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COAC Public Meeting, September 14, 2022

The Commercial Customs Operations Advisory Committee (COAC) will hold its quarterly meeting on Wednesday, September 14, 2022, in Chicago, Illinois. The meeting will be open for the public to attend in person or via webinar. Due to COVID-19 restrictions, the in-person capacity is limited to 75 persons for public attendees. Information about the COAC meeting is below.

Dear COAC committee,

Our company can at times experience significant FDA compliance review delays with products that have been imported to the US many times. When you add in all the years it can take to get commercial FDA approval people get confused at our company when I tell them the FDA is reviewing the import entry and documentation. Speeding up this process would save our company significantly on storage charges, delays, and failure to deliver fees. We are respectfully requesting that the COAC committee create an initiative or pilot program with the FDA to expand their trusted trader program to drug importers. The FDA has advised us that this request should come COAC and specifically the 1USG working group. Please find below my proposed criteria and expected benefits for the trade community. Our company would also be interested in partnering with COAC with further questions or discussions on moving forward with this initiative.

Criteria for trusted trader:

  • No unresolved FDA warning letters
  • No debarment from FDA
  • No unresolved FDA NOA’s
  • No recent penalties or fines from FDA (Last 2-3 years?)
  • No seized goods to due to FDA actions
  • Active drug manufacturer for at least 10 years
  • Valid and active FEI
  • Some FDA review/validation of import compliance program
  • Also willing to pay service fee to cover some FDA costs
  • Expected benefits for trade
  • Priority processing status for PGA review
  • Priority processing for FDA compliance review (Electronic & Formal)
  • Point of contact for escalation or resolving processing issues

Thank you for the consideration.

Last Modified: Oct 26, 2022