Yes, I kind of suspected that the HTS code request was from a UK based CTM manufacturer since we don't use them for importation of CTMs in the US.
The IND number is very essential. I sent you a contact request via RAPS, please accept and respond with your email so that I can privately send you any other codes you may need for the importation of your product at the port of entry. Since this is a drug product, all you may need is the Open IND number but sometimes the FDA at the port of entry may ask other details so I'll double check and get back to you.
------------------------------
GRSAOnline
------------------------------
Original Message:
Sent: 02-Jun-2020 16:19
From: John Wetzel
Subject: HTS Code for clinical trial material
Dear Narayan,
So far, the only request for an HTS code was on a shipping request form provided by the CTM manufacturer in the UK. If I understand correctly, you're saying that we do not even need to provide this code, but we may need to provide an Importation Code. We will also provide the IND number. Where can I learn more about the Importation Code and how to assign it? Is this different from the AofC code, which I believe is simply the IND number?
Thanks again for your comments. Feel free to contact me at 740-698-0420 if that would be easier for you.
John
------------------------------
John Wetzel
Principal
Albany OH
United States
Original Message:
Sent: 02-Jun-2020 13:31
From: Narayan Rao
Subject: HTS Code for clinical trial material
Can you please advise who is asking this tariff code for importation? FDA at the port of entry?
The above tariff schedule does not apply to any IND products. Importation codes are different.
------------------------------
GRSAOnline
Original Message:
Sent: 02-Jun-2020 13:18
From: John Wetzel
Subject: HTS Code for clinical trial material
It seems to me that either heading 3003 or 3004 should apply.
3003 is defined as follows: Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed
together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale.
3004 is defined as follows: Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or
prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale.
The clinical trial material is "put up in measured doses", but these are not for retail sale. So, I'm confused as to which of the above categories is appropriate. I am leaning towards 3003, as the medicament is not [put up in measured doses for retail sale].
------------------------------
John Wetzel
Principal
Albany OH
United States
Original Message:
Sent: 02-Jun-2020 13:07
From: John Wetzel
Subject: HTS Code for clinical trial material
Hi Narayan,
Thank you for your response.
I am trying to import clinical trial material consisting of an NCE in a parenteral formulation filled into vials. This CTM was manufactured in the UK for a US-based sponsor. The clinical studies occur in the US. There is an IND open.
John
------------------------------
John Wetzel
Principal
Albany OH
United States
Original Message:
Sent: 02-Jun-2020 12:49
From: Narayan Rao
Subject: HTS Code for clinical trial material
Yours is an investigational IND product! is it a NCE? or is your IND product contains an approved API? Regardless, I am puzzled as to why you are looking at tariff schedule to import an IND product vials into the US for clinical research purposes?
Is your product detained by the FDA? I am familiar with importation codes used for APIs and IND products to satisfy the FDA compliance office at the airport so Please provide more details.
------------------------------
GRSAOnline
Original Message:
Sent: 02-Jun-2020 11:22
From: John Wetzel
Subject: HTS Code for clinical trial material
Hello All,
I am trying to figure out the correct Harmonized Tariff Schedule (HTS) Code for the importation into the US of vials of an investigational drug product for use in clinical trials. There is an open IND. The indication is oncology.
I am looking in the following website, but having difficulty identifying the appropriate code: Harmonized Tariff Schedule PDFs
Any suggestions would be appreciated.
------------------------------
John M Wetzel, PhD
Wetzel Chemistry Consulting, LLC
4141 Baker Road
Albany, OH 45710
------------------------------