Registration of Oursourcing Facilitites and Payment of Fees

Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K

OMB: 0910-0776

IC ID: 212974

Documents and Forms

Document Name Document Type
FINAL GUIDANCE FOR USER FEES 8-28-14.doc Other-Guidance
3908 Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request FDA FORM 3908 USER FEE 8-29-14.pdf Form and Instruction
0776 Registration of Outsourcing Facilities under 503B GFI.pdf Other-Agency Guidance