CLA-2-29:OT:RR:NC:N2:238

Ms. Laura G. Walsh
EirGen Pharma Ltd.
Westside Business Park
Old Kilmeaden Road
Waterford, Ireland

RE: The tariff classification of Calcifediol Monohydrate (CAS No. 63283-36-3) in bulk powder form, from Netherlands

Dear Ms. Walsh:

In your letter dated October 26, 2016, you requested a tariff classification ruling. We apologize for the delay as the information was sent to our laboratory for analysis.

The subject product, Calcifediol Monohydrate, is a derivative of cholecalciferol (Vitamin D3) in the monohydrate form and a metabolite of vitamin D3. It is indicated for the treatment of chronic kidney disease. According to our laboratory, Calcifediol (also known as 25-hydroxyvitamin D3) is produced in the liver and is often used as an indicator of the body's vitamin D stores. It is also used as a treatment for vitamin D deficiency in rickets and osteomalacia.

The applicable subheading for the Calcifediol Monohydrate in bulk form will be 2936.29.5020, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent: Vitamins and their derivatives, unmixed: Other vitamins and their derivatives: Other: Other: Vitamins D and their derivatives.” 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 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 judy.h.lee@cbp.dhs.gov.

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division