Last updated: October 27, 2026

Pharmaceutical imports: who holds the Importer of Record role, and what it now carries

Since September 29, 2026, patented pharmaceuticals and their ingredients enter the United States under Section 232 duties that range from zero to 100 percent, and the rate on any given entry turns on facts the Importer of Record (IOR) declares: country of origin, patent status, the company’s agreements with the Department of Commerce, and the end use of the goods. This page is for compliance, regulatory, and finance leaders at companies that import finished drugs, active pharmaceutical ingredients, or key starting materials. It sets out the duties in force, who typically holds the IOR role in a pharmaceutical supply chain, what that party must have in place, and where the 2026 customs enforcement order points.

The Section 232 duties in force today

Proclamation 11020, Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States, was issued under 19 U.S.C. §1862 and published at 91 FR 18183. It covers patented finished pharmaceutical products, their active pharmaceutical ingredients, and the key starting materials for those ingredients, as listed in Annex I and narrowed by the technical corrections the Bureau of Industry and Security published on September 23, 2026 at 91 FR 60360. CBP’s filing guidance is CSMS #70054007 of September 28, 2026.

Each rate is reported under a Chapter 99 heading on the entry summary:

CBP states that if a product is subject to more than one rate under the proclamation, the lowest applicable rate applies. The duties are collected in addition to any special rate under a free trade agreement or preference program. Goods admitted to a foreign trade zone on or after the effective date must be admitted in privileged foreign status under 19 C.F.R. §146.41 unless eligible for domestic status under 19 C.F.R. §146.43. Drawback is available. Antidumping and countervailing duties continue to apply. Imports of United States origin pharmaceutical products are not subject to the duties.

The September 23 notice also opened an ongoing process for submissions on products that meet an urgent United States health need. It sets no decision deadline. The Section 232 pharmaceutical post walks through the notice and the HTS revision in detail.

Who holds the Importer of Record role in a pharmaceutical supply chain

On every formal entry one party is named as Importer of Record. Under 19 U.S.C. §1484 that party must be the owner or purchaser of the goods, or a licensed customs broker they designate, and it carries the duties, the bond, the records, and the reasonable care obligation. In pharmaceutical trade the role sits in one of three places.

Which party holds the role is a commercial choice, but it is not a free one. The onshoring plan and pricing agreement rates under headings 9903.04.64 and 9903.04.65 attach to the company that made the agreement with Commerce, and the specialty and clinical trial rates attach to facts about the product and its use. The Importer of Record is the party CBP looks to for each of those facts. The who needs a United States Importer of Record page compares the situations side by side.

What the Importer of Record must declare on a pharmaceutical entry

A pharmaceutical entry carries two sets of obligations, one to CBP and one to FDA, and the Importer of Record answers for both.

To CBP. The entry summary reports the Chapter 1 to 97 classification, the Chapter 99 heading that sets the Section 232 rate, the country of origin, and the customs value. Each reduced rate rests on a fact: that the product is a product of the United Kingdom or a listed jurisdiction, that the active ingredient packaged in dosage form is a product of the United States, that the article is generic, that it falls within a specialty category defined in the September 23 notice, that it is solely for clinical trials or research, or that the company holds a qualifying agreement with Commerce. Under 19 U.S.C. §1484(a)(1) the IOR must use reasonable care in making those declarations, and under 19 U.S.C. §1592 penalties for negligence, gross negligence, and fraud attach to the IOR. CBP’s guidance states that no lower rate or duty free claim is allowed where CBP’s information indicates otherwise.

To FDA. Under 21 U.S.C. §360(i), every foreign establishment that manufactures a drug imported or offered for import into the United States must register, name its United States agent, and re-register each year between October 1 and December 31. Under 21 U.S.C. §360(j) the establishment lists each drug it manufactures for commercial distribution. Under 21 U.S.C. §381(a), FDA may refuse admission to a drug that appears to be adulterated, misbranded, manufactured under insanitary conditions, or in violation of the approval requirements of 21 U.S.C. §355, and a refused article must be exported or destroyed. The prior notice requirement in 21 U.S.C. §381(m) applies to food, not to drugs. Separately, 21 U.S.C. §381(s) provides for the registration of commercial drug importers under regulations the Secretary of Health and Human Services issues, with a unique facility identifier once that system is specified.

Records. Under 19 U.S.C. §1508 and 19 C.F.R. Part 163 the Importer of Record keeps the entry, the commercial invoice, the packing list, proof of payment, and the documents behind each rate claim for five years, and produces them on demand under 19 U.S.C. §1509. For a pharmaceutical entry those documents include the evidence of patent status, the origin of the active ingredient, the agreement with Commerce where one is claimed, and the FDA registration and listing of the manufacturer.

Valuation decides the duty

A 100 percent ad valorem duty makes the customs value the single largest number on the entry. Under 19 U.S.C. §1401a that value follows a sequential hierarchy of methods beginning with transaction value, the price actually paid or payable for the goods when sold for export to the United States, with statutory additions for assists, royalties, and proceeds. Most pharmaceutical entries are filed under transaction value without testing whether it is the correct method for the facts.

Three features of pharmaceutical trade put that test in play. Sales between a foreign manufacturer and its United States affiliate are related party transactions, and transaction value applies to them only where the relationship did not influence the price or the value closely approximates a test value. Licensing and royalty payments tied to the imported product may be dutiable additions under 19 U.S.C. §1401a(b)(1)(D). Where transaction value cannot be used, the statute moves in order through the transaction value of identical or similar merchandise, deductive value, computed value, and the fallback method under 19 U.S.C. §1401a(f). The customs valuation page walks through each method and the documentation CBP expects behind it. Whichever method applies, the Importer of Record declares it, and the work of establishing the correct value and documenting it belongs before importation, not after liquidation.

What changed in 2026 for pharmaceutical importers

Two federal actions landed on this sector in the same year.

The Section 232 duties described above took effect for all companies on September 29, 2026. For a foreign manufacturer that has been entering goods in its own name, the duty now sits on a nonresident importer that also has to meet the Form 5106 accuracy enforcement in effect since September 18, 2026, under which CBP voids the IOR number of any importer whose form lists a registered agent, broker, forwarder, or other third party as its own address or contacts.

Executive Order 14411, Strengthening Customs Enforcement, signed June 3, 2026 and published at 91 FR 35125, directs minimum tangible domestic assets or bonding for Importers of Record, heightened formal entry requirements for foreign entities, a good standing requirement with increased vetting, and a 50 percent minimum penalty floor. As of October 12, 2026 those directives remain in rulemaking with no effective date. CBP opened an advance notice of proposed rulemaking on supply chain disclosures on September 2, 2026, with comments due December 1, 2026. The enforcement order tracker carries the current position of each directive. A pharmaceutical importer entering high value goods under a 100 percent duty is the kind of importer the bonding and vetting directives describe.

Frequently asked questions

Related

• What an Importer of Record is responsible for
• Section 232 pharmaceutical duties apply to all companies as of September 29, 2026
• Customs valuation under 19 U.S.C. §1401a
• Who needs a US Importer of Record
• Steel and aluminum imports: the Importer of Record under Section 232
• Chemical imports: the Importer of Record under Section 301
• What changed in 2026: the enforcement order tracker
• Nonresident importer in the United States
• How it works

Sources

• Proclamation 11020, Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States, 91 FR 18183, April 9, 2026
• Bureau of Industry and Security, Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals, 91 FR 60360, September 23, 2026
• CBP, CSMS #70054007, Updated Guidance: Section 232 Duties on Imports of Pharmaceutical Articles and Ingredients, September 28, 2026
• CBP, Trade Remedies, Section 232 Pharmaceuticals and Pharmaceutical Ingredients
• 19 U.S.C. §1484, entry of merchandise
• 19 U.S.C. §1401a, value
• 19 U.S.C. §1508, recordkeeping
• 19 U.S.C. §1592, penalties
• 19 C.F.R. §141.18, entry by nonresident corporation
• 21 U.S.C. §360, registration of producers of drugs and devices
• 21 U.S.C. §381, imports and exports
• Executive Order 14411, Strengthening Customs Enforcement, 91 FR 35125, June 10, 2026
• CBP, Accuracy of Importer of Record Data Submitted to CBP, Federal Register, August 19, 2026

This page summarizes publicly available federal actions for general information. It is not legal advice. Requirements are subject to rulemaking and change. Verify current requirements against the Federal Register and CBP guidance.