Personal importation of prescription medicines into the United States
The FDA guidance covers FDA-regulated personal goods carried into the United States in baggage or sent from abroad by mail or courier. FDA guidance defines personal importation as bringing in a product that is not intended for further sale or distribution into U.S. commerce.
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FDA guidance states that the DEA generally decides whether controlled substances may be imported for personal use. When a controlled substance falls under both DEA and FDA jurisdiction, the agencies coordinate their determination of whether the product may enter.
VerifiedFDA guidance says products violating FDA laws or regulations are generally not permitted, but FDA personnel may consider a more permissive decision for personal-use medications in specified situations. This describes possible discretion rather than an unconditional permission to import.
VerifiedFor medication sent by mail or courier to someone visiting the United States, the FDA guidance suggests including documentation showing that the medication is for the recipient's own use during the visit.
VerifiedThe FDA guidance explains that the agency cannot ensure the safety and effectiveness of medicines obtained from foreign internet sources, businesses that purchase foreign medicines for customers, or trips abroad. It therefore recommends obtaining medicines from legal U.S. sources.
VerifiedFDA guidance states that personal importation of drugs or devices is illegal in most circumstances because products purchased abroad often lack FDA approval for U.S. use and sale. It specifically states that approval in another country does not permit importation of a drug that is an unapproved new drug in the United States.
VerifiedThe FDA guidance defines a foreign national as someone who is neither a U.S. citizen nor a permanent resident. It states that foreign nationals may bring or ship a 90-day supply of drug products and may have additional medication sent if their stay exceeds 90 days.
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