CLA-2-29:OT:RR:NC:N2:238
Ms. Inge Forstenzer
Ren-Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Misoprostol HPMC 1% dispersion (CAS-103601-27-0) and Acitretin (CAS-55079-83-9), imported in bulk form, from Taiwan and China, respectively
Dear Ms. Forstenzer:
In your letter dated February March 25, 2009, you requested a tariff classification ruling.
The first product, Misoprostol HPMC 1% dispersion, is the prostaglandin Misprostol in the form of a solid 1:100 ratio dispersion with hydroxypropyl methylcellulose (HPMC), which is a widely used material in controlled-release drug formulations. According to patent literature, Misoprostol is unstable in pure form for further formulation. The only way known in the art to stabilize Misoprostol is to process it into a dispersion comprising 1 part Misoprostol in from about 50 to about 500 parts of a polymer. This dispersion provides a stabilized product which may then be further compounded with a binder, lubricant and other ingredients to make a mixture which can be compressed into a tablet. Misoprostol is a synthetic prostaglandin E1 analog used for the prevention of gastric injury by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
The second product, Acitretin, is a second generation retinoid and is indicated for treatment of severe psoriasis in adults.
The applicable subheading for the Misoprostol HPMC 1% dispersion imported in bulk form, will be 3003.39.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments…consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Other: Other.” The rate of duty will be free.
The applicable subheading for the Acitretin imported in bulk form, will be 2918.99.3000, HTSUS, which provides for “Carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulfonated, nitrated or nitrosated derivatives: Other: Aromatic: Other: Drugs.” Pursuant to General Note 13, HTS, 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 http://www.usitc.gov/tata/hts/.
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 Harvey Kuperstein at (646) 733-3033.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division