CLA-2-29:RR:NC:2:238 I86442
Ms. Laura Mannisto
Interchem Corporation
120 Route 17 North
P.O. Box 1579
Paramus, NJ 07653-1579
RE: The tariff classification of Cilostazol (CAS-73963-72-1) and Tacrolimus [CAS-109581-93-3; CAS-104987-11-3 (anhydrous)], imported in bulk form, from Belgium and China, respectively
Dear Ms. Mannisto:
In your letter dated September 10, 2002, you requested a tariff classification ruling.
The first product, Cilostazol, is indicated for the reduction of symptoms of intermittent claudication.
The second product, Tacrolimus, is a macrolide isolated from Streptomyces tsukubaensis. It is indicated for use as an immunosuppressant drug. We are unable to find any evidence in the scientific literature that Tacrolimus has the ability to kill or inhibit the growth of microorganisms. Accordingly, pursuant to Lonza, Inc. v. U.S. [46 F.3d 1098 (Fed. Cir. 1995)] and the Explanatory Notes to heading 2941, HTS, it is our determination that Tacrolimus is precluded from classification as an antibiotic, for tariff purposes.
The applicable subheading for Cilostazol, imported in bulk form, will be 2933.79.0800, HTS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other lactams: Aromatic or modified aromatic: Other: Products described in additional U.S. note 3 to section VI.” Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Tacrolimus, imported in bulk form, will be 2934.99.4700, HTS, which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs.” Pursuant to General Note 13, HTS, 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 301-443-1544.
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