The tariff classification of MKC-442 (CAS 149950-60-7) from Japan.
Issued August 18, 1998 by U.S. Customs and Border Protection.
Tariff classification
HTS codes: 2933.59.7000
Headings: 2933
Product description
This product does not comply with the two part test for drugs as articulated in Lonza, Inc. v. U.S., 46 F.3d 1098, 1109 (Fed. Cir. 1995). It is presently undergoing Phase I/II clinical trials and is not awaiting FDA approval. Therefore we cannot state that it is an ingredient in medicine.
CBP rationale
The applicable subheading will be 2933.59.7000, Harmonized Tariff Schedule of the United States (HTS), which provides for heterocyclic compounds with nitrogen hetero-atom(s) only; nucleic acids and their salts: compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: other.
Full text
NY D80743 August 18, 1998 CLA-2-29:RR:NC:2:239 D80743 CATEGORY: Classification TARIFF NO.: 2933.59.7000 Mr. Jerome J. Neville Pricewaterhouse Coopers LLP Silicon Valley 150 Almaden Blvd. San Jose, CA 95113 RE: The tariff classification of MKC-442 (CAS 149950-60-7) from Japan. Dear Mr. Neville: In your letter dated July 15, 1998, on behalf of your client Triangle Pharmaceuticals, you requested a tariff classification ruling for MKC-442 (Chemical Name - 1-(Ethoxymethyl)-5-(1-Methylethyl)-6-(Phenylmethyl)-2,4(1H,3H)-Pyrimidinedione) which you have stated is imported in bulk form and pressed into tablets where it is consumed in clinical testing for treatment against HIV infection. This product does not comply with the two part test for drugs as articulated in Lonza, Inc. v. U.S., 46 F.3d 1098, 1109 (Fed. Cir. 1995). It is presently undergoing Phase I/II clinical trials and is not awaiting FDA approval. Therefore we cannot state that it is an ingredient in medicine. The applicable subheading will be 2933.59.7000, Harmonized Tariff Schedule of the United States (HTS), which provides for heterocyclic compounds with nitrogen hetero-atom(s) only; nucleic acids and their salts: compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: other. The rate of duty will be 10.7 percent ad valorem. 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 Thomas Brady at 212-466-5747. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division
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