Sentry recently completed a week-long trip to the Pacific Northwest region to satisfy multiple requests to learn more about the company’s foreign trade zone (FTZ) service offering. Client interest focused on importing high value active pharmaceutical ingredients (API) into Sentry’s FTZ for an indefinite storage term.
As supply chains become more intricate in our ever shrinking world, any weak link that chain can produce devastating results for temperature-sensitive biotech drug products. “Most of us in pharma and biotech have our stories of disasters or near calamities concerning product movements globally” stated Tim Mitchell, President of Sentry. “In light of the tremendous investment in treasury and time required to bring a new medication to market, it is critical to not allow product safety, identity, strength, purity and quality (SISPQ) to be impacted by delays which are inherent with the standard drug importation process.”
Sentry can help prevent time-out-of-temperature excursions through the utilization of its Foreign Trade Zone (FTZ), subzone 11 of zone 72 located at its facility in Indianapolis, Indiana.
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.
Benefits to the Biopharmaceutical Industry
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 FTZ 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 U.S. Customs and Border Protection agency (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.