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1NY K83189

March 11, 2004
CLA-2-90:RR:NC:N1:105 K83189


TARIFF NO.: 3004.39.0050, 9018.39.0050

Mr. Ron Reuben
DHL Danzas
510 W. 102nd Street
Los Angeles, CA 90050

RE: The tariff classification of a Pen Injector Delivery System from Switzerland

Dear Mr. Reuben:

In your letter dated February 09, 2004, for Amylin Pharmaceuticals, Inc., you requested a tariff classification ruling.

Per the 1-13-04 letter you forwarded from W. Cooper of Amylin, “The disposable pen injector devices are made from various types of plastic and are manufactured in Switzerland. The glass cartridges containing drug candidate pramlintide acetate are manufactured in either the United Kingdom or the United States. As of this writing, the final assembly of the plastic pen injector parts together with the drug cartridge has not been finalized. We propose to import both the unassembled pen injector parts and the fully assembled pen injector device, including drug cartridge, into the United States.”

Regarding the “unassembled pen injector parts,” we take those to be the three parts in the plastic bag. If the subparts of the subassembly with the ratchet-like device were imported in separate shipments, some of them might be classified other than in Chapter 90 since Note 1 to Chapter 90 excludes multiple items, including “parts of general use.” However, we take that not to be your intention.

The applicable subheading for the three sample parts will be 9018.39.0050, Harmonized Tariff Schedule of the United States (HTS), which provides for, inter alia, parts and accessories of syringe-like devices. The rate of duty will be free.

The second product consists of a disposable, pen injector device containing a non-removable glass cartridge. The cartridge is filed with SYMLIN®, the brand name for an investigational medication, in liquid form, containing Pramlintide acetate, a synthetic analogue of human amylin (a pancreatic hormone), as the active ingredient. An article found on your client’s website indicates that a New Drug Application (NDA) for SYMLIN® was submitted to the FDA in December 2000, with an amendment to the NDA being submitted in June of 2003, which is currently waiting approval.

The applicable subheading for SYMLIN®, imported put up in glass cartridges containing various doses of pramlintide acetate will be 3004.39.0050 (EN), Harmonized Tariff Schedule of the United States (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.

The sample is being returned to you in a separate mailing.

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 J. Sheridan at 646-733-3012.


Robert B. Swierupski

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