CLA-2-30:OT:RR:NC:N1:138
Ms. Rachel Gahan
EirGen Pharma
Westside Business Park
Old Kilmeaden Road
Waterford, X91 YV67
Ireland
RE: The tariff classification of OPK-88004 capsules in dosage form, from Ireland
Dear Ms. Gahan:
In your letter dated October 24, 2017, you requested a tariff classification ruling.
OPK-88004 is a selective androgen receptor modulator (SARM) that is currently undergoing phase II clinical trials for the treatment of benign prostatic hyperplasia (BPH). In your letter, you indicated OPK-88004 will be imported in capsule form in dosages of 5 mg, 15 mg and 25 mg for use in phase II clinical trials.
The applicable subheading for OPK-88004 capsules in dosage form will be 3004.90.9290, Harmonized Tariff Schedule of the United States (HTSUS), 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: Other.” The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
In your letter, you stated that placebos will be imported as well but in a follow-up email to this office you indicated that you are not seeking a ruling for the placebos. Therefore, this ruling letter applies only to the OPK-88004 capsules in dosage form and not to the placebos.
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 Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division