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U.S. Department of Health and Human Services

For Industry

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Travelers Alert

 
 


The U.S. Customs Service enforces Federal laws and regulations, including those of the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA).

The United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 331(d), and 355(a)), which is administered by FDA, prohibits the interstate shipment (which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness. It is the importer's obligation to demonstrate to FDA that any drugs offered for importation have been approved by FDA.

FDA has developed guidance entitled "Coverage of Personal Importations" which sets forth that agency's enforcement priorities with respect to the personal importation of unapproved new drugs by individuals for their personal use. The guidance identifies circumstances in which FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs. Those circumstances are as follows:

"1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;

2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;

3) the product is considered not to represent an unreasonable risk;

and

4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than a 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country/area." (Emphasis added)

FDA's guidance is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S. Even if all of the factors noted in the guidance are present, the drugs remain illegal and FDA may decide that such drugs should be refused entry or seized. The guidance represents FDA's current thinking regarding the issues of personal importation and is intended only to provide operating guidance for FDA personnel. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind FDA or the public.

 

To avoid travel delays and to prevent possible harm from taking unsafe or ineffective medications, residents and visitors upon arrival to or departure from the U.S. should keep in mind the following precautions:

  • Do not assume that medications which are legal in foreign countries/areas are also approved for use in the United States. These products may be illegal and may include addictive and dangerous substances;

     

  • Be aware that the labeled uses (conditions for which the product is represented to be effective) for a product purchased outside the U.S. may not be approved in the United States;

     

  • It can be dangerous to take some medications without medical supervision. The reason why some medications are limited to prescription use in the United States is that either they are unsafe without medical supervision or a medical diagnosis is required to ensure that the medication is appropriate for your condition;

     

  • Avoid purchasing any drug products that are not approved for sale in the U.S. (including foreign-manufactured versions of U.S. approved drugs). FDA cannot assure that these products conform to the manufacturing and quality assurance procedures mandated by U.S. laws and regulations and, therefore, these products may be unsafe. In addition, such products are illegal in the U.S. and, therefore, may be subject to entry refusal;

     

  • Some medications which may appear to be U.S. approved drug products may in fact be counterfeit versions of such products. (The term "counterfeit drug" is defined as "a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor." See 21 U.S.C. 321(g)(2));

     

  • In the event you develop complications from using a medication which require medical attention, your treatment could be delayed or made more difficult unless there is sufficient information available about the product, such as the generic name of the product, dosage form and strength, and how often you need to take the product.

     

  • Possession of certain medications without a prescription from a physician licensed in the United States may violate Federal, State, and/or local laws;

     

  • It is important to have medications in the originally-dispensed container;

     

  • FDA's personal importation guidance provides that when bringing unapproved drugs into the U.S. for use in treating serious or life threatening illnesses, such products should be used under the care and supervision of a U.S. licensed physician. It is advisable to make available for examination by U.S. Customs Inspectors or other appropriate government authorities appropriate documentation of such monitoring;

     

  • It is against the law not to properly declare imported medications to U.S. Customs.

     

  • When the type of drug, the quantity, or the combination of various drugs arouse suspicions, U.S. Customs Inspectors will ordinarily contact the nearest FDA or DEA office for advice and will then make a final determination about whether to release or detain the article. (See 19 U.S.C. 1499).

For more detailed information on FDA's personal importation guidance, contact your local FDA office.