Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,926
6819-7008 p. ; 28 cm.View a full description of this periodical.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
(A) does not exceed the amount a practitioner antici-
pates may be used in the practitioner's office or facility before the be-
yond use date of the drug;
(B) is reasonable considering the intended use of the
compounded drug and the nature of the practitioner's practice; and
(C) for any practitioner and all practitioners as a whole,
is not greater than an amount the pharmacy is capable of compound-
ing in compliance with pharmaceutical standards for identity, strength,
quality, and purity of the compounded drug that are consistent with
United States Pharmacopoeia guidelines and accreditation practices.
(42) Segregated Compounding Area--A designated space,
either a demarcated area or room, that is restricted to preparing low-risk
level compounded sterile preparations with 12-hour or less beyond-use
date. Such area shall contain a device that provides unidirectional air-
flow of ISO Class 5 air quality for preparation of compounded sterile
preparations and shall be void of activities and materials that are extra-
neous to sterile compounding.
(43) Single-dose container--A container intended for a
single use, other than single-dose vials and single-dose large volume
potential solutions. Examples of single-dose containers include
pre-filled syringes, cartridges, and fusion-sealed containers without
preservatives.
(44) Single-dose vial--A vial intended for a single use. Ex-
ceptions to this definition would be single dose vials routinely used
to compound total potential nutrition (TPN) preparations (e.g., sodium
chloride, sodium acetate, sodium phosphate, potassium chloride, potas-
sium acetate, potassium phosphate, calcium glucontae, magnesium sul-
fate, multivitamin for injection, multi-trace elements, ascorbic acid,
folic acid, heparin, phytonadione, 1-carnitine, cysteine, selenium, in-
jectable zinc).
(45) Single-dose large volume parenteral solution--Large
volume parenteral solutions (i.e., containers of solution of at least 1000
mL) routinely used for compounding sterile TPN preparations or for
batch compounding (e.g., sterile water for injection (SWFI); 5%, 10%,
and 70% dextrose in SWFI; 0.9% sodium chloride; 0.45% sodium chlo-
ride; 5% dextrose/0.9% sodium chloride; 5% dextrose/0.45% sodium
chloride).
(46) SOPs--Standard operating procedures.
(47) Terminal Sterilization--The application of a lethal
process, e.g., steam under pressure or autoclaving, to sealed final
preparation containers for the purpose of achieving a predetermined
sterility assurance level of usually less than 106, i.e., or a probability
of less than one in one million of a non-sterile unit.
(48) Unidirectional Flow--An airflow moving in a single
direction in a robust and uniform manner and at sufficient speed to re-
producibly sweep particles away from the critical processing or testing
area.
(49) USP/NF--The current edition of the United States
Pharmacopeia/National Formulary.
(c) Personnel.
(1) Pharmacist-in-charge.
(A) General. The pharmacy shall have a pharmacist-
in-charge in compliance with the specific license classification of the
pharmacy.
(B) Responsibilities. In addition to the responsibilities
for the specific class of pharmacy, the pharmacist-in-charge shall havethe responsibility for, at a minimum, the following concerning the com-
pounding of sterile preparations:
(i) developing a system to ensure that all pharmacy
personnel responsible for compounding and/or supervising the com-
pounding of sterile preparations within the pharmacy receive appropri-
ate education and training and competency evaluation;
(ii) determining that all personnel involved in com-
pounding sterile preparations obtain continuing education appropriate
for the type of compounding done by the personnel;
(iii) supervising a system to ensure appropriate pro-
curement of drugs and devices and storage of all pharmaceutical mate-
rials including pharmaceuticals, components used in the compounding
of sterile preparations, and drug delivery devices;
(iv) ensuring that the equipment used in compound-
ing is properly maintained;
(v) developing a system for the disposal and distri-
bution of drugs from the pharmacy;
(vi) developing a system for bulk compounding or
batch preparation of drugs;
(vii) developing a system for the compounding,
sterility assurance, quality assurance, and quality control of sterile
preparations; and
(viii) if applicable, ensuring that the pharmacy has a
system to dispose of hazardous waste in a manner so as not to endanger
the public health.
(2) Pharmacists. Special requirements for compounding
sterile preparations.
(A) All pharmacists engaged in compounding sterile
preparations shall:
(i) possess the education, training, and proficiency
necessary to properly and safely perform compounding duties under-
taken or supervised; and
(ii) obtain continuing education appropriate for the
type of compounding done by the pharmacist.
(B) A pharmacist shall inspect and approve all compo-
nents, drug preparation containers, closures, labeling, and any other
materials involved in the compounding process.
(C) A pharmacist shall review all compounding records
for accuracy and conduct in-process and final checks to ensure that
errors have not occurred in the compounding process.
(D) A pharmacist is responsible for the proper mainte-
nance, cleanliness, and use of all equipment used in the compounding
process.
(E) A pharmacist shall be accessible at all times to re-
spond to patients' and other health professionals' questions and needs.
Such access may be through a telephone or pager which is answered
24 hours a day.
(3) Pharmacy technicians and pharmacy technician
trainees. Pharmacy technicians and pharmacy technician trainees may
compound sterile preparations provided the pharmacy technicians
and/or pharmacy technician trainees:
(A) have completed the education and training specified
in paragraph (4) of this subsection; and
(B) are supervised by a pharmacist who has completed
the training specified in paragraph (4) of this subsection, conducts37 TexReg 6926 August 31, 2012 Texas Register
Upcoming Pages
Here’s what’s next.
Search Inside
This issue can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Periodical.
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/m1/107/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.