CLA-2-38:OT:RR:NC:N3: 139
Dr. Raimar Loebenberg
RS Therapeutics Incorporated
21002 RPO Terwillegar
Edmonton T6R 2V4
Canada
RE: The tariff classification and eligibility of the United States-Mexico-Canada Agreement (USMCA) of a
non-aqueous, multi-component formulated preparation from Canada
Dear Dr. Loebenberg:
In your letter dated March 17, 2026, you requested a binding ruling on the tariff classification and eligibility
of a formulated, water-free, self-emulsifying chemical preparation under the United States-Mexico-Canada
Agreement (USMCA). You state that the instant item has the product name of FoamaDerm® Water-Free
Microemulsion Preconcentrate (FoamaDerm®).
You state that FoamaDerm® consists of the following components:
• Caprylocaproyl macrogol-8 glycerides (country of origin France)
• Polyglyceryl-3 oleate (country of origin France)
• Diethylene glycol monoethyl ether (country of origin France)
• Medium-chain triglycerides (country of origin France)
• Butylated Hydroxytoluene (BHT) (country of origin United States)
• Benzyl Alcohol (country of origin United States)
You state that FoamaDerm® is an intermediate product that is a ready-to-use pharmaceutical compounding
base after its hydration with water.
In your submissions, you stated that FoamaDerm® is produced at your facility located at the Drug
Development and Innovation Center which is at the University of Alberta in Edmonton. After the receipt of
all the raw materials and their passing of quality control inspection, they are portioned out by weight as per
the provided bill of materials. The BHT is dissolved into the diethylene glycol monoethyl ether for a set
period of time. The benzyl alcohol, caprylocaproyl macrogol-8 glycerides, polyglyceryl-3 oleate, and the
medium-chain triglycerides are then introduced sequentially, with certain set periods of time between each
introduction to ensure that a certain developmental result is obtained. After it is determined that a
self-emulsifying microemulsion preconcentrate has been achieved, the instant item is packed into its shipping
container.
Classification:
You stated that you believe that FoamaDerm® should be classified under Heading 3824 Harmonized Tariff
Schedule of the United States (HTSUS). We concur.
The applicable subheading for FoamaDerm® will be 3824.99.9397, Harmonized Tariff Schedule of the
United States (HTSUS), which provides for Prepared binders for foundry molds or cores; chemical products
and preparations of the chemical or allied industries (including those consisting of mixtures of natural
products), not elsewhere specified or included: Other: Other: Other: Other: Other: Other: Other: Other. The
rate of duty will be 5 percent ad valorem.
The duties cited above are current as of this ruling’s issuance. 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/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at
https://www.cbp.gov/trade/programs-administration/trade-remedies.
USMCA:
The USMCA was signed by the Governments of the United States, Mexico, and Canada on November 30,
2018. The USMCA was approved by the U.S. Congress with the enactment on January 29, 2020, of the
USMCA Implementation Act, Pub. L. 116-113, 134 Stat. 11, 14 (19 U.S.C. § 4511(a)). General Note ("GN")
11 of the HTSUS implements the USMCA. GN 11(b) sets forth the criteria for determining whether a good is
an originating good for purposes of the USMCA. GN 11(b) states:
For the purposes of this note, a good imported into the customs territory of the United States from the
territory of a USMCA country, as defined in subdivision (l) of this note, is eligible for the preferential
tariff treatment provided for in the applicable subheading and quantitative limitations set forth in the
tariff schedule as a "good originating in the territory of a USMCA country" only if-
(i) the good is a good wholly obtained or produced entirely in the territory of one or more
USMCA countries;
(ii) the good is a good produced entirely in the territory of one or more USMCA countries,
exclusively from originating materials;
(iii) the good is a good produced entirely in the territory of one or more USMCA countries
using non-originating materials, if the good satisfies all applicable requirements set forth in
this note (including the provisions of subdivision (o));
Since FoamaDerm® contains non-originating ingredients, it is not considered a good wholly obtained or
produced entirely in a USMCA country under GN 11(b)(i), nor are the products produced exclusively from
originating materials per GN 11(b)(ii). Thus, we must determine whether FoamaDerm® qualifies under GN
11(b)(iii). As previously noted, FoamaDerm® is classified under subheading 3824.99.9397, HTSUS. The
applicable rule of origin for goods classified under subheading 3824.99.9397, HTSUS, is in GN 11(o)/
38.5(A), HTSUS, which provides in relevant part:
(A) A change to subheadings 3823.11 through 3826.00 from any other subheading, including another
subheading within that group.
Based on the facts provided, FoamaDerm® will qualify for USMCA preferential tariff treatment, because it
will meet the requirements of HTSUS General Note 11(b)(iii). The good will therefore be entitled to a free
rate of duty under the USMCA upon compliance with all applicable laws, regulations, and agreements.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
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, please contact
National Import Specialist John Bobel at [email protected].
Sincerely,
(for)
James Forkan
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division