CLA-2-29:RR:NC:2:238 K86506

Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Exemestane (CAS-107868-30-4) and Levonorgestrel (CAS-797-63-7), imported in bulk form, from Italy

Dear Ms. Forstenzer:

In your letter dated June 1, 2004, you requested a tariff classification ruling. The first product, Exemestane, is a synthetic steroidal agent indicated for the treatment of advanced breast cancer in postmenopausal women. Exemestane acts by inhibiting the activity of the enzyme, aromatase, which results in the suppression of estrogen production.

The second product, Levonorgestrel (also known as D-norgestrel), is the active levorotary isomer of Norgestrel (CAS-6533-00-2), a synthetic progestin. Levonorgestrel is used in combination hormonal oral contraceptives containing both an estrogen and a progestin.

The applicable subheading for Exemestane, imported in bulk form, will be 2937.29.9090, Harmonized Tariff Schedule of the United States (HTS), which provides for “Steroidal hormones, their derivatives and structural analogues: Other: Other: Other.” The rate of duty will be free.

The applicable subheading for Levonorgestrel, imported in bulk form, will be 2937.23.5050, HTS, which provides for “Steroidal hormones, their derivatives and structural analogues: Estrogens and progestins: Other: Other: 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
Director,
National Commodity
Specialist Division