Frequently Asked Questions

Do I need a cleanroom or can I use an SCA?

For low-risk, short BUD products, a Segregated Compounding Area (SCA) may be sufficient. However, medium/high-risk CSPs require ISO-classified cleanrooms per USP <797>.

How long does it take to become USP compliant?

Typical compliance timelines range from 8 to 16 weeks, depending on the scope of renovation, staff readiness, and documentation needs.

What’s the difference between USP <797> and <800>?

USP <797> governs sterile compounding. USP <800> covers hazardous drug handling (HDs) and is often required concurrently if you prepare drugs like chemotherapy.

Do you help with Joint Commission or PCAB inspections?

Yes. We provide mock audits, SOP alignment, and documentation review tailored for accreditation success.