FlyerTalk Forums - View Single Post - Bringing back prescription drugs marketed under different names abroad
Old Apr 11, 2023 | 6:21 pm
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TWA884
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From the CBP website:

Traveling with Medication
Prescription medications should be in their original containers with the doctor's prescription printed on the container. It is advised that you travel with no more than personal use quantities, a rule of thumb is no more than a 90 day supply. If your medications or devices are not in their original containers, you must have a copy of your prescription with you or a letter from your doctor. A valid prescription or doctors note is required on all medication entering the United States.


The U.S. Food & Drug Administration (FDA) is responsible for pharmaceutical admissibility determinations. If you have any questions as to whether a specific pharmaceutical may be imported into the United States, visit the FDA's website, or call (301) 796-0356.
U.S. Residents Entering the United States with Prescription Medicine
U.S. residents entering the United States at international land borders who are carrying a validly obtained controlled substance (other than narcotics such as marijuana, cocaine, heroin, or LSD), are subject to certain additional requirements. If a U.S. resident wants to bring in a controlled substance (other than narcotics such as marijuana, cocaine, heroin, or LSD) but does not have a prescription for the substance issued by a U.S.-licensed practitioner (e.g., physician, dentist, etc.) who is registered with, and authorized by the Drug Enforcement Administration (DEA) to prescribe the medication, the individual may not import more than 50 dosage units of the medication into the United States. If the U.S. resident has a prescription for the controlled substance issued by a DEA registrant, more than 50 dosage units may be imported by that person, provided all other legal requirements are met.
And the FDA:

5 Tips for Traveling to the U.S. With Medications
Q: What if there’s a generic available overseas but not here?

A: FDA does not permit personal importation of unapproved versions of FDA-approved drugs from foreign countries. FDA cannot assure that foreign-made versions of FDA-approved drugs have been properly manufactured, are safe and effective, and are the same formulation as the FDA-approved versions.

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FDA understands that there are cases in which someone may need treatment with a foreign drug that’s not available in the U.S. and there are no other U.S. medicines available to treat the condition. FDA’s Personal Importation Policy provides instructions for FDA personnel relating to the personal importation of drugs that may be illegal in the United States. FDA considers the following when reviewing such an application:
  • The drug is for a serious condition for which there is no effective treatment available in the U.S.
  • There is no marketing or promotion of the drug to U.S. residents.
  • The drug doesn’t represent an unreasonable health risk.
  • You verify in writing that you’re importing the drug for your own personal use.
  • You have a letter, written in English, from your doctor saying the drug is a continuation of treatment that began outside the United States or you provide the name and address of a U.S. licensed physician who will supervise your use of the foreign drug. The letter should accompany the package and be addressed to a Customs and Border Protection officer or broker.
  • You’re not importing more than a three-month supply of the drug.
Personal Importation
Can I purchase or bring drug or device products from a foreign country to the U.S.?

U.S. Citizens:
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In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S. If a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import.

The FDA cannot ensure the safety and effectiveness of medicine purchased over the Internet from foreign sources, storefront businesses that offer to buy foreign medicine for you, or during trips outside the U.S. For these reasons, the FDA recommends only obtaining medicines from legal sources in the U.S.

Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?

The FDA has guidance for personal importation of drug or device products. Below provides information regarding situations for which this might be allowed:
  • Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); or
  • Product is for the treatment of a serious condition ( Prescription Drug Products):
    • The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
    • There is no known commercialization or promotion of the product to persons residing in the U.S.
    • The product does not represent an unreasonable risk.
    • The consumer affirms in writing that the product is for personal use.
    • The quantity is generally not more than a three month supply and either:
      1. Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
      2. Provide evidence that the product is for the continuation of a treatment begun in a foreign country.
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