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  1. Compliance Manuals

Manual of Compliance Policy Guides


Compliance Policy Guides (CPGs) are intended to advise Food and Drug Administration (FDA) staff as to the Agency's strategy when assessing and enforcing industry compliance.

They typically establish FDA policy and interpretation where there is a need for clarification or to address other issues not covered by existing FDA laws, regulations, or guidance.

The CPGs are organized by subject-matter in the following chapters:

  • General
  • Biologics
  • Devices
  • Human Drugs
  • Food, Colors, and Cosmetics
  • Veterinary Medicine

FDA staff is encouraged to contact the Office of Strategic Planning and Operational Policy (OSPOP)/Division of Operational Policy (DOP), within the Office of Regulatory Affairs (ORA) should they see a need for a new CPG or the revision of an existing one.

Please send comments or suggestions to ORAPolicyStaffs@fda.hhs.gov


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