Compounding Flashcards
Compounds you cannot make:
-drug removed from market by FDA because component unsafe
-large amounts of drug that are copies of commercial products (but can be for individual patient if there is change to it slightly or if product temp unavail)
-large amounts of drug in cases where there is no historical pattern (would constitute as manufacturing)
A pharmacy must have a person designated to be responsible for implementation of compounding procedures (non-sterile, sterile, or hazardous). True or false
True-could be the same person for all 3 if necessary; does not have to be a pharmacist
Opthalmic and inhalation suspensions do not need to be sterile. True or false
False!
Hazardous drug compounding can be sterile or non sterile. True or false
True
Compounded drugs are subject to GMP?
No-they are not FDA approved drugs
Non-sterile compounding frequency of competency?
Initially and then every 12 months
What garb is required for non-sterile compounding?
Gloves. Change or wipe gloves when starting new procedure. Gowns not required but can be reused
For non sterile products-how often does temp need to be monitored?
Daily
Does non sterile compounding require its own room?
No-should have its own designated area.
What is required before something is compounded for the first time?
Master Formulation record; then a compounding record must be completed each time it occurs
What must be included in a master formulation?
-name/strength/dosage form
-calculations needed
-compatibility/stability
-mixing
-sample labeling with BUD guidance
-container for dispensing
Every non sterile compound requires a label saying what
“This is a compounded preparation”
What must be included in a compound record?
name/strength/dosage
MFR used
info of components (source/lot/exp)
total quantity prepared
name of person who prepared
name of person with quality control
date of prep
Rx number
BUD
Who often do you need to undergo media fill tests for category 1 and 2 preparations?
every 6 months
Who often do you need to undergo media fill/garbing tests for category 3 preparations?
every 3 months
What must be applied to gloves before sterile compounding?
70% IPA
What circumstances may be gown be reworn in sterile compounding?
-gown maintained in classified area to prevent contamination
-class 1 and 2 compounding
remember everything else must be discarded
Category 3 compounding garb rules”
-no exposed skin; face or neck must be covered
-all low lint outer garb must be sterile
-disposable garb can’t be reused
A drug infusion can finish after BUD date. True or false
True-it must just be started before BUD date
When must a single use container be used in ISO5 air?
12 hours
How long is BUD for multi dose vial?
28 days
Category 1 CSP
-can be prepped in unclassified segregated compounding area
-BUD </= 12 hrs room temp and </= 24 hours refrigerated
Immediate use CSPs are exempt from garbing and ISO5 as long as:
-no more than 3 different sterile products
-administration is within 4 hours of start of prep
-cannot be stored/prepped in advance
Category 2 CSP
-must be in a cleanroom suite
-BUD >12 hrs room temp and >24 hrs refrigerated
