CLA-2-30:OT:RR:NC:N2:238
Ms. Kelly Jo Cox
Mylan Pharmaceuticals Inc.
781 Chestnut Ridge Road
Morgantown, WV 26505
RE: The tariff classification of Glatiramer Acetate (CAS No. 147245-92-9) in bulk form and Glatiramer Acetate injection in dosage form, from India
Dear Ms. Cox:
In your letter dated January 18, 2017, you requested a tariff classification ruling.
Glatiramer Acetate will be imported in bulk form and in 20mg/mL and 40mg/mL single dose pre-filled syringes. Glatiramer Acetate is an immunomodulator drug that is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The active ingredient, Glatiramer Acetate, is a random polymer of 4 amino acids found in myelin basic protein (glutamic acid, lysine, alanine and tyrosine).
The applicable subheading for the Glatiramer Acetate injection in 20mg/mL and 40mg/mL single dose pre-filled syringes will be 3004.90.9215, 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: Other: Other: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free.
The applicable subheading for the Glatiramer Acetate in bulk form will be 3504.00.5000, HTS, which provides for “Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed: Other.” The general rate of duty will be 4 percent ad valorem.
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 World Wide Web at https://hts.usitc.gov/current.
In your letter, you suggest Glatiramer Acetate in bulk form and Glatiramer Acetate Injection in dosage form should be classified in heading 3002, HTSUS, which provides for “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products.” However, we note that in NY N248290, dated March 20, 2014, Glatiramer Acetate in bulk form was determined to be a mixture of synthetic proteins and classified in heading 3504, HTSUS, as other protein substances. Glatiramer Acetate injection in dosage form is a medicament that is indicated for the treatment of multiple sclerosis and is properly described as an immunosuppressive medicament in heading 3004, HTSUS, and not as an immunological product of heading 3002, HTSUS.
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 merchandise may also be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.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