CLA-2-29:RR:NC:2:238 D86038

Mr. Craig M. Schau
Emery Customs Brokers
6940A Engle Road
Middleburg Heights, OH 44130

RE: The tariff classification of Phentolamine Mesylate (CAS-65-28-1), imported in bulk form, from France

Dear Mr. Schau:

In your letter dated December 15, 1998, on behalf of your client, Zonagen, Inc., you requested a tariff classification ruling.

The subject product, Phentolamine Mesylate, is the methanesulfonate salt of Phentolamine, an antiadrenergic which blocks the hypertensive action of epinephrine and norepinephrine, and most smooth muscle responses involving -adrenergic cell receptors. It has the same antiadrenergic actions as the base (i.e., Phentolamine), and is indicated for use as an antihypertensive in patients with pheochromocytoma (a disorder of the adrenal glands) during preoperative preparation and surgical excision. It is also indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine, and for the diagnosis of pheochromocytoma.

The applicable subheading for the Phentolamine Mesylate, imported in bulk form, will be 2933.29.2000, Harmonized Tariff Schedule of the United States (HTS), which provides for: “[H]eterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs.” Pursuant to General Note 13, HTS, the rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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 212-466-5770.


Sincerely,

Robert B. Swierupski
Director,
National Commodity
Specialist Division