Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,929
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macy provided the pharmacy complies with the provisions of 291.125
of this title (relating to Centralized Prescription Dispensing).
(F) Compounding pharmacies/pharmacists may adver-
tise and promote the fact that they provide sterile prescription com-
pounding services, which may include specific drug preparations and
classes of drugs.
(G) A pharmacy may not compound veterinary prepa-
rations for use in food producing animals except in accordance with
federal guidelines.
(2) Microbial Contamination Risk Levels. Risk Levels for
sterile compounded preparations shall be as outlined in Chapter 797,
Pharmacy Compounding--Sterile Preparations of the USP/NF and as
listed below.
(A) Low-risk level compounded sterile preparations.
(i) Low-Risk conditions. Low-risk level com-
pounded sterile preparations are those compounded under all of the
following conditions.
(I) The compounded sterile preparations are
compounded with aseptic manipulations entirely within ISO Class 5 or
better air quality using only sterile ingredients, products, components,
and devices.
(I) The compounding involves only transfer,
measuring, and mixing manipulations with closed or sealed packaging
systems that are preformed promptly and attentively.
(III) Manipulations are limited to aseptically
opening ampuls, penetrating sterile stoppers on vials with sterile
needles and syringes, and transferring sterile liquids in sterile syringes
to sterile administration devices and packages of other sterile products.
(IV) For a low-risk preparation, in the absence of
direct sterility testing results or appropriate information sources that
justify different limits, the storage periods may not exceed the follow-
ing periods: before administration, 48 hours at controlled room tem-
perature, for not more than 14 days if stored at a cold temperature, and
for 45 days if stored in a frozen state at minus 20 degrees Celsius or
colder). For delayed activation device systems, the storage period be-
gins when the device is activated.
(ii) Examples of Low-Risk Compounding. Exam-
ples of low-risk compounding include the following.
(I) Single volume transfers of sterile dosage
forms from ampuls, bottles, bags, and vials using sterile syringes
with sterile needles, other administration devices, and other sterile
containers. The solution content of ampules shall be passed through a
sterile filter to remove any glass particles.
(II) Manually measuring and mixing no more
than three manufactured products to compound drug admixtures.
(B) Low-Risk Level compounded sterile preparations
with 12-hour or less beyond-use date. Low-risk level compounded ster-
ile preparations are those compounded pursuant to a physician's order
for a specific patient under all of the following conditions.
(i) The compounded sterile preparations are com-
pounded in compounding aseptic isolator or compounding aseptic con-
tainment isolator that does not meet the requirements described in para-
graph (5)(A)(ii)(II) of this subsection relating to Low and Medium Risk
Preparations or the compounded sterile preparations are compounded
in laminar airflow workbench or a biological safety cabinet that cannot
be located within an ISO Class 7 buffer area.(ii) The primary engineering control device is lo-
cated in a segregated compounding area restricted to sterile compound-
ing activities that minimizes the risk of contamination of the com-
pounded sterile preparation.
(iii) The segregated compounding area shall not be
in a location that has unsealed windows or doors that connect to the
outdoors, or that is adjacent to construction sites, warehouses, or food
preparation.
(iv) For a low-risk preparation compounded as de-
scribed in clauses (i) - (iii) of this subparagraph, administration of such
compounded sterile preparations must commence within 12 hours of
preparation or as recommended in the manufacturers' package insert,
whichever is less.
(C) Medium-risk level compounded sterile prepara-
tions.
(i) Medium-Risk Conditions. Medium-risk level
compounded sterile preparations, are those compounded aseptically
under low-risk conditions and one or more of the following conditions
exists.
(I) Multiple individual or small doses of sterile
products are combined or pooled to prepare a compounded sterile
preparation that will be administered either to multiple patients or to
one patient on multiple occasions.
(II) The compounding process includes complex
aseptic manipulations other than the single-volume transfer.
(III) The compounding process requires unusu-
ally long duration, such as that required to complete the dissolution or
homogenous mixing (e.g., reconstitution of intravenous immunoglob-
ulin or other intravenous protein products).
(IV) The compounded sterile preparations do not
contain broad spectrum bacteriostatic substances and they are admin-
istered over several days (e.g., an externally worn infusion device).
(V) For a medium-risk preparation, in the ab-
sence of direct sterility testing results or appropriate information
sources that justify different limits the beyond use dates may not
exceed the following time periods: before administration, the com-
pounded sterile preparations are properly stored and are exposed for
not more than 30 hours at controlled room temperature, for not more
than 9 days at a cold temperature, and for 45 days in solid frozen state
at minus 20 degrees Celsius or colder.
(ii) Examples of medium-risk compounding. Exam-
ples of medium-risk compounding include the following.
(I) Compounding of total parenteral nutrition flu-
ids using a manual or automated device during which there are multiple
injections, detachments, and attachments of nutrient source products to
the device or machine to deliver all nutritional components to a final
sterile container.
(II) Filling of reservoirs of injection and infusion
devices with multiple sterile drug products and evacuations of air from
those reservoirs before the filled device is dispensed.
(III) Filling of reservoirs of injection and infu-
sion devices with volumes of sterile drug solutions that will be admin-
istered over several days at ambient temperatures between 25 and 40
degrees Celsius (77 and 104 degrees Fahrenheit).
(IV) Transfer of volumes from multiple ampuls
or vials into a single, final sterile container or product.
(D) High-risk level compounded sterile preparations.ADOPTED RULES August 31, 2012 37 TexReg 6929
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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/m1/110/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.