FDA – Drugs
Drug Listing
Fee: $199 / product
Registered drug establishments list the drugs they have in commercial distribution with FDA. The listing information is reviewed and updated each June and December; if nothing has changed, a no-change certification can be made with the annual registration.
Who Is Obligated?
Owners of drug establishments registered with FDA.
What We Do
- We identify the products to be listed and the information required.
- We file the listing on your behalf.
- We track the June and December updates.
What You Receive
- Drug listing records
- Update period reminder
FDA Drug Listing Application
Product, label, and manufacturing establishment details for listing your drugs with the FDA (SPL submission).
Frequently Asked Questions
- I have registered my establishment. Do I also need to list?
- Yes. Registered drug establishments separately list the drugs they have in commercial distribution with FDA.
- When is the listing updated?
- Each June and December. If nothing has changed, a no-change certification can be made with the annual registration.
- What information do you need for listing?
- We identify together the products to be listed and the information required for each; we send you a product-by-product list of what is needed.
Sources: 21 CFR 207.17; 21 CFR 207.57.