Payment for Import Samples
Per 21 CFR 1.91, “The Food and Drug Administration will pay for all import samples which are found to be in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act…Payment for samples will not be made if the article is found to be in violation of the act, even though subsequently brought into compliance…”.
- What type of import samples will the FDA pay for?
- What costs will the FDA reimburse?
- Where do I submit the request for payment?
- What information should be submitted with the request for payment?
What type of import samples will the FDA pay for?
The FDA will pay for import samples physically collected by the FDA and found to be in compliance with the requirements of the Act and applicable regulations, including samples collected by the FDA to audit private laboratory analytical results. The FDA will not pay for samples of products:
- collected in connection with the supervision of reconditioning.
- initially found to be in violation, even if the product is subsequently released.
What costs will the FDA reimburse?
The FDA is only required to pay for the vendor’s actual cost of import samples physically collected (NOT the market value). The actual cost is indicated in the “Samples Collected” section of the Notice of FDA Action issued at the time of sampling. The FDA only pays for the amount of product collected. For example, if one pound is collected from a 20-pound bag, the FDA will only pay for the one pound collected.
Where do I submit the request for payment?
You may bill the FDA office associated with the port where your product made entry. If you have questions about payment for samples, please contact the FDA Officer identified on the most recent Notice of FDA Action received.
What information should be submitted with the request for payment?
A request for payment should include an invoice with the following elements:
- An invoice from the requester, on their letterhead, indicating an invoice number and the amount being billed
- Description of the product
- Quantity collected.
- Entry number
- Copy of the FDA Notice of Action
- Vendor’s Tax ID (EIN)
- Telephone number to contact the firm, if additional information is required.
- Physical address where the payment should be mailed
NOTE: To expedite payment, if the bank information is provided, the payment can be submitted electronically. The bank information shall consist of the Bank’s Name, Routing Number and Account Number for submission of electronic payment.