The FDA Debarment List: Compliance in the Healthcare Industry

The healthcare industry has been under scrutiny recently, which gives you all the more reason to ensure that your hiring practices protect you from any liability. One way to do that is to check prospective employees against the F.D.A. Debarment list.

The F.D.A. Debarment list is maintained by the U.S. Food and Drug Administration (F.D.A.) and identifies individuals convicted of a felony related to the development, approval of a pharmaceutical product, or otherwise related to any drug product under the Food, Drug and Cosmetic Act (FDCA).

Screening against this list will ensure that your new employee has no convictions against them and is a compliant hire.

Who is on the F.D.A. Debarment List?

Individuals on the F.D.A. debarment list may have committed fraud in a health care or medical setting, submitted or assisted in the submission of a falsified or otherwise fraudulent drug application, imported a non-FDA approved food or drug into the United States, or other activity relating to 21 U.S.C. § 335a of the FDCA. This penalty was added in an amendment in 1992, to the FDCA which was passed in 1938.

Individuals, corporations, partnerships, and associations found guilty may find themselves on the F.D.A. Debarment list. This means that their privilege to work in a position relating to products regulated by the F.D.A. has been revoked. Debarment may last for a stated amount of time, such as a number of years, or may be permanent.

Why Screen for F.D.A. Debarment?

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When applying for drug product approval, your business must certify that you do not and will not use the services of someone who has been disbarred by the F.D.A. Screening prospective employees against the F.D.A. debarment list prevents you from accidentally or unknowingly hiring someone who has been debarred.

Screening serves several purposes:

  • Perhaps most importantly, it protects your business against fines of up to $250,000 per person and up to $1 million per organization for non-compliance.
  • It preserves your reputation and protects the public, as well as maintaining the integrity and trust placed in the F.D.A. by the public.
  • It verifies the candidate's claims of eligibility, by screening against the debarment list, you confirm their eligibility before hiring them.

The Importance of Comprehensive Candidate Screening

Candidate screening against the F.D.A. debarment list as a part of a comprehensive criminal background check will help your business remain in compliance with F.D.A. regulations. This helps maintain the integrity of the drug approvals process and the public’s confidence in the F.D.A. and protects the reputation of your business. And, most importantly, helps you identify the best candidate for the job.

Topics: Compliance

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