Part 15.
TEXAS STATE BOARD OF PHARMACY
Chapter 281.
ADMINISTRATIVE PRACTICE AND PROCEDURES
Subchapter A. GENERAL PROVISIONS
The Texas State Board of Pharmacy proposes amendments to Chapter 281,
Subchapter A, §§281.1, 281.2, 281.4 - 281.10 and 281.17; and the
repeal of §§281.12, 281.14, and 281.16, concerning General Provisions.
The proposed amendments and repeals, if adopted, restructure Chapter 281 to
update and amend definitions and delete unnecessary rules in accordance with
governing statues and rules.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the proposal is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the amended rules or repeal.
Ms. Dodson has determined that, for each year of the first five-year period
the proposal will be in effect, the public benefit anticipated as a result
of enforcing the amendments and repeal will ensure organized, accurate rules
regarding administrative practice and procedures. There is no fiscal impact
for individuals, small or large businesses or to other entities which are
required to comply with this proposal.
Comments on the amendments and repeal may be submitted to Allison Benz,
R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy,
333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082.
Comments must be received by 5:00 p.m., January 26, 2007.
22 TAC §§281.1, 281.2, 281.4 - 281.10, 281.17
The amendments are proposed under §551.002 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 §554.051(a) as authorizing the agency
to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the proposed amendments: Chapters 551 - 566 and
568 - 569, Texas Occupations Code.
§281.1.Objective and Scope.
The objective of this chapter is to obtain a just, fair, and equitable
determination of any matter within the jurisdiction of the board. To the end
that this objective may be attained with as great expedition and at the least
expense as possible to the parties and the state, the provisions of this chapter
shall be given a liberal construction. The provisions of this chapter govern
the procedure for the institution, conduct, and determination of all proceedings
before the board.
All actions taken by the board shall be in accordance
with the Act, the Government Code, the Occupations Code, the board's rules
and any other applicable laws or rules.
[
§281.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise:
(1)
(No change.)
(2)
Administrative law judge[
[(3)
Alternative Dispute Resolution (ADR)--Processes
used at the State Office of Administrative Hearings (SOAH) to resolve disputes
outside the formal contested case hearing processes, including mediation,
mediated settlement conferences, and arbitration.]
(3)
[
(4)
[
[(6)
Authorized representative--An attorney
authorized to practice law in the State of Texas or, if authorized by applicable
law, a person designated by a party to represent the party.]
(5)
[
[(8)
Business day--A weekday on which state
offices are open.]
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
[(16)
Party--A person or agency named or admitted
as a party.]
(13)
[
[(18)
Pleading--A written document submitted
by a party, or a person seeking to participate in a case as a party, which
requests procedural or substantive relief, makes claims, alleges facts, makes
legal argument, or otherwise addresses matters involved in the case.]
(14)
[
(15)
[
(16)
[
[(22)
Register--The
Texas Register
established by the APA.]
[(23)
Rule--Any agency statement of general
applicability that implements, or prescribes law or policy by defining general
standards of conduct, rights, or obligations of persons, or describes the
procedure or practice requirements that prescribe the manner in which public
business before an agency may be initiated, scheduled, or conducted, or interprets
or clarifies law or agency policy, whether with or in the absence of an explicit
grant of power to the agency to make rules. The term includes the amendment
or repeal of a prior rule but does not include statements concerning only
the internal management or organization of the agency and not affecting private
rights or procedures. This definition includes regulations.]
(17)
[
(18)
[
(19)
[
§281.4.Official Acts in Writing and Open to the Public.
(a)
All official acts of the board shall be evidenced
by a written record. Such writings shall be open to the public in accordance
with the Act and the Texas Public Information Act, Government Code Chapter
552. Any hearing and any Board meeting shall be open to the public in accordance
with the Texas Open Meetings Act, Government Code, Chapter 551, provided,
however, that pursuant to §552.011, Texas Pharmacy Act, the board may,
in its discretion, conduct deliberations relative to licensee disciplinary
actions in a closed meeting. The board in a closed meeting may conduct disciplinary
hearings relating to a pharmacist or pharmacy student who is impaired because
of chemical abuse or mental or physical illness. At the conclusion of its
deliberations relative to licensee disciplinary action, the board shall vote
and announce its decision relative to the licensee in open session. All disciplinary
hearings before the State Office of Administrative Hearings shall be open
to the public, including those relating to a pharmacist or pharmacy student
who is impaired because of chemical abuse or mental or physical illness. Official
action of the board shall not be bound or prejudiced by any informal statement
or opinion made by any member of the board or the employees of the agency.
(b)
The president shall be the chairman and
preside over all meetings of the board at which the president is present unless
otherwise provided for under this chapter. In the absence of the president,
the vice president shall preside. In the vice president's absence, one of
the other Board members shall preside as acting chairman. The acting chairman
shall be selected by mutual agreement of the board members present or, lacking
mutual agreement, shall be the member senior in length of service on the board.
§281.5.Initiating Proceedings Before the Board.
(a)
Rules. Any interested person may petition
the board requesting the adoption of a rule. Petitions shall be sent to the
executive director/secretary. Within 60 days after the submission of a petition,
the board shall either deny the petition in writing, stating the reasons for
the denial, or shall initiate rulemaking proceedings. Petitions shall be deemed
sufficient if they contain:
(1)
the exact wording of the new, changed, or amended proposed
rule;
(2)
specific reference to the existing rule which is proposed
to be changed or amended in the case of a changed or amended rule; and
(3)
a justification for the proposed action set out in narrative
form with sufficient particularity to inform the board and any other interested
party of the reasons and arguments on which the petitioner is relying.
(b)
Other. In any other matter, any person
desiring that the board perform some official act permitted or required by
law shall request such performance in writing. Such requests shall be directed
to the executive director/secretary of the board. Any written request shall
be deemed sufficient to initiate the proceedings and present the subject matter
to the board for its official determination if the request reasonably gives
notice to the board of the act desired. The board may also initiate proceedings
on its own motion.
[(a)
Proceedings may be initiated before the
board as follows:]
[(1)
Any interested person may petition the board requesting
the adoption of a rule in accordance with §281.73 of this title (relating
to Petition for Adoption of Rules).]
[(2)
In any other matter, any person desiring that the board
perform some official act permitted or required by law shall request such
performance in writing. Such requests shall be directed to the executive director/secretary
of the board. Subject to §281.28 of this title (relating to Pleadings),
any written request shall be deemed sufficient to initiate the proceedings
and present the subject matter to the board for its official determination
if the request reasonably gives notice to the board of the act desired. The
board may also initiate proceedings on its own motion.]
[(b)
Matters that arise through appeal pursuant
to §281.28 of this title shall be initiated in accordance with this section.]
§281.6.[
For the purposes of the Act, §565.001(a)(4) and §565.052,
shall be applied as follows.
(1)
The board may
discipline an applicant or licensee
[
(2)
Upon probable cause that the applicant or licensee has
developed a mental or physical incapacity that in the estimation of the board
would prevent a pharmacist from engaging in the practice of pharmacy with
a level of skill and competence that ensures the public health, safety,
and welfare,
the following is applicable:
(A)
The executive director/secretary, legal counsel of the
agency, or other representative of the agency as designated by the executive
director/secretary, shall request the [
(B)
The [
(C)
The [
(D)
The [
(3)
If the [
(A)
The executive director/secretary shall cause to be issued
an order requiring the pharmacist or applicant to show cause why he/she will
not submit to the examination.
(B)
The executive director/secretary shall schedule a hearing
before the board or the State Office of Administrative Hearings on the order,
within 30 days after notice is served on the [
(C)
The [
(D)
At the hearing, the [
(E)
After the hearing, the board shall issue an order either
requiring the [
§281.7.Grounds for Discipline for a Pharmacist License.
(a)
For the purposes of the Act, §565.001(a)(2), "unprofessional
conduct" shall include, but not be limited to:
(1)
(No change.)
(2)
dispensing a prescription drug order pursuant to a prescription
from a practitioner as follows:
(A)
(No change.)
(B)
the provisions of subparagraph (A)(i) and (ii) of this
paragraph are not applicable for prescriptions dispensed to persons with intractable
pain
in accordance with the requirements of the Intractable Pain Treatment
Act,
or to a narcotic drug dependent person in accordance with the requirements
of Title 21, Code of Federal Regulations, §1306.07
, and the Regulation
of Narcotic Drug Treatment Programs Act
;
(3) - (26)
(No change.)
(27)
the sale, purchase, or trade or the offer to sell, purchase,
or trade of prescription drug samples; provided however, this paragraph does
not apply to:
(A) - (B)
(No change.)
(C)
prescription drug samples possessed by a pharmacy of a
health care entity which provides health care primarily to indigent or low
income patients at no or reduced cost and if:
(i)
(No change.)
(ii)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986
, §501(c)(3)
, or by a
city, state or county government; and
(iii)
(No change.)
(28)
the sale, purchase, or trade or the offer to sell, purchase,
or trade of prescription drugs:
(A) - (C)
(No change.)
(D)
provided that subparagraphs (A) - (C) of this paragraph
do not apply to:
(i)
(No change.)
(ii)
the sale, purchase, or trade of a drug or an offer to
sell, purchase, or trade a drug by an organization described in
subparagraph
(C) of this paragraph
[
(iii) - (v)
(No change.)
(29) - (31)
(No change.)
(b)
For the purposes of the Act, §565.001(a)(3), the term
"gross immorality" shall include, but not be limited to:
(1)
conduct which is willful, flagrant,
and
[
(2)
engaging in an act which is a felony; [
(3)
engaging in an act that constitutes sexually deviant behavior
; or
[
(4)
being required to register with the Department
of Public Safety as a sex offender under Chapter 62, Code of Criminal Procedure.
(c)
(No change.)
§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)
(No change.)
(2)
the pharmacy possesses or engages in the sale, purchase,
or trade or the offer to sell, purchase, or trade prescription drug samples;
provided however, this paragraph does not apply to:
(A) - (B)
(No change.)
(C)
prescription drug samples possessed by a pharmacy of a
health care entity which provides health care primarily to indigent or low
income patients at no or reduced cost and if:
(i)
(No change.)
(ii)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986
, §501(c)(3)
, or by a
city, state or county government; and
(iii)
(No change.)
(3) - (4)
(No change.)
(5)
the owner or managing officer has previously
been disciplined by the board.
(c)
(No change.)
§281.9.Grounds for Discipline for a Pharmacy Technician or a Pharmacy Technician Trainee.
(a)
For the purposes of the Act, §568.003(a)(2), the term
"gross immorality" shall include, but not be limited to:
(1) - (2)
(No change.)
(3)
engaging in an act that constitutes sexually deviant behavior
; or
[
(4)
being required to register with the Department
of Public Safety as a sex offender under Chapter 62, Code of Criminal Procedure.
(b)
(No change.)
§281.10.Denial of [
[
[(b)
No disciplinary action against a license
is effective unless, prior to the institution of proceedings, the agency gave
notice by personal service or by registered or certified mail to the licensee
or the licensee's attorney of facts or conduct alleged to warrant the intended
action, and the licensee is given an opportunity to show compliance with all
requirements of law for the retention of the license.]
§281.17.Historically Underutilized Businesses.
The Texas State Board of Pharmacy adopts by reference the rules promulgated
by the Texas Building and Procurement Commission, which are set forth in
1 TAC Chapter 111, Subchapter B, §§111.11, et. al.
[
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 December 4, 2006.
TRD-200606473
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
22 TAC §§281.12, 281.14, 281.16
(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 Texas State Board of Pharmacy or in the Texas Register office, Room
245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566 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(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.
§281.12.Closed Meetings.
§281.14.Charges for Public Records.
§281.16.Enforcement of Orders, Decisions, and Rules.
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 December 4, 2006.
TRD-200606474
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes new §281.20, amendments
to §281.22, and the repeal of §§281.23 - 281.56, and simultaneously
proposes new §§281.30 - 281.34 of Subchapter B, concerning Procedures
in a Contested Case. The proposed new sections, amendments, and repeal, if
adopted, clarify procedures, include rules required for the State Office of
Administrative Hearings, and delete unnecessary rules.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the proposal is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the proposal.
Ms. Dodson has determined that, for each year of the first five-year period
the proposal will be in effect, the public benefit anticipated as a result
of enforcing the proposal will ensure more organized rules regarding administrative
practice and procedures. There is no fiscal impact for individuals, small
or large businesses or to other entities which are required to comply with
this proposal.
Comments on the proposed new sections, amendments, and repeal may be submitted
to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State
Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701,
Fax (512) 305-8082. Comments must be received by 5:00 p.m., January 26, 2007.
22 TAC §§281.20, 281.22, 281.30 - 281.34
The new sections and amendments are proposed under §551.002
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 §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by the new sections and amendments: Chapters 551
- 566 and 568 - 569, Texas Occupations Code.
§281.20.Application of Other Laws.
All disciplinary action shall be taken by the board in accordance with
Chapters 2001 and 2003, Government Code, the State Office of Administrative
Hearings Rules of Procedure, the board's rules, and any other applicable law
or rule.
§281.22.Informal Disposition of a Contested Case.
(a) - (f)
(No change.)
(g)
Informal conferences shall be attended by the executive
director/secretary or designated representative, legal counsel of the agency
or an attorney employed by the office of the attorney general, and other representative(s)
of the agency as the executive director/secretary and legal counsel may deem
necessary for proper conduct of the conference. The licensee or registrant
and/or the licensee's or registrant's authorized representative(s) may attend
the informal conference and shall be provided an opportunity to be heard.
All communications from the licensee or registrant shall be directed to the
legal counsel of the agency.
(h) - (j)
(No change.)
§281.30.Notice and Service for Hearing.
The board may serve notice of a contested case hearing at the State
Office of Administrative Hearings by sending it to the party's last known
address as shown by the board's records.
§281.31.Burden of Proof.
(a)
In a contested case hearing at the State Office of Administrative
Hearings involving grounds for disciplinary action, the board has the burden
to prove that grounds to discipline respondent exist. However, the party that
claims any exemption or exception, including mitigating factors under §281.62
of this chapter, has the burden to prove that the exemption or exception should
be applied.
(b)
In a contested case hearing at the State Office of Administrative
Hearings involving a petition for reinstatement or removal of restriction,
the petitioner has the burden to prove that the license should be reinstated
or that a restriction on the license should be removed in accordance with §281.66
of the chapter.
§281.32.Failure to Attend Hearing and Default.
(a)
If a party who does not have the burden of proof fails
to appear at a contested case hearing at the State Office of Administrative
Hearings, the administrative law judge shall issue a default proposal for
decision, rather than continuing or dismissing the case and requiring the
board to dispose of the case on a default basis as an informal disposition.
(b)
If a party who does have the burden of proof fails to appear
at a contested case hearing at the State Office of Administrative Hearings,
the administrative law judge shall dismiss the case for want of prosecution,
any relevant application will be withdrawn, and the board may not consider
a subsequent petition from the party until the first anniversary of the date
of dismissal of the case.
§281.33.Proposal for Decision.
(a)
The administrative law judge shall submit a proposal for
decision to the agency, and the board shall render the final decision in the
contested case. The board may request that the proposal for decision be presented
to the board by the administrative law judge at the next board meeting.
(b)
If a party submitted proposed findings of fact, the proposal
for decision shall include a ruling on each proposed finding by the administrative
law judge.
(c)
The parties may submit to the board for consideration,
prior to the final decision, an alternative proposed board order with changes
to the proposal for decision in compliance with the APA.
§281.34.Record of Hearing.
(a)
The board shall arrange for a stenographic recording of
all contested case hearings before the State Office of Administrative Hearings
on a regular basis. The administrative law judge may waive the requirement
as authorized by the State Office of Administrative Hearings Rules of Procedure.
Any party may request a written transcript of all or part of the hearing.
The cost of a transcript shall be paid by the requesting party.
(b)
A party who appeals a final decision in a hearing shall
pay the cost of preparation of the original or a certified copy of the record
of the board proceeding that is required to be sent to the reviewing court.
A charge imposed under this section is a court cost and may be assessed by
the court in accordance with the Texas Rules of Civil Procedure.
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 December 4, 2006.
TRD-200606466
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
22 TAC §§281.23 - 281.56
(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 Texas State Board of Pharmacy or in the Texas Register office, Room
245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under §551.002 and §554.051
of the Texas Pharmacy Act (Chapters 551 - 566 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(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.
§281.23.Referring a Contested Case to the State Office of Administrative Hearing.
§281.24.Venue.
§281.25.Notice and Service.
§281.26.Filing Documents or Serving Documents
§281.27.Service of Documents on Parties.
§281.28.Pleadings.
§281.29.Motions.
§281.30.Briefs.
§281.31.Orders.
§281.32.Stipulations.
§281.33.Discovery.
§281.34.Subpoenas.
§281.35.Summary Dispositions.
§281.36.Procedure at Hearing.
§281.37.Hearing Conducted by the State Office of Administrative Hearings.
§281.38.Computation of Time.
§281.39.Representation of Parties.
§281.40.Participation by Telephone.
§281.41.Conduct and Decorum.
§281.42.Failure to Attend Hearing and Default.
§281.43.Public Attendance and Comment at Hearing.
§281.44.Interpreters for Deaf or Hearing Impaired Parties and Witnesses.
§281.45.Evidence.
§281.46.Making a Record of a Contested Case.
§281.47.Record.
§281.48.Original or Certified Copies of Record.
§281.49.Consideration of Agency Policy in a Contested Case.
§281.50.Ex Parte Consultations.
§281.51.Proposal for Decision.
§281.52.Final Decision.
§281.53.Motion for Rehearing.
§281.54.Modification of Time Limits.
§281.55.Application or Reissuance or Removal of Restrictions of a License.
§281.56.Official Action To Be Taken.
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 December 4, 2006.
TRD-200606468
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
22 TAC §§281.62 - 281.64, 281.66
The Texas State Board of Pharmacy proposes amendments to §§281.62
- 281.64, and new §281.66 of Subchapter C, concerning Disciplinary Guidelines.
The proposed amendments and new rule, if adopted, provide a more organized
Chapter 281, clarify factors to consider for criminal offenses, and add sanctions
for drug related offenses.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the amendments and new rule are in effect, there
will be no fiscal implications for state or local government as a result of
enforcing or administering the proposal.
Ms. Dodson has determined that, for each year of the first five-year period
the amendments and new rule will be in effect, the public benefit anticipated
as a result of enforcing the proposal will ensure more organized rules regarding
administrative practice and procedures. There is no fiscal impact for individuals,
small or large businesses, or to other entities which are required to comply
with the proposal.
Comments on the proposed amendments and new rule may be submitted to Allison
Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of
Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512)
305-8082. Comments must be received by 5:00 p.m., January 27, 2007.
The amendments and new rule are proposed under §551.002
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 §554.051(a) as authorizing
the agency to adopt rules for the proper administration and enforcement of
the Act.
The statutes affected by the amendments and new rule: Chapters 551 - 566
and 568 - 569, Texas Occupations Code.
§281.62.Aggravating and Mitigating Factors.
(a)
Aggravation. The following may be considered as aggravating
factors so as to merit more severe or more restrictive action by the board:
(1) - (12)
(No change.)
(13)
lack of rehabilitative potential or likelihood for future
conduct of a similar nature; [
(14)
relevant circumstances increasing the seriousness of the
conduct which serves as a basis for disciplinary action under the Act
; and
[
(15)
circumstances indicating intoxication
due to ingestion of alcohol and/or drugs.
(b)
Extenuation and Mitigation. The following may be considered
as extenuating and mitigating factors so as to merit less severe or less restrictive
action by the board:
(1) - (2)
(No change.)
[(3)
absence of environmental harm;]
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
treatment and/or monitoring of an impairment.
§281.63.Considerations for Criminal Offenses.
(a)
The purpose of this section is to establish guidelines
and criteria on the eligibility of persons with criminal backgrounds to obtain
a license or registration from the board and on the disciplinary actions taken
by the board. The section applies to
all
criminal convictions and
to
all
deferred adjudication community supervisions or deferred
dispositions, as authorized by the Act, for all types of licenses and registrations.
(b)
The board may suspend, revoke, or impose other authorized
disciplinary action on a current license or registration, disqualify a person
from receiving a license or registration, or deny to a person the opportunity
to be examined for a license or registration because of a person's conviction
or deferred adjudication of a crime that serves as a ground for discipline
under the Act, and that
the board determines
directly relates to
the duties and responsibilities of a licensee, a registrant, or of an owner
of a pharmacy. This subsection applies to persons who are not imprisoned at
the time the board considers the conviction or deferred adjudication.
(c) - (e)
(No change.)
(f)
The board shall by rule determine and list in this
section which criminal offenses directly relate to the occupation of a licensee
or registrant, or the operation of a pharmacy. For all other offenses not
listed in this section, in
[
(1) - (4)
(No change.)
(g)
The board has the authority to impose disciplinary
action as authorized by the Act, for those criminal offenses that provide
grounds for discipline under the Act.
In reaching a decision regarding
the
severity
[
(1)
(No change.)
(2)
the amount of time that has elapsed since
the person's last criminal activity;
(3)
the person's rehabilitation or rehabilitative
effort while incarcerated or following release as corroborated by extrinsic
evidence;
(4)
the age of the person at the time of the
commission of the crime, if younger than 21 years of age at the time of the
crime;
(5)
the conduct and work activity of the person
prior to and following the criminal activity; and
[(2)
the age of the person at the time of
the commission of the crime;]
[(3)
the amount of time that has elapsed since
the person's last criminal activity;]
[(4)
the conduct and work activity of the
person prior to and following the criminal activity;]
[(5)
evidence of the person's rehabilitation
or rehabilitative effort while incarcerated or following release; and]
(6)
(No change.)
(h)
In order to establish the factors in subsection (g)
of this section, a
[
(1)
(No change.)
(2)
cooperate with the board by providing the information required
by this section, including proof that he or she has:
(A)
(No change.)
(B)
supported his or her dependents, as evidenced by salary
stubs, income tax records or other employment records for the time since the
conviction or deferred adjudication and/or release from imprisonment, and
a
recommendation
[
(C)
maintained a record of good conduct as evidenced by
recommendations
[
(D)
paid all outstanding court costs, supervision fees, fines,
and restitution as may have been ordered in all criminal cases in which he
or she has been convicted, as evidenced by certified copies of a court release
or other documentation from the court system that all monies have been paid
; and
[
(E)
obtained appropriate treatment and/or
counseling, if applicable.
(i)
The following crimes
directly
relate to
duties and responsibilities of
board licensees or registrants. The commission
of each indicates an inability or a tendency for the person to be unable to
perform or to be unfit for licensure or registration, because violation of
such crimes indicates a lack of integrity and respect for one's fellow human
being and the community at large.
In addition, the
[
(1) - (3)
(No change.)
(4)
a misdemeanor or felony offense under the Texas Penal Code
involving:
(A) - (P)
(No change.)
(Q)
solicitation of professional employment under the Penal
Code §38.12(d) or Occupations Code, Chapter 102; [
(R)
mail fraud;
or
(S)
any criminal offense which requires the
individual to register with the Department of Public Safety as a sex offender
under Chapter 62, Code of Criminal Procedure;
(5)
any crime of moral turpitude;
(6)
a misdemeanor or felony offense under
Chapters 431 and 481 - 486, Health and Safety Code and the Comprehensive Drug
Abuse Prevention and Control Act of 1970; or
[(5)
delivery, possession, manufacture, or
use of, or dispensing or prescribing a controlled substance, dangerous drug,
or narcotic; or]
(7)
[
§281.64.Sanctions for Applicants with Criminal Offenses.
(a) - (b)
(No change.)
(c)
The board has determined that the nature and seriousness
of certain crimes outweigh other factors to be considered in §281.63(g)
and necessitate the disciplinary action listed below.
The following
sanctions apply to applicants with the criminal offenses
as
described
below:
(1)
(No change.)
(2)
Felony offenses:
(A)
Drug-related offenses, such as those listed in Chapter
481 or 483, Health and Safety Code:
(i)
Offenses involving manufacture, delivery, or possession
with intent to deliver
, fraud, or theft or drugs
:
(I) - (V)
(No change.)
(ii)
Offenses involving possession[
(I) - (V)
(No change.)
(B) - (C)
(No change.)
(3)
Misdemeanor offenses:
(A)
Drug-related offenses, such as those listed in Chapter
481 or 483, Health and Safety Code:
(i)
Offenses involving manufacture, delivery, or possession
with intent to deliver
, fraud, or theft of drugs:
(I) - (III)
(No change.)
(ii)
Offenses involving possession[
(I) - (II)
(No change.)
(B) - (C)
(No change.)
(d)
(No change.)
(e)
An applicant who suffers from an impairment
as described by §565.001(a)(4) or (7) or §568.003(a)(5), may provide
mitigating information including treatment, counseling, and monitoring in
order to mitigate the sanctions imposed.
§281.66.Application for Reissuance or Removal of Restrictions of a License.
(a)
A person whose pharmacy license or license to practice
pharmacy has been canceled, revoked, or restricted, whether voluntary or by
action of the board, may, after 12 months from the effective date of such
cancellation, revocation, or restriction, apply to the board for reinstatement
or removal of the restriction of the license.
(1)
The application shall be given under oath and on the form
prescribed by the board.
(2)
A person applying for reinstatement or removal of restrictions
has the burden of proof.
(3)
On investigation and hearing, the board may in its discretion
grant or deny the application or it may modify its original finding to reflect
any circumstances that have changed sufficiently to warrant the modification.
(4)
If such application is denied by the board, a subsequent
application may not be considered by the board until 12 months from the date
of denial of the previous application.
(5)
The board in its discretion may require a person to pass
an examination or examinations to reenter the practice of pharmacy.
(b)
The board may consider the following items in determining
the reinstatement of an applicant's previously revoked or canceled pharmacist
license:
(1)
moral character in the community;
(2)
employment history;
(3)
financial support to his/her family;
(4)
participation in continuing education programs or other
methods of maintaining currency with the practice of pharmacy;
(5)
criminal history record, including arrests, indictments,
and convictions relating to felonies or misdemeanors involving moral turpitude;
(6)
offers of employment as a pharmacist;
(7)
involvement in public service activities in the community;
(8)
failure to comply with the provisions of the board order
revoking or canceling the applicant's license;
(9)
action by other state or federal regulatory agencies;
(10)
any physical, chemical, emotional, or mental impairment;
(11)
the gravity of the offense for which the applicant's license
was canceled, revoked, or restricted and the impact the offense had upon the
public health, safety and welfare;
(12)
the length of time since the applicant's license was canceled,
revoked or restricted, as a factor in determining whether the time period
has been sufficient for the applicant to have rehabilitated himself/herself
to be able to practice pharmacy in a manner consistent with the public health,
safety and welfare;
(13)
competency to engage in the practice of pharmacy; or
(14)
other rehabilitation actions taken by the applicant.
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 December 4, 2006.
TRD-200606475
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
22 TAC §§281.71 - 281.76
(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 Texas State Board of Pharmacy or in the Texas Register office, Room
245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Texas State Board of Pharmacy proposes the repeal of §§281.71
- 281.76 of Subchapter D, concerning Rulemaking. The proposed repeal, if adopted,
clarifies the organization of Chapter 281 and deletes rules that are unnecessary.
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 or local government as a result of enforcing or administering
the repeal.
Ms. Dodson has determined that, for each year of the first five-year period
the repeal will be in effect, the public benefit anticipated as a result of
enforcing the repeal will ensure more organized rules regarding administrative
practice and procedures. There is no fiscal impact for individuals, small
or large businesses, or to other entities which are required to comply with
this repeal.
Comments on the proposed repeal may be submitted to Allison Benz, R.Ph.,
M.S., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments
must be received by 5:00 p.m., January 26, 2007.
The repeal is proposed under §551.002 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 §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.
§281.71.Prerequisites to Adopting, Repealing, or Amending Rules.
§281.72.Effective Date of Rules.
§281.73.Petition for Adoption of Rules.
§281.74.President to Preside.
§281.75.Amendments and the Repeal of Conflicting Rules.
§281.76.Effective Date.
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 December 4, 2006.
TRD-200606472
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
Subchapter A. ALL CLASSES OF PHARMACIES
22 TAC §291.5
The Texas State Board of Pharmacy proposes amendments to §291.5,
concerning Closing a Pharmacy. The amendments, if adopted, will prohibit closed
pharmacies from renewing the license of the pharmacy.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the amendments are in effect, there will be no
fiscal implications for state or local government as a result of enforcing
or administering the amended rule.
Ms. Dodson has determined that, for each year of the first five-year period
the amendments will be in effect, the public benefit anticipated as a result
of enforcing the amended rule will be to ensure that once a pharmacy has notified
the Board that the pharmacy is closed, the pharmacy may not renew the previously
issued license and must apply for a new license if the pharmacy chooses to
reopen, which allows the Board to ensure legal operation of the pharmacy.
There is no fiscal impact for individuals, small or large businesses or to
other entities which are required to comply with the amendments.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph.,
M.S., Director of Professional Services, Texas State Board of Pharmacy, 333
Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments
must be received by 5:00 p.m., January 26, 2007.
The amendments are proposed under §551.002 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 §554.051(a) as authorizing the agency
to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Texas Pharmacy Act, Chapters 551
- 566 and 568 - 569, Texas Occupations Code.
§291.5.Closing a Pharmacy.
(a) - (b)
(No change.)
(c)
After closing.
(1) - (2)
(No change.)
(3)
Once the pharmacy has notified the board
that the pharmacy is closed, the license may not be renewed. The pharmacy
may apply for a new license as specified in §291.1 of this title (relating
to Pharmacy License Application).
(d) - (e)
(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 December 4, 2006.
TRD-200606471
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy (TSBP) proposes the repeal of §291.25,
concerning Pharmacies Compounding Non-Sterile Pharmaceuticals and simultaneously
proposes new §291.25, concerning Pharmacies Compounding Non-Sterile Preparations.
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) revised
General Chapter 795 (Pharmaceutical Compounding-Non-sterile Preparations)
in accordance with S.B. 492 passed during the 79th Regular Session of the
Texas Legislature regarding compounding.
The TSBP established the Task Force in September 2005. 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 Task Force was established to review the current standards
of practice for pharmacy compounding and was charged with: (1) reviewing current
federal and state requirements for pharmacy compounding; (2) reviewing SB
492 passed by the 79th Texas Legislature with regard to pharmacy compounding;
and (3) making recommendations to the Board of Pharmacy regarding standards
for pharmacy compounding in Texas that provide necessary compounded medications
while protecting the health, safety, and welfare of the public. The Task Force
met three times and presented its recommendations to the Board at the October
31, 2006 meeting. The Task Force recommended incorporating many of the proposed
revisions to USP General Chapter 795 (Pharmaceutical Compounding-Non-Sterile
Preparations) into the rules. In accordance with S.B. 492, the Task Force
recommended changes to the rules to allow: (1) Class A (Community), Class
B (Nuclear), Class C (Institutional) or Class E (Non-resident) pharmacies
to compound preparations for "office use" by a practitioner or for use by
veterinarians as specified in §563.054 of the Texas Pharmacy Act; (2)
Class A pharmacies to compound preparations for a Class C pharmacy; and (3)
Class C pharmacies to compound preparations to other Class C pharmacies under
common ownership.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the proposal is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the proposal. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the proposal will be in effect, the public benefit anticipated as a result
of enforcing the proposal will be the establishment of standards for the safe
compounding of non-sterile preparations by pharmacies. Ms. Dodson has also
determined that, for each year of the first five-year period the proposal
will be in effect, an economic cost may exist for entities/persons required
to comply with the proposal 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 proposal;
however, it is difficult to determine the exact costs. Pharmacies that do
not already maintain a copy of USP Chapter 795 would incur a minimum cost
of $225.00.
A public hearing to receive comments on the proposal will be held at 9:00
a.m. on Tuesday, February 13, 2007, 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 proposal 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 5:00 p.m., January 26, 2007.
22 TAC §291.25
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas State Board of Pharmacy or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under §§551.002,
551.003, 554.001, and 554.051 of 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 the repeal: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
§291.25.Pharmacies Compounding Non-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 December 4, 2006.
TRD-200606478
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
22 TAC §291.25
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 Preparations.
(a)
Purpose. Pharmacies compounding non-sterile preparations,
prepackaging pharmaceutical products and distributing those products shall
comply with all requirements for their specific license classification and
this section. The purpose of this section is to provide standards for the:
(1)
compounding of non-sterile preparations pursuant to a prescription
or medication order for a patient from a practitioner in Class A (Community),
Class B (Nuclear), Class C (Institutional), and Class E (Non-resident) pharmacies;
(2)
compounding, dispensing, and delivery of a reasonable quantity
of a compounded non-sterile preparation in a Class A (Community), Class B
(Nuclear), Class C (Institutional), and Class E (Non-resident) pharmacies
to a practitioner's office for office use by the practitioner;
(3)
compounding and distribution of compounded non-sterile
preparations by a Class A (Community) pharmacy for a Class C (Institutional)
pharmacy; and
(4)
compounding of non-sterile preparations by a Class C (Institutional)
pharmacy and the distribution of the compounded preparations to other Class
C (Institutional) pharmacies under common ownership.
(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 or time after which the compounded
non-sterile preparation shall not be stored or transported or begin to be
administered to a patient. The beyond-use date is determined from the date
when the preparation was compounded.
(2)
Component--Any ingredient intended for use in the compounding
of a drug preparation, including those that may not appear in such preparation.
(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, based on the practitioner-patient-pharmacist relationship
in the course of professional practice;
(B)
for administration to a patient by a practitioner as the
result of a practitioner's initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(C)
in anticipation of prescription drug or medication orders
based on routine, regularly observed prescribing patterns; or
(D)
for or as an incident to research, teaching, or chemical
analysis and not for sale or dispensing, except as allowed under Section 562.154
or Chapter 563 of the Occupations Code.
(4)
SOPs--Standard operating procedures.
(5)
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 ensure 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 and pharmacy technician trainees.
All pharmacy technicians and pharmacy technician trainees engaged in non-sterile
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 or pharmacy technician trainee;
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 preparations 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;
(ii)
in anticipation of future prescription drug or medication
orders based on routine, regularly observed prescribing patterns; or
(iii)
in reasonable quantities for office use by a practitioner
and for use by a veterinarian.
(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 preparation compounded in anticipation of future
prescription drug or medication orders shall be labeled. Such label shall
contain:
(I)
name and strength of the compounded preparation 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 paragraph (4)(C) of this subsection;
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;
(ii)
the pharmacy maintains documentation that the product
is not reasonably available; and
(iii)
the prescribing practitioner has requested that the drug
be compounded.
(D)
A pharmacy may not compound preparations that are essentially
copies of commercially available products (e.g., the preparation is dispensed
in a strength that is only slightly different from a commercially available
product) unless the prescribing practitioner specifically orders the strength
or dosage form and specifies why the patient needs the particular strength
or dosage form of the preparation. The prescribing practitioner shall provide
documentation of a patient specific medical need and the preparation produces
a clinically significant therapeutic response (e.g., the physician requests
an alternate product due to hypersensitivity to excipients or preservatives
in the FDA-approved products, or the physician requests an effective alternate
dosage form) or if the drug product is not commercially available. The unavailability
of such drug product must be documented prior to compounding. The methodology
for documenting unavailability includes printing the screen of the wholesaler's
notification showing back-ordered, discontinued, or out-of-stock items. This
documentation must be available for inspection by the Board.
(E)
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).
(F)
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.
(G)
A pharmacy may not compound veterinary preparations for
use in food producing animals in accordance with federal guidelines.
(2)
Library. In addition to the library requirements of the
pharmacy's specific license classification, a pharmacy shall maintain a current
copy, in hard-copy or electronic format, of Chapter 795 of the USP/NF concerning
Pharmacy Compounding Non-Sterile Preparations.
(3)
Environment.
(A)
Pharmacies regularly engaging in compounding shall have
a designated and adequate area for the safe and orderly compounding of non-sterile
preparations, 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.
(4)
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 periodic inspection
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.
(5)
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 from a peer reviewed
source and retained in the pharmacy. The reference data should follow the
same preparation instructions for combining raw materials and packaged in
a container with similar properties.
(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.
(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 preparation
was compounded by the pharmacy must be included in this written information.
If there is no written information available, the patient should be advised
that the drug has been compounded and how to contact a pharmacist, and if
appropriate the prescriber, concerning the drug.
(7)
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 and the pharmacist
shall compare the monograph of drugs in a similar class to the Certificate
of Analysis.
(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 preparation that contains
ingredients appearing on a federal Food and Drug Administration list of drug
products withdrawn or removed from the market for safety reasons.
(8)
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)
preparation evaluation;
(vi)
quality assurance;
(vii)
preparation recall;
(viii)
packaging; and
(ix)
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 preparations
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 preparations from contamination.
(E)
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.
(9)
Quality Assurance.
(A)
Initial formula validation. Prior to routine compounding
of a non-sterile preparation, a pharmacy shall conduct an evaluation that
shows that the pharmacy is capable of compounding a product that contains
the stated amount of active ingredient(s).
(B)
Finished preparation checks. The prescription drug and
medication orders, written compounding procedure, preparation records, and
expended materials used to make compounded non-sterile preparations shall
be inspected for accuracy of correct identities and amounts of ingredients,
packaging, labeling, and expected physician appearance before the sterile
preparations are dispensed.
(10)
Quality Control.
(A)
The pharmacy shall follow established quality control procedures
to monitor the quality of compounded drug preparations 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
or pharmacy technician trainee performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising pharmacy technicians or pharmacy technician trainees and conducting
in-process and final checks of compounded preparations if pharmacy technicians
or pharmacy technician trainees perform the compounding function;
(v)
the quantity in units of finished preparations 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;
(V)
unique lot or control number assigned to batch;
(VI)
beyond use date of batch-prepared preparations;
(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-preparation evaluation and testing specifications,
if applicable; and
(XI)
comparison of actual yield to anticipated yield, when
appropriate.
(f)
Office Use Compounding and Distribution of Compounded Preparations
to Class C Pharmacies or Veterinarians in Accordance With Section 563.054
of the Act.
(1)
General.
(A)
A pharmacy may dispense and deliver a reasonable quantity
of a compounded preparation to a practitioner for office use by the practitioner
in accordance with this subsection.
(B)
A Class A (Community) pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile
compounded preparations to a Class C (Institutional) pharmacy.
(C)
A Class C (Institutional) pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile
compounded preparations that the Class C pharmacy has compounded for other
Class C pharmacies under common ownership.
(D)
To dispense and deliver a compounded preparation under
this subsection, a pharmacy must:
(i)
verify the source of the raw materials to be used in a
compounded drug;
(ii)
comply with applicable United States Pharmacopoeia guidelines,
including the testing requirements, and the Health Insurance Portability and
Accountability Act of 1996 (Pub. L. No. 104-191);
(iii)
enter into a written agreement with a practitioner for
the practitioner's office use of a compounded preparation;
(iv)
comply with all applicable competency and accrediting
standards as determined by the board; and
(v)
comply with the provisions of this subsection.
(2)
Written Agreement. A pharmacy that provides non-sterile
compounded preparations to practitioners for office use or to another pharmacy
shall enter into a written agreement with the practitioner or pharmacy. The
written agreement shall:
(A)
address acceptable standards of practice for a compounding
pharmacy and a practitioner and receiving pharmacy that enter into the agreement
including a statement that the compounded preparations may only be administered
to the patient and may not be dispensed to the patient or sold to any other
person or entity except as authorized by Section 563.054 of the Act;
(B)
require the practitioner or receiving pharmacy to include
on a patient's chart, medication order, or medication administration record
the lot number and beyond-use date of a compounded preparation administered
to a patient; and
(C)
describe the scope of services to be performed by the pharmacy
and practitioner or receiving pharmacy, including a statement of the process
for:
(i)
a patient to report an adverse reaction or submit a complaint;
and
(ii)
the pharmacy to recall batches of compounded preparations.
(3)
Recordkeeping.
(A)
Maintenance of Records.
(i)
Records of orders and distribution of non-sterile compounded
preparations to a practitioner for office use or to a Class C (Institutional)
pharmacy for administration to a patient shall:
(I)
be kept by the pharmacy and be available, for at least
two years from the date of the record, for inspecting and copying by the board
or its representative and to other authorized local, state, or federal law
enforcement agencies;
(II)
maintained separately from the records of products dispensed
pursuant to a prescription or medication order; and
(III)
supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the Texas State Board of Pharmacy or its representative.
Failure to provide the records set out in this subsection, either on site
or within 72 hours for whatever reason, constitutes prima facie evidence of
failure to keep and maintain records.
(ii)
Records may be maintained in an alternative data retention
system, such as a data processing system or direct imaging system provided
the data processing system is capable of producing a hard copy of the record
upon the request of the board, its representative, or other authorized local,
state, or federal law enforcement or regulatory agencies.
(B)
Orders. The pharmacy shall maintain a record of all non-sterile
compounded preparations ordered by a practitioner for office use or by a Class
C pharmacy for administration to a patient. The record shall include the following
information:
(i)
date of the order;
(ii)
name, address, and phone number of the practitioner who
ordered the preparation and if applicable, the name, address and phone number
of the Class C (Institutional) pharmacy ordering the preparation; and
(iii)
name, strength, and quantity of the preparation ordered.
(C)
Distributions. The pharmacy shall maintain a record of
all non-sterile compounded preparations distributed pursuant to an order to
a practitioner for office use or by a Class C pharmacy for administration
to a patient. The record shall include the following information:
(i)
date the preparation was compounded;
(ii)
date the preparation was distributed;
(iii)
name, strength and quantity in each container of the
preparation;
(iv)
pharmacy's lot number;
(v)
quantity of containers shipped; and
(vi)
name, address, and phone number of the practitioner or
Class C (Institutional) pharmacy to whom the preparation is distributed.
(D)
Audit Trail.
(i)
The pharmacy shall store the order and distribution records
of preparations for all non-sterile compounded preparations ordered by and
or distributed to a practitioner for office use or by a Class C (Institutional)
pharmacy for administration to a patient in such a manner as to be able to
provide a audit trail for all orders and distributions of any of the following
during a specified time period.
(I)
any strength and dosage form of a preparation (by either
brand or generic name or both);
(II)
any ingredient;
(III)
any lot number;
(IV)
any practitioner;
(V)
any facility; and
(VI)
any pharmacy, if applicable.
(ii)
The audit trail shall contain the following information:
(I)
date of order and date of the distribution;
(II)
practitioner's name, address, and name of the Class C
(Institutional) pharmacy, if applicable;
(III)
name, strength and quantity of the preparation in each
container of the preparation;
(IV)
name and quantity of each active ingredient;
(V)
quantity of containers distributed; and
(VI)
pharmacy's lot number;
(4)
Labeling. The pharmacy shall affix a label to the preparation
containing the following information:
(A)
name, address, and phone number of the compounding pharmacy;
(B)
the statement: "For Institutional or Office Use Only -
Not for Resale"; or if the preparation is distributed to a veterinarian the
statement: "Compounded Preparation";
(C)
name and strength of the preparation or list of the active
ingredients and strengths;
(D)
pharmacy's lot number;
(E)
beyond-use date as determined by the pharmacist using appropriate
documented criteria;
(F)
quantity or amount in the container;
(G)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including hazardous drug warning labels where appropriate;
and
(H)
device-specific instructions, where appropriate.
(5)
Recall Procedures. The pharmacy shall have written procedure
for the recall of any compounded non-sterile preparations provided to a practitioner
for office use or to a pharmacy for administration. The recall procedures
shall require:
(A)
notification to the practitioner, facility, and pharmacy
to which the preparation was distributed;
(B)
notification to the Texas Department of State Health Services;
(C)
notification to the patient;
(D)
quarantine of the product if there is a suspicion of harm
to a patient;
(E)
a mandatory recall if there is confirmed or probable harm
to a patient; and
(F)
notification to the board if a mandatory recall is instituted.
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 December 4, 2006.
TRD-200606479
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy (TSBP) proposes the repeal of §291.26,
concerning Pharmacies Compounding Sterile Pharmaceuticals and simultaneously
proposes new §291.26, concerning Pharmacies Compounding Sterile Preparations.
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) revised
General Chapter 797 (Pharmaceutical Compounding-Sterile Preparations) in accordance
with Senate Bill (SB) 492 passed during the 79th Regular Session of the Texas
Legislature regarding compounding.
The TSBP established the Task Force in September 2005. 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 Task Force was charged with: (1) reviewing current federal
and state requirements for pharmacy compounding; (2) reviewing SB 492 passed
by the 79th Texas Legislature with regard to pharmacy compounding; and (3)
making recommendations to the Board of Pharmacy regarding standards for pharmacy
compounding in Texas that provide necessary compounded medications while protecting
the health, safety, and welfare of the public. The Task Force met three times
and presented its recommendations to the Board at the October 31, 2006 meeting.
The Task Force recommended incorporating many of the proposed revisions to
USP General Chapter 797 (Pharmaceutical Compounding - Sterile Preparations)
into the rules. In accordance with SB 492, the Task Force recommended changes
to the rules to allow: (1) Class A (Community), Class B (Nuclear), Class C
(Institutional) or Class E (Non-resident) pharmacies to compound preparations
for "office use" by a practitioner or for use by veterinarians as specified
in §563.054 of the Texas Pharmacy Act; (2) Class A pharmacies to compound
preparations for a Class C pharmacy; and (3) Class C pharmacies to compound
preparations to other Class C pharmacies under common ownership.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the proposal is in effect, there will be no fiscal
implications for state government as a result of enforcing or administering
the proposal. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period
the proposal will be in effect, the public benefit anticipated as a result
of enforcing the proposal will be the establishment of standards for the safe
compounding of sterile preparations by pharmacies. Ms. Dodson has also determined
that, for each year of the first five-year period the proposal will be in
effect, an economic cost may exist for entities/persons required to comply
with the proposal 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 proposal.
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 proposal. These costs would involve bringing the sterile
compounding area of pharmacies into compliance with the new provisions of
the rules and in establishing media fill test procedures. TSBP cannot precisely
determine the number of pharmacies affected because TSBP records do not provide
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 purposes of this rule which is intended to protect the health and safety
of the public. Pharmacies that do not already maintain a copy of the USP would
incur a minimum cost of $690.
Examples of new requirements under the rules are: (1) low- and medium-risk
preparations must be prepared in a designated room for compounding; (2) when
preparing high-risk preparations, the primary engineering control must be
located in a buffer room that provides a physical separation, through the
use of walls, doors and pass through and has a minimum differential positive
pressure of 0.02 to 0.05 inches water column; (3) the pharmacy must establish
medial fill test procedures for low, medium and high-risk preparations; and
(4) the pharmacy must establish a quality control and 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 dollars.
A public hearing to receive comments on the proposal will be held at 9:00
a.m. on Tuesday, February 13, 2007, 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 proposal 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 5:00 p.m., January 26, 2007.
22 TAC §291.26
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas State Board of Pharmacy or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under §§551.002,
551.003, 554.001, and 554.051 of 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 the repeal: Chapters 551 - 566 and 568 - 569,
Texas Occupations Code.
§291.26.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 December 4, 2006.
TRD-200606477
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
22 TAC §291.26
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.
§291.26.Pharmacies Compounding Sterile Preparations.
(a)
Purpose. Pharmacies compounding sterile preparations, prepackaging
pharmaceutical products, and distributing those products shall comply with
all requirements for their specific license classification and this section.
The purpose of this section is to provide standards for the:
(1)
compounding of sterile preparations pursuant to a prescription
or medication order for a patient from a practitioner in Class A (Community),
Class B (Nuclear), Class C (Institutional) and Class E (Non-resident) pharmacies;
(2)
compounding, dispensing, and delivery of a reasonable quantity
of a compounded sterile preparation in a Class A (Community), Class B (Nuclear),
Class C (Institutional) and Class E (Non-resident) pharmacies to a practitioner's
office for office use by the practitioner;
(3)
compounding and distribution of compounded sterile preparations
by a Class A (Community) pharmacy for a Class C (Institutional) pharmacy;
and
(4)
compounding of sterile preparations by a Class C (Institutional)
pharmacy and the distribution of the compounded preparations to other Class
C (Institutional) pharmacies under common ownership.
(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
that 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
that 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 that 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 preparation
and administration of compounded sterile preparations.
(4)
Anteroom--An ISO Class 8 or better area where personnel
may perform hand hygiene and garbing procedures, staging of components, order
entry, labeling, and other high-particulate generating activities. It is also
a transition area that:
(A)
provides assurance that pressure relationships are constantly
maintained so that air flows from clean to dirty areas; and
(B)
reduces the need for the heating, ventilating and air conditioning
(HVAC) control system to respond to large disturbances.
(5)
Aseptic Processing--The technique involving procedures
designed to preclude contamination of drugs, packaging, equipment, or supplies
by microorganisms during preparation.
(6)
Automated compounding device--An automated device that
compounds, measures, and/or packages a specified quantity of individual components
in a predetermined sequence for a designated sterile preparation.
(7)
Batch--A specific quantity of a drug or other material
that is intended to have uniform character and quality, within specified limits,
and is produced during a single preparation cycle.
(8)
Batch preparation compounding--Compounding of multiple
sterile preparation 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 preparation units pursuant
to patient specific medication orders.
(9)
Beyond-use date--The date or time after which the compounded
sterile preparation shall not be stored or transported or begin to be administered
to a patient. The beyond-use date is determined from the date or time the
preparation is compounded.
(10)
Biological Safety Cabinet, Class II--A ventilated cabinet
for personnel, product, and environmental protection having an open front
with inward airflow for personnel protection, downward HEPA filtered laminar
airflow for product protection, and HEPA filtered exhausted air for environmental
protection.
(11)
Buffer Area, Buffer or Core Room, Buffer or Clean Room
Areas, Buffer Room Area, Buffer or Clean Area--An ISO Class 7 area where the
primary engineering control area is physically located. Activities that occur
in this area include the preparation and staging of components and supplies
used when compounding sterile preparations.
(12)
Clean room--A room in which the concentration of airborne
particles is controlled to meet a specified airborne particulate cleanliness
class. Microorganisms in the environment are monitored so that a microbial
level for air, surface, and personnel gear are not exceeded for a specified
cleanliness class.
(13)
Component--Any ingredient intended for use in the compounding
of a drug preparation, including those that may not appear in such preparation.
(14)
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 based on the practitioner-patient-pharmacist relationship
in the course of professional practice;
(B)
for administration to a patient by a practitioner as the
result of a practitioner's initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(C)
in anticipation of prescription drug or medication orders
based on routine, regularly observed prescribing patterns; or
(D)
for or as an incident to research, teaching, or chemical
analysis and not for sale or dispensing, except as allowed under Section 562.154
or Chapter 563 of the Occupations Code.
(15)
Compounding Aseptic Isolator--A form of barrier isolator
specifically designed for compounding pharmaceutical ingredients or preparations.
It is designed to maintain an aseptic compounding environment within the isolator
throughout the compounding and material transfer processes. Air exchange into
the isolator from the surrounding environment shall not occur unless it has
first passed through a microbial retentive filter (HEPA minimum).
(16)
Critical Area--A critical area is an ISO Class 5 environment.
(17)
Critical Sites--Sterile ingredients of compounded sterile
preparations and locations on devices and components used to prepare, package,
and transfer compounded sterile preparations that provide opportunity for
exposure to contamination.
(18)
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.
(19)
Disinfectant--A disinfectant is an agent that frees from
infection, usually a chemical agent but sometimes a physical one, and that
destroys disease-causing pathogens or other harmful microorganisms but may
not kill bacterial spores. It refers to substances applied to inanimate objects.
(20)
Hazardous drug--Any drug identified by at least one of
the following six criteria: carcinogenicity, teratogenicity or developmental
toxicity, reproductive toxicity in humans, organ toxicity at low doses in
humans or animals, genotoxicity, or new drugs that mimic existing hazardous
drugs in structure or toxicity.
(21)
HVAC--Heating, ventilation, and air conditioning.
(22)
Immediate use--A sterile preparation which shall be stored
for no longer than one hour before beginning to be administered to a patient.
(23)
IPA--Isopropyl alcohol (2-propanol).
(24)
Media Fill Test--A media fill test is used to qualify
aseptic technique of compounding personnel or processes and to ensure that
the processes used are able to produce sterile preparation without microbial
contamination. During this test, a microbiological growth medium such as Soybean-Casein
Digest Medium (SCDM) is substituted for the actual drug product to simulate
admixture compounding. The issues to consider in the development of a media
fill test are the following: media-fill procedures, media selection, fill
volume, incubation, time and temperature, inspection of filled units, documentation,
interpretation of results, and possible corrective actions required.
(25)
Multiple-Dose Container--A multiple-unit container for
articles or preparations intended for parenteral administration only and usually
contains antimicrobial preservatives. The beyond-use date for an opened or
entered (e.g., needle-punctured) multiple-dose container with antimicrobial
preservatives is 28 days, unless otherwise specified by the manufacturer.
(26)
Negative Pressure Room--A room that is at a lower pressure
compared to adjacent spaces and, therefore, the net flow of air is into the
room.
(27)
Office use--The administration of a compounded drug to
a patient by a practitioner in the practitioner's office or by the practitioner
in a health care facility or treatment setting, including a hospital, ambulatory
surgical center, or pharmacy in accordance with Chapter 562 of the Act, or
for administration or provision by a veterinarian in accordance with Section
563.054 of the Act.
(28)
Pharmacy Bulk Package--A container of a sterile preparation
for parenteral use that contains many single doses. The contents are intended
for use in a pharmacy admixture program and are restricted to the preparation
of admixtures for infusion or, through a sterile transfer device, for the
filling of empty sterile syringes. The closure shall be penetrated only one
time after constitution with a suitable sterile transfer device or dispensing
set, which allows measured dispensing of the contents. The pharmacy bulk package
is to be used only in a suitable work area such as a laminar flow hood (or
an equivalent clean air compounding area).
(29)
Prepackaging--The act of repackaging and relabeling quantities
of drug products from a manufacturer's original container into unit dose packaging
or a multiple dose container for distribution within a facility licensed as
a Class C pharmacy or to other pharmacies under common ownership for distribution
within those facilities. The term as defined does not prohibit the prepackaging
of drug products for use within other pharmacy classes.
(30)
Preparation or Compounded Sterile Preparation--A sterile
admixture compounded in a licensed pharmacy or other healthcare-related facility
pursuant to the order of a licensed prescriber; the article may or may not
contain sterile products.
(31)
Primary Engineering Control--A device or room that provides
an ISO Class 5 environment for the exposure of critical sites when compounding
sterile preparations. Such devices include, but may not be limited to, laminar
airflow workbenches, biological safety cabinets, and compounding aseptic isolators.
(32)
Product--A product is a commercially manufactured sterile
drug or nutrient that has been evaluated for safety and efficacy by the U.S.
Food and Drug Administration (FDA). Products are accompanied by full prescribing
information, which is commonly known as the FDA-approved manufacturer's labeling
or product package insert.
(33)
Positive Control--A quality assurance sample prepared
to test positive for microbial growth.
(34)
Positive Pressure Room--A room that is at a higher pressure
compared to adjacent spaces and, therefore, the net airflow is out of the
room.
(35)
Quality assurance--The set of activities used to ensure
that the process used in the preparation of sterile drug products lead to
products that meet predetermined standards of quality.
(36)
Quality control--The set of testing activities used to
determine that the ingredients, components (e.g., containers), and final compounded
sterile preparations prepared meet predetermined requirements with respect
to identity, purity, non-pyrogenicity, and sterility.
(37)
Reasonable quantity--An amount of a compounded drug that:
(A)
does not exceed the amount a practitioner anticipates may
be used in the practitioner's office or facility before the beyond use date
of the drug;
(B)
is reasonable considering the intended use of the compounded
drug and the nature of the practitioner's practice; and
(C)
for any practitioner and all practitioners as a whole,
is not greater than an amount the pharmacy is capable of compounding in compliance
with pharmaceutical standards for identity, strength, quality, and purity
of the compounded drug that are consistent with United States Pharmacopoeia
guidelines and accreditation practices.
(38)
Single-Dose Container--A container intended for a single
use. Examples of single-dose containers include pre-filled syringes, cartridges,
and fusion-sealed containers.
(39)
SOPs--Standard operating procedures.
(40)
Terminal Sterilization--The application of a lethal process,
e.g., steam under pressure or autoclaving, to sealed final preparation containers
for the purpose of achieving a predetermined sterility assurance level of
usually less than 106, i.e., or a probability of less than one in one million
of a non-sterile unit.
(41)
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 the compounding of sterile preparations:
(i)
developing a system to ensure that all pharmacy personnel
responsible for compounding and/or supervising the compounding of sterile
preparations within the pharmacy receive appropriate education and training
and competency evaluation;
(ii)
determining that all pharmacists involved in compounding
sterile preparations obtain continuing education appropriate for the type
of compounding done by the pharmacist;
(iii)
supervising a system to ensure appropriate procurement
of drugs and devices and storage of all pharmaceutical materials including
pharmaceuticals, components used in the compounding of sterile preparations,
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 hazardous waste in a manner so as not to endanger the public
health.
(2)
Pharmacists. Special requirements for compounding sterile
preparations.
(A)
All pharmacists engaged in compounding sterile preparations
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 preparation 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 ensure 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 or pager which is answered 24 hours a day.
(3)
Pharmacy technicians and pharmacy technician trainees.
Pharmacy technicians and pharmacy technician trainees may compound sterile
preparations provided the pharmacy technicians and/or pharmacy technician
trainees:
(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 preparations.
(A)
General.
(i)
All pharmacy personnel preparing sterile preparations 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 preparation 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.
(ii)
The aseptic technique of each person compounding or responsible
for the direct supervision of personnel compounding sterile preparations shall
be observed and evaluated as satisfactory through written and practical tests,
and media fill challenge testing, and such evaluation documented.
(iii)
Although media fill tests may be incorporated into the
experiential portion of a training program, media fill tests must be conducted
at each pharmacy where an individual compounds sterile preparations. No preparation
intended for patient use shall be compounded by an individual until the on-site
media fill tests test indicates that the individual can competently perform
aseptic procedures, except that a pharmacist may temporarily compound sterile
preparations and supervise pharmacy technicians compounding sterile preparations
without media fill tests 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 media fill tests within seven days
of commencing work at the pharmacy.
(iv)
Media fill tests procedures for assessing the preparation
of specific types of sterile preparations 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 ensure continuing competency
of pharmacy personnel through in-service education, training, and media fill
tests 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 for low- and medium-risk level
compounding, and every six months for high-risk level compounding.
(B)
Pharmacists.
(i)
All pharmacists who compound sterile preparations or supervise
pharmacy technicians compounding sterile preparations shall:
(I)
complete through a single course, a minimum of 20 hours
of instruction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training may be 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.
(II)
possess knowledge about:
(-a-)
aseptic processing;
(-b-)
quality control and quality assurance as related to environmental,
component, and finished preparation release checks and tests;
(-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 and pharmacy technician trainees.
In addition to qualifications for specific license classifications all pharmacy
technicians and pharmacy technician trainees who compound sterile preparations
shall:
(i)
have a high school or equivalent education or be working
to achieve a high school or equivalent diploma;
(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. Individuals enrolled in training programs
accredited by the American Society of Health-System Pharmacists may compound
sterile preparations 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.
(D)
Documentation of Training. The pharmacy shall maintain
a record on each person who compounds sterile preparations. The record shall
contain, at a minimum, a written record of initial and in-service training,
continuing education, and the results of written or practical testing and
media fill testing of pharmacy personnel. The record shall be maintained and
contain the following information:
(i)
name of the person receiving the training or completing
the testing or media fill tests;
(ii)
date(s) of the training, testing, or media fill challenge
testing;
(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 media fill challenge testing; and
(v)
signature (first initial and last name or full signature)
of the person receiving the training or completing the testing or media fill
challenge testing 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 media fill challenge testing of personnel.
(d)
Operational Standards.
(1)
General Requirements.
(A)
Sterile preparations 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;
(ii)
in anticipation of future prescription drug or medication
orders based on routine, regularly observed prescribing patterns; or
(iii)
in reasonable quantities for office use by a practitioner
and for use by a veterinarian.
(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)(G)
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 preparation compounded in anticipation of future
prescription drug or medication orders shall be labeled. Such label shall
contain:
(I)
name and strength of the compounded preparation 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 paragraph (5)(G) of this subsection;
(IV)
quantity or amount in the container;
(V)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including hazardous drug 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;
(ii)
the pharmacy maintains documentation that the product
is not reasonably available; and
(iii)
the prescribing practitioner has requested that the drug
be compounded.
(D)
A pharmacy may not compound preparations that are essentially
copies of commercially available products (e.g., the preparation is dispensed
in a strength that is only slightly different from a commercially available
product) unless the prescribing practitioner specifically orders the strength
or dosage form and specifies why the patient needs the particular strength
or dosage form of the preparation. The prescribing practitioner shall provide
documentation of a patient specific medical need and the preparation produces
a clinically significant therapeutic response (e.g. the physician requests
an alternate product due to hypersensitivity to excipients or preservative
in the FDA-approved product, or the physician requests an effective alternate
dosage form) or if the drug product is not commercially available. The unavailability
of such drug product must be documented prior to compounding. The methodology
for documenting unavailability includes printing the screen of the wholesaler's
notification showing back-ordered, discontinued, or out-of-stock items. This
documentation must be available for inspection by the Board.
(E)
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).
(F)
Compounding pharmacies/pharmacists may advertise and promote
the fact that they provide sterile prescription compounding services, which
may include specific drug preparations and classes of drugs.
(G)
A pharmacy may not compound veterinary preparations for
use in food producing animals in accordance with federal guidelines.
(2)
Microbial Contamination Risk Levels. Risk Levels for sterile
compounded preparations shall be as outlined in Chapter 797, Pharmacy Compounding-Sterile
Preparations of the USP/NF and as listed below.
(A)
Low-risk level compounded sterile preparations.
(i)
Low-Risk conditions. Low-risk level compounded sterile
preparations 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 using no more than three commercially manufactured sterile
products including the sterile diluent and two other sterile products and
no more than two entries into one container package (e.g., bag, vial) of sterile
product to make the sterile preparation.
(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,
package containers of other sterile products, and containers for storage and
dispensing.
(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 at a cold temperature, and for 45 days if stored in
a frozen state at minus 20 degrees Celsius or colder). For delayed activation
device systems, the storage period begins when the device is activated.
(ii)
Examples of Low-Risk Compounding. Examples of low-risk
compounding include the following.
(I)
Single volume 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 solution content
of ampules shall be passed through a sterile filter to remove glass particles.
(II)
Manually measuring and mixing no more than three manufactured
products, including the sterile diluent and two other sterile products, to
compound drug admixtures.
(B)
Medium-risk level compounded sterile preparations.
(i)
Medium-Risk Conditions. Medium-risk level compounded sterile
preparations, are those compounded aseptically under low-risk conditions and
one or more of the following conditions exists.
(I)
Multiple individual or small doses of sterile products
are combined or pooled to prepare a compounded sterile preparation 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 (e.g.,
reconstitution of intravenous immunoglobulin or other intravenous protein
products).
(IV)
For a medium-risk preparation, in the absence of passing
a sterility test the beyond use dates may not exceed the following time periods:
before administration, the sterile products are properly stored and are exposed
for not more than 30 hours at controlled room temperature, for not more than
9 days at a cold temperature, and for 45 days in solid frozen state at minus
20 degrees Celsius or colder.
(ii)
Examples of medium-risk compounding. 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 more than three sterile drug products and evacuations of air from those
reservoirs before the filled device is dispensed.
(III)
Transfer of volumes from multiple ampuls or vials into
one or more final sterile containers.
(C)
High-risk level compounded sterile preparations.
(i)
High-risk Conditions. High-risk level compounded sterile
preparations 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 contents of commercially manufactured products,
compounded sterile preparations that lack effective antimicrobial preservatives,
and sterile surfaces of devices and containers for the preparation, transfer,
sterilization, and packaging of compounded sterile preparations are exposed
to air quality worse than ISO Class 5 for more than 1 hour.
(III)
Before sterilization, non-sterile procedures such as
weighing and mixing are conducted in air quality worse than ISO Class 7, compounding
personnel are improperly garbed and gloved; or water-containing preparations
are stored for more than 6 hours.
(IV)
A pharmacy shall obtain documentation from suppliers,
including a certificate of analysis, to ensure that the chemical purity and
content strength of ingredients meet the original or compendial specifications
in unopened or in opened packages of bulk ingredients. The documentation may
be stored electronically and shall be available for inspection.
(V)
For a sterilized high-risk preparation, in the absence
of passing sterility test, the beyond use date 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.
(VI)
All non-sterile measuring, mixing, and purifying equipment
is rinsed thoroughly with sterile, pyrogen-free water, and then thoroughly
drained or dried immediately before use for high-risk compounding. All high-risk
compounded sterile aqueous solutions subjected to terminal sterilization are
passed through a filter with a nominal porosity not larger than 1.2 micron
preceding or during filling into their final containers to remove particulate
matter. All high-risk compounded sterile non-aqueous solutions subjected to
terminal sterilization are passed through a filter with a nominal porosity
5 microns or small preceding or during filling into their final containers
to remove particulate matter. Sterilization of high-risk level compounded
sterile aqueous solutions by filtration shall be performed with a sterile
0.22 micron or 0.2 micron porosity filter entirely within an ISO Class 5 or
superior air quality environment.
(ii)
Examples of high-risk compounding. Examples of high-risk
compounding include the following.
(I)
Dissolving non-sterile bulk drug powders to make solutions,
which will be terminally sterilized.
(II)
Exposing the sterile ingredients and components used to
prepare and package compounded sterile preparations to room air quality worse
than ISO Class 5 for more than 1 hour.
(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)
Immediate Use Compounded Sterile Preparations. For the
purpose of emergency or immediate patient care, compounded sterile preparations
are exempted from the requirements described in this paragraph for low-risk,
medium-risk, and high-risk level compounded sterile preparations when all
of the following criteria are met.
(A)
Only simple aseptic measuring and transfer manipulations
are performed with not more than three sterile non-hazardous commercial drug
and diagnostic radiopharmaceutical drug products, including an infusion or
diluent solution.
(B)
Unless required for the preparation, the preparation procedure
occurs continuously without delays or interruptions and does not exceed 1
hour.
(C)
At no point during preparation and prior to administration
are critical surfaces and ingredients of the compounded sterile preparation
directly exposed to contact contamination such as human touch, cosmetic flakes
or particulates, blood, human body substances (excretions and secretions e.g.,
nasal and oral), and nonsterile inanimate sources.
(D)
Administration begins not later than one hour following
the start of preparing the compounded sterile preparation.
(E)
When the compounded sterile preparations is not administered
by the person who prepared it, or its administration is not witnessed by the
person who prepared it, the compounded sterile preparation shall bear a label
listing patient identification information such as name and identification
number(s), the names and amounts of all ingredients, the name or initials
of the person who prepared the compounded sterile preparation, and the exact
1-hour beyond-use time and date.
(F)
If administration has not begun within one hour following
the start of preparing the compounded sterile preparation, the compounded
sterile preparation is promptly and safely discarded. Immediate use compounded
sterile preparations shall not be stored for later use.
(G)
Compounded sterile preparations containing three or fewer
commercial sterile drug products, including the sterile diluent and two other
sterile products, that are stored in excess of one hour before beginning to
be administered must comply with the low-risk level standards described in
paragraph (2)(A) of this subsection. Compounded sterile preparations containing
more than three commercial sterile drug products and those requiring complex
manipulations and/or preparation methods must comply with the medium-risk
level standards described in paragraph (2)(B) of this subsection. Compounded
sterile preparations prepared from nonsterile ingredients or components must
comply with the high-risk level standards described in paragraph (2)(C) of
this subsection.
(H)
Hazardous drugs shall not be prepared as immediate use
compounded sterile preparations.
(4)
Single-Dose and Multiple-Dose Containers.
(A)
Opened or needle-punctured single-dose containers such
as ampuls, bags, bottles, syringes, and vials of sterile products and compounded
sterile preparations shall be used within 1 hour if opened in worse than ISO
Class 5 air quality, and any remaining contents must be discarded. Single-dose
vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after
initial needle puncture. Opened single-dose ampuls shall not be stored for
any time period.
(B)
Multiple-dose containers (e.g., vials) are formulated for
removal of portions on multiple occasions because they contain antimicrobial
preservatives. The beyond-use date after initially entering or opening (e.g.,
needle-punctured) multiple-dose containers is 28 days, unless otherwise specified
by the manufacturer.
(5)
Library. In addition to the library requirements of the
pharmacy's specific license classification, a pharmacy shall maintain current
or updated copies in hard-copy or electronic format of each of the following:
(A)
a reference text on injectable drug preparations, such
as Handbook on Injectable Drug Products;
(B)
a specialty reference text appropriate for the scope of
pharmacy services provided by the pharmacy, e.g., if the pharmacy prepares
hazardous drugs, a reference text on the preparation of hazardous drugs; and
(C)
the United States Pharmacopeia/National Formulary.
(6)
Environment. Compounding facilities shall be physically
designed and environmentally controlled to minimize airborne contamination
of critical sites.
(A)
Low and Medium Risk Preparations.
(i)
Effective April 1, 2008, a pharmacy that prepares low-
and medium-risk preparations shall have a designated room for the compounding
of sterile preparations that is constructed to minimize the opportunities
for particulate and microbial contamination. The designated room shall:
(I)
be clean, well lit, and of sufficient size to support sterile
compounding activities;
(II)
be used only for the compounding of sterile preparations;
(III)
be designed such that hand sanitizing and gowning occurs
outside the buffer area but is accessible without use of the hands of the
compounding personnel;
(IV)
have non-porous and washable floors or floor covering
to enable regular disinfection;
(V)
be ventilated in a manner to avoid disruption from the
HVAC system and room cross-drafts;
(VI)
have walls, ceilings, floors, fixtures, shelving, counters,
and cabinets that are smooth, impervious, free from cracks and crevices (e.g.,
coved), nonshedding and resistant to damage by disinfectant agents;
(VII)
have junctures of ceilings to walls coved or caulked
to avoid cracks and crevices;
(VIII)
have drugs and supplies stored on shelving areas above
the floor to permit adequate floor cleaning;
(IX)
contain only the appropriate compounding supplies and
not be used for bulk storage for supplies and materials. Objects that shed
particles shall not be brought into the controlled area;
(X)
contain an anteroom that provides at least an ISO class
8 air quality which may contain a sink that enables hands-free use with a
closed system of soap dispensing to minimize the risk of extrinsic contamination;
and
(XI)
contain a buffer zone or buffer room designed to maintain
at least ISO Class 7 conditions. The following is applicable for the buffer
area.
(-a-)
There shall be some demarcation designation that delineates
the anteroom or area from the buffer area.
(-b-)
The buffer area shall be segregated from surrounding,
unclassified spaces to reduce the risk of contaminants being blown, dragged,
or otherwise introduced into the filtered unidirectional airflow environment,
and this segregation should be continuously monitored.
(-c-)
A buffer room that provides a physical separation, through
the use of walls, doors and pass-throughs shall have a minimum differential
positive pressure of 0.02 to 0.05 inches water column.
(-d-)
A buffer zone that is not physically separated from the
anteroom shall employ the principle of displacement airflow as defined in
Chapter 797, Pharmaceutical Compounding-Sterile Preparations, of the USP/NF,
with limited access to personnel.
(-e-)
The buffer area shall not contain sources of water (i.e.,
sinks) or floor drains.
(ii)
The pharmacy shall prepare sterile pharmaceuticals in
a primary engineering control device, such as a laminar air flow hood, biological
safety cabinet, compounding aseptic isolator which is capable of maintaining
at least ISO Class 5 conditions during normal activity.
(I)
The primary engineering control shall:
(-a-)
be located in the buffer area or room and placed in the
buffer area in a manner as to avoid conditions that could adversely affect
its operation such as strong air currents from opened doors, personnel traffic,
or air streams from the heating, ventilating and air condition system.
(-b-)
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 and when it is relocated, in accordance with the manufacturer's
specifications; and
(-c-)
have pre-filters inspected periodically and replaced
as needed, in accordance with written policies and procedures and the manufacturer's
specification, and the inspection and/or replacement date documented.
(II)
compounding aseptic isolator must be placed in an ISO
Class 7 cleanroom unless the compounding aseptic isolator meets all of the
following conditions.
(-a-)
The isolator must provide isolation from the room and
maintain ISO Class 5 during dynamic operating conditions including transferring
ingredients, components, and devices into and out of the isolator and during
preparation of compounded sterile preparations.
(-b-)
Particle counts sampled approximately 6 to 12 inches
upstream of the critical exposure site must maintain ISO Class 5 levels during
compounding operations.
(-c-)
The pharmacy shall maintain documentation from the manufacturer
that the compounding aseptic isolator meets this standard when located in
worse than ISO Class 7 environments.
(B)
High-risk Preparations. In addition to the requirements
in subparagraph (A) of this paragraph, when high-risk preparations are compounded,
the primary engineering control shall be located in a buffer room that provides
a physical separation, through the use of walls, doors and pass-throughs and
has a minimum differential positive pressure of 0.02 to 0.05 inches water
column.
(C)
Automated compounding device. If automated compounding
devices 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, based on the
manufacturer's recommendations.
(D)
Hazardous drugs. In addition to the requirements specified
in subparagraphs (A) and (B) of this paragraph, if the preparation is also
hazardous, the following is applicable.
(i)
General.
(I)
All personnel involved in the compounding of hazardous
products shall wear appropriate protective apparel, such as gowns, face masks,
eye protection, hair covers, shoe covers or dedicated shoes, and appropriate
gloving.
(II)
Appropriate safety and containment techniques for compounding
hazardous drugs shall be used in conjunction with aseptic techniques required
for preparing sterile preparations.
(III)
Disposal of hazardous waste shall comply with all applicable
local, state, and federal requirements.
(IV)
Prepared doses of hazardous drugs must be dispensed, labeled
with proper precautions inside and outside, and distributed in a manner to
minimize patient contact with hazardous agents.
(ii)
Primary engineering control device.
(I)
Hazardous drugs must be prepared in a Class II or III biological
safety cabinet or compounding aseptic isolator that is located in a ISO Class
7 room that is physically separated from other preparation areas and optimally
has no less than 0.01-inch water column negative pressure to adjacent positive
pressure ISO Class 7 or better, anterooms, thus providing inward airflow to
contain any airborne drug.
(II)
If a compounding isolator is used outside of a cleanroom,
the room must maintain a minimum negative pressure of 0.01-inch water column
and have a minimum of 12 air changes per hour. Note that an anteroom leading
to a negative pressure room shall meet at least ISO Class 7 criteria so that
air drawn into the negative pressure environment is of the same ISO Class
7 quality. A pressure indictor shall be installed that can be readily monitored
for correct room pressurization.
(III)
Pharmacies that prepare very low volume of hazardous
drugs (e.g., less than five preparations per week), the use of two tiers of
containment, e.g., closed-system vial-transfer device within a biological
safety cabinet or compounding aseptic isolator that are located in a non-negative
pressure room is acceptable.
(E)
Cleaning and disinfecting the sterile compounding areas.
The following cleaning and disinfecting practices and frequencies apply to
direct and contiguous compounding areas, which include ISO Class 5 compounding
areas for exposure of critical sites as well as buffer rooms, anterooms, and
ante-areas.
(i)
The pharmacist-in-charge is responsible for developing
written procedures for cleaning and disinfecting the direct and contiguous
compounding areas and assuring the procedures are followed.
(ii)
These procedures shall be conducted prior to each work
shift and when there are spills or environmental quality breaches.
(iii)
Before compounding is performed, all items are removed
from the direct and contiguous compounding areas and all surfaces are cleaned
of loose material and residue from spills, followed by an application of a
residue-free disinfecting agent (e.g., IPA), that is left on for a time sufficient
to exert its antimicrobial effect.
(iv)
Work surfaces in the ISO Class 7 buffer areas and ISO
Class 8 anterooms or ante-areas are cleaned and disinfected at least daily,
and dust and debris are removed when necessary from storage sites for compounding
ingredients and supplies, using a method that does not degrade the ISO Class
7 or 8 air quality.
(v)
Floors in the buffer or clean area are cleaned by mopping
at least once daily when no aseptic operations are in progress preceding from
the buffer or clean room area to the anteroom area.
(vi)
In the anteroom area, walls, ceilings, and shelving shall
be cleaned monthly.
(vii)
Supplies and equipment removed from shipping cartons
must be wiped with a disinfecting agent, such as IPA. However, if supplies
are received in sealed pouches, the pouches may be removed as the supplies
are introduced into the buffer or clean area without the need to disinfect
the individual supply items. No shipping or other external cartons may be
taken into the buffer or clean area.
(viii)
Cleaning and disinfecting of counters and other easily
cleanable surfaces of the anteroom area is performed at least daily in accordance
with written procedures.
(ix)
Storage shelving, emptied of all supplies, walls, and
ceilings are cleaned and disinfected at planned intervals, monthly, if not
more frequently.
(F)
Security requirements. The pharmacy may authorize personnel
to gain access to that area of the pharmacy containing dispensed sterile preparations,
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.
(G)
Storage requirements and beyond-use dating.
(i)
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 temperature--A 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--A temperature between 8 degrees and 15 degrees
Celsius (46 degrees 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 on the labeling; and
(IV)
controlled room temperature--A temperature maintained
thermostatically between 15 degrees and 30 degrees Celsius (59 degrees and
86 degrees Fahrenheit).
(ii)
Beyond-use dating.
(I)
Beyond-use dates for compounded sterile preparations shall
be assigned based on professional experience, which shall include careful
interpretation of appropriate information sources for the same or similar
formulations.
(II)
Beyond-use dates for compounded sterile preparations that
are prepared strictly in accordance with manufacturers' product labeling must
be those specified in that labeling, or from appropriate literature sources
or direct testing.
(III)
Beyond-use dates for compounded sterile preparations
that lack justification from either appropriate literature sources or by direct
testing evidence must be assigned as described in Chapter 797, Pharmaceutical
Compounding-Sterile Preparations of the USP/NF.
(7)
Equipment and supplies. Pharmacies compounding sterile
preparations shall have the following equipment and supplies:
(A)
a calibrated 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 calibrated 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 periodic inspection by the Texas State Board of Pharmacy;
(D)
equipment and utensils necessary for the proper compounding
of sterile preparations. 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 preparation 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, hazardous waste from the preparation of hazardous
drugs and/or biohazardous waste;
(F)
appropriate packaging or delivery containers to maintain
proper storage conditions for sterile preparations;
(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)
hazardous spill kits, if applicable; and
(vii)
masks, caps, coveralls or gowns with tight cuffs, shoe
covers, and sterile gloves, as applicable.
(8)
Labeling.
(A)
Prescription drug or medication orders. 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.
(i)
The generic name(s) or the official name(s) of the principal
active ingredient(s) of the compounded sterile preparation.
(ii)
A statement that the compounded sterile preparation has
been compounded by the pharmacy. (An auxiliary label may be used on the container
to meet this requirement).
(iii)
A beyond-use date after which the compounded sterile
preparation shall not be used. The beyond-use date shall be determined as
outlined in Chapter 797, Pharmacy Compounding-Sterile Preparations of the
USP/NF, and paragraph (5) of this subsection.
(B)
Batch. If the sterile pharmaceutical is compounded in a
batch, the following shall 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 hazardous drug warning labels where appropriate;
and
(iv)
device-specific instructions, where appropriate.
(C)
Pharmacy bulk package. The label of a pharmacy bulk package
shall:
(i)
state prominently "Pharmacy Bulk Package-Not for Direct
Infusion;"
(ii)
contain or refer to information on proper techniques to
help ensure safe use of the preparation; and
(iii)
bear a statement limiting the time frame in which the
container may be used once it has been entered, provided it is held under
the labeled storage conditions.
(9)
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 preparation
was compounded by the pharmacy must be included in this written information.
If there is no written information available, the patient shall be advised
that the drug has been compounded and how to contact a pharmacist, and if
appropriate, the prescriber, concerning the drug.
(10)
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 preparations 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 to ensure 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 preparation 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
to ensure that:
(I)
the patient and/or patient's caregiver receives information
regarding drugs and their safe and appropriate use; and
(II)
healthcare 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 healthcare provider.
(11)
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 and the pharmacist
shall compare the monograph of drugs in a similar class to the Certificate
of Analysis.
(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 preparation beyond the desired result.
(F)
Components, drug preparation 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 preparation.
(H)
A pharmacy may not compound a preparation that contains
ingredients appearing on a federal Food and Drug Administration list of drug
products withdrawn or removed from the market for safety reasons.
(12)
Compounding process.
(A)
Standard operating procedures (SOPs). 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)
preparation evaluation;
(vi)
quality assurance;
(vii)
preparation recall;
(viii)
packaging; and
(ix)
storage of compounded sterile preparations.
(B)
USP/NF. 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)
Personnel Cleansing and Garbing.
(i)
Any person with an apparent illness or open lesion that
may adversely affect the safety or quality of a drug preparation being compounded
shall be excluded from direct contact with components, drug preparation containers,
closures, any materials involved in the compounding process, and drug products
until the condition is corrected.
(ii)
Before entering the clean area, compounding personnel
must remove the following:
(I)
personal outer garments (e.g., bandanas, coats, hats, jackets,
scarves, sweaters, vests);
(II)
all cosmetics, because they shed flakes and particles;
and
(III)
all hand, wrist, and other body jewelry.
(iii)
The wearing of artificial nails or extenders is prohibited
while working in the sterile compounding environment.
(iv)
Personnel must don personal protective equipment and perform
hand hygiene in an order that proceeds from the dirtiest to the cleanest activities
as follows:
(I)
Activities considered the dirtiest include donning of dedicated
shoes or shoe covers, head and facial hair covers (e.g., beard covers in addition
to face masks), and face mask/eye shield. Eye shields are optional unless
working with irritants like germicidal disinfecting agents.
(II)
After donning dedicated shoes or shoe covers, head and
facial hair covers, and face masks, personnel shall perform a hand hygiene
procedure by removing debris from underneath fingernails using a nail cleaner
under running warm water followed by vigorous hand washing. Personnel shall
begin washing arms at the elbows and continue washing to hands for at least
30 seconds with either a plain (non-antimicrobial) soap, or antimicrobial
soap, and water while in the anteroom/ante-area.
(III)
After completion of hand washing, personnel shall don
non-shedding disposable gowns with sleeves that fit snugly around the wrists.
(IV)
Once inside the clean area, prior to donning powder-free
sterile gloves, antiseptic hand cleansing must be performed using an alcohol-based
surgical hand scrub with persistent activity (e.g., alcohol-based preparations
containing either 0.5% or 1.0% chlorhexidine gluconate) following manufacturers'
recommendations. Allow hands to dry thoroughly before donning sterile gloves.
(V)
Sterile gloves that form a continuous barrier with the
gown shall be the last item donned before compounding begins.
(VI)
Sterile gloves shall be disinfected by applying 70% IPA
or appropriate disinfectant to all contact surface areas of the sterile gloves
and letting the sterile gloves dry thoroughly. Routine application of 70%
IPA shall occur throughout the compounding day and whenever nonsterile surfaces
are touched.
(VII)
When compounding personnel must temporarily exit the
ISO Class 7 environment during a work shift, the exterior gown, if not visibly
soiled, may be removed and retained in the ISO Class 8 anteroom/ante-area,
to be re-donned during that same work shift only. However, shoe covers, hair
and facial hair covers, face mask/eye shield, and sterile gloves must be replaced
with new ones before re-entering the ISO Class 7 clean environment along with
performing proper hand hygiene.
(D)
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.
(13)
Quality Assurance.
(A)
Initial Formula Validation. Prior to routine compounding
of a sterile preparation, a pharmacy shall conduct an evaluation that shows
that the pharmacy is capable of compounding a product that is sterile and
that contains the stated amount of active ingredient(s).
(i)
Low risk preparations.
(I)
Quality assurance practices include, but are not limited
to the following:
(-a-)
Routine disinfection and air quality testing of the direct
compounding environment to minimize microbial surface contamination and maintain
ISO Class 5 air quality.
(-b-)
Visual confirmation that compounding personnel are properly
donning and wearing appropriate items and types of protective garments and
goggles.
(-c-)
Review of all orders and packages of ingredients to ensure
that the correct identity and amounts of ingredients were compounded.
(-d-)
Visual inspection of compounded sterile preparations
to ensure the absence of particulate matter in solutions, the absence of leakage
from vials and bags, and the accuracy and thoroughness of labeling.
(II)
Example of a Media-Fill Test Procedure. This, or an equivalent
test, is performed at least annually by each person authorized to compound
in a low-risk level under conditions that closely simulate the most challenging
or stressful conditions encountered during compounding of low-risk level sterile
produce. Once begun, this test is completed without interruption within an
ISO Class 5 air quality environment. Three sets of four 5-milliliter aliquots
of sterile Soybean-Casein Digest Medium are transferred with the same sterile
10-milliliter syringe and vented needle combination into separate sealed,
empty, sterile 30-milliliter clear vials (i.e., four 5-milliliter aliquots
into each of three 30-milliliter vials). Sterile adhesive seals are aseptically
affixed to the rubber closures on the three filled vials. The vials are incubated
within a range of 20- 35 degrees Celsius for 14 days. Failure is indicated
by visible turbidity in the medium on or before 14 days. The media-fill test
must include a positive-control sample.
(ii)
Medium risk preparations.
(I)
Quality assurance procedures for medium-risk level compounded
sterile preparations include all those for low-risk level compounded sterile
preparations, as well as a more challenging media-fill test passed annually,
or more frequently.
(II)
Example of a Media-Fill Test Procedure. This, or an equivalent
test, is performed at least annually under conditions that closely simulate
the most challenging or stressful conditions encountered during compounding.
This test is completed without interruption within an ISO Class 5 air quality
environment. Six 100-milliliter aliquots of sterile Soybean-Casein Digest
Medium are aseptically transferred by gravity through separate tubing sets
into separate evacuated sterile containers. The six containers are then arranged
as three pairs, and a sterile 10-milliliter syringe and 18-gauge needle combination
is used to exchange two 5-milliliter aliquots of medium from one container
to the other container in the pair. For example, after a 5-milliliter aliquot
from the first container is added to the second container in the pair, the
second container is agitated for 10 seconds, then a 5-milliliter aliquot is
removed and returned to the first container in the pair. The first container
is then agitated for 10 seconds, and the next 5-milliliter aliquot is transferred
from it back to the second container in the pair. Following the two 5-milliliter
aliquot exchanges in each pair of containers, a 5-milliliter aliquot of medium
from each container is aseptically injected into a sealed, empty, sterile
10-milliliter clear vial, using a sterile 10-milliliter syringe and vented
needle. Sterile adhesive seals are aseptically affixed to the rubber closures
on the three filled vials. The vials are incubated within a range of 20- 35
degrees Celsius for 14 days. Failure is indicated by visible turbidity in
the medium on or before 14 days. The media-fill test must include a positive-control
sample.
(iii)
High risk preparations.
(I)
Procedures for high-risk level compounded sterile preparations
include all those for low-risk level compounded sterile preparations. In addition,
a media-fill test that represents high-risk level compounding is performed
twice a year by each person authorized to compound high-risk level compounded
sterile preparations.
(II)
Example of a Media-Fill Test Procedure Compounded Sterile
Preparations Sterilized by Filtration. This test, or an equivalent test, is
performed under conditions that closely simulate the most challenging or stressful
conditions encountered when compounding high-risk level compounded sterile
preparations. Note: Sterility tests for autoclaved compounded sterile preparations
are not required unless they are prepared in batches of more than 25 units.
This test is completed without interruption in the following sequence:
(-a-)
Dissolve 3 grams of nonsterile commercially available
Soybean-Casein Digest Medium in 100 milliliters of non-bacteriostatic water
to make a 3% non-sterile solution.
(-b-)
Draw 25 milliliters of the medium into each of three
30-milliliter sterile syringes. Transfer 5 milliliters from each syringe into
separate sterile 10-milliliter vials. These vials are the positive controls
to generate exponential microbial growth, which is indicated by visible turbidity
upon incubation.
(-c-)
Under aseptic conditions and using aseptic techniques,
affix a sterile 0.2-micron porosity filter unit and a 20-gauge needle to each
syringe. Inject the next 10 milliliters from each syringe into three separate
10-milliliter sterile vials. Repeat the process for three more vials. Label
all vials, affix sterile adhesive seals to the closure of the nine vials,
and incubate them at 20 to 35 degrees Celsius. Inspect for microbial growth
over 14 days as described in Chapter 797 Pharmaceutical Compounding-Sterile
Preparations, of the USP/NF.
(B)
Finished preparation release checks and tests.
(i)
High-risk level compounded sterile preparations.
(I)
All high-risk level compounded sterile preparations 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 71, Sterility Tests of the USP/NF.
(II)
All high-risk level compounded sterile preparations, except
those for inhalation and ophthalmic administration, that are prepared in groups
of more than 25 identical individual single-dose packages (such as ampules,
bags, syringes, vials), or in multiple-dose vials for administration to multiple
patients, or exposed longer than 12 hours at 2 to 8 degrees Celsius and longer
than 6 hours at warmer than 8 degrees Celsius before they are sterilized must
be tested to ensure that they do not contain excessive bacterial endotoxins
as specified in Chapter 85, Bacterial Endotoxins Test of the USP/NF.
(III)
When high-risk level compounded sterile preparations
are dispensed before receiving the results of their sterility tests, there
shall be a written procedure requiring daily observation for each batch of
the incubating test specimens and immediate recall of the dispensed compounded
sterile preparations when there is any evidence of microbial growth in the
test specimens. In addition, the patient and the physician of the patient
to whom a potentially contaminated compounded sterile preparations was administered
are notified of the potential risk.
(ii)
All compounded sterile preparations that are intended
to be solutions must be visually examined for the presence of particulate
matter and not administered or dispensed when such matter is observed.
(iii)
The prescription drug and medication orders, written
compounding procedure, preparation records, and expended materials used to
make compounded sterile preparations at all contamination risk levels shall
be inspected for accuracy of correct identities and amounts of ingredients,
aseptic mixing and sterilization, packaging, labeling, and expected physical
appearance before they are administered or dispensed.
(14)
Quality control.
(A)
Quality control procedures. The pharmacy shall follow established
quality control procedures to monitor the compounding environment and quality
of compounded drug preparations for conformity with the quality indicators
established for the preparation. When developing these procedures, pharmacy
personnel shall consider the provisions of Chapter 797, Pharmaceutical Compounding-Sterile
Preparations, Chapter 1075, Good Compounding Practices, and Chapter 1160,
Pharmaceutical Calculations in Prescription Compounding of the current USP/NF.
Such procedures shall be documented and be available for inspection.
(B)
Verification of compounding accuracy and sterility.
(i)
The accuracy of identities, concentrations, amounts, and
purities of ingredients in compounded sterile preparations shall be confirmed
by reviewing labels on packages, observing and documenting correct measurements
with approved and correctly standardized devices, and reviewing information
in labeling and certificates of analysis provided by suppliers.
(ii)
If the correct identify, purity, strength, and sterility
of ingredients and components of compounded sterile preparations cannot be
confirmed such ingredients and components shall be discarded immediately.
(iii)
If individual ingredients, such as bulk drug substances,
are not labeled with expiration dates, when the drug substances are stable
indefinitely in their commercial packages under labeled storage conditions,
such ingredients may gain or lose moisture during storage and use and shall
require testing to determine the correct amount to weigh for accurate content
of active chemical moieties in compounded sterile preparations.
(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
or pharmacy technician trainee performing the compounding;
(iv)
signature or initials of the pharmacist responsible for
supervising pharmacy technicians or pharmacy technician trainees 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/distributor 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)
finished preparation evaluation and testing specifications,
if applicable; and
(XI)
comparison of actual yield to anticipated yield, when
appropriate.
(f)
Office Use Compounding and Distribution of Compounded Preparations
to Class C Pharmacies or Veterinarians in Accordance with Section 563.054
of the Act.
(1)
General.
(A)
A pharmacy may dispense and deliver a reasonable quantity
of a compounded preparation to a practitioner for office use by the practitioner
in accordance with this subsection.
(B)
A Class A (Community) pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute sterile
compounded preparations to a Class C (Institutional) pharmacy.
(C)
A Class C (Institutional) pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute sterile
compounded preparations that the Class C pharmacy has compounded for other
Class C pharmacies under common ownership.
(D)
To dispense and deliver a compounded preparation under
this subsection, a pharmacy must:
(i)
verify the source of the raw materials to be used in a
compounded drug;
(ii)
comply with applicable United States Pharmacopoeia guidelines,
including the testing requirements, and the Health Insurance Portability and
Accountability Act of 1996 (Pub. L. No. 104-191);
(iii)
enter into a written agreement with a practitioner for
the practitioner's office use of a compounded preparation;
(iv)
comply with all applicable competency and accrediting
standards as determined by the board; and
(v)
comply with the provisions of this subsection.
(2)
Written Agreement. A pharmacy that provides sterile compounded
preparations to practitioners for office use or to another pharmacy shall
enter into a written agreement with the practitioner or pharmacy. The written
agreement shall:
(A)
address acceptable standards of practice for a compounding
pharmacy and a practitioner and receiving pharmacy that enter into the agreement
including a statement that the compounded drugs may only be administered to
the patient and may not be dispensed to the patient or sold to any other person
or entity except as authorized by Section 563.054 of the Act;
(B)
require the practitioner or receiving pharmacy to include
on a patient's chart, medication order or medication administration record
the lot number and beyond-use date of a compounded preparation administered
to a patient;
(C)
describe the scope of services to be performed by the pharmacy
and practitioner or receiving pharmacy, including a statement of the process
for:
(i)
a patient to report an adverse reaction or submit a complaint;
and
(ii)
the pharmacy to recall batches of compounded preparations;
(3)
Recordkeeping.
(A)
Maintenance of Records.
(i)
Records of orders and distribution of sterile compounded
preparations to a practitioner for office use or to a Class C pharmacy for
administration to a patient shall:
(I)
be kept by the pharmacy and be available, for at least
two years from the date of the record, for inspecting and copying by the board
or its representative and to other authorized local, state, or federal law
enforcement agencies;
(II)
maintained separately from the records of products dispensed
pursuant to a prescription or medication order; and
(III)
supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the Texas State Board of Pharmacy or its representative.
Failure to provide the records set out in this subsection, either on site
or within 72 hours for whatever reason, constitutes prima facie evidence of
failure to keep and maintain records.
(ii)
Records may be maintained in an alternative data retention
system, such as a data processing system or direct imaging system provided
the data processing system is capable of producing a hard copy of the record
upon the request of the board, its representative, or other authorized local,
state, or federal law enforcement or regulatory agencies.
(B)
Orders. The pharmacy shall maintain a record of all sterile
compounded preparations ordered by a practitioner for office use or by a Class
C pharmacy for administration to a patient. The record shall include the following
information:
(i)
date of the order;
(ii)
name, address, and phone number of the practitioner who
ordered the preparation and if applicable, the name, address and phone number
of the Class C Pharmacy ordering the preparation; and
(iii)
name, strength, and quantity of the preparation ordered.
(C)
Distributions. The pharmacy shall maintain a record of
all sterile compounded preparations distributed pursuant to an order to a
practitioner for office use or by a Class C pharmacy for administration to
a patient. The record shall include the following information:
(i)
date the preparation was compounded;
(ii)
date the preparation was distributed;
(iii)
name, strength and quantity in each container of the
preparation;
(iv)
pharmacy's lot number;
(v)
quantity of containers shipped; and
(vi)
name, address, and phone number of the practitioner or
Class C Pharmacy to whom the preparation is distributed.
(D)
Audit Trail.
(i)
The pharmacy shall store the order and distribution records
of preparations for all sterile compounded preparations ordered by and or
distributed to a practitioner for office use or by a Class C pharmacy for
administration to a patient in such a manner as to be able to provide a audit
trail for all orders and distributions of any of the following during a specified
time period.
(I)
any strength and dosage form of a preparation (by either
brand or generic name or both);
(II)
any ingredient;
(III)
any lot number;
(IV)
any practitioner;
(V)
any facility; and
(VI)
any pharmacy, if applicable.
(ii)
The audit trail shall contain the following information:
(I)
date of order and date of the distribution;
(II)
practitioner's name, address, and name of the Class C
pharmacy, if applicable;
(III)
name, strength and quantity of the preparation in each
container of the preparation;
(IV)
name and quantity of each active ingredient;
(V)
quantity of containers distributed; and
(VI)
pharmacy's lot number;
(4)
Labeling. The pharmacy shall affix a label to the preparation
containing the following information:
(A)
name, address, and phone number of the compounding pharmacy;
(B)
the statement: "For Institutional or Office Use Only-Not
for Resale"; or if the preparation is distributed to a veterinarian the statement:
"Compounded Preparation";
(C)
name and strength of the preparation or list of the active
ingredients and strengths;
(D)
pharmacy's lot number;
(E)
beyond-use date as determined by the pharmacist using appropriate
documented criteria;
(F)
quantity or amount in the container;
(G)
appropriate ancillary instructions, such as storage instructions
or cautionary statements, including hazardous drug warning labels where appropriate;
and
(H)
device-specific instructions, where appropriate.
(5)
Recall Procedures. The pharmacy shall have written procedure
for the recall of any compounded sterile preparations provided to a practitioner
for office use or to a pharmacy for administration. The recall procedures
shall require:
(A)
notification to the practitioner, facility, and pharmacy
to which the preparation was distributed;
(B)
notification to the Texas Department of State Health Services;
(C)
notification to the patient;
(D)
quarantine of the product if there is a suspicion of harm
to a patient;
(E)
a mandatory recall if there is confirmed or probable harm
to a patient; and
(F)
notification to the board if a mandatory recall is instituted.
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 December 4, 2006.
TRD-200606481
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: January 14, 2007
For further information, please call: (512) 305-8028
The provisions of the
Administrative Procedure Act (APA), Government Code, Chapter 2001, govern
where ambiguity or differences exist between the provisions of this chapter
and APA.
]
, ALJ, or judge
]--
A judge employed by the State Office of Administrative Hearings.
[
An individual appointed by the chief administrative law judge of the State
Office of Administrative Hearings (SOAH) under Government Code, Chapter 2003, §2003.041.
]
(4)
] Agency--The Texas State Board
of Pharmacy, and its divisions, departments, and employees.
(5)
] Administrative Procedure Act
(APA)--Government Code, Chapter 2001, as amended.
(7)
] Board--The Texas State Board
of Pharmacy.
(9)
] Contested case--A proceeding,
including but not restricted to licensing, in which the legal rights, duties,
or privileges of a party are to be determined by the board after an opportunity
for adjudicative hearing.
(10)
] Diversion of controlled substances--An
act or acts which result in the distribution of controlled substances from
legitimate pharmaceutical or medical channels in violation of the Controlled
Substances Act or rules promulgated pursuant to the Controlled Substances
Act or rules relating to controlled substances promulgated pursuant to this
Act.
(11)
] Executive director/secretary--The
secretary of the board and executive director of the agency.
(12)
] License--The whole or part
of any agency permit, certificate, approval, registration, or similar form
of permission required by law.
(13)
] Licensee--Any individual
or person to whom the agency has issued any permit, certificate, approved
registration, or similar form of permission authorized by law.
(14)
] Licensing--The agency process
relating to the granting, denial, renewal, revocation, suspension, annulment,
withdrawal, or amendment of a license.
(15)
] Official act--Any act performed
by the board pursuant to a duty, right, or responsibility imposed or granted
by law, rule, or regulation.
(17)
] Person--An individual, corporation,
government or governmental subdivision or agency, business trust, estate,
trust, partnership, association, or any other legal entity.
(19)
] President--The president
of the Texas State Board of Pharmacy.
(20)
] Presiding Officer--The president
of the Texas State Board of Pharmacy or, in the president's absence, the highest
ranking officer present at a Board meeting.
(21)
] Quorum--A majority of the
members of the board appointed and serving on the board.
(24)
] State Office of Administrative
Hearings (SOAH)--The agency to which contested cases are referred by the Texas
State Board of Pharmacy.
(25)
] Sample--A prescription drug
which is not intended to be sold and is intended to promote the sale of the
drug.
(26)
] Texas Public Information
Act--Government Code, Chapter 552.
Pharmacist ] Mental or Physical Examination.
reprimand, fine, restrict, suspend, cancel, retire, or revoke
any license granted by the board
] if the board finds that the applicant
or licensee has developed a mental or physical incapacity that in the estimation
of the board would prevent a pharmacist from engaging in the practice of pharmacy
with a level of skill and competence that ensures the public health, safety
and welfare.
pharmacist or
] applicant
or licensee
to submit to a mental or physical examination by a physician
or
other healthcare professional
[
physicians
] designated
by the board.
pharmacist or
] applicant
or licensee
shall be notified in writing, by either personal service or certified
mail with return receipt requested, of the request to submit to the examination.
pharmacist or
] applicant
or licensee
shall submit to the examination within 30 days of the date of the receipt
of the request.
pharmacist or
] applicant
or licensee
shall authorize the release of the results of the examination and the
results shall be submitted to the board within 15 days of the date of the
examination.
pharmacist or
] applicant
or licensee
does not comply with the provisions of paragraph (2) of this section,
the following is applicable.
pharmacist or
] applicant
or licensee
.
pharmacist or
] applicant
or licensee
shall be notified of the hearing by either personal service or certified
mail with return receipt requested.
pharmacist or
] applicant
or licensee
and if applicable, the [
pharmacist's or
] applicant's
or licensee's
attorney, are entitled to present any testimony and other
evidence to show why the
applicant or licensee
[
pharmacist
] should not be required to submit to the examination.
pharmacist or
] applicant
or licensee
to
submit to the examination or withdrawing the request for examination.
paragraph (28)(C) of this subsection
]
to a nonprofit affiliate of the organization to the extent otherwise permitted
by law;
or
] shameless, and which shows a moral indifference to standards of
the community;
or
]
.
]
.
]
or Disciplinary Action Against ] a License.
(a)
]
If an applicant's original application or
request for renewal of a license is denied, he shall have 30 days from the
date of denial to make a written request for a hearing. If so requested, the
hearing will be granted and the provisions of APA and this chapter with regard
to a contested case shall apply.
Subchapter B of 1 TAC §§111.11 - 111.24
] regarding Historically
Underutilized Business Certification Program.
Subchapter B. GENERAL PROCEDURES IN A CONTESTED CASE
Subchapter C. DISCIPLINARY GUIDELINES
and
]
.
]
(4)
] absence of potential harm
to the public;
(5)
] self-reported and voluntary
admissions of the conduct which serves as a basis for disciplinary action
under the Act;
(6)
] absence of premeditation to
commit the conduct which serves as a basis for disciplinary action under the
Act;
(7)
] absence of intent to commit
the conduct which serves as a basis for disciplinary action under the Act;
(8)
]motive;
(9)
]absence of prior conduct of
a similar or related nature;
(10)
] absence of a disciplinary
actions taken by any regulatory agency of the federal government or any state;
(11)
] implementation of remedial
measures to correct or mitigate harm from the conduct which serves as a basis
for disciplinary action under the Act;
(12)
] rehabilitative potential;
(13)
] prior community service and
present value to the community;
(14)
] relevant circumstances reducing
the seriousness of the conduct which serves as a basis for disciplinary action
under the Act; [
and
]
(15)
] relevant circumstances lessening
responsibility for the conduct which serves as a basis for disciplinary action
under the Act
; and
[
.
]
In
] considering whether a criminal
conviction or deferred adjudication directly relates to the occupation of
a licensee or a registrant, or the operation of a pharmacy, the board shall
consider:
type
] of disciplinary sanction to impose
on a license or registration, the board shall
, in its discretion,
also
determine the person's fitness to perform the duties and discharge the responsibilities
of a licensee or registrant
by evaluating and balancing these factors
in the following priority with the first being the highest priority
[
based on
]:
A
] person with a conviction or deferred
adjudication shall:
letter
] from the spouse or other parent;
letters of recommendation
], absence of other
criminal activity or documentation of community service since conviction or
deferred adjudication; [
and
]
.
]
The
]
direct relationship to a license or registration is presumed when any [
the
] crime occurs in connection with the practice of pharmacy or the
operation of a pharmacy.
The crimes are as follows:
or
]
(6)
] other misdemeanors or felonies
which serve as grounds for discipline under the Act, including violations
of the Penal Code, Titles 4, 5, 6, 7, 8, 9, and 10, which indicate an inability
or tendency for the person to be unable to perform as a licensee or registrant,
or to be unfit for licensure or registration, if action by the board will
promote the intent of the Pharmacy Act, board rules including this chapter,
and Occupations Code, Chapter 53.
, fraud, or theft of
drugs
]:
, fraud, or theft of
drugs
]:
Subchapter D. RULEMAKING
Chapter 291.
PHARMACIES
Subchapter A. ALL CLASSES OF PHARMACIES
Subchapter A. ALL CLASSES OF PHARMACIES
Subchapter B. COMMUNITY PHARMACY (CLASS A)