CLA-2-29:OT:RR:NC:N3:140
Ms. Sherry L. Markle
Mylan Pharmaceuticals
781 Chestnut Ridge Road
Morgantown, WV 26505
RE: The tariff classification of laboratory reference standards for analytical testing from France
Dear Ms. Markle:
In your letter dated August 5, 2021, you requested a tariff classification ruling. Documents received with your request were sent to the CBP Laboratory for review. That review is now complete. Our determination on the classification of your merchandise follows.
Mylan will import the following four products: Rivastigmine impurity D CRS (CAS No. 415973-05-6); Naloxone impurity D (CAS No. 26451-92-3); Captopril impurity J (CAS No. 64838-55-7) and Ondansetron Impurity D CRS (CAS No. 99614-64-9).
In your letter, you stated the above products are impurity reference standards for analytical testing. An impurity reference standard is a pure compound representing a possible degradation product or manufacturing process impurity for an analyte of interest. Various gram sample quantities of the impurity reference standard will be imported and then utilized to determine the purity of various raw materials such as active pharmaceutical ingredients.
First, we note that the instant chemical products, Rivastigmine impurity D CRS and Ondansetron Impurity D CRS, are not the same either in name, CAS Number, or structure to any other listed in the Pharmaceutical Appendix (PA). Simply containing part of a name does not indicate that it is the same product. There are no synonyms or other names known for these products that indicate that they are the same as any listed name in the PA but known by these names. We note, too, that in no instance is there any language to include isomers of Table 1 listed chemicals in the eligible Pharmaceutical Appendix products. CBP has no authority to expand the Pharmaceutical Appendix to include chemical products which are not listed in the Tables. Isomers are not eligible unless they are specifically named. In pertinent part, the various isomers and other structures do not contain the same reactive sites and are therefore specific to certain uses. Prefixes such as D, L, S, O, M, P, etc., refer to various isomeric differences in the chemical products. That is, they are different and distinct chemical species. They are not synonyms and cannot be considered under the “whatever name known” references in the Tables. They do not refer to salts, esters, or hydrates of those species. These two products, therefore, are not eligible for duty-free treatment under GN 13 as suggested in your submission.
The applicable subheading for Rivastigmine impurity D CRS (CAS No. 415973-05-6), which is an optical isomeric intermediate, will be 2924.29.7100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other:” The general rate of duty will be 6.5 Percent ad valorem.
The applicable subheading for Naloxone impurity D (CAS No. 26451-92-3) will be 2939.19.2000, HTSUS, which provides for “Alkaloids, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives: Alkaloids of opium and their derivatives; salts thereof: Other: Other: Synthetic.” The rate of duty will be free.
The applicable subheading for Captopril impurity J (CAS No. 64838-55-7), (also known as (2S)-1-(3-Acetylthio-2-methyl-1-oxopropyl)-L-proline), will be 2933.99.9701, HTSUS, which provides for: Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Other: Other: Other. It is listed under Table 3 of the Pharmaceutical Appendix as (2S)-1-(3-Acetylthio-2-methyl-1-oxopropyl)-L-proline. Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for Ondansetron Impurity D CRS (CAS No. 99614-64-9), (also known as 9-methyl-3-methylidene-1,2-dihydrocarbazol-4-one), will be 2933.99.7900, Harmonized Tariff Schedule of the United States (HTSUS), which provides for: heterocyclic compounds with nitrogen hetero-atom(s) only: aromatic or modified aromatic: other. The 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 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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division