| (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.
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for
the recall of any compounded non-sterile preparations 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 non-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 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.
|
| Source Note: The provisions of this §291.131 adopted to be effective September 18, 2007, 32 TexReg 6352; amended to be effective March 6, 2008, 33 TexReg 1801; amended to be effective September 9, 2012, 37 TexReg 6917; amended to be effective January 4, 2018, 42 TexReg 7700; amended to be effective August 24, 2022, 47 TexReg 4977 |
