USFDA OTC & Prescription Drug Compliance

Market: USA | HS: 30

COMPLIANCE CHECKLISTS

All Frontier Global Nexus · Commission-Only · allfrontierglobal.com

Compliance Overview

Step-by-Step Compliance Checklist

• Confirm HS code classification and applicable regulatory framework
• Identify required certifications and testing standards for this market
• Engage accredited third-party testing/certification body
• Complete product testing against applicable standards
• Prepare technical documentation dossier
• Obtain certification or declaration of conformity
• Update product labelling and marking to market requirements
• File export documentation (Shipping Bill, COO, certificates)
• Maintain post-market surveillance records
• Renew certification annually or per audit cycle

Key Documentation Required

• Certificate of Conformity / Test Report from accredited lab
• Declaration of Conformity (EU) or equivalent
• Technical Data Sheet / Safety Data Sheet (SDS for chemicals)
• Certificate of Origin (appropriate form for destination)
• Commercial Invoice with correct HS classification
• Packing List with compliant labelling details

Common Non-Compliance Risks

• Wrong HS classification → wrong duty rate or wrong regulation applies
• Expired or non-accredited certification body → market rejection
• Missing or incorrect product labelling → customs hold or recall
• SPS/MRL violation → RASFF alert, market withdrawal, blacklisting
• Delayed COO → loss of FTA preference → additional duties payable

AJG Compliance Intelligence

This checklist is part of AJG's 80,000+ data point compliance database. For vertical-specific compliance under any of the 273 FTAs, contact All Frontier Global Nexus commission-only brokerage.

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