Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Megestrol Acetate (CAS-595-33-5), Clavulanate Potassium (CAS-61177-45-5), Aripiprazole (CAS-129722-12-9), and Atomoxetine Hydrochloride (CAS-82248-59-7), all imported in bulk form, from Italy, Turkey, Spain, and Italy, respectively
Dear Ms. Forstenzer:
In your letter dated January 31, 2005, you requested a tariff classification ruling.
The first product, Megestrol Acetate, is a synthetic derivative of the naturally occurring steroid hormone, progesterone. It is indicated, among other things, for the palliative treatment of breast and endometrial carcinoma.
The second product, Clavulanate Potassium, which you refer to as Potassium Clavulanate, is the potassium salt of clavulanic acid. Structurally, it is a ß-lactam that functions as a ß-lactamase inhibitor by binding to these particular enzymes (produced by a wide range of pathogenic microorganisms) and inactivating them. When combined with ß-lactam antibiotics, such as Amoxicillin, in various medications, the ß-lactamase activity of Clavulanate Potassium serves to prevent the destruction of the ß-lactam antibiotics, which are substrates for these enzymes. This activity thus allows the antibiotic to kill or inhibit the growth of the targeted microorganisms.
The third product, Aripiprazole, is indicated for the treatment of schizophrenia.
The fourth product, Atomoxetine Hydrochloride, is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). For the record, we note that the International Nonproprietary Name (INN) for Atomoxetine is Tamoxetine, which is listed in Table 1 of the Pharmaceutical Appendix to the Tariff Schedule.
The applicable subheading for Megestrol Acetate, imported in bulk form, will be 2937.23.5050, Harmonized Tariff of the United States (HTS), which provides for “Steroidal hormones, their derivatives and structural analogues: Estrogens and progestins: Other: Other: Other: Other.” The rate of duty will be free.
The applicable subheading for Clavulanate Potassium, imported in bulk form, will be 2934.99.4700, HTS, which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs.” Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Aripiprazole, imported in bulk form, will be 2933.79.0800, HTS, which provides for “Lactams: Other lactams: Aromatic or modified aromatic: 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 Atomoxetine Hydrochloride, imported in bulk form, will be 2922.19.0900, HTS, which provides for “Amino-alcohols, other than those containing more than one kind of oxygen function, their ethers and esters; salts thereof: Other: Aromatic: 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 1-888-443-6332.
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