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U.S. Customs Import Regulations on Prescription Medication

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    Concerns

    • The FDA recommends that consumers obtain medication from legal sources within the United States to ensure safety and effectiveness.

    Personal Importations

    • Individuals are prohibited from importing prescription drugs into the United States that have not been approved by the FDA. Importing medication that has been misbranded or altered is also prohibited.

    Importations by Manufacturers

    • FDA-approved medication that was manufactured in the United States and exported may be imported back into the United States by the original manufacturer.

    Exceptions

    • The FDA may allow an individual to enter the United States with a three-month supply of a medication if all of the following conditions are met: the drug is to treat a serious condition and treatment is not available domestically, the drug is for personal use only, the drug does not present an unreasonable risk, and the individual affirms in writing that all the conditions are met and provides contact information for a physician in the United States who is responsible for his care.

    Questions

    • Questions about pharmaceutical importations should be directed to the FDA, Division of Import Operations and Policy, at (301) 443-6553. Questions about importing controlled substances should be directed to the Drug Enforcement Administration, Office of Diversion Control, International Drug Unit, at (202) 307-2414.

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