Compliance Policy Guide Section 110.800 
Post Detention Sampling 
Guidance for Industry 
 
 
 
 
 
 
This guidance is for immediate implementation. 
 
 
 
 
FDA is issuing this guidance for immediate implementation in accordance with  
21 CFR 10.115(g)(4)(i).  Submit one set of either electronic or written comments on this 
guidance at anytime.  Submit electronic comments to https://www.regulations.gov/.  Submit 
written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  You should identify all comments with 
docket number FDA-2019-N-0999.   
 
 
 
 
For questions regarding this draft document contact the ORA Office of Strategic Planning and 
Operational Policy (OSPOP) at ORAPolicyStaffs@fda.hhs.gov.  
 
 
 
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration 
Office of Regulatory Affairs 
 
March 2020 
 
 
   
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Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 3 
II.  BACKGROUND ............................................................................................................... 3 
III.  POLICY ............................................................................................................................. 3 
IV.  REFERENCES .................................................................................................................. 4 
 
 
 
 
 
ii  Compliance Policy Guide Section 110.800 
Post Detention Sampling 
Guidance for Industry 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I.  INTRODUCTION 
 
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 FDAs 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.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the FDAs 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 FDAs guidances means that something is suggested or 
recommended, but not required. 
 
 
II.  BACKGROUND 
 
 
Importers of articles regulated by the FDA sometimes request permission from the FDA for 
samples to be collected from an article they have offered for import but that has been detained by 
CBP on behalf of FDA.  The article may be in the physical possession of the importer and held 
under redelivery bond, or the article may be in the custody of CBP pending final disposition. 
 
 
III.  POLICY 
 
The FDA does not object to the collection of reasonable samples from a detained article for 
appropriate analysis or other appropriate examination, such as for the purpose of introducing 
evidence relevant to the admissibility, destruction, or reconditioning of the article, or to explore 
the possibility of reconditioning the article.  Regardless of whether the article is in CBP custody 
or in the physical possession of the importer under redelivery bond, the importer is responsible 
for obtaining permission from CBP for the sample collection and complying with any CBP 
3  requirements.  The importer should take the steps necessary to account to CBP for whatever 
amount is missing from the article due to the sampling if he or she is called upon to redeliver the 
detained article to CBP custody for destruction or exportation. 
 
Issued: 3/15/77 
Revised: 10/1/80, 8/31/89, 03/12/2020 
 
IV.  REFERENCES  
   
 
1.  U.S. Food and Drug Administration. Manual of Compliance Policy Guides. Last updated 
09/19/2018.  Last accessed 3/12/2020. 
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default
.htm 
 
 
 
 
 
 
 
 
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