CLA-2-30:OT:RR:NC:N3:138
Ronald L. Heydt
DF Young Inc.
504 McCormick Drive
Glen Burnie, MD 21061
RE: The tariff classification of APCABRY DualPak™ and APCABRY TriplePak™ from Austria
Dear Mr. Heydt:
In your letter dated February 4, 2022, on behalf of Phathom Pharmaceuticals Inc., you requested a tariff classification ruling.
The APCABRY TriplePak™ is supplied as a carton of 14 daily administration blister cards for morning and evening dosing each containing:
Two Vonoprazan tablets, 20 mg
Two Clarithromycin tablets, USP, 500 mg
Four Amoxicillin capsules, USP, 500 mg
The APCABRY DualPak™ is supplied as a carton of 14 daily administration blister cards for morning, mid-day, and evening dosing each containing:
Two Vonoprazan tablets, 20 mg
Six Amoxicillin capsules, USP, 500 mg
Both the APCABRY TriplePak™ and APCABRY DualPak™ are indicated for the treatment of patients with Helicobacter Pylori (H. Pylori) infection. Amoxicillin (penicillin antibiotic) and Clarithromycin (macrolide antibiotic) are antibiotics indicated for the treatment of many different bacterial infections. Vonoprazan is a potassium-competitive acid blocker used in the treatment of erosive diseases of the digestive tract, including reflux esophagitis and duodenal ulcers.
You assert, pursuant to Rule 3(b) of the General Rules of Interpretation (GRI), Harmonized Tariff Schedule of the United States (HTSUS), that both the DualPak and TriplePak are properly classified in subheading 3004.90.9260, 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: Medicaments primarily affecting the digestive system: Other.” You further state that Vonoprazan provides the essential character of the set because it makes the other two products more effective by raising the pH in the stomach which keeps the antibiotics from degrading and makes the H. Pylori bacteria more susceptible to the antibiotics. We disagree. The APCABRY DualPak™ and APCABRY TriplePak™ are both sets and will be classified according to the medicament that imparts the essential character of the set, which are the antibiotics. The Vonoprazan tablets merely inhibit gastric acid secretion to aid the Amoxicillin capsules and the Clarithromycin tablets to be more effective in treating H. Pylori infections. The Clarithromycin tablets are included in only one pack. The Amoxicillin capsules, which are included in both packs and in greater quantities, impart the essential character.
The applicable subheading for the APCABRY TriplePak™ and APCABRY DualPak™ will be 3004.10.5060, 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: Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives: 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 the 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.
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