USP Flashcards
immediate use CSP must contain more than _____ sterile products
3
administration of compounded sterile product is NOT included in USP 797
Required sterile products
refill cartridge (solution) of baclofen for an implanted intrathecal infusion
antibiotic opthalamic ointment
heparin solution for IV infusion
dry powder corticosteriod for inhalation
scope + purpose of USP 797
- describe minimum practice and quality standards for sterile compounded products
- describe conditions and practices to prevent harm from sterile compounded products
immediate usp CSP per USP 797 means administration within how many hours
4
topical opthlamaic preparations must be prepared in compliance with USP 797
immediate use CSPs are exempt from 797
minimum core competency area that ALL personnel that compound or oversee compounding must demonstrate knowledge in
- hand hygiene
- garbing
- cleaning and sanitizing
- handling and transporting CNSPs
- measuring and mixing
- proper use of equpiment and devices selected to compound CNSPs
- documentation of compounding process
personnel who compound must complete training at least
every 12 months
USP 795 training and observation of personnel can be performed by
designate person
assigned trainer
CNSP
compounded nonsterile preparation
Facilities compounding nonsterile preparations must develop SOPs on all aspects of compounding
designated person must ensure follow up occurs any time there is a deviation from SOPs
quality assurance
ensures that the compounding process consistently meets quality standards
quality control
sampling, testing, and documentation of results that taken together ensure that specifications have been met for the CNSP
Items that must be contained in SOP for recall of dispensed CNSPs
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
CNSP facilities
temperature logs must be maintained by all facilities where CNSP’s are made
calibration records of all equipment use in compounding
packaging and transportation of CNSP
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
USP 800
is a minimum standard
national institute for occupational safety and health
maintains a list of antineoplastic and other hazardous drugs used in healthcare
NIOSH
non regulatory agency
only federal agency with mandate to conduct and fund occupation safety and health research + training
NIOSH governed by CDC
negative pressure ensures
net flow of air is into the room
pharmacies involved in hazadorous compounding should perform wipe sampling of all surfaces initially and at least every
6 months
spill kit contains
N95 respirator
waste bag
spill report exposure form
yellow trace chemotherapy waste bin
chemo gown and outer shoe covers
all trace antineoplastic waste
outer chemotherapy gloves
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
USP 797 what is prohibited in buffer room
gum
earbuds
outer garments
no skin can be exposed in buffer room when compounding
Category 3
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
when compounding non hazadorous sterile products the buffer room should have a ________ air pressure
positive
ISO Class 5 particle count
3520
USP 797 area used for performing non-aseptic activities
ante-room
primary engineering control (PEC)
laminar airflow workbench
temperature and humidity must be monitored in the cleanroom suite a minimum of ____
every 24 hours
Where is gowning performed
Ante Room
disinfectant
chemical or physical agent used on inanimate surfaces and objects
how often should sporicidal disinfectant be used on work surfaces outside of the PEC for entities compounding Category 3 CSPs
weekly
considerations in choosing disinfectants
inactivation of organic matter
preparation requirements
shelf life
critical sites
IV bag septum
vial stoppers
ampule necks
considerations when selecting components
must have COA or documentation
must comply with USP-NF
parameters that determine BUDs
whether or not sterility testing is performed
conditions of the environment in which it is prepared
storage conditions
items found in compounding record
total quantity compounded
lot number and expiration dates of each ingredient
assigned BUD
bacterial endotoxin testing required for which CSP categories
category 2
category 3
quality assurance and control programs must be reviewed
once every 12 months
requirements for documentation
SOPs, MFRs, and CRs
receipt of components
release inspection and testing records
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
AECAs
surfaces must be smooth free from cracks/crevices
all surfaces must be cleanable
no carpet
all documentation must be retrievable for
2 years
handling + storing CSPs
controlled temperature area must be established and monitored
if unable to determine integrity or quality of CSP, must be discarded
packaging materials should protect CSPs from
degradation
damage
leakage
minimum garbing requirements for compounding allergenic extracts
low lint disposable head covers
low lint garment with sleeves
face mask
hard lozenges
base of sucrose or syrup
soft lozenges
base of PEG
chewable lozenge
base of glycerin or gelatin
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
water in oil
occlusive
water - internal phase
oil - external/continuous phase
oil in water
external to provide cooling effect
water - continuous phase
oil - internal phase
emulsifying agent
soluble in both water and oil
wetting agent
removes air around dry product ; helps with levigating (mineral oil, glycerin)
suspending
thickening substance; add structure to suspensions and allows easier dispersion of particles (carboxymethylcellulose, tragacanth)
what dosage forms can be prepared as nonsterile
otic preparation
nasal irrigation
topical ointments
USP 795 exiting compounding area what garb should be discarded immediately
gown
bonnet
booties
gloves
suspensions are a _____ phase system consisting of a ____ material dispersed in a vehicle (medium) such as a solid, liquid, or gas
two; immisicble
humectant
draws water up from the dermis
drug labeling examples
medication guide
patient package insert
principal display panel on a carton
occlusive
holds water in after it has been supplied either by moisturizer or a soak in water
when measuring liquids measure no less than ___ percent of the capacity of the graduate
20
emollient
fills in rough spots to make skin feel smooth; does not affect water content
pneumatic tube systems cannot be used to transport any liquids HDs or antineoplastics
Class I Biological Safety Cabinets
can be used for the preparation of non-sterile hazadorous drugs
designed to protect personnel and environment
how often should chemotherapy drugs be changed when compounding hazardous drugs
every 30 mins
single dose containers
holding a sterile product for parenteral administration
multiple dose containers
more than one dose of a drug
pharmacy bulk packages
sterile product for parenteral use that contains many single doses
when compounding a nonhazadorous sterile products, the buffer should have a _____ air pressure
positive
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
bacterial endotoxin testing requried for
Category 2
Category 3
air flow in a vertical laminar flow hood
down
if laminar flow hood turned off it must be on for at least _____ minutes before compounding
30
handling and storing CSPs
controlled temperature
if unable to determine integrity must be discarded
temp monitored weekly
BUD for terminally sterilized CSP under controlled room temperature is good for
45 days
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
Airflow testing
performed to determine acceptability of air velocity, room air exchange rate, and room pressure differential
HEPA filter integrity testing
must be performed to ensure leak testing at the factory and again after installation and as part of recertification
total particle count testing
must be performed under dynamic and operating conditions to comply with ISO classification
Dynamic airflow smoke pattern test
must be performed for each PEC during operating conditions to demonstrate unidirectional airflow away from the preparation
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
CSP labeling must display
route of admin
special handling instructions
warning statements
compounding facility name + contact info
