FDA Debarment List (Drug Product Applications)

In August 2026, the “FDA Debarment List (Drug Product Applications)” will be added to AEB's portfolio of restricted party lists. Should this list be relevant for your company, and you wish to include it into your AEB Compliance Screening software, the “FDA Debarment List (Drug Product Applications)” list can be licensed in addition to your already existing content.

What is the meaning of this restricted party list?

The FDA, or Food and Drug Administration, is a federal agency within the U.S. Department of Health and Human Services. Its mission is to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the food supply, cosmetics, and tobacco products.  

The FDA is required by law to ban individuals who have been convicted of felonies or misdemeanours relating to drug product development, approval, or regulation under the federal Food, Drug, and Cosmetic Act (FD&C Act). Consequently, the “FDA Debarment List (Drug Product Applications)” is a public registry of individuals and entities legally prohibited from participating in any capacity in the pharmaceutical industry, particularly concerning the development, submission, or approval of drug products, pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)).

The original list can be found at the following URL:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/fda-debarment-list-drug-product-applications

Which companies should screen against the “FDA Debarment List (Drug Product Applications)”?

Screening against this list is relevant for companies subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Moreover, other companies may choose to conduct screening against the “FDA Debarment List (Drug Product Applications)” if, for example, their corporate compliance policies or contractual obligations require them to do so. 

Do you need to license this list if you use third-party content in Compliance Screening?

If you screen your business partners against restricted party list content from third parties – such as Reguvis or Dow Jones – in your AEB Compliance Screening application, the “FDA Debarment List (Drug Product Applications)” may already be included in your content. In that case you do not need to license this list separately/additionally. For more information, please contact your content provider.

Efficient restricted party list screening – the “FDA Debarment List (Drug Product Applications)” list and more: How can AEB help?

The AEB Compliance Screening Module takes care of restricted party list screening against the “FDA Debarment List (Drug Product Applications)”and performs the screening automatically in the background – upon request also integrated into SAP®, Salesforce, Microsoft Dynamics 365, and other ERP and CRM systems. Please find an overview of AEB's available restricted party lists here.  

If you wish to include the “FDA Debarment List (Drug Product Applications)”in your Compliance Screening, please request a non-binding quotation. Via the form, you can also contact a product expert.