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.”

1 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.

2 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

2 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.

3 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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