Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,928
6819-7008 p. ; 28 cm.View a full description of this periodical.
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to another pharmacy unless the pharmacies are under common owner-
ship and control and use a common training program; or
(-b-) completion of a course sponsored by an
ACPE accredited provider which provides 40 hours of instruction and
experience in the areas listed in subparagraph (A) of this paragraph; or
(II) a training program which is accredited by the
American Society of Health-System Pharmacists. Individuals enrolled
in training programs accredited by the American Society of Health-
System Pharmacists may compound sterile preparations in a licensed
pharmacy provided:
(-a-) the compounding occurs only during
times the individual is assigned to a pharmacy as a part of the experien-
tial component of the American Society of Health-System Pharmacists
training program;
(-b-) the individual is under the direct super-
vision of and responsible to a pharmacist who has completed training
as specified in subparagraph (B) of this paragraph; and
(-c-) the supervising pharmacist conducts
in-process and final checks.
(ii) acquire the required experiential portion of the
training programs specified in this subparagraph under the supervision
of an individual who has already completed training as specified in
subparagraph (B) or (C) of this paragraph.
(D) Documentation of Training. The pharmacy shall
maintain a record on each person who compounds sterile preparations.
The record shall contain, at a minimum, a written record of initial and
in-service training, education, and the results of written and practical
testing and media-fill testing of pharmacy personnel. The record shall
be maintained and contain the following information:
(i) name of the person receiving the training or com-
pleting the testing or media-fill tests;
(ii) date(s) of the training, testing, or media-fill chal-
lenge testing;
(iii) general description of the topics covered in the
training or testing or of the process validated;
(iv) name of the person supervising the training,
testing, or media-fill challenge testing; and
(v) signature or initials of the person receiving the
training or completing the testing or media-fill challenge testing and the
pharmacist-in-charge or other pharmacist employed by the pharmacy
and designated by the pharmacist-in-charge as responsible for training,
testing, or media-fill challenge testing of personnel.
(d) Operational Standards.
(1) General Requirements.
(A) Sterile preparations may be compounded in li-
censed pharmacies:
(i) upon presentation of a practitioner's prescription
drug or medication order based on a valid pharmacist/patient/prescriber
relationship;
(ii) in anticipation of future prescription drug or
medication orders based on routine, regularly observed prescribing
patterns; or
(iii) in reasonable quantities for office use by a prac-
titioner and for use by a veterinarian.
(B) Sterile compounding in anticipation of future pre-
scription drug or medication orders must be based upon a history of re-
ceiving valid prescriptions issued within an established pharmacist/pa-tient/prescriber relationship, provided that in the pharmacist's profes-
sional judgment the quantity prepared is stable for the anticipated shelf
time.
(i) The pharmacist's professional judgment shall be
based on the criteria used to determine a beyond-use date outlined in
paragraph (5)(G) of this subsection.
(ii) Documentation of the criteria used to determine
the stability for the anticipated shelf time must be maintained and be
available for inspection.
(iii) Any preparation compounded in anticipation of
future prescription drug or medication orders shall be labeled. Such
label shall contain:
(I) name and strength of the compounded prepa-
ration or list of the active ingredients and strengths;
(II) facility's lot number;
(III) beyond-use date as determined by the phar-
macist using appropriate documented criteria as outlined in paragraph
(5)(G) of this subsection;
(IV) quantity or amount in the container;
(V) appropriate ancillary instructions, such as
storage instructions or cautionary statements, including hazardous
drug warning labels where appropriate; and
(VI) device-specific instructions, where appro-
priate.
(C) Commercially available products may be com-
pounded for dispensing to individual patients provided the following
conditions are met:
(i) the commercial product is not reasonably avail-
able from normal distribution channels in a timely manner to meet pa-
tient's needs;
(ii) the pharmacy maintains documentation that the
product is not reasonably available due to a drug shortage or unavail-
ability from the manufacturer; and
(iii) the prescribing practitioner has requested that
the drug be compounded as described in subparagraph (D) of this para-
graph.
(D) A pharmacy may not compound preparations that
are essentially copies of commercially available products (e.g., the
preparation is dispensed in a strength that is only slightly different from
a commercially available product) unless the prescribing practitioner
specifically orders the strength or dosage form and specifies why the
patient needs the particular strength or dosage form of the preparation.
The prescribing practitioner shall provide documentation of a patient
specific medical need and the preparation produces a clinically sig-
nificant therapeutic response (e.g. the physician requests an alternate
product due to hypersensitivity to excipients or preservative in the
FDA-approved product, or the physician requests an effective alternate
dosage form) or if the drug product is not commercially available.
The unavailability of such drug product must be documented prior
to compounding. The methodology for documenting unavailability
includes maintaining a copy of the wholesaler's notification showing
back-ordered, discontinued, or out-of-stock items. This documenta-
tion must be available in hard-copy or electronic format for inspection
by the board.
(E) A pharmacy may enter into an agreement to com-
pound and dispense prescription/medication orders for another phar-37 TexReg 6928 August 31, 2012 Texas Register
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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/m1/109/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.