CLA-2-29:OT:RR:NC:N2:238

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

RE: The tariff classification of Lanreotide Acetate (CAS 127984-74-1) in bulk form, from Spain

Dear Ms. Forstenzer:

In your letter dated April 27, 2016, you requested a tariff classification ruling.

The subject product, Lanreotide Acetate, is an analogue of somatostatin, a polypeptide hormone produced from the hypothalamus and the pancreas. It is indicated for the treatment of acromegaly, a growth hormone disorder in which the pituitary gland produces too much growth hormone.

The applicable subheading for the Lanreotide Acetate in bulk form will be 2937.19.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: Other.” The rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.

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 Judy Lee at judy.h.lee@cbp.dhs.gov.

Sincerely,

Deborah C. Marinucci
Acting Director
National Commodity Specialist Division