Sterile Compounding

Question 1

“Ante area” means an ISO class 8 or better area where personnel hand hygiene and garbing
procedures, staging of components, order entry, labeling, and other high-particulate-generating
activities are performed. The “ante area” is also a transition area that:

Answer 1

1) Provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and
2) Reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances.

Question 2

“Biological safety cabinet” (PEC) means:

Answer 2

a ventilated cabinet for compounded sterile preparations that has an open front with inward airflow for personnel protection, downward high-efficiency
particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhaust air for environmental protection

Question 3

“Buffer area” (SEC) means:

Answer 3

an ISO class 7 area where the PEC control is physically located and where the preparation and staging of components and supplies used in compounding sterile preparations occurs

Question 4

“Cleanroom” means:

Answer 4

a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness (ISO) class. Microorganisms in the environment are monitored, so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. A “cleanroom” includes a buffer area or room and an ante area or room.

Question 5

“Compounding” means:

Answer 5

the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner’s prescription or medication order or initiative based on the relationship of the practitioner or the patient with the pharmacist in the course of professional practice, or for the purpose of, or incident to, research, teaching, or chemical analysis and not
for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly observed prescribing patterns. Compounding includes mixing, reconstituting, or assembling a drug according to the product’s labeling or to the manufacturer’s directions.

Question 6

“Compounding aseptic containment isolator” means:

Answer 6

a compounding aseptic isolator designed to provide worker protection from exposure to undesirable levels of airborne hazardous drugs throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter
(high-efficiency particulate air (HEPA) minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded.

Question 7

“Compounding aseptic isolator” means:

Answer 7

a form of isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic
compounding environment within the isolator throughout the compounding and material transfer
process. Air exchanges into the isolator from the surrounding environment should not occur
unless the air has first passed through a microbially retentive filter (high-efficiency particulate air
(HEPA) minimum).

Question 8

“Immediate use compounded sterile preparations” means:

Answer 8

preparations intended for emergency patient care and involve only simple aseptic measuring and transfer manipulations of no more than three sterile non-hazardous commercial drug and diagnostic radiopharmaceutical drug products, including an infusion or diluent solution. Unless required for the preparation, the compounding process occurs continuously without delays or interruptions and does not exceed one hour.

Question 9

Administration of immediate use compounded sterile preparations shall:

Answer 9

begin within one hour of preparation or the sterile preparations shall be discarded.

Question 10

Immediate-use compounded sterile preparations shall not:

Answer 10

be compounded and stored for anticipated needs

and shall not be compounded as batch preparations

Question 11

At no time during the compounding process, nor prior to administration, are critical sites and ingredients of the compounded sterile preparation directly exposed to:

Answer 11

contact contamination, such as human touch, cosmetic flakes, or particulates, blood, human body substances, and non-sterile inanimate sources.

Question 12

“ISO Class 5 air quality conditions” means conditions in which the air particle count is no greater than:

Answer 12

a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air (100 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air

Question 13

“ISO class 7 air quality conditions” means conditions in which the air particle count is no greater than:

Answer 13

total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air (10,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air.

Question 14

“ISO class 8 air quality conditions” means conditions:

Answer 14

in which the air particle count is no greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air (100,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air

Question 15

“Negative pressure room” means: (for HD drugs)

Answer 15

a room that is at a lower pressure than the adjacent spaces and, therefore, the net airflow is into the room.

Question 16

“Positive pressure room” means: (for non-HD drugs)

Answer 16

a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.

Question 17

“Primary engineering control” means:

Answer 17

a device or room that provides an ISO class 5 environment for the exposure of critical sites when compounding sterile preparations. Such devices include laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators.

Question 18

“Risk levels for compounded sterile preparations” means:

Answer 18

the established classification for compounded sterile preparations based on the potential for microbial, chemical, and physical contamination of the preparations and are defined as follows:

Question 19

“Low-risk level compounded sterile preparations” means:

Answer 19

preparations compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices.

Question 20

The compounding process involves only assembling, transferring, measuring, and mixing, using no more than:

Answer 20

3 commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations. The compounding process is limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.

Question 21

“Medium-risk level compounded sterile preparations” means :

Answer 21

preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The compounding process includes complex aseptic manipulations other than single-volume transfer and requires an unusually long duration, such as that required to complete dissolution or homogeneous mixing.

Question 22

“High-risk level compounded sterile preparations” means:

Answer 22

preparations compounded from non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO Class 5 for more than one hour.

Question 23

Water containing preparations that are stored for more than 6 hours before terminal sterilization are also classified as:

Answer 23

high-risk level compounded sterile preparations

Question 24

An applicant for a new pharmacy who wishes to compound sterile preparations shall:

Answer 24

satisfy all pharmacy permit application requirements set forth in N.J.A.C. 13:39-4.1.

Question 25

As part of the permit application, the applicant shall:

Answer 25

submit plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. An
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.

Question 26

The holder of an existing pharmacy permit who wishes to compound sterile preparations shall submit:

Answer 26

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.

Question 27

A pharmacy permit holder who is approved to compound sterile preparations shall:

Answer 27

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 PIC 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.

Question 28

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:

Answer 28

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.

Question 29

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 :

Answer 29

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.

Question 30

Notwithstanding the requirements of (a) through (e) above, a pharmacy permit holder or pharmacy applicant may:

Answer 30

compound sterile preparations for the sole purposes of process, equipment, personnel, and environmental testing. Any sterile preparations compounded for these purposes shall be destroyed

Question 31

Approval by the Board to dispense compounded sterile preparations shall be:

Answer 31

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.

Question 32

The pharmacy shall have a designated area for sterile preparation compounding, known as the:

Answer 32

“cleanroom.” A cleanroom shall be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites.

Question 33

Critical sites are locations that include:

Answer 33

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 HEPAfiltered), moisture (for example, oral and mucosal secretions), or touch contamination.

Question 34

A cleanroom shall include a:

Answer 34

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.

Question 35

All sterile compounding shall take place within the confines of the buffer area, except for the following:

Answer 35

1) Compounding in a compounding aseptic isolator or compounding aseptic containment isolator pursuant to N.J.A.C. 13:39-11.8;
2) Compounding in a laminar airflow 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.

Question 36

A cleanroom shall be:

Answer 36

1) Accessible only to designated personnel;
2) Used only for the compounding of sterile preparations or such other tasks that require
a cleanroom;
3) Structurally isolated from other areas within the pharmacy by means of restricted entry or access; and
4) Air-conditioned to maintain a temperature of 59 to 77 degrees Fahrenheit with an
the ideal temperature of 66 degrees Fahrenheit.

Question 37

A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following:

Answer 37

1) For compounding of non-hazardous drugs, if the buffer area and the ante area are
physically separated through the use of walls, doors, and pass-throughs, a minimum
differential positive pressure of 0.02 inch to 0.05 inch water column shall be required.
For buffer areas not physically separated from the ante area, the principle of
displacement airflow shall be employed. Using displacement airflow, an air velocity
of 40 feet per minute or more from the buffer area across the line of demarcation into
the ante area is required.
2) For compounding of antineoplastic agents and other hazardous substances, the
standards set forth in N.J.A.C. 13:39-11B.
e) No chewing gum, drinks, candy, or food items shall be brought into the cleanroom.

Question 38

The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the cleanroom shall be:

Answer 38

smooth, impervious, free from cracks and crevices, and nonshedding, thereby minimizing spaces in which microorganisms and other contaminants may accumulate.

Question 39

Work surfaces shall be:

Answer 39

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.

Question 40

Junctures, where ceilings meet walls, shall be:

Answer 40

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.

Question 41

Ceilings that consist of inlaid panels shall be:

Answer 41

impregnated with a polymer to render them

impervious and hydrophobic and shall either be caulked or weighted and clipped.

Question 42

Walls shall be:

Answer 42

constructed of flexible material (for example, heavy gauge polymer), panels locked together and sealed, or of epoxy-coated gypsum board.

Question 43

Floors shall have a covering that shall be:

Answer 43

seamless or have heat-welded seams and

coving to the sidewall. There shall be no floor drains.

Question 44

There shall be no dust-collection overhangs (such as ceiling utility pipes) and ledges (such as window sills) shall be avoided. All sprinkler heads shall be:

Answer 44

flush with the ceiling.

Question 45

Ceiling lighting fixtures shall have:

Answer 45

exterior lens surfaces which are smooth, mounted flush, and airtight

Question 46

Carts shall be of:

Answer 46

stainless steel wire, nonporous plastic, or sheet metal construction with good quality, cleanable casters to promote mobility.

Question 47

Refrigerators shall be…

Answer 47

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.

Question 48

The ante area shall have:

Answer 48

appropriate environmental control devices capable of maintaining ISO class 8 air quality conditions for non-hazardous drug compounding activities.

Question 49

The ante area shall contain the following equipment:

Answer 49

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

Question 50

The anteroom shall:

Answer 50

continuously maintain ISO Class 8 air quality under dynamic conditions.

Question 51

The buffer area shall contain only the following:

Answer 51

1) Items such as furniture, equipment, supplies, and other materials that are required for
the tasks to be performed there;
2) Items that are nonpermeable, nonshedding, cleanable, and resistant to damage from
disinfectants; and
3) Items that have been cleaned and disinfected immediately prior to their being placed in the buffer area.

Question 52

Equipment and other items used in the buffer area shall not:

Answer 52

be taken from these areas except for calibration, servicing, or other activities associated with the proper maintenance of the item.

Question 53

The buffer area shall be:

Answer 53

kept clean and arranged in an orderly fashion. All required equipment shall be maintained in good operating condition.

Question 54

The buffer area shall not be:

Answer 54

used for bulk storage, warehousing, or clerical and secretarial functions

Question 55

The buffer area shall not:

Answer 55

contain any sinks

Question 56

The buffer area shall be:

Answer 56

a minimum of 100 square feet in size and shall continuously maintain ISO Class 7 air quality under dynamic conditions.

Question 57

The buffer area shall contain:

Answer 57

waste containers in compliance with Occupational Safety and Health Administration (OSHA) standards for disposal of used needles and syringes set forth in 29 CFR 1910.1030 and for disposal of chemotherapy waste

Question 58

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 isolators can
provide isolation from the room and maintain:

Answer 58

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. Particle counts sampled approximately 6 to 12 inches upstream of the critical exposure site must maintain ISO class 5 air quality levels during compounding operations.

Question 59

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:

Answer 59

only be traveled by persons engaging in the compounding of sterile preparations.

Question 60

A pharmacy holding an institutional pharmacy permit may:

Answer 60

utilize ISO class 5 laminar airflow
workbenches not located in a buffer area to prepare low-risk level compounded sterile
preparations provided that the administration of such preparations commences within 12 hours
of the preparation or as recommended by the manufacturer, whichever is less.

Question 61

Such workbenches shall be located in an area which is:

Answer 61

maintained under sanitary conditions and
which 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.

Question 62

A pharmacy holding an institutional pharmacy permit may:

Answer 62

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

Question 63

The pharmacist-in-charge (PIC) shall:

Answer 63

supervise all sterile compounding performed by

pharmacy personnel. The PIC shall be trained in aseptic manipulation skills.

Question 64

The PIC shall be responsible for, at a minimum, the following:

Answer 64

1) Determining the procedural, environmental, and quality control practices that are
necessary for the risk levels he or she assigns to specific compounded sterile
preparations;
2) Ensuring that the selected sterilization method both sterilizes and maintains the
strength, purity, quality, and packaging integrity of the compounded sterile
preparations;
3) Ensuring the placement in buffer areas and ante areas of equipment (for example,
refrigerators), devices (for example, computers and printers) and objects (for
example, carts and cabinets) that are not essential to compounding is dictated by
their effect on the required environmental quality of air atmospheres and surfaces,
which shall be verified by monitoring;
4) Storage of all materials pertinent to the compounding of sterile preparations,
including drugs, chemicals, and biologicals, and the establishment of specific procedures for procurement of the materials in accordance with State and Federal laws and regulations;
5) Ensuring that all packaging and labeling of all compounded sterile preparations in the
pharmacy are performed under the immediate personal supervision of a pharmacist;
6) Ensuring that preparation and compounding of sterile preparations is performed only
by pharmacists who have been trained in aseptic manipulation skills, or by pharmacy
technicians, pharmacy interns or pharmacy externs who have been trained in aseptic
manipulation skills working under the immediate personal supervision of a pharmacist
trained in aseptic manipulation skills;
7) Recording all transactions of the pharmacy as may be necessary under applicable
State, Federal, and local laws and rules, to maintain accurate control over, and
accountability for, all pharmaceutical materials, and ensuring that policies and
procedures exist with respect to the maintenance of the audit trail required pursuant
to N.J.A.C. 13:39-11.20;
8) Ensuring that all pharmacists, pharmacy technicians, pharmacy interns, and
pharmacy externs who compound sterile preparations are trained and evaluated
consistent with the requirements of N.J.A.C. 13:39-11.16;
9) Establishing procedures for maintaining the integrity of the product and the
manufacturer’s control identity when repackaging sterile products. A pharmacist shall
check all repackaging and shall initial the repackaging records;
10) Disposal of all unused drugs and materials used in compounding sterile preparations,
including antineoplastic agents and other hazardous substances, in accordance with
accepted professional standards, and the Medical Waste Act, N.J.S.A. 13:1E-48.1 et
seq., so as not to endanger the public health;
11) Ensuring that the compounding area and its contents and other areas where
compounded sterile preparations are present are secured, so as to prevent access by
unauthorized personnel;
12) Ensuring that the pharmacy contains, in addition to the minimum reference library
mandated in N.J.A.C. 13:39-5.8(a)1, the most recent edition of references pertinent
to compounding sterile preparations;
13) Ensuring that records are maintained that document, at least twice daily, that
appropriate controlled cold (refrigerator), controlled freezer, if applicable, and
controlled room temperatures, as these terms are defined in United States Pharmacopeia 797, are maintained. Such records shall be maintained for no less than 5 years and shall be made available to the Board for inspection upon request;
14) Ensuring that all information required to be maintained as part of a pharmacy’s
patient profile record system pursuant to N.J.A.C. 13:39-7.19 or 9.19 is maintained
for all compounded sterile preparations;
15) Ensuring that initial and ongoing multidisciplinary clinical monitoring and
comprehensive care plans are maintained and readily available; and
16) Maintaining a policy and procedures manual detailing the pharmacy’s standard operating procedures with regard to compounded sterile preparations, consistent with the requirements of N.J.A.C. 13:39-11.23, ensuring compliance with such policies and procedures, and maintaining a written quality assurance program, consistent with the requirements of N.J.A.C. 13:39-11.24.

Question 65

Pharmacists shall:

Answer 65

provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy externs who are performing sterile compounding. The ratio of pharmacists to pharmacy technicians shall not exceed 1:2 at any given time unless all of the requirements of N.J.A.C. 13:39-6.15 are met.

Question 66

Supervision shall include, but is not limited to:

Answer 66

the checking of each ingredient used,
the quantity of each ingredient whether weighed, measured or counted, and the
finished label.

Question 67

The pharmacist may delegate to:

Answer 67

pharmacy technicians, pharmacy interns, or pharmacy externs only the following tasks: recording of the prescription, selection of the drugs, container, and diluent, labeling, and compounding of preparations. The pharmacist shall ensure that each task has been performed correctly.

Question 68

All personnel who engage in compounding sterile preparations shall comply with the following requirements before entering the buffer area:

Answer 68

1) Personnel shall remove personal outer garments (for example, bandanas, coats,
hats, jackets, scarves, sweaters, vests), all cosmetics, and hand, wrist, and other
visible jewelry or piercings (for example, earrings, or lip or eyebrow piercings);
2) The wearing of artificial nails or extenders is prohibited while working in the
compounding area. Natural nails shall be kept neat and trimmed;

Question 69

Personnel protective equipment shall be donned in the following order:

Answer 69

i) Dedicated shoes or shoe covers;
ii) Head and facial hair covers (for example, beard covers in addition to face masks);
iii) Face masks; and
iv) Eye shields, if required;

Question 70

A hand and forearm cleansing procedure shall be performed. Personnel shall remove debris from underneath fingernails using a nail cleaner under running warm water, followed by vigorous hand washing for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using:

Answer 70

using either lint-free disposable towels or an

electric hand dryer

Question 71

Personnel shall wear:

Answer 71

non-shedding gowns with sleeves that fit snugly around the wrists and enclosed at the neck, that are designed for buffer area use.

Question 72

Following the completion of all steps in (a) above, and once inside the buffer area, personnel shall perform antiseptic hand cleansing, using a:

Answer 72

waterless alcohol-based surgical hand scrub with persistent activity following manufacturers’ recommendations. Once hands are dried thoroughly, personnel shall don sterile gloves. Gloves shall be routinely inspected for holes, punctures, or tears, and shall be replaced immediately if any are detected.

Question 73

Gloves become contaminated when they make contact with non-sterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by:

Answer 73

wiping or rubbing sterile 70 percent Isopropyl Alcohol (IPA) on all contact surface areas of the gloves and letting the gloved hands dry thoroughly. Routine application of sterile 70 percent IPA shall occur throughout the compounding process and whenever non-sterile surfaces (for example, vials, countertops, chairs, and carts) are touched.

Question 74

When compounding personnel exit the cleanroom during a work shift, the exterior gown may be removed and:

Answer 74

retained in the cleanroom if not visibly soiled, and may be redonned during that same work shift only. Shoe covers, hair and facial hair covers, face masks/eye shields, and gloves, however, shall be replaced with new ones before reentering the buffer area, and proper hand hygiene shall be performed

Question 75

The cleanroom, buffer area, and ante area shall be cleaned and disinfected consistent with the following requirements:

Answer 75

1) All surfaces in laminar airflow workbenches, biological safety cabinets, compounding
aseptic isolators, and compounding aseptic containment isolators shall be cleaned
and disinfected at the beginning of each work shift, before each batch preparation is
started, after spills, and when surface contamination is known or suspected;
2) All counters, work surfaces, and floors shall be cleaned and disinfected daily; and
3) All walls, ceilings, and storage shelving shall be cleaned monthly

Question 76

The PIC shall be responsible for ensuring that, prior to compounding sterile preparations and annually thereafter, all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall have:

Answer 76

passed a written test that demonstrates competency in all areas set forth in (a) above, and in the pharmacy’s standard operating procedures with regard to compounding sterile preparations as set forth in the policy and procedure manual required to be maintained pursuant to N.J.A.C. 13:39-11.23.

Question 77

The PIC shall be:

Answer 77

responsible for testing of the aseptic technique of all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations consistent with the methods set forth in USP 797 concerning “Aseptic Manipulation Competency Evaluation,” incorporated herein by reference, as amended and supplemented, and which is available for purchase at the
United States Pharmacopeia website

Question 78

Aseptic technique retesting shall be:

Answer 78

conducted annually for all personnel
engaged in compounding low- and medium-risk level preparations and semi-annually for
all personnel engaged in compounding high-risk level preparations.

Question 79

All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs engaging in the compounding of sterile preparations shall:

Answer 79

successfully complete an initial gloved fingertip/thumb sampling procedure prior to compounding sterile preparations. Gloved fingertip/thumb sampling shall be conducted annually for all personnel engaged in compounding low- and medium-risk level preparations and semi-annually for all
personnel engaged in compounding high-risk level preparations

Question 80

Individuals who fail the written test and/or the test of aseptic technique shall be:

Answer 80

prohibited from compounding sterile preparations until passing both tests.

Question 81

All test results shall be:

Answer 81

maintained by the permit holder for 5 years and shall be made available to the Board for inspection upon request.

Question 82

Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, consistent with N.J.A.C. 13:39-11.13, may compound sterile preparations in a quantity that is
supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist:

Answer 82

1) Documents a history of valid prescriptions or medication orders subsequently received, within the beyond-use dating time of each product, which have been generated solely within an established professional prescriber-patient-pharmacist relationship;
2) Maintains the prescription or medication order on file for all such products dispensed
at the pharmacy;
3) Documents the batch preparation process, including selection of the drugs,
containers, and diluents, lot numbers and expiration dates of the drugs, containers, and diluents, if any, and verification that the compounded sterile preparation has
been visually inspected to ensure the absence of particulate matter in solutions, the
absence of leakage from vials and bags, and the accuracy and thoroughness of
labeling. Each batch shall be given a unique batch number to identify the specific
batch; and
4) Ensures that the labeling requirements set forth at N.J.A.C. 13:39-11.21(a)1, 5, 7, 9,
and 10 are satisfied.

Question 83

Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not:

Answer 83

batch prepare compounded sterile preparations for human use without a prescription for a licensed prescriber to use in his or her practice, except to the extent permitted by Federal law. Anyone batch preparing compounds for non-human use without a prescription pursuant to this section shall comply with all requirements of N.J.A.C. 13:39- 11.18 and the documentation requirements of N.J.A.C. 13:39-11.20(c).

Question 84

In the absence of a valid patient-specific prescription or medication order, pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not:

Answer 84

prepare compounded sterile preparations for human use for a licensed prescriber to use in his or her practice, except to the extent permitted by Federal law. A pharmacy may prepare compounded sterile preparations for a licensed prescriber for non-human use in the prescriber’s practice without a prescription consistent with State and Federal laws pertinent to the prescriber’s health care
practice.

Question 85

For purposes of this section, stability means:

Answer 85

the extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

Question 86

In the absence of supporting valid scientific sterility testing and stability information that is directly applicable to specific preparations, the following dates and times for storage
and initiation of administration of the compounded sterile preparations shall:

Answer 86

apply, according to the assigned risk level of the preparation, unless the manufacturer’s package indicates a different stability time:

Question 87

Opened or needle-punctured single-dose containers of sterile products (for example, bags, bottles, syringes, and vials) used in the compounding of sterile preparations for
immediate use in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.11, shall be:

Answer 87

used within 1 hour if opened in worse than ISO Class 5 air quality, and any remaining contents shall be discarded.

Question 88

Single-dose vials used in the compounding of sterile preparations exposed to ISO Class 5 or cleaner air quality may be:

Answer 88

used up to 6 hours after an initial puncture.

Question 89

Opened single-dose ampules used in the compounding of sterile preparations shall not:

Answer 89

be stored for any period of time

Question 90

Opened or needle-punctured multiple-dose vials used in the compounding of sterile preparations shall be:

Answer 90

used within 28 days after initially entering the vial, unless otherwise specified by the manufacturer

Question 91

The pharmacist shall:

Answer 91

ensure that compounded sterile preparations have been properly prepared, consistent with the assigned risk level of the preparation, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter. The pharmacist shall be responsible for the accuracy and appropriateness of the compounded prescription. When more than one pharmacist is involved in the steps of the compounding process, the pharmacist shall be responsible for the accuracy and appropriateness of each step he or she performed or he or she approved and reviewed, and his or her unique and secure user identifier(s) shall be recorded in the audit trail.

Question 92

A pharmacy shall maintain an audit trail for all:

Answer 92

compounded sterile preparations consistent with the requirements of N.J.A.C. 13:39-7.6.

Question 93

A pharmacy shall maintain a compounding record for each compounded sterile preparation that contains the following information:

Answer 93

1) Selection of the drugs, container, and diluent prior to their being compounded, including documentation of lot numbers and expiration dates of the drugs, containers, and diluents, if applicable;
2) Verification that ingredients comply with the prescription or medication order;
3) Verification that the prescription or medication order label complies with the
requirements of N.J.A.C. 13:39-11.21;
4) Verification that the compounded sterile preparation has been visually inspected to
ensure the absence of particulate matter in solutions, the absence of leakage from
vials and bags, and the accuracy and thoroughness of labeling; and
5) Verification that the prescription or medication order is complete and ready to be
dispensed, including any necessary ancillary supplies.

Question 94

The dispensed container for any compounded sterile preparation shall bear a permanently affixed label with at least the following information:

Answer 94

1) The date and the time prepared;
2) In the retail pharmacy only, the name of the prescriber;
3) The name of the patient;
4) Directions for use;
5) The name and strength or quantity of all active ingredients, and the name and
volume of the diluent, vehicle, and base solution(s), if applicable;
6) The name, address, and telephone number of the pharmacy;
7) The phrase “use by” followed by the preparation’s use by date and time (if no time is
stated, it is presumed to be 11:59 P.M. of the stated use by date).
8) Any ancillary and cautionary instructions as needed;
9) As pertinent, a warning consistent with applicable Federal and State law, that
antineoplastic agents and other hazardous substances products are biohazardous;
10) As pertinent, the requirements for proper storage; and
11) In a retail pharmacy, for those medications not dispensed pursuant to the
requirements of N.J.A.C. 13:39-9, the prescription number.

Question 95

For immediate use compounded sterile preparations, when the preparation is not administered by the person who prepared it, or its administration is not witnessed by the
person who prepared it, the compounded sterile preparation shall be:

Answer 95

labeled consistent with the requirements of (a) above and shall also include the name or identifier of the person who prepared the compounded sterile preparation

Question 96

The pharmacy shall be responsible for the proper handling and packaging of compounded sterile preparations for delivery from the pharmacy to the patient in order to assure and maintain the integrity, efficacy, stability, and sterility of these preparations. The PIC shall ensure that:

Answer 96

1) Tamper-evident packaging is utilized;
2) Delivery is made from the pharmacy to the patient or patient care location within a
reasonable time; and
3) Proper in-transit storage is provided consistent with product labeling.

Question 97

The policy and procedures manual shall include policies and procedures governing the following:

Answer 97

1) A risk-management program, including, but not limited to, documentation of incidents,
adverse drug reactions, and product contamination.
i) The risk-management program shall require that the PIC report all confirmed incidents of product contamination to the New Jersey Board of Pharmacy within 48 hours of becoming aware of such incidents;
2) Security measures ensuring that the premises where compounded sterile drugs are
present are secured, so as to prevent access by unauthorized personnel;
3) Equipment;
i) Procedures for use; and
ii) Documentation of appropriate certifications;
4) Cleaning and disinfecting standards and procedures, consistent with the
requirements of N.J.A.C. 13:39-11.15;
5) Reference materials as set out in N.J.A.C. 13:39-5.8 and 11.12(b)12;
6) Information concerning drug:
i) Preparation;
ii) Storage and handling;
iii) Dispensing;
iv) Labeling;
v) Delivery; and
vi) Destruction, recalls and returns;
7) Patient recordkeeping as set forth in N.J.A.C. 13:39-11.12(b)14;
8) Handling, dispensing and documentation of investigational new drugs;
STATE BOARD OF PHARMACY LAW AND PUBLIC SAFETY
Chapter 39 Page 144 of 174 Last Revision Date: 03/02/2020
9) A quality assurance program as set forth in N.J.A.C. 13:39-11.24;
10) Verification of training and competency guidelines as set forth in N.J.A.C. 13:39-
11.16;
11) Compounding process validation;
12) Documentation as set forth in N.J.A.C. 13:39-11.20;
13) Description of appropriate garb and garbing procedures, consistent with the
requirements of N.J.A.C. 13:39-11.14;
14) Conduct guidelines for personnel in the cleanroom;
15) Personnel responsibilities;
16) Patient education;
17) Protocol and procedures to maintain the integrity of the interior work area of the
laminar airflow workbenches, compounding aseptic isolators, compounding aseptic
containment isolators, and biological safety cabinets; and
18) Written procedures in compliance with the Occupational Safety and Health
Administration standards for handling small and large spills of antineoplastic agents
and other hazardous substances.

Question 98

The policy and procedures manual shall be reviewed, at a minimum:

Answer 98

once every 24 months and shall be updated, on a continuous basis, to reflect current practice.
Documentation of the review shall be made available to the Board upon request.

Question 99

A reasonable effort shall be made by the pharmacist to assure that compounded sterile preparations shall be:

Answer 99

kept under appropriate controlled conditions at the location of use by providing adequate labeling and verbal or written instructions
regarding proper storage and administration as set forth by the product manufacturer,
with each compounded sterile preparation dispensed;

Question 100

The quality assurance program encompasses:

Answer 100

all phases of sterile compounding for each unique type of compounded sterile preparation dispensed;

Question 101

After the preparation of every admixture, the contents of the container are thoroughly mixed and then visually inspected to:

Answer 101

ensure the absence of particulate matter in
solutions, the absence of leakage from vials and bags, or any other defects, and the
accuracy and thoroughness of labeling;

Question 102

All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations shall have:

Answer 102

their aseptic technique tested consistent with the requirements of N.J.A.C. 13:39-11.16;

Question 103

All high-risk level compounded sterile preparations that are prepared in groups of more than 25 identical individual single-dose packages (for example, ampules, bags, syringes, vials), or in multiple-dose vials for administration to multiple patients, or that are exposed longer than 12 hours at two degrees to eight degrees Celsius and longer than 6 hours at warmer than eight degrees Celsius before they are sterilized, and all compounded sterile preparations whose BUD has been exceeded, shall be:

Answer 103

tested to ensure that they are sterile before they are dispensed or administered. The USP membrane filtration method shall be used where feasible. Another method may be used if verification results demonstrate that the alternative is at least as effective and reliable as the membrane filtration method or the USP direct inoculation of the culture medium method, consistent with the standards set forth in USP 797 concerning “Sterility Testing,” 2012 edition, incorporated herein by reference, as amended and supplemented, and available for purchase at the United States Pharmacopeia website,

Question 104

When high-risk level compounded sterile preparations are dispensed before receiving the results of the sterility tests set forth in (a)5 above, the written quality assurance procedure shall:

Answer 104

require daily observation of the incubating test
specimens and immediate recall of the dispensed compounded sterile
preparations when there is any evidence of microbial growth in the test specimens. The patient and the physician of the patient to whom a potentially contaminated compounded sterile preparation was administered shall be notified immediately of the potential risk. Positive sterility tests shall require rapid and
systematic investigation of aseptic technique, environmental control, and other sterility assurance controls in order to identify sources of contamination and to take corrective action.

Question 105

All high-risk level compounded sterile preparations, except those for inhalation and ophthalmic administration, shall be tested:

Answer 105

to ensure that they do not contain excessive bacterial endotoxins;

Question 106

Air and surface sampling for microbial organisms in ISO class 5 primary engineering controls, such as laminar airflow workbenches, compounding aseptic isolators,
compounding aseptic containment isolators, and biological safety cabinets, and in all other ISO classified areas shall b:e

Answer 106

certified by an independent certification company once every 6 months and at any time when microbial contamination is suspected;

Question 107

Pressure differential monitoring shall be:

Answer 107

conducted consistent with the requirements
of N.J.A.C. 13:39-11.4(d). A pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante area and between the ante area and the general environment outside the cleanroom. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily) or by a continuous recording device

Question 108

A cleanroom shall be certified by an independent certification company every:

Answer 108

6 months and whenever the room or a PEC in the room is relocated or altered, or whenever major service to the facility is performed, to ensure that the cleanroom meets appropriate ISO classifications. Such certifications shall be
performed consistent with procedures outlined in the Controlled Environment Testing
Association (CETA) Certification Guide for Sterile Compounding Facilities (CAG-003-
2006) (revised December 8, 2008), incorporated herein by reference, as amended
and supplemented, and which may be found at the CETA website,

Question 109

Whenever test results indicate that the cleanroom or any primary engineering controls do not meet the standards established in this section, the pharmacy shall:

Answer 109

immediately cease using the cleanroom or primary engineering control that is out of
compliance until such time that the cleanroom and/or the primary engineering control
meets the requisite standards. The pharmacy shall notify the Board in writing within 48 hours of any air and/or surface sampling test results that are out of compliance.

Question 110

A pharmacist shall not:

Answer 110

compound preparations that contain drug products that appear on the Federal Food and Drug Administration’s List of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR 216.24.

Question 111

A pharmacist shall not compound any commercially available drug products unless:

Answer 111

1) The commercially available product is modified to produce a significant difference, in
the professional judgment of the prescriber, between the compounded product for the
patient and the comparable commercially available product; or
2) The commercially available product is not available from normal distribution channels
in a timely manner to meet the patient’s needs, and the dispensing of the compounded product has been approved by the prescriber and the patient.
c) A pharmacist who compounds a commercially available product consistent with the requirements of (b) above shall maintain documentation of the reason for such
compounding.