Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Diclofenac Epolamine (CAS-119623-66-4) in bulk form, from Taiwan
Dear Ms. Forstenzer:
In your letter dated May 14, 2009, you requested a tariff classification ruling.
The subject product, Diclofenac Epolamine, is a non-opioid analgesic and is used as an active (1.3%) ingredient in topically adhesive patches for pain relief and as an anti-inflammatory.
The applicable subheading for the Diclofenac Epolamine in bulk form, will be 2933.99.5590 Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic:
Other: Drugs: Drugs primarily affecting the central nervous system: Analgesics, antipyretics and
nonhormonal anti-inflammatory agents: Other.” The rate of duty will be 6.5% ad valorem.
Pursuant to General Note 13, HTSUS, Diclofenac Epolamine is not eligible for duty free treatment. “Whenever a rate of duty of "Free" followed by the symbol "K" in parentheses appears in the "Special" subcolumn for a heading or subheading, any product (by whatever name known) classifiable in such provision which is the product of a country eligible for tariff treatment under column 1 shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule. Products in the pharmaceutical appendix include the salts, esters and hydrates of the International Non-proprietary Name (INN) products enumerated in table 1 of the appendix that contain in their names any of the prefixes or suffixes listed in table 2 of the appendix, provided that any such salt, ester or hydrate is classifiable in the same 6-digit tariff provision as the relevant product enumerated in table 1.” In this case, the Diclofenac and the Epolamine would be classified in different 6-digit tariff subheadings.
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.
Robert B. Swierupski
National Commodity Specialist Division