INDEX

A

accreditation organizations, 1

action levels, 6

     for air sampling, 135–136

     gloved fingertip and thumb test and, 48

     in sampling plan, 132

     for surface sampling, 138, 139–140

action plan, 143–144

active air sampling, 134–136

active pharmaceutical ingredients (APIs)

     beyond-use dates (BUDs) of, 112

     compounding, 97

     eye and respiratory risk when working with, 27

     use of, 55–56

addEASE®, 95, 112

ADD-Vantage™, 95, 112

administration of medications, 37–41

     administration, defined, 37

     compounding distinguished from, 11

     policies concerning, 37

     preparation for, 37–38

air changes per hour (ACPH)

     for air handing system, 73

     calculating, 68

     for chemo room, 67

     for cleanroom suite, 73

     for containment segregated compounding area, 75

     facility requirements for, 59, 62–63

     for IV room, 66

     for segregated compounding area, 63

     for storage room, 64

air flow

     dwell time and, 120

     dynamic air flow testing of PEC, 84

     environmental monitoring and, 131

     in pass-through chambers, 72, 77, 78

     training and, 41

air handling system, 62, 66, 85, 139

albumin, 98

alcohol as disinfectant/sanitizing agent, 120, 126

alcohol-based hand sanitizer, 28

alert level, 132

algorithm, 95–96

allergenic extracts, 5, 7

     compounding area, 80–81

     compounding process, 101

     immediate use and, 40

allergenic extracts compounding area (AECA), 69, 80–81

amber dropper bottles, 97

American Chemical Society (ACS) marking, 56

anesthesia personnel, 40

animals, application of USP <797> to, 9

anterooms, 68–71

     active air sampling in, 135

     air changes per hour (ACPH) in, 59, 62

     cleaning, 70, 128

     in cleanroom suite, 66, 70–71, 72–73, 74, 75

     dirty side distinguished between clean side, 70

     facility requirements for, 68–71

     garb and, 28, 30–31, 34

     gloved fingertip and thumb test in, 47, 48

     line of demarcation in, 68, 70

     mold in, 139

     office space in, cleaning, 128

     pass-through chambers to, 76

     pressure in, 66, 67, 69, 72, 85

antibiotics

     beyond-use-dates, 113

     master formulation record (MFR) for, 100

     saline bag used for reconstituting, 113

     syringes, reconstituted and frozen, 110

     vials, reconstitution of, 38

Aseptic Compounding Technique: Learning and Mastering the Ritual, 42

aseptic technique, 5, 50

     beyond-use dates (BUDs) and, 105, 106

     competency in, 15, 41

     immediate use preparations and, 11

     insanitary conditions and, 142

     training in, 50

ASTM F739-12e1 (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact), 30

ASTM Standard D6978, the Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, 29–30

autoclaves, 41, 97, 105

autologous serum, 98

automated compounding device (ACD), 78

     cleaning, 126

     sampling, 136

     testing, 86, 89

availability of USP <797>, 1

B

bacterial contamination, 85, 131, 133, 135

bag systems, 112

Banana Bag, 39

beyond-use dates (BUDs), 6, 105–115

     for active pharmaceutical ingredients and other components, 112

     anteroom and, 70

     of chemos, 106

     for compounded stock bags, 115

     compounding aseptic isolators and, 65

     designated person for monitoring, 14

     expiration date differentiated from, 105

     4 hour allowance and, 11, 39

     general information, 105–112

     for high-risk preparations, 112

     immediate use and, 37

     infusion time differentiated from, 105

     in-use time differentiated from, 105

     in master formulation record (MFRs), 103, 104

     maximum, 97, 106, 108, 109–110, 111

     for medium-risk preparations, 112

     reconstituting systems and, 95

     sterility testing and, 97

     vial/bag systems, 112

     vials and other dosage forms, 113–114

biological safety cabinet (BSC), 33, 61, 62, 64–65, 72, 81

biologics, 98

biomechanical engineering, 78, 86

Biosafety in Microbiological and Biomedical Laboratories (BMBL) document, 98

bleach, 124

blood components, 20, 98

Board of Pharmacy Specialties (BPS), 14, 43

     Certified Sterile Compounding Pharmacist (BCSCP) certification, 43

bubble point test, 97

buffer rooms

     active air sampling in, 135

     air changes per hour (ACPH) in, 59, 62, 67, 71, 75

     anterooms and, 68, 69, 70–71

     cleaning and disinfecting, 121, 125, 128

     cleanroom suites and, 72, 73

     containment segregated compounding areas and, 75

     dynamic conditions in, 89

     engineering controls for, 64–65, 66, 67, 68

     facility requirements for, 59, 60, 61

     garbing and, 31, 34

     mold in, 140

     monitoring, 83, 85

     negative pressure, 31, 62, 64–65, 67, 74, 75, 77, 83, 85, 140

     pass-through chambers and, 76

     positive pressure, 34, 62, 66, 72, 83, 85

     presterilization procedures and, 71

     refrigerators or freezers in, 77

     segregated compounding areas and, 74

bulk drug substances, 56, 94–95

C

calculations, 15, 41, 101

calibration, 21, 23, 52, 62, 79, 83, 87, 134

cameras, 65, 101

cardboard, 63

cefazolin syringes, 97

cellphones, 93

Centers for Disease Control and Prevention (CDC)

     Biosafety in Microbiological and Biomedical Laboratories (BMBL) document, 98

     hand hygiene defined by, 28

     Safe Injection Practices, 37

Certificate of Analysis (CoA), 52, 56, 94, 97

certification

     of engineering controls, 87–91

     environmental monitoring distinguished from, 131

     monitoring distinguished from, 84

     recertification, 89, 90

Certification Application Guides (CAGs), 87, 88, 91

certification reports, 63

Certified Compounded Sterile Preparation Technician™ (CSPT™), 14, 43

certifier, qualifications of, 87

Chapter <800>Answer Book, The, 3, 20, 27, 42, 59, 61, 65, 73, 129

chemo

     beyond-use dates (BUDs) for, 106

     gloves, 29–30

     gowns, 31

     rooms, 67, 69, 73, 74, 90, 106, 119

classified devices or rooms, 59–60

cleaning and disinfecting, 119–129

     cleaning solutions, 124–125

     compounding areas, 127–128

     core competencies in, 41

     general information, 119–123

     PECs and other compounding equipment, 125–127

     policies required and recommended in USP <797>, 24

     respiratory protection for, 33

     supplies needed for compounding, 129

     syringes, 129

cleanroom suites, 72–73, 74

     beyond-use dates (BUDs) and, 106

     engineering controls, 65, 66, 67

     pass-through chambers to, 75–77

clean side of anteroom, 70

clerkship students, 43

closed system drug-transfer devices, 41

Code of Federal Regulations (CFR), 94

colony-forming units (CFUs), 46, 48, 133, 134, 136, 139, 140

commissioning, 64, 90, 121, 132

community pharmacies, 10

competence, documenting, 15–16

Competence Assessment Tools for Health-System Pharmacies, 15

competencies

     of compounding personnel, 15, 41–44

     documentation of, 16, 42

     initial training and, 41–44

     retraining and, 53

compliance with USP <797>, 3, 9, 11

components

     of allergen extracts, 81

     aseptic technique and, 50

     beyond-use-dates (BUDs) and, 105, 106, 109–110, 112

     blood, 20, 98

     cleaning, 125–127, 129

     compounded sterile preparations, 55–57

     core competencies in moving, 41

     labeling, 117–118

     manufactured products as, 56

     media fill test and, 51

     nonsterile starting, 55–57

     in nonsterile-to-sterile compounding, 97–98

     of pass-through chambers, 75

     policies required and recommended in USP 797, 23

     of quality assurance program, 25, 141

     of required garb, 27, 34–35

     storage of, 61–62, 64

     water as, 56

Compounded Drug Products That Are Essentially Copies of Commercially Available Drug Products under Section 503A of the Federal Food, Drug, and Cosmetic Act, 11

compounded sterile preparations (CSPs)

     antibiotics, 38, 100, 110, 113

     facility requirements for, 59

     immediate-use (see immediate-use CSPs)

     initial training to mix, 41

     intrathecal or epidural, 94, 111

     labeling, 117–118

     presterilization areas for weighing powders, 71

     risk levels, 133

     segregated compounding areas for nonhazardous, 73–74

Compounded Sterile Preparations Pharmacist (BCSCP), 14

compounded stock bags, 115

compounding, 93–104

     administering medications distinguished from, 11

     algorithm for determining appropriateness of, 95–96

     allergenic extracts, 5, 7, 40, 80–81, 101

     areas (see Compounding areas)

     with blood components, 98

     cleaning supplies needed for, 129

     Compounded Drug Products That Are Essentially Copies of Commercially Available Drug Products, 11

     on drugs that should not be compounded, 94

     general information, 93–96

     immediate-use CSPs in ambient air, 79–80

     Insanitary Conditions at Compounding Facilities, 142

     List of Drug Products That Have Been Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, 94

     master formulation records (MFRs), 98–100, 103–104

     nonsterile-to-sterile, 97–98

     personnel (see compounding personnel)

     radiopharmaceuticals, 102

     records, 100–101, 104

     repackaging/prepackaging and, 3, 95

compounding areas

     allergenic extracts, 80–81

     cellphones in, 93

     cleaning and disinfecting, 127–128

     containment segregated, for hazardous CSPs, 74–75

     facilities design for, 59–63

     maximum number of personnel in, 93

     monitoring of, 21, 24

     order of donning garb for, 34

     other equipment in, 78–79

     policies required and recommended in USP <797>, 22, 24

     presterilization area for weighing powders, 71

     segregated, for nonhazardous CSPs, 73–74

     segregated radiopharmaceutical processing area, 81–82

     for storage, 63–64

     temperature and humidity requirements for, 24, 61–62

compounding aseptic containment isolators (CACIs), 28, 29, 33, 40, 61, 62, 64–65, 72, 88

compounding aseptic isolators (CAIs), 28, 29, 30, 47, 51, 62, 65, 71, 72, 88

compounding personnel

     responsibilities of, 15, 21

     students as, 93

     training of (see personnel training)

compounding records (CRs), 21, 100–101, 104

Compounding Sterile Preparations, 42

computer equipment

     cleaning, 126

     tablets, 79

contact lenses, 33

contact plates, 138

containers, sterile, 38, 97, 142

containment segregated compounding areas (C-SCAs), 31, 60, 74–75, 137

containment ventilated enclosure (CVE), 62, 71

contents of sections of USP <797>, 5–7

Controlled Environment Testing Association (CETA), 63, 64, 76, 84, 87, 91

conventionally manufactured products, 7, 21, 23, 55–56, 82, 97, 98, 115

cross-contamination, 20, 98, 142

D

daily nonviable monitoring, 83–86

deactivating, 119

decontaminating, 119

dehumidifiers, 85

depyrogenation, 6

dirty side of anteroom, 70

disinfecting. See Cleaning and disinfecting

dispensing, 21, 117–118

dispensing and packaging, 117–118

disposable garb, 28

DNV-GL Healthcare, 1

documentation

     certification reports, 63

     of competence, 15, 43

     policies required and recommended in USP 797, 20–21

     of training, 42, 44

doffing of PPE, 28

donning of PPE, 28, 34

doors

     in allergenic extracts compounding area, 81

     to buffer room, 68

     cleaning, 122

     in pass-through cleanroom, 75

     placement of, 67

     pressure and, 85

     refrigerator, 77, 78

     in segregated compounding areas, 73–74

     in segregated radiopharmaceutical processing area, 82

dropper bottles, 97

dry anterooms, 70

dwell time, 119, 120, 122, 124, 127

dynamic conditions, 89

E

earrings, 31

electrolyte bags, 115

enforcement of USP <797>, 11

engineering controls

     certification of, 87–91

     primary, 64–65

     secondary, 66–68, 131

environmental monitoring, 131–140

     active air sampling, 134–136

     general information, 131–134

     out-of-specification results, 139–140

     surface sampling, 136–139

Environmental Protection Agency (EPA), 119, 120, 121, 122, 124, 127, 129

epidural CSPs, 94, 111

equipment and supplies

     calibration of, 21, 23, 52, 62, 79, 83, 87, 134

     cleaning solutions, 124–125, 129

     computers, 79, 126

     incubators (see incubation)

     other, in compounding area, 78–79

     policies required and recommended in USP 797, 23

     printers, 68, 78

     refrigerator and freezer (see freezers; Refrigerators)

     storage of, 63–64

     warmers, 52, 79, 83, 110, 133

expiration date

     of active pharmaceutical ingredients, 112

     beyond-use date (BUDs) differentiated from, 105

     of chemicals marked USP or NF, 56

     in compounding record, 100, 104

     of manufactured solution, 113

     1-year expiry date, 56

Extended Stability for Parenteral Drugs, 42, 111

eyeglasses, 32

eye protection, 32–33, 119

eye wash, placement of plumbed, 66

F

face shields, 32, 33

facility design, 59–82

     allergenic extracts compounding area, 80–81

     anterooms, 68–71

     cleanroom suites, 72–73

     compounding immediate-use CSPs in ambient air, 79–80

     containment segregated compounding areas for hazardous CSPs, 74–75

     general facility design information, 59–63

     other compounding area equipment, 78–79

     pass-through chambers, 75–77

     presterilization area for weighing powders, 71

     refrigerator and freezer placement, 77–78

     segregated compounding areas for nonhazardous CSPs, 73–74

     segregated radiopharmaceutical processing area, 81–82

     storage areas, 63–64

503A pharmacies, 11, 55, 56, 94–95

503B outsourcing facilities, 55, 94–95, 115

Food and Drug Administration (FDA), 1

4 hour allowance, 11, 39

freezers

     beyond-use dates (BUDs) and, 106, 109–110

     placement of, 77–78

     temperatures in, 83, 102, 105, 108

fungal contamination, 52, 85, 131, 133, 135

G

garbing, 27–35

     for cleaning, 119

     core competencies in, 41

     eye protection, 32–33

     general information, 27–28

     gloves, 27, 29–30

     gowns, 27, 30–31

     hair/head covers, 31

     masks, 32, 33, 34

     policies required and recommended in USP 797, 22–23

     procedures, 34–35

     respiratory protection, 33

     shoe covers, 32

     sleeves, 32

     training in, 45–46

General Chapters, 1

General Notices, 1

general principles of USP <797>, 3–4

Glossary, USP <797>, 7

gloved fingertip and thumb test, 46–50

     clerkship students and, 43

     competency and, 40

     environmental services personnel and, 123

     immediate-use CSPs and, 40, 93

     for personnel who mix only immediate-use CSPs, 53

     requalification, 53

     training, 16, 43, 93

gloves, 27, 29–30

goggles, 22, 28, 32, 33, 119

gowns, 27, 30–31

Guidelines for Safe Preparation of Compounded Sterile Preparations (ISMP), 65, 114

Guidelines on Compounding Sterile Preparations and Guidelines on Handling Hazardous Drugs, ASHP, 95

Guidelines on Handling Hazardous Drugs, ASHP, 95

Guide to Parenteral Admixtures, King’s, 111

H

hair/head covers, 27, 31

Handbook of Injectable Drugs, ASHP, 105

hand hygiene, 28–29

     competency in, 41, 45

     documenting, 45

     Hand Hygiene in Healthcare Settings (CDC), 44

     meaning of, 28

     policies required and recommended in USP <797>, 20

     training in, 44–45

hazardous drugs (HDs), 3, 5, 9, 10

     chemo gloves for handling, 29–30

     cleaning supplies for, 129

     containment segregated compounding areas for, 74–75

     decontamination for, 119

     garb for, 27

     hazard communication plan for, 16–17

     minimum facility requirements for, 59

Hazardous Drugs—Handling in Healthcare Settings: ASHP’s Guide to USP Chapter <800>, 42

high efficiency particulate air (HEPA) filters

     active air sampling and, 135

     air changes per hour (ACPH) and, 62

     certifier and, 84, 87, 88

     cleaning agents applied to, 125

     in cleanroom suites, 72, 73, 74, 75

     out-of-specification results and, 140

     in pass-through chambers, 75–76

     secondary engineering controls and, 66

     surface sampling and, 137

highly pathogenic organisms, 132

high-risk preparations

     bacterial and fungal contamination of, 132, 135

     beyond-use dates (BUDs) for, 108, 109–110, 112

high-touch areas, 127

hoods

     allergenic extracts compounding area and, 81

     beyond-use dates (BUDs) and, 114

     certification of, 88–91

     cleaning, 125, 126–127, 128

     computer tablet in, 79

     engineering controls and, 64, 65, 67

     facility requirements for, 59, 60, 61

     in nuclear medicine department, 82

     out-of-specification results and, 140

     perimeter around, 74

     testing before using, 132

human resources, 13–17

     compounding personnel, responsibilities of, 15

     designated person, 13–14

     documenting competence, 15–16

     hazard communication plan, 16–17

humidifiers, 62, 85

humidity requirements and monitoring

     dehumidifiers, 85

     documenting, 83

     gauges, 63

     humidifiers for, 62, 85

     for IV room, 66, 68

     policies required and recommended in USP <797>, 24

     for sterile compounding area, 61–62, 85

I

immediate-use CSPs, 37–41

     approved labeling, 37–38

     beyond-use dates (BUDs) and, 113

     compounding, in ambient air, 79–80

     conditions that must be met to be considered as, 37

     defined, 37

     4-hour allowance and, 39

     mixing, 38, 93

     time limit for using, 11, 39

incubation, 133–134

     length of, 135

     media fill test and, 51, 52

     methods of, 46, 133

     by microbiology laboratory, 133

     by outside laboratory, 133

     in pharmacy, 133, 134

     in sterile compounding area, 79

     temperature, 23, 52, 53, 83, 132, 133, 135, 137

Infection Control Committee meeting, 141–142

infusion time, 11

     beyond-use date (BUDs) differentiated from, 105

     organizational policy on, 108

initial personnel training, 21–22, 41–44

insanitary conditions, 142

Insanitary Conditions at Compounding Facilities (FDA), 142

Institute for Safe Medication Practices (ISMP), 65, 114

International Journal of Pharmaceutical Compounding, 99

International Organization for Standardization (ISO) standards

     for active air sampling, 135–136

     for air changes per hour (ACPH), 62

     for ambient air, 79, 80

     for anterooms, 68, 69, 70, 139

     for beyond-use-dates (BUDs), 113, 114, 115

     for cleanrooms, 59–60, 72, 74

     for containment segregated compounding areas, 75

     for HEPA-filtered pass-throughs, 76

     for hoods, 64

     for incubation, 134

     for nuclear medicine departments, 82

     for presterilization procedures, 71

     for segregated compounding areas, 74

     for surface sampling, 136, 137, 138, 139

intrathecal CSPs, 94, 111

intravenous immunoglobulin (IVIG), 98

in-use time, beyond-use date (BUDs) differentiated from, 105, 114

irrigation, 9

     bottles, 114

     sterile water for, 56, 125

IV bags

     beyond-use dates (BUDs) of, 113

     cleaning, 129

IV hoods, 39, 88

IV rooms

     ceiling HEPA filters in, 89

     cleaning and disinfecting, 120, 121

     facility design, 66

     for office-related space, 60

     pass-through chambers and, 76

     temperature of storage areas outside, 84

IV software systems, 90

IV solutions, immediate-use, 38–39

J

The Joint Commission, 1

L

labeling, 23–24, 37–38, 117–118

Lactated Ringers, 40

laminar airflow workbenches (LAFWs), 62, 72

lidocaine syringes, 40

line of demarcation, 68, 70

long-term care (LTC) facilities, 10

lot numbers, 53, 100, 101, 104, 117, 129

low-linting disposable towels/wipers, 29, 125

low-linting gowns, 30

M

mail-order pharmacies, 10

malt extract agar, 135

mannitol warmer, 52, 133

marking, 56

     American Chemical Society, 56

     in anteroom, 68

     beyond-use dates (BUDs), 112

     nonsterile-to-sterile compounding, 97

     in surface sampling, 138

     USP or NF, 56

masks, 32, 33, 34

master formulation records (MFRs), 14, 21, 23, 98–100, 117

material safety data sheets (MSDSs), 17

measuring and mixing, 15, 41

media fill test, 51–53

     aseptic technique and, 50

     clerkship students and, 43

     competency and, 41

     gloved fingertip and thumb test and, 47, 49

     immediate-use CSPs and, 40

     for personnel who mix only immediate-use CSPs, 53

     training, 15, 43, 51–53, 93

medications, administration of. See Administration of medications

meningitis scare of 2012, 1

microbial contamination, 1, 31, 61, 83, 131, 132, 134, 136

microbiology departments/laboratories, 52, 133–134

MINI-BAG Plus, 95

mold, 139–140

monitoring

     nonviable, 24, 83–86

     viable, 24, 83, 131

monographs. See USP monographs

monthly cleaning, 122

mops, reusable, 120

music, 93

must in USP <797>, 3

N

N95 respirators, 33

National Formulary (NF) marking, 56

National Institute for Occupational Safety and Health (NIOSH), 11, 17, 30, 33, 37, 61, 64–65, 67, 74, 77, 129

needles, cleaning of, 129

negative pressure buffer rooms, 31, 62, 64–65, 67, 74, 75, 77, 83, 85, 140

neonatal total parenteral nutrition (TPN), 114, 115

nonhazardous CSPs

     cleaning supplies for, 129

     segregated compounding areas for, 73–74

nonsterile preparations, 1, 10, 11, 91, 102

nonsterile starting components, 55–57

nonsterile-to-sterile compounding, 97–98

nonviable monitoring, 24, 83–86

nuclear medicine departments, 49, 53, 78, 82, 102

nuclear medicine technologists, 49, 53

Nuclear Regulatory Commission (NRC), 102

nursing homes, 10

O

Occupational Safety and Health Administration (OSHA), 16–17

one off compounding, 101

one-step disinfectant cleaner, EPA-registered, 120, 121, 122, 124, 127, 129

ongoing personnel training, 21, 22

operating room (OR)

     beyond-use dates (BUDs) and prepping for, 113

     OR greens for, 28

out-of-specification results, 139–140

outsourcing facilities

     bulk list for, 94–95

     premixed solutions from, 95

     stock bags from, 115

P

packaging, 7, 21, 117–118

paddles for surface sampling, 138

paper towels, 29

pass-through chambers, 75–77

     air sampling in, 135

     cleaning of, 128

personal hygiene, 5, 28–29, 41

personal protective equipment (PPE), 27, 28, 33

     See also Garbing

personnel training, 41–54

     aseptic technique, 50

     for compounding personnel, 16, 21–22, 41–44

     for designated person, 14, 22

     documented, 42

     evaluation, 5

     garbing, 45–46

     gloved fingertip and thumb test, 46–50

     hand hygiene, 44–45

     initial, 21–22, 41–44

     media fill test, 51–53

     ongoing, 21, 22

     policies required and recommended in USP 797, 21–22

     requalification, 53–54

pharmaceutical manufacturers

     compliance of, 10

     expiration dates, 56

     lot numbers, 100

     premixed solutions from, 95

     vial tops from, 94

pharmacy bulk package (PBP), 114

Pharmacy Competency Assessment Center, ASHP, 15

Pharmacy Compounding Accreditation Boards, 1

Pharmacy Technician Certification Board (PTCB), 14, 43

physician offices, 10, 13

plastic curtains/drapes, 60

platelet, 98

policies and procedures, 19–25

     compounding, 23

     documentation, 20–21

     garbing, 22–23

     general, 20

     personnel training, 21–22

positive pressure buffer rooms, 34, 62, 66, 72, 83, 85

powder hoods, 91

powders

     garb for compounding, 27, 35

     presterilization area for weighing, 71

powered air purifying respirators (PAPRs), 33

power loss, 127

premixed solutions, 95

prepackaging, 9, 11, 95

preparation for administration, 37–41

pressure requirements and monitoring

     in anterooms, 66, 67, 72, 83, 85

     in negative pressure buffer rooms, 31, 62, 64–65, 67, 74, 75, 77, 83, 85, 140

     in positive pressure buffer rooms, 34, 62, 66, 72, 76, 83, 85

presterilization area for weighing powders, 71

primary engineering controls (PEC), 64–65

     certification, 131

     cleaning and disinfecting, 121, 125–127

     surface sampling, 136–138

printers, 68, 78

probability of a nonsterile unit (PNSU), 97

proprietary bag systems, 95

Q

quality assurance and quality control, 7, 25, 141–142

R

radiopharmaceuticals, 1, 5, 143

     addressed in <797>, 4

     compounding, 102

     immediate use of, 49, 53

     segregated processing area for, 81–82

     UltraTag™, 98

recertification, 89, 90

reconstitution, 38, 95, 110, 113

red cells, 98

refrigerator and freezer placement, 77–78

refrigerators

     beyond-use dates (BUDs) and, 106, 108–110, 114, 115, 140

     cleaning of, 128

     low wall return for, 78

     pass-through, 77, 78

     placement of, 77–78

     in sterile compounding area, 68

     surface sampling and, 136

     temperatures in, 79, 105, 108

release inspections and testing, 6, 21, 24

religious head coverings, 31

repackaging, 3, 5, 11, 82, 95

repeater pumps, 78, 83, 86, 89, 126, 136

requalification, 45, 46, 47–49, 52, 53–54

respirators, 22, 33

restricted access barrier system (RABS), 23, 72

reusable garb, 28

reusable mops, 120

revisions to USP <797>, in 2008 and 2023, 3

risk levels, 133

robots, 65

RODACTM, 138

S

Safe Injection Practices (CDC), 37

safety data sheets (SDSs), 17

sampling plan, 132

sanitizing. See Cleaning and disinfecting

scales, 65

scope of USP <797>, 9–11

secondary engineering controls (SEC), 66–68, 131

segregated compounding areas (SCA)

     air changes per hour (ACPH) in, 63

     allergen extracts preparation in, 80

     anterooms for, 69, 70–71

     beyond-use dates (BUDs) and, 106

     cardboard in, 63

     cleaning and disinfecting of, 121

     facility design and, 60, 61

     garb in, 28, 30, 34

     gloved fingertip and thumb test done in, 47, 48

     for nonhazardous CSPs, 73–74

     restrictions, 44

     as secondary engineering control, 66, 67

     surface sampling and, 137

segregated compounding areas for nonhazardous CSPs, 73–74

segregated radiopharmaceutical processing area (SRPA), 81–82

settling plates, 135

shelving, 63, 67, 68, 70, 122

shipping boxes, 63

shoe covers, 28

should in USP <797>, 3

single-dose ampules, 113

single-dose vials, 113

sinks

     in allergenic extracts compounding area, 81

     in anteroom, 68, 70, 139

     cleaning and disinfecting, 121, 122

     in cleanroom suite, 73

     in containment segregated compounding areas, 75

     facility design and, 61, 66

     garbing and, 27, 34–35, 61

     in segregated compounding areas, 74

     in segregated radiopharmaceutical processing area, 82

sleeve covers, 32

Small Entity Compliance Guide for Employers That Use Hazardous Chemicals, 17

sodium bicarbonate IV, 11, 38–39

soybean-casein digest media, 51, 52

spills, 15, 33, 126

sporicidal agents

     reason for using, 119

     rotating, 120

sporicidals

     bleach as, 124

     for cleaning hoods after power outage, 127

     for mold, 139, 140

     reason for using, 119

     rotating, 120

sprinkler heads, 67

stability, 11, 24, 99, 105–107, 110, 111, 112, 114

standard operating procedures (SOPs), 7, 19–25

sterile containers, 38–39

sterile products and preparation. See USP <797> Pharmaceutical Compounding—Sterile Preparations

sterile products and supplies, 55–57

     general information, 55

     use of nonsterile starting components, 55–57

Sterile Products Preparation Certificate Program, ASHP, 14

sterility tests, 6, 97, 106, 107, 109–110

sterilization and depyrogenation, 6

storage areas

     air changes per hour (ACPH), 64

     in anterooms, 70

     facility design and, 63–64

     for garb, 61

     policies required and recommended in USP <797>, 22, 23

     segregated compounding areas used as, 68

     temperature in, 83

supplies. See Equipment and supplies

surface sampling, 136–139

surfaces and finishes, 63, 66, 69, 71

syringes

     cefazolin, 97

     cleaning, 129

     containers, 95

     immediate-use provisions, 40

     reconstituted and frozen, 110

T

tape, for separating anteroom, 71

technician certification, 43

temperature requirements and monitoring

     beyond-use-dates (BUDs) and, 108

     gauges for, 63, 67

     for incubation/incubators, 23, 52, 53, 83, 132, 133, 135, 137

     monitoring, 83, 84

     policies required and recommended in USP <797>, 23, 24

     secondary engineering controls, 66, 68

     for shipped products, 118

     for sterile compounding area, 61–62

terminal cleaning, 125

terminal sterilization, 23, 97

TNTC (too numerous to count), 134

total parenteral nutrition (TPN), 114

touchscreen monitors, 65

training. See Personnel training

trypticase soy agar (TSA), 46, 135, 137

U

UltraTag™, 98

United States Pharmacopeial Convention, 1

United States Pharmacopeia–National Formulary (USP–NF), 56, 94, 107

United States Pharmacopeia (USP) marking, 56

USP <71> Sterility Tests, 52

USP <659> Packaging and Storage Requirements, 84, 108

USP <795> Pharmaceutical Compounding—Nonsterile Preparations, 1, 9, 10, 11, 91

USP <797> Pharmaceutical Compounding—Sterile Preparations, 1

     administration, immediate use and preparation for, 37–41

     allergens, 4

     as an official standard, 1

     applied animals, 9

     availability of, 1

     beyond-use dates (BUDs), 105–115

     certification of engineering controls, 87–91

     cleaning and disinfecting, 119–129

     compliance with, 3, 9, 11

     compounding, 93–104

     contents of sections of, 5–7

     daily nonviable monitoring, 83–86

     dispensing and packaging, 117–118

     enforcement of, 11

     environmental monitoring, 131–140

     examples of preparations that must comply, 9

     facility design, engineering controls, and equipment, 59–82

     full text of, where to find, 1

     garb and hand hygiene, 27–35

     general information, 55

     general principles of, 3–4

     as a guideline versus a requirement, 1

     hazardous drugs addressed in, 3, 5, 9, 10

     human resources, 13–17

     mixed by nurses for immediate use, 38

     must and should in, distinction between, 3

     need for, meningitis scare of 2012 and, 1

     nonsterile-to-sterile compounding of, 97–98

     personnel training and competence documentation, 41–54

     policies and procedures, 19–25

     quality assurance and quality control, 141–142

     receiving areas for, 61

     revisions to, in 2008 and 2023, 3

     scope of, 9–11

     as a standard, 1, 2, 9

     sterile products and supplies, 55–57

     where to start with information from, 143–144

     See also Compounded sterile preparations (CSPs)

USP <800> Hazardous Drugs—Handling in Healthcare Settings, 1, 3, 42

USP <825> Radiopharmaceutical—Preparation, Compounding, Dispensing, and Repackaging, 1, 4, 10, 49, 53, 82, 98, 102, 143

USP <1113> Microbial Characterization, Identification, and Strain Typing, 134

USP <1163> Quality Assurance in Pharmaceutical Compounding, 141

USP <1168> Compounding for Phase 1 Investigational Studies, 10

USP <1178> Good Repackaging Practices, 95

USP Compounding Compendium, 1, 99, 107

USP monographs, 1

     active pharmaceutical ingredient and, 56

     beyond-use dates (BUDs) and, 105, 107, 110–111

     drugs that should not be compounded and, 94

     in master formulation record (MFRs), 103

     where to find, 94, 99, 107

V

vaccines, 98

veterinary clinics, 13

viable monitoring, 24, 83, 131

vial/bag systems, 112

VIAL-MATE, 95, 112

vials

     beyond-use dates (BUDs) of, 114

     cleaning of, 129

     tops of, 94, 114

vials and other dosage forms, 113–114

vial tops, 94, 114

W

warmers, 52, 79, 83, 110, 133

washable gowns, 30

water as component, 56

weekly cleaning, 122

weighing rooms, 71

wet anterooms, 70

white cells, 98

windows in pass-through chambers, 76

wipers, 29, 125, 127