All communications to the FDA must be submitted electronically as XML files in Structured Product Labeling (SPL) format, a requirement since June, 2009. Prior to this, Repackagers simply had to submit copies of the medication insert, patient guide, and repackaging label along with Form 2657. Now, the text and images contained in the inserts, and all label copy must be converted to SPL Revision 4 XML format.

Fortunately for Repackagers, SPL files for most source medications are available on the FDA Daily Med site, so the data does not have to be recreated from scratch. The FDA's xForms tool for SPL submissions allows you to import and modify most version 4 SPL files. However, xForms is not an ideal solution for the following reasons:

• xForms is time consuming to use.
• xForms may not import or allow editing of all sections.
• xForms will not import Revision 3 files (most source files are still Revision 3).
• xForm files with multiple strengths and package sizes operates very slowly

Let Onesource perform this service for you. Why choose Onesource?

Onesource has developed tools specifically designed for the medication repackager and we can perform this service more efficiently and cost effectively. Contact us for more information about this service.

Useful Links

	Official FDA SPL Web Site - Go here for information about Structured Product Labeling.
	Validator Web Site for testing submissions
Daily         Med	Daily Med Web Site. Locate your source XML files here.
	Search for FDA Application Numbers.