Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,933
6819-7008 p. ; 28 cm.View a full description of this periodical.
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(ii) For outpatient prescription orders only, a state-
ment that the compounded sterile preparation has been compounded
by the pharmacy. (An auxiliary label may be used on the container to
meet this requirement).
(iii) A beyond-use date. The beyond-use date shall
be determined as outlined in Chapter 797, Pharmacy Compounding--
Sterile Preparations of the USP/NF, and paragraph (4) of this subsec-
tion.
(B) Batch. If the sterile pharmaceutical is compounded
in a batch, the following shall also be included on the batch label.
(i) unique lot number assigned to the batch;
(ii) quantity;
(iii) appropriate ancillary instructions, such as stor-
age instructions or cautionary statements, including hazardous drug
warning labels where appropriate; and
(iv) device-specific instructions, where appropriate.
(C) Pharmacy bulk package. The label of a pharmacy
bulk package shall:
(i) state prominently "Pharmacy Bulk Package--Not
for Direct Infusion;"
(ii) contain or refer to information on proper tech-
niques to help ensure safe use of the preparation; and
(iii) bear a statement limiting the time frame in
which the container may be used once it has been entered, provided it
is held under the labeled storage conditions.
(8) Written drug information for prescription drug orders
only. Written information about the compounded preparation or its
major active ingredient(s) shall be given to the patient at the time of
dispensing a prescription drug order. A statement which indicates that
the preparation was compounded by the pharmacy must be included
in this written information. If there is no written information available,
the patient shall be advised that the drug has been compounded and how
to contact a pharmacist, and if appropriate, the prescriber, concerning
the drug.
(9) Pharmaceutical Care Services. In addition to the
pharmaceutical care requirements for the pharmacy's specific license
classification, the following requirements for sterile preparations
compounded pursuant to prescription drug orders must be met.
(A) Primary provider. There shall be a designated
physician primarily responsible for the patient's medical care. There
shall be a clear understanding between the physician, the patient, and
the pharmacy of the responsibilities of each in the areas of the delivery
of care, and the monitoring of the patient. This shall be documented in
the patient medication record (PMR).
(B) Patient training. The pharmacist-in-charge shall de-
velop policies to ensure that the patient and/or patient's caregiver re-
ceives information regarding drugs and their safe and appropriate use,
including instruction when applicable, regarding:
(i) appropriate disposition of hazardous solutions
and ancillary supplies;
(ii) proper disposition of controlled substances in
the home;
(iii) self-administration of drugs, where appropriate;(iv) emergency procedures, including how to con-
tact an appropriate individual in the event of problems or emergencies
related to drug therapy; and
(v) if the patient or patient's caregiver prepares ster-
ile preparations in the home, the following additional information shall
be provided:
(I) safeguards against microbial contamination,
including aseptic techniques for compounding intravenous admixtures
and aseptic techniques for injecting additives to premixed intravenous
solutions;
(I) appropriate storage methods, including stor-
age durations for sterile pharmaceuticals and expirations of self-mixed
solutions;
(III) handling and disposition of premixed and
self-mixed intravenous admixtures; and
(IV) proper disposition of intravenous admixture
compounding supplies such as syringes, vials, ampules, and intra-
venous solution containers.
(C) Pharmacist-patient relationship. It is imperative
that a pharmacist-patient relationship be established and maintained
throughout the patient's course of therapy. This shall be documented
in the patient's medication record (PMR).
(D) Patient monitoring. The pharmacist-in-charge shall
develop policies to ensure that:
(i) the patient's response to drug therapy is moni-
tored and conveyed to the appropriate health care provider; and
(ii) the first dose of any new drug therapy is admin-
istered in the presence of an individual qualified to monitor for and
respond to adverse drug reactions.
(10) Drugs, components, and materials used in sterile com-
pounding.
(A) Drugs used in sterile compounding shall be a
USP/NF grade substances manufactured in an FDA-registered facility.
(B) If USP/NF grade substances are not available shall
be of a chemical grade in one of the following categories:
(i) Chemically Pure (CP);
(ii) Analytical Reagent (AR);
(iii) American Chemical Society (ACS); or
(iv) Food Chemical Codex.
(C) If a drug, component or material is not purchased
from a FDA-registered facility, the pharmacist shall establish purity
and stability by obtaining a Certificate of Analysis from the supplier
and the pharmacist shall compare the monograph of drugs in a similar
class to the Certificate of Analysis.
(D) All components shall:
(i) be manufactured in an FDA-registered facility; or
(ii) in the professional judgment of the pharmacist,
be of high quality and obtained from acceptable and reliable alternative
sources; and
(iii) stored in properly labeled containers in a clean,
dry area, under proper temperatures.
(E) Drug product containers and closures shall not
be reactive, additive, or absorptive so as to alter the safety, identity,ADOPTED RULES August 31, 2012 37 TexReg 6933
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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/m1/114/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.