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NY I88532




December 2, 2002

CLA-2-30:RR:NC:2:238 I88532

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.40.0040

Mr. James F. Morgan
PBB Global Logistics
883-D Airport Park Road
Glen Burnie, MD 21061

RE: The tariff classification of AVP-923 Capsules from Canada

Dear Mr.Morgan:

In your letter dated November 12, 2002, on behalf of your client, Patheon, Inc., you requested a tariff classification ruling.

The subject product, AVP-923 Capsules, consists of a medicament containing AVP-923 - an investigational new drug consisting of a combination of Dextromethorphan Hydrobromide and Quinidine Sulfate Dihydrate - as the active ingredient. According to an article found on the World Wide Web, AVP-923 is presently undergoing evaluation in FDA-regulated Phase II-III clinical trials to determine its efficacy for the treatment of pseudobulbar affect in patients with ALS (Amyotrophic Lateral Sclerosis).

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, Vol 34, No. 21, dated May 24, 2000), the applicable subheading for the subject capsules will be 3004.40.0040, Harmonized Tariff Schedule of the United States (HTS), 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: Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics: Other: Medicaments primarily affecting the central nervous system: Other.” The general rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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

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