OTC Pharmaceuticals Labeling Submissions to the FDA



Hi all,

I work at a company that does some OTC repackaging. Our SME for labeling is on an unexpected medical leave of absence, leaving me (his back-up) as the point person for labels. For the most part, I’m fairly comfortable with the OTC monographs and labeling requirements, and I understand how we’re assigning NDCs and ensuring no duplication occurs, so I believe those aspects of the labeling process is under control. However, we’re going live on a product soon, meaning I need to do the actual label submission to the FDA, and I have very little understanding of SPL or how this process works. The documents I found on the FDA’s website aren’t really user-friendly for this process.

Could anyone point me to a “dummies” guide anywhere? Or towards any resources that may help with this project?
Thank you!
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