BIS Set to Publish Notice on Applications for Pharmaceutical Company-Specific Agreements

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May 12, 2026
By: Hannah B. Kreinik

Following President Trump’s proclamation adjusting imports of pharmaceuticals and pharmaceutical ingredients, the Bureau of Industry and Science (BIS) is gearing up to publish a notice with application instructions for companies pursuing company-specific onshoring agreements. The applications for country-specific onshoring agreements will be due 30 days from the date of publication of the notice.

In the April 2^nd proclamation, the President implemented Section 232 tariffs at a 100% ad valorem rate for certain patented pharmaceutical goods and ingredients for companies not listed in Annex III. The proclamation’s duties are effective as of September 29, 2026. The proclamation also permits the Secretary of Commerce to enter into company-specific onshoring agreements to reduce the tariff to 20%. In addition, companies that also reach an MFN agreement with the Department of Health and Human Services will have a zero rate of duty until January 20, 2029. Applications for company-specific onshoring agreements can be found at https://www.bis.gov/about-bis/bis-leadership-and-offices/SIES/section-232-investigations. Applications should be submitted via email: pharma232@bis.doc.gov.

Applications should include basic organization information like company name, address, ownership information, company headquarters, company products, manufacturing and production information, and representative contact information. The application should also include the total investment to be made in the U.S. between January 20, 2025, and January 20, 2029. Companies should also include an explanation of the patented product portfolio that will be moved to the U.S. The application requests the percentage of sales for patented products with APIs produced in the U.S. starting January 20, 2025, and predicted sales that are U.S.-made by January 20, 2029. For the part of the patented pharmaceutical product portfolio that will not be moved to the U.S., the applications should include the following:

• Specific product portfolio information,
• Statement that it is commercially unfeasible to onshore the designated products in the U.S.,
• A hypothetical cost breakdown to move production to the U.S. for those products,
• The amount the company will commit to building facilities over what was previously specified in the application,
• Annex A progress milestones through January 20, 2029,
• A commitment statement to present, at least, semiannual reports on the milestones to Commerce, and
• A statement ensuring compliance with any additional information requests from Commerce.

Annex A is a pre-drafted template for companies to explain the planned production investments for their pharmaceutical goods. Companies should submit an Annex B for the products that are to receive the reduced tariff rate and should include the following information for the products: HTSUS, advertised name, brand, and active ingredient in the product, country of origin, importer of record name and number, exporter name and address, the foreign manufacturers name, owner, and address, and the CBP Manufacturer Identification Code (MID) for the products.

Finally, the company-specific onshoring applications should include a certification from a senior official at the company and include pre-written representations and acknowledgements located in the notice.

Barnes, Richardson & Colburn attorneys are here to assist pharmaceutical importers with production line assessments and BIS company-specific applications.