Compounding & Hazardous Drugs: Basics Flashcards
USP standards for compounding
USP 795 = non-sterile compounding
USP 797 = sterile compounding
USP 800 = Handling hazardous drugs
considered minimum acceptable standards for compounding by FDA
Non-sterile compounding is primarily used to….
prepare dose or formulation that isnt commercially available
avoid an excipient = gluten or red dye
add a flavor
3 Categories of non-sterile compounding
based on complexity
Simple = follow instructions
Moderate = involves special calculations or procedures
Complex = specialized training
Compounding space info
should be specifically designed for non-sterile compounding
al components, equipment and containers stored off the floor
2 types of water = potable and purified
Sterile compounding is used to prepare…..
injections = IV, IM, SC
eye drops
irrigations
pulmonary inhalations
Acronym for IV bag/container < 100 ml
SVP = small volume parenteral
Acronym for IV bag/container > 100ml
LVP = large volume parenteral
In critical areas, closest to exposed sterile drugs the air quality must be at least….
ISO 5
The buffer area (SEC, which containers PEC) air quality must be…
ISO 7
The anteroom air quality must be….
ISO 8 if it opens into a positive pressure buffer area
ISO 7 if it opens into a negative pressure buffer area
HEPA filters
> 99.9% efficient in removing particles as small as 0.3 microns or larger, inc bacteria/viruses/fungi
Where is HEPA filter in vertical airflow biological safety cabinet
at the top of the hood
Where is HEPA filter in laminar airflow workbench
back of hood
Where is the cleanest air in a hood
area where air comes directly out of HEPA filter, known as direct compounding area
air from HEPA filter is known as first air
