CLA-2-30:RR:NC:2:238 H83706
Ms. Iliana G. Fuller
Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine, CA 92623-9534
RE: The tariff classification of ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5%
Dear Ms. Fuller:
In your letter dated July 9, 2001, you requested a tariff classification ruling.
The subject product (a sample of which was submitted), ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5%, is an ophthalmic medicament containing ketorolac tromethamine, a nonsteroidal anti-inflammatory drug, as the active ingredient. The product is supplied in a white, opaque, plastic bottle, with a controlled dropper-tip. The plastic bottle, in turn, is put up packed for retail sale in a paperboard container. ACULAR® is indicated for the temporary relief of ocular itching, due to seasonal allergic conjunctivitis, and for the treatment of postoperative inflammation in patients who have undergone cataract surgery.
The applicable subheading for the subject product will be 3004.90.9085, Harmonized Tariff Schedule of the United States (HTS), which provides for "Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other." 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 212-637-7068.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division