CLA-2-30:OT:RR:NC:N3:138
Matthew Lapin
Wiley Rein LLP
2050 M St., NW
Washington, D.C. 20036
RE: The tariff classification of Peritoneal Dialysis (PD) solutions of Extraneal® (icodextrin) and Dianeal®
(dextrose), in dosage form, from Mexico
Dear Mr. Lapin:
In your letter dated April 11, 2025, filed on behalf of Vantive US Healthcare LLC, you requested a tariff
classification ruling. We note that the request did not seek a determination as to country of origin, or as to the
applicability of preferential treatment under the U.S.-Mexico-Canada Agreement; as such, this ruling does
not address those issues.
The Peritoneal Dialysis (PD) solutions imported in ultrabags are used to remove excess fluid, correct
electrolyte problems, and remove toxins in those with kidney failure. Extraneal (icodextrin) is indicated for
the management of kidney failure in patients requiring long-term kidney replacement therapy. Dianeal
(dextrose) is indicated for the management of acute or chronic renal failure.
The applicable subheading for the Peritoneal Dialysis (PD) solutions of Extraneal® (icodextrin) and
Dianeal® (dextrose) in dosage form will be 3004.90.9270, Harmonized Tariff Schedule of the United States
(HTSUS), which provides for “Medicaments…consisting of mixed or unmixed products for therapeutic or
prophylactic uses, put up in measured doses…or in forms or packings for retail sale: Other: Other: Other:
Preparations primarily affecting the electrolytic, caloric or water balance: Other.” The HTSUS column 1 rate
of duty will be free.
In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS,
which applies to articles and parts and accessories of articles specifically designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles . . . Other.” The term “blind or other physically or mentally handicapped persons” includes
“any person suffering from a permanent or chronic physical or mental impairment which substantially limits
one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. T hus, eligibility
within subheading 9817.00.96, HTSUS, depends on whether the article is “specially designed or adapted for
the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within an
y of the enumerated exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
You have suggested that the above PD solutions are eligible for duty-free treatment under the Nairobi
Protocol in subheading 9817.00.96, HTSUS and that the primary classification of the PD solutions in heading
3004 is not determinative as to the applicability of the Nairobi Protocol. You also cited the following rulings
in support of your claim. In our opinion, the rulings you cited in support of the requested duty-free treatment
under the Nairobi Protocol are not applicable to the facts presented in the request.
The PD solutions of N231918 (September 21, 2012) were imported with tubing and other apparatus, such
that the PD solution was not considered the essential character. Secondary classification of the product in
heading 9817 was allowed on the basis of apparatus and not the PD solution.
The colostomy belts of NY N320543 (July 27, 2021) are not a medicament or a drug and are not relevant to
this case. The colostomy belts are accessories for an ostomy pouching system. They are designed to wrap
around the abdomen and help hold the ostomy pouch in place.
In contrast, the instant PD solutions are medicaments or drugs, used for dialysis therapy. See HQ 966023,
dated November 20, 2002, which affirmed NY I84690, dated August 7, 2002.
Therefore, the PD solutions in the request are specifically excluded from classification under 9817.00.96 as
“medicine or drugs.” U.S. Note 4(b)(iv), Subchapter XVII, Chapter 98, HTSUS. As a result, it is the opinion
of this office that a secondary classification will not apply in subheading 9817.00.96, HTSUS.
The column 1 duty rate is provided for your convenience and can be subject to change (please note that this
ruling does not address the applicability of any other types of duties, tariffs or fees). The text of the most
recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are
administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and
Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by
visiting their website at www.fda.gov.
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 Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division