N.J. Admin. Code § 13:39-11.3 - Application and pre-approval requirements for compounding sterile preparations
(a) An applicant for a new pharmacy who
wishes to compound sterile preparations shall satisfy all pharmacy permit
application requirements set forth in
N.J.A.C.
13:39-4.1. As part of the permit application,
the applicant shall submit plans detailing the physical arrangements necessary
to ensure compliance with the requirements in this subchapter. An applicant for
a pharmacy permit shall not compound sterile preparations at the site until
receiving written approval from the Board to engage in such activities. Prior
to issuing the written approval, the Board shall conduct an inspection of the
pharmacy to ensure compliance with the requirements in this
subchapter.
(b) The holder of an
existing pharmacy permit who wishes to compound sterile preparations shall
submit an amended pharmacy permit application to the Board. The amended permit
application shall contain plans detailing the physical arrangements necessary
to ensure compliance with the requirements in this subchapter. The holder of an
existing pharmacy permit shall not compound sterile preparations at the site
until receiving written approval from the Board to engage in such activities.
Prior to issuing the written approval, the Board shall conduct an inspection of
the pharmacy to ensure compliance with the requirements in this
subchapter.
(c) A pharmacy permit
holder who is approved to compound sterile preparations shall notify the Board
at least 60 days in advance of any remodeling, change of location, or change in
size of the pharmacy cleanroom, consistent with the requirements of
N.J.A.C.
13:39-4.7 and 4.8. Such notification shall
include the pharmacy's remodeling or relocation plans, as appropriate, the
pharmacy's interim plans for the continuation of sterile compounding
operations, which the Board shall review and approve, and the anticipated date
of completion. The pharmacy permit holder and the pharmacist-in-charge shall
ensure compliance with all requirements set forth in this subchapter while
compounding operations continue during the remodeling or relocation process.
The pharmacy permit holder shall notify the Board upon completion of the
remodeling or relocation process, at which time the Board shall inspect the
premises.
(d) A pharmacy holding an
institutional permit that is approved to compound sterile preparations and that
intends to compound sterile preparations using a laminar airflow workbench not
located in a buffer area, as provided in
N.J.A.C.
13:39-11.10, shall notify the Board at least
60 days in advance of its intention and of all locations where such equipment
will be installed. The pharmacy permit holder shall notify the Board upon
completion of such installation, at which time the Board shall inspect the
equipment. The pharmacy shall not utilize such equipment to compound sterile
preparations until receiving Board approval.
(e) A pharmacy permit holder who is approved
to compound sterile preparations and who intends to utilize compounding aseptic
isolators or compounding aseptic containment isolators not located in a buffer
area, as provided in
N.J.A.C.
13:39-11.8, shall notify the Board at least
60 days in advance of its intention and of all locations where such equipment
will be installed. The pharmacy permit holder shall notify the Board upon
completion of such installation, at which time the Board shall inspect the
equipment. The pharmacy shall not utilize such equipment to compound sterile
preparations until receiving Board approval.
(f) Notwithstanding the requirements of (a)
through (e) above, a pharmacy permit holder or pharmacy applicant may compound
sterile preparations for the sole purposes of process, equipment, personnel,
and environmental testing. Any sterile preparations compounded for these
purposes shall be destroyed.
(g)
Approval by the Board to dispense compounded sterile preparations shall be
contingent upon demonstration that, as is related to maintaining a sterile
compounding environment, all environmental control and processes have been
tested and validated, and all equipment has been certified, tested, and
validated.
Notes
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