The tariff classification of Testosterone Gel in dosage form, from China

N360873May 15, 2026CLA-2-30:OT:RR:NC:N3:138
CATEGORY: Classification
TARIFF NO.: 3004.39.0055
Ciara HorganNorthstar Healthcare UC3300 Cork Airport Business ParkCork T12XN72IrelandRE: The tariff classification of Testosterone Gel in dosage form, from ChinaDear Ms. Horgan:In your letter dated
April 21, 2026
, you requested a tariff classification ruling.Testosterone Gel is a steroid hormone for topical use only and available as a metered-dose pump. Each pumpactuation delivers 20.25 mg of testosterone in 1.25 g of gel. It is indicated for replacement therapy in malesfor conditions associated with a deficiency or absence of endogenous testosterone such as primaryhypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).The applicable subheading for the Testosterone Gel in dosage form will be 3004.39.0055, Harmonized TariffSchedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed orunmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packingsfor retail sale: Other, containing hormones or other products of heading 2937: Other: Other: Other.” Thegeneral rate of duty will be free.The duties cited above are current as of this ruling’s issuance. 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 providedat https://hts.usitc.gov/.This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public HealthSecurity and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which areadministered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, andCosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or byvisiting their website at www.fda.gov.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or othercharges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and otherduties as provided for in Subchapter III to Chapter 99, HTSUS.Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with eitherthe Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisionscovering exceptions to such tariffs.For further information to assist with the importation process, please refer to the frequently updated CargoSystems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.The holding set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Judy Lee at [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division