A

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

B

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

C

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

D

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

E

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

F

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

G

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

H

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

I

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)

J

The Joint Commission (TJC), 1, 13

L

LAFW. See laminar airflow workbench (LAFW)

laminar airflow workbench (LAFW), 85, 86, 106

low use exemption, 4, 90

M

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)

N

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

O

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

P

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)

Q

quality assurance and quality control activities, 149

R

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

S

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

T

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

U

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

V

valproic acid, 124

vented flammable cabinet, 68

ventilation systems, 113, 117

W

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