Compounding Sterile and Nonsterile
Preparations in Retail and Institutional
Pharmacies
This is the second article in a series that summarizes
critical changes in the new regulation and will cover
N.J.A.C. 13:39-11.8-11.11 of the sterile compounding
regulations, encompassing the requirements for the compounding environment.
The substantially modified N.J.A.C. 13:39-11 (Compounding Sterile and Non-Sterile
Preparations in Retail
and Institutional Pharmacies) is now in effect, and can
be accessed in the updated “Pharmacy Regulations” hyperlink at www.njconsumeraffairs.gov/pharm/phar_rules
.htm, which was last revised on June 3, 2013. The new
regulation divides the subchapter into sterile compounding (N.J.A.C. 13:39-11.1-24)
and nonsterile compounding (N.J.A.C. 13:39-11A.1-15), and brings New Jersey
regulations into agreement with the practice standards
established by the United States Pharmacopeia General
Chapter 797 (Pharmaceutical Compounding of Sterile
Preparations) and General Chapter 795 (Pharmaceutical
Compounding of Nonsterile Preparations). The Board
urges all licensees to become familiar with the new
regulation.
♦ N.J.A.C. 13:39-11.8 is a new regulation that addresses the use of compounding
aseptic isolators and
compounding aseptic containment isolators located
outside a cleanroom or buffer area.
13:39-11.8 Use of compounding aseptic isolators
and compounding aseptic containment isolators
located outside of a cleanroom
A pharmacy may utilize compounding aseptic
isolators and compounding aseptic containment
isolators not located in a cleanroom to prepare
compounded sterile preparations, provided the
compounding aseptic isolators and compounding aseptic containment i
solators can provide isolation from the room and maintain ISO
class 5 air quality during dynamic operating
conditions, including transferring ingredients,
components, and devices into and out of the
isolator and during preparation of compounded
sterile preparations. A pharmacy utilizing a
compounding aseptic containment isolator not
located in a cleanroom to compound antineoplastic agents and other hazardous substances
shall comply with the requirements of N.J.A.C.
13:39-11.4(d)3. Particle counts sampled approximately six to 12 inches upstream of the
critical exposure site must maintain ISO class
5 air quality levels during compounding operations. Compounding personnel shall obtain
documentation from the manufacturer that the
compounding aseptic isolator or compounding aseptic
containment isolator will meet this
standard when located in worse than ISO class 7
environments. A compounding aseptic isolator
and compounding aseptic containment isolator
not located in a buffer area shall be located in
an area that is maintained under sanitary conditions and
such area shall only be traveled by
persons engaging in the compounding of sterile
preparations.
♦ N.J.A.C. 13:39-11.9 is a new regulation that addresses
the compounding of antineoplastic agents
and other hazardous substances.
◊ N.J.A.C. 13:39-11.9(b) prohibits pharmacies from
preparing these products as immediate-use compounded sterile preparations.
◊ N.J.A.C. 13:39-11.9(c) outlines the equipment
and conditions required for the compounding of
hazardous drugs.
◊ N.J.A.C. 13:39-11.9(d) describes the required
room pressurization for compounding hazardous
substances.
◊ N.J.A.C. 13:39-11.9(e) describes the standards
that must be met by all personnel who compound
and dispense these products.
◊ N.J.A.C. 13:39-11.9(f) outlines the storage and
handling requirements for these products.
◊ Please note that N.J.A.C. 13:39-11.4(d)3 also
applies: “For compounding of antineoplastic
agents and other hazardous substances outside
of a cleanroom pursuant to N.J.A.C. 13:39-11.8,
if a compounding aseptic containment isolator is
used outside of a buffer area, the compounding
area shall be physically separated from other areas
and shall maintain a minimum negative pressure
of 0.01 inch water column and have a minimum
of 12 air exchanges per hour.”
13:39-11.9 Compounding of antineoplastic
agents and other hazardous substances
(a) For purposes of this section, hazardous
substances are those substances identified
as hazardous by the National Institute for
Occupational Safety and Health (NIOSH)
in NIOSH Publication No. 2004-165:
Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in
Health Care Settings, Appendix A (2012
Edition). The sample list of drugs that shall
be handled as hazardous (Appendix A) is incorporated herein by reference, as amended
and supplemented, and can be found at the
Centers for Disease Control and Prevention
Web site, www.cdc.gov, specifically, www
.cdc.gov/niosh/docs/2004-165/.
(b) Pharmacies shall not prepare antineoplastic
agents and other hazardous substances as
immediate use compounded sterile preparations.
(c) Pharmacies shall compound antineoplastic
agents and other hazardous substances
only in:
1. A compounding aseptic containment
isolator or a Class II or Class III biological safety
cabinet in a negative pressure
cleanroom. When handling volatile
hazardous drugs, such devices shall be
vented to the outside air; or
2. A compounding aseptic containment
isolator located outside of a negative
pressure cleanroom, consistent with
N.J.A.C. 13:39-11.8. When handling
volatile hazardous drugs, such devices
shall be vented to the outside air.
(d) Correct room pressurization shall be maintained at all
times when compounding
antineoplastic agents and other hazardous
substances, consistent with N.J.A.C. 13:39-
11.4(d).
(e) Personnel who compound and dispense antineoplastic agents
and other hazardous substances shall adhere to standards established
by the Occupational [Safety and Health]
Administration (OSHA) set forth in Section
VI, Chapter 2 of OSHA’s Technical Manual
on Controlling Occupational Exposure to
Hazardous Drugs (effective date January
20, 1999). OSHA’s Technical Manual is incorporated herein by reference, as amended
and supplemented, and can be found at the
OSHA Web site, www.osha.gov, specifiContinued from page 1
Continued on page 5
Page 4cally, www.osha.gov/dts/osta/otm/otm_vi/
otm_vi_2.html. Personnel shall also comply
with the standards established by NIOSH in
NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic
and Other Hazardous Drugs in Health Care
Settings. The NIOSH Publication No. 2004-
165 (2012 Edition) is incorporated herein by
reference, as amended and supplemented,
and can be found at the CDC Web site, www
.cdc.gov, specifically, www.cdc.gov/niosh/
docs/2004-165/.
(f) Antineoplastic agents and other hazardous
substances used to compound sterile preparations shall be stored separately from other
inventory in a manner to prevent contamination and personnel exposure. Such storage
is preferable within a containment area such
as a negative pressure room. The storage
area shall have sufficient general exhaust,
at least 12 air exchanges per hour to dilute
and remove any airborne contaminants. Antineoplastic agents and hazardous substances
used to compound sterile preparations shall
be handled with caution using appropriate
chemotherapy gloves during distribution,
receiving, stocking, inventorying, preparing
for administration, and disposal.
♦ N.J.A.C. 13:39-11.10 has been recodified from the
old N.J.A.C. 13:39-11.22:
◊ The terminology “laminar air flow hood” has been
replaced by “laminar airflow workbench.”
◊ The requirement that laminar air flow hoods be
certified by an independent certification company
prior to use when first installed, or after being
moved, and again at six-month intervals has been
deleted.
◊ The new regulation permits a pharmacy holding
an institutional pharmacy permit to use ISO Class
5 laminar airflow workbenches not located in a
buffer area to prepare low-risk level compounded
sterile preparations under certain conditions.
13:39-11.10 Institutional pharmacy use of
airflow workbenches not in a buffer area for
low-risk level compounded sterile preparations
A pharmacy holding an institutional pharmacy
permit may utilize ISO class 5 laminar airflow
workbenches not located in a buffer area to
prepare low-risk level compounded sterile
Page 5 – October 2013
The New Jersey State Board of Pharmacy News is published by the New
Jersey State Board of Pharmacy and the National Association of Boards of
Pharmacy Foundation, Inc, to promote compliance of pharmacy and drug
law. The opinions and views expressed in this publication do not necessarily
reflect the official views, opinions, or policies of the Foundation or the Board
unless expressly so stated.
New Jersey State Board of Pharmacy - State News Editor
Carmen A. Catizone, MS, RPh, DPh - National News Editor
& Executive Editor
Deborah Zak - Communications Manager
preparations provided that the administration
of such preparations commences within 12
hours of the preparation or as recommended
by the manufacturer, whichever is less. Such
workbenches shall be located in an area that
is maintained under sanitary conditions and
that is traveled only by persons engaging in
the compounding of sterile preparations. Such
workbenches shall not be in a location that has
unsealed windows or doors that connect to the
outdoors or high traffic flow, or that is adjacent
to areas including, but not limited to, construction sites,
warehouses, or food preparation.
Sinks may not be located adjacent to the ISO
class 5 workbench environments and must be
separated from the immediate area of ISO class
5 workbenches. Personnel engaged in sterile
compounding in such areas shall follow the
procedures relating to cleansing and garbing
set forth in N.J.A.C. 13:39-11.14.
♦ N.J.A.C. 13:39-11.11 is a new regulation that permits
a pharmacy holding an institutional pharmacy permit
to prepare non-hazardous immediate use compounded
sterile preparations outside of an ISO Class 5 laminar
airflow workbench when the delay resulting from
the use of the workbench would harm the patient,
including situations in which the patient experiences
a sudden change in clinical status.
13:39-11.11 Compounding immediate use compounded sterile
preparations in an institutional
pharmacy
A pharmacy holding an institutional pharmacy
permit may prepare non-hazardous immediate
use compounded sterile preparations outside
of an ISO class 5 laminar airflow workbench
when the delay resulting from the use of the
workbench would harm the patient, including
situations in which the patient experiences a
sudden change in clinical status.
quoted from here
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