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Sentry's GMP pharmaceutical facility maintains active foreign trade zone (FTZ) status per Foreign Trade Zones Act 19 (U.S. Code Title 19, Chapter 1A), in compliance with 15 CFR Part 400, FTZ regulations. Sentry's active FTZ status and customs bond, support import optimization and control of temperature-sensitive biological and pharmaceutical ingredients, materials, semi-finished and finished drug products.
Interestingly, a FTZ in the United States (US) is not technically considered a part of the US, and the same is true for foreign trade zones in other countries. Drug product entering a FTZ in the US is not subject to customs inspection when it enters the zone – only when the product leaves the zone for US consumption. This is regulated by The U.S. Customs and Border Protection (CBP) agency, which is one of the world's largest law enforcement organizations. For additional information about the CBP see the short video below.
Here are some of Sentry's foreign trade zone (FTZ) benefits:
As an example of this important Sentry attribute, Sentry has the capacity to accept the congregation of controlled substances III-V from outside the US in preparation for the CS product’s commercial launch. Upon the approval of clearance from CBP, FDA and DEA the CS drug product can leave Sentry’s FTZ and be distributed by Sentry to pharmacies or to another distribution center according to the direction of the pharmaceutical product’s owner.
In addition, pharmaceutical companies do not have to supply a bond to store their pharmaceutical products within a FTZ, nor do they have to pay duties on their drug product unless they plan to distribute them within the US for consumption. Biotech, pharmaceutical and medical device manufacturers can store both foreign and domestic goods in a foreign trade zone, and none of these products are subject to tax or duties (again, unless the products are intended for distribution within the country).