| (H) device-specific instructions, where appropriate.
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for
the recall 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 specified 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) the board is notified of the recall, in writing,
not later than 24 hours after the recall is issued;
(D) if the preparation is distributed for office use,
the Texas Department of State Health Services, Drugs and Medical Devices
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 require a pharmacy to initiate a recall if there is potential
for or confirmed harm to a patient.
(5) A pharmacy that compounds sterile preparations
shall notify the board immediately of any adverse effects reported
to the pharmacy or that are known by the pharmacy to be potentially
attributable to a sterile preparation compounded by the pharmacy.
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| Source Note: The provisions of this §291.133 adopted to be effective December 10, 2013, 38 TexReg 8869; amended to be effective September 11, 2014, 39 TexReg 7128; amended to be effective June 11, 2015, 40 TexReg 3647; amended to be effective September 14, 2015, 40 TexReg 6111; amended to be effective June 12, 2016, 41 TexReg 4257; amended to be effective September 11, 2016, 41 TexReg 6718; amended to be effective January 4, 2018, 42 TexReg 7700; amended to be effective September 16, 2018, 43 TexReg 5784 |
