When cleaning out closets at home, organization experts recommend tossing or donating anything you haven’t worn in the past year. Last month, the U.S. Food and Drug Administration (FDA) announced a major effort akin to cleaning out its “closets” – in this case, its database of drug listings.
Of course, the FDA initiative is about much more than having an organized wardrobe; it’s aimed at safeguarding the nation’s drug supply chain. By ensuring that establishment registrations and product listings are current and accurate, FDA can more quickly handle drug quality issues, adverse event reports, inspections, recalls, shortages and other security issues throughout the drug supply chain.
FDA begins inactivating non-compliant drug products
While the rules in question have been around for many years, FDA recently discovered that too many drug product listings are out of compliance with drug establishment registration and drug listing requirements. Some haven’t been updated in over a year. Some aren’t certified as being up to date. Others point to a manufacturing establishment that isn’t currently registered with FDA. In fact, many of these drugs appear to be out of commercial distribution.
What does this mean for your products and your company? If all of your listing files and your annual registration are up to date, this initiative will have no immediate impact. If your listings and/or registration aren’t current, however, you need to act swiftly. FDA has announced that outdated records would start being inactivated as of September 13, 2019 – and any product with an inactive listing cannot be legally marketed in the U.S. until the company brings those records up to date.
Not sure if you are compliant?
Take these two steps right away:
- Check the status of your listing(s) at the National Drug Code (NDC) Directory. The NDC Directory includes both finished and unfinished products, so be sure to click on the appropriate radio button for each product’s status.
- Check the status of your establishment registration at the Drug Establishments Current Registration Site (DECRS) page. It shows the current information submitted by drug firms to meet establishment registration requirements.
FDA provides an in-depth Q&A on its Electronic Drug Registration and Listing Instructions page.
3 easy steps to avoid FDA inactivation
Submitting Structured Product Labeling (SPL) data to the FDA can be a time consuming and rigorous process. Reed Tech can help. 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.
If you have questions – or want assistance ensuring that your registration and listing(s) are appropriately updated, certified or associated with a registered establishment – reach out to Reed Tech. Our SPL Services for Rx, OTC and Biologics are designed to help you stay on top of electronic submission compliance.
With our simple and quick 3-step process we’ll manage the whole SPL process for you to update and list your products and register your establishment before the 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. For further details about our 3-step process to help ensure you meet these mandatory FDA initiatives, click below…
* Depending on the complexity of your submission, certification can be completed in approximately two days and it may be more economical than you think.