Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,930
6819-7008 p. ; 28 cm.View a full description of this periodical.
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(i) High-risk Conditions. High-risk level com-
pounded sterile preparations are those compounded under any of the
following conditions.
(I) Non-sterile ingredients, including manufac-
tured products are incorporated or a non-sterile device is employed be-
fore terminal sterilization.
(II) Sterile ingredients, components, devices,
and mixtures are exposed to air quality inferior to ISO Class 5. This
includes storage in environments inferior to ISO Class 5 of opened
or partially used packages of manufactured sterile products that lack
antimicrobial preservatives.
(III) Non-sterile preparations are exposed no
more than 6 hours before being sterilized.
(IV) It is assumed, and not verified by examina-
tion of labeling and documentation from suppliers or by direct determi-
nation, that the chemical purity and content strength of ingredients meet
their original or compendial specifications in unopened or in opened
packages of bulk ingredients.
(V) For a high-risk preparation, in the absence of
direct sterility testing results or appropriate information sources that
justify different limits, the storage periods cannot exceed the following
time periods: before administration, the compounded sterile prepara-
tions are properly stored and are exposed for not more than 24 hours at
controlled room temperature, for not more than 3 days at a cold tem-
perature, and for 45 days in solid frozen state at minus 20 degrees or
colder.
(VI) All non-sterile measuring, mixing, and pu-
rifying equipment is rinsed thoroughly with sterile, pyrogen-free wa-
ter, and then thoroughly drained or dried immediately before use for
high-risk compounding while assuring cleanliness. All high-risk com-
pounded sterile aqueous solutions subjected to terminal sterilization are
passed through a filter with a nominal porosity not larger than 1.2 mi-
cron preceding or during filling into their final containers to remove
particulate matter. Sterilization of high-risk level compounded ster-
ile preparations by filtration shall be performed entirely within an ISO
Class 5 or superior air quality environment.
(ii) Examples of high-risk compounding. Examples
of high-risk compounding include the following.
(I) Dissolving non-sterile bulk drug powders to
make solutions, which will be terminally sterilized.
(II) Exposing the sterile ingredients and compo-
nents used to prepare and package compounded sterile preparations to
room air quality worse than ISO Class 5.
(III) Measuring and mixing sterile ingredients in
non-sterile devices before sterilization is performed.
(IV) Assuming, without appropriate evidence or
direct determination, that packages of bulk ingredients contain at least
95% by weight of their active chemical moiety and have not been con-
taminated or adulterated between uses.
(3) Immediate Use Compounded Sterile Preparations. For
the purpose of emergency or immediate patient care, such situations
may include cardiopulmonary resuscitation, emergency room treat-
ment, preparation of diagnostic agents, or critical therapy where the
preparation of the compounded sterile preparation under low-risk level
conditions would subject the patient to additional risk due to delays
in therapy. Compounded sterile preparations are exempted from the
requirements described in this paragraph for low-risk, medium-risk,and high-risk level compounded sterile preparations when all of the
following criteria are met.
(A) Only simple aseptic measuring and transfer manip-
ulations are performed with not more than three sterile non-hazardous
commercial drug and diagnostic radiopharmaceutical drug products,
including an infusion or diluent solution.
(B) Unless required for the preparation, the preparation
procedure occurs continuously without delays or interruptions and does
not exceed 1 hour.
(C) Administration begins not later than one hour fol-
lowing the completion of preparing the compounded sterile prepara-
tion.
(D) When the compounded sterile preparations is not
administered by the person who prepared it, or its administration is
not witnessed by the person who prepared it, the compounded sterile
preparation shall bear a label listing patient identification information
such as name and identification number(s), the names and amounts of
all ingredients, the name or initials of the person who prepared the
compounded sterile preparation, and the exact 1-hour beyond-use time
and date.
(E) If administration has not begun within one hour fol-
lowing the completion of preparing the compounded sterile prepara-
tion, the compounded sterile preparation is promptly and safely dis-
carded. Immediate use compounded sterile preparations shall not be
stored for later use.
(F) Cytotoxic drugs shall not be prepared as immediate
use compounded sterile preparations.
(4) Library. In addition to the library requirements of the
pharmacy's specific license classification, a pharmacy shall maintain
current or updated copies in hard-copy or electronic format of each of
the following:
(A) a reference text on injectable drug preparations,
such as Handbook on Injectable Drug Products;
(B) a specialty reference text appropriate for the scope
of pharmacy services provided by the pharmacy, e.g., if the pharmacy
prepares hazardous drugs, a reference text on the preparation of haz-
ardous drugs; and
(C) the United States Pharmacopeia/National Formu-
lary or the USP Pharmacist's Pharmacopeia containing USP Chapter
797, Pharmaceutical Compounding--Sterile Preparations.
(5) Environment. Compounding facilities shall be physi-
cally designed and environmentally controlled to minimize airborne
contamination of critical sites.
(A) Low and Medium Risk Preparations.
(i) A pharmacy that prepares low- and medium-risk
preparations shall have a clean room/controlled area for the compound-
ing of sterile preparations that is constructed to minimize the opportuni-
ties for particulate and microbial contamination. The clean room/con-
trolled area shall:
(I) be clean, well lit, and of sufficient size to sup-
port sterile compounding activities;
(II) be used only for the compounding of sterile
preparations;
(III) be designed such that hand sanitizing and
gowning occurs outside the buffer area but allows hands-free access
by compounding personnel to the buffer room/area;37 TexReg 6930 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/m1/111/: accessed April 19, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.