QUESTION: Under 21 CFR section 201.122 (c), import of an API (drug substance) for further manufacturing/use in a drug (commercial/human use) is permissible under a pending or near approval of an FDA application (BLA in this instance) so long as affirmation that the API will not be exported and that the products manufactured with the […]
QUESTION: I received an email from a buyer who made arrangements for the vendor to prepay and add freight for a shipment to our Canadian entity. The vendor sold them on the idea that prepay and add is DDP. I did not think that was correct and an email from the courier asking for our […]
QUESTION:If our company name is listed on the master house bill of lading as the consignee (We are the turnover agent) and the shipment goes into General Order, would our company be liable and or responsible for any storage or other charges? Concerned that the mere mention of our company name would put us in […]
QUESTION: I’m curious how the membership handles the creation of invoices for exporting items that aren’t part of inventory. Examples would be sending laptops to colleagues in Canada, items for testing, “free” gifts from the marketing department etc. Currently our process is very manual. We have a form for the requestor to complete which includes […]
FYI – for previous question: DDTC Partner, Last week, in response to your submission to the DDTCCustomerService@state.gov email, you received an automated reply reading, “this email is no longer monitored.” This message was sent in error, caused when a system update redirected incoming mail to an inactive mailbox. The issue has been resolved and the […]
QUESTION: I would like to ask members who are with smaller to mid-sized companies how they handle dual sourced parts? Currently don’t have an ERP system that holds more than 1 COO per part. However, even if we did there would still need to be some “lot control” or other process to know which COO […]
QUESTION: TMP(b)(3) references “foreign origin” items. An aircraft operator in Turkey send me a 9A610 item to analyze and send back (unchanged). Can I use TMP even if the item was manufactured in the USA? I presume in the context of TMP, that “foreign origin” does not mean what we typically think of in the […]
QUESTION: It just came to my attention that we have a US entity who is supported by their related Belarus entity for IT services. The US company pays for the services on a cost plus transfer price. Are these services allowable under the newer sanctions in response to the Ukraine war? ========== Answer: The U.S. […]
QUESTION: Our company currently has different processes for customs invoices, based on shipping location: mix of company owned warehouse and third party warehouse. We are trying to standardize our Customs Invoice process to one process, but there is concern over providing a customs invoice with pricing to third party warehouses. How are other companies managing […]
QUESTION: How long does your company retain visitor logs physically (paper copies)? How long does your company retain visitor logs electronically (scans of paper logs)? ========== Answers: As a rule, 5 years for both types of records. This means that, at the end of 2021, we kept 2016-2021. We typically purge at the end of […]
QUESTION: We have some imports that are set up as pay in advance rather than Net terms. These invoices from our suppliers frequently have an additional banking fee included on it to cover their charge for the wire transfer. If the bank fee is charged directly by the supplier, then does it become a part of the […]
QUESTION: Can freight charges listed on a commercial invoice be distributed through out all of the line items or should it be added/deducted as the full amount on the 7501? *************** If you have a way to substantiate (prove) the freight charges, you don’t need to include that value in the total value of your […]
