Compliance Policy Guides (CPG) explain the Food and Drug Administration (FDA) policy on
regulatory issues related to the FDA laws or regulations. These include Current Good
Manufacturing Practice (CGMP) regulations and application commitments. They advise the
field inspection and compliance staffs as to the Agency's standards and procedures to be
applied when determining industry compliance. Compliance Policy Guides may derive from a
request for an advisory opinion, from a petition from outside the Agency, or from a
perceived need for a policy clarification by FDA personnel.
The field staff is continually encouraged to contact the Division of Compliance Policy
(HFC-230) when they need clarification on an existing CPG or see a need for a new CPG. The
Office of Enforcement is committed to providing the needed guidance.
The Compliance Policy Guides Manual was updated last year and published in a bound
format. This is the second bound edition of the manual. It contains both revised and new
Compliance Policy Guides. The index at the end of the manual identifies all forty CPGs
that were revised and the two new CPGs (CPG 7150.19 and CPG 7125.40) issued since the last
edition.
