| (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 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 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 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.
(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 |
