CLA-2-29:RR:NC:2:238 L82595
Herbert J. Lynch, Esq.
Sullivan & Lynch, P.C.
56 Roland Street, Suite 303
Boston, MA 02129-1223
RE: The tariff classification of ML8054, imported in bulk and capsule forms, from Canada and the United Kingdom
Dear Mr. Lynch:
In your letter dated February 3, 2005, on behalf of your client, Millennium Pharmaceuticals, Inc., you requested a tariff classification ruling.
The subject product, presently identified by your client’s code designation: “ML8054,” is an investigational new drug your client intends to import for use in FDA-regulated, Phase I clinical trials to evaluate its suitability for eventual use in the treatment of cancer.
The molecular structure of ML8054 reveals the presence of a pyrimidine ring fused to a seven-sided ring containing (only) a nitrogen hetero-atom. Presumably, based on the presence of these two rings in the molecule, you propose that ML8054, imported in bulk form, should be classified in subheading 2933.99.7900, HTS, as an other heterocyclic compound with nitrogen hetero-atom only. We disagree. In our opinion, pursuant to Rule 3(a) and Rule 6 of the General Rules of Interpretation, HTS, subheading 2933.59, HTS (i.e., compounds containing a pyrimidine ring in the structure), provides the most specific description for ML8054 (when imported in bulk form), and is, therefore, to be preferred to subheading 2933.99, HTS, which provides a more general description.
Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research, published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, and Rule 3(a) and Rule 6 of the General Rules of Interpretation, HTS, the applicable subheading for ML8054, imported in bulk form, will be 2933.59.7000, Harmonized Tariff of the United States (HTS), which provides for “Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Other: Aromatic or modified aromatic: Products described in additional U.S. note 3 to section VI.” The general rate of duty will be 6.5 percent ad valorem.
Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research, published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for ML8054, imported put up in capsule form, will be 3004.90.9115, HTS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” 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 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.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division