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Federal Circuit Confirms Qualification as a "U.S.-Made End Product" under the TAA, Does Not Require Substantial Transformation in the U.S.

Client Alert | 1 min read | 02.10.20

Today, in Acetris Health, LLC v. United States, the Federal Circuit held that a pharmaceutical manufactured in the United States qualified for sale, under the TAA, to the Department of Veterans Affairs even though the active pharmaceutical ingredient (API) came from a non-designated country, India. In reaching this decision, the court questioned, without deciding, the longstanding Customs and Border Enforcement position that the country where the API was manufactured defined the location of “substantial transformation” for any resulting pharmaceutical. In any event, the court held that under the Federal Acquisition Regulation definition, to qualify as a “U.S.-made end product” under the TAA, the product need be either “manufactured” in the U.S. or “substantially transformed” in the U.S. – it need not be both.

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Client Alert | 7 min read | 12.17.25

CARB Proposes Regulations Implementing California GHG Emissions and Climate-Related Financial Risk Reporting Laws

After hosting a series of workshops and issuing multiple rounds of materials, including enforcement notices, checklists, templates, and other guidance, the California Air Resources Board (CARB) has proposed regulations to implement the Climate Corporate Data Accountability Act (SB 253) and the Climate-Related Financial Risk Act (SB 261) (both as amended by SB 219), which require large U.S.-based businesses operating in California to disclose greenhouse gas (GHG) emissions and climate-related risks. CARB also published a Notice of Public Hearing and an Initial Statement of Reasons along with the proposed regulations. While CARB’s final rules were statutorily required to be promulgated by July 1, 2025, these are still just proposals. CARB’s proposed rules largely track earlier guidance regarding how CARB intends to define compliance obligations, exemptions, and key deadlines, and establish fee programs to fund regulatory operations....

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