| (i) If the pharmacy is using a compounding aseptic
containment isolator (CACI) as its PEC for the preparation of low-
and medium-risk hazardous drugs, the CACI shall be located in a separate
room away from other areas of the pharmacy and shall:
(I) provide at least 0.01 inches water column negative
pressure compared to the other areas of the pharmacy;
(II) provide unidirectional airflow within the main
processing and antechambers, and be placed in an ISO Class 7 buffer
area, unless the CACI meets all of the following conditions;
(-a-) The isolator must provide isolation from the
room and maintain ISO Class 5 during dynamic operating conditions
including transferring ingredients, components, and devices into and
out of the isolator and during preparation of compounded sterile preparations;
(-b-) Particle counts sampled approximately 6 to 12
inches upstream of the critical exposure site must maintain ISO Class
5 levels during compounding operations;
(-c-) The CACI must be certified for operational efficiency
using certification procedures, such as those outlined in the Certification
Guide for Sterile Compounding Facilities (CAG-003-2006), which shall
be performed by a qualified independent individual no less than every
six months and whenever the device or room is relocated or altered
or major service to the facility is performed; and
(-d-) The pharmacy shall maintain documentation from
the manufacturer that the isolator meets this standard when located
in worse than ISO Class 7 environments.
(ii) If the CACI meets all conditions specified in
clause (i) of this subparagraph, the CACI shall not be located in
the same room as a CAI, but shall be located in a separate room in
the pharmacy, that is not required to maintain ISO classified air.
The room in which the CACI is located shall provide a minimum of 0.01
inches water column negative pressure compared with the other areas
of the pharmacy and shall meet the following requirements:
(I) be clean, well lit, and of sufficient size;
(II) be maintained at a temperature of 20 degrees Celsius
or cooler and a humidity below 60%;
(III) be used only for the compounding of hazardous
sterile preparations;
(IV) be located in an area of the pharmacy with walls,
ceilings, floors, fixtures, shelving, counters, and cabinets that
are smooth, impervious, free from cracks and crevices, non-shedding
and resistant to damage by disinfectant agents; and
(V) have non-porous and washable floors or floor covering
to enable regular disinfection.
(iii) If the CACI is used in the compounding of high-risk
hazardous preparations, the CACI shall be placed in an area or room
with at least ISO 8 quality air so that high-risk powders, weighed
in at least ISO-8 air quality conditions, are not exposed to lesser
air quality prior to the completion of compounding and packaging of
the high-risk preparation.
(iv) Pharmacies that prepare a low volume of hazardous
drugs, are not required to comply with the provisions of clauses (i)
and (iii) of this subparagraph if the pharmacy uses a device that
provides two tiers of containment (e.g., CACI that is located in a
non-negative pressure room).
(8) Additional 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 preparations are stored in the refrigerator;
(B) a calibrated system or device to monitor the temperature
where bulk chemicals are stored;
(C) a temperature-sensing mechanism suitably placed
in the controlled temperature storage space to reflect accurately
the true temperature;
(D) if applicable, a Class A prescription balance,
or analytical balance and weights. Such balance shall be properly
maintained and subject to periodic inspection by the Texas State Board
of Pharmacy;
(E) 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
contact components, in-process material, or drug products shall not
be reactive, 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;
(F) appropriate disposal containers for used needles,
syringes, etc., and if applicable, hazardous waste from the preparation
of hazardous drugs and/or biohazardous waste;
(G) appropriate packaging or delivery containers to
maintain proper storage conditions for sterile preparations;
(H) infusion devices, if applicable; and
(I) all necessary supplies, including:
(i) disposable needles, syringes, and other supplies
for aseptic mixing;
(ii) disinfectant cleaning solutions;
(iii) sterile 70% isopropyl alcohol;
(iv) sterile gloves, both for hazardous and non-hazardous
drug compounding;
(v) sterile alcohol-based or water-less alcohol based
surgical scrub;
(vi) hand washing agents with bactericidal action;
(vii) disposable, lint free towels or wipes;
(viii) appropriate filters and filtration equipment;
(ix) hazardous spill kits, if applicable; and
(x) masks, caps, coveralls or gowns with tight cuffs,
shoe covers, and gloves, as applicable.
(9) Labeling.
(A) Prescription drug or medication orders. In addition
to the labeling requirements for the pharmacy's specific license classification,
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;
(ii) for outpatient prescription orders other than
sterile radiopharmaceuticals, a statement that the compounded sterile
preparation has been compounded by the pharmacy. (An auxiliary label
may be used on the container to meet this requirement); and
(iii) a beyond-use date. The beyond-use date shall
be determined as outlined in Chapter 797, Pharmacy Compounding--Sterile
Preparations of the USP/NF, and paragraph (7)(G) of this subsection;
(B) Batch. If the sterile preparation is compounded
in a batch, the following shall also be included on the batch label:
(i) unique lot number assigned to the batch;
(ii) quantity;
(iii) appropriate ancillary instructions, such as storage
instructions or cautionary statements, including hazardous drug warning
labels where appropriate; and
(iv) device-specific instructions, where appropriate.
(C) Pharmacy bulk package. The label of a pharmacy
bulk package shall:
(i) state prominently "Pharmacy Bulk Package--Not for
Direct Infusion;"
(ii) contain or refer to information on proper techniques
to help ensure safe use of the preparation; and
(iii) bear a statement limiting the time frame in which
the container may be used once it has been entered, provided it is
held under the labeled storage conditions.
(10) Written drug information for prescription drug
orders only. Written information about the compounded preparation
or its major active ingredient(s) shall be given to the patient at
the time of dispensing a prescription drug order. A statement which
indicates that the preparation was compounded by the pharmacy must
be included in this written information. If there is no written information
available, the patient shall be advised that the drug has been compounded
and how to contact a pharmacist, and if appropriate, the prescriber,
concerning the drug. This paragraph does not apply to the preparation
of radiopharmaceuticals.
(11) Pharmaceutical Care Services. In addition to the
pharmaceutical care requirements for the pharmacy's specific license
classification, the following requirements for sterile preparations
compounded pursuant to prescription drug orders must be met. This
paragraph does not apply to the preparation of radiopharmaceuticals.
Cont'd... |
