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NY F88325




September 13, 2000

CLA-2-30:RR:NC:2:238 F88325

CATEGORY: CLASSIFICATION

TARIFF NO.: 2937.99.9550; 3004.39.0050.

Mr. Ron Rubin
AEI Customs Brokerage Services
5510 W. 102nd Street
Los Angeles, CA 90045

RE: The tariff classification of Pramlintide Acetate (CAS-151126-32-8), imported in bulk form; and SYMLIN™ (pramlintide acetate), put up in 1.5 mL glass cartridges and 5 mL vials

Dear Mr. Rubin:

In your letter dated May 29, 2000, on behalf of your client, Amylin Pharmaceuticals, Inc., you requested a tariff classification ruling. We regret the delay in responding.

The first product, Pramlintide Acetate, is an investigational new drug presently in Phase 3 clinical-trial testing, to ascertain its efficacy for use in the treatment of type 1 and insulin-using type 2 diabetes. According to a report issued to this office by the U.S. Customs laboratory in New York, Pramlintide Acetate, is a synthetic analog of human amylin, a pancreatic hormone.

According to your letter, the second product, SYMLIN™ (pramlintide acetate), is a solubilized form of Pramlintide Acetate, put up in 1.5 mL glass cartridges and 5 mL vials, for administration by injection.

The applicable subheading for Pramlintide Acetate, imported in bulk form, will be 2937.99.9550, Harmonized Tariff Schedule of the United States (HTS), which provides for "[H]ormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones: Other hormones and their derivatives; other steroids used primarily as hormones: Other: Other: Other." The rate of duty will be free. The applicable subheading for SYMLIN™ (pramlintide acetate), imported put up in 1.5 mL glass cartridges and 5 mL vials, will be 3004.39.0050, HTS, which provides for “[M]edicaments 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 hormones or other products of heading 2937 but not containing antibiotics: Other: 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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