CLA-2-39:OT:RR:NC:N1:137
David Watson
Apellis Pharmaceuticals, Inc.
100 5th Avenue
Waltham, Massachusetts 02451
RE: The tariff classification of APL-2, pegcetacoplan (CAS # 2019171-69-6) from Switzerland
Dear Mr. Watson:
In your letter dated December 21, 2020, you requested a tariff classification ruling.
The subject product is APL-2, also referred to as pegcetacoplan (CAS # 2019171-69-6). The product is marketed for use in clinical trials to treat various immunological diseases. You state that the product targets the part of the immune system known as the complement system. The product is formed in a single reaction between Peptide 1603 and polyethylene glycol (PEG). You note that the pegylated product is preferred because the PEG extends the half-life of the compound, allowing the APL-2 drug product to be dosed less frequently and in smaller amounts. The product will be imported into the United States as a pure bulk solid.
In your letter, you suggest classification in subheading 3002.13.0000, HTSUS, which provides for “Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale.” In our opinion, the subject product is not considered to be an immunological product as described in Chapter 30 Note 2.
The applicable subheading for the APL-2, pegcetacoplan (CAS # 2019171-69-6) will be 3907.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for polyacetals, other polyethers and epoxide resins, in primary forms: other polyethers. The general rate of duty will be 6.5 percent ad valorem.
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 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 Christina Allen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division