ACPH. See air changes per hour (ACPH)
active pharmaceutical ingredient (API)
administering, 141
concentrated hormone solutions, 121
C-PEC required for compounding, 79, 81
decontamination and cleaning, 145
defined, 20, 115
environmental monitoring, 149
facility design/requirements, 91, 93, 94, 96–97, 98
PPE, 39, 40–44
risk assessment, 23, 26
spills, 155
storage of, 65, 66, 68–69, 72
transporting, 139
weighing, in BSC, 120
ADC. See automated dispensing cabinet (ADC)
administering HDs, 141–144
chemo, 142–143
chemo-certified nurse for, 144
crushing HDs, 142
CSTDs, 142–143
diluent to be mixed with the drug just prior to, 143
IM methotrexate, 142
non-antineoplastic drugs, 143
nursing competencies, 143
to patients in an outpatient infusion setting, 143
PPE, 141
stat oxytocin drip, 143
air changes per hour (ACPH)
anterooms, 101
calculating, 97–98
compounding facilities, 91, 92, 93, 96, 97–98, 117, 167
C-PEC, 85, 86
C-SCA, 86, 97–98, 106–107
C-SEC, 79, 102–103, 181, 182
defined, 91
flammable cabinets, 68, 70
storage requirements, 65, 116
ambulatory patients, dispensing finished dosage forms to, 136–137
American Society for Testing and Materials (ASTM)
Standard ASTM F739 for gloves, 47
Standard D6978 for gloves, 29, 39, 40, 47, 48–49, 76, 167, 169
Standard F739-99a for testing gloves for permeation to general chemicals, 47
Standard F3267 for gowns, 49
American Society of Health-System Pharmacists (ASHP)
ASHP Guidelines on Handling Hazardous Drugs, 18, 51, 115, 153, 155, 156, 165
ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs, 18
ASHP Technical Assistance Bulletin on Handling Cytotoxic Drugs in Hospitals, 3
Assessment of Risk Toolkit, 30
Compounding Resource Center, 115, 159
Pharmacy Competency Assessment Center, 33, 34, 143
Sterile Compounding certificate program, 33
American Society of Heating, Refrigerating, and Air‑Conditioning Engineers (ASHRAE), 80, 83, 96
answer key, 180–187
OSHA-recommended steps for treatment of workers with skin or eye contact with HDs, 187
recommendations for compounding and handling nonsterile HD dosage forms, 181
recommendations for spill cleanup procedure, 186–187
recommendations for use of class II BSCs, 181–182
recommendations for use of class II BSCs and CACIs, 182–183
recommendations for use of gloves, 184
recommendations for use of gowns, 184
recommendations for working in any C-PEC, 185
recommended contents of HD spill kit, 186
anteroom, 101
ACPH, 79, 91, 97–98, 101, 102, 167
check of chemo items occurring in, 122
cleaning, 146
cleanroom suite, 106, 107
corrugated cardboard in, 124
C-SCA, 101, 107
decontaminating, 146
facility design/requirements, 101, 103
floor drains, 113
ISO 7, 79, 85, 94, 101, 102, 106
negative pressure, 101, 102, 106
PPE, 42, 50
API. See active pharmaceutical ingredient (API)
aseptic technique
Bacillus Calmette-Guérin, 121
defined, 169
eye protection and respirators, 170
needles and syringes, 126
PPE, 169–170
ASHP. See American Society of Health-System Pharmacists (ASHP)
ASHRAE. See American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE)
Assessment of Risk Toolkit (ASHP), 30
ASTM. See American Society for Testing and Materials (ASTM)
automated dispensing cabinet (ADC), 71, 132, 135
availability of USP <800>, 1
Bacillus Calmette-Guérin (BCG), 121, 122
BCG. See Bacillus Calmette-Guérin (BCG)
beyond-use dates (BUDs), 85, 86–87, 102–104, 129
biological safety cabinet (BSC)
alarm for malfunctioning, 88
antineoplastic agents, 105
aseptic technique, 169
Bacillus Calmette-Guérin, 121
biological preparations in, 121
canopy connection, 88, 103
certification of, 84, 100
classes of, 87–88 (See also BSC classes)
cleaning, 146, 147, 170–171
in cleanroom suite, 106
dosing of antineoplastics, 131
emergency power, 113
environmental monitoring, 150
exhaust, 103
eye and respiratory protection, 170
eye protection, 53, 170
facility design/requirements, 168
gloves, 48, 170
labeling chemo pre-meds, 119
labeling non-chemo pre-meds, 122
low use exemption, 4, 90
methotrexate, 29, 119–120, 142
negative pressure cleanroom, 87
non-antineoplastic HDs, 84
nonsterile compounds prepared in a negative pressure room in, 82
nonsterile HDs, compounding, 168
on NSF Certified Biosafety Cabinetry list, 84
opening packages in, 58–59
packaging in, 29, 75, 81, 131–132, 133, 134, 135
perimeter around, in C-SCA, 107, 108
PPE, 44
reconstituting HDs, 126, 143
respiratory protection, 43, 54, 55, 170
robotic devices, 83, 168, 169
shoe covers, 52
stat meds for urgent patient situations, 124
sterile compounding in, 78, 80
sterile HDs, compounding, 168
total exhaust, 88
transferring HD to IV bag, 126
weighing APIs, 120
what was allowed in 2008 <797> and what is allowed in <800> and 2023 <797>, 77, 93
wipe samples collected in, 150
Biosafety Cabinetry Certification (NSF/ANSI 49), 88
BSC. See biological safety cabinet (BSC)
BSC classes
Class I, 58–59, 79, 82, 87, 168
Class II, 78, 83, 84, 87–88, 100, 103, 121, 126, 168, 181–182
Class III, 87, 168, 182–183
types of, 87
BUDs. See beyond-use dates (BUDs)
buffer room
ACPH, 79, 97–98, 102, 121
BCG compounded in, 121
check of chemo items occurring in, 122
cleaning, 146
in a cleanroom suite, 106, 107
counting and packaging HDs, 75
C-PEC, 86
decontaminating, 146
engineering controls, 77, 79, 85, 86, 87, 102–103, 168
eyewash stations in, 113
facility design/requirements, 91, 92, 93–94, 96–100, 103, 167
HEPA-filtered air in, 97
ISO 7, 79, 94, 101, 102, 104–105, 106
low volume exemption, 111
negative pressure, 101, 104, 106
pass-through chambers, 108, 110
PPE, 42, 45, 50, 51, 52, 170
presterilization procedures, 120
receiving personnel, 58, 59, 63
refrigerator and freezer placement, 110, 111, 112
storage of HDs, 66, 68, 69, 70, 71, 73
for weighing powders, 101–102
CACI. See compounding aseptic containment isolator (CACI)
CAGs. See Certification Application Guides (CAGs)
carmustine, 49
carousels, 72
CDC. See Centers for Disease Control and Prevention (CDC)
Center for Biologics Evaluation and Research (CBER), 19, 121, 122
Center for Drug Evaluation and Research (CDER), 19, 121, 122
Center for Improvement in Healthcare Quality (CIHQ), 1
Centers for Disease Control and Prevention (CDC)
hand hygiene defined by, 39–40
Hand Hygiene Guidance, 40
Centers for Medicare & Medicaid Services (CMS), 21, 29, 125, 133–134
certification
administering monoclonal antibody, 144
BSC, 84, 100
CETA Certification Application Guides (CAGs), 102–103
C-PEC, 100, 117, 150
C-SEC, 100, 117, 150
hoods, 100
Certification Application Guides (CAGs), 102–103
CETA. See Controlled Environment Testing Association (CETA)
chemo agents
administering, 142–143
certification for administering monoclonal antibody, 144
CSTDs for administering, 142
dispensing finished dosage forms to ambulatory patients, 136
exposure, 17
eye protection, 53
face shields, 53
feeding tube for administering, 142–143
head and beard covers used for, 52
need for <800>, 12
personnel, 15
pregnant or breast-feeding pharmacy technicians, 31–32
recording lot numbers for, 124
respirator, 55
shoe covers used for, 52
transport of, by volunteers, 139
chemo bag, 45, 46, 58, 59, 72, 135
chemo-certified nurse, 144
chemo gloves. See gloves
chemo gown, 45, 46, 50, 51
chemo hood, 35, 111, 134, 145, 147–148, 168. See also containment primary engineering control (C-PEC)
chemo infusion center, 122
chemo mat, 58
chemo room
anteroom to, 101, 110
cart pass-through in, 110
doffing garb in, 122
HD totes delivered to, 59
nonsterile chemo drugs stored in, 68
pass-through chambers, 109–110
pass-through refrigerator in, 110
taking HD packages into, 59
unpacking the wholesaler tote in, 58
chloramphenicol, 89
Class I BSCs, 58–59, 79, 82, 87, 168
classified rooms, 96
Class II BSCs, 78, 83, 84, 87–88, 100, 103, 121, 126, 168, 181–182
Class III BSCs, 87, 168, 182–183
cleaning. See decontamination and cleaning
cleanroom suite
ACPH, 97–98, 117
approval to build, 112
BSC, 87, 106, 120
CACI, 106
corrugated cardboard in, 124
engineering controls, 77, 85, 86, 87, 102–107
facility design/requirements, 92, 93–94, 96, 97–98, 106, 112
HEPA-filtered air in, 97
instead of C-SCA, 104
negative pressure, 87
negative pressure cleanroom compared to C-SEC, 106
pass-through chambers, 108, 109
PPE, 45, 51, 52
printer in, 112
receiving personnel, 58, 59–60
refrigerator and freezer placement, 110
refrigerator in, 112
shelving in, 112
spills, 156
closed system drug-transfer device (CSTD), 89–90
in <800> vs. other USP chapters, 4, 78
administering chemo, 142–143
administering HDs, 89, 142–143
antineoplastics, 143
chloramphenicol, 89
compounding HDs, 89
defined, 77, 79, 89, 168–169
FDA approval of, 90
incompatibility with specific HDs, 90
in isolator, 123
low use exemption allowed in 2008 <797>, 90
more than just antineoplastic drugs, 89–90
negative pressure technique, 124, 126
NIOSH performance protocol for, 90
non-chemo agents, 125
nursing vs. pharmacy use of, 90
ONB code, 90
using instead of a hood for occasional HD compounding, 90
when compounding in a CACI, 89
CMS. See Centers for Medicare & Medicaid Services (CMS)
competence, documenting, 34–35
competence assessment exam, 177–179
Competence Assessment Tools for Health-System Pharmacies (Murdaugh), 33, 34, 143, 165, 166, 168, 170
competence checklist, 175–176
compounded sterile preparation (CSP)
chemo and non-HD CSPs compounded in the same C-PEC, 85
decontaminating, 115, 148
PPE, 41, 42, 48, 122, 135, 169
transporting, 135
compounding aseptic containment isolator (CACI). See also containment primary engineering control (C-PEC)
alarm for malfunctioning, 88
antineoplastic agents compounded in, 105
aseptic technique, 169
beyond-use dates (BUDs), 87, 96
BSC used instead of, 78
cleaning, 146, 147, 170–171
in cleanroom suite, 106
CSTDs used when compounding in, 89
emergency power, 113
eye protection, 53, 170
facility design/requirements, 168
gloves, 48, 170
head/hair/shoe covers, 42, 52
installed in a segregated room, 86
low use exemption, 4
in a negative pressure room, 85, 86, 87, 104–105
for non-antineoplastic HDs, 84
non-externally vented, for preparing oral HDs, 82
packaging, 131–132, 135
perimeter around, in C-SCA, 107, 108
placement of, 92
in a positive pressure room, 77–78, 97
PPE, 44
RABS compared to, 83
reconstituting HDs, 126, 143
respiratory protection, 43, 54, 55, 170
robotic devices, 83, 168, 169
shoe covers, 52
to split methotrexate tablets, 119–120
transferring HD to IV bag, 126
vents outside of, 104
what was allowed in 2008 <797> and what is allowed in <800>, 102
what was allowed in 2008 <797> and what is allowed in <800> and 2023 <797>, 77, 93
wipe samples collected in, 150
compounding aseptic isolator (CAI), 83, 85, 86, 106, 178
compounding HDs, 115–127, 165–171
alcohol, spraying, 123
alcohol gel instead of washing hands, 124
API, 115
aseptic technique, 169–170
BCG, 121
biologics not listed on the NIOSH HD list, 122
BSCs, 121
check of chemo items, 122
compounded topical cream, 121
compounding non-HDs in the negative pressure hood and room, 119
compounding nonsterile HDs in an open room, 119
concentrated hormone solutions, 121
corrugated cardboard, 124
crushing tablets to make a solution, 119
CSTDs, 123, 124, 125
CVE, 119–120
definition of HDs, 166
disposable mortar and pestle, 124
emergent need for, 124–125
facility design/requirements, 167–169
learning objectives, 165
lot numbers for chemo, 124
medical surveillance program, 171
methotrexate, 119–120
negative pressure technique, 126–127
non-antineoplastic hazardous oral solutions, 119
nonsterile, non-antineoplastic hazardous medications, 119
outside of the proper facility, 125
overview, 165–166
plastic-backed preparation mat, 122–123
policies required and recommended in USP <800>, 115–118
PPE, 122
precautions, 166–167
pre-saturated gauze to disinfect vials, 123
vs. regular compounding, 124
spray bottles of cleaners, 123
weighing out HD APIs in a BSC, 120
when is a HD not a HD, 120
work practices, 170–171
Compounding Resource Center (ASHP), 115, 159
containment primary engineering control (C-PEC), 78–88
ACPH, 85, 86
acrylic glove boxes, 85
BSCs, 84, 87–88
in a buffer room, 86
buying, 84
CACI, 83, 85, 86–87
certification, 100, 117, 150
chemo and non-HD CSPs compounded in the same, 85
classified rooms for sterile compounding, 96
compliant for compounding nonsterile HDs, 79
compliant for compounding sterile HDs, 83
compounding chemo and non-HD CSPs in the same, 85
counting and packaging HDs, 75
crushing tablets in, 119
C-SCA, 79, 87, 106, 108
C-SEC, 79, 102, 103
CSPs, 84, 85
CVE, 78, 99
defined, 77, 78
facility design/requirements, 92, 96, 97, 98, 99
HEPA filters, 85
LAFW, 86
laminar air flow hoods, 84
mixing chemo pre-meds in a hood, 85
for nonsterile compounding, 79–83, 117
placing a regular hood in the negative pressure cleanroom to mix pre-meds, 86
policies required and recommended, 117, 118
PPE, 41–42, 45–46, 48, 53, 54, 55, 99
presterilization procedures, including weighing and mixing, 101–102
RABS, 83
receiving personnel, HD precautions for, 58–59, 61
for sterile compounding, 83–88, 117
storage of HDs, 73
uninterrupted power source for, 113, 117
venting, 83–84, 85
containment secondary engineering control (C-SEC), 102–106
ACPH, 79, 102–103, 181, 182
certification of, 100, 117, 150
cleaning, 146
cleanroom compared to, 106
C-PEC placed in, 79, 102
C-SCA compared to, 77, 78, 103
defined, 77, 106
facility design/requirements, 102–106
HEPA-filtered air in, 103
negative pressure cleanroom compared to, 106
containment segregated compounding area (C-SCA), 106–108
in <797> vs. C-SCA in <800>, 106–107
ACPH, 86, 97–98, 106–107
as an area and not a room, 106
anteroom in, 101, 107
BUDs, 86, 96, 103, 105, 129
chemo mixed in, 94
cleaning, 146
cleanroom instead of, 104
corrugated cardboard in, 124
C-SEC compared to, 77, 78, 103
CVE compounding in, 105
decontaminating, 146
defined, 79, 106
example of room requirements, 107, 108
facility design/requirements, 86–87, 91, 92, 93–94, 103
HEPA-filtered air in, 97–98, 106, 107, 112
ISO classification required for, 96
low use exemption, 5
negative pressure cleanroom compared to, 106
as a negative pressure room, 107
packaging HDs, 75
perimeter of, 107
personal protective equipment for, 42, 45, 50, 51, 52
printer in, 112
receiving HDs, 58, 59, 63
refrigerator in, 112
shelving in, 112
sink placement, 98–99
sterile HDs mixed in, 96
storage of HDs, 70, 73
un-gowning area, 105, 107
what was and wasn’t allowed in the 2008 version of <797> and in <800>, 102
containment strategies, in <800>, 5. See also engineering controls; personal protective equipment (PPE); work practices
containment ventilated enclosure (CVE)
buying, 80
compliant for compounding nonsterile HDs, 79
defined, 78
environmental monitoring, 149
HEPA-filtered air in, 78
methotrexate tablets in, 81, 119–120
for non-hazardous compounding, 105
nonsterile compounds be prepared in, 82
opening packages in, 58–59
packaging in, 131–132, 133, 134
turning off, 99
weighing and mixing in, 101–102, 120
contamination, finding, 150, 151
Controlled Environment Testing Association (CETA), 102–103
corrugated cardboard, 124
counting and packaging HDs, 75–76
automated packaging machines, 75
community pharmacy, 76
manufacturer unit-dose or unit-of-use packages, 75–76
unit-dose solid oral antineoplastics, 75
C-PEC. See containment primary engineering control (C-PEC)
crushing HDs, 142
C-SCA. See containment segregated compounding area (C-SCA)
C-SEC. See containment secondary engineering control (C-SEC)
CSP. See compounded sterile preparation (CSP)
CSTD. See closed system drug-transfer device (CSTD)
CVE. See containment ventilated enclosure (CVE)
cyclophosphamide, 122, 150
decontamination and cleaning, 145–148
agents used for, 145
alcohol used for, 148
cleaning guidelines under USP <800>, 146
cleaning supplies required by USP <800>, 148
deactivation, 146, 147
decontaminating and cleaning schedule, 147
dilutions of decontamination and cleaning solutions, 147
disinfection, 145, 146–147, 148
floors, 148
mops, 148
wipe sampling, 148
designated person, 32–33, 151
diluent to be mixed with the drug just prior to administering HDs, 143
dispensing HDs, 135–137
finished dosage forms to ambulatory patients, 136–137
finished dosage forms to patient care units, 135–136
disposable mortar and pestle, 124
disposal, 4, 8, 11, 14, 27, 116, 118, 153, 171
acknowledgment of HD risk form, 37
hazardous waste disposal bags, in spill kit, 186
noninjectable dosage forms of HDs, 181
personnel training, 33, 57
supply and drug waste in the class III BSC, 183
of used PPE, 8, 117
DNV Healthcare, 1
donning and doffing, 39, 45–46
defined, 39
order of, 45–46
engineering controls, 77–88
BSC for sterile compounding, 78
CACI, 78
C-PEC, defined, 78
C-PEC for nonsterile compounding, 79–83
C-PEC for sterile compounding, 83–88
C-SCA, 79
C-SEC, 79
CVE, 78
general information, 77–79
HEPA filters, 79
PECs, 77, 79
SECs, 77–78, 79
types of, 77–79
entity, 3
environmental monitoring, 149–151
contamination, finding, 150, 151
drugs commonly assayed, 150
microbial monitoring, 149
quality assurance and quality control activities, 149
surface sampling, 149–150, 151
using an isolator instead of a BSC, 150
wipe samples, 150, 151
Environmental Protection Agency (EPA), 3, 12, 82, 146, 147, 153, 166
EPA. See Environmental Protection Agency (EPA)
estrogens, 22, 67
exhaust air, 97
exposure
chemo agents, 17
developing policies, 115
double-gloving, 29
final dosage forms as being safer than powders, 18
HD defined by, 18
nursing competencies, 143
PPE available to receiving personnel, 60
PPE worn based on the dosage form administered, 141
PPE worn by nurse when crushing HDs, 142
PPE worn by personnel who are administering HDs, 43
types of, 17–18
eye protection, 53–54
aseptic technique, 170
face shield, 53
goggles, 53
meaning of, 53
prescription eyeglasses as, 53
when cleaning HD areas outside a C-PEC, 53
when cleaning the area inside a BSC or CACI, 53
when cleaning up a spill, 54
when mixing chemo, 53
when to use, 53
facility design/requirements, 91–113, 167–169
anteroom, 101, 103
BSC, 168
buffer room, 91, 92, 93–94, 96–100, 103, 167
CACI, 168
certification of engineering controls, 100
cleanroom suite, 92, 93–94, 96, 97–98, 106, 112
for compounding nonsterile HDs, 168
for compounding sterile HDs, 168–169
C-PEC, 92, 96, 97, 98, 99
C-SCA, 106–108
C-SEC, 102–106
emergency power, 113
eyewash stations, 113
finishes for the floors, walls, and ceilings, 112–113
freezers, 110–111
general information, 91–100
HEPA-filtered air, 92
ISO 7, 92
low volume exemption eliminated from 2023 797, 111–112
pass-through chambers, 108–110
pre-sterilization areas for weighing powders, 101–102
printers, 112
refrigerators, 110–111, 112
shelving, 112
sinks, 112
storing and compounding HDs, 167–168
USP <795>, 92, 93, 98, 112, 113
USP <797>, 92, 93, 98, 112, 113
USP <800>, 91–113
FDA. See U.S. Food and Drug Administration (FDA)
finished dosage forms, dispensing
to ambulatory patients, 136–137
to patient care units, 135–136
fluorouracil, 28, 67, 150
fosphenytoin, 13, 124
freezers, 110–111, 112
general principles of USP <800>, 3–5
gloves, 47–49
changing, 49
chemo-rated, 47
double-gloving, 29, 47–48
how to sterilize, 47
isolator gloves, 48
permeability of, 49
standards for, 47
sterile chemo gloves, 47, 48
tested per ASTM D6978 and lab chemical tested per ASTM F739, 47
tested to meet ASTM standard D6978, 40
use with carmustine or thiotepa, 49
when handling non-antineoplastic HDs, 47
when to use sterile gloves, 47
when working in a compounding isolator, 48
working inside a CACI, 48
gowns, 49–51
blue vs. yellow, 50
changing, 51
chemo-rated, 49
construction of, 50
hanging in the anteroom for use later in the day, 50
material used for, 50
permeability of, 49
removed, retained, and used throughout the work shift if it isn’t soiled, in 2008 <797> vs. <800>, 50
reusable gowns qualified as disposable, 50
re-worn during the day if a compounder must leave the HD compounding area, 50
standards for, 49
un-gowning area inside a negative pressure room, 107
use for non-HDs vs. those used for chemo, 49
use of a gown throughout one shift, 45
washable, 50
wearing a regular gown under a chemo gown, 51
wearing one vs. two, when compounding, 51
when compounding HDs, 45
Guidelines on Handling Hazardous Drugs (ASHP), 18, 51, 115, 153, 155, 156, 165
hair covers, 42, 52
hand hygiene, 39–40
Hand Hygiene Guidance (CDC), 40
Hazard Communication Plan, 35–37
hazardous drugs (HDs)
administering, 141–144
compounding, 115–127, 165–171
counting and packaging, 75–76
definition of, 18–19, 166
dispensing, 135–137
identifying, 20
letter concerning risks of, 13
receiving personnel and, 57–63
risk assessment, 23–30
storage of, 65–74
transporting, 139
types of, 19
hazardous waste, 153
HDs. See hazardous drugs (HDs)
head covers, 42
heating/ventilating/air conditioning (HVAC), 95, 103
HEPA. See high-efficiency particulate air (HEPA)
high-efficiency particulate air (HEPA)
ACPH, 97–98
BSC, 87, 88
BUDs, 102, 103, 112
C-PEC, 78, 80, 82, 85
C-SCA, 97–98, 106, 107, 112
C-SEC, 103
CVE, 78
facility design/requirements, 92
gases stopped by, 79
pass-through chambers, 99–100, 108, 109–110
pre-filter as, 80
redundant, 80
removing the requirement for, 1
requirements for compounding nonsterile HDs, 168
in series, 80
hoods. See also containment ventilated enclosure (CVE)
buying, 80
certification, 100
chemo hoods, 35, 111, 134, 145, 147–148, 168
cleaning and decontaminating, 148
laminar airflow, 84
requirements for, 5, 7, 8, 91, 94
rusty, 148
human resources, 31–37
designated person, 32–33
documenting competence, 34–35
Hazard Communication Plan, 35–37
medical surveillance, 31–32
personnel training, 33–34
IARC. See International Agency for Research on Cancer (IARC)
ifosfamide, 150
IM methotrexate, 142
Improving Safe Handling at a Community-Based Health System (Roussel and Bennie), 159
Insanitary Conditions (FDA), 99–100, 108, 109, 110, 148
International Agency for Research on Cancer (IARC), 19
International Standards Organization (ISO) 5, 96
International Standards Organization (ISO) 7
air quality standards, 167
anteroom, 79, 85, 94, 101, 102, 106
buffer room, 79, 94, 101, 102, 104–105, 106
cleanroom, 94, 96, 103, 106
facility design/requirements, 92
storage in the buffer area, 69
International Standards Organization (ISO) 8, 101, 120
intravenous (IV)
Assessment of Risk, 25
bag, 126–127
checking, 42
room, 85, 101, 111, 168
intravenous immunoglobulin (IVIG), 85
IPA. See isopropyl alcohol (IPA)
ISO 5. See International Standards Organization (ISO) 5
ISO 7. See International Standards Organization (ISO) 7
ISO 8. See International Standards Organization (ISO) 8
isopropyl alcohol (IPA), 126, 127
IV. See intravenous (IV)
IVIG. See intravenous immunoglobulin (IVIG)
IV room, 85, 101, 111, 168. See also containment secondary engineering control (C-SEC)
The Joint Commission (TJC), 1, 13
LAFW. See laminar airflow workbench (LAFW)
laminar airflow workbench (LAFW), 85, 86, 106
low use exemption, 4, 90
MABs. See monoclonal antibodies (MABs)
Managing Hazardous Drug Exposures: Information for Healthcare Settings (NIOSH), 3, 159, 166
developing policies, 115
double-gloving, 29
final dosage forms as being safer than powders, 18
HD defined by, 18
nursing competencies, 143
PPE available to receiving personnel, 60
PPE worn based on the dosage form administered, 141
PPE worn by nurse when crushing HDs, 142
PPE worn by personnel who are administering HDs, 43
material safety data sheets (MSDS), 167. See also safety data sheet (SDS)
medical surveillance, 31–32, 171
megestrol, 21, 29, 133
methotrexate, 23, 29, 59, 67, 73, 81, 119–120, 125, 137, 142, 150
microbial monitoring, 149
mitomycin, 125
monoclonal antibodies (MABs), 21, 25, 144
mortar, disposable, 124
MSDS. See material safety data sheets (MSDS)
N95 respirator
fit-testing for, 55–56
need for separate N95 respirator for each person, 56
respirators that provide better protection, 54
surgical N95 respirator vs. a regular N95 respirator, 55
what it does and does not protect against, 54
when compounding HDs that could cause a respiratory risk, 42
National Institute for Occupational Safety and Health (NIOSH). See also NIOSH List of Hazardous Drugs in Healthcare Settings
Alert, 3 (See also Managing Hazardous Drug Exposures: Information for Healthcare Settings (NIOSH))
CSTD defined by, 168–169
letter concerning risks of HDs, 13
performance protocol for CSTDs, 90
Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs (NIOSH), 40, 41, 43, 44
Workplace Solutions, 40, 41, 43, 44
National Toxicology Program (NTP), 19
needles and syringes, aseptic technique for, 126
negative pressure requirements, 91
NIOSH. See National Institute for Occupational Safety and Health (NIOSH)
NIOSH List of Hazardous Drugs in Healthcare Settings
administering HDs, 144
BCG, 121
biologics missing from, 122
compounding HDs, 121, 122
dispensing HDs, 135
hazardous waste, 153
PPE, 39, 40, 41, 43, 44
storage of HDs, 65
non-antineoplastic drugs
administering, 143
Assessment of Risk, 28, 29, 94, 143
BSC for, 84
compounded and prepared in a negative pressure environment, 119, 133
CSTD required for, 143
LAWF or CAI used for, 86
PPE, 40, 41, 43, 44, 47, 50
receiving personnel, 58
storage, 69, 71, 135
NSF/ANSI, 88
NSF Certified Biosafety Cabinetry, 84
NSF Code of Ethics, 88
NTP. See National Toxicology Program (NTP)
nursing competencies, 143
occasional nonsterile compounding, 81
Occupational Safety and Health Administration (OSHA), 3
fit-testing of respirators, 55–56
Hazard Communication Program, 8, 35
hazardous chemical standard, 35–36
letter concerning risks of HDs, 13
Safety and Health Topics, 12
SDS, 36, 155
training for receiving personnel, 57
ONB code, 90, 126, 182, 183
Oncology Nursing Society (ONS), 3, 31, 32, 43, 141, 143
ONS. See Oncology Nursing Society (ONS)
OSHA. See Occupational Safety and Health Administration (OSHA)
oxytocin, 143
packaging, 131–134. See also counting and packaging HDs
PAPR. See powered air-purifying respirator (PAPR)
pass-through chambers, 99–100, 108–110
patient care units, dispensing finished dosage forms to, 135–136
personal protective equipment (PPE), 39–56
administering HDs, 43
for administering HDs, 141
aseptic technique, 166, 169–170
benefits of, 39
cleaning up a spill, 44
in a cleanroom suite, 45
compounding from powders, 42
compounding HDs, 41
in a compounding room for nonsterile HD preparation, 46
C-PEC, 41–42, 45–46, 48, 53, 54, 55, 99
crushing HDs, 142
C-SCA, 42, 45–46, 50, 51, 52
CSP, 41, 42, 48, 122, 135, 169
discarding HD trash, 43–44
donning and doffing, 39, 45–46
eye protection, 53–54
general information, 39–46
gloves, 47–49
gowns, 49–51
hair covers, 42, 52
hand hygiene, 39–40
head covers, 42
negative pressure lab, 42
nonsterile vs. sterile compounding, 43
packaging HDs, 41
pharmacist, 42, 45
receiving personnel, 40, 60, 62
requirements, 39, 141
respiratory protection, 54–56 (See also N95 respirator)
reusing, 44
shoe covers, 42, 52
transporting drugs to an infusion area, 43
transporting HDs, 40
using a compounding isolator, 44
Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs (NIOSH), 40, 41, 43, 44
personnel training, 33–34
for administering HDs, 143
antineoplastic contamination, 151
cleaning the C-SEC, 146
designated person, 33
in employee consent form, 37
frequency of, 34
HD spill cleanup, 156
listed in <795>, 34
listed in <797>, 35
listed in <800>, 35
of receiving personnel, 57
required, 33–34
surface sampling, 149
of transport personnel, 135, 136, 139
to use the chemo hood, 35
who needs to be trained, 34
pestle, disposable, 124
pharmacist, PPE for, 42, 45
answering the phone, 42
checking only items, 45
checking the preparation compounded in the C-PEC, 42
completes the checking of a CSP in the anteroom, 42
counseling a patient, 42
Pharmacy Competency Assessment Center (ASHP), 33, 34, 143
Pharmacy Compounding Accreditation Board, 1
planning, 17–22
exposure, types of, 17–18
NIOSH list of HDs, 18–22
plastic-backed preparation mat, 122–123
plastic pouch to contain particles, 142
platinum-based agents, 150
policies, developing, 115
powder containment hood. See containment ventilated enclosure (CVE)
powered air-purifying respirator (PAPR), 43, 44, 54
PPE. See personal protective equipment (PPE)
predominant air, 97
pregnancy
methotrexate for ectopic pregnancy, 73, 125
oxytocin as situational hazard to, 143
premixed oxytocin, 143
presterilization areas for weighing powders, 101–102, 120
Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings (NIOSH), 3
primary engineering control (PEC), 77, 79, 94, 150. See also containment primary engineering control (C-PEC)
quality assurance and quality control activities, 149
RABS. See restricted access barrier system (RABS)
receiving personnel, 57–63
boxes of chemotherapy, 63
broken or damaged HDs, 63
damaged or broken HD containers, 60
delivery and acceptance of HDs, 57
hazardous residue on the outside of packages, 59
HD precautions for C-PEC, 58–59, 61
HDs in a negative pressure area, 62
HDs packaged by suppliers, 62
HD totes, 59, 62
ideal process for receiving HDs, 63
identifying HD containers, 62
labeling HD containers, 58
opening HDs, 57–59
PPE, 40, 60, 62
pressure monitoring, 59
receipt of antineoplastics that will be dispensed without manipulation, 59–60
requirements and recommendations, 61
training, 57
unpacking HDs, 58
where to receive HD shipments, 62
wholesalers’ designation of hazardous items in their ordering system, 62
wiping the packages of HDs prior to storage, 63
refrigerators, 71, 110–111, 112
requirements, 39
requirements based on the activity performed, 39
requirements based on the dosage form administered, 141
respiratory protection, 54–56. See also N95 respirator
aseptic technique, 170
fit-testing, 55–56
meaning of, 54
surgical masks, 55
when cleaning up a spill, 56
when compounding, 55
when mixing chemo, 55
when to use, 54
when unpacking HDs, 55
when working in a BSC or CACI, 54, 55
restricted access barrier system (RABS), 83
risk assessment, 23–30
Safe Handling of Hazardous Drugs (ONS), 31, 32, 43, 141, 143
safety data sheet (SDS), 36, 155, 167
safe work practices, 118
scope of USP <800>, 11–15
facilities, 15
handling HDs, 13–14
necessity of <800>, 11–13
personnel, 15
regulations, 14
SDS. See Safety Data Sheet (SDS)
secondary engineering controls (SEC), 77, 94, 102, 150. See also containment secondary engineering control (C-SEC)
sections of USP <800>, 7–10. See also USP <800>
Administering, 9
Appendix 1: Acronyms, 10
Appendix 2: Examples of Design for Hazardous Drugs Compounding Areas, 10
Appendix 3: Types of Biological Safety Cabinets, 10
Compounding, 9
Deactivating, Decontaminating, Cleaning, and Disinfecting, 9
Dispensing Final Dosage Forms, 8–9
Documentation and Standard Operating Procedures, 9
Environmental Quality and Control, 8
Facilities and Engineering Controls, 7–8
Four tables describe details of particular issues, 10
Glossary, 10
Hazard Communication Program, 8
Introduction and Scope, 7
Labeling, Packaging, Transport, and Disposal, 8
List of Hazardous Drugs, 7
Medical Surveillance, 9–10
Personnel Training, 8
PPE, 8
Receiving, 8
References, 10
Responsibilities of Personnel Handling Hazardous Drugs, 7
Spill Control, 9
Types of Exposure, 7
shoe covers, 42, 52
sIPA. See sterile 70% isopropyl alcohol (sIPA)
Small Entity Compliance Guide for Employers That Use Hazardous Chemicals (OSHA), 35
spill kit, 155–156, 186
spills, 155–157
API, 155
cleanroom suite, 156
personnel training, 156
policy and procedure, 156, 157
PPE, 44, 156
recommendations for spill cleanup procedure, 186–187
respiratory protection, 56
responsibility for cleanup, 156
spill kit, 155–156, 186
work practices, 155, 171
sterile 70% isopropyl alcohol (sIPA), 47
Sterile Compounding certificate program (ASHP), 33
storage of HDs, 65–74
in ADCs, 71
alternative containment strategies for oral antineoplastic agents, 67
antineoplastic requiring only counting or packaging, 67
awaiting return to suppliers, 74
in buffer area, USP <797> and, 69
in carousels, 72
chemo agents, 67–68, 70–71
chemo vials in smooth-coated cardboard boxes, 70
in community pharmacy, 73
door signs, 67
estrogens, 67
flammable cabinet to store chemo, 70
injectable medications, 66–67, 73
intact HDs, 72
keeping two sets of inventory, 66
list of hazardous medications that release volatile vapors during storage, 69
manufacturers’ requirement to clean the outer packaging, 66
methotrexate, 73
minimum storage requirements, 65
in negative pressure cabinet located in a neutral area, 70
in a negative pressure room, 65, 66, 67, 68, 70–71
non-chemo agents, 66
non-HD APIs, 66, 68–69
nonsterile chemo drugs, 68
non-volatile materials, 72
in nursing unit, 72
oncology support medication stored alongside HD in a C-SCA, 70
oral HDs, 67, 73
refrigeration, 69–70, 73
refrigerator placement for refrigerated antineoplastic HDs, 71
saline vials and other similar non-hazardous items, 70
“separate,” in <797> storage information, 72
separation of HDs and non-HDs, 71
transporting inventory that has been received into a negative pressure room, 72–73
in vented flammable cabinet, 68
supplemental engineering controls, 77, 78, 79. See also closed system drug-transfer device (CSTD)
defined, 77
supply air, 97
surface sampling, 149–150, 151
Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs (ASHP), 18
Technical Assistance Bulletin on Handling Cytotoxic Drugs in Hospitals (ASHP), 3
thiotepa, 49
TJC. See The Joint Commission (TJC)
transporting HDs, 139
unclassified room, 98
uninterrupted power source (UPS), 113
United States Pharmacopeia (USP). See USP <795>; USP <797>; USP <800>
UPS. See uninterrupted power source (UPS)
U.S. Food and Drug Administration (FDA)
CBER, 19, 121, 122
CDER, 19, 121, 122
Insanitary Conditions, 99–100, 108, 109, 110, 148
ONB code, 90, 126, 182, 183
USP <795>
BUDs, 103, 117, 129
cleaning guidelines, 146, 148
differences between <800> and, 4
environmental monitoring, 149
facility design/requirements, 92, 93, 98, 112, 113
in full text of USP <800>, 1
lot numbers for chemo, 124
risk assessment, 26, 27
for storing and compounding nonsterile HDs, 9
training requirements, 33, 34, 116
used in conjunction with <800>, 11
wording in, 14
USP <797>
BSCs, 93
BUDs, 102–103, 117, 129
CACI, 77, 93, 102
cleaning guidelines, 146, 148
C-SCAs, 102, 106–107
differences between <800> and, 4
elimination of low volume exemption from 2023 <797>, 111–112
environmental monitoring, 149
facility design/requirements, 92, 93, 98, 112, 113
in full text of USP <800>, 1
gowns, 50
lot numbers for chemo, 124
low-, medium-, and high-risk terminology in, 104
low use exemption, 90
risk assessment, 26, 27
storage in the buffer area, 69
for storing and compounding sterile HDs, 9
training requirements, 33, 34, 116
used in conjunction with <800>, 11
wording in, 14
USP <800>. See also sections of USP <800>
administering HDs, 141–144
answer key, 180–187
availability of, 1
BUDs, 129
competence assessment exam, 177–179
competence checklist, 175–176
compounding HDs, 115–127, 165–171
containment strategies in, 5
contents of sections of, 7–10
counting and packaging HDs, 75–76
CSTD, 89–90
decontamination and cleaning, 145–148
dispensing HDs, 135–137
engineering controls, 77–88
environmental monitoring, 149–151
facility design/requirements, 91–113
general principles of, 3–5
hazardous waste, 153
human resources, 31–37
low-, medium-, and high-risk terminology in, 104
packaging, 131–134
planning, 17–22
PPE, 39–56
receiving personnel and HDs, 57–63
risk assessment, 23–30
scope of, 11–15
spills, 155–157
storage of HDs, 65–74
transporting HDs, 139
where to start with information from, 159–160
valproic acid, 124
vented flammable cabinet, 68
ventilation systems, 113, 117
warfarin, 24, 133
water column (wc), 65, 86, 91, 92, 94, 95, 99, 101, 103, 104, 106, 167
wc. See water column (wc)
wipe samples, 150, 151
work practices, 5, 7, 13, 21
administering HDs, 141
Assessment of Risk, 23, 24, 25, 26, 28, 29
compounding HDs, 115, 116, 118, 119, 121, 123, 124–125, 170
counting and packaging HDs, 75
CSTDs, 89, 90
decontamination and cleaning, 145, 170–171
direct skin or eye contact, 171
disposal, 171
engineering controls, 77, 81, 82, 84, 86
environmental monitoring, 149, 151
facility design/requirements, 91, 94, 97, 98, 105
human resources, 31
packaging, 131, 133
PPE, 40–41, 43–44, 51
receiving personnel, 57
spills, 155, 171
storage of HDs, 65, 66, 68, 69
transporting HDs, 139