Index

A

accreditation organizations, 1

action levels, 6

for air sampling, 127–128

gloved fingertip and thumb test and, 44

in sampling plan, 124

for surface sampling, 129, 130–131

action plan, 135–136

active air sampling, 121, 123, 124, 126–128

active pharmaceutical ingredients (APIs)

beyond-use dates (BUDs) of, 106

compounding, 89

eye and respiratory risk when working with, 23

use of, 52–53

addEASE^®, 89, 106

ADD-Vantage™, 89, 106

administration of medications

compounding distinguished from, 10–12

policies concerning, 33

preparation for, 33–34

air changes per hour (ACPH)

for air handing system, 69

calculating, 64

for chemo room, 63

for cleanroom suite, 69

for containment segregated compounding area, 71

facility requirements for, 55, 58–59

for IV room, 62

for segregated compounding area, 59

for storage room, 60

air flow

dwell time and, 114

dynamic air flow testing of PEC, 80

environmental monitoring and, 123

in pass-through chambers, 68, 73, 74

training and, 37

air handling system, 58, 62, 81, 131

albumin, 91–92

alcohol as disinfectant/sanitizing agent, 114, 120

alcohol-based hand gel, 24

alert level, 124

algorithm, 89–90

allergenic extracts, 6

compounding area, 76–77

compounding process, 95

immediate use and, 36

allergenic extracts compounding area (AECA), 76–77

allergens, 4

amber dropper bottles, 91

American Chemical Society (ACS) marking, 53

anesthesia personnel, 36

animals, application of USP <797> to, 9

anterooms, 21, 64–67

active air sampling in, 127

air changes per hour (ACPH) in, 58

cleaning, 64, 121

in cleanroom suite, 62, 68–69, 70, 71

dirty side distinguished between clean side, 64

facility requirements for, 55, 56

garb and, 24, 26–27, 30

gloved fingertip and thumb test in, 43, 44

line of demarcation in, 64, 66

mold in, 131

office space in, cleaning, 121

pass-through chambers to, 72

pressure in, 62, 63, 68, 79, 81

antibiotics

beyond-use-dates, 104

master formulation record for, 93

saline bag used for reconstituting, 107

syringes, reconstituted and frozen, 104

vials, reconstitution of, 34

appendices, USP <797>, 7

Aseptic Compounding Technique: Learning and Mastering the Ritual, 39

aseptic technique, 5, 6, 46

beyond-use dates (BUDs) and, 99, 101

competency in, 15, 37

immediate use preparations and, 11

insanitary conditions and, 134

training in, 46

ASHP Guidelines on Compounding Sterile Preparations and Guidelines on Handling Hazardous Drugs, 89

ASTM F739-12e1 (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact), 26

ASTM Standard D6978, the Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, 25–26

autoclaves, 37, 91, 99

autologous serum, 91

automated compounding device (ACD)

cleaning, 120

sampling, 128

testing, 82

availability of USP <797>, 1–2

B

bacterial contamination, 81, 123, 125, 127

Banana Bag, 35

Basics of Aseptic Compounding Technique Videos and Training, 39

beyond-use dates (BUDs), 5, 7, 22, 99–109

4-hour allowance and, 35

for active pharmaceutical ingredients and other components, 106

anteroom and, 66–67

biologics, 91–92

of chemos, 100

for compounded stock bags, 108–109

compounding aseptic isolators and, 61

designated person for monitoring, 14

expiration date differentiated from, 99

general information on, 99–105

for high-risk preparations, 102, 103, 105

immediate use and, 33

infusion time differentiated from, 99

in-use time differentiated from, 99

for low-risk preparations, 100, 102, 103, 105

in master formulation record (MFRs), 97, 98

maximum, 100, 102–103

for medium-risk preparations, 100, 103, 105

reconstituting systems and, 89

sterility testing and, 91

for vial/bag systems, 106

for vials and other dosage forms, 106–108

biological safety cabinet (BSC), 5, 21, 29, 57, 58, 60, 77

biologics, 91–92

biomechanical engineering, 74, 82

Biosafety in Microbiological and Biomedical Laboratories (BMBL) document, 91

bleach, 117–118

blood components, 91

Board of Pharmacy Specialties (BPS), 14, 39

Certified Sterile Compounding Pharmacist (BCSCP) certification, 39

bubble point test, 91

buffer rooms

active air sampling in, 127

air changes per hour (ACPH) in, 55, 58, 71

anterooms and, 64, 65, 66–67

cleaning and disinfecting, 115, 118, 121

cleanroom suites and, 68, 69

containment segregated compounding areas and, 71

dynamic conditions in, 84

engineering controls for, 60–61, 62, 63, 64

facility requirements for, 55, 56, 57

garbing and, 26–27, 30

mold in, 132

monitoring, 79, 81

negative pressure, 26–27, 58, 60–61, 63, 70, 71, 73, 79, 81, 132

pass-through chambers and, 72

policies required and recommended in USP <797>, 21

positive pressure, 30, 58, 62, 68, 79, 81

presterilization procedures and, 67

refrigerators or freezers in, 73

segregated compounding areas and, 70

bulk drug substances, 52, 88

C

calculations, 15, 37, 94

calibration, 48, 58, 75, 79, 83, 125

cameras, 61

cardboard, 59

cefazolin syringes, 91

cellphones, 87

Centers for Disease Control and Prevention (CDC)

Biosafety in Microbiological and Biomedical Laboratories (BMBL) document, 91

hand hygiene defined by, 24

Safe Injection Practices, 33

Certificate of Analysis (CoA), 48, 53, 88, 90

certification and recertification, 80, 83–86, 123

Certification Application Guides (CAGs), 80, 83, 86

certification reports, 59

Certified Compounded Sterile Preparation Technician™ (CSPT™), 14, 40

Chapter <800> Answer Book, The, 3, 20, 23, 39, 55, 57, 61, 69, 122

chemo

beyond-use dates (BUDs) for, 100

gloves, 25–26

gowns, 26–27

rooms, 63, 65, 69, 70, 85, 113

classified devices or rooms, 55–56

cleaning and disinfecting, 6, 113–122

cleaning solutions for, 117–118

compounding areas, 120–122

core competencies in, 37

general information, 113–117

PECs and other compounding equipment, 118–120

policies required and recommended in USP <797>, 22

respiratory protection for, 29

supplies needed for compounding, 122

cleanroom suites, 67–69, 70

beyond-use dates (BUDs) and, 100

engineering controls, 61–64, 67–69, 70

pass-through chambers to, 71–73

clean side of anteroom, 64

clerkship students, 40

closed system drug-transfer devices, 37

Code of Federal Regulations (CFR), 88

colony-forming units (CFUs), 43, 44–45, 124, 126, 131, 132

commissioning, 124

community pharmacies, 10

competence, documenting, 15–16

Competence Assessment Tools for Health-System Pharmacies, 15

competencies

of compounding personnel, 15, 37–40

documentation of, 16, 38

hand hygiene, 117

initial training and, 37–40

retraining and, 49

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

components

of allergen extracts, 77

aseptic technique and, 46

beyond-use-dates (BUDs) and, 99, 100, 103, 104, 106

blood, 91

cleaning, 119, 120, 122

compounded sterile preparations, 51–52

core competencies in moving, 37

of immediate-use preparations, 33, 35

labeling, 111–112

manufactured products as, 51

media fill test and, 47

nonsterile starting, 52–53

in nonsterile-to-sterile compounding, 90–92

of pass-through chambers, 71

policies required and recommended in USP <797>, 20, 21

of quality assurance program, 133

of required garb, 23, 24, 29–30

storage of, 57–58, 60

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, 34, 93, 104, 107

facility requirements for, 55

immediate-use (see immediate-use CSPs)

initial training to mix, 37

intrathecal or epidural, 88, 105

labeling, 111–112

for long-term care facilities, 10

maintaining sterility, purity, and stability of, 7

presterilization areas for weighing powders, 67

risk levels, 5, 6, 49, 51–52, 100, 102, 127

segregated compounding areas for nonhazardous, 69–70

Compounded Sterile Preparations Pharmacist (BCSCP), 14

compounded stock bags, 109–110

compounding

activities not considered as, 10

administering medications distinguished from, 11–12

algorithm for determining appropriateness of, 89–90

allergenic extracts, 6, 36, 76–77, 95

with blood components, 91

cleaning supplies needed for, 122

compounding records, 94–95, 98

general information, 87–90

of immediate-use CSPs in ambient air, 75–76

master formulation records (MFRs), 14, 21, 92–93, 97

nonsterile-to-sterile, 90–92

personnel (see compounding personnel)

policies required and recommended in USP <797>, 21

radiopharmaceuticals, 95–96

compounding areas

allergenic extracts, 76–77

cellphones in, 87

cleaning of, 120–122

designation of, 21

facilities design for, 55–59

maximum number of personnel in, 87

monitoring of, 20

order of donning garb for, 30

other equipment in, 74–75

policies required and recommended in USP <797>, 20–21

segregated radiopharmaceutical processing areas, 77–78

temperature and humidity requirements for, 57–58

compounding aseptic containment isolators (CACIs), 58

compounding aseptic isolators (CAIs), 24, 25, 43, 47, 58, 61, 67, 68

compounding personnel

responsibilities of, 15, 21

students as, 87

training of, 15–16, 20, 37–41

compounding records (CRs), 94–95, 98

Compounding Sterile Preparations, 39

Compounding Sterile Preparations: ASHP’s Video Guide to Chapter <797>, 39

computer equipment

cleaning, 120

tablets, 75

contact lenses, 28

contact plates, 130

containers, sterile, 91

containment segregated compounding areas (C-SCAs), 56, 70–71, 129

containment ventilated enclosure (CVE), 67

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

Controlled Environment Testing Association (CETA), 21, 59, 60, 72, 80, 83, 86

conventionally manufactured products, 51–52, 78, 80, 92, 108

CriticalPoint, LLC, 14, 38

cross-contamination, 91, 134

D

daily nonviable monitoring, 79–82

deactivating, 113

decontaminating, 113

dehumidifiers, 81

depyrogenation. see sterilization and depyrogenation

designated person, 13–14, 20

dirty side of anteroom, 64

disinfecting. see cleaning and disinfecting

dispensing, 10, 111–112

disposable garb, 24

DNV-GL Healthcare, 1

documentation

certification reports, 59

of competence, 16, 38

of training, 38, 40

doffing of PPE, 24

donning of PPE, 24, 30

doors

in allergenic extracts compounding area, 77

cleaning, 116

in pass-through cleanroom, 71

placement of, 63

pressure and, 81

refrigerator, 73, 74

in segregated compounding areas, 69–70

in segregated radiopharmaceutical processing area, 78

dropper bottles, 91

dry anterooms, 66

dwell time, 113, 114, 116, 117, 120

dynamic conditions, 84

E

earrings, 27

electrolyte bags, 108–109

engineering controls, 60–64

primary, 60–61

secondary, 62–64

environmental monitoring, 123–130

active air sampling, 126–128

general information, 123–126

out-of-specification results, 131–132

surface sampling, 128–130

Environmental Protection Agency (EPA), 113–117, 120, 122

epidural CSPs, 88, 105

equipment and supplies

calibration of, 48, 58, 75, 79, 83, 125

cleaning, 118–120

computers, 75, 120

core competencies in using, 37

incubators (see incubation)

other compounding area, 74–75

printers, 64, 74

records of, 21

refrigerator and freezer (see freezers; refrigerators)

storage of, 59–60

warmers, 48, 75, 79, 104, 125

expiration date

1-year expiry date, 53

of active pharmaceutical ingredients, 106

beyond-use date (BUDs) differentiated from, 99

of chemicals marked USP or NF, 53

in compounding record, 94, 98

of a manufactured solution, 107

Extended Stability for Parenteral Drugs, 39, 105

eyeglasses, 28

eye protection, 28–29, 113

eyewash stations, 21, 63

F

face shields, 28

facility design

allergenic extracts in compounding area, 76–77

anterooms, 64–67

cleanroom suites, 68–69

compounding immediate-use CSPs in ambient air, 75–76

containment segregated compounding areas for hazardous CSPs, 70–71

general information on, 55–59

other compounding equipment, 74–75

pass-through chambers, 71–73

presterilization area for weighing powders, 67

refrigerator and freezer placement, 73–74

segregated compounding areas for nonhazardous CSPs, 69–70

segregated radiopharmaceutical processing area, 77–78

storage areas, 59–60

filtration, 67, 91, 99, 101

Food and Drug Administration (FDA), 1

503A pharmacies, 11, 51, 52, 88

503B outsourcing facilities, 51, 88, 89, 109

approved labeling, 33–34

beyond-use dates (BUDs) and, 106

on bulk drug substances, 52, 88

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

on drugs that should not be compounded, 88

Insanitary Conditions at Compounding Facilities, 134

List of Drug Products That Have Been Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, 88

repackaging and, documents on, 3, 89

four hour beyond-use date, 35

freezers

beyond-use dates (BUDs) and, 100, 103–104

placement of, 73–74

temperatures in, 21, 79, 99, 102

fungal contamination, 47, 81, 123, 125, 127

G

garbing, 23–31

for cleaning, 113

core competencies in, 37

eye protection, 28–29, 113

general information on, 23–24

gloves, 20, 25–26

gowns, 20, 26–27

hair/head covers, 20, 27, 30

masks, 20, 27–28, 29

policies required and recommended in USP <797>, 20

procedures, 29–31

shoe covers, 20, 28

storage, 57

training in, 42

General Chapters, 1

General Notices, 1

general principles of USP <797>, 3–4

Getting Started in Aseptic Compounding, 39

Glossary, USP <797>, 7

gloved fingertip and thumb test

clerkship students and, 40

competency and, 37

environmental services personnel and, 116–117

immediate-use CSPs and, 36

for personnel who mix only immediate-use CSPs, 48

requalification, 49

training, 15–16, 40, 87

gloves, 20, 25–26

goggles, 24, 28, 113

gowns, 20, 26–27

Guidelines for Safe Preparation of Compounded Sterile Preparations (ISMP), 61

Guide to Parenteral Admixtures, 105

H

hair/head covers, 20, 27, 30

Handbook of Injectable Drugs, 105

hand hygiene, 24–25

competency in, 37, 41

documenting, 41

Hand Hygiene in Healthcare Settings (CDC), 41

meaning of, 24

policies required and recommended in USP <797>, 20

hazard communication plan, 16–17

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

chemo gloves for handling, 25–26

cleaning supplies for, 122

containment segregated compounding areas for, 70–71

decontamination for, 113

garb for, 23

hazard communication plan for, 16–17

minimum facility requirements for, 55

Hazardous Drugs—Handling in Healthcare Settings: ASHP’s Guide to USP Chapter <800>, 39

high efficiency particulate air (HEPA) filters

active air sampling and, 127

air changes per hour (ACPH) and, 58

certifier and, 80, 83, 84

cleaning agents applied to, 118

in cleanroom suites, 68, 69, 70, 71

out-of-specification results and, 132

in pass-through chambers, 71–72

secondary engineering controls and, 62

surface sampling and, 129

highly pathogenic organisms, 124

high-risk preparations

bacterial and fungal contamination of, 125, 127

beyond-use dates (BUDs) for, 102, 103, 105

mixing, 15–16, 43, 46, 49

overview of, 52

high-touch areas, 121

hoods

allergenic extracts compounding area and, 77

beyond-use dates (BUDs) and, 108

certification of, 84–86

cleaning, 118–119, 120, 121

computer tablet in, 75

engineering controls and, 60, 61, 63

facility requirements for, 55, 56, 57

in nuclear medicine department, 78

out-of-specification results and, 132

perimeter around, 70

testing before using, 124

hospital pharmacies, 10

human resources, 13–17

compounding personnel, responsibilities of, 15

designated person, 13–14

documenting competence, 15–16

hazard communication plan, 16–17

humidifiers, 58, 81

humidity requirements and monitoring

dehumidifiers, 81

documenting, 79

gauges, 59

humidifiers for, 58, 81

for IV room, 62, 64

for sterile compounding area, 57–58, 81

I

immediate use, defined, 33

immediate-use CSPs, 33–36

4-hour allowance and, 35

compounding, in ambient air, 75–76

mixing, 34, 87

time limit for using, 11, 35

incubation, 125–126

length of, 127

media fill test and, 47, 48

methods of, 43, 125

by microbiology laboratory, 125

by outside laboratory, 125

in pharmacy, 125, 126

in sterile compounding area, 75

temperature, 42, 79, 124, 125, 127, 129

Infection Control Committee meeting, 133–134

infusion time, 99, 102

beyond-use date (BUDs) differentiated from, 99

organizational policy on, 102

initial training, 37–41

insanitary conditions, 134

Insanitary Conditions at Compounding Facilities (FDA), 134

Institute for Safe Medication Practices (ISMP), 61

International Journal of Pharmaceutical Compounding, 93

International Organization for Standardization (ISO) standards

for active air sampling, 127–128

for air changes per hour (ACPH), 58

ambient air and, 75, 76

for anterooms, 64, 65, 66–67, 131

beyond-use-dates (BUDs) and, 107, 108, 109

for cleanrooms, 55–56, 68

for containment segregated compounding areas, 71

for HEPA-filtered pass-throughs, 72

for hoods, 60

for incubation, 125

for nuclear medicine departments, 78

for presterilization procedures, 67

for segregated compounding areas, 70

for surface sampling, 128, 129, 130, 131

intrathecal CSPs, 88, 105

intravenous immunoglobulin (IVIG), 91–92

in-use time, beyond-use date (BUDs) differentiated from, 99

investigational agents, 10

irrigation, 9

bottles, 107

sterile water for, 53, 118

IV bags

beyond-use dates (BUDs) of, 107

cleaning, 121

IV hoods, 35

IV rooms

ceiling HEPA filters in, 84

cleaning and disinfecting, 115, 116

for office-related space, 56

pass-through chambers and, 72

temperature of storage areas outside, 80

IV software systems, 85

IV solutions, immediate-use, 35

J

The Joint Commission, 1

L

labeling, 22, 33–34, 111–112

Lactated Ringers, 36

laminar airflow workbenches (LAFWs), 58, 68

lidocaine preparations, 36

line of demarcation in anterooms, 64, 66

long-term care (LTC) facilities, 10

lot numbers, 48, 94, 95, 111, 122

low-linting disposable towels/wipers, 25, 118

low-linting gowns, 26

low-risk preparations

bacterial and fungal contamination and, 125

beyond-use dates (BUDs) for, 100, 102, 103, 105

overview of, 51, 52

M

mail-order pharmacies, 10

malt extract agar, 127

mannitol warmer, 48, 125

marking

American Chemical Society, 53

in anteroom, 64

beyond-use dates (BUDs), 106

in nonsterile-to-sterile compounding, 90

in surface sampling, 130

USP or NF, 52, 53

masks, 20, 27–28, 29

master formulation records (MFRs), 14, 21, 92–93, 97

material safety data sheets (MSDSs), 16–17

measuring and mixing, 37

media fill test

aseptic technique and, 46

clerkship students and, 40

competency and, 37

gloved fingertip and thumb test and, 43, 45

immediate-use CSPs and, 36

for personnel who mix only immediate-use CSPs, 48

requalification, 49

training, 15–16, 40, 46–49, 87

medications, administration of. see administration of medications

medium-risk preparations

bacterial and fungal contamination and, 125

beyond-use dates (BUDs) for, 100, 103, 105

mixing, 15–16, 43, 46, 49

overview of, 52

meningitis scare of 2012, 1

microbial contamination risk levels, 5

microbiology departments, 125–126

MINI-BAG Plus, 89, 106

mold, 131–132

monitoring, daily nonviable, 79–82

monographs, 1, 52, 88, 93, 99, 101, 104

monthly cleaning, 116

mops, reusable, 114

music, 87

N

N95 respirators, 29

National Formulary (NF) marking, 53

National Institute for Occupational Safety and Health (NIOSH), 16, 26, 29, 33, 57, 60–61, 63, 70, 73, 122

needles, cleaning of, 122

negative pressure buffer rooms, 26–27, 58, 60–61, 63, 70, 71, 73, 79, 81, 132

neonatal total parenteral nutrition (TPN), 108–109

nonhazardous CSPs

cleaning supplies for, 122

segregated compounding areas for, 69–70

nonsterile preparations, 1, 9, 10, 11, 86, 95–96

nonsterile starting components, 52–53

nonsterile-to-sterile compounding, 90–92

nonviable monitoring, 79–82

nuclear medicine departments, 78

nuclear medicine technologists, 45, 49

Nuclear Regulatory Commission (NRC), 95–96

nursing homes, 10

O

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

one off compounding, 94

one-step disinfectant cleaner, EPA-registered, 113, 114, 115, 116, 117, 120, 122

operating room (OR)

beyond-use dates (BUDs) and prepping for, 107

OR greens for, 24

out-of-specification results, 131–132

outsourcing facilities

bulk list for, 88

premixed solutions from, 89

stock bags from, 110

P

packaging, 22, 111–112

paddles for surface sampling, 129

paper towels, 25, 118

pass-through chambers, 71–73

air sampling in, 127

cleaning of, 121

personal hygiene, 5, 20, 24–25, 37

personal protective equipment (PPE), 23, 24, 29. See also garbing

personnel training. See training

pharmaceutical manufacturers

compliance of, 10

expiration dates, 52–53

lot numbers, 94

premixed solutions from, 89

vial tops from, 88

pharmacy bulk package (PBP), 108

Pharmacy Competency Assessment Center, ASHP, 15

Pharmacy Compounding Accreditation Boards, 1

Pharmacy Technician Certification Board (PTCB), 14, 39–40

physician offices, 10, 13

plastic curtains/drapes, 56

platelet, 91

policies and procedures, 19–22

positive pressure buffer rooms, 30, 58, 62, 68, 72, 79, 81

powder hoods, 86

powders

garb for compounding, 23, 31

presterilization area for weighing, 67

powered air purifying respirators (PAPRs), 29

power loss, 120

premixed solutions, 89

prepackaging, 11, 89

preparation for administration, 33–34

pressure requirements and monitoring

in anterooms, 62, 63, 68, 79, 81

in negative pressure buffer rooms, 26–27, 58, 60–61, 63, 70, 71, 73, 79, 81, 132

in positive pressure buffer rooms, 30, 58, 62, 68, 72, 79, 81

presterilization area for weighing powders, 67

presterilization areas, 67

primary engineering controls (PEC), 60–61

certification, 123

cleaning and disinfecting of, 115, 118–120

surface sampling, 128–129

printers, 64, 74

probability of a nonsterile unit (PNSU), 91

proprietary bag systems, 7, 89

Q

quality assurance and quality control, 6, 22, 133–134

R

radiopharmaceuticals, 1, 5, 135

addressed in 797, 3

compounding, 95–96

immediate use of, 45, 49

segregated processing area for, 77–78

UltraTag™, 92

recertification, 84–85

reconstitution, 34, 104

red cells, 91

refrigerators

beyond-use dates (BUDs) and, 100, 103–104, 108–109, 132

cleaning of, 121

low wall return for, 74

pass-through, 73, 74

placement of, 73–74

in sterile compounding area, 64

surface sampling and, 128

temperatures in, 21, 79, 99, 102

release preparation release checks and tests, 7, 21

religious head coverings, 27

repackaging, 3, 11

repeater pumps, 74, 79, 82, 84, 120, 128

requalification, 49

respirators, 27, 28, 29

restricted access barrier system (RABS), 68

reusable garb, 24

reusable mops, 114

risk levels, 5, 6, 49, 51–52, 100, 102, 127

robots, 61

RODAC™, 130

S

Safe Injection Practices (CDC), 33

safety data sheets (SDSs), 16–17

sampling plan, 124

sanitizing. See cleaning and disinfecting

scales, 61

scope of USP <797>, 9–11

secondary engineering controls (SEC), 62–64, 123

segregated compounding areas (SCA)

air changes per hour (ACPH) in, 59

allergen extracts preparation in, 76

anterooms for, 65, 66–67

beyond-use dates (BUDs) and, 100

cardboard in, 59

cleaning and disinfecting of, 115

facility design and, 56, 57

garb in, 24, 26, 30

gloved fingertip and thumb test done in, 43, 44

for nonhazardous CSPs, 69–70

restrictions, 40–41

as secondary engineering control, 62, 63

surface sampling and, 129

segregated radiopharmaceutical processing area (SRPA), 77–78

settling plates, 127

shelving, 21, 59, 63, 64, 66, 116

shipping boxes, 59

shoe covers, 20, 28

single-dose ampules, 107

single-dose vials, 107

sinks

in allergenic extracts compounding area, 77

in anteroom, 64, 66, 131

in cleanroom suite, 69

in containment segregated compounding areas, 71

facility design and, 57, 62

garbing and, 23, 29–31, 64

in segregated compounding areas, 70

in segregated radiopharmaceutical processing area, 78

sleeve covers, 28

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

sodium bicarbonate IV, 11, 34–35

soybean-casein digest media, 47, 127

spills, 15, 20, 29, 119, 120

sporicidal agents, 115, 116, 122

bleach as, 117–118

for cleaning hoods after power outage, 120

for mold, 132

reason for using, 113

rotating, 114

sprinkler heads, 63

stability, 11, 92, 97, 99, 100, 101, 104, 105, 106, 108

standard operating procedures (SOPs), 6, 19–22

sterile containers, 34–35

sterile products and preparations. see USP <797> Pharmaceutical Compounding—Sterile Preparations

Sterile Products Preparation Certificate Program, ASHP, 14

sterilization and depyrogenation, 6

storage areas

in anterooms, 66

facility design and, 59–60

for garb, 57

policies required and recommended in USP <797>, 21

segregated compounding areas used as, 64

temperature in, 79

supplies. see equipment and supplies

surface sampling, 128–130

surfaces and finishes, 59, 62, 63, 67

syringes

cefazolin, 91

cleaning, 122

containers, 89

immediate-use provisions, 36

reconstituted and frozen, 104

sterility tests and, 91

T

tape, for separating anteroom, 67

technician certification, 39–40

temperature requirements and monitoring

beyond-use-dates (BUDs) and, 102

gauges for, 59

for incubators, 129

monitoring, 79, 80

secondary engineering controls, 62, 64

for shipped products, 112

for sterile compounding area, 57–58

terminal cleaning, 119

terminal sterilization, 91

TNTC (too numerous to count), 126

total parenteral nutrition (TPN), 52, 108

touchscreen monitors, 61

training, 37–49

aseptic technique, 46

for compounding personnel, 15–16, 20, 37–41

for designated person, 14

documented, 38

evaluation, 5

garbing, 42

gloved fingertip and thumb test, 42–45

hand hygiene, 41

initial, 37–41

media fill test, 15–16, 46–49

requalification, 49

trypticase soy agar (TSA), 42, 127, 129

U

UltraTag™, 92

United States Pharmacopeia (USP) marking, 52

United States Pharmacopeial Convention, 1United States Pharmacopeia–National Formulary (USP–NF), 52, 53, 88, 101

USP <71> Sterility Tests, 47

USP <659> Packaging and Storage Requirements, 80, 102

USP <795> Pharmaceutical Compounding—Nonsterile Preparations, 1, 9, 10, 11, 86, 95–96

USP <797> Pharmaceutical Compounding—Sterile Preparations, 1

administration, immediate use and preparation for, 33–36

allergens, 4

applied animals, 9

availability of, 1–2

beyond-use dates (BUDs), 5, 7, 14, 22, 33, 61, 67, 89, 91, 98, 99–109, 111

certification of engineering controls, 83–86

cleaning and disinfecting, 113–122

compounding, 87–98

contents of sections of, 5–7

daily nonviable monitoring, 79–82

dispensing and packaging, 111–112

enforcement of, 11

environmental monitoring, 123–132

examples of preparations that must comply, 9

facility design, engineering controls, and equipment, 55–78

full text of, where to find, 1

garb and hand hygiene, 6, 23–31

general information, 51

general principles of, 3–4

as a guideline versus a requirement, 1

hazardous drugs addressed in, 3

human resources, 13–17

initial training for compounding, 37–41

mixed by nurses for immediate use, 34

must and should in, distinction between, 3

need for, meningitis scare of 2012 and, 1

nonsterile-to-sterile compounding of, 90–92

personnel training and competence documentation, 37–49

policies and procedures, 19–22

quality assurance and quality control, 6, 22, 133–134

receiving areas for, 57

revision to, in 2019, 3

scope of, 9–11

as a standard, 1–2, 9

sterile products and supplies, 51–53

where to start with information from, 135–136

see also compounded sterile preparations (CSPs)

USP <800> Course, 39

USP <800> Hazardous Drugs—Handling in Healthcare Settings, 1, 3, 39

USP <825> Radiopharmaceutical—Preparation, Compounding, Dispensing, and Repackaging, 1, 3, 45, 49, 77–78, 92, 95–96, 135

USP <1113> Microbial Characterization, Identification, and Strain Typing, 126

USP <1163> Quality Assurance in Pharmaceutical Compounding, 133

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

USP <1178> Good Repackaging Practices, 89

USP Compounding Compendium, 1, 93, 101

USP monographs, 1

active pharmaceutical ingredient and, 52

beyond-use dates (BUDs) and, 99, 101, 104

drugs that should not be compounded and, 88

in master formulation record (MFRs), 97

where to find, 93, 101

V

vaccines, 91–92

veterinary clinics, 13

viable monitoring, 79, 123

vial bag systems, 7, 89

VIAL-MATE, 89, 106

vials

beyond-use dates (BUDs) of, 108

cleaning of, 122

tops of, 88, 108

W

warmers, 48, 75, 79, 104, 125

washable gowns, 26

waste segregation and disposal, 22

water as component, 53

weekly cleaning, 116

weighing rooms, 67

wet anterooms, 66

white cells, 91

windows in pass-through chambers, 72

wipers, 25, 118