Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,938
6819-7008 p. ; 28 cm.View a full description of this periodical.
Extracted Text
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(A) name, address, and phone number of the com-
pounding pharmacy;
(B) the statement: "For Institutional or Office Use
Only--Not for Resale"; or if the preparation is distributed to a veteri-
narian 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 warn-
ing labels where appropriate; and
(H) device-specific instructions, where appropriate.
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for the re-
call of any compounded sterile preparation provided to a patient, to a
practitioner for office use, or a pharmacy for administration. Written
procedures shall include, but not be limited to the requirements as spec-
ified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall of any
sterile preparation compounded by the pharmacy upon identification of
a potential or confirmed harm to a patient.
(3) In the event of a recall, the pharmacist-in-charge shall
ensure that:
(A) each practitioner, facility, and/or pharmacy to
which the preparation was distributed is notified, in writing, of the
recall;
(B) each patient to whom the preparation was dispensed
is notified, in writing, of the recall;
(C) if the preparation is prepared as a batch, the board
is notified of the recall, in writing;
(D) if the preparation is distributed for office use, the
Texas Department of State Health Services, Drugs and Medical De-
vices Group, is notified of the recall, in writing;
(E) the preparation is quarantined; and
(F) the pharmacy keeps a written record of the recall
including all actions taken to notify all parties and steps taken to ensure
corrective measures.
(4) If a pharmacy fails to initiate a recall, the board may re-
quire a pharmacy to initiate a recall if there is potential for or confirmed
harm to a patient.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of the Secretary of State on August 20, 2012.
TRD-201204392Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 9, 2012
Proposal publication date: June 22, 2012
For further information, please call: (512) 305-8028
CHAPTER 295. PHARMACISTS
The Texas State Board of Pharmacy adopts amendments to
295.5, concerning Pharmacist License or Renewal Fees, and
295.8, concerning Continuing Education Requirements. The
amendments are adopted without changes to the proposed text
as published in the June 22, 2012, issue of the Texas Register
(37 TexReg 4525).
The amendments to 295.5 will raise pharmacist license fees
to generate additional revenue needed to make revenue pro-
jections. The amendments to 295.8 will allow pharmacists to
receive continuing education credit for programs approved by
other state boards of pharmacy.
No comments were received.
22 TAC 295.5
The amendments are adopted 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 these amendments: Texas Pharmacy
Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of the Secretary of State on August 20, 2012.
TRD-201204393
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: October 1, 2012
Proposal publication date: June 22, 2012
For further information, please call: (512) 305-8028
22 TAC 295.8
The amendments are adopted 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 these amendments: Texas Pharmacy
Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.37 TexReg 6938 August 31, 2012 Texas Register
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Texas. Secretary of State. Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012, periodical, August 31, 2012; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth253227/m1/119/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.