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Registered Outsourcing Facilities

The FDA’s updated list of Section 503B outsourcing facilities details registration dates, annual fee requirements, and inspection status as of February 18, 2026. Facilities must complete initial registration and then re‑register each year between October 1 and December 31, otherwise they are delisted on January 1. Once registered, facilities enter a risk‑based inspection schedule, with FDA Form 483 issued for significant objectionable conditions. The table also notes that state pharmacy boards may have separate enforcement actions not reflected in the FDA data.