H306891

H306891 March 11, 2025 OT:RR:CTF:CPMMA H306891 TJD CATEGORY: Classification TARIFF NO.: 2922.19.09 Ms. Janet Lambertucci Ren-Pharm International, LTD 350 Jericho Turnpike Suite 204 Jericho, NY 11753 RE: Modification of NY J81823, NY 891019, and NY 810507; Tariff classification of Propafenone Hydrochloride Dear Ms. Lambertucci: This is to inform you that U.S. Customs and Border Protection (“CBP”) has reconsidered New York Ruling Letters (“NY”) J81823, dated March 12, 2003, and issued to Ren-Pharm International, Ltd.; NY 891019 dated November 5, 1993, and issued to Interchem Corporation; and NY 810507, dated May 26, 1995, and issued to Interchem Corporation, regarding the classification of propafenone hydrochloride under the Harmonized Tariff Schedule of the United States (“HTSUS”). In each case, CBP classified propafenone hydrochloride in subheading 2922.50.14, HTSUS, which provides for “Oxygen-function amino-compounds: Amino-alcohol-phenols, amino- acid-phenols and other amino-compounds with oxygen function: Aromatic: Other: Cardiovascular drugs.” We have determined that the three CBP rulings are partly in error, and that the proper classification of propafenone hydrochloride is subheading 2922.19.09, HTSUS, which provides for “Oxygen-function amino-compounds: Amino-alcohols, other than those containing more than one kind of oxygen function, their ethers and esters: salts thereof: Other: Aromatic: Drugs.” Accordingly, for the reasons set forth below, we are modifying NY J81823, NY 891019, and NY 810507, solely with respect to the classification of propafenone hydrochloride.1 1 Each ruling letter classified multiple types of drugs. This modification only concerns the classification of propafenone hydrochloride. 1 Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. § 1625(c)(1)), as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), a notice of the proposed action was published in the Customs Bulletin, Volume 59, No. 5, on January 29, 2025. No comments were received in response to this notice. FACTS: Propafenone hydrochloride is not described in NY J81823, NY 891019, and NY 810507 beyond its function as an anti-arrhythmic drug. Propafenone hydrochloride is an oral medication taken to treat certain types of irregular heartbeat; it is used to restore normal heart rhythm and maintain a regular, steady heartbeat.2 Chemically, propafenone hydrochloride is 2'-[2-Hydroxy-3- (propylamino)- propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3•HCl.3 Propafenone hydrochloride occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20° C), chloroform, and ethanol. In CBP Laboratory report NY20190073, propafenone hydrochloride is described as a whole with following functional groups: aromatic, secondary amine, ether, phenol, hydroxyl, and ketone. Of these, the following are oxygen groups: ketone, ether, phenol, and hydroxyl. The lab report further states “[t]he only oxygen-containing functional group relevant to classification is the alcohol, being the only oxygen function present in that part of the molecule between the amine and the ether function.” The Chemical Abstract Service (“CAS”) registry number of propafenone hydrochloride is 34183-22-7. The CAS number of propafenone is 54063- 53-5. Propafenone hydrochloride is an inorganic salt of the organic compound propafenone. ISSUES: Whether propafenone hydrochloride is classified under subheading 2922.50.14, HTSUS, which provides for “Oxygen-function amino-compounds: Amino-alcohol-phenols, amino-acid- phenols and other amino-compounds with oxygen function: Aromatic: Other: Cardiovascular drugs” or subheading 2922.19.09, HTSUS, which provides for “Oxygen-function amino- compounds: Amino-alcohols, other than those containing more than one kind of oxygen function, their ethers and esters: salts thereof: Other: Aromatic: Drugs.” Whether the subject merchandise is eligible for duty free treatment pursuant to General Note 13, HTSUS. LAW AND ANALYSIS: Classification under the HTSUS is made in accordance with the General Rules of Interpretation (“GRIs”). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order. 2 https://www.webmd.com/drugs/2/drug-22258-4070/propafenone-hcl-oral/propafenone-oral/details 3 https://www.rxlist.com/rythmol-drug.htm 2 The 2025 HTSUS provisions under consideration in this case are as follows: 2922 Oxygen-function amino-compounds: Amino-acids, other than those containing more than one kind of oxygen function, and their esters; salts thereof: 2922.19 Other: Aromatic: 2922.19.09 Drugs * * * 2922 Oxygen-function amino-compounds: 2922.50 Amino-alcohol-phenols, amino-acid-phenols and other amino-compounds with oxygen function: Aromatic: 2922.50.14 Other: Drugs * * * General Note 13 to the HTSUS, states, in relevant part: Pharmaceutical products. Whenever 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 which is the product of a country eligible for tariff treatment under column 1 shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule. Products in the pharmaceutical appendix include the salts, esters and hydrates of the International Non- proprietary Names (INN) products enumerated in table 1 of the appendix that contain in their names any of the prefixes or suffixes listed in table 2 of the appendix, provided that any such salt, ester or hydrate is classifiable in the same 6-digit tariff provision as the relevant product enumerated in table 1. Table 1 provides: This table enumerates products described by International Non-proprietary Names INN 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 such product by whatever name known. Table 2 provides: 3 Sales, esters and hydrates of the products enumerated in table 1 above that contain in their names any of the prefixes or suffixes listed below shall also be entered free of duty under general note 13 to the tariff schedule, provided that any such salt, ester or hydrate is classifiable in the same 6-digit tariff provision as the relevant product enumerated in table 1. For purposes of the tariff schedule, any reference to a product covered by this table includes such product by whatever name known. Chapter Note 1(a) to Chapter 29, HTSUS, states, in pertinent part, “Except where the context otherwise requires, the headings of this chapter apply only to: (a) Separately defined organic compounds, whether or not containing impurities.” Note 4 to Chapter 29, HTSUS states that for purposes of heading 2922, HTSUS, oxygen- function is restricted to the functions (the characteristic organic oxygen-containing groups) referred to in headings 2905 to 2920, HTSUS. Chapter Note 5(c)(1) to Chapter 29 states that: Subject to Note 1 to Section VI and Note 2 to Chapter 28 (1) Inorganic salts of organic compounds such as acid-, phenol- or encl-function compounds or organic bases, of sub-Chapters I to X or heading 29.42, are to be classified in the heading appropriate to the organic compound. In interpreting the HTSUS, the 

Classification under the HTSUS is made in accordance with the General Rules of Interpretation (“GRIs”). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order. 2 https://www.webmd.com/drugs/2/drug-22258-4070/propafenone-hcl-oral/propafenone-oral/details 3 https://www.rxlist.com/rythmol-drug.htm 2 

 The 2025 HTSUS provisions under consideration in this case are as follows: 2922 Oxygen-function amino-compounds: Amino-acids, other than those containing more than one kind of oxygen function, and their esters; salts thereof: 2922.19 Other: Aromatic: 2922.19.09 Drugs * * * 2922 Oxygen-function amino-compounds: 2922.50 Amino-alcohol-phenols, amino-acid-phenols and other amino-compounds with oxygen function: Aromatic: 2922.50.14 Other: Drugs * * * General Note 13 to the HTSUS, states, in relevant part: Pharmaceutical products. Whenever 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 which is the product of a country eligible for tariff treatment under column 1 shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule. Products in the pharmaceutical appendix include the salts, esters and hydrates of the International Non- proprietary Names (INN) products enumerated in table 1 of the appendix that contain in their names any of the prefixes or suffixes listed in table 2 of the appendix, provided that any such salt, ester or hydrate is classifiable in the same 6-digit tariff provision as the relevant product enumerated in table 1. Table 1 provides: Th