What is a Foreign Trade Zone?
The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.
Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which resides in a foreign trade zone. Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).
During its stay in the FTZ, the biopharmaceutical product can be further labeled and secondarily packaged while greatly mitigating the numerous logistic and economic challenges encountered throughout the drug importation and development process.
|Unlimited Storage Terms||Term of pharmaceutical material storage in an FTZ is indefinite.|
|Eliminated U.S. Quota Restrictions||Product previously subject to quota limitations is now exempt from such restrictions.|
|Strengthened Foreign Pharmaceutical Supply Chain||Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.|
|Uninterrupted Local Manufacture Prior to Importation||Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.|
|Expedited Release to Market||Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.|
|Duty Deferral or Duty Aversion||Import, admit and hold product without paying U.S. Customs duties.|
|Zero Inventory Taxes||All materials held in an FTZ are exempt from state, county and local ad valorem taxes.|
|Country of Origin Marking and Labeling||Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.|
Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.
Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org