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USP Flashcards

1
Q

immediate use CSP must contain more than _____ sterile products

A

3

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2
Q

administration of compounded sterile product is NOT included in USP 797

A
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3
Q

Required sterile products

A

refill cartridge (solution) of baclofen for an implanted intrathecal infusion
antibiotic opthalamic ointment
heparin solution for IV infusion
dry powder corticosteriod for inhalation

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4
Q

scope + purpose of USP 797

A
  1. describe minimum practice and quality standards for sterile compounded products
  2. describe conditions and practices to prevent harm from sterile compounded products
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5
Q

immediate usp CSP per USP 797 means administration within how many hours

A

4

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6
Q

topical opthlamaic preparations must be prepared in compliance with USP 797

A
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7
Q

immediate use CSPs are exempt from 797

A
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8
Q

minimum core competency area that ALL personnel that compound or oversee compounding must demonstrate knowledge in

A
  1. hand hygiene
  2. garbing
  3. cleaning and sanitizing
  4. handling and transporting CNSPs
  5. measuring and mixing
  6. proper use of equpiment and devices selected to compound CNSPs
  7. documentation of compounding process
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9
Q

personnel who compound must complete training at least

A

every 12 months

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10
Q

USP 795 training and observation of personnel can be performed by

A

designate person
assigned trainer

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11
Q

CNSP

A

compounded nonsterile preparation

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12
Q

Facilities compounding nonsterile preparations must develop SOPs on all aspects of compounding

A
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13
Q

designated person must ensure follow up occurs any time there is a deviation from SOPs

A
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14
Q

quality assurance

A

ensures that the compounding process consistently meets quality standards

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15
Q

quality control

A

sampling, testing, and documentation of results that taken together ensure that specifications have been met for the CNSP

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16
Q

Items that must be contained in SOP for recall of dispensed CNSPs

A

determine severity of problem/urgency for implementation of recall
determine the distribution of any affected CNSP
identify patients who have received CNSP
disposal and documentation of recalled CNSP
investigate and document reason for recall

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17
Q

CNSP facilities

A

temperature logs must be maintained by all facilities where CNSP’s are made
calibration records of all equipment use in compounding

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18
Q

packaging and transportation of CNSP

A

packaging selected for CNSP should protect CNSP from damage and leakage
facility is required to have SOPs describing mode of transportation of CNSP and special handling instructions

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19
Q

USP 800

A

is a minimum standard

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20
Q

national institute for occupational safety and health

A

maintains a list of antineoplastic and other hazardous drugs used in healthcare

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21
Q

NIOSH

A

non regulatory agency
only federal agency with mandate to conduct and fund occupation safety and health research + training
NIOSH governed by CDC

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22
Q

negative pressure ensures

A

net flow of air is into the room

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23
Q

pharmacies involved in hazadorous compounding should perform wipe sampling of all surfaces initially and at least every

A

6 months

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24
Q

spill kit contains

A

N95 respirator
waste bag
spill report exposure form

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25
Q

yellow trace chemotherapy waste bin

A

chemo gown and outer shoe covers
all trace antineoplastic waste
outer chemotherapy gloves

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26
Q

PPE required when sterile compounding that is NOT required fro non sterile

A

2 pairs of ASTM chemotherapy glovers
two pairs of shoe covers
face mask

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27
Q

USP 797 what is prohibited in buffer room

A

gum
earbuds
outer garments

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28
Q

no skin can be exposed in buffer room when compounding

A

Category 3

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29
Q

USP 797 hand hygiene

A

dry hands + forearms up to the elbows completely with low lint disposable towels or wipes
wash hands and forearms up to elbows with soap and water for at least 30 sec

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30
Q

when compounding non hazadorous sterile products the buffer room should have a ________ air pressure

A

positive

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31
Q

ISO Class 5 particle count

A

3520

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32
Q

USP 797 area used for performing non-aseptic activities

A

ante-room

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33
Q

primary engineering control (PEC)

A

laminar airflow workbench

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34
Q

temperature and humidity must be monitored in the cleanroom suite a minimum of ____

A

every 24 hours

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35
Q

Where is gowning performed

A

Ante Room

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36
Q

disinfectant

A

chemical or physical agent used on inanimate surfaces and objects

37
Q

how often should sporicidal disinfectant be used on work surfaces outside of the PEC for entities compounding Category 3 CSPs

A

weekly

38
Q

considerations in choosing disinfectants

A

inactivation of organic matter
preparation requirements
shelf life

39
Q

critical sites

A

IV bag septum
vial stoppers
ampule necks

40
Q

considerations when selecting components

A

must have COA or documentation
must comply with USP-NF

41
Q

parameters that determine BUDs

A

whether or not sterility testing is performed
conditions of the environment in which it is prepared
storage conditions

42
Q

items found in compounding record

A

total quantity compounded
lot number and expiration dates of each ingredient
assigned BUD

43
Q

bacterial endotoxin testing required for which CSP categories

A

category 2
category 3

44
Q

quality assurance and control programs must be reviewed

A

once every 12 months

45
Q

requirements for documentation

A

SOPs, MFRs, and CRs
receipt of components
release inspection and testing records

46
Q

all compounding personnel must be trained to

A

report any problems, deviations, failures, or errors to the designated person
recognize potential problems that could potentially result in contamination on CSP quality

47
Q

AECAs

A

surfaces must be smooth free from cracks/crevices
all surfaces must be cleanable
no carpet

48
Q

all documentation must be retrievable for

A

2 years

49
Q

handling + storing CSPs

A

controlled temperature area must be established and monitored
if unable to determine integrity or quality of CSP, must be discarded

50
Q

packaging materials should protect CSPs from

A

degradation
damage
leakage

51
Q

minimum garbing requirements for compounding allergenic extracts

A

low lint disposable head covers
low lint garment with sleeves
face mask

52
Q

hard lozenges

A

base of sucrose or syrup

53
Q

soft lozenges

A

base of PEG

54
Q

chewable lozenge

A

base of glycerin or gelatin

55
Q

topical emulsion

A

two phase liquid preparation consisting of 2 or more immiscible liquids in which small globules of one liquid are dispersed uniformly throughout liquid

56
Q

water in oil

A

occlusive
water - internal phase
oil - external/continuous phase

57
Q

oil in water

A

external to provide cooling effect
water - continuous phase
oil - internal phase

58
Q

emulsifying agent

A

soluble in both water and oil

59
Q

wetting agent

A

removes air around dry product ; helps with levigating (mineral oil, glycerin)

60
Q

suspending

A

thickening substance; add structure to suspensions and allows easier dispersion of particles (carboxymethylcellulose, tragacanth)

61
Q

what dosage forms can be prepared as nonsterile

A

otic preparation
nasal irrigation
topical ointments

62
Q

USP 795 exiting compounding area what garb should be discarded immediately

A

gown
bonnet
booties
gloves

63
Q

suspensions are a _____ phase system consisting of a ____ material dispersed in a vehicle (medium) such as a solid, liquid, or gas

A

two; immisicble

64
Q

humectant

A

draws water up from the dermis

65
Q

drug labeling examples

A

medication guide
patient package insert
principal display panel on a carton

66
Q

occlusive

A

holds water in after it has been supplied either by moisturizer or a soak in water

67
Q

when measuring liquids measure no less than ___ percent of the capacity of the graduate

A

20

68
Q

emollient

A

fills in rough spots to make skin feel smooth; does not affect water content

69
Q

pneumatic tube systems cannot be used to transport any liquids HDs or antineoplastics

A
70
Q

Class I Biological Safety Cabinets

A

can be used for the preparation of non-sterile hazadorous drugs
designed to protect personnel and environment

71
Q

how often should chemotherapy drugs be changed when compounding hazardous drugs

A

every 30 mins

72
Q

single dose containers

A

holding a sterile product for parenteral administration

73
Q

multiple dose containers

A

more than one dose of a drug

74
Q

pharmacy bulk packages

A

sterile product for parenteral use that contains many single doses

75
Q

when compounding a nonhazadorous sterile products, the buffer should have a _____ air pressure

A

positive

76
Q

compounded multiple dose CSPs

A

contain a preservative
intended to be punctured multiple times
time limit for puncturing is not intended to restrict BUD of final CSP

77
Q

bacterial endotoxin testing requried for

A

Category 2
Category 3

78
Q

air flow in a vertical laminar flow hood

A

down

79
Q

if laminar flow hood turned off it must be on for at least _____ minutes before compounding

A

30

80
Q

handling and storing CSPs

A

controlled temperature
if unable to determine integrity must be discarded
temp monitored weekly

81
Q

BUD for terminally sterilized CSP under controlled room temperature is good for

A

45 days

82
Q

BUD applies to

A

all CSPs
date after which a CSP must not be used
time during which a product can be expected to meet requirements per USP-NF

83
Q

Airflow testing

A

performed to determine acceptability of air velocity, room air exchange rate, and room pressure differential

84
Q

HEPA filter integrity testing

A

must be performed to ensure leak testing at the factory and again after installation and as part of recertification

85
Q

total particle count testing

A

must be performed under dynamic and operating conditions to comply with ISO classification

86
Q

Dynamic airflow smoke pattern test

A

must be performed for each PEC during operating conditions to demonstrate unidirectional airflow away from the preparation

87
Q

label on CSP immediate container must display

A

ID #
active ingredients + amounts
storage
BUD
dosage form
total volume
single dose container - statement
multiple dose container - statement

88
Q

CSP labeling must display

A

route of admin
special handling instructions
warning statements
compounding facility name + contact info

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