In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm breaks down simplifying your fda otc drug registration. Watch the video below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa, an FDA compliance attorney. Let’s talk about OTC drug registration — and how to make it less overwhelming. If you manufacture, repack, or relabel OTC drugs for distribution in the United States, you are required to register your establishment with the FDA and list your drug products. This is mandatory, not optional. Establishment registration and drug listing are done through the FDA’s Unified Registration and Listing System, also known as FURLS. The process requires information about your facility, your drugs, and the NDC — National Drug Code — for each product. Here’s the key thing to keep in mind: registration and listing are separate steps. You first register the facility, then list the individual drug products. Both have to be in place before you can legally market your OTC drug. Registrations must be renewed annually between October 1 and December 31. Drug listings need to be updated when you make changes to your products. If this sounds like a lot, it is — but with the right preparation and guidance, it’s very manageable. That’s what we’re here for. Reach out if you need help. See you in the next video.
Have questions about FDA compliance? Contact Capote Law Firm or call (786) 871-5680 to speak with an FDA compliance attorney.