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N294507 N2 Ruling Active

The tariff classification of Felbamate Oral Suspension in dosage form, from Israel

Issued March 14, 2018 by U.S. Customs and Border Protection.

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N2 N294507 (March 14, 2018)

Tariff classification

HTS codes: 3004.90.9230

Headings: 3004

Product description

Felbamate is an antiepileptic medication that is indicated for the treatment of severe epilepsy. It is used to treat partial seizures with and without generalization in adults and partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Felbamate will be imported in oral suspension of 600 mg/5 ml.

CBP rationale

The applicable subheading for the Felbamate Oral Suspension in dosage form will be 3004.90.9230, 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: Anticonvulsants, hypnotics and sedatives.

Full text

N294507 March 14, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.90.9230 Ms. Rhona M. Keeler NorthStar Healthcare 330 Cork Airport Business Park, Kinsale Road Cork, T12 XN72, Ireland RE: The tariff classification of Felbamate Oral Suspension in dosage form, from Israel Dear Ms. Keeler: In your letter dated February 20, 2018, you requested a tariff classification ruling. Felbamate is an antiepileptic medication that is indicated for the treatment of severe epilepsy. It is used to treat partial seizures with and without generalization in adults and partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Felbamate will be imported in oral suspension of 600 mg/5 ml. The applicable subheading for the Felbamate Oral Suspension in dosage form will be 3004.90.9230, 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: Anticonvulsants, hypnotics and sedatives.” 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 on World Wide Web at https://hts.usitc.gov/current. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). 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. 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

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