Outsourcing Facility Registration:
Under section 503B(b) of the FD&C Act, a compounder can elect to become an outsourcing facility and register with the FDA. Each outsourcing facility must report to FDA certain information about the drug products it compounds.
Docent Pharma’s Registration Expert can register pharmacies/facilities as outsourcing facilities as well as help in the submission of annual drug product reports to FDA. Docent Pharma can serve as registrant contact for outsourcing facilities.
Under the Drug Supply Chain Security Act (DSCSA), FDA requires WDD and 3PL providers to report state licensure and other information about facilities.
Docent Pharma’s Registration Expert can report WDD/3PL licenses to ensure compliance with DSCSA.
For assistance with Outsourcing Facility Registration and WDD/3PL reporting requirements, please Contact Our Registration Expert.