U.S. FDA Regulations for Outsourcing Facilities
- Compound drugs under the supervision of a licensed pharmacist.
- Pay an annual establishment fee.
- Submit drug product reports to FDA in SPL format upon initial registration, and thereafter in June and December of each subsequent year.
- Submit adverse event reports.
- Designate a Registrant Contact for FDA communications.
Registrar Corp serves as Registrant Contact for Outsourcing Facilities. As your Registrant Contact, we help you comply with the above requirements, including guidance on FDA’s Small Business Adjustment Factors to mitigate the annual establishment fee. Simply complete the form below for more information: