Foreword

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.

Please telephone or send comments or suggestions for improvement to the Division of Compliance Policy (HFC-230), 15800 Crabbs Branch Way, Suite 130, (HFC-230), Rockville, MD 20855 (telephone number 240-632-6860). As usual, we appreciate all comments and suggestions.

Howard R. Sklamberg
Director
Office of Enforcement