Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
State board outlines 503B outsourcing inspection program, warns of scale and cGMP expectations
Summary
Supervising inspector JK Fujimoto told the Enforcement & Compounding Committee that 503B outsourcing facilities operate at industrial scale, are subject to federal CGMP standards (21 CFR parts 210 and 211) and FDA risk-based inspection, and that California—s board conducts multi-day annual licensure inspections to supplement federal oversight. The
Supervising inspector JK Fujimoto of the California State Board of Pharmacy told the committee on Oct. 16 that 503B outsourcing facilities differ from traditional compounding pharmacies in scale, regulation and risk.
"Outsourcing facilities are typically not open to the public," Fujimoto said, describing sites that can range from tens of thousands to more than 750,000 square feet, with specialized warehousing, laboratories, HVAC and water-for-injection systems. He said products from 503B firms can be distributed nationwide and often in case or pallet quantities.
The distinction matters because 503B facilities must comply with current good manufacturing practices under federal law. "They must follow 21 CFR parts 210 and 211," Fujimoto said, adding that FDA inspects on a risk-based schedule and…
Already have an account? Log in
Subscribe to keep reading
Unlock the rest of this article — and every article on Citizen Portal.
- Unlimited articles
- AI-powered breakdowns of topics, speakers, decisions, and budgets
- Instant alerts when your location has a new meeting
- Follow topics and more locations
- 1,000 AI Insights / month, plus AI Chat
