Ms. Vittoria A. Crea
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Rd.
P.O. Box 368
Ridgefield, CT 06877-0368
RE: The tariff classification of Investigational Drug BI 10773 in bulk form, from Germany
Dear Ms. Crea:
In your letter dated October 28, 2009, you requested a tariff classification ruling.
The subject product, Investigational Drug BI 10773, is a novel investigational sodium-dependent glucose transporter-2 inhibitor (SGLT-2 inhibitor) anti-diabetic compound presently in U.S. Food and Drug Administration (FDA) Phase II clinical trials.
The applicable subheading for Investigational Drug BI 10773 in bulk form will be 2932.19.1000 Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with oxygen hetero-atom(s) only: Compounds containing an unfused furan ring (whether or not hydrogenated) in the structure: Other: Aromatic.” The rate of duty will be 6.5 percent ad valorem.
However, you state that BI 10773 is in the development stage as a “lead compound” in connection with the treatment of Type II Diabetes. It will be imported in limited noncommercial quantities for investigation of its efficacy, safety and pharmacokinetics. Furthermore, it is not approved, nor will it be offered for sale, or used in other products which are sold. BI 10773 is not subject to quantitative restrictions, antidumping orders or countervailing duty orders.
Based upon the facts presented above, it is the opinion of this office that the importation of BI 10773 satisfies all the conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, HTSUS. BI 10773 is eligible for classification in subheading 9817.85.01, HTSUS, which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” 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 http://www.usitc.gov/tata/hts/.
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 Harvey Kuperstein at (646) 733-3033.
Robert B. Swierupski
National Commodity Specialist Division