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USP Flashcards

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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
yellow trace chemotherapy waste bin
chemo gown and outer shoe covers all trace antineoplastic waste outer chemotherapy gloves
26
PPE required when sterile compounding that is NOT required fro non sterile
2 pairs of ASTM chemotherapy glovers two pairs of shoe covers face mask
27
USP 797 what is prohibited in buffer room
gum earbuds outer garments
28
no skin can be exposed in buffer room when compounding
Category 3
29
USP 797 hand hygiene
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
30
when compounding non hazadorous sterile products the buffer room should have a ________ air pressure
positive
31
ISO Class 5 particle count
3520
32
USP 797 area used for performing non-aseptic activities
ante-room
33
primary engineering control (PEC)
laminar airflow workbench
34
temperature and humidity must be monitored in the cleanroom suite a minimum of ____
every 24 hours
35
Where is gowning performed
Ante Room
36
disinfectant
chemical or physical agent used on inanimate surfaces and objects
37
how often should sporicidal disinfectant be used on work surfaces outside of the PEC for entities compounding Category 3 CSPs
weekly
38
considerations in choosing disinfectants
inactivation of organic matter preparation requirements shelf life
39
critical sites
IV bag septum vial stoppers ampule necks
40
considerations when selecting components
must have COA or documentation must comply with USP-NF
41
parameters that determine BUDs
whether or not sterility testing is performed conditions of the environment in which it is prepared storage conditions
42
items found in compounding record
total quantity compounded lot number and expiration dates of each ingredient assigned BUD
43
bacterial endotoxin testing required for which CSP categories
category 2 category 3
44
quality assurance and control programs must be reviewed
once every 12 months
45
requirements for documentation
SOPs, MFRs, and CRs receipt of components release inspection and testing records
46
all compounding personnel must be trained to
report any problems, deviations, failures, or errors to the designated person recognize potential problems that could potentially result in contamination on CSP quality
47
AECAs
surfaces must be smooth free from cracks/crevices all surfaces must be cleanable no carpet
48
all documentation must be retrievable for
2 years
49
handling + storing CSPs
controlled temperature area must be established and monitored if unable to determine integrity or quality of CSP, must be discarded
50
packaging materials should protect CSPs from
degradation damage leakage
51
minimum garbing requirements for compounding allergenic extracts
low lint disposable head covers low lint garment with sleeves face mask
52
hard lozenges
base of sucrose or syrup
53
soft lozenges
base of PEG
54
chewable lozenge
base of glycerin or gelatin
55
topical emulsion
two phase liquid preparation consisting of 2 or more immiscible liquids in which small globules of one liquid are dispersed uniformly throughout liquid
56
water in oil
occlusive water - internal phase oil - external/continuous phase
57
oil in water
external to provide cooling effect water - continuous phase oil - internal phase
58
emulsifying agent
soluble in both water and oil
59
wetting agent
removes air around dry product ; helps with levigating (mineral oil, glycerin)
60
suspending
thickening substance; add structure to suspensions and allows easier dispersion of particles (carboxymethylcellulose, tragacanth)
61
what dosage forms can be prepared as nonsterile
otic preparation nasal irrigation topical ointments
62
USP 795 exiting compounding area what garb should be discarded immediately
gown bonnet booties gloves
63
suspensions are a _____ phase system consisting of a ____ material dispersed in a vehicle (medium) such as a solid, liquid, or gas
two; immisicble
64
humectant
draws water up from the dermis
65
drug labeling examples
medication guide patient package insert principal display panel on a carton
66
occlusive
holds water in after it has been supplied either by moisturizer or a soak in water
67
when measuring liquids measure no less than ___ percent of the capacity of the graduate
20
68
emollient
fills in rough spots to make skin feel smooth; does not affect water content
69
pneumatic tube systems cannot be used to transport any liquids HDs or antineoplastics
70
Class I Biological Safety Cabinets
can be used for the preparation of non-sterile hazadorous drugs designed to protect personnel and environment
71
how often should chemotherapy drugs be changed when compounding hazardous drugs
every 30 mins
72
single dose containers
holding a sterile product for parenteral administration
73
multiple dose containers
more than one dose of a drug
74
pharmacy bulk packages
sterile product for parenteral use that contains many single doses
75
when compounding a nonhazadorous sterile products, the buffer should have a _____ air pressure
positive
76
compounded multiple dose CSPs
contain a preservative intended to be punctured multiple times time limit for puncturing is not intended to restrict BUD of final CSP
77
bacterial endotoxin testing requried for
Category 2 Category 3
78
air flow in a vertical laminar flow hood
down
79
if laminar flow hood turned off it must be on for at least _____ minutes before compounding
30
80
handling and storing CSPs
controlled temperature if unable to determine integrity must be discarded temp monitored weekly
81
BUD for terminally sterilized CSP under controlled room temperature is good for
45 days
82
BUD applies to
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
Airflow testing
performed to determine acceptability of air velocity, room air exchange rate, and room pressure differential
84
HEPA filter integrity testing
must be performed to ensure leak testing at the factory and again after installation and as part of recertification
85
total particle count testing
must be performed under dynamic and operating conditions to comply with ISO classification
86
Dynamic airflow smoke pattern test
must be performed for each PEC during operating conditions to demonstrate unidirectional airflow away from the preparation
87
label on CSP immediate container must display
ID # active ingredients + amounts storage BUD dosage form total volume single dose container - statement multiple dose container - statement
88
CSP labeling must display
route of admin special handling instructions warning statements compounding facility name + contact info

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