Compounding Sterile and Nonsterile
Preparations in Retail and Institutional
Pharmacies
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 New
Jersey State Board of Pharmacy urges all licensees to become
familiar with the new regulation. Accordingly, in this issue the
Board Newsletter will begin a series of articles designed to
summarize critical changes in the new regulation. This issue
will cover N.J.A.C. 13:39-11.4-7 of the sterile compounding regulations, encompassing new spatial requirements and
terminology.
♦ N.J.A.C. 13:39-11.4 was recodified from the old N.J.A.C.
13:39-11.16 and amended to refer to “cleanrooms” instead
of the old term “controlled environment for compounded
sterile preparations.”
◊ 13:39-11.4(a) sets forth the physical criteria that a cleanroom must meet to minimize airborne contamination
from contacting critical sites.
◊ 13:39-11.4(b) requires that all sterile compounding
take place within the confines of a buffer area unless
it meets one of the exceptions set forth in paragraphs
(b)1 through 3.
◊ 13:39-11.4(c)(4) is amended to add that 66ºF is the ideal
temperature for a cleanroom.
◊ 13:39-11.4(d) requires a pressure indicator or air velocity meter to monitor the room for correct room pressurization or air velocity.
13:39-11.4 Cleanroom: Use, Access, Location; Temperature; Air Pressure
(a) The pharmacy shall have a designated area for
sterile preparation compounding, known as the
“cleanroom.” A cleanroom shall be physically designed and environmentally controlled to minimize
airborne contamination from contacting critical
sites. Critical sites are locations that include any
component or fluid pathway surfaces (for example,
vial septa, injection ports, beakers), openings (for
example, opened ampules, needle hubs), exposed
and at risk of direct contact with air (for example,
ambient room or HEPA-filtered), moisture (for
example, oral and mucosal secretions), or touch
contamination. A cleanroom shall include a buffer
area and an ante area. The buffer area shall contain
an ISO class 5 or better primary engineering control,
such as a laminar airflow workbench, biological
safety cabinet, compounding aseptic isolator, and/or
compounding aseptic containment isolator, unless
the buffer area has ISO class 5 or better air quality.
(b) All sterile compounding shall take place within the
confines of the buffer area, except for the following:
1. Compounding in a compounding aseptic isolator
or a compounding aseptic containment isolator
pursuant to N.J.A.C. 13:39-11.8;
2. Compounding in a laminar air flow workbench
in an institutional pharmacy pursuant to N.J.A.C.
13:39-11.10; and
3. Compounding immediate use compounded
sterile preparations in an institutional pharmacy
pursuant to N.J.A.C. 13:39-11.11.
(c) A cleanroom shall be:
1. Accessible only to designated personnel;
2. Used only for the compounding of sterile
preparations or such other tasks that require a
cleanroom;
(i) Carts shall be of stainless steel wire, nonporous
plastic, or sheet metal construction with good quality, cleanable casters to promote mobility.
(j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the
integrity of the compounded sterile preparations,
consistent with the requirements of N.J.A.C.
13:39-11.12(b)3.
♦ N.J.A.C. 13:39-11.6 was recodified from the old N.J.A.C.
13:39-11.20 and amended to refer to “ante areas” instead
of “anterooms.”
◊ 13:39-11.6(a) was amended to require that the ante
area have appropriate environmental control devices
capable of maintaining ISO Class 8 air quality conditions for non-hazardous drug compounding activities
and ISO Class 7 air quality conditions for hazardous
drug compounding activities. The old 13:39-11.20
required only that the anteroom have an air quality of
ISO Class 7 or better, and did not differentiate between
non-hazardous and hazardous drug compounding
activities.
◊ 13:39-11.6(b)(1) was amended to require that an ante
area contain a sink with hot and cold running water
with an integrated and closed plumbing system.
◊ The old 13:39-11.20(c) (which required that a refrigerator be reasonably accessible to the anteroom) was
deleted.
13:39-11.6 Ante Area Requirements
(a) The ante area shall have appropriate environmental
control devices capable of maintaining ISO class
8 air quality conditions for non-hazardous drug
compounding activities and ISO class 7 air quality conditions for hazardous drug compounding
activities as provided in N.J.A.C. 13:39-11.4(d)2.
(b) The ante area shall contain the following equipment:
1. A sink with hot and cold running water with an
integrated and closed plumbing system;
2. Waste containers for all personal protective
equipment;
3. An eyewash station; and
4. A hazardous waste spill kit.
♦ N.J.A.C. 13:39-11.7 was recodified from the old N.J.A.C.
13:39-11.18 and amended to refer to “buffer areas” instead of “controlled environment for compounded sterile
preparations.”
◊ 13:39-11.7(a) requires that a buffer area have appropriate environmental control devices capable of
maintaining ISO Class 7 air-quality conditions during
normal activity.
◊ 13:39-11.7(c) prohibits removal of any equipment or
other items from the buffer area, with certain exceptions. The old N.J.A.C. 13:39-11.18(b) discouraged
equipment removal but did not strictly prohibit it.
13:39-11.5(e) was amended to refer to “walls” instead
of “solid walls” and to permit walls to be constructed
of flexible materials such as heavy gauge polymer
in addition to the other materials specified in the old
N.J.A.C. 13:39-11.17(e) regulation.
◊ 13:39-11.5(f) was amended to prohibit the use of floor
drains.
◊ 13:39-11.5(g) was amended to state that ledges (such
as windowsills) should be avoided, but are not strictly
prohibited as they were in the old N.J.A.C. 13:39-
11.17(g).
◊ 13:39-11.5(j) requires that refrigerators be within, or
reasonably accessible to, cleanrooms in order to ensure
the integrity of the compounded preparations.
◊ The old N.J.A.C. 13:39-11.17(j), which required Board
approval for cleanroom construction other than that
specified in N.J.A.C. 13:39-11.17(a-i) prior to installation and use, was deleted.
13:39-11.5 Cleanroom Requirements
(a) The surfaces of ceilings, walls, floors, fixtures,
shelving, counters, and cabinets in the cleanroom
shall be smooth, impervious, free from cracks and
crevices, and nonshedding, thereby minimizing
spaces in which microorganisms and other contaminants may accumulate.
(b) Work surfaces shall be constructed of smooth,
impervious materials, such as stainless steel or
molded plastic, so that the work surfaces may be
readily cleaned and sanitized. All work surfaces
shall be resistant to damage from cleaning and
sanitizing agents.
(c) Junctures where ceilings meet walls shall be
covered, caulked, or sealed to avoid cracks and
crevices in which microorganisms and other contaminates can accumulate. All areas in ceilings
and walls where the surface has been penetrated
shall be sealed.
(d) Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked
or weighted and clipped.
(e) Walls shall be constructed of flexible material (for
example, heavy gauge polymer), panels locked
together and sealed, or of epoxy-coated gypsum
board.
(f) Floors shall have a covering and shall be seamless or have heat-welded seams and coving to the
sidewall. There shall be no floor drains.
(g) There shall be no dust-collection overhangs (such
as ceiling utility pipes) and ledges (such as window sills) should be avoided. All sprinkler heads
shall be flush with the ceiling.
(h) Ceiling lighting fixtures shall have exterior lens
surfaces which are smooth, mounted f1ush, and
air tight (i) Carts shall be of stainless steel wire, nonporous
plastic, or sheet metal construction with good quality, cleanable casters to promote mobility.
(j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the
integrity of the compounded sterile preparations,
consistent with the requirements of N.J.A.C.
13:39-11.12(b)3.
♦ N.J.A.C. 13:39-11.6 was recodified from the old N.J.A.C.
13:39-11.20 and amended to refer to “ante areas” instead
of “anterooms.”
◊ 13:39-11.6(a) was amended to require that the ante
area have appropriate environmental control devices
capable of maintaining ISO Class 8 air quality conditions for non-hazardous drug compounding activities
and ISO Class 7 air quality conditions for hazardous
drug compounding activities. The old 13:39-11.20
required only that the anteroom have an air quality of
ISO Class 7 or better, and did not differentiate between
non-hazardous and hazardous drug compounding
activities.
◊ 13:39-11.6(b)(1) was amended to require that an ante
area contain a sink with hot and cold running water
with an integrated and closed plumbing system.
◊ The old 13:39-11.20(c) (which required that a refrigerator be reasonably accessible to the anteroom) was
deleted.
13:39-11.6 Ante Area Requirements
(a) The ante area shall have appropriate environmental
control devices capable of maintaining ISO class
8 air quality conditions for non-hazardous drug
compounding activities and ISO class 7 air quality conditions for hazardous drug compounding
activities as provided in N.J.A.C. 13:39-11.4(d)2.
(b) The ante area shall contain the following equipment:
1. A sink with hot and cold running water with an
integrated and closed plumbing system;
2. Waste containers for all personal protective
equipment;
3. An eyewash station; and
4. A hazardous waste spill kit.
♦ N.J.A.C. 13:39-11.7 was recodified from the old N.J.A.C.
13:39-11.18 and amended to refer to “buffer areas” instead of “controlled environment for compounded sterile
preparations.”
◊ 13:39-11.7(a) requires that a buffer area have appropriate environmental control devices capable of
maintaining ISO Class 7 air-quality conditions during
normal activity.
◊ 13:39-11.7(c) prohibits removal of any equipment or
other items from the buffer area, with certain exceptions. The old N.J.A.C. 13:39-11.18(b) discouraged
equipment removal but did not strictly prohibit it.