Chapter 17: Compounding III; Documentation and Preparation Flashcards
BUD for Non-aqueous Formulations
Not later than 6 months (180 days). Store at room temperature
BUD for Water Containing Oral Formulation
Not later than 14 days when stores at controlled cold temperature
BUD for Water Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations (cream or lotion)
Not later than 30 days. Store at room temperature
Label requirements
- Names and amounts or concentrations of ingredients
- Total volume
- BUD
- Route of administration
- Storage requirements
- Hazardous requirements
- Special handling
- High alert meds
Avoiding pyrogens
- Glassware and utensils should be rinse with sterile water
- Then depyrogenated using dry-heat (steam) sterilization and an autoclave
Endotoxin testing
-The reagent for bacterial endotoxins test (BET) is called the Limulus Amebocyte Lysate (LAL)
Low-risk compounding
Has 1 to 3 components (including the diluent) that are supplied as sterile from the manufacturer
Medium-risk compounding
Has more than 3 sterile components (including the diluent)
Also includes making batches of drugs
High-risk compounding
Uses non-sterile ingredients and equipment and the end product will need to be sterilized prior to use.
High-risk CSPs intended for use beyond that recommneded BUD will need sterility testing with either tryptic soy broth (TSB) or fluid thioglycollate medium (FTM) and include bacterial endotoxin testing prior to use
BUD for low-risk
Room temp: 48 hours
Fridge: 14 days
Freezer: 45 days
BUD for medium-risk
Room temp: 30 hours
Fridge: 9 days
Freezer: 45 days
BUD for high-risk
Room temp: 24 hours
Fridge: 3 days
Freezer: 45 days
BUD for low-risk CSP prepared not in a clean room
Room temp: 12 hours
Fridge: 12 hours
Freezer: N/A
BUD for immediate use
Room temp: 1 hour
Fridge: N/A
Freezer: N/A
