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U.S. FDA Regulations for Outsourcing Facilities

Compounding pharmacies registered as Outsourcing Facilities with the U.S. Food and Drug Administration (FDA) may qualify for exemption from certain FDA requirements, including those concerning (i) New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) approval requirements, and (ii) labeling of drugs with adequate directions for use, so long as certain conditions are met (Section 503B of the FD&C Act). To qualify for these exemptions, FDA requires, among other things, registered outsourcing facilities to:
  • 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: