Is It Legal To Import Medicines Into The U.S?
No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act and is illegal. Unapproved new drugs are any drugs — including foreign-made versions of U.S. approved drugs — that have not been manufactured in accordance with and pursuant to FDA approval.
FDA recognizes that some individuals may seek treatment with an unapproved new drug in a foreign country and may wish to continue such treatment upon their return to the USA. Likewise, FDA recognizes some individuals suffer from conditions for which no FDA approved treatment exist. FDA has developed a guidance that identifies circumstances under which FDA may consider allowing entry of such drugs. Generally referred to as the Personal Import Policy, found in Chapter 9-2 Coverage of Personal Importations, this guidance provides FDA field offices the opportunity to exercise enforcement discretion in allowing entry of drugs when certain criteria are met. These include:
- the drug is unapproved and intended for use 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 drug to persons residing in the U.S. by those involved in the distribution of the product;
- the product is considered not to represent an unreasonable risk;
- the individual seeking to import the product, affirms in writing that it is for the patient’s own use (generally not more than a three-month supply), and provides the name and address of the doctor licensed in the U.S. responsible for his/her treatment with the product, or provides evidence that the product is for the continuation of treatment begun in a foreign country.
This FDA 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 drug remains illegal and FDA may determine that such drugs should be refused entry or seized. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind FDA or the public. Most importantly, this policy is not intended to allow importation of foreign versions of drugs that are approved in the U.S.
The homepage of the FDA Import Program is:
You may also find information regarding concerns of bringing foreign medications into the U.S. at: Importing Prescription Drugs and Azithromycin In Mexico: Everything You Should Know