OT:RR:CTF:CPMMA H356809 GIH
Mr. Christopher P. Remkus
Hampton Pharma LLC
33 Flying Point Road
Southhampton, NY 11968
RE: Affirmation of NY N351915; Tariff classification of Polyethylene Glycol (PEG) 3350
USP (CAS # 25322-68-3)
Dear Mr. Remkus:
This letter is in response to your correspondence, dated January 13, 2026, in which you
request reconsideration of New York Ruling Letter (NY) N351915, dated August 13, 2025
(reconsideration request). NY N351915, which was issued to you on behalf of Hampton Pharma
LLC (Hampton), involves the tariff classification of Polyethylene Glycol (PEG) 3350 USP 1
(PEG 3350) (CAS # 25322-68-3), under the Harmonized Tariff Schedule of the United States
(HTSUS). In NY N351915, U.S. Customs and Border Protection (CBP) classified the subject
product under subheading 3907.29.00, HTSUS, which provides for “[p]olyacetals, other
polyethers and epoxide resins, in primary forms; polycarbonates, alkyd resins, polyallyl esters
and other polyesters, in primary forms: other polyethers: other.”
In your reconsideration request, you assert that the classification is incorrect because:
the high purity, USP grade, and dedicated function of the product as a specific
chemical compound and Active Pharmaceutical Ingredient (API) mandate its
classification within Section VI, Chapter 29 (Organic Chemicals).
You further assert and that the PEG 3350 is correctly classifiable in heading 2909,
HTSUS, which provides for “[e]thers, ether-alcohols, ether-phenols, ether-alcohol- phenols,
alcohol peroxides, ether peroxides, acetal and hemiacetal peroxides, ketone peroxides (whether
or not chemically defined), and their halogenated, sulfonated, nitrated or nitrosated derivatives.”
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NY N351915 transposed the numerical reference as 3550 - 3350 is the actual number.
Alternatively, if not classified in heading 2909, HTSUS, you assert the subject merchandise is
classifiable in heading 3004, HTSUS which provides for “[m]edicaments (excluding goods of
heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or
prophylactic uses, put up in measured doses (including those in the form of transdermal
administration systems) or in forms or packings for retail sale.” To support your argument, you
cite to Headquarters Ruling (HQ) Letter 962562, dated July 10, 2000, and NY N342461, dated
September 18, 2004. Having reviewed NY N351915 and determined that it is correct, we hereby
affirm NY N351915 for the reasons set forth below.
The product at issue was described in NY N351915, as follows:
The product under consideration is Polyethylene Glycol (PEG) 3350 CAS# 25322-68-3. The
product is a white granular powder and will be imported in bulk. It is noted to be pharmaceutical
grade and is intended for sale to pharmaceutical manufacturers for further processing.
The descriptions of the PEG 3350 included in your reconsideration request further state that the
product is a high-purity active pharmaceutical ingredient (API) that contains a separate
chemically defined compound engineered for osmotic laxative applications and has a narrow
molecular weight distribution.
Classification under the HTSUS is in accordance with the General Rules of Interpretation
(GRIs). GRI 1 provides that the classification of goods will 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 will then be applied in order.
The Explanatory Notes (ENs), although neither dispositive nor legally binding, provide a
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).
You argue that the PEG 3350 is classifiable in heading 2909, HTSUS, because it is a
separate chemically defined organic compound consisting of a high purity level (USP grade) and
possesses a dedicated function as a chemical compound. Heading 2909, HTSUS provides for
“[e]thers, ether-alcohols, ether-phenols, ether-alcohol- phenols, alcohol peroxides, ether
peroxides, acetal and hemiacetal peroxides, ketone peroxides (whether or not chemically
defined), and their halogenated, sulfonated, nitrated or nitrosated derivatives.” EN C to Chapter
29 provides:
This Chapter further includes pegylated (polyethylene glycol (or PEGs) polymers) derivatives of
products of headings 29.36 to 29.39 and 29.41. For these products, a pegylated derivative remains
classified in the same heading as its non-pegylated form. However, pegylated derivatives of
products of all other headings of Chapter 29 are excluded (generally heading 39.07). (Emphasis
added).
Thus, Chapter 29 precludes pegylated derivatives, including polyethylene glycol (or
PEGs) polymers, from classification in heading 2909, HTSUS. Therefore, the PEG 3350 is
precluded from classification in heading 2909, HTSUS.
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If not classified in heading 2909, HTSUS, you argue for classification under heading
3004, HTSUS, which provides for “[m]edicaments (excluding goods of heading 30.02, 30.05 or
30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in
measured doses (including those in the form of transdermal administration systems) or in forms
or packings for retail sale.” While the PEG 3350 is intended for therapeutic use, the product as
described will be imported in bulk and is intended for sale to pharmaceutical manufacturers for
further processing. Thus, the product is not put up in measured doses or in forms or packages for
retail sale and cannot be classified as a product of heading 3004, HTSUS 2.
Seeing as the polyethylene glycol is precluded from classification in headings 2909 and
3004, HTSUS, we turn next to heading 3907, HTSUS. Heading 3907, HTSUS, provides for
“[p]olyacetals, other polyethers and epoxide resins, in primary forms; polycarbonates, alkyd
resins, polyallyl esters and other polyesters, in primary forms.” The ENs to heading 3907
instruct that the heading includes pegylated derivatives of products of Chapter 29, namely
polyethylene glycol (or PEGs) polymers.
Chapter 39 legal note 6 provides in pertinent part:
In headings 39.01 to 39.14, the expression “primary forms” applies only to the following forms:
(a) Liquids and pastes, including dispersions (emulsions and suspensions) and solutions;
(b) Blocks of irregular shape, lumps, powders (including moulding powders), granules, flakes and similar
bulk forms.
There is no dispute that the subject PEG 3350 is a polymer. The technical analysis provided with
your request describes the subject merchandise as “white granular, powder or flakes.” Thus, the
product is imported in “primary form” for the purposes of heading 3907, HTSUS. Moreover,
Chapter 39 does not contain any exclusions of polymers in primary forms based on purity levels
or uses. See, e.g., NY F81171, dated June 13, 2000 (concerning hydroxy propyl chitosan
powder, imported in bulk form as an ingredient in the manufacture of pharmaceuticals).
Therefore, given that the subject merchandise is a polyether compound derived from ethylene
oxide and is imported in primary form, it is a product of heading 3907, HTSUS.
Having considered the rulings you cite in support of your contentions (see the discussion
of NY N342461 in footnote 2), we conclude that HQ 962562 (concerning medicaments,
imported in bulk or put up in dosage form, and imported for use in a clinical trial) is
unpersuasive and the related arguments made in the request for reconsideration to be
inapplicable to the classification of subject merchandise. Under GRI 1, classification of the PEG
3350 is determined according to the terms of the headings and any relative Section or Chapter
Notes — resort to GRI 3(a) is unnecessary.
Accordingly, by application of GRI 1, the subject PEG 3350 is properly classified
subheading 3907.29.00, HTSUS which provides for “[p]olyacetals, other polyethers and epoxide
resins, in primary forms; polycarbonates, alkyd resins, polyallyl esters and other polyesters, in
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NY N342461, which considered an oral osmotic laxative in dosage form and you assert is pertinent to this
reconsideration, is inapplicable to the classification of the merchandise at issue.
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primary forms: other polyethers: other.” The column 1, general rate of duty is 6.5 percent ad
valorem. Thus, NY N351915, dated August 13, 2025, is affirmed.
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 online at:
https://hts.usitc.gov.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
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