CLA-2-29:OT:RR:NC:N3:140

Ms. Sheila Heerdt
Ren Pharm International Ltd.
350 Jericho Tpke.
Jericho, NY 11753

RE: The eligibility under the Pharmaceutical Appendix of L-Asparagine monohydrate (CAS# 5794-13-8), imported in bulk form, from Italy.

Dear Ms. Heerdt:

In your letter dated August 13, 2020, you requested review of the eligibility of L-Asparagine monohydrate (CAS# 5794-13-8) under the Pharmaceutical Appendix of the HTSUS.

The subject product, L-Asparagine monohydrate (CAS# 5794-13-8), also known as L-Asparagine hydrate, is an acyclic amide-function compound which you state is a synthetically derived, 100% single-ingredient, prescription, bulk pharmaceutical that will be imported in powder form. It is indicated for use as a dietary supplement, which assists in building important proteins by synthesizing neurotransmitters in the body. You submitted a follow up ruling request, asking for a review of the products eligibility under the Pharmaceutical Appendix (K) in the HTSUS.

The applicable subheading for L-Asparagine monohydrate (CAS# 5794-13-8), will be 2924.19.8000, Harmonized Tariff Schedule of the United States (HTS), which provides for Acyclic amides (including acyclic carbamates) and their derivatives; salts thereof: Other: Other. The general rate of duty will be 6.5 percent ad valorem.

The instant product is also listed eonomine in the Pharmaceutical Appendix under Table 3 as L-Asparagine hydrate, (CAS # 5794-13-8).

General note 13, HTSUS, provides in pertinent part, that "[W]henever a rate of duty of “Free” followed by the symbol “K” in parentheses appears in the “Special” subcolumn for a heading or subheading, any product (by whatever name known) classifiable in such provision . . . shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule. The note to Table 3 of the Pharmaceutical Appendix states: "[T]his table enumerates further products which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known."

The instant product (L-Asparagine hydrate 5794-13-8), is specifically provided for, and will be eligible for the free rate of duty enumerated in Table 3 of the Pharmaceutical Appendix (K), if claimed during entry/entry summary or appropriate post entry processes. 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 Paul Hodgkiss at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division