What is new in SPL R4?
A. For pharmas, SPL is now used for establishment registration (in place of Form 2656) and NDC Labeler Code Requests. Also, for label submissions, the following is now required: – establishment and marketing information, – UNII codes for ingredients, and – jpeg images of the representative sample of package labels and the text of their principal display panels, in place of the representative sample of the packaging that you previously supplied with drug product listing submissions. For animal drugs, OTC products, and biologic products, everything is new, as they are first being required to file in SPL. For all companies filing SPL R4, submissions now are done through the electronic gateway. If you don’t already have a gateway account account, you need to apply for one; see the home page for the FDA Electronic Submissions Gateway (ESG) (Home Page) There are also technical changes to the XML tagging used for SPL, but that is DCL’s responsibility, and we’ll spare you the details.
