Federal Register #B-119-2026

Proposed Production Activity at Merck, Sharp & Dohme LLC in FTZ 49 (Drug Products and Intermediates)

This opportunity concerns proposed production activity at Merck, Sharp & Dohme LLC's facilities in Rahway, New Jersey, within Foreign-Trade Zone (FTZ) 49, as notified by the Foreign-Trade Zones Board (Commerce Department). - Government Buyer: - Foreign-Trade Zones Board, U.S. Department of Commerce - OEM/Vendor: - Merck, Sharp & Dohme LLC - Products/Services Requested: - Manufacture of finished drug products and intermediates for: - Immunological disorders - Oncology - Infectious diseases - Neurologic diseases - Metabolic disorders - Specific products include: - Immunological disorder drug products - Oncology spray dried intermediates - Infectious disease spray dry intermediates - Deuterated neurologic disease drug products - Metabolic disorders drug products - Metabolic disorders spray dry intermediates - Neurologic disease spray dry intermediates - Materials/Components: - Foreign-status active pharmaceutical ingredients and intermediates such as: - Morpholine, monoclonal antibodies, pyrrolidine, imidazole, alkaloids, pyrimidine, sulfonamide, deuterated compounds, furan, peptide, lactam, indole, and others - Duty rates range from duty-free to 6.5% - Some materials subject to duties under section 232 (Trade Expansion Act of 1962) or section 301 (Trade Act of 1974), depending on country of origin - Regulatory requirement: Certain materials must be admitted to FTZs in privileged foreign status - Unique/Notable Requirements: - Use of foreign-status materials with specific duty and regulatory requirements - Production covers a wide range of pharmaceutical products for major disease categories - FTZ admission rules apply for some components

Description

Notification of proposed production activity at Merck, Sharp & Dohme LLC within FTZ 49, Rahway, New Jersey, involving drug products and intermediates. The proposed finished products include various drug products for immunological disorders, oncology, infectious diseases, neurologic diseases, and metabolic disorders. The notification details specific foreign-status materials and components used in production, with duty rates ranging from duty-free to 6.5%. Public comments are invited until November 3, 2026.

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