Bristol-Myers Squibb Holdings Pharma, Ltd. (BMS) submitted a notification of proposed production activity to the FTZ Board for its facility in Manati, Puerto Rico. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on May 13, 2019.
BMS already has authority to produce certain pharmaceutical products within Subzone 7J. The current request would add finished products and a foreign status material/component to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status material/component and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt BMS from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status material/component noted below and in the existing scope of authority, BMS would be able to choose the duty rates during customs entry procedures that apply to pegbelfermin in measured and finished dosages (duty-free). BMS would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The material/component sourced from abroad is pegbelfermin—active pharmaceutical ingredient (duty-free).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Christopher Wedderburn at