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NY F84310




March 28, 2000

CLA-2-30:RR:NC:2:238 F84310

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9040

Mr. Mark A. Defries
SHS North America
P.O. Box 117
Gaithersburg, MD 20884-0117

RE: The tariff classification of Lorenzo’s Oil™, put up in 720 ml containers, from the United Kingdom

Dear Mr. Defries:

In your letter dated February 7, 2000, resubmitted on March 10, 2000, you requested a tariff classification ruling.

The subject product, Lorenzo’s Oil™, is an investigational medicament (IND No. 32336) consisting of a blend of four parts glyceryl trioleate oil (CAS-122-32-7) and one part glyceryl trierucate oil (CAS-2752-99-0).

Enclosed with your ruling request is a letter dated March 8, 2000, from Hugo W. Moser, M.D., Director of Neurogenetic Research, Kennedy Krieger Institute, Johns Hopkins University, addressed to you, confirming that Lorenzo’s Oil is presently in Phase II of the clinical-trial process, “[w]ith approximate enrollment of 150 individuals who have been diagnosed with Adrenoleukodystrophy/Adrenomyeloneuropathy.” You state in your letter that your firm “[h]as been committed to supplying the oil to Dr. Moser’s patients at the cost of manufacturing (emphasis added) and would like to continue to do so.” Finally, you indicate that Lorenzo’s Oil will be imported put up in cases containing six, clear, plastic, 720-milliliter containers, each of which will be labelled according to FDA standards. After importation, the product will be distributed by your firm directly to those patients participating in the clinical trial.

The applicable subheading for the subject product will be 3004.90.9040, 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: Other: Other: Other: Medicaments primarily affecting the central nervous system: Other.” The 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 212-637-7068.

Sincerely,

Robert B. Swierupski

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