Requirements for drug establishment registration and drug listing are set forth in Section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), Section 351 of the Public Health Service Act (the PHS Act), and in the Code of Federal Regulations (CFR) Title 21 Part 207.
Changes in the FD&C Act, resulting from the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. As a result, since June 1, 2009, the FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. Moving from a paper-based format to an electronic system will improve the timeliness and accuracy of the submissions.
For your reference, see Guidance - Drug Establishment Registration and Drug Listing
The Generic Drug User Fee Amendments of 2012 (GDUFA), requires the identification of facilities, sites and organizations involved in the manufacture of human generic drugs and associated active pharmaceutical ingredients. By October 1, 2012, FDA will publish notice of the self-identification requirement in the Federal Register. Upon publication, business entities will have 60 days to complete the self-identification process. Please note that the requirement for self-identification is distinct from the requirement to register and list.
Answers to specific questions about the GDUFA self-identification can be found in Guidance for industry Self-Identification of Generic Drug Facilities, Sites and Organizations including which organizations need to self-identify, what information they are required to submit, and the means and format for submission of required information. Additional information about GDUFA is available at www.fda.gov/gdufa.
Refer to the eSubmitter Quick Guide - Generic Drug Facility Self-Identification for more information about creating and submitting a facility self-identification SPL file using the eSubmitter tool.
Self-identification files may be generated using eSubmitter, or any of the following other SPL tools:
- Xforms available at: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm. Step-by-step instructions for electronically creating, validating, and submitting self-identification information using Xforms are available at: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm; or
- Software tools developed internally by generic manufacturers utilizing the SPL technical specifications. Additional information is available at: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
- Other commercially available applications (e.g., vendor tools).