Drug Product Listing Renewal | No Changes Certification
FDA Blanket No Changes Certification of Drug Product Listing
Keep your NDC listings active and your products in the FDA directory. Send us your labeler code and we'll handle the SPL submission in 48 hours.
What Is the Blanket No Changes Certification?
Every registered drug establishment, domestic or foreign, is required to certify its drug product listings with FDA each year. If your product formulations, labeling, and listing data have not changed since your last submission, you can satisfy this requirement with a single blanket no changes certification covering all of your listed NDCs.
This certification tells FDA: nothing about these products has changed. It is submitted electronically in Structured Product Labeling (SPL) format and must reach FDA between October 1 and December 31 each year, as part of your annual registration renewal window.
The requirement applies under 21 CFR 207.57(b). It covers finished drug products, OTC drugs, prescription drugs, and active pharmaceutical ingredients (APIs) listed under your labeler code.
Who Needs to Submit
You need a blanket no changes certification if:
- You are a domestic or foreign drug establishment registered with FDA
- You have active NDCs listed under your labeler code
- None of your listed products had labeling, formulation, or distribution changes during the calendar year
- You did not otherwise submit an updated SPL listing for those NDCs during the year
US agents, importers, and authorized consultants may submit on behalf of a registered establishment. If you are a Private Label Distributor (PLD) with your own labeler code, you are responsible for certifying your own listings separately from the registered manufacturer.
What Happens If You Don't Certify
Any NDC that is neither updated nor certified during the October-December window is considered expired as of January 1 of the following year. Expired listings are removed from the FDA NDC Directory and from DailyMed. A drug that remains on the market without an active listing is considered misbranded under federal law.
Reinstatement requires submitting a full updated drug listing SPL, which takes more time and effort than the annual certification. It is worth doing the certification on time.
How the Submission Works
The certification is submitted as an SPL file, which stands for Structured Product Labeling. SPL is the XML-based format FDA uses for all drug registration and listing submissions. The file is submitted through CDER Direct (FDA's electronic drug registration and listing system) or via FDA's Electronic Submission Gateway (ESG).
The file must include your establishment information, your authorized agent details, and your labeler code. It covers all NDCs under that labeler code that have not been updated during the calendar year. FDA processes accepted submissions within approximately 24 business hours, after which your listings appear as certified through December 31 of the following year.
If FDA has identified any data deficiency or error in an existing listing (marked with an "E" in the NDC Directory), that listing cannot be certified with a blanket submission. It requires a corrected full listing SPL instead.
What FDABasics Does for You
Preparing and submitting SPL files requires specific authoring software and familiarity with FDA's submission gateway. Most drug companies, especially international ones, do not keep this capability in-house.
When you work with FDABasics, here's what happens:
You send us your labeler code. We review your active listings, prepare the blanket no changes certification SPL file, and submit it to FDA on your behalf. We confirm the submission and follow up on acceptance. You get confirmation that your listings are certified, without having to learn SPL authoring tools or navigate CDER Direct.
We work with clients in more than 50 countries, including manufacturers of OTC drugs, prescription drugs, homeopathic products, and APIs. If you also need your annual establishment registration renewal completed at the same time, we can handle both.
Pricing:
- Up to 10 NDCs: $299
- Each additional block of 10 NDCs: $25
- Turnaround: 2 business days (48 hours)
Frequently Asked Questions
Can a US agent submit the certification on my behalf?
Yes. Authorized agents, including US agents and compliance consultants, may submit blanket no changes certifications on behalf of registered establishments. FDABasics can submit as your authorized agent.
What if some of my products changed and some did not?
Products that were updated during the calendar year do not need to be included in the blanket certification. Those are already considered current. The blanket certification covers only the unchanged listings.
Is the blanket no changes certification the same as renewing my establishment registration?
No. These are two separate submissions. Your establishment registration renewal is a no change notification submitted under a different SPL document type. Your drug product listings require a separate blanket no changes certification SPL. FDABasics can handle both in a single engagement.
What if my FEI number is missing from my registration?
If your FDA-assigned FEI is missing from your establishment registration SPL, the submission will fail validation. In that case, an establishment registration update (not just a no change notification) is required before the listing certification can be accepted. We check for this before submitting.
Can I submit outside the October-December window?
The blanket certification SPL is only accepted during the annual October 1 to December 31 window. Outside that window, certification requires submitting a full updated listing SPL for each individual NDC.
Ready to Get This Off Your Plate?
The certification window opens October 1. Most of our clients send us their labeler code and have their submission confirmed within 48 hours. We serve drug establishments in more than 100 countries and are familiar with the full range of submission scenarios, including multi-labeler code situations, PLD listings, and establishments with pre-existing data deficiencies.
Or email us directly: info@fdabasics.com
Why Choose FDABasics?
FDABasics has been helping foreign manufacturers navigate US FDA requirements since 1995, with over 30 years of regulatory experience serving clients across the food, drug, medical device, and cosmetics industries. We are headquartered in New York, USA and combine deep expertise with the most competitive fees in the industry.
30+ Years of Experience
Originally founded in 1995 as Tobias Systems, we have guided thousands of foreign companies through FDA registration, US Agent services, and full compliance across all four regulated industries.
5-Star Rated on Trustpilot and Google
Our clients consistently rate us 5 stars on both Trustpilot and Google for fast turnaround times, clear communication, and expert handling of their FDA compliance needs.
Strict Client Confidentiality
We believe in ethical business practices and maintain strict confidentiality for all clients. We do not share your information and we do not offer advice simply to sell services.
Lowest Fees, No Hidden Charges
Our fees are straightforward with no hidden charges. We guarantee a cost-effective solution for your business, whether you are a startup or an established manufacturer.
Fast Turnaround and Responsive Service
We know that FDA registration issues can hold up your shipments and delay your market entry. We work quickly and respond promptly so that your compliance is never a bottleneck for your business.
Global Clients, US-Based Team
We serve manufacturers from over 100+ countries and are physically located in the United States, which is a legal requirement for any company serving as your official US FDA Agent.
Not Sure Where To Start?
FDA compliance requirements can be complex, and the right path depends on your specific product, your role in the supply chain, and whether you are a foreign or domestic company. The FDABasics team is happy to point you in the right direction. Contact us for a free consultation and we will help you identify exactly what your business needs to stay compliant and keep products moving into the US market.
