OIG Compliance Program Guidance for Pharmaceutical Manufacturers

Dated: April 18, 2003.
Elizabeth M. Duke,
Administrator.
[FR Doc. 03–10934 Filed 5–2–03; 8:45 am] BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

OIG Compliance Program Guidance for Pharmaceutical Manufacturers

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Notice

SUMMARY: This Federal Register notice sets forth the recently issued Compliance Program Guidance for Pharmaceutical Manufacturers developed by the Office of Inspector General (OIG). Through this notice, the OIG is setting forth its general views on the value and fundamental principles of compliance programs for pharmaceutical manufacturers and the specific elements that pharmaceutical manufacturers should consider when developing and implementing an effective compliance program.

FOR FURTHER INFORMATION CONTACT:
Mary E. Riordan or Nicole C. Hall, Office of Counsel to the Inspector General, (202) 619–2078.

Background

Developing the Compliance Program Guidance for Pharmaceutical Manufacturers

Elements for an Effective Compliance Program

Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers

  1. Introduction
  2. Compliance Program Elements
    1. The Basic Compliance Elements
    2. Written Policies and Procedures
    3. Designation of a Compliance Officer and a Compliance Committee
    4. Conducting Effective Training and Education
    5. Developing Effective Lines of Communication
    6. Auditing and Monitoring
    7. Enforcing Standards Through Well-Publicized Disciplinary Guidelines
    8. Responding to Detected Problems and Developing Corrective Action Initiatives
    9. Reporting
  3. Conclusion
    Endnotes

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