CLA-2-30:OT:RR:NC:N1:138

Mr. Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 North
Pennington, NJ 08534

RE: The tariff classification of Clobetasol Propionate Ointment 0.05% and Ursodiol Tablets in dosage form, from India

Dear Mr. Shah:

In your letter dated August 17, 2018, you requested a tariff classification ruling.

Clobetasol Propionate Ointment 0.05% is a medicinal preparation containing Clobetasol Propionate, a synthetic corticosteroid, as the active ingredient. It is indicated for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses.

Ursodiol imported in 250 mg and 500 mg tablet form is a naturally occurring bile acid found (in small quantities) in normal human bile, and (in larger quantities) in the biles of certain species of bears. It is indicated for the treatment of patients with primary biliary cirrhosis.

The applicable subheading for the Clobetasol Propionate Ointment in dosage form will be 3004.32.0000, 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 hormones or other products of heading 2937: Containing corticosteroid hormones, their derivatives or structural analogues.” The rate of duty will be free.

The applicable subheading for the Ursodiol Tablets in dosage form will be 3004.90.9260, 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: Medicaments primarily affecting the digestive system: 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