OT:RR:CTF:CPMMA H306891 TJD
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 Harmonized Commodity Description and Coding System
Explanatory Notes (“ENs”) may be utilized. The ENs, though not dispositive or legally binding,
provide commentary on the scope of each heading of the HTSUS, and are the official interpretation
of the Harmonized System at the international level. See T.D. 89-80, 54 Fed. Reg. 35127, 35128
(Aug. 23, 1989).
According to the ENs of Chapter 29.22
The term “oxygen-function amino-compounds” means amino-compounds which
contain, in addition to an amine function, one or more of the oxygen functions
defined in Note 4 to Chapter 29 (alcohol, ether, phenol, acetal, aldehyde, ketone,
etc., functions), as well as their organic and inorganic acid esters. This heading
therefore covers amino-compounds which are substitution derivatives of amines
containing oxygen functions of headings 29.05 to 29.20, and esters and salts thereof
For subheadings 2922.11 to 2922.50, the ENs further state
For subheading classification purposes, ether or organic or inorganic acid ester
functions are regarded either as alcohol, phenol or acid functions, depending on the
position of the oxygen function in relation to the amine group. In these cases, only
those oxygen functions present in that part of the molecule situated between the
4
amine function and the oxygen atom of either the ether or the ester function should
be taken into consideration. A segment containing an amine function is referred to as
a “parent” segment. For example, in the compound 3-(2-aminoethoxy)propionic
acid, the parent segment is aminoethanol, and the carboxylic acid group is
disregarded for classification purposes; as an ether of an amino-alcohol, this
compound is classifiable in subheading 2922.19.
Additionally, the World Customs Organization (“WCO”) INN DCI list4 classifies
propafenone in the six-digit heading 2922.19.
* * *
There is no dispute that propafenone hydrochloride is properly classified under heading
2922, HTSUS. Based on its chemical structure, propafenone hydrochloride is an oxygen-function
amino compound. As described in CBP laboratory report NY20190073, propafenone hydrochloride
is a whole with the several oxygen function groups: ketone, ether, phenol, and hydroxyl.
Additionally, since propafenone hydrochloride is an inorganic salt of the organic compound
propafenone, it satisfies the conditions of Chapter 29 Note 5(c)(1), and it is classified in the same six
digit heading as propafenone, 2922.19, HTSUS. As stated in the lab report, propafenone
hydrochloride is aromatic. Thus, it is properly classified in 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.”
Classification under heading 2922.50, HTSUS is inappropriate because propafenone
hydrochloride is an inorganic salt of the organic compound propafenone. As noted, Note 5(c)(1) and
the ENs to Chapter 29 dictate that inorganic salts are classified under the same six digit heading as
their organic compound, precluding classification in subheading 2922.50.14, HTSUS.
Under General Note 13 to the HTSUS, products listed in the Pharmaceutical Appendix of
the HTSUS may be subject to a special duty rate of “free” when the symbol “K” appears in the
“Special Duty” column for the applicable subheading of the product. Table 1 of the Pharmaceutical
Appendix lists out the INNs of drugs that are covered under the special duty rate when the letter
“K” appears. Table 2 covers any salts, esters, and hydrates of products enumerated in Table 1, so
long as the salt, ester, or hydrate is classifiable in the same six-digit tariff provision as the product
enumerated in Table 1.
As noted, propafenone hydrochloride is a salt of the product propafenone. Propafenone is
listed in Table 1 of the Pharmaceutical Appendix. The suffix hydrochloride is listed in Table 2 of
the Appendix. Special duty rate symbol “K” appears with subheading 2922.19.09, HTSUS.
Propafenone hydrochloride may be entered duty free under General Note 13 because its INN is
listed in Table 1 of the Pharmaceutical Appendix, and its suffix is covered in Table 2 of the
Appendix.
4
The WCO INN DCI list represents classifications of International Nonproprietary Names (INN) pharmaceutical
substances adopted by the Harmonized System Committee.
5
HOLDING:
By application of GRI 1, propafenone hydrochloride is classified in 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.” The 2024 column one, duty rate is 6.5% ad valorem. However, propafenone
hydrochloride is subject to the column two, special duty rate of “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 at https://hts.usitc.gov/current.
EFFECT ON OTHER RULINGS:
NY J81823, dated March 12, 2003, NY 891019, dated November 5, 1993, and NY 810507,
dated May 26, 1995, are hereby MODIFIED.
In accordance with 19 U.S.C. § 1625(c), this ruling will become effective 60 days after its
publication in the Customs Bulletin.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
CC: Ms. Joan von Doehren
Interchem Corporation
120 Rt. 17 North, Suite 115
Paramus, NJ 07652
6