William J. Maloney, Esq.
Rode & Qualey
55 West 39th Street
New York, NY 10018
RE: The tariff classification of Indiplon (CAS-325715-02-4), imported in bulk form, from Portugal
Dear Mr. Maloney:
In your letter dated June 29, 3004, on behalf of your client, Pfizer Inc., you requested a tariff classification ruling.
The subject product, Indiplon, is an investigational drug being evaluated for use in the treatment of insomnia. A press release, found on the World Wide Web, dated June 7, 2004, from Neurocrine Biosciences, Inc. (the firm which your client entered into an agreement with for the exclusive worldwide development and commercialization of Indiplon), states the following: “Neurocrine Biosciences, Inc. announced today that six studies from Phase I, II and III clinical trials, with both formulations of indiplon (i.e., an immediate-release capsule and a modified-release capsule) will be presented at the Associated Professional Sleep Societies (APSS) Meeting, June 5-10, 2004 in Philadelphia, PA.”
You submit that Indiplon is properly classifiable under subheading 2924.19.1050, HTS, which provides for other acyclic amides. However, the structure diagram you submitted for Indiplon reveals the presence of four, closed rings, namely: an unfused benzene ring; a fused ring system, made up of two heterocyclic rings, containing nitrogen hetero-atoms; and an unfused thiophene ring, which contains a sulfur hetero-atom. Therefore, contrary to your assertion, structurally, Indiplon is a cyclic compound which happens to contain both nitrogen and sulfur hetero-atoms. Hawley’s Condensed Chemical Dictionary, Fourteenth Edition (pp 319 and 566).
Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, Vol 34, No. 21, May 24, 2000), and Section VI, additional U.S. note 2(a), HTS, the applicable subheading for Indiplon, imported in bulk form, will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” The rate of duty will be 6.5 percent ad valorem. At the present time, Indiplon, “by what ever name known,” is not listed in the Pharmaceutical Appendix to the Tariff Schedule. General Note 13, HTS.
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.
Robert B. Swierupski