meet their original
or compendial specifications in unopened or in opened packages of bulk ingredients.
(v)
For a high-risk preparation, in the absence
of passing sterility test, the storage periods cannot exceed the following
time periods: before administration, the compounded sterile preparations are
properly stored and are exposed for not more than 24 hours at controlled room
temperature for not more than 3 days at a cold temperature, and for 45 days
in solid frozen state at minus 20 degrees or colder.
(B)
Examples of high-risk compounding include
the following.
(i)
Dissolving non-sterile bulk drug and nutrient
powders to make solutions, which will be terminally sterilized.
(ii)
Sterile ingredients, components, devices,
and mixtures are exposed to air quality inferior to ISO Class 5. This includes
storage in environments inferior to ISO Class 5 of opened or partially used
packages of manufactured sterile products that lack antimicrobial preservatives.
(iii)
Measuring and mixing sterile ingredients
in non- sterile devices before sterilization is performed.
(iv)
Assuming, without appropriate evidence
or direct determination, that packages of bulk ingredients contain at least
95% by weight of their active chemical moiety and have not been contaminated
or adulterated between uses.
(c)
[
(1)
General requirements.
(A)
The pharmacy shall be enclosed and lockable.
(B)
The pharmacy shall have a designated controlled area for
radiopharmaceuticals that is functionally separate from other areas of the
facility. If non-sterile radiopharmaceuticals are dispensed, the controlled
area for sterile radiopharmaceuticals shall be functionally separate from
the controlled area for non-sterile radiopharmaceuticals.
(C)
The pharmacy shall have adequate space necessary for the
storage, compounding, labeling, dispensing, and sterile preparation of drugs
prepared in the pharmacy, and additional space, depending on the size and
scope of pharmaceutical services.
(D)
The pharmacy shall be arranged in an orderly fashion and
shall be kept clean. All required equipment shall be clean and in good operating
condition.
(E)
A sink with hot and cold running water, exclusive of restroom
facilities, designated primarily for use of admixtures, shall be available
within the pharmacy area to all pharmacy personnel and shall be maintained
in a sanitary condition at all times.
(F)
The pharmacy shall be properly lighted and ventilated.
(G)
The temperature of the pharmacy shall be maintained within
a range compatible with the proper storage of drugs; the temperature of the
refrigerator shall be maintained within a range compatible with the proper
storage of drugs requiring refrigeration.
(H)
Animals, including birds and reptiles, shall not be kept
within the pharmacy and in immediately adjacent areas under the control of
the pharmacy. This provision does not apply to fish in aquariums, guide dogs
accompanying disabled persons, or animals for sale to the general public in
a separate area that is inspected by local health jurisdictions.
(2)
Special requirements for the compounding of sterile radiopharmaceuticals.
When the pharmacy compounds sterile radiopharmaceuticals, the following is
applicable.
(A)
Aseptic environment control device(s). The pharmacy shall
prepare sterile radiopharmaceuticals in an appropriate aseptic environmental
control device(s) or area, such as a laminar air flow hood, biological safety
cabinet, or clean room which is capable of maintaining at least Class 100
conditions during normal activity unless the use of such device will expose
pharmacy personnel to unacceptable levels of nuclear radiation. The aseptic
environmental control device(s) shall:
(i)
be certified by an independent contractor according to
Federal Standard 209E, et seq., for operational efficiency at least every
year or when it is relocated; and
(ii)
have pre-filters inspected periodically and replaced as
needed, in accordance with written policies and procedures, and the inspection
and/or replacement date documented.
(B)
Controlled area.
(i)
Low and Medium Risk Preparations.
The
pharmacy shall have a designated controlled area for the compounding of sterile
radiopharmaceuticals that is functionally separate from areas for the preparation
of non- sterile pharmaceuticals and is constructed to minimize the opportunities
for particulate and microbial contamination.
This controlled area for
the preparation of sterile pharmaceuticals shall:
(I)
have a controlled environment that is
aseptic or contains an aseptic environmental control device(s). If the aseptic
environmental control device is located within the controlled area, the controlled
area must extend a minimum of six feet from the device and clearly marked
to identify the separation between the controlled and non-controlled area;
(II)
be clean, well lighted, and of sufficient
size to support sterile compounding activities;
(III)
be used only for the compounding of
sterile pharmaceuticals;
(IV)
be designed to avoid outside traffic
and air flow;
(V)
be designed such that hand sanitizing
and gowning occurs outside the controlled area but accessible without use
of the hands of the compounding personnel;
(VI)
have non-porous and washable floors or
floor covering to enable regular disinfection;
(VII)
be ventilated in a manner not interfering
with aseptic environmental control conditions;
(VIII)
have walls, ceilings, and fixtures,
shelving, counters, and cabinets that are smooth, impervious, free from cracks
and crevices, and nonshedding. (acoustical ceiling tiles that are coated with
an acrylic paint are acceptable);
(IX)
have drugs and supplies stored on shelving
areas above the floor to permit adequate floor cleaning; and
(X)
contain only the appropriate compounding
supplies and not be used for bulk storage for supplies and materials. Objects
that shed particles may not be brought into the controlled area.
(ii)
High-risk Preparations. In addition to
the requirements in subclause (I), when high-risk preparations are compounded,
the aseptic environment control device(s) shall be located in a controlled
area that maintains at least an ISO Class 8 (formerly Class 100,000) environment.
(C)
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.
(3)
Security requirements.
(A)
All areas occupied by a pharmacy shall be capable of being
locked by key or combination, so as to prevent access by unauthorized personnel
when a pharmacist is not on-site.
(B)
The pharmacy may authorize personnel to gain access to
that area of the pharmacy containing dispensed sterile radiopharmaceuticals,
in the absence of the pharmacist, for the purpose of retrieving dispensed
prescriptions to deliver to patients. If the pharmacy allows such after-hours
access, the area containing the dispensed sterile radiopharmaceuticals shall
be an enclosed and lockable area separate from the area containing undispensed
prescription drugs. A list of the authorized personnel having such access
shall be in the pharmacy's policy and procedure manual.
(C)
Each pharmacist while on duty shall be responsible for
the security of the prescription department, including provisions for effective
control against theft or diversion of prescription drugs, and records for
such drugs.
(d)
[
(1)
Generic Substitution. A pharmacist may substitute on a
prescription drug order issued for a brand name product provided the substitution
is authorized and performed in compliance with Chapter 309 of this title (relating
to Generic Substitution).
(2)
Prescription containers (immediate inner containers).
(A)
A drug dispensed pursuant to a radioactive prescription
drug order shall be dispensed in an appropriate immediate inner container
as follows.
(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.
(B)
Immediate inner prescription containers or closures shall
not be re-used.
(3)
Delivery containers (outer containers).
(A)
Prescription containers may be placed in suitable containers
for delivery which will transport the radiopharmaceutical safely in compliance
with all applicable laws and regulations.
(B)
Delivery containers may be re-used provided they are maintained
in a manner to prevent cross contamination.
(4)
Labeling.
(A)
The immediate inner container of a radiopharmaceutical
shall be labeled with:
(i)
standard radiation symbol;
(ii)
the words "caution-radioactive material";
(iii)
the name of the radiopharmaceutical; and
(iv)
the unique identification number of the prescription.
(B)
The outer container of a radiopharmaceutical shall be labeled
with:
(i)
the name, address, and phone number of the pharmacy;
(ii)
the date dispensed;
(iii)
the directions for use, if applicable;
(iv)
the unique identification number of the prescription;
(v)
the name of the patient if known, or the statement, "for
physician use" if the patient is unknown;
(vi)
the standard radiation symbol;
(vii)
the words "caution-radioactive material";
(viii)
the name of the radiopharmaceutical;
(ix)
the amount of radioactive material contained in millicuries
(mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that
applies to this activity, if different from the requested calibration date
and time;
(x)
the name or initials of the person preparing the product
and the authorized nuclear pharmacist who checked and released the final product
unless documents are maintained in the pharmacy identifying these individuals
for each prescription dispensed;
(xi)
if a liquid, the volume in milliliters;
(xii)
the requested calibration date and time; and
(xiii)
the expiration date and/or time.
(C)
The amount of radioactivity shall be determined by radiometric
methods for each individual preparation immediately at the time of dispensing
and calculations shall be made to determine the amount of activity that will
be present at the requested calibration date and time, due to radioactive
decay in the intervening period, and this activity and time shall be placed
on the label per requirements set out in paragraph (4) of this subsection.
(e)
[
(1)
The following minimum level of pharmaceutical care services
shall be provided whenever a therapeutic prescription drug order is dispensed
and, when in the professional judgement of the pharmacist dispensing a diagnostic
prescription drug order, the services are necessary to protect the patient's
health while striving to produce positive patient outcomes. When it is determined
that the following services are necessary, the dispensing pharmacist shall
assure that efforts are made to gather the information necessary to properly
perform the services.
(A)
Drug utilization review. A systematic ongoing process of
drug utilization review shall be designed, followed, and documented to increase
the probability of desired patient outcomes and decrease the probability of
undesired outcomes from drug therapy with radiopharmaceuticals.
(B)
Drug regimen review.
(i)
For the purpose of promoting therapeutic appropriateness,
an authorized nuclear pharmacist shall, prior to or at the time of dispensing,
evaluate therapeutic prescription drug orders and patient medication history
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;
(X)
proper utilization, including overutilization or underutilization;
and
(XI)
clinical laboratory or clinical monitoring methods to
monitor and evaluate drug effectiveness, side effects, toxicity, or adverse
effects, and appropriateness to continued use of the drug in its current regimen.
(ii)
Upon identifying any clinically significant conditions,
situations, or items listed in clause (i) of this subparagraph, the authorized
nuclear pharmacist shall take appropriate steps to avoid or resolve the problem
including consultation with the prescribing practitioner.
(iii)
The drug regimen review may be conducted by remotely
accessing the pharmacy's electronic data base from outside the pharmacy by
an individual Texas licensed pharmacist employee of the pharmacy, provided
the pharmacy establishes controls to protect the privacy of the patient and
the security of confidential records.
(2)
Other pharmaceutical care services which may be provided
by authorized nuclear pharmacists 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)
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.
(f)
[
(1)
vertical laminar flow hood;
(2)
dose calibrator;
(3)
refrigerator
and a system or device (i.e., thermometer)
to monitor the temperature and humidity to ensure that proper storage requirements
are met, if sterile pharmaceuticals are stored in the refrigerator
;
(4)
Class A prescription balance, and accurate weights or balance
of greater sensitivity if compounding occurs in the pharmacy which requires
weighing;
(5)
scintillation analyzer;
(6)
microscope and hemocytometer;
(7)
equipment and utensils necessary for the
proper compounding of prescription drug or medication orders. Such equipment
and utensils used in the compounding process shall be:
(A)
of appropriate design, appropriate capacity,
and be operated within designed operational limits;
(B)
of suitable composition so that surfaces
that contact components, in-process material, or drug products shall not be
reactive, additive, or absorptive so as to alter the safety, identity, strength,
quality, or purity of the drug product beyond acceptable standards;
(C)
cleaned and sanitized immediately prior
to each use; and
(D)
routinely inspected, calibrated (if necessary),
or checked to ensure proper performance;
(8)
appropriate disposal containers for used
needles, syringes, etc., and if applicable, cytotoxic waste from the preparation
of chemotherapeutic agents, and/or biohazardous waste;
(9)
all necessary supplies, including:
(A)
disposable needles, syringes, and other
aseptic mixing;
(B)
disinfectant cleaning solutions;
(C)
hand washing agents with bactericidal
action;
(D)
disposable, lint free towels or wipes;
(E)
appropriate filters and filtration equipment;
(F)
cytotoxic spill kits, if applicable; and
(G)
masks, caps, coveralls or gowns with tight
cuffs, shoe covers, and gloves, as applicable.
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
[
(16)
[
(g)
[
(1)
United States Pharmacopoeia/National Formulary with supplements;
(2)
federal and state laws and regulations relating to Texas
pharmacy;
(3)
Texas Regulations for Control of Radiation;
(4)
reference on the safe handling of radioactive materials;
(5)
a minimum of three texts dealing with nuclear medicine
science;
(6)
reference on sterile product preparation; and
(7)
Code of Federal Regulations, Title 49, Parts 106-199, with
recent amendments.
(h)
[
(1)
General requirements.
(A)
Radiopharmaceuticals may only be dispensed pursuant to
a radioactive prescription drug order.
(B)
An authorized nuclear pharmacist may distribute radiopharmaceuticals
to authorized users for patient use. A nuclear pharmacy may also furnish radiopharmaceuticals
for departmental or physicians' use if such authorized users maintain a Texas
radioactive materials license, and the radiopharmaceutical is labeled "for
physician use," provided such distribution is documented in the control system.
(C)
An authorized nuclear pharmacist may transfer to authorized
users radioactive materials not intended for drug use in accordance with Part
41 of the Texas Regulations for Control of Radiation, Texas Department of
Health.
(D)
The transportation of radioactive materials from the nuclear
pharmacy must be in accordance with current state and federal transportation
regulations.
(2)
Procurement and storage.
(A)
The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from other
appropriate staff relative to such responsibility.
(B)
Prescription drugs and devices shall be stored within the
prescription department or a locked storage area.
(C)
All drugs shall be stored at the proper temperature, as
defined by the following terms.
(i)
Cold--Any temperature not exceeding 8 degrees Centigrade
(46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature
is maintained thermostatically between 2 and 8 degrees Centigrade (36 and
46 degrees Fahrenheit). A freezer is a cold place in which the temperature
is maintained thermostatically between -20 and -10 degrees Centigrade (-4
and -14 degrees Fahrenheit).
(ii)
Cool--Any temperature between 8 and 15 degrees Centigrade
(46 and 59 degrees Fahrenheit). An article for which storage in a cool place
is directed may, alternatively, be stored in a refrigerator unless otherwise
specified in the labeling.
(iii)
Room temperature--The temperature prevailing in a working
area. Controlled room temperature is a temperature thermostatically between
15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).
(iv)
Warm--Any temperature between 30 and 40 degrees Centigrade
(86 and 104 degrees Fahrenheit).
(v)
Excessive heat--Temperature above 40 degrees Centigrade
(104 degrees Fahrenheit).
(vi)
Protection from freezing where, in addition to the risk
of breakage of the container, freezing subjects a product to loss of strength
or potency, or to destructive alteration of the dosage form, the container
label bears an appropriate instruction to protect the product from freezing.
(3)
Out-of-date and other unusable drugs or devices.
(A)
Any drug or device bearing an expiration date shall not
be dispensed beyond the expiration date of the drug or device.
(B)
Outdated and other unusable drugs or devices shall be removed
from dispensing stock and shall be quarantined together until such drugs or
devices are disposed of properly.
(i)
[
(1)
Automated compounding device may be loaded with bulk drugs
only by an authorized nuclear pharmacist or by supportive personnel under
the direction and direct supervision of an authorized pharmacist.
(2)
The label of an automated compounding 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.
(3)
Records of loading bulk drugs into an automated compounding
device shall be maintained to show:
(A)
name of the drug, strength, and dosage form;
(B)
manufacturer or distributor;
(C)
manufacturer's lot number;
(D)
expiration date;
(E)
quantity added to the automated compounding device;
(F)
date of loading;
(G)
name, initials, or electronic signature of the person loading
the automated compounding device; and
(H)
name, initials, or electronic signature of the responsible
authorized nuclear pharmacist.
(4)
The automated compounding device shall not be used until
an authorized nuclear pharmacist verifies that the system is properly loaded
and affixes his or her signature or electronic signature to the record specified
in paragraph (3) of this subsection.
(j)
[
(1)
Expiration date.
(A)
The expiration date assigned shall be based on:
(i)
established manufacturer's guidelines;
(ii)
published literature; or
(iii)
in-house or contracted stability studies.
(B)
The method for establishing expiration dates shall be documented.
(2)
Radioactive Drug Quality control. There shall be a documented,
ongoing quality control program that monitors and evaluates personnel performance,
equipment and facilities. Procedures shall be in place to assure that the
pharmacy is capable of consistently preparing radiopharmaceuticals which are
sterile and stable. Quality control procedures shall include, but are not
limited to, the following:
(A)
recall procedures;
(B)
storage and dating;
(C)
documentation of appropriate functioning of refrigerator,
freezer, and other equipment;
(D)
documentation of aseptic environmental control device(s)
certification at least every year and the regular replacement of pre-filters
as necessary;
(E)
a process to evaluate and confirm the quality of the prepared
radiopharmaceutical; and
(F)
documentation of facility maintenance such as cleaning
and environmental testing.
§291.55.Records.
(a)
(No change.)
(b)
Prescriptions.
(1) - (3)
(No change.)
(4)
Electronic radioactive prescription drug orders. For the
purpose of this paragraph, electronic radioactive prescription drug orders
shall be considered the same as verbal radioactive prescription drug orders.
(A)
An electronic radioactive prescription drug order may be
transmitted by a practitioner or a practitioner's designated agent:
(i)
directly to a pharmacy; or
(ii)
through the use of a data communication device provided:
(I)
the
confidential
prescription information is
not altered during transmission; and
(II)
confidential patient information is not accessed or maintained
by the operator of the data communication device
other than for legal
purposes under federal and state law.
[
(B) - (C)
(No change.)
(5) - (7)
(No change.)
(c)
(No change.)
(d)
Other records. Other records to be maintained by a pharmacy:
(1) - (3)
(No change.)
(4)
suppliers' invoices of dangerous drugs and controlled substances;
a pharmacist
[
(5) - (9)
(No change.)
(e) - (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 15, 2004.
TRD-200401926
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
22 TAC §§291.72 - 291.76
The Texas State Board of Pharmacy (TSBP) proposes amendments
to §291.72 concerning Definitions, §291.73 concerning Personnel, §291.74
concerning Operational Standards, and §291.75 concerning Records in
a Class C (Institutional) Pharmacy and §291.76 concerning Class C Pharmacies
Located in a Freestanding Ambulatory Surgical Center. The amendments to §§291.72-291.74
and §291.76, if adopted, will amend the current provisions relating
to compounding of sterile pharmaceuticals to match new section §291.26
which outlines new provisions for the compounding of sterile pharmaceuticals.
New §291.26 is proposed elsewhere in this issue of the
Texas Register
. New §291.26 outlines operating standards for pharmacies
that compound sterile pharmaceuticals, implements the recommendations of
the TSBP appointed Task Force on Compounding (Task Force), and incorporates
many of the provisions included in the United States Pharmacopeia (USP) new
General Chapter 797 (Pharmaceutical Compounding Sterile Preparations). The
amendments to §291.75 and §291.76(e), if adopted, will specify
that only a pharmacist may verify the receipt of controlled substances by
a pharmacy.
The TSBP established the Task Force in August 2002. The Task Force was
composed of representatives from the pharmacy community appointed by the
three major pharmacy associations in Texas and pharmacists primarily involved
in compounding. The members of TSBP established the Task Force in response
to two issues. The first issue was the 2002 United States Supreme Court decision
which struck down the pharmacy compounding provisions of the federal Food,
Drug, and Cosmetic Act. This action left the federal law without any provisions
that allowed pharmacy compounding. In fact, if the federal law is read strictly,
all pharmacy compounding would be considered manufacturing. The second and
more important issue consisted of several incidences in other states in which
patient deaths had occurred after they had received injections of pharmaceuticals
that were compounded in pharmacies and were contaminated with bacteria.
The Task Force was charged with: (1) reviewing current federal and state
requirements for pharmacy compounding; (2) reviewing the current standards
of practice for pharmacy compounding; and (3) making recommendations to TSBP
regarding standards for compounding that will provide the necessary compounded
medications while protecting the health, safety, and welfare of the public.
The Task Force met two times and presented its recommendations to the Board
at the February 5, 2003 meeting.
At the February meeting, the members of TSBP directed staff to develop
draft rules based on the recommendations of the Task Force. The members of
TSBP reviewed the draft rules at the May 2003 meeting and directed staff
to continue to circulate the draft rules among the profession and incorporate
the recommendations from the profession. In August 2003, the members of TSBP
voted to publish the rules as proposed rules in the Texas Register. A public
hearing on this first set of rules was held on November 18, 2003. After receiving
comments, the members of TSBP voted to withdraw the first set of rules and
directed staff to incorporate the majority of the comments received at the
public hearing and bring a new draft to the February 2004 meeting. After
reviewing the second set of draft rules at the February 2004 meeting, the
members of TSBP voted to publish the second set of draft rules as proposed
rules in the
Texas Register
.
The one major item not included in this second set of proposed rules is
a section that allows pharmacies to compound pharmaceuticals for physician
offices without a prescription for an individual patient. As pointed out
in the November 2003 public hearing, the Board does not have the authority
to set a percentage limit on the amount of compounded sterile pharmaceuticals
that a pharmacy may sell to a physician's office without a prescription.
In fact, the Board believes that to adopt a rule that allowed a pharmacy
to compound sterile pharmaceuticals without a prescription for an individual
patient would be in violation of both the federal and state Food, Drug, and
Cosmetic Act. Specifically, the definition of manufacture in Section 431.002
of the Health and Safety Code indicates that manufacturing does not include
compounding that is done within the practice of pharmacy and pursuant to
a prescription from a practitioner for a patient. Thus, the rules as published
do not include any provision for compounding for use in a physician office
unless the pharmacy has a prescription for a specific patient. However, the
members of TSBP understand that there are some instances in which compounding
for physician office use may be necessary. Therefore, the members of TSBP
have instructed the staff of TSBP to develop a policy that defines an appropriate
level of enforcement regarding this necessary physician office compounding.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be the establishment of standards for the safe compounding
of sterile pharmaceuticals by pharmacies. Ms. Dodson has also determined
that, for each year of the first five-year period the rule will be in effect,
an economic cost may exist for entities/persons required to comply with the
rule as described below.
There might be an adverse economic effect on micro, small, and large businesses
or to other entities/persons who are required to comply with this section.
Based on the significant variances in pharmacies' physical structure and
layout, it is difficult for TSBP to determine the actual cost to businesses
required to comply with this rule. These costs would involve bringing the
sterile compounding area of pharmacies into compliance with the new provisions
of the rules and in establishing an end product evaluation process. TSBP
records indicate that approximately 582 community pharmacies intended to provide
sterile compounding services to patients and approximately 92 hospital pharmacies
intended to compound sterile products for out-patients. However, TSBP cannot
precisely determine the number of pharmacies affected because TSBP records
do not provide additional information about the details of the pharmacies'
compounding operations. In addition, TSBP is unable to reduce these costs
because to do so would compromise the safety of sterile compounding practices.
Examples of new requirements under the rules are: (1) if the aseptic controlled
device is located within the controlled area, there must be six feet of separation
around the aseptic control device; (2) the controlled area must be accessible
without using hands; (3) when preparing high-risk pharmaceuticals, the controlled
area must maintain an environment of at least ISO Class 8 (Class 100,000);
(4) the pharmacy must establish end product evaluation procedures for all
products including high-risk preparations; and (5) the pharmacy must establish
a quality assurance program that meets the requirements of Chapter 797 of
the USP. The actual dollar amount for bringing the pharmacy into compliance
may vary greatly between pharmacies and could range from one hundred to several
tens of thousand dollars. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between one dollar
per employee to several thousand.
Pharmacies that are compounding for physician offices without receiving
a prescription for a specific patient from the physician may experience loss
of revenues. The actual loss may vary greatly between pharmacies and TSBP
cannot feasibly calculate the loss, since TSBP does not have access to financial
data from pharmacies. It is reasonable to presume that the amount of compounding
performed by pharmacies for physician office use without a prescription should
not change significantly, because the same amount of the drugs would still
be used by physicians, but would now require a prescription to be generated
prior to dispensing of the compounded drug to the physician for administration
in the physician office.
Some pharmacies may disagree with this presumption, but with the absence
of financial data, TSBP has no method to confirm their assertions. If TSBP
assumes that a loss of revenue would occur, the loss of revenue to the pharmacy
could range from a few hundred to thousands of dollars, depending on the
amount of a pharmacy's business that would be lost which involves compounding
for physician office use. The majority of pharmacies have less than 100 employees,
such that the cost per employee would result in an amount between less than
100 dollars per employee to several thousand.
Both state and federal law prohibit compounding without a prescription
for a specific patient. If pharmacies are compounding for physician office
use without a prescription, they are currently in violation of state and
federal law, such that the revenues generated therefrom are the result of
an illegal activity. If an adverse economic effect exists for micro and small
businesses based on the requirements of the rule, including the prohibition
in the rule against compounding for physician office use without a prescription,
TSBP is unable to reduce that impact because doing so would not be legal
and feasible considering the purpose of state and federal law concerning
pharmacy compounding and would compromise the purposes of this rule which
is intended to protect the health and safety of the public.
A public hearing to receive comments on the proposed amendments will be
held at 9:00 a.m. on Tuesday, May 4, 2004, at the Health Professions Council
Board Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701.
Persons planning to present comments to the Board are asked to provide a
written copy of their comments prior to the hearing or bring 20 copies to
the hearing. Written comments on the amendments may be submitted to Allison
Benz, R.Ph., M.S., Director of Professional Services, 333 Guadalupe Street,
Suite 3-600, Austin, Texas, 78701, FAX: 512/305-8082, E-mail: allison.benz@tsbp.state.tx.us.
Comments must be received by 5 p.m., April 28, 2004.
The amendments are proposed under sections 551.002, 551.003,
554.001, and 554.051 of the Texas Pharmacy Act (Chapters 551-566 and 568-569,
Texas Occupations Code). The Board interprets section 551.002 as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets section 551.003(9) as authorizing
the agency to adopt rules concerning the compounding of prescriptions. The
Board interprets section 551.003(33) as authorizing the agency to adopt rules
concerning the practice of pharmacy. The Board interprets section 554.001(a)
as authorizing the agency to adopt rules to administer and enforce the Act
and rules adopted under the Act as well as enforce other laws relating to
the practice of pharmacy. The Board interprets section 554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by this rule: Chapters 551-566 and 568-569, 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) - (3)
(No change.)
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(4)
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(5)
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(6)
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(7)
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(8)
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(9)
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(10)
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(A)
is not included in Penalty Group 1, 2, 3, or 4, Chapter
481, Health and Safety Code, and is unsafe for self-medication; or
(B)
bears or is required to bear the legend:
(i)
"Caution: federal law prohibits dispensing without prescription"
or "Rx only" or another legend that complies with federal law; or
(ii)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(11)
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(12)
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(13)
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(14)
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(15)
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(16)
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(17)
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(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).
(18)
[
(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.
(19)
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(20)
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(A)
a hospital or other in-patient facility that is licensed
under chapter 241 or 577, Health and Safety code;
(B)
a hospice in-patient facility that is licensed under Chapter
142, Health and Safety Code;
(C)
an ambulatory surgical center licensed under Chapter 243,
Health and Safety Code; or
(D)
a hospital maintained or operated by the state.
(21)
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(22)
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(23)
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(24)
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(25)
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(26)
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(27)
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(28)
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(29)
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(30)
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(31)
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(32)
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(33)
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(34)
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(35)
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(36)
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(A)
not registered as a pharmacy technician by the board, and
either:
(B)
participating in a pharmacy's technician training program;
or
(C)
currently enrolled in a:
(i)
pharmacy technician training program accredited by the
American Society of Health-System Pharmacists; or
(ii)
health science technology education program in a Texas
high school that is accredited by the Texas Education Agency.
(37)
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(38)
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(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 "Rx only" or another legend that complies with federal law
;
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.
(39)
[
(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.
[
(40)
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(41)
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(42)
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(43)
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(44)
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(45)
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(46)
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§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) - (B)
(No change.)
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(C)
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(D)
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(E)
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(F)
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(G)
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(H)
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(I)
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(J)
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(K)
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(L)
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(M)
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(N)
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(O)
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(P)
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(Q)
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(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) - (2)
(No change.)
(3)
Special requirements for compounding.
(A)
Non-Sterile Pharmaceuticals . All pharmacists
engaged in compounding non-sterile pharmaceuticals shall meet the training
requirements specified in §291.25 of this title (relating to Pharmacies
Compounding Non-sterile Pharmaceuticals).
(B)
Sterile Pharmaceuticals. All pharmacists engaged
in compounding non-sterile pharmaceuticals shall meet the training requirements
specified in §291.26 of this title (relating to Pharmacies Compounding
Sterile Pharmaceuticals).
(e)
Pharmacy technicians.
(1)
(No change.)
(2)
Duties.
Duties may include, but need not be limited
to, the following functions under the direct supervision of and responsible
to a pharmacist:
(A)
pre-packing and labeling unit
and multiple dose packages, provided a pharmacist supervises and conducts
in-process and final checks and affixes his or her signature (first initial
and last name or full signature) or electronic signature to the appropriate
quality control records;
[
(B)
preparing, packaging, compounding,
or labeling prescription drugs pursuant to medication orders, provided a
pharmacist supervises and checks the preparation;
(C)
bulk compounding or batch preparation
provided a pharmacist supervises and conducts in-process and final checks
and affixes his or her initials to the appropriate quality control records;
(D)
distributing routine orders
for stock supplies to patient care areas;
(E)
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);
(F)
loading bulk unlabeled drugs
into an automated compounding or counting device 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;
(G)
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; and
(H)
[
(i)
have completed the training specified in
§291.26
of this title (relating to pharmacies compounding sterile pharmaceuticals;
[
(ii)
are supervised by a pharmacist who has completed the
training specified in
§291.26 of this title
[
(3)
Special requirements for compounding.
(A)
Non-Sterile Pharmaceuticals. All pharmacy technicians
engaged in compounding non-sterile pharmaceuticals shall meet the training
requirements specified in §291.25 of this title.
(B)
Sterile Pharmaceuticals. Pharmacy technicians
may compound sterile pharmaceuticals pursuant to medication orders provided
the pharmacy technicians:
(i)
have completed the training specified subsection
§291.26 of this title; and
(ii)
are supervised by a pharmacist who has completed
the training specified in §291.26 of this title and who conducts in-process
and final checks, and affixes his or her initials to the label or if batch
prepared, to the appropriate quality control records. (The initials are not
required on the label if it is maintained in a permanent record of the pharmacy).
(4)
[
(A)
pharmacy technicians shall handle medication orders in
accordance with standard, written procedures and guidelines.
(B)
pharmacy technicians shall handle prescription drug orders
in the same manner as those working in a Class A pharmacy.
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(f)
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(1)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge which bears the person's name and identifies
him or her as a pharmacy technician trainee a registered pharmacy technician,
or a certified pharmacy technician, if the technician maintains current certification
with the Pharmacy Technician Certification Board or any other entity providing
an examination approved by the Board.
(2)
Pharmacist interns. All pharmacist interns shall wear an
identification tag or badge which bears the person's name and identifies
him or her as a pharmacist intern.
(3)
Pharmacists. All pharmacists shall wear an identification
tag or badge which bears the person's name and identifies him or her as a
pharmacist.
§291.74.Operational Standards.
(a)
Licensing requirements.
(1) - (8)
(No change.)
(9)
A Class C pharmacy, licensed under the Act, §560.051(a)(3),
which also operates another type of pharmacy which would otherwise be required
to be licensed under the Act, §560.051(a)(1) (Community Pharmacy (Class
A)) or the Act, §560.051(a)(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),
and
§291.35
of this title (relating to
Official
[
(10)
A Class C
(Institutional)
pharmacy engaged
in non-sterile compounding of drug products for inpatients of the hospital
shall comply with the provisions of
§291.25 of this title (relating
to Pharmacies Compounding Non-Sterile Pharmaceuticals)
[
(11)
A Class C (Institutional)
pharmacy engaged in the compounding of sterile pharmaceuticals shall comply
with the provisions of §291.26 of this title (relating to Pharmacies
Compounding Sterile Pharmaceuticals).
(12)
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(13)
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(b)
Environment.
(1)
(No change.)
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(2)
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(A)
All areas occupied by an institutional pharmacy shall be
capable of being locked by key or combination, so as to prevent access by
unauthorized personnel by force.
(B)
Each pharmacist on duty shall be responsible for the security
of the institutional pharmacy, including provisions for adequate safeguards
against theft or diversion of dangerous drugs, controlled substances, and
records for such drugs.
(C)
The institutional pharmacy shall have locked storage for
Schedule II controlled substances and other drugs requiring additional security.
(c)
Equipment and supplies.
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(1)
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(2)
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(d)
Library . A reference library shall be maintained which
includes the following in hard-copy or electronic format:
(1) - (4)
(No change.)
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(5)
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(e)
(No change.)
(f)
Drugs.
(1) - (3)
(No change.)
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(4)
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(A)
patient's name and location;
(B)
name and amount of drug(s) added;
(C)
name of the basic solution;
(D)
name or identifying code of person who prepared admixture;
and
(E)
expiration date of solution.
(5)
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(A)
Medication orders.
(i)
Drugs may be given to patients in facilities only on the
order of a practitioner. No change in the order for drugs may be made without
the approval of a practitioner.
(ii)
Drugs may be distributed only from the original or a direct
copy of the practitioner's medication order.
(iii)
Supportive personnel may not receive verbal medication
orders.
(iv)
Institutional pharmacies shall be exempt from the labeling
provisions and patient notification requirements of §556.006 and §556.009
of the Act, as respects drugs distributed pursuant to medication orders.
(B)
Procedures.
(i)
Written policies and procedures for a drug distribution
system (best suited for the particular institutional pharmacy) shall be developed
and implemented by the pharmacist-in-charge, with the advice of the committee
performing the pharmacy and therapeutics function for the facility.
(ii)
The written policies and procedures for the drug distribution
system shall include, but not be limited to, procedures regarding the following:
(I)
pharmaceutical care services;
(II)
handling, storage and disposal of cytotoxic drugs and
waste;
(III)
disposal of unusable drugs and supplies;
(IV)
security;
(V)
equipment;
(VI)
sanitation;
(VII)
reference materials;
(VIII)
drug selection and procurement;
(IX)
drug storage;
(X)
controlled substances;
(XI)
investigational drugs, including the obtaining of protocols
from the principal investigator;
(XII)
prepackaging and manufacturing;
(XIII)
stop orders;
(XIV)
reporting of medication errors, adverse drug reactions/events,
and drug product defects;
(XV)
physician orders;
(XVI)
floor stocks;
(XVII)
drugs brought into the facility;
(XVIII)
furlough medications;
(XIX)
self-administration;
(XX)
emergency drug supply;
(XXI)
formulary;
(XXII)
monthly inspections of nursing stations and other areas
where drugs are stored, distributed, administered or dispensed;
(XXIII)
control of drug samples;
(XXIV)
outdated and other unusable drugs;
(XXV)
routine distribution of inpatient medication;
(XXVI)
preparation and distribution of sterile pharmaceuticals;
(XXVII)
handling of medication orders when a pharmacist is
not on duty;
(XXVIII)
use of automated compounding or counting devices;
(XXIX)
use of data processing and direct imaging systems;
(XXX)
drug administration to include infusion devices, drug
delivery systems, and first dose monitoring;
(XXXI)
drug labeling;
(XXXII)
recordkeeping;
(XXXIII)
quality assurance/quality control;
(XXXIV)
duties and education and training of professional and
nonprofessional staff; and
(XXXV)
emergency preparedness plan, to include continuity of
patient therapy and public safety.
(g) - (j)
(No change.)
§291.75.Records.
(a) - (d)
(No change.)
(e)
Other records. Other records to be maintained by a pharmacy:
(1) - (3)
(No change.)
(4)
suppliers' invoices of dangerous drugs and controlled substances;
a pharmacist
[
(5) - (10)
(No change.)
(f) - (g)
(No change.)
§291.76.Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center.
(a)
(No change.)
(b)
Definitions. The following words and terms, when used in
these sections, shall have the following meanings, unless the context clearly
indicates otherwise.
(1) - (18)
(No Change.)
(19)
Prescription drug
(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 "Rx only" or another legend that complies with federal law
;
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.
(20) - (25)
(No change.)
(c)
Personnel.
(1)
Pharmacist-in-charge.
(A)
(No change.)
(B)
Responsibilities. The pharmacist-in-charge shall have the
responsibility for, at a minimum, the following:
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(i)
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(ii)
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(iii)
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(iv)
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(v)
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(vi)
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(vii)
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(viii)
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(ix)
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(x)
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(xi)
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(xii)
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(xiii)
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(2)
(No change.)
(3)
Pharmacists.
(A) - (B)
(No change.)
(C)
Special requirements for compounding.
(i)
Non-Sterile Pharmaceuticals. All pharmacists
engaged in compounding non-sterile pharmaceuticals shall meet the training
requirements specified in §291.25 of this title (relating to Pharmacies
Compounding Non-Sterile Pharmaceuticals).
(ii)
Sterile Pharmaceuticals. All pharmacists engaged
in compounding non-sterile pharmaceuticals shall meet the training requirements
specified in §291.26 of this title (relating to Pharmacies Compounding
Sterile Pharmaceuticals).
[
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(4)
Pharmacy technicians.
(A)
(No change.)
(B)
Duties. Duties may include, but need not be limited to,
the following functions, under the direct supervision of a pharmacist:
(i) - (ii)
(No change.)
(iii)
compounding sterile pharmaceuticals pursuant to medication
orders provided the pharmacy technicians:
(I)
have completed the training specified in
§291.26
of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals)
[
(II)
are supervised by a pharmacist who has completed the
sterile products training specified in
§291.26 of this title,
[
(iv)- (ix)
(No change.)
(C)
(No change.)
(D)
Special requirements for compounding.
(i)
Non-Sterile Pharmaceuticals . All pharmacy
technicians engaged in compounding non-sterile pharmaceuticals shall meet
the training requirements specified in §291.25 of this title.
(ii)
Sterile Pharmaceuticals. Pharmacy technicians
may compound sterile pharmaceuticals pursuant to medication orders provided
the pharmacy technicians:
(I)
have completed the training specified in §291.26
of this title; and
(II)
are supervised by a pharmacist who has completed
the training specified in §291.26 of this title and who conducts in-process
and final checks, and affixes his or her initials to the label or if batch
prepared, to the appropriate quality control records. (The initials are not
required on the label if it is maintained in a permanent record of the pharmacy).
(5)
(No change.)
(d)
Operational standards.
(1)
Licensing requirements.
(A) - (H)
(No change.)
(I)
An ASC pharmacy, licensed under the Act, §560.051(a)(3),
concerning institutional pharmacy (Class C), which also operates another
type of pharmacy which would otherwise be required to be licensed under the
Act, §560.051(a)(1), concerning community pharmacy (Class A), or the
Act, §560.051(a)(2), concerning nuclear pharmacy (Class B), is not required
to secure a license for the other type of pharmacy; provided, however, such
license 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),
and
§291.35 of this
title (relating to
(Official)
[
(J)
An ASC pharmacy engaged in
non-sterile compounding of drug products for inpatients of the hospital shall
comply with the provisions of §291.25 of this title (relating to Pharmacies
Compounding Non-Sterile Pharmaceuticals).
(K)
An ASC pharmacy engaged in
the compounding of sterile pharmaceuticals shall comply with the provisions
of §291.26 of this title (relating to Pharmacies Compounding Sterile
Pharmaceuticals).
(L)
An ASC pharmacy engaged in
the provision of remote pharmacy services, including storage and dispensing
of prescription drugs, shall comply with the provisions of §291.20 of
this title (relating to Remote Pharmacy Services).
(M)
An ASC pharmacy engaged in
centralized prescription dispensing and/or prescription drug or medication
order processing shall comply with the provisions of §291.37 of this
title (relating to Centralized Prescription Dispensing) and/or §291.38
of this title (relating to Centralized Prescription Drug or Medication Order
Processing).
(2)
Environment.
(A)
(No change.)
(B)
Special requirements.
(i)
The ASC pharmacy shall have locked storage for Schedule
II controlled substances and other controlled drugs requiring additional
security.
(ii)
The ASC pharmacy shall have a designated area for the
storage of poisons and externals separate from drug storage areas.
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(C)
(No change.)
(3)
Equipment and supplies. Ambulatory surgical centers supplying
drugs for postoperative use shall have the following equipment and supplies:
(A) - (C)
(No change.)
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[
(4)
Library. A reference library shall be maintained which
includes the following in hard-copy or electronic format:
(A)
current copies of the following:
(i)
Texas Pharmacy Act and rules;
(ii)
Texas Dangerous Drug Act and rules;
(iii)
Texas Controlled Substances Act and rules;
(iv)
Federal Controlled Substances Act and rules or official
publication describing the requirements of the Federal Controlled Substances
Act and rules;
(B)
at least one current or updated reference
from each of the following categories:
(i)
Drug interactions. A reference text on
drug interactions, such as Drug Interaction Facts. A separate reference is
not required if other references maintained by the pharmacy contain drug
interaction information including information needed to determine severity
or significance of the interaction and appropriate recommendations or actions
to be taken;
(ii)
[
(I)
[
(II)
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(III)
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(IV)
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(V)
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(C)
a current or updated reference on injectable drug
products, such as Handbook of Injectable Drugs;
[
(D)
basic antidote information and the telephone number of
the nearest regional poison control center.
(E)
if the pharmacy compounds sterile
pharmaceuticals, specialty references appropriate for the scope of services
provided by the pharmacy, e.g., if the pharmacy prepares cytotoxic drugs,
a reference text on the preparation of cytotoxic drugs, such as Procedures
for Handling Cytotoxic Drugs.
(F)
metric-apothecary weight and
measure conversion charts.
(5)
Drugs.
(A) - (C)
(No change.)
[
(6) - (9)
(No change.)
(e)
Records.
(1) - (4)
(No change.)
(5)
Other records. Other records to be maintained by the pharmacy
include:
(A) - (C)
(No change.)
(D)
suppliers' invoices of dangerous drugs and controlled substances;
a pharmacist
[
(E) - (J)
(No change.)
(6) - (7)
(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 15, 2004.
TRD-200401927
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 25, 2004
For further information, please call: (512) 305-8028
Civil Statutes
].
, Chapters
] 301, 303, and 304.
Professional
] Nurse Education, Licensure and Practice
to nurses, employers, and the public to ensure informed professionals, allied
health professionals, and consumers.
, Sections
] 301.051 through 301.059, the board
shall consist of members appointed by the Governor with the advice and consent
of the Senate.
not more than
] one-third of the members
as possible
shall expire [
in a single calendar year. The terms of one member
who is a practicing registered nurse, one member who is a nurse engaged in
nurse education, and at least one member who is representative of the public
expire
] on January 31 of each odd-numbered year. Upon completion of
a term, a member may continue to serve until a successor has been appointed.
A member may be reappointed to successive terms at the discretion of the Governor.
, Sections
] 301.052
and 301.053.
V.T.C.A.,
] Occupations Code
§
[
, Chapter
] 301.057, the Governor shall designate one of the members
of the board as presiding officer. During the last meeting of the fiscal year,
the board shall elect from among its membership a vice president. All elections
and any other issues requiring a vote of the board shall be decided by a simple
majority of the members present and voting.
, Section
] 301.058.
, Chapter
] 551 and copies
shall be sent to the board members.
registered
] nurses, shall constitute a
quorum for the transaction of all business at any regular or special meeting.
, Chapter
] 551.
registered
]
nurse.
, Chapter
] 551.
Chapter 213.
PRACTICE AND PROCEDURE
professional
] nursing in Texas, regardless of the method
through which licensure was sought.
Professional
] Nurse Education, Licensure and Practice and has been issued a license
to practice professional
or vocational
nursing in Texas. For purposes
of this subchapter, the term includes a person who practices pursuant to a
multistate licensure privilege.
registered
] nurse in another state that has enacted the Nurse
Licensure Compact, Texas Occupations Code Annotated Chapter. 304.
registered
] nurse licensing agency
at the time of the mailing.
RN
]/Respondent Name, License Number, Social Security Number, Date of
Birth, Employer, Dates of Occurrence(s), Description of Facts or Conduct,
Witnesses, Outcome, Complainant Identification (Name, Address, and Telephone
Number), and Written Instructions For Providing Information to the Board.
Complaints may be made on the agency's complaint form.
professional
] nurse.
professional
]
nursing in this state has been revoked, suspended, or surrendered may apply
for reinstatement of the license. In the case of revocation, petition shall
not be made prior to one year after the effective date of the revocation.
The Board may approve or deny a petition. In the case of denial, the Board
may set a reasonable time that must elapse before another petition may be
filed. The Board may impose reasonable conditions that a petitioner must satisfy
before reinstatement of an unencumbered license.
professional
] nursing based on his or her history of nursing-related
employment or education.
professional
] nursing
in any jurisdiction and has been disciplined, or allowed to voluntarily surrender
in lieu of discipline, in that jurisdiction.
professional
] nursing in any jurisdiction
or an or an individual who resigned in lieu of disciplinary action (disciplined
individual) is deemed not to have present good professional character and
fitness and is, therefore, ineligible to file an Application for Endorsement
to the Texas Board of Nursing during the period of such discipline imposed
by such jurisdiction, and in the case of revocation or surrender in lieu of
disciplinary action, until the disciplined individual has filed an application
for reinstatement in the disciplining jurisdiction and obtained a final determination
on that application.
professional
] nursing; and
professional
] nursing without a license issued under the NPA;
professional
] nursing practice;
professional
] nursing practice;
professional
] nursing in accordance with the Nursing Practice Act, Board rules and
generally accepted standards of [
professional
] nursing.
(6/99)
]
(6/99)
]
registered
] nurse unless such person
can demonstrate sobriety and abstinence for the preceding twelve consecutive
months through verifiable and reliable evidence, or can establish eligibility
to participate in a peer assistance program created pursuant to Chapter 467
of the Health and Safety Code;
professional
] nursing until the
individual has attained a five-year term of sobriety and abstinence or until
such person has successfully completed participation in a board-approved peer
assistance program created pursuant to Chapter 467 of the Health and Safety
Code.
Professional
]
Nursing Practice;
registered
]
nurse to practice on a delinquent license:
Part 12.
BOARD OF VOCATIONAL NURSE EXAMINERS
Subchapter B. GENERAL PRACTICE AND PROCEDURE
Subchapter C. BOARD RULES
Chapter 235.
LICENSING
Subchapter B. BOARD REVIEW OF APPLICATION
Chapter 239.
CONTESTED CASE PROCEDURE
Subchapter C. HEARINGS PROCESS
Subchapter D. INFORMAL DISPOSITIONS
Part 15.
TEXAS STATE BOARD OF PHARMACY
Chapter 291.
PHARMACIES
$351
] for processing the application
and issuance of the pharmacy license as authorized by the Act §554.006;
and
]
(C)
] $5 surcharge to fund the Office
of Patient Protection as authorized by Chapter 101, Subchapter G, Occupations
Code.
Subchapter B. COMMUNITY PHARMACY (CLASS A)
(8)
Component--Any ingredient
intended for use in the compounding of a drug product, including those that
may not appear in such product.]
(9)
Compounding--The preparation,
mixing, assembling, packaging, or labeling of a drug or device:]
(A)
as the result of a practitioner's prescription
drug order or initiative based on the practitioner-patient-pharmacist relationship
in the course of professional practice;]
(B)
in anticipation of prescription drug 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.]
(10)
] 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 order.
(11)
] 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, II, III,
IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act
of 1970, as amended (Public Law 91-513).
(12)
] Dangerous drug A drug or
device that:
(13)
] Data communication device--An
electronic device that receives electronic information from one source and
transmits or routes it to another (e.g., bridge, router, switch or gateway).
(14)
] Deliver or delivery--The
actual, constructive, or attempted transfer of a prescription drug or device
or controlled substance from one person to another, whether or not for a
consideration.
(15)
] Designated agent--
(16)
] 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.
(17)
] Dispensing pharmacist--The
pharmacist responsible for the final check of the dispensed prescription
before delivery to the patient.
(18)
] Distribute--The delivery
of a prescription drug or device other than by administering or dispensing.
(19)
] Downtime--Period of time
during which a data processing system is not operable.
(20)
] Drug regimen review--An evaluation
of prescription drug orders and patient medication records for:
(21)
] Electronic prescription drug
order--A prescription drug order which is transmitted by an electronic device
to the receiver (pharmacy).
(22)
] 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:
(23)
] 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.
(24)
] Hard copy--A physical document
that is readable without the use of a special device (i.e., cathode ray tube
(CRT), microfiche reader, etc.).
(25)
Manufacturing--The production,
preparation, propagation, conversion, or processing of a drug or device,
either directly or indirectly, by extraction from substances of natural origin
or independently by means of chemical or biological synthesis and includes
any packaging or repackaging of the substances or labeling or relabeling
of the container and the promotion and marketing of such drugs or devices.
Manufacturing also includes the preparation and promotion of commercially
available products from bulk compounds for resale by pharmacies, practitioners,
or other persons but does not include compounding.]
(26)
] Medical Practice Act--The
Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
(27)
] 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.
(28)
] New prescription drug order--A
prescription drug order that:
(29)
] Original prescription--The:
(30)
] Part-time pharmacist--A pharmacist
who works less than full-time.
(31)
] 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.
(32)
] 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.
(33)
] 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.
(34)
] Pharmacy technician-An individual
whose responsibility in a pharmacy is to provide technical services that
do not require professional judgment regarding preparing and distributing
drugs and who works under the direct supervision of and is responsible to
a pharmacist. Pharmacy technician includes registered pharmacy technicians
and pharmacy technician trainees.
(35)
] Pharmacy technician trainee
A person who is not registered as a pharmacy technician by the board and
is either:
(36)
] 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, and issued an identification number by the Texas State
Board of Medical Examiners.
(37)
] Practitioner--
(38)
] 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.
(39)
] Prescription drug order--
(40)
] Prospective drug use review--A
review of the patient's drug therapy and prescription drug order or medication
order prior to dispensing or distributing the drug.
(41)
] State--One of the 50 United
States of America, a U.S. territory, or the District of Columbia.
(42)
] Texas Controlled Substances
Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter
481, as amended.
(43)
] 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.
(D)
bulk compounding of drugs;]
(E)
] storage of all materials, including
drugs, chemicals, and biologicals;
(F)
] maintaining records of all
transactions of the Class A pharmacy necessary to maintain accurate control
over and accountability for all pharmaceutical materials required by applicable
state and federal laws and sections;
(G)
] supervising a system to assure
maintenance of effective controls against the theft or diversion of prescription
drugs, and records for such drugs;
(H)
] adherence to policies and procedures
regarding the maintenance of records in a data processing system such that
the data processing system is in compliance with Class A (community) pharmacy
requirements;
(I)
] legal operation of the pharmacy,
including meeting all inspection and other requirements of all state and
federal laws or sections governing the practice of pharmacy; and
(J)
] effective September 1, 2000,
if the pharmacy uses an automated pharmacy dispensing system, shall be responsible
for the following:
nonsterile
] compounding.
possess
the education, training, and proficiency necessary to properly and safely
perform compounding duties undertaken or supervised. Continuing education
shall include training in the art and science of compounding and the legal
requirements for compounding.
]
A pharmacist shall inspect and approve
all components, drug product containers, closures, labeling, and any other
materials involved in the compounding process.
]
(C)
A pharmacist shall review
all compounding records for accuracy and conduct in-process and final checks
to assure that errors have not occurred in the compounding process.]
(D)
A pharmacist is responsible
for the proper maintenance, cleanliness, and use of all equipment used in
the compounding process.]
sterile
] pharmaceuticals shall comply
with the provisions of
§291.25 of this title (relating to Pharmacies
Compounding Non-sterile Pharmaceuticals)
[
§§291.36 of
this title (relating to Class A Pharmacies Compounding Sterile Pharmaceuticals)
].
(10)
] A Class A (Community) pharmacy
engaged in the provision of remote pharmacy services, including storage and
dispensing of prescription drugs, shall comply with the provisions of §291.20
of this title (relating to Remote Pharmacy Services).
(11)
] A Class A (Community) pharmacy
engaged in centralized prescription dispensing and/or prescription drug or
medication order processing shall comply with the provisions of §291.37
of this title (relating to Centralized Prescription Dispensing) and/or §291.38
of this title (relating to Centralized Prescription Drug or Medication Order
Processing).
(2)
Special requirements for nonsterile
compounding.]
(A)
Pharmacies regularly engaging in compounding
shall have a designated and adequate area for the safe and orderly compounding
of drug products, including the placement of equipment and materials. Pharmacies
involved in occasional compounding shall prepare an area prior to each compounding
activity which is adequate for safe and orderly compounding.]
(B)
Only personnel authorized by the responsible
pharmacist shall be in the immediate vicinity of a drug compounding operation.]
(C)
A sink with hot and cold running water, exclusive
of rest room facilities, shall be accessible to the compounding areas and
be maintained in a sanitary condition. Supplies necessary for adequate washing
shall be accessible in the immediate area of the sink and include:]
(i)
soap or detergent; and]
(ii)
air-driers or single-use towels.]
(D)
If drug products which require special precautions
to prevent contamination, such as penicillin, are involved in a compounding
operation, appropriate measures, including dedication of equipment for such
operations or the meticulous cleaning of contaminated equipment prior to
its use for the preparation of other drug products, must be utilized in order
to prevent cross-contamination.]
(3)
] Security.
(4)
] Temporary absence of pharmacist.
(1)
]
Class A pharmacies dispensing prescription
drug orders shall have the following equipment and supplies:
(A)
] typewriter or comparable equipment;
(B)
] refrigerator;
(C)
] adequate supply of child-resistant,
light-resistant, tight, and if applicable, glass containers;
(D)
] adequate supply of prescription,
poison, and other applicable labels;
(E)
] appropriate equipment necessary
for the proper preparation of prescription drug orders; and
(F)
] metric-apothecary weight and
measure conversion charts.
(2)
If the community pharmacy
compounds prescription drug orders, the pharmacy shall:]
(A)
have a Class A prescription balance, or analytical
balance and weights which shall be properly maintained and inspected at least
every three years by the appropriate authority as prescribed by local, state,
or federal law or regulations; and]
(B)
have equipment and utensils necessary for the
proper compounding of prescription drug orders. Such equipment and utensils
used in the compounding process shall be:]
(i)
of appropriate design, appropriate capacity,
and be operated within designed operational limits;]
(ii)
of suitable composition so that surfaces that
contact components, in- process material, or drug products shall not be reactive,
additive, or absorptive so as to alter the safety, identity, strength, quality,
or purity of the drug product beyond acceptable standards;]
(iii)
cleaned and sanitized immediately prior to
each use; and]
(iv)
routinely inspected, calibrated (if necessary),
or checked to ensure proper performance.]
(4)
Drugs, components, and materials
used in nonsterile compounding.]
(A)
Drugs used in nonsterile compounding shall:]
(i)
meet official compendia requirements; or]
(ii)
be of a chemical grade in one of the following
categories:]
(I)
Chemically Pure (CP);]
(II)
Analytical Reagent (AR); or]
(III)
American Chemical Society (ACS); or]
(iii)
in the professional judgment of the pharmacist,
be of high quality and obtained from acceptable and reliable alternative
sources.]
(B)
All components shall be stored in properly
labeled containers in a clean, dry area, under proper temperatures as defined
in paragraph (1) of this subsection.]
(C)
Drug product containers and closures shall
not be reactive, additive, or absorptive so as to alter the safety, identity,
strength, quality, or purity of the compounded drug product beyond the desired
result.]
(D)
Components, drug product containers, and closures
shall be rotated so that the oldest stock is used first.]
(E)
Container closure systems shall provide adequate
protection against foreseeable external factors in storage and use that can
cause deterioration or contamination of the compounded drug product.]
(5)
] Class A Pharmacies may not
sell, purchase, trade or possess prescription drug samples, unless the pharmacy
meets all of the following conditions:
(i)
Nonsterile compounding.]
(1)
Purpose. The purpose of this subsection is
to provide standards for the compounding of nonsterile drug products in licensed
pharmacies for dispensing and/or administration to humans or animals. Licensed
pharmacies compounding nonsterile drug products shall comply with the following
paragraphs in addition to all other provisions of this section and §§291.31,
291.32, 291.34, and 291.35 of this title (relating to Definitions, Personnel,
Records, and Triplicate Prescription Requirements).]
(2)
General requirements.]
(A)
Nonsterile drug products may be compounded
in licensed pharmacies:]
(i)
when there exists a valid pharmacist/patient/prescriber
relationship and upon the presentation of a valid prescription drug order;
or]
(ii)
in anticipation of future prescription drug
orders based on routine, regularly observed prescribing patterns.]
(B)
Nonsterile compounding in anticipation of future
prescription drug orders must be based upon a history of receiving valid
prescriptions issued within an established pharmacist/patient/prescriber
relationship, provided that in the pharmacist's professional judgment the
quantity prepared is stable for the anticipated shelf time.]
(i)
The pharmacist's professional judgment should
be based on criteria such as:]
(I)
physical and chemical properties of active
ingredients;]
(II)
use of preservatives and/or stabilizing agents;]
(III)
dosage form;]
(IV)
storage conditions; and]
(V)
scientific, laboratory, or reference data.]
(ii)
Documentation of the criteria used to determine
the stability for the anticipated shelf time must be maintained with the
nonsterile compounding record.]
(iii)
Any product compounded in anticipation of
future prescription drug orders shall be labeled. Such label shall contain:]
(I)
name and strength of the compounded medication
or list of the active ingredients and strengths;]
(II)
facility's lot number;]
(III)
"use by" date as determined by the pharmacist
using appropriate documented criteria as outlined in clause (i) of this subparagraph;
and]
(IV)
quantity or amount in the container.]
(C)
Commercially available drug products may be
compounded for individual patients under the provisions of subparagraph (A)
of this paragraph provided the prescribing practitioner has requested that
the drug product be compounded.]
(D)
Drug products may be compounded for the exclusive
use of the pharmacy where the products are compounded. Compounded drug products
may not be distributed for resale, including distribution to pharmacies under
common ownership or control, except that a practitioner may obtain compounded
drug products for administration to patients, but not for dispensing. Products
compounded for physician administration to patients shall be labeled. Such
label shall contain:]
(i)
the statement: "For Office Use Only";]
(ii)
name and strength of the compounded medication
or list of the active ingredients and strengths;]
(iii)
facility's control number;]
(iv)
"use by" date as determined by the pharmacist
using appropriate documented criteria as outlined in subparagraph (B)(i)
of this paragraph; and]
(v)
quantity or amount in the container.]
(E)
Compounding pharmacies/pharmacists may advertise
and promote the fact that they provide nonsterile prescription compounding
services, but shall not solicit business by promoting to compound specific
drug products.]
(3)
Compounding process.]
(A)
Any person with an apparent illness or open
lesion that may adversely affect the safety or quality of a drug product
being compounded shall be excluded from direct contact with components, drug
product containers, closures, any materials involved in the compounding process,
and drug products until the condition is corrected.]
(B)
Personnel engaged in the compounding of drug
products shall wear clean clothing appropriate to the operation being performed.
Protective apparel, such as coats/jackets, aprons, hair nets, gowns, hand
or arm coverings, or masks shall be worn as necessary to protect personnel
from chemical exposure and drug products from contamination.]
(C)
At each step of the compounding process, the
pharmacist shall ensure that components used in compounding are accurately
weighed, measured, or subdivided as appropriate to conform to the formula
being prepared.]
(D)
The pharmacist shall establish and conduct
quality control procedures to monitor the output of compounded drug products
for uniformity and consistency such as capsule weight variations, adequacy
of mixing, clarity, or pH of solutions. Such procedures shall be documented
in the nonsterile compounding record.]
(E)
Compounding records for all drugs compounded
in anticipation of future prescription drug orders shall be maintained by
the pharmacy electronically or manually as part of the prescription, formula
record, formula book, or compounding log and shall include:]
(i)
the date of preparation;]
(ii)
facility's lot number;]
(iii)
manufacturer's lot number(s) and expiration
date(s) for all components (if the original manufacturer's lot number(s)
and expiration date(s) are not known, the pharmacy shall record the source
of acquisition of the components);]
(iv)
a complete formula, including methodology
and necessary equipment;]
(v)
signature or initials of the pharmacist or
supportive person performing the compounding;]
(vi)
signature or initials of the pharmacist responsible
for supervising supportive personnel and conducting in-process and finals
checks of compounded products if supportive personnel perform the compounding
function;]
(vii)
the brand name(s) of the raw materials, or
if no brand name, the generic name(s) and the name(s) of the manufacturer(s)
of the raw materials;]
(viii)
the quantity in units of finished products
or grams of raw materials;]
(ix)
the package size and the number of units prepared;]
(x)
documentation of performance of quality control
procedures; and]
(xi)
the criteria used to determine the "use by"
date.]
(F)
Compounding records for all drugs compounded
pursuant to an individual prescription and not in anticipation of future
prescription drug orders shall be maintained by the pharmacy electronically
or manually as part of the prescription, formula record, formula book, or
compounding log and shall include:]
(i)
the date of preparation;]
(ii)
a complete formula which includes the brand
name(s) of the raw materials, or if no brand name, the generic name(s) and
name(s) of the manufacturer(s) of the raw materials and the quantities of
each;]
(iii)
signature or initials of the pharmacist or
supportive person performing the compounding;]
(iv)
signature or initials of the pharmacist responsible
for supervising supportive personnel and conducting in-process and finals
checks of compounded products if supportive personnel perform the compounding
function;]
(v)
the quantity in units of finished products
or grams of raw materials;]
(vi)
the package size and the number of units prepared;
and]
(vii)
documentation of performance of quality control
procedures. Documentation of the performance of quality control procedures
is not required if the compounding process involves the mixing of two or
more commercially available oral liquids or commercially available preparations
when the final product is intended for external use.]
(j)
] Automated devices and systems.
unless the operator is
authorized to receive the confidential information as specified in subsection
(k) of this section.
]
pharmacists or other responsible individuals
]
shall verify that the controlled drugs listed on the invoices were actually
received by clearly recording
his/her
[
their
] initials
and the actual date of receipt of the controlled substances;
Subchapter C. NUCLEAR PHARMACY (CLASS B)
(3)
] Administer--The direct application
of a prescription drug and/or radiopharmaceutical, by injection, inhalation,
ingestion, or any other means to the body of a patient by:
(4)
] Airborne particulate cleanliness
class--The level of cleanliness specified by the maximum allowable number
of particles per cubic foot of air as specified in Federal Standard 209E,
et seq. For example:
(5)
] Authentication of product
history--Identifying the purchasing source, the intermediate handling, and
the ultimate disposition of any component of a radioactive drug.
(6)
] Authorized nuclear pharmacist--A
pharmacist who has completed the specialized training requirements specified
by these rules for the preparation and distribution of radiopharmaceuticals.
(7)
] Authorized user--Any individual
named on a Texas radioactive material license, issued by the Texas Department
of Health, Bureau of Radiation Control.
(8)
] Automated compounding or
drug dispensing device--An automated device that compounds, measures, counts,
packages, and/or labels a specified quantity of dosage units for a designated
drug product.
(9)
] 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.
(10)
] Board--The Texas State Board
of Pharmacy.
(11)
] Class B pharmacy license
or nuclear pharmacy license--A license issued to a pharmacy dispensing or
providing radioactive drugs or devices for administration to an ultimate user.
(12)
] Clean room--A room in which
the concentration of airborne particles is controlled and there are one or
more clean zones according to
the International Organization of Standardization
(ISO), Specifications for testing and monitoring to prove continued compliance
with ISO 14644-1 and/or ISO 14644-2.
[
Federal Standard 209E, et
seq.
]
(13)
] Clean zone--A defined space
in which the concentration of airborne particles is controlled to meet a specified
airborne particulate cleanliness class.
(14)
] Controlled area--A controlled
area is the area designated for preparing sterile radiopharmaceuticals.
(15)
] 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 Schedule I, II,
III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control
Act of 1970, as amended (Public Law 91-513).
(16)
] Dangerous drug--A drug or
device that:
(17)
] Data communication device--An
electronic device that receives electronic information from one source and
transmits or routes it to another (e.g., bridge, router, switch, or gateway).
(18)
] Deliver or delivery--The
actual, constructive, or attempted transfer of a prescription drug or device,
radiopharmaceutical, or controlled substance from one person to another, whether
or not for a consideration.
(19)
] Designated agent--
(20)
] Device--An instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other similar
or related articles, including any component parts or accessory that is required
under federal or state law to be ordered or prescribed by a practitioner.
(21)
] Diagnostic prescription
drug order--A radioactive prescription drug order issued for a diagnostic
purpose.
(22)
] Dispense--Preparing, packaging,
compounding, or labeling for delivery a prescription drug or device, or a
radiopharmaceutical in the course of professional practice to an ultimate
user or his agent by or pursuant to the lawful order of a practitioner.
(23)
] Dispensing pharmacist--The
authorized nuclear pharmacist responsible for the final check of the dispensed
prescription before delivery to the patient.
(24)
] Distribute--The delivering
of a prescription drug or device, or a radiopharmaceutical other than by administering
or dispensing.
(25)
] Electronic radioactive prescription
drug order--A radioactive prescription drug order which is transmitted by
an electronic device to the receiver (pharmacy).
(26)
] Internal test assessment--Validation
of tests for quality control necessary to insure the integrity of the test.
(27)
] Nuclear pharmacy technique--The
mechanical ability required to perform the nonjudgmental, technical aspects
of preparing and dispensing radiopharmaceuticals.
(28)
] Original prescription--The:
(29)
] 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.
(30)
] Pharmacy technician--An
individual whose responsibility in a pharmacy is to provide technical services
that do not require professional judgment regarding preparing and distributing
drugs and who works under the direct supervision of and is responsible to
a pharmacist. Pharmacy technician includes registered pharmacy technicians
and pharmacy technician trainees.
(31)
] Pharmacy technician trainee--A
person who is not registered as a pharmacy technician by the board and is
either:
(32)
] 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.
(33)
] Radiopharmaceutical--A prescription
drug or device that exhibits spontaneous disintegration of unstable nuclei
with the emission of a nuclear particle(s) or photon(s), including any nonradioactive
reagent kit or nuclide generator that is intended to be used in preparation
of any such substance.
(34)
] Radioactive drug quality
control--The set of testing activities used to determine that the ingredients,
components (e.g., containers), and final radiopharmaceutical prepared meets
predetermined requirements with respect to identity, purity, non-pyrogenicity,
and sterility and the interpretation of the resulting data in order to determine
the feasibility for use in humans and animals including internal test assessment,
authentication of product history, and the keeping of mandatory records.
(35)
] Radioactive drug service--The
act of distributing radiopharmaceuticals; the participation in radiopharmaceutical
selection and the performance of radiopharmaceutical drug reviews.
(36)
] Radioactive prescription
drug order--An order from a practitioner or a practitioner's designated agent
for a radiopharmaceutical to be dispensed.
(37)
] Sterile radiopharmaceutical--A
dosage form of a radiopharmaceutical free from living micro-organisms.
(38)
] Therapeutic prescription
drug order--A radioactive prescription drug order issued for a specific patient
for a therapeutic purpose.
(39)
] Ultimate user--A person
who has obtained and possesses a prescription drug or radiopharmaceutical
for his or her own use or for the use of a member of his or her household.
(C)
]
supervising a system
to assure appropriate
[
establishing policies for
] procurement
of drugs and devices and storage of all pharmaceutical materials including
radiopharmaceuticals, components used in the compounding of radiopharmaceuticals,
and drug delivery devices;
(D)
] developing a system for the
disposal and distribution of drugs from the Class B pharmacy;
(E)
] developing a system for the
compounding, sterility assurance, and quality control of sterile radiopharmaceuticals;
(F)
] maintaining records of all
transactions of the Class B pharmacy necessary to maintain accurate control
over and accountability for all pharmaceutical materials including radiopharmaceuticals,
required by applicable state and federal laws and rules;
(G)
] developing a system to assure
the maintenance of effective controls against the theft or diversion of prescription
drugs, and records for such drugs;
(H)
] assuring that the pharmacy
has a system to dispose of radioactive and cytotoxic waste in a manner so
as not to endanger the public health; and
(I)
] legal operation of the pharmacy,
including meeting all inspection and other requirements of all state and federal
laws or rules governing the practice of pharmacy.
(2)
] Duties. Duties which may only
be performed by an authorized nuclear pharmacist are as follows:
(2)
] Duties.
(b)(2)
] of this
section provided:
(3)
] Ratio of authorized nuclear
pharmacist to pharmacy technicians.
American Council
on Pharmaceutical Education
] approved provider which provides 20 hours
of instruction and experience in the areas listed in this paragraph; and
effective January 1, 2000,
] complete
through a single course, a minimum of
[
a recognized course in an
accredited college of pharmacy or a course sponsored by an American Council
on Pharmaceutical Education approved provider which provides
] 20 hours
of instruction and experience in the areas listed in paragraph (1) of this
subsection
. Such training may be obtained through:
[
; and
]
(B)
Pharmacists shall discontinue
preparation of sterile radiopharmaceuticals if the training specified in subparagraph
(A) of this paragraph is not completed by January 1, 2000.]
(C)
] The required experiential
portion of the training programs specified in this paragraph must be supervised
by an individual who has already completed training in the compounding of
sterile pharmaceuticals
as specified in paragraph (2) or (3) of this
subsection.
(B)
complete through a single
course, a structured on-the-job didactic and experiential training program
at this pharmacy which provides 40 hours of instruction and experience in
the areas listed in paragraph (1) of this subsection. Such training may not
be transferred to another pharmacy unless the pharmacies are under common
ownership and control and use a common training program;]
(C)
acquire the required experiential
portion of the training programs specified in this paragraph under the supervision
of an individual who has already completed training in the compounding of
sterile pharmaceuticals.]
(D)
effective January 1, 2001,
be certified pharmacy technicians.]
(E)
on January 1, 2001, discontinue
preparation of sterile pharmaceuticals if the technician has not taken and
passed the National Pharmacy Technician Certification Exam or other examination
approved during an open meeting by the Board. Such pharmacy technicians may
continue to compound sterile pharmaceuticals during the interim between the
effective date of these rules and January 1, 2001, if they maintain documentation
of completion of the training specified in subparagraph (B) of this paragraph.]
Triplicate
] Prescription Requirements)[
; and §291.36 of this
title (relating to Class A Pharmacies Dispensing Compounded Sterile Parenteral
and/or Enteral Products), contained in Community Pharmacy (Class A)
],
to the extent such rules are applicable to the operation of the pharmacy.
§§291.31 - 291.34 of this title (relating to Definitions, Personnel,
Operational Standards, and Records for Class A (Community) Pharmacies) to
the extent such rules are applicable to nonsterile compounding of drug products.
]
(b)
] Environment.
(c)
] Prescription dispensing and
delivery.
(d)
] Pharmaceutical Care Services.
(e)
] Equipment. The following minimum
equipment is required in a nuclear pharmacy:
(7)
] adequate glassware, utensils,
gloves, syringe shields and remote handling devices, and adequate equipment
for product quality control;
(8)
] adequate shielding material;
(9)
] typewriter or comparable
equipment;
(10)
] radiation dosimeters for
visitors and personnel and log entry book;
(11)
] exhaust/fume hood with monitor,
for storage and handling of all volatile radioactive drugs if applicable,
to be determined by the Texas Radiation Control Bureau;
(12)
] calculator; and
(13)
] adequate radiation monitor(s).
(f)
] Library. A nuclear pharmacy
shall maintain a reference library which shall include the following in hard
copy or electronic format:
(g)
] Radiopharmaceuticals and/or
radioactive materials.
(h)
] Loading bulk drugs into automated
compounding devices.
(i)
] Sterile radiopharmaceuticals.
unless the operator is authorized
to receive the confidential information as specified in subsection (f) of
this section.
]
pharmacists or other responsible individuals
]
shall verify that the controlled drugs listed on the invoices were actually
received by clearly recording
his/her
[
their
] initials
and the actual date of receipt of the controlled substances;
Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)
(4)
Airborne particulate cleanliness
class--The level of cleanliness specified by the maximum allowable number
of particles per cubic foot of air as specified in Federal Standard 209E
et seq. For example:
(A)
Class 100 is an atmospheric environment which
contains less than 100 particles 0.5 microns in diameter per cubic foot of
air;]
(B)
Class 10,000 is an atmospheric environment
which contains less than 10,000 particles 0.5 microns in diameter per cubic
foot of air; and]
(C)
Class 100,000 is an atmospheric environment
which contains less than 100,000 particles 0.5 microns in diameter per cubic
foot of air.]
(5)
Aseptic preparation--The technique
involving procedures designed to preclude contamination of drugs, packaging,
equipment, or supplies by microorganisms during processing.]
(6)
] Automated compounding or counting
device--An automated device that compounds, measures, counts and/or packages
a specified quantity of dosage units of a designated drug product.
(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)
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.]
(9)
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.]
(10)
] Board--The State Board of
Pharmacy.
(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:]
(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.]
(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--A drug or
device that:
(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--
(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 licensed hospital, or other hospital or facility maintained
or operated by the state, 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.
An inpatient includes a person confined in any correctional institution operated
by the state of Texas.
(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)
] Medical Practice Act--The
Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
(39)
] 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.
(40)
] Part-time pharmacist--A pharmacist
either employed or under contract, who routinely works less than full-time.
(41)
] 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.
(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)
] 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.
(44)
] 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.
(45)
] Pharmacy technician--An individual
whose responsibility in a pharmacy is to provide technical services that
do not require who works under the direct supervision of and is responsible
to a pharmacist. Pharmacy technician includes registered pharmacy technicians
and pharmacy technician trainees.
(46)
] Pharmacy technician trainee--A
person who is:
(47)
] 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.
(48)
] Prescription drug--
(49)
] Prescription drug order--
(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, the 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 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.
(C)
developing a system for the
compounding, sterility assurance, quality assurance and quality control of
sterile pharmaceuticals compounded within the institutional pharmacy;]
(D)
developing a system to assure
that all pharmacy personnel responsible for compounding and/or supervising
the compounding of sterile pharmaceuticals within the pharmacy receive appropriate
education and training and competency evaluation;]
(E)
] providing written guidelines
and approval of the procedure to assure that all pharmaceutical requirements
are met when any part of preparing, sterilizing, and labeling of sterile
pharmaceuticals is not performed under direct pharmacy supervision;
(F)
developing a system for bulk
compounding or batch preparation of drugs;]
(G)
establishing specifications
for procurement and storage of all pharmaceutical materials including pharmaceuticals,
components used in the compounding of pharmaceuticals, and drug delivery
devices;]
(H)
] participating in the development
of a formulary for the facility, subject to approval of the appropriate committee
of the facility;
(I)
] developing a system to assure
that drugs to be administered to inpatients are distributed pursuant to an
original or direct copy of the practitioner's medication order;
(J)
] developing a system for the
filling and labeling of all containers from which drugs are to be distributed
or dispensed;
(K)
] assuring that the pharmacy
maintains and makes available a sufficient inventory of antidotes and other
emergency drugs as well as current antidote information, telephone numbers
of regional poison control center and other emergency assistance organizations,
and such other materials and information as may be deemed necessary by the
appropriate committee of the facility;
(L)
] maintaining records of all
transactions of the institutional pharmacy as may be required by applicable
law, state and federal, and as may be necessary to maintain accurate control
over and accountability for all pharmaceutical materials including pharmaceuticals,
components used in the compounding of pharmaceuticals, and drug delivery
devices;
(M)
] participating in those aspects
of the facility's patient care evaluation program which relate to pharmaceutical
utilization and effectiveness;
(N)
] participating in teaching and/or
research programs in the facility;
(O)
] implementing the policies and
decisions of the appropriate committee(s) relating to pharmaceutical services
of the facility;
(P)
] providing effective and efficient
messenger or delivery service to connect the institutional pharmacy with
appropriate areas of the facility on a regular basis throughout the normal
workday of the facility;
(Q)
] developing a system for the
labeling, storage, and distribution of investigational new drugs, including
maintenance of information in the pharmacy and nursing station where such
drugs are being administered, concerning the dosage form, route of administration,
strength, actions, uses, side effects, adverse effects, interactions and
symptoms of toxicity of investigational new drugs;
(R)
] assuring that records in a
data processing system are maintained such that the data processing system
is in compliance with Class C (Institutional) pharmacy requirements;
(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:
(A)
providing those acts or services
necessary to provide pharmaceutical care;]
(B)
]
compounding
[
Sterile pharmaceuticals. Pharmacy technicians may compound
] sterile
pharmaceuticals pursuant to medication orders provided the pharmacy technicians:
subsection (f) of this section;
] and
subsection
(f) of this section
] and who conducts in-process and final checks,
and affixes his or her initials to the label or if batch prepared, to the
appropriate quality control records. (The initials are not required on the
label if it is maintained in a permanent record of the pharmacy)
(3)
] Procedures.
(f)
Special education, training,
and evaluation requirements for pharmacy personnel compounding or responsible
for the direct supervision of pharmacy personnel compounding sterile pharmaceuticals.]
(1)
General.]
(A)
All pharmacy personnel preparing sterile pharmaceuticals
shall receive didactic and experiential training and competency evaluation
through demonstration, testing (written or practical) as outlined by the
pharmacist-in-charge and described in the policy and procedure or training
manual. Such training shall include instruction and experience in the following
areas:]
(i)
aseptic technique;]
(ii)
critical area contamination factors;]
(iii)
environmental monitoring;]
(iv)
facilities;]
(v)
equipment and supplies;]
(vi)
sterile pharmaceutical calculations and terminology;]
(vii)
sterile pharmaceutical compounding documentation;]
(viii)
quality assurance procedures;]
(ix)
aseptic preparation procedures, including
proper gowning and gloving technique;]
(x)
the handling of cytotoxic and hazardous drugs;
and]
(xi)
general conduct in the controlled area.]
(B)
The aseptic technique of each
person compounding or responsible for the direct supervision of personnel
compounding sterile pharmaceuticals shall be observed and evaluated as satisfactory
through written or practical tests and process validation and such evaluation
documented.]
(C)
Although process validation
may be incorporated into the experiential portion of a training program,
process validation must be conducted at each pharmacy where an individual
compounds sterile pharmaceuticals. No product intended for patient use shall
be compounded by an individual until the on-site process validation test
indicates that the individual can competently perform aseptic procedures,
except that a pharmacist may compound sterile pharmaceuticals and supervise
pharmacy technicians compounding sterile pharmaceuticals without process
validation provided the pharmacist:]
(i)
has completed a recognized course in an accredited
college of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in this paragraph; and]
(ii)
completes the on-site process validation within
seven days of commencing work at the pharmacy.]
(D)
Process validation procedures
for assessing the preparation of specific types of sterile pharmaceuticals
shall be representative of all types of manipulations, products, and batch
sizes that personnel preparing that type of pharmaceutical are likely to encounter.]
(E)
The pharmacist-in-charge shall
assure continuing competency of pharmacy personnel through in-service education,
training, and process validation to supplement initial training. Personnel
competency shall be evaluated:]
(i)
during orientation and training prior to the
regular performance of those tasks;]
(ii)
whenever the quality assurance program yields
an unacceptable result;]
(iii)
whenever unacceptable techniques are observed;
and]
(iv)
at least on an annual basis.]
(2)
Pharmacists.]
(A)
All pharmacists who compound sterile pharmaceuticals
or supervise pharmacy technicians compounding sterile pharmaceuticals shall:]
(i)
complete through a single course, a minimum
20 hours of instruction and experience in the areas listed in paragraph (1)
of this subsection. Such training may be evidenced by either:]
(I)
completion of a structured on-the-job didactic
and experiential training program at this pharmacy which provides 20 hours
of instruction and experience in the areas listed in paragraph (1) of this
subsection. Such training may not be transferred to another pharmacy unless
the pharmacies are under common ownership and control and use a common training
program; or]
(II)
completion of a recognized course in an accredited
college of pharmacy or a course sponsored by an American Council on Pharmaceutical
Education approved provider which provides 20 hours of instruction and experience
in the areas listed in paragraph (1) of this subsection; and]
(ii)
possess knowledge about:]
(I)
aseptic processing;]
(II)
quality control and quality assurance as related
to environmental, component, and end-product testing;]
(III)
chemical, pharmaceutical, and clinical properties
of drugs;]
(IV)
container, equipment, and closure system selection;
and]
(V)
sterilization techniques.]
(B)
The required experiential portion of the training
programs specified in this paragraph must be supervised by an individual
who has already completed training as specified in paragraph (2) or (3) of
this subsection.]
(3)
Pharmacy technicians. In addition
to the qualifications and training outlined in subsection (e) of this section,
all pharmacy technicians who compound sterile pharmaceuticals shall:]
(A)
have a high school or equivalent education;]
(B)
either:]
(i)
complete through a single course, a minimum
of 40 hours of instruction and experience in the areas listed in paragraph
(1) of this subsection. Such training may be obtained through the:]
(I)
completion of a structured on-the-job didactic
and experiential training program at this pharmacy which provides 40 hours
of instruction and experience in the areas listed in paragraph (1) of this
subsection. Such training may not be transferred to another pharmacy unless
the pharmacies are under common ownership and control and use a common training
program; or
(II)
completion of a course sponsored by an ACPE
approved provider which provides 40 hours of instruction and experience in
the areas listed in paragraph (1) of this subsection; or]
(ii)
complete a training program which is accredited
by the American Society of Health- System Pharmacists (formerly the American
Society of Hospital Pharmacists). Individuals enrolled in training programs
accredited by the American Society of Health-System Pharmacists may compound
sterile pharmaceuticals in a licensed pharmacy provided:]
(I)
the compounding occurs only during times the
individual is assigned to a pharmacy as a part of the experiential component
of the American Society of Health-System Pharmacists training program;]
(II)
the individual is under the direct supervision
of and responsible to a pharmacist who has completed training as specified
in paragraph (2) of this subsection; and]
(III)
the supervising pharmacist conducts in-process
and final checks; and]
(C)
on January 1, 2001, discontinue preparation
of sterile pharmaceuticals if the technician has not taken and passed the
National Pharmacy Technician Certification Exam or other examination approved
during an open meeting by the Board. Such pharmacy technicians may continue
to compound sterile pharmaceuticals during the interim between the effective
date of these rules and January 1, 2001, if they maintain documentation of
completion of the training specified in subparagraph (B) of this paragraph.]
(D)
acquire the required experiential portion of
the training programs specified in this paragraph under the supervision of
an individual who has already completed training as specified in this paragraph
or paragraph (2) of this subsection.]
(4)
Documentation of Training.
A written record of initial and in-service training and the results of written
or practical testing and process validation of pharmacy personnel shall be
maintained and contain the following information:]
(A)
name of the person receiving the training or
completing the testing or process validation;]
(B)
date(s) of the training, testing, or process
validation;]
(C)
general description of the topics covered in
the training or testing or of the process validated;]
(D)
name of the person supervising the training,
testing, or process validation; and]
(E)
signature (first initial and last name or full
signature) of the person receiving the training or completing the testing
or process validation and the pharmacist-in-charge or other pharmacist employed
by the pharmacy and designated by the pharmacist-in-charge as responsible
for training, testing, or process validation of personnel.]
(g)
] Identification of pharmacy
personnel. All pharmacy personnel shall wear an identification tag or badge
which bears the person's name and identifies him or her by title or function
as follows:
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.
§§291.31
- 291.34 of this title to the extent such rules are applicable to non-sterile
compounding of drug products
].
(11)
] A Class C (Institutional)
pharmacy engaged in the provision of remote pharmacy services, including
storage and dispensing of prescription drugs, shall comply with the provisions
of §291.20 of this title (relating to Remote Pharmacy Services).
(12)
] A Class C (Institutional)
pharmacy engaged in centralized prescription dispensing and/or prescription
drug or medication order processing shall comply with the provisions of §291.37
of this title (relating to Centralized Prescription Dispensing) and/or §291.38
of this title (relating to Centralized Prescription Drug or Medication Order
Processing).
(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)
Aseptic environment control device(s). The
institutional pharmacy shall prepare sterile pharmaceuticals in an appropriate
aseptic environmental control device(s) or area, such as a laminar air flow
hood, biological safety cabinet, or clean room, which is capable of maintaining
at least Class 100 conditions during normal activity. Such aseptic environmental
control device(s) shall:]
(I)
be certified by an independent contractor according
to Federal Standard 209E et seq for operational efficiency at least every
six months or when it is relocated; and]
(II)
have pre-filters inspected periodically and
replaced as needed, in accordance with written policies and procedures, and
the inspection and/or replacement date documented.]
(ii)
Controlled area. The institutional pharmacy
shall have a designated controlled area for the compounding of sterile pharmaceuticals
that is functionally separate from areas for the preparation of non-sterile
pharmaceuticals and is constructed to minimize the opportunities for particulate
and microbial contamination. This controlled area for the preparation of
sterile pharmaceuticals shall:]
(I)
have a controlled environment that is aseptic
or contains an aseptic environmental control device(s);]
(II)
be clean, well lighted, and of sufficient
size to support sterile compounding activities;]
(III)
be used only for the compounding of sterile
pharmaceuticals;]
(IV)
be designed to avoid outside traffic and air
flow and be ventilated in a manner not interfering with aseptic environmental
control conditions;]
(V)
have drugs and supplies stored on shelving
areas above the floor to permit adequate floor cleaning;]
(VI)
have non-porous and washable floors or floor
covering to enable regular disinfection;]
(VII)
have hard cleanable walls and ceilings (acoustical
ceiling tiles that are coated with an acrylic paint are acceptable); and]
(VIII)
contain only the appropriate compounding
supplies and not be used for bulk storage for supplies and materials.]
(iii)
End-product evaluation.]
(I)
The responsible pharmacist shall verify that
the sterile pharmaceutical was compounded accurately with respect to the
use of correct ingredients, quantities, containers, and reservoirs.]
(II)
End product sterility testing according to
policies and procedures, which include a statistically valid sampling plan
and acceptance criteria for the sampling and testing, shall be performed
if deemed appropriate by the pharmacist-in-charge.]
(III)
The pharmacist-in-charge shall establish
a mechanism for recalling all products of a specific batch if end-product
testing procedures yield unacceptable results.]
(B)
Cytotoxic drugs. In addition to the requirements
specified in subparagraph (A) of this paragraph, if the product is also cytotoxic,
the following is applicable.]
(i)
General.]
(I)
All personnel involved in the compounding of
cytotoxic products shall wear appropriate protective apparel, such as masks,
gloves, and gowns or coveralls with tight cuffs.]
(II)
Appropriate safety and containment techniques
for compounding cytotoxic drugs shall be used in conjunction with aseptic
techniques required for preparing sterile pharmaceuticals.]
(III)
Disposal of cytotoxic waste shall comply
with all applicable local, state, and federal requirements.]
(IV)
Prepared doses of cytotoxic drugs must be
dispensed, labeled with proper precautions inside and outside, and distributed
in a manner to minimize contact with cytotoxic agents.]
(ii)
Aseptic environment control device(s).]
(I)
Cytotoxic drugs must be prepared in a vertical
flow biological safety cabinet.]
(II)
If the vertical flow biological safety cabinet
is also used to prepare non-cytotoxic sterile pharmaceuticals, the cabinet
must be thoroughly cleaned prior to its use to prepare non-cytotoxic sterile
pharmaceuticals.]
(3)
] Security requirements.
(1)
]
Institutional pharmacies distributing medication
orders shall have the following equipment:
(A)
] typewriter or comparable equipment;
and
(B)
] refrigerator and a system or
device (e.g., thermometer) to monitor the temperature
and humidity
[
daily
] to ensure that proper storage requirements are met.
(2)
If the institutional pharmacy
compounds medication orders which require the use of a balance, a Class A
prescription balance or analytical balance with weights. Such balance shall
be properly maintained and inspected at least every three years by the appropriate
authority as prescribed by local, state, or federal law or regulations.]
(3)
If the institutional pharmacy
compounds sterile pharmaceuticals, the pharmacy shall have the following
equipment:]
(A)
appropriate disposal containers for used needles,
syringes, etc., and if applicable, cytotoxic waste from the preparation of
chemotherapeutic agents, cytotoxic waste;]
(B)
infusion devices, if applicable;]
(C)
all necessary supplies, including:]
(i)
disposable needles, syringes, and other supplies
for aseptic mixing;]
(ii)
disinfectant cleaning solutions;]
(iii)
hand washing agents with bacteriocidal action;]
(iv)
disposable, lint free towels or wipes;]
(v)
appropriate filters and filtration equipment;]
(vi)
cytotoxic spill kits, if applicable; and]
(vii)
masks, caps, coveralls or gowns with tight
cuffs, shoe covers, and gloves, as applicable.]
(5)
if the pharmacy compounds
sterile pharmaceuticals, specialty references appropriate for the scope of
services provided by the pharmacy, e.g., if the pharmacy prepares cytotoxic
drugs, a reference text on the preparation and safe handling of cytotoxic
drugs.]
(6)
] metric-apothecary weight and
measure conversion charts.
(4)
Sterile pharmaceuticals compounded
in the pharmacy.]
(A)
Batch preparation.]
(i)
Master work sheet. A master work sheet shall
be developed and approved by a pharmacist for each batch of sterile pharmaceuticals
to be prepared. Once approved, a duplicate of the master work sheet shall
be used as the preparation work sheet from which each batch is prepared and
on which all documentation for that batch occurs. The master work sheet shall
contain at a minimum:]
(I)
the formula;]
(II)
the components;]
(III)
the compounding directions;]
(IV)
a sample label;]
(V)
evaluation and testing requirements;]
(VI)
sterilization method(s), if applicable;]
(VII)
storage requirements; and]
(VIII)
specific equipment used during aseptic preparation
(e.g., specific automated compounding device).]
(ii)
Preparation work sheet. The preparation work
sheet for each batch of sterile pharmaceuticals shall document the following:]
(I)
identity of all solutions and ingredients and
their corresponding amounts, concentrations, or volumes;]
(II)
manufacturer lot number for each component;]
(III)
component manufacturer or suitable identifying
number;]
(IV)
container specifications (e.g., syringe, pump
cassette);]
(V)
unique lot or control number assigned to batch;]
(VI)
expiration date of batch-prepared products;]
(VII)
date of preparation;]
(VIII)
name, initials, or electronic signature
of the person(s) involved in the preparation;]
(IX)
name, initials, or electronic signature of
the responsible pharmacist;]
(X)
end-product evaluation and testing specifications,
if applicable; and]
(XI)
comparison of actual yield to anticipated
yield, when appropriate.]
(B)
Labeling. The label of each sterile pharmaceutical
shall bear at a minimum:]
(i)
for patient-specific products, the patient's
name and location or identification number;]
(ii)
for batch prepared products, the unique lot
or control number assigned to the batch;]
(iii)
all solution and ingredient names, amounts,
strengths, and concentrations, when applicable;]
(iv)
expiration date and time, when applicable;]
(v)
directions for use, including infusion rate,
when appropriate;]
(vi)
name or initials of the person preparing the
product and, if prepared by supportive personnel, the name or initials of
the pharmacist who checked and released the final product. (This information
is not required on the label if it is maintained in a permanent record of
the pharmacy);]
(vii)
appropriate ancillary instructions such as
storage instructions or cautionary statements, including cytotoxic warning
labels where appropriate; and]
(viii)
device-specific instructions, when appropriate.]
(C)
Expiration date.]
(i)
The expiration date assigned shall be based
on currently available drug stability information and sterility considerations
or appropriate in-house or contract service stability testing.]
(ii)
Sources of drug stability information shall
include the following:]
(I)
references (e.g., Remington's Pharmaceutical
Sciences, Handbook on Injectable Drugs);]
(II)
manufacturer recommendations; and]
(III)
reliable, published research.]
(iii)
When interpreting published drug stability
information, the pharmacist shall consider all aspects of the final sterile
product being prepared (e.g., drug reservoir, drug concentration, storage
conditions).]
(iv)
Methods used for establishing expiration dates
shall be documented.]
(D)
Quality control. There shall be a documented,
ongoing quality control program that monitors and evaluates personnel performance,
equipment and facilities. Procedures shall be in place to assure that the
pharmacy is capable of consistently preparing pharmaceuticals which are sterile
and stable. Quality control procedures shall include, but are not limited
to, the following:]
(i)
recall procedures;]
(ii)
storage and dating; and]
(iii)
documentation of appropriate functioning
of refrigerator, freezer and other equipment;]
(iv)
documentation of aseptic environmental control
device(s) certification at least every six months and the regular replacement
of pre-filters as necessary; and]
(v)
a process to evaluate and confirm the quality
of the prepared pharmaceutical product.]
(E)
Quality assurance.]
(i)
There shall be a documented, ongoing quality
assurance program for monitoring and evaluating personnel performance and
patient outcomes to assure an efficient drug delivery process, patient safety,
and positive clinical outcomes.]
(ii)
There shall be documentation of quality assurance
audits at regular, planned intervals including infection control, sterile
technique, delivery systems/times, order transcription accuracy, drug administration
systems, adverse drug reactions and drug therapy appropriateness, as applicable.]
(iii)
A plan for corrective action of problems
identified by quality assurance audits shall be developed which includes
procedures for documentation of identified problems and action taken.]
(iv)
A periodic evaluation of the effectiveness
of the quality assurance activities shall be completed and documented.]
(5)
] Sterile pharmaceuticals prepared
in a location other than the pharmacy. A distinctive supplementary label
shall be affixed to the container of any admixture. The label shall bear
at a minimum:
(6)
] Distribution.
pharmacists or other responsible individuals
]
shall verify that the controlled drugs listed on the invoices were actually
received by clearly recording
his/her
[
their
] initials
and the actual date of receipt of the controlled substances;
(i)
preparation and sterilization
of parenteral medications compounded within the ASC pharmacy;]
(ii)
admixture of parenteral products,
including education and training of nursing personnel concerning incompatibility
and provision of proper incompatibility information when the admixture of
parenteral products is not performed within the ASC pharmacy;]
(iii)
bulk compounding of drugs;]
(iv)
] establishment of specifications
for procurement and storage of all materials, including drugs, chemicals,
and biologicals;
(v)
] participation in the development
of a formulary for the ASC, subject to approval of the appropriate committee
of the ASC;
(vi)
] distribution of drugs to
be administered to inpatients pursuant to an original or direct copy of the
practitioner's medication order;
(vii)
] filling and labeling all
containers from which drugs are to be distributed or dispensed;
(viii)
] maintaining and making available
a sufficient inventory of antidotes and other emergency drugs, both in the
pharmacy and inpatient care areas, as well as current antidote information,
telephone numbers of regional poison control center and other emergency assistance
organizations, and such other materials and information as may be deemed
necessary by the appropriate committee of the ASC;
(ix)
] records of all transactions
of the ASC pharmacy as may be required by applicable state and federal law,
and as may be necessary to maintain accurate control over and accountability
for all pharmaceutical materials;
(x)
] participation in those aspects
of the ASC's patient care evaluation program which relate to pharmaceutical
material utilization and effectiveness;
(xi)
] participation in teaching
and/or research programs in the ASC;
(xii)
] implementation of the policies
and decisions of the appropriate committee(s) relating to pharmaceutical
services of the ASC;
(xiii)
] effective and efficient
messenger and delivery service to connect the ASC pharmacy with appropriate
areas of the ASC on a regular basis throughout the normal workday of the
ASC;
(xiv)
] labeling, storage, and distribution
of investigational new drugs, including maintenance of information in the
pharmacy and nursing station where such drugs are being administered, concerning
the dosage form, route of administration, strength, actions, uses, side effects,
adverse effects, interactions, and symptoms of toxicity of investigational
new drugs;
(xv)
] meeting all inspection and
other requirements of the Texas Pharmacy Act and this subsection; and
(xvi)
] maintenance of records
in a data processing system such that the data processing system is in compliance
with the requirements for a Class C (institutional) pharmacy located in a
freestanding ASC.
(C)
Special requirements. All
pharmacists who compound sterile parenteral and/or enteral products shall
meet minimal standards of training and experience in the preparation, sterilization,
and admixture of parenteral and/or enteral products; such standards of training
and experience may be evidenced by either:]
(i)
documentation of completion of a minimum of
20 hours of on- the-job training in the preparation, sterilization, and admixture
of parenteral and/or enteral products; or]
(ii)
documentation of completion of a recognized
course in an accredited college of pharmacy or a course sponsored by an ACPE
approved provider. The course must provide a minimum of 20 hours of education
or experience in the preparation, sterilization, and admixture of parenteral
and/or enteral products.]
§291.73 of this title (relating to Personnel)
]; and
§291.73 of this title,
] conducts in-process and final checks,
and affixes his or her initials to the label or if batch prepared, to the
appropriate quality control records (The initials are not required on the
label if it is maintained in a permanent record of the pharmacy.).
Triplicate
] Prescription
Records)[
, and §291.36 of this title (relating to Class A Pharmacies
Dispensing Sterile Products) 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.
]
(iii)
If the ASC pharmacy prepares
sterile products, the ASC pharmacy shall have a designated area for the laminar
air flow hood for the preparation of sterile products, which shall:]
(I)
be designed to avoid outside traffic and air
flow;]
(II)
have cleanable surfaces, walls, and floors;]
(III)
be ventilated in a manner not interfering
with laminar flow hood conditions; and]
(IV)
not be used for bulk storage for supplies
and materials.]
(D)
special equipment according
to the following requirements which shall be maintained:]
(i)
if the ASC pharmacy compounds prescriptions
or medication orders, a Class A prescription balance or analytical balance
with weights. Such balance shall be properly maintained and inspected at
least every three years by the appropriate authority as prescribed by local,
state, or federal law or regulations; and]
(ii)
if the ASC pharmacy prepares sterile parenteral
and enteral products, an annually certified laminar air flow hood and other
equipment necessary for manipulation of sterile products.]
(B)
]
General information.
A general information reference text, such as:
(i)
] Facts and Comparisons with
current supplements;
(ii)
] United States Pharmacopeia
Dispensing Information Volume I (Drug Information for the Healthcare Provider);
(iii)
] AHFS Drug Information with
current supplements;
(iv)
] Remington's Pharmaceutical
Sciences; or
(v)
]
Clinical Pharmacology;
[
Micromedex;
]
a reference on
injectable drug products, such as, Handbook on Injectable Drugs (if sterile
parenteral or enteral products are compounded in the facility);
]
(D)
IV admixtures. Policies shall
be established by the pharmacist-in-charge, with approval of the appropriate
committee, which govern the proper preparation and sterility assurance of
parenteral products compounded within the ambulatory surgical center.]
pharmacists or other responsible individuals
] shall verify that the controlled drugs listed on the invoices were
actually received by clearly recording
his/her
[
their
]
initials and the actual date of receipt of the controlled substances;
Subchapter F. NON-RESIDENT PHARMACY (CLASS E)