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).
Registrar Corp serves as Registrant Contact for Outsourcing Facilities. Simply complete the form below for more information:
