CLA-2-30:OT:RR:NC:N3:138

Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 N
Pennington, NJ 08534

RE:  The tariff classification of Acepromazine Maleate Tablets from Ireland and Selamectin Topical Solution from China

Dear Mr. Shah:

In your letter dated November 21, 2023, you requested a tariff classification ruling.

Acepromazine Maleate, imported in dosages of 10 mg and 25 mg tablets, is a potent neuroleptic agent.  It is used as an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures. In your letter, you stated the active ingredient of Acepromazine Maleate is from Ireland and imported from India.

Selamectin, imported as a topical solution in dosages of 0.25 mL (15 mg), 0.75 mL (45 mg), 1 mL (60 mg), 0.25 mL (30 mg), 0.50 mL (60 mg), 1.0 mL (120 mg), 2.0 mL (240 mg) and 3.0 mL (360 mg), is a topical parasiticide. Selamectin is recommended for use in dogs six weeks of age or older and cats eight weeks of age and older for the following parasites and indications:

Kills adult fleas and prevents flea eggs from hatching for one month. Prevents and controls flea infestations (Ctenocephalides felis). Prevents heartworm disease caused by Dirofilaria immitis. Treats and controls ear mite (Otodectes cynotis) infestations. Treats and controls sarcoptic mange (Sarcoptes scabiei) in dogs. Controls Dermacentor variabilis tick infestations in dogs. Treats and controls intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections in cats.

In your letter, you stated the active ingredient of Selamectin Topical Solution is from China and imported from India.

The applicable subheading for the Acepromazine Maleate Tablets in dosage form will be 3004.90.9203, 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: For veterinary use.” The rate of duty will be free.

The applicable subheading for the Selamectin Topical Solution will be 3808.99.9501, HTSUS, which provides for “Insecticides, rodenticides, fungicides, herbicides, antisprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulfur-treated bands, wicks and candles, and flypapers): Other: Other: Other: Other.” The rate of duty will be 5 percent ad valorem.

Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 3808.99.9501, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.03, in addition to subheading 3808.99.9501, HTSUS, listed above. The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading.  For background information regarding the Section 301 trade remedy, you may refer to the relevant parts of the USTR and CBP websites, which are available at: https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions https://www.cbp.gov/trade/remedies/301-certain-products-china

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/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.

This merchandise may also be subject to the requirements of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs. Information on the FIFRA can be obtained by calling the EPA at (202) 260-2090, or by visiting their website at www.epa.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