Sterile compounding

Question 1

What is the BUD of a sterile compound for immediate used (no ISO air)?

Answer 1

4h

Question 2

What is the BUD of a Category 1 sterile compound (glove box)?

Answer 2

Room temp: 12h
Refrigerated: 24h

Question 3

What is the BUD of a Category 2 sterile compound (ISO 5 in ISO 7/8)?

Answer 3

Room temp: 1-45 days
Refrigerated: 4-60 days
Freezer: 45-90 days

Question 4

What is the BUD of a Category 3 sterile compound (ISO 5 in ISO7/8 plus additional requirements)?

Answer 4

Room temp: 60-90 days
Refrigerated: 90-120 days
Freezer: 120-180 days

Question 5

What must be included on a sterile product label?

Answer 5

1. Names and amount/ concentration of ingredients
2. BUD
3. Dosage form/route of admin
4. Total volume
5. Storage requirements
6. Internal ID number
7. Warning labels (if high-risk med)/ auxiliary labels prn