On September 12, 2019, the U.S. Food and Drug Administration (FDA) will begin removing
inactive drug listings from its drug listing database. In other words, inactive drug listings will no longer be “listed” with FDA, as required by law. A removed drug listing can be especially harmful for imported drugs as FDA commonly issues import detentions and subsequent import refusals, if it is not resolved, for unlisted drugs.
What is the Drug Listing Requirement?
The Federal Food, Drug, and Cosmetic Act (FDCA) requires all drug manufacturers,
repackers, relabelers, and salvagers to provide a list of all the drugs that
they “manufacture.” A drug listing consists of a variety of information, such
as the drug’s active pharmaceutical ingredients, its package type, the drug’s basis
to be marketed, and other information. As part of this requirement, a
manufacturer must ensure that their listings are up-to-date and “active.”
When
is a Drug Listing Considered “Inactive”?
FDA
considers a drug listing inactive when it has not been appropriately updated,
certified, or associated with a registered establishment. This current announcement
comes two years after FDA declared in 2017 that it was implementing the drug
certification requirement where a company must either update their associated
drug listings or certify that no changes occurred with the previously submitted
drug listing information.
What are Some Possible Consequences of an Unlisted Drug?
If
a drug is not appropriately listed with FDA, it is misbranded. For a domestic
product, failure to comply with this requirement may result in a Warning Letter.
Beyond this FDA concern, a no longer valid drug listing (and associated NDC
number) may impact insurance reimbursements.
These
concerns are true for imported drugs, but the consequences of an unlisted drug
can be more immediate and impactful. As a misbranded drug, any unlisted drug is
subject to an import detention – threat of refusal – based on the drug being
unlisted. This is a common cause of drug import detentions. If the importer and
manufacturer do not work together to timely list the drug, FDA will issue an
import refusal. This means the importer must either export or destroy the
unlisted drug product.
Now What? FDA observed that tens of thousands of drug listings have not been updated in the previous year and are therefore at risk of being deleted soon. Therefore, we recommend all drug manufacturers, repackers, relabelers, salvagers, distributors, and importers who are not sure of the status of their drugs immediately check the status of their drug listing information and update any drug listing information that is expired or inaccurate. FDA’s National Drug Code Directory, available here, may be used to check the listing status of drugs.
