CLA-2-30:OT:RR:NC:N3:138
Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 N Pennington, NJ 08534
RE: The tariff classification of Icosapent Ethyl Capsules in dosage form, from China, and the classification of Norelgestromin and Ethinyl Estradiol Transdermal System from Argentina and India
Dear Mr. Shah:
In your letter dated February 1, 2023, you requested a tariff classification ruling.
Icosapent Ethyl, imported in 0.5 gram capsules, belongs to a class of drugs called Lipid-Lowering Agents. It is available by prescription only as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia. In your letter, you stated Icosapent Ethyl Capsules will be imported from Italy.
Norelgestromin and Ethinyl Estradiol Transdermal System, imported in 150 mcg/35 mcg day, is a combination transdermal contraceptive system containing norelgestromin (a progestin) and ethinyl estradiol (an estrogen). It is indicated for the prevention of pregnancy in women with a body mass index BMI < 30 kg/m2 for whom a transdermal delivery system is an appropriate method of contraception. In your letter, you stated Norelgestromin and Ethinyl Estradiol Transdermal Systems will be imported from India.
The applicable subheading for the Icosapent Ethyl Capsules in dosage form will be 3004.90.9220, 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: Cardiovascular medicaments.” The rate of duty will be free.
The applicable subheading for the Norelgestromin and Ethinyl Estradiol Transdermal System will be 3006.60.0000, HTSUS, which provides for “Pharmaceutical goods specified in note 4 to this chapter: Chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spermicides.” The 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 at https://hts.usitc.gov/current.
This merchandise 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 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