Sterile Products
What ISO class is required for an IV hood (PEC)?
ISO class 5
What USP chapter covers nonsterile compounding?
USP 795
What is a unit dose package?
A single-use, individually packaged medication
What is repackaging?
Taking medications from bulk containers and packaging them into smaller/useful units
Sterile or nonsterile? Cough syrup compound
Nonsterile
Name the room where sterile compounding occurs.
Cleanroom/ buffer area
Name one reason a medication must be compounded
Patient allergy, dosage form change, discontinued product, specialized dose
What’s one advantage of unit dosing?
Fewer errors / increased efficiency / reduced waste
What is required to track recall information after repackaging?
Lot number
Sterile or nonsterile? Ophthalmic drops
Sterile
What does USP <797> regulate?
Sterile compounding standards
What is a common tool used to mix ointments?
Ointment slab or spatula
What information must be on a unit dose label?
Drug name, strength, lot number, expiration date
What determines the expiration date on a repackaged drug?
The manufacturer’s expiration or repackaging guidelines (whichever is shorter)
What do you call a bulk container split into smaller doses?
Repackaged
What movement rule helps maintain sterility inside the hood?
Work at least 6 inches inside the hood, dont block airflow (first air concept)
What type of compound requires geometric dilution?
Very potent active ingredients
Who typically uses unit dose systems?
Hospitals and long-term care facilities
Why is documentation important during repackaging?
For accountability, traceability, and preventing errors
What documentation logs every compounded product?
Master formulation record / Compounding record
Why must the hood run for at least 30 minutes before use?
To clean and stabilize airflow
What is the definition of BUD?
Beyond-use date (when the product expires after compounding)
True or False: Unit dose packaging reduces medication waste.
True
Who may legally repackage drugs?
Licensed pharmacy personnel under pharmacist supervision
True or False: Nonsterile compounds must be prepared in a cleanroom.
False