CLA-2-29:OT:RR:NC:N2:238
Ms. Inge Forstenzer
Ren-Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Lacosamide (CAS-175481-36-4) in bulk form, from Italy
Dear Ms. Forstenzer:
In your letter dated May 14, 2009, you requested a tariff classification ruling.
The subject product, Lacosamide, is an anticonvulsant. It is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
The applicable subheading for the Lacosamide 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.
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/.
The U.S. Drug Enforcement Administration (DEA) has ruled that Lacosamide (INN) be placed into Schedule V of the Controlled Substances Act (CSA) effective June 22, 2009. The Controlled Substances Act is enforced by the DEA. You may contact the DEA Office of Diversion Control at 2401 Jefferson Davis Highway, Alexandria VA 22301, telephone (800) 882-9539.
This merchandise may also 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.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division