CLA-2-30:OT:RR:NC:N138
Keith Bell
Almac Clinical Services
9 Charlestown Road Craigavon BT63 5PW United Kingdom
RE: The tariff classification of NMRA-335140 tablets and placebo tablets from the United Kingdom
Dear Mr. Bell:
In your letter dated May 27, 2024, you requested a tariff classification ruling on behalf of Neumora Therapeutics.
NMRA-335140 tablets imported in 80 mg is a medicinal preparation containing, Navacaprant, a selective k-opioid receptor antagonist, as the active ingredient. The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The matching placebo tablets contains 33 percent microcrystalline cellulose, 66 percent lactose monohydrate and 1 percent magnesium stearate. NMRA-335140 tablets and its matching placebo tablets are packaged in separate boxes but will be shipped together in the same shipment. In your letter, you stated, NMRA-335140 is the product code designation for an investigational new drug (IND No. 145761) currently being evaluated in a randomized, double-blind FDA Phase 3 clinical trial to study the effects of Oral NMRA-335140 versus placebo in participants with major depressive disorder. You have provided three different scenarios for the imported NMRA-335140 and the matching placebo tablets with the following products:
In the first scenario, you stated the products are shipped from the Almac facility in Northern Ireland to the Almac facility in Souderton, Pennsylvania. The unlabeled bottles containing either active or placebo tablets are packed into plastic boxes per item type and lot number. The plastic boxes contain each item type separately, the placebo is packed separately in its own plastic box. This is the same for the other 2 items, NMRA-335140 (80 mg) 30 count bottle is packed separately in its own plastic box and NMRA-335140 (80 mg) 17 count bottle is packed separately in its own plastic box. Each plastic box contains 288 unlabeled bottles packaged in 12 plastic card boxes as follows:
3 plastic boxes each containing 288 bottles (total 864 bottles)
4 plastic boxes each containing 288 bottles (total 1152 bottles)
The plastic boxes are then placed into temperature controlled shipping units. After importation, the material undergoes further processing with an FDA compliant clinical trial label applied at Almac US. Once the labelling operation is completed, the material is stored in the Almac US warehouse.Afterwards, when the US Clinical sites are activated and are ready to start the clinical trial, Almac US will receive a drug order form requesting specific bottle numbers (medication ID) to be shipped to the site. Your distribution team will then pick and pack the required bottles and place them into a cardboard inner box. The quantity of active and placebo shipped to a particular site will depend on patient recruitment and the treatment that patients have been assigned to., e.g. the shipment may contain all active, or all placebo or a mix of both. The cardboard inner box is then placed into a temperature controlled shipper to ensure the product is maintained at the correct temperature range during transit to the clinical site.
In the second scenario, you stated it is the same as the first scenario except the active and placebo products are already labelled with an FDA compliant clinical trial label by Almac in Northern Ireland. The active and placebo in this scenario have already been labelled at Almac Northern Ireland. Both products are received by Almac US and stored in the warehouse and then shipped to clinical sites upon receipt of a drug order.
In the third scenario, you stated the product will be shipped from the Almac facility in Northern Ireland directly to a clinical site/hospital in the US, although this scenario has changed. We need additional information to make a classification determination. Please submit detailed information exactly how the products are imported along with its contents. Include clear pictures and labels including any post importation manipulation processes. If you decide to resubmit your request, please include all of the material that we have returned to you and mail your request to Director, National Commodity Specialist Division, Customs and Border Protection, 201 Varick Street, Suite 501, New York NY 10014, Attn: Binding Ruling Request. If your request was submitted electronically and the information required does not involve sending a sample, you can re-submit your request and the additional information electronically.
In your letter, you suggest classification for the NMRA-335140 tablets and the matching placebo tablets in subheading 3006.93.1000, Harmonized Tariff Schedule of the United States (HTSUS) which provides for Pharmaceutical goods specified in note 4 to this chapter: Other: Placebos and blinded (or double-blinded) clinical trial kits for a recognized clinical trial, put up in measured doses: Packaged with medicinal preparations. We disagree. Based on the first and second scenario, the NMRA-335140 tablets and the matching placebo tablets are packaged separately and will be classified elsewhere.
The applicable subheading for the NMRA-335140 tablets in dosage form will be 3004.90.9239, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents: Other. The rate of duty will be free.
The applicable subheading for the matching placebo tablets in dosage form will be 3006.93.5000, HTS, which provides for Placebos and blinded (or double-blinded) clinical trial kits for a recognized clinical trial, put up in measured doses: Containing ingredients having nutritional value, in which starch or other foodstuff predominates by weight. The rate of duty will be 6.4 percent ad valorem.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/.
This product may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division