CLA-2-30:OT:RR:NC:N3:138
Ciara Horgan
NorthStar Healthcare
3300 Cork Airport Business Park Cork T12 XN72 Ireland
RE: The tariff classification of Testosterone Gel, 1.62 % in dosage form, from the Netherlands
Dear Ms. Horgan:
In your letter dated April 9, 2024, you requested a tariff classification ruling.
Testosterone Gel, 1.62% is a steroid sex hormone for topical use only and available as a metered-dose pump. Each pump actuation delivers 20.25 mg of testosterone in 1.25 g of gel. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone such as primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The applicable subheading for the Testosterone Gel, 1.62% in dosage form will be 3004.39.0050, 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, containing hormones or other products of heading 2937: 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 at https://hts.usitc.gov/.
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.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division