CLA-2-29:RR:NC:2:238 I87674
Ms. Janice Lambertucci
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753-1317
RE: The tariff classification of Enalapril Maleate (CAS-76095-16-4), Ethacridine Lactate (CAS-1837-57-6), Etodolac (CAS-41340-25-4), Felodipine (CAS-72509-76-3; CAS-86189-69-7), and Fenofibrate (CAS-49562-28-9), all imported in bulk form, from Spain and Italy
Dear Ms. Lambertucci:
In your letter dated November 1, 2002, you requested a tariff classification ruling.
The first product, Enalapril maleate (the maleate salt of enalapril), is indicated for the treatment of hypertension.
You state in your letter that the second product, Ethacridine lactate, will be used as an “Intermediate” in the production of Atgam®, a medicament used in immunosuppressive therapy.
The third product, Etodolac, is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of osteoarthritis, rheumatoid arthritis, and for the management of pain.
The fourth product, Felodipine, is also indicated for the treatment of hypertension.
The fifth product, Fenofibrate, is a lipid-regulating agent indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.
The applicable subheading for Enalapril Maleate, imported in bulk form, will be 2933.99.5300, Harmonized Tariff Schedule of the United States (HTS), which provides for
“Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or
modified aromatic: Other: Drugs: Cardiovascular drugs: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.
Pursuant to Section VI, Additional U.S. Note 3, HTS, the applicable subheading for Ethacridine Lactate will be 2933.99.7900, HTS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Other: Products described in additional U.S. note 3 to section VI.” Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Etodolac, imported in bulk form, will be 2934.99.3000, HTS, which provides for “Nucleic acids and their salts, whether or not chemically defined, other heterocyclic compounds: Other: Aromatic or modified aromatic: Other: Drugs.” Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Felodipine, imported in bulk form, will be 2933.39.4100, HTS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Fenofibrate, imported in bulk form, will be 2918.90.3000, HTS, which provides for “Carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids, their halogenated, sulfonated, nitrated or nitrosated derivatives: Other: Aromatic: Other: Drugs.” Pursuant to General Note 13, HTS, the rate of duty will be free.
Enalapril Maleate, Etodolac, Felodipine, and Fenofibrate 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.
Ethacridine Lactate 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