| (x) Cleaning must be done by personnel trained in appropriate
cleaning techniques.
(xi) Proper documentation and frequency of cleaning
must be maintained and shall contain the following:
(I) date and time of cleaning;
(II) type of cleaning performed; and
(III) name of individual who performed the cleaning.
(G) Security requirements. The pharmacist-in-charge
may authorize 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 preparations 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.
(H) 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 manufacturers' product
labeling must be those specified in that labeling, or from appropriate
literature sources or direct testing.
(III) When assigning a beyond-use date, compounding
personnel shall consult and apply drug-specific and general stability
documentation and literature where available, and they should consider
the nature of the drug and its degradation mechanism, the container
in which it is packaged, the expected storage conditions, and the
intended duration of therapy.
(IV) The sterility and storage and stability beyond-use
date for attached and activated container pairs of drug products for
intravascular administration shall be applied as indicated by the
manufacturer.
(7) Primary engineering control device. The pharmacy
shall prepare sterile preparations in a primary engineering control
device (PEC), such as a laminar air flow hood, biological safety cabinet,
compounding aseptic isolator (CAI), or compounding aseptic containment
isolator (CACI) which is capable of maintaining at least ISO Class
5 conditions for 0.5 micrometer particles while compounding sterile
preparations.
(A) Laminar air flow hood. If the pharmacy is using
a laminar air flow hood as its PEC, the laminar air flow hood shall:
(i) be located in the buffer area and placed in the
buffer area in a manner as to avoid conditions that could adversely
affect its operation such as strong air currents from opened doors,
personnel traffic, or air streams from the heating, ventilating and
air condition system;
(ii) 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;
(iii) have pre-filters inspected periodically and replaced
as needed, in accordance with written policies and procedures and
the manufacturer's specification, and the inspection and/or replacement
date documented; and
(iv) be located in a buffer area that has a minimum
differential positive pressure of 0.02 to 0.05 inches water column.
A buffer area that is not physically separated from the ante-area
shall employ the principle of displacement airflow as defined in Chapter
797, Pharmaceutical Compounding--Sterile Preparations, of the USP/NF,
with limited access to personnel.
(B) Biological safety cabinet.
(i) If the pharmacy is using a biological safety cabinet
(BSC) as its PEC for the preparation of hazardous sterile compounded
preparations, the biological safety cabinet shall be a Class II or
III vertical flow biological safety cabinet located in an ISO Class
7 area that is physically separated from other preparation areas.
The area for preparation of sterile chemotherapeutic preparations
shall:
(I) have not less than 0.01 inches water column negative
pressure to the adjacent positive pressure ISO Class 7 or better ante-area;
and
(II) have a pressure indicator that can be readily
monitored for correct room pressurization.
(ii) Pharmacies that prepare a low volume of hazardous
drugs, are not required to comply with the provisions of clause (i)
of this subparagraph if the pharmacy uses a device that provides two
tiers of containment (e.g., closed-system vial transfer device within
a BSC).
(iii) If the pharmacy is using a biological safety
cabinet as its PEC for the preparation of non-hazardous sterile compounded
preparations, the biological safety cabinet shall:
(I) be located in the buffer area and placed in the
buffer area in a manner as to avoid conditions that could adversely
affect its operation such as strong air currents from opened doors,
personnel traffic, or air streams from the heating, ventilating and
air condition system;
(II) 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;
(III) have pre-filters inspected periodically and replaced
as needed, in accordance with written policies and procedures and
the manufacturer's specification, and the inspection and/or replacement
date documented; and
(IV) be located in a buffer area that has a minimum
differential positive pressure of 0.02 to 0.05 inches water column.
(C) Compounding aseptic isolator.
(i) If the pharmacy is using a compounding aseptic
isolator (CAI) as its PEC, the CAI shall provide unidirectional airflow
within the main processing and antechambers, and be placed in an ISO
Class 7 buffer area unless the isolator meets all of the following
conditions:
(I) 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;
(II) Particle counts sampled approximately 6 to 12
inches upstream of the critical exposure site must maintain ISO Class
5 levels during compounding operations;
(III) The CAI 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
(IV) 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 isolator meets the requirements in clause
(i) of this subparagraph, the CAI may be placed in a non-ISO classified
area of the pharmacy; however, the area shall be segregated from other
areas of the pharmacy and shall:
(I) be clean, well lit, and of sufficient size;
(II) be used only for the compounding of low- and medium-risk,
non-hazardous sterile preparations;
(III) be located in an area of the pharmacy with non-porous
and washable floors or floor covering to enable regular disinfection;
and
(IV) be an area in which the CAI is placed in a manner
as to avoid conditions that could adversely affect its operation.
(iii) In addition to the requirements specified in
clauses (i) and (ii) of this subparagraph, if the CAI is used in the
compounding of high-risk non-hazardous preparations, the CAI 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,
compounding utensils for measuring and other compounding equipment
are not exposed to lesser air quality prior to the completion of compounding
and packaging of the high-risk preparation.
(D) Compounding aseptic containment isolator.
Cont'd... |
