The Federal Food, Drug, and Cosmetic Act (the Act) prohibits persons from importing into the United States any prescription drug that has not been approved for sale by the United States Food and Drug Administration (FDA), or which is adulterated or misbranded within the meaning of the Act. Moreover, in those instances where a United States manufacturer makes an FDA-approved prescription drug and sends it abroad, the Act also prohibits any person other than the original manufacturer from importing the drug back into the United States. Thus, in virtually all instances, individual citizens are prohibited from importing prescription drugs into the United States.FDA Enforcement Policy Regarding the Personal Importation of Violative DrugsThe FDA has developed guidance entitled “Coverage of Personal Importations” which sets forth the FDA enforcement priorities with respect to the personal importation of unapproved new drugs by individuals for their personal use. Under this guidance, as an exercise of enforcement discretion, FDA may allow an individual entering the United States to import a three month supply of an unapproved drug if all of the following conditions are met:
The 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, please contact the FDA, Division of Import Operations and Policy, at (301) 796-0356.If you have any questions regarding the importation of a controlled substance into the United States, please contact the Drug Enforcement Administration, Office of Diversion Control, International Drug Unit, at (202) 305-8800.
- The intended use of the drug is for a serious condition for which effective treatment may not be available domestically;
- The drug will not be distributed commercially by the importer;
- The product is considered not to represent an unreasonable risk;
- The individual seeking to import the product affirms in writing that the drug is for the patient’s own use and provides the name and address of the doctor licensed in the United States 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.
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