Overview of the OIG Compliance Program Guidance for Pharmaceutical Manufacturers

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Pharmeceuticals
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Protiviti

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Overview: On April 23, 2003, the Office of Inspector General (OIG) of the Department of Health and Human Services released the final Compliance Program Guidance for Pharmaceutical Manufacturers. The Guidance applies to companies that develop, manufacture, market, and sell pharmaceutical drugs or biological products, and is intended to assist these companies in implementing internal controls to ensure compliance with applicable laws and requirements of the federal health care program. Although targeted to pharmaceutical manufacturers, the OIG indicates that the Guidance may be applicable to manufacturers of other products, such as medical devices, that may be reimbursed by federal health care programs.

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