Immediate use compounds are prepared under which conditions and have what BUD?

• A. Class 5 or greater conditions; BUD 1 hour
• B. Less than Class 5 conditions; BUD 24 hours
• C. Less than Class 5 conditions; BUD = 1 hour
• D. Any clean room conditions; BUD 4 hours

Answer: (C)

Immediate-use compounds are sterile preparations meant for urgent administration and are not made in an ISO 5 (Class 5) clean room. They’re prepared in a less-clean environment and must be used within 1 hour from the start of compounding, with any remainder discarded after that window. The short 1-hour BUD reflects the higher contamination risk when aseptic processing isn’t performed in a controlled cleanroom. Longer BUDs (like 24 hours or 4 hours) or requiring a clean-room condition would require more stringent sterility controls, which aren’t permitted for immediate-use preparations.