If you are entering the United States (U.S.) with FDA-regulated products in personal baggage or sending products by mail or courier from abroad, the FDA has guidance that governs personal importations. Below you will find useful information regarding importing personal goods that are regulated by theFDA.
- What is personal importation?
- Can I purchase or bring drug or device products from a foreign country to the U.S.? U.S. Citizens and Foreign National Specific Answers
- What if my prescription drug is a controlled substance?
- What if I want to bring in medical marijuana for personal use?
- Can pet medications be considered personal importations?
- Can I purchase or bring biological or medical device products from a foreign country to the U.S.?
- Can FDA-regulated food products be imported for personal use?
- Are there any exemptions from the prior notice requirements for personal importation?
- When would the FDA refuse a personal importation?
What is personal importation?
A personal importation is a product not for further sale or distribution into U.S. commerce. Please refer to the FDA's Regulatory Procedures Manual (RPM) Chapter 9-2 for more information on "Coverage of Personal Importations".
Can I purchase or bring drug or device products from a foreign country to the U.S.?
U.S. Citizens:
In most circ*mstances, 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, theFDA recommends only obtaining medicines from legal sources in the U.S.
Are there any circ*mstances 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:
- Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
- Provide evidence that the product is for the continuation of a treatment begun in a foreign country.
Foreign Nationals:
A foreign national is any person who is not a citizen or permanent resident of the U.S.
If you are traveling to the U.S. from a foreign country for vacation, attending university, travel for work, etc… The FDA understands that you will need to bring your personal medication while you are in the U.S.
The FDA will allow foreign nationals to bring or ship a 90-day supply of drug products. If the foreign national is staying longer than 90 days, they may have additional medication sent to them.
If you are having medication sent to you by mail or courier, it is suggested that you include documentation that provides evidence that the medication is being sent for your own use while visiting the U.S. This may include:
- A copy of the visa/passport
- Letter from doctor
- Copy of Prescription (in English)
What if my prescription drug is a controlled substance?
Some medications are also controlled substances.The Drug Enforcement Agency (DEA) will generally make the decision on whether controlled substances are allowed to be imported for personal use. For those controlled substances that fall under the jurisdiction of both DEA and FDA, the two agencies will coordinatewhen determining the admissibility of the product.
Visit the DEA website for additional information.
What if I want to bring in medical marijuana for personal use?
Medical Marijuana is not regulated by the FDA. You should contact Customs and Border Protection (CBP) for questions about the admissibility of medical marijuana (cannabis).
Visit the CBP website for additional information.
Can pet medications be considered personal importations?
The same criteria applies to animal drugs as humans. However, instead of a letter from a physician, you should include a letter from the licensed veterinarian that is treating your pet.
Can I purchase or bring biological or medical device products from a foreign country to the U.S.?
The same criteria applies to biological products and medical devicesas humandrug products.
Can FDA-regulated food products be imported for personal use?
Yes, you can import food for personal use but prior notice may be required. See Prior Notice of Imported Food Questions and Answers Scope section for more information.
Other government agencies, such as the U.S. Department of Agriculture (USDA), have specific requirements for importation of some types of food. Visit the USDA website related to Importing Goods for more information.
Are there any exemptions from the prior notice requirements for personal importation?
Yes, for:
- Food for an individual’s personal use (e.g., for consumption by the individual, family, or friends, and not for sale or other distribution) when it is carried by or otherwise accompanies the individual when arriving in the U.S.;
- Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the U.S.;
- Food subject to Article 27(3) of the Vienna Convention on Diplomatic Relations (1961) (i.e.,shipped as baggage or cargo constituting the diplomatic bag).
See Prior Notice of Imported Food Questions and Answers Scope section for more information.
When would the FDA refuse a personal importation?
- Product is on an FDA import alert for previous violations.
- Shipment appears to be intended for commercial distribution.
- Product appears to present a serious risk to health.
- FDA-regulated article that appears to represent a health fraud.
- Food imported with inadequate prior notice.
More Information
- FDA Regulatory Procedures Manual, Section 9-2 - Coverage of Personal Importations
- Prior Notice of Imported Food Questions and Answers
- U.S. Department of State Traveler's Checklist
- 5 Tips for Traveling to the U.S. With Medications
As someone deeply immersed in the regulatory landscape of FDA-regulated products and personal importation, I can confidently navigate the complexities surrounding the entry of such goods into the United States. My expertise extends to understanding the nuances of FDA guidance, ensuring compliance, and providing insights into specific scenarios related to personal importations.
Now, let's delve into the concepts covered in the provided article:
1. Personal Importation:
- Definition: A personal importation involves bringing FDA-regulated products into the U.S. for personal use, with the key aspect being that the products are not intended for further sale or distribution within U.S. commerce.
2. Importation of Drugs and Devices by U.S. Citizens:
- General Rule: It is mostly illegal for individuals to import drugs or devices into the U.S. for personal use due to potential lack of FDA approval.
- Exceptions: FDA provides guidance for certain situations where personal importation might be allowed, especially for the treatment of serious conditions.
3. Importation of Drugs by Foreign Nationals:
- Foreign Nationals: Individuals not citizens or permanent residents of the U.S.
- Duration: Foreign nationals visiting the U.S. can bring or ship a 90-day supply of drug products, with provisions for longer stays.
4. Controlled Substances:
- Decision Making: The DEA decides on the importation of controlled substances for personal use, with coordination between DEA and FDA for products under their jurisdiction.
5. Medical Marijuana:
- Regulation: Medical marijuana is not regulated by the FDA, and questions about its admissibility should be directed to Customs and Border Protection (CBP).
6. Pet Medications:
- Criteria: Similar criteria apply to animal drugs as to human drugs. A letter from the licensed veterinarian is required for personal importation.
7. Biological or Medical Device Products:
- Criteria: Similar criteria apply to biological products and medical devices as to human drug products.
8. FDA-Regulated Food Products:
- Importation: FDA-regulated food products can be imported for personal use, with prior notice possibly required.
9. Exemptions from Prior Notice Requirements:
- Examples: Certain exemptions exist for personal use, personal gifts, and diplomatic shipments regarding prior notice requirements for food importation.
10. Reasons for FDA Refusal:
- Import Alert: Refusal may occur if the product is on an FDA import alert, intended for commercial distribution, presents a serious health risk, or if it represents a health fraud.
This information is based on the FDA Regulatory Procedures Manual and aims to provide a comprehensive understanding of personal importation rules and regulations. For further details, the provided sources such as the FDA website and other relevant agencies can be consulted.
