CLA-2-30:OT:RR:NC:N3:138
Ms. Jennifer Jurosco
Mylan Pharmaceuticals, Inc.
781 Chestnut Ridge Road
Morgantown, WV 26505
RE: The tariff classification of Dactinomycin for injection in dosage form, from India
Dear Ms. Jurosco:
In your letter dated October 11, 2019, you requested a tariff classification ruling.
Dactinomycin for injection, USP is a sterile, yellow to orange, lyophilized powder imported in vials containing 0.5 mg (500 micrograms) of Dactinomycin and 20.0 mg of mannitol. It is a cytotoxic antibiotic produced from the bacteria Streptomyces parvullus. It is indicated for the treatment of various type of cancers including Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, metastatic nonseminomatous testicular cancer and gestational trophoblastic neoplasia.
The applicable subheading for the Dactinomycin for injection in dosage form will be 3004.20.0060, Harmonized Tariff Schedule of the United States (HTSUS), 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, containing antibiotics: Other: Other.” The rate of duty will be free.
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 the World Wide Web at https://hts.usitc.gov/current.
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 Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division