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 Phenylephrine Hydrochloride (CAS-61-76-7) and Azelastine Hydrochloride (CAS-79307-93-0), imported in bulk form, from Taiwan and Italy, respectively

Dear Ms. Forstenzer:

In your letter dated August 26, 2013, you requested a tariff classification ruling.

The first product, Phenylephrine Hydrochloride, is a selective a1-adrenergic receptor agonist. It is indicated for use as a decongestant.

The second product, Azelastine Hydrochloride, is a selective histamine-H1-receptor antagonist. It is an antihistamine that is used to treat hay fever and allergy symptoms, including runny nose, sneezing, and itchy nose. It is also used to treat itching of the eye associated with allergic conjunctivitis.

The applicable subheading for the Phenylephrine Hydrochloride, imported in bulk form, will be 2922.50.1300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Oxygen-function amino-compounds: Amino-alcohol-phenols, amino-acid-phenols and other amino-compounds with oxygen function: Aromatic: Other: Drugs: Isoetharine hydrochloride; Isoxsuprine hydrochloride; Nylidrin hydrochloride; Phenylephrine hydrochloride; Salbutamol (Albuterol); and Terbutaline sulfate.” The rate of duty will be free.

The applicable subheading for the Azelastine Hydrochloride, imported in bulk form, will be 2933.99.2600, 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: Antihistamines.” 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 Judy Lee at (646) 733-3033.

Sincerely,

Myles B. Harmon
Acting Director
National Commodity Specialist Division