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Is it legal for me to personally import drugs?
In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.
FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:
- The drug is for use for a serious condition for which effective treatment is not available in the United States;
- There is no commercialization or promotion of the drug to U.S. residents;
- The drug is considered not to represent an unreasonable risk;
- The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
- Generally, not more than a 3-month supply of the drug is imported.
- What does FDA inspect?
- When and why was FDA formed?
- What doesn’t FDA regulate? How do I contact the agencies that do?
- What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
- FDA Basics Metrics: July 2011
- FDA Basics Metrics: June 2011
- FDA Basics Metrics: May 2011
- FDA Basics Metrics: March 2011
- What does FDA do?
- How is FDA organized?
- What does FDA regulate?
- How many people are employed by FDA and in what areas do they work?
- FDA Basics Metrics: July 2012
- FDA Basics Metrics: June 2012
- FDA Basics Metrics: December 2011
- FDA Basics Metrics: May 2012
- FDA Basics Metrics: April 2012
- FDA Basics Metrics: March 2012
- FDA Basics Metrics: February 2012
- FDA Basics Metrics: January 2012
- FDA Basics Metrics: November 2011
- FDA Basics Metrics: October 2011
- FDA Basics Metrics : September 2011
- FDA Basics Metrics: August 2011
- FDA Basics Metrics: April 2011
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