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Avoid FDA Inactivation

Avoid FDA Inactivation

3 EASY STEPS TO AVOID FDA INACTIVATION:

1. Use the form below to contact our SPL team. They will provide you with the documents you need, and walk you through the process.

2. Send the completed information to our SPL team for review. They’ll create the required SPL document and ensure it meets all FDA business rules for validation.

3. They will submit your information to the FDA and manage the process until it is approved and ensure it is successfully filed with the FDA.

DEADLINE: DECEMBER 31, 2019.

Don’t wait to certify and register. To meet this year’s December 31 deadline, it’s wise to start the process now to avoid the end-of-the year rush or any unanticipated requests by the FDA.

Avoid FDA Drug Inactivation by Submitting your Blanket- No-Change Certification and Establishment Registration. FDA Annual Deadline is December 31.

Submitting Structured Product Labeling (SPL) data to the FDA is time consuming and a rigorous process. For more than 15 years, Reed Tech has provided over 1,000 drug manufacturers and distributors with fast, accurate and cost-effective* solutions to gather, convert, and submit SPL data to the FDA.

Follow the 3 easy steps shown above, and we’ll manage the whole SPL process to update and list your products and register your establishments with the FDA and avoid inactivation.

As of September 13, 2019, the FDA will begin making non-compliant drug product records inactive.

This process will result in the closure of drug records in all public drug listing databases maintained by the FDA, including the National Drug Code (NDC) Directory and the NDC SPL Data Elements (NSDE) file. Any product with an inactive listing cannot be legally marketed in the U.S. and is subject to import and reimbursement issues until the company brings those records up to date.

* Depending on complexity of your submission, certification can be completed in approximately two days and it may be more economical than you think.

 

Not sure if you’re compliant?

Use the form above to contact our SPL team, and we’ll research your drug certification status and handle any necessary data collection, application and submission needs to ensure your drug and establishment meet FDA compliance.

Get this off your “to-do” list.

Contact us to get started or to ask any questions.

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