This Compliance Policy Guide (CPG) provides guidance to importers whose U.S. Food and Drug Administration (FDA) regulated articles offered for import have been detained by U.S Customs and Border Protection (CBP). A previous version of this CPG, numbered 110.800, was revised in FDA’s Compliance Policy Guides Manual in 1989. This CPG supersedes that version and includes minor revisions to clarify existing language, as well as other minor stylistic revisions.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.