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Federal Register: FDA · August 31, 2026 · Primary source

Rahim Shafa; Denial of Hearing; Final Debarment Order

Score 46PRIMARYenforcementFederal Register

Summary

FDA issued a final debarment order permanently barring Rahim Shafa from providing services to any entity with an approved or pending drug application, and debarring him for 20 years from importing or offering drugs for import into the United States. The order follows FDA's denial of Dr. Shafa's hearing request and is grounded in his conviction of multiple federal felonies related to drug regulation under the FD&C Act. The action is a standard FDA debarment proceeding with no direct Medicare/Medicaid billing, AKS, FCA, or behavioral health compliance dimension.

What this may mean

The debarment order bars Dr. Shafa personally from participation in the drug-application and importation process under the FD&C Act; it does not impose obligations on third-party healthcare organizations. Any entity that knowingly employs or contracts with a debarred individual in a covered capacity faces exposure under 21 U.S.C. § 335a. The action has no direct effect on provider reimbursement, fraud-and-abuse statutes, or behavioral health regulation.

Informational only. Not legal, medical, financial, or other professional advice. Always consult a qualified professional familiar with your specific facts before relying on any item.

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