CLA-2-29:RR:NC:2:238 I85503
Ms. Meryl Epstein
Ren-Pharm International, Ltd.
350 Jericho Turnpike
Jericho, NY 11753
RE: The tariff classification of Labetalol Hydrochloride (CAS-32780-64-6), Metformin Hydrochloride (CAS-1115-70-4), Norgestimate (CAS-35189-28-7), Pamoic Acid (CAS-130-85-8), and Ursodiol (CAS-128-13-2), all imported in bulk form, from Italy
Dear Ms. Epstein:
In your letter dated August 12, 2002, you requested a tariff classification ruling.
The first product, Labetalol Hydrochloride, is indicated for the treatment of hypertension.
The second product, Metformin Hydrochloride, is an oral antihyperglycemic drug used in the management of non-insulin-dependent diabetes mellitus.
The third product, Norgestimate, is a synthetic progestin (i.e., a synthetic steroid with progestational activity). It is most often used (in conjunction with estrogens) for hormone replacement therapy in postmenopausal women, and (either alone or combined with estrogens) for contraception.
The fourth product, Pamoic acid, is chemically known as 4,4’-Methylenebis[3-hydroxy-2-naphthalenecarboxylic acid].
The fifth product, Ursodiol, the International Nonproprietary Name (INN) for which is “Ursodeoxycholic Acid,” is a naturally occurring bile acid found (in small quantities) in normal human bile, and (in larger quantities) in the biles of certain species of bears. It is indicated for the treatment of patients with primary biliary cirrhosis.
The applicable subheading for Labetalol Hydrochloride, imported in bulk form, will be 2924.29.6250, Harmonized Tariff Schedule of the United States (HTS), which provides for “Carboxyamide-function compounds; amide-function compounds of carbonic acid: Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other: Drugs: Other: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Metformin Hydrochloride, imported in bulk form, will be 2925.20.9000, HTS, which provides for “Carboxyimide-function compounds (including saccharin and its salts) and imine-function compounds: Imines and their derivatives; salts thereof: Other: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Norgestamate, imported in bulk form, will be 2937.23.5050, HTS, which provides for “Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones: Steroidal hormones, their derivatives and structural analogues: Estrogens and progestins: Other: Other: Other: Other.” The rate of duty will be free.
Pursuant to additional U.S. note 3 to section VI, HTS, the applicable subheading for Pamoic Acid will be 2918.29.7500, HTS, which provides for “Carboxylic acids with phenol function but without other oxygen function, their anhydrides, halides, peroxides, peroxyacids and their derivatives. Other: Other: Other.” The rate of duty will be 0.7 cents per kilogram plus 8.8 percent ad valorem.
The applicable subheading for Ursodiol, imported in bulk form, will be 2918.19.9000, HTS, which provides for “Carboxylic acids with alcohol function but without other oxygen function, their anhydrides, halides, peroxides, peroxyacids and their derivatives. Other: Other: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.
Labetalol Hydrochloride, Metformin Hydrochloride, Norgestamate, and Ursodiol 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.
Pamoic Acid may be subject to the requirements of the Toxic Substances Control Act (TSCA), which is administered by the U.S. Environmental Protection Agency. You may contact them at 401 M Street, S.W., Washington, D.C. 20460, telephone number (202) 554-1404, or EPA Region II at (732) 321-6669.
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