Out of Date Drug Listings

FDA to deactivate out-of-date drug listings in its database

The US Food and Drug Administration (FDA) has announced that it will deactivate out of date drug listings in its database including any that have not been recently updated or are inaccurate, as required by regulation, or that include an establishment with an expired registration.

“FDA regulations require all drug manufacturers to register their manufacturing facilities and provide a list of all drugs they are actively manufacturing for commercial distribution in the US as one of the safeguards protecting our drug supply chain,” said FDA Acting Commissioner Ned Sharpless, MD. “It is vital that the FDA database accurately describes drugs currently available to patients in the US.”

The agency has found that tens of thousands of drug listing records have not been updated or certified in the past year and are therefore not in compliance with federal regulations. Out of date drug listings not only provide the wrong information to consumers but can also slow down surveillance operations for certain FDA programs.

In many cases, the listings are for products that are no longer being marketed in the US, but the manufacturer or labeler (i.e., the party who labels with the NDC relabeler code) never updated or deactivated the listing. The FDA has said that such outdated listings compromise the integrity of the database and its ability to make accurate and timely decisions to protect public health.

“While most companies are compliant, we have observed that some drug listings contain obsolete or inaccurate information,” added Sharpless. “To ensure we’re working with the most updated and complete information, the agency is putting companies on notice that these outdated records will be inactivated. Products with inactivated listings may not be legally marketed in the US until the company brings their records up-to-date.” (emphasis added).

“We’ll continue to enforce drug establishment registration and listing requirements and we’ll work closely with manufacturers to ensure that registration or listing deficiencies do not affect the availability and quality of medicines for patients or result in drug shortages.”

The agency urges companies to update inaccurate active drug listing submissions as soon as possible, as inactive listings as of 12 September 2019 will be removed from the database.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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