Ms. Inge Forstenzer
Ren-Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Darifenacin (CAS-133099-04-4), Darifenacin Hydrobromide (CAS-133099-07-7) and Tolterodine (CAS-124937-51-5) in bulk form, from Spain
Dear Ms. Forstenzer:
In your letter dated August 1, 2006, you requested a tariff classification ruling.
The first two products, Darifenacin and Darifenacin Hydrobromide, are muscarinic receptor antagonists. They are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
The third product, Tolterodine, is an antimuscarinic drug and is also used in the treatment of urinary incontinence.
The applicable subheading for the Darifenacin and Darifenacin Hydrobromide in bulk form will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs: Other.” Pursuant to General Note 13, HTSUS, the rate of duty for will be free.
The applicable subheading for the Tolterodine in bulk form will be 2922.29.2700, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Oxygen-function amino-compounds: Amino-naphthols and other amino-phenols, their ethers and esters, other than those containing more than one kind of oxygen function; salts thereof: Other: Other: Drugs.” Pursuant to General Note 13, HTSUS, 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.
Robert B. Swierupski
National Commodity Specialist Division