CBER reminds manufacturers of biological drug products subject to 21 C.F.R. Part 2071 of the need to ensure that their registration and listing information is up to date and has been submitted to FDA in the proper electronic format.
Under Section 510 of the Federal Food, Drug, and Cosmetic Act (the Act) and the regulations in 21 C.F.R. Part 207, manufacturers of biological drug products must:
1) register their establishments annually on or before December 31st of each year; and,
2) list all of their products in commercial distribution at the time of initial registration, with bi-annual updates to their listings in June and December, as necessary.
Under Section 510(p) of the Act, as amended by the Food and Drug Administration Amendments Act of 2007, establishment registration and product listing information must be submitted to FDA electronically, unless a waiver is granted. FDA has adopted Structured Product Labeling (SPL) as the electronic means for submission of registration and listing information to the Agency. As of June 1, 2009, FDA is no longer accepting paper registration and listing submissions, unless a waiver is granted.
For more information on electronic submission of registration and listing, please refer to the Guidance for Industry: Providing Regulatory Submissions in Electronic Format –Drug Establishment Registration and Drug Listing Industry, dated May 2009.
1 This includes, for example, manufacturers engaged in the production of vaccines, allergenic products, and any plasma derivative, including albumin, Immune Globulin, Factor VIII, Factor IX, bulk product substances such as fraction intermediates or pastes, or recombinant version of plasma derivatives or animal derived plasma derivatives