Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,934
6819-7008 p. ; 28 cm.View a full description of this periodical.
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strength, quality, or purity of the compounded drug preparation beyond
the desired result.
(F) Components, drug preparation containers, and clo-
sures shall be rotated so that the oldest stock is used first.
(G) Container closure systems shall provide adequate
protection against foreseeable external factors in storage and use that
can cause deterioration or contamination of the compounded drug
preparation.
(H) A pharmacy may not compound a preparation that
contains ingredients appearing on a federal Food and Drug Adminis-
tration list of drug products withdrawn or removed from the market for
safety reasons.
(11) Compounding process.
(A) Standard operating procedures (SOPs). All signif-
icant procedures performed in the compounding area shall be covered
by written SOPs designed to ensure accountability, accuracy, quality,
safety, and uniformity in the compounding process. At a minimum,
SOPs shall be developed for:
(i) the facility;
(ii) equipment;
(iii) personnel;
(iv) preparation evaluation;
(v) quality assurance;
(vi) preparation recall;
(vii) packaging; and
(viii) storage of compounded sterile preparations.
(B) USP/NF. Any compounded formulation with an of-
ficial monograph in the USP/NF shall be compounded, labeled, and
packaged in conformity with the USP/NF monograph for the drug.
(C) Personnel Cleansing and Garbing.
(i) Any person with an apparent illness or open le-
sion that may adversely affect the safety or quality of a drug preparation
being compounded shall be excluded from direct contact with compo-
nents, drug preparation containers, closures, any materials involved in
the compounding process, and drug products until the condition is cor-
rected.
(ii) Before entering the clean area, compounding
personnel must remove the following:
(I) personal outer garments (e.g., bandanas,
coats, hats, jackets, scarves, sweaters, vests);
(II) all cosmetics, because they shed flakes and
particles; and
(III) all hand, wrist, and other body jewelry.
(iii) The wearing of artificial nails or extenders is
prohibited while working in the sterile compounding environment.
(iv) Personnel must don personal protective equip-
ment and perform hand hygiene in an order that proceeds from the dirt-
iest to the cleanest activities as follows:
(I) Activities considered the dirtiest include don-
ning of dedicated shoes or shoe covers, head and facial hair covers (e.g.,
beard covers in addition to face masks), and face mask/eye shield. Eye
shields are optional unless working with irritants like germicidal disin-
fecting agents.(II) After donning dedicated shoes or shoe cov-
ers, head and facial hair covers, and face masks, personnel shall per-
form a hand hygiene procedure by removing debris from underneath
fingernails using a nail cleaner under running warm water followed
by vigorous hand washing. Personnel shall begin washing arms at the
hands and continue washing to elbows for at least 30 seconds with ei-
ther a plain (non-antimicrobial) soap, or antimicrobial soap, and water
while in the anteroom/ante-area.
(III) After completion of hand washing, person-
nel shall don clean non-shedding gowns with sleeves that fit snugly
around the wrists.
(IV) Gloves that form a continuous barrier with
the gown shall be the last item donned before compounding begins.
(V) Gloves, either those which are sterile or have
been disinfected by applying 70% IPA or appropriate disinfectant to
all contact surface areas and allowed to dry, that form a continuous
barrier with the gown shall be the last item donned before compounding
begins. Routine application of 70% IPA shall occur throughout the
compounding day and whenever nonsterile surfaces are touched.
(VI) When compounding personnel must tem-
porarily exit the ISO Class 7 environment during a work shift, the
exterior gown, if not visibly soiled, may be removed and retained
in the ISO Class 8 anteroom/ante-area, to be re-donned during that
same work shift only. However, shoe covers, hair and facial hair
covers, face mask/eye shield, and gloves must be replaced with new
ones before re-entering the ISO Class 7 clean environment along with
performing proper hand hygiene.
(D) At each step of the compounding process, the phar-
macist shall ensure that components used in compounding are accu-
rately weighed, measured, or subdivided as appropriate to conform to
the formula being prepared.
(12) Quality Assurance.
(A) Initial Formula Validation. Prior to routine com-
pounding of a sterile preparation, a pharmacy shall conduct an evalua-
tion that shows that the pharmacy is capable of compounding a product
that is sterile and that contains the stated amount of active ingredient(s).
(i) Low risk preparations.
(I) Quality assurance practices include, but are
not limited to the following:
(-a-) Routine disinfection and air quality test-
ing of the direct compounding environment to minimize microbial sur-
face contamination and maintain ISO Class 5 air quality.
(-b-) Visual confirmation that compounding
personnel are properly donning and wearing appropriate items and
types of protective garments and goggles.
(-c-) Review of all orders and packages of in-
gredients to ensure that the correct identity and amounts of ingredients
were compounded.
(-d-) Visual inspection of compounded sterile
preparations to ensure the absence of particulate matter in solutions, the
absence of leakage from vials and bags, and the accuracy and thorough-
ness of labeling.
(II) Example of a Media-Fill Test Procedure.
This, or an equivalent test, is performed at least annually by each
person authorized to compound in a low-risk level under conditions
that closely simulate the most challenging or stressful conditions
encountered during compounding of low-risk level sterile produce.
Once begun, this test is completed without interruption within an ISO
Class 5 air quality environment. Three sets of four 5-milliliter aliquots37 TexReg 6934 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/m1/115/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.