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  1. Guidance, Compliance, & Regulatory Information

Human Drug Imports

FDA protects patients and consumers at the border

Imported drugs must meet FDA’s standards for quality, safety and effectiveness. FDA works to ensure medicines imported into the U.S. comply with legal and regulatory requirements. Ensuring the integrity of the U.S. supply chain is a critical component to protecting patients and consumers. Medicines from outside the legitimate drug supply chain do not have the same assurance of safety, effectiveness and quality as drugs subject to FDA oversight.



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