Ms. Rita La Puerta
IPR Pharmaceuticals, Inc.
P.O. Box 1624
Canovanas, PR 00729-1624
RE: The tariff classification of AZD7325 Hydrogen Sulfate in bulk form, from United Kingdom
Dear Ms. La Puerta:
In your letter dated July 29, 2009, you requested a tariff classification ruling.
The subject product, AZD7325 Hydrogen Sulfate, is currently undergoing FDA Phase I clinical trials for the treatment of anxiety disorder and panic disorder. Per your letter, it is an investigational drug that contains the active ingredient AZD7325 Hydrogen Sulfate GABA A receptor.
In “Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research,” May 24, 2000, CUSTOMS BULLETIN, Vol. 34, No. 21, Customs announced its intention to classify separate chemically defined organic compounds imported in bulk, for use in Phase II or III FDA clinical trials, in the "drug" provisions of Chapter 29. Since AZD7325 is not yet in Phase II clinical trials, it is the opinion of this office that the proper classification is subheading 2933.99.7900, Harmonized Tariff Schedule of the United States (HTSUS).
The applicable subheading for the AZD7325 Hydrogen Sulfate in bulk form will be 2933.99.7900, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Other: Products described in additional U.S. note 3 to section VI.” The rate of duty will be 6.5 percent ad valorem.
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