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.

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,  list your products, register your establishments with the FDA and avoid inactivation.

As of September 13, 2019, the FDA began 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.

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 need to ensure your drug and establishment meet FDA compliance.