Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,923
6819-7008 p. ; 28 cm.View a full description of this periodical.
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(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 Phar-
macy or its representative. If the pharmacy maintains the records in an
electronic format, the requested records must be provided in an elec-
tronic format. 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 practi-
tioner 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 practi-
tioner or Class C pharmacy to whom the preparation is distributed.
(D) Audit Trail.
(i) The pharmacy shall store the order and distribu-
tion records of preparations for all non-sterile compounded prepara-
tions 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 infor-
mation:
(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 prepara-
tion 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 prepa-
ration containing the following information:
(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 non-sterile preparations provided to a patient,
to a practitioner for office use, or a pharmacy for administration. Writ-
ten 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 identifica-
tion 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.ADOPTED RULES August 31, 2012 37 TexReg 6923
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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/m1/104/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.