Effective Aug 29th, the United States FDA (Food and Drug Administration) Government Agency will require clearance for all biological samples entering into the US. The FDA is a partner government agency of US Customs and has a separate clearance process.

 

What is changing?

 

Low value biological samples have been previously exempted from FDA clearance but will no longer be exempt as of August 29th. The majority of Marken’s biological samples importing the US are low value, so FDA clearance was usually not needed. This will now change. All biological samples will require FDA clearance, regardless of value.

 

What does it mean for the TOMS Marken Team?

 

We will likely see more FDA clearance delays for Marken’s shipments importing into the US due to this new FDA requirement. Marken will not be the only UPS Customer affected, so 4009/SDF will likely have many packages pending clearance with this change. As a result, 4009/SDF will need to send packages pending FDA clearance to hold containers where they will remain till cleared. Once cleared, they will unload the containers for the packages to proceed in the network for delivery. Important: 4009/SDF may not immediately unload the container when the package is cleared. It is SDF/4009 decision alone as to when they unload the container.

 

How does the Marken TOMS Team need to React?

 

  • If working on a Marken US Import package pending clearance, ensure we use proper tools (ISPS, IVP) to identify if cleared/released or not.
  • When communicating to Marken, provide accurate clearance status. If pending FDA clearance, do not provide a timeline for expected clearance. If Marken asks for a timeline, advise we cannot provide and it is at the FDA’s discretion.
    • Utilize ISPS and IVP to determine if on an FDA hold.
  • If package has been cleared, but still held in a container, communicate similar wording to Marken as follows: “Package or shipment is released and will be processed in SDF according to standard operating procedures”
    • Do not provide a timeline as to when SDF will forward for delivery
    • *See below example on how to identify if being held in a container*
  • If Marken requests additional information about standard operating procedures and timelines, send to me or your Supervisor, who will send to CPM to address
    • CPM has already communicated to Marken about this change and will support us if Marken continues to ask questions
    • Do not contact CPM directly
    • Do not repeatedly email Brokerage or SDF/4009 to “drop in sort”
      • One email may be sent