Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,932
6819-7008 p. ; 28 cm.View a full description of this periodical.
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cies apply to direct and contiguous compounding areas, which include
ISO Class 5 compounding areas for exposure of critical sites as well as
buffer rooms, anterooms, and ante-areas.
(i) The pharmacist-in-charge is responsible for de-
veloping written procedures for cleaning and disinfecting the direct
and contiguous compounding areas and assuring the procedures are fol-
lowed.
(ii) These procedures shall be conducted prior to
and after each work shift (at a minimum of every 12 hours while the
pharmacy is open) and when there are spills or environmental quality
breaches.
(iii) Before compounding is performed, all items are
removed from the direct and contiguous compounding areas and all
surfaces are cleaned of loose material and residue from spills, followed
by an application of a residue-free disinfecting agent (e.g., IPA), that is
left on for a time sufficient to exert its antimicrobial effect.
(iv) Work surfaces near the direct and contiguous
compounding areas in the buffer or clean area are cleaned of loose ma-
terial and residue from spills, followed by an application of a residue-
free disinfecting agent that is left on for a time sufficient to exert its
antimicrobial effect.
(v) Floors in the buffer or clean area are cleaned by
mopping at least once daily when no aseptic operations are in progress
preceding from the buffer or clean room area to the anteroom area.
(vi) In the anteroom area, walls, ceilings, and shelv-
ing shall be cleaned monthly.
(vii) Supplies and equipment removed from ship-
ping cartons must be wiped with a disinfecting agent, such as IPA.
However, if supplies are received in sealed pouches, the pouches may
be removed as the supplies are introduced into the buffer or clean area
without the need to disinfect the individual supply items. No shipping
or other external cartons may be taken into the buffer or clean area.
(viii) Storage shelving, emptied of all supplies,
walls, and ceilings are cleaned and disinfected at planned intervals,
monthly, if not more frequently.
(F) Security requirements. The pharmacy may autho-
rize personnel to gain access to that area of the pharmacy containing
dispensed sterile preparations, in the absence of the pharmacist, for the
purpose of retrieving dispensed prescriptions to deliver to patients. If
the pharmacy allows such after-hours access, the area containing the
dispensed sterile pharmaceuticals shall be an enclosed and lockable
area separate from the area containing undispensed prescription drugs.
A list of the authorized personnel having such access shall be in the
pharmacy's policy and procedure manual.
(G) Storage requirements and beyond-use dating.
(i) Storage requirements. All drugs shall be stored at
the proper temperature and conditions, as defined in the USP/NF and
in 291.15 of this title (relating to Storage of Drugs).
(ii) Beyond-use dating.
(I) Beyond-use dates for compounded sterile
preparations shall be assigned based on professional experience, which
shall include careful interpretation of appropriate information sources
for the same or similar formulations.
(II) Beyond-use dates for compounded sterile
preparations that are prepared strictly in accordance with manufactur-
ers' product labeling must be those specified in that labeling, or from
appropriate literature sources or direct testing.(III) Beyond-use dates for compounded sterile
preparations that lack justification from either appropriate literature
sources or by direct testing evidence must be assigned as described in
Chapter 797, Pharmaceutical Compounding--Sterile Preparations of
the USP/NF.
(6) Equipment and supplies. Pharmacies compounding
sterile preparations shall have the following equipment and supplies:
(A) a calibrated system or device (i.e., thermometer) to
monitor the temperature to ensure that proper storage requirements are
met, if sterile pharmaceuticals are stored in the refrigerator;
(B) a calibrated system or device to monitor the tem-
perature where bulk chemicals are stored;
(C) if applicable, a Class A prescription balance, or an-
alytical balance and weights. Such balance shall be properly main-
tained and subject to periodic inspection by the Texas State Board of
Pharmacy;
(D) equipment and utensils necessary for the proper
compounding of sterile preparations. Such equipment and utensils
used in the compounding process shall be:
(i) of appropriate design, appropriate capacity, and
be operated within designed operational limits;
(ii) of suitable composition so that surfaces that con-
tact components, in-process material, or drug products shall not be re-
active, additive, or absorptive so as to alter the safety, identity, strength,
quality, or purity of the drug preparation beyond the desired result;
(iii) cleaned and sanitized immediately prior to and
after each use; and
(iv) routinely inspected, calibrated (if necessary), or
checked to ensure proper performance;
(E) appropriate disposal containers for used needles,
syringes, etc., and if applicable, hazardous waste from the preparation
of hazardous drugs and/or biohazardous waste;
(F) appropriate packaging or delivery containers to
maintain proper storage conditions for sterile preparations;
(G) infusion devices, if applicable; and
(H) all necessary supplies, including:
(i) disposable needles, syringes, and other supplies
for aseptic mixing;
(ii) disinfectant cleaning solutions;
(iii) hand washing agents with bactericidal action;
(iv) disposable, lint free towels or wipes;
(v) appropriate filters and filtration equipment;
(vi) cytotoxic spill kits, if applicable; and
(vii) masks, caps, coveralls or gowns with tight
cuffs, shoe covers, and gloves, as applicable.
(7) Labeling.
(A) Prescription drug or medication orders. In addition
to the labeling requirements for the pharmacy's specific license clas-
sification, the label dispensed or distributed pursuant to a prescription
drug or medication order shall contain the following.
(i) The generic name(s) or the official name(s) of the
principal active ingredient(s) of the compounded sterile preparation.37 TexReg 6932 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/m1/113/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.