Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Fampridine (CAS-504-24-5), in bulk form, from India, Milnacipran Hydrochloride (CAS-101152-94-7) and Rufinamide (CAS-106308-44-5) in bulk form, from Italy
Dear Ms. Forstenzer:
In your letter dated July 6, 2009, you requested a tariff classification ruling.
The first product, Fampridine, is also known as 4-Aminopyridine, a potassium channel blocker and is currently an investigational drug for improving walking ability in people with multiple sclerosis (MS).
The second product, Milnacipran Hydrochloride, is a Norepinephrine Serotonin Reuptake Inhibitor (NSRI) antidepressant drug. It is used for the treatment of clinical depression and chronic pain, especially fibromyalgia.
The last product, Rufinamide, is an anticonvulsant and is indicated for the adjunctive treatment for severe epilepsy disorder, especially Lennox-Gastaut syndrome (LGS).
The applicable subheading for the Fampridine in bulk form will 2933.39.4100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” The rate of duty will be 6.5% ad valorem.
The applicable subheading for the Milnacipran Hydrochloride in bulk form will be 2924.29.6250, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Carboxyamide-function compounds; amide-function compounds of carbonic acid: Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other: Drugs: Other: Other.” Pursuant to GN13, HTSUS, the rate of duty will be free.
The applicable subheading for the Rufinamide in bulk form will be 2933.99.6500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Drugs primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives.” Pursuant to General Note 13, HTSUS, 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 http://www.usitc.gov/tata/hts/.
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 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 Harvey Kuperstein at (646) 733-3033.
Robert B. Swierupski
National Commodity Specialist Division