Foreign-Trade Zone (FTZ) 49; Authorization of Limited Production Activity; Merck, Sharp & Dohme LLC; (Pharmaceutical Products for Research and Development); Rahway, New Jersey

On April 2, 2025, Merck, Sharp & Dohme LLC (Merck) submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 49Y, in Rahway, New Jersey.

The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (90 FR 15541, April 14, 2025). On November 14, 2025, the applicant was notified of the FTZ Board's decision that the proposed activity has been authorized on a limited basis, subject to the FTZ Act and the Board's regulations, including section 400.14, and subject to a three-year limited authorization as well as a requirement that after two years, Merck demonstrate to the satisfaction of the FTZ Board that any foreign status API be sourced from trusted, secure providers that manufacture in countries with adequate health and safety regulations that are not in countries of concern. Merck may submit requests for the FTZ Board to review proposed sources of API, and the FTZ Board should ordinarily review such applications within 90 days of receiving the request.