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NY K83788




March 5, 2004
CLA-2-30:RR:NC:2:238 K83788

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.39.0050

Mr. Ron Reuben
Danzas AEI Customs Brokerage Services
5510 West 102nd Street
Los Angeles, CA 90045

RE: The tariff classification of Nutropin® [somatotropin (rDNA origin) for injection, Nutropin AQ® [somatotropin (rDNA origin) for injection], Nutropin Depot™ [somatotropin (rDNA origin) for injectable suspension] and Protropin® (somatrem for injection)

Dear Mr.Reuben:

In your letter dated February 23, 2004, on behalf of your client, Genentech, Inc., you requested a tariff classification ruling.

Nutropin® [somatotropin (rDNA origin) for injection, Nutropin AQ® [somatotropin (rDNA origin) for injection], Nutropin Depot™ [somatotropin (rDNA origin) for injectable suspension] and Protropin® (somatrem for injection) are medicaments containing recombinant human growth hormone (rhGH) as the active ingredient. The amino acid sequence for the rhGH in the first three products is identical to that of pituitary-derived human growth hormone (hGH). The rhGH in Protropin® (somatrem for injection) contains the identical sequence of 191 amino acids making up hGH, plus an additional amino acid, methionine, on the N-terminus of the molecule. All four products are indicated for the treatment of various abnormalities and conditions associated with GH deficiency.

Nutropin® [somatotropin (rDNA origin) for injection is supplied as a lyophilized powder, put up in vials. Each vial, in turn, is put up packed, along with either one or two vials of water for injection, in a paperboard carton. Nutropin AQ® [somatotropin (rDNA origin) for injection] is supplied as a sterile liquid, put up in vials or pen cartridges. Nutropin Depot™ [somatotropin (rDNA origin) for injectable suspension] Is supplied as a powder, put up in vials. Each vial, in turn, is put up packed, along with a single-use vial of diluent and three, 21-gauge, ½” needles, in a paperboard carton. Protropin® (somatrem for injection) is supplied as a lyophilized powder, put up in vials. Each vial, in turn, is put up packed, along with one vial of water for injection, in a paperboard carton.

The applicable subheading for the four subject products will be 3004.39.0050, 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 (including those in the form of transdermal administration systems) 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 1-888-443-6332.

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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