CLA-2-30:OT:RR:NC:1:138
Mr. Craig A. Lewis
Hogan Lovells US LLP
555 Thirteenth Street, N.W.
Washington, DC 20004-1109
RE: The tariff classification of the Optinose® XHANCE™ in dosage form imported from Canada and the Molded Nasal Applicator and the Molded Nose Piece imported from the United Kingdom
Dear Mr. Lewis:
In your letter dated November 28, 2017, on behalf of Optinose US, Inc., you requested a tariff classification ruling. A sample of the Optinose XHANCE without the fluticasone propionate was provided with your letter and will be retained for reference only.
The Optinose XHANCE is a corticosteroid nasal spray indicated for the treatment of nasal polyps in patients 18 years or older. The recommended dosage is 1 spray (93 mcg of fluticasone propionate per spray) in each nostril twice daily (total daily dose, 372 mcg). The complete product (Optinose XHANCE) consists of a liquid formulation of fluticasone propionate (a corticosteroid), as the active ingredient and an Exhalation Delivery System (EDS) that is designed to deliver the medication into the high and deep regions of the nasal passages where nasal polyps originate. In your letter, you state that nasal polyps are growths on the lining of the nasal passage or sinuses that can block nasal passages and lead to breathing problems. The EDS system consists of a container for the fluticasone propionate, a spray pump and a liquid delivery subassembly consisting of plastic components. You further state XHANCE is not reusable and once the fluticasone propionate is used up, the entire XHANCE (the delivery system and drug) is designed for disposal and is intended to be marketed to physicians, hospitals, and patients only.
Two parts (Molded Nasal Applicator and Molded Nose Piece) of the EDS’ liquid delivery subassembly will be imported separately. The Molded Nasal Applicator is described as a plastic component of the subassembly that is attached to the stem of the metered dose spray pump. When the pump is actuated, a volume of formulation is displaced through the stem of the pump and into the applicator. The displaced formulation is forced past the bi-lobial swirl chamber on the stone, and through a small hole in the tip of the applicator outer, which atomizes the formulation into a spray.
The Molded Nasal Piece is described as an asymmetrically shaped part of the delivery mechanism that uses the patient’s exhaled breath to naturally seal close the soft palate and to facilitate delivery of the drug to the nasal passages through the sealing Molded Nasal Piece. The Molded Nasal Piece is designed to create a seal with the nostril, to expand and stent the upper part of the nasal valve.
The applicable subheading for the Optinose XHANCE in dosage form will be 3004.32.0000, 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, containing hormones or other products of heading 2937: Containing corticosteroid hormones, their derivatives or structural analogues.” The general rate of duty will be free.
The applicable subheading for the Optinose Molded Nasal Applicator and the Optinose Molded Nose Piece will be 9019.20.0000, HTSUS, which provides for “Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus and parts and accessories thereof.” The general rate of duty will be free.
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 on World Wide Web at https://hts.usitc.gov/current.
This Optinose XHANCE 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.
This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division