CBP Posts FDA Notice on the Personal Importation of Prescription Drugs and Unapproved New Drugs

(FDA sources explain that the discretionary policy for certain unapproved new drugs has been developed in part for individuals with a serious illness (i.e. certain forms of cancer, AIDS, etc.) for which a certain drug is not approved by FDA. These sources note that the policies described below are not aimed at those individuals who become sick while traveling abroad, etc.)

Prescription Drugs - Personal Importations

Not approved by FDA, etc. According to FDA, the Federal Food, Drug, and Cosmetic Act (Act) prohibits persons from importing into the U.S. any prescription drug that has not been approved for sale by the FDA, or which is adulterated or misbranded within the meaning of the Act. (According to FDA sources, unapproved prescription drugs may be eligible for the discretionary policy for unapproved new drugs described below.)

FDA-approved. The FDA also states that in those instances where a U.S. manufacturer makes an FDA-approved prescription drug and sends it abroad, the Act prohibits any person other than the original manufacturer from importing the prescription drug back into the U.S.

Consequently, the importation of prescription drugs for personal use is illegal under current law with few exceptions.

Unapproved New Drugs - Discretionary Policy for Certain Personal Importations

FDA states that its guidance entitled Coverage of Personal Importations sets forth, among other things, FDA enforcement priorities with respect to the personal importation of unapproved new drugs by individuals for their personal use.

Under this guidance, located in Chapter 9 of the FDA's Regulatory Procedures Manual, as an exercise of enforcement discretion, FDA may allow an individual entering the U.S. to import a three month supply of an unapproved drug if all of the following conditions are met:

1. The intended use of the drug is for a serious condition for which effective treatment may not be available domestically;

2. The drug will not be distributed commercially by the importer;

3. The product is considered not to represent an unreasonable risk;

4. 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 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.

(DEA and U.S. government sources state that in cases where the unapproved new drug is a controlled substance, the FDA will share or transfer the decision-making authority regarding the personal importation with (or to) DEA, as controlled substances fall under the jurisdiction of both FDA and DEA. )

FDA pharmaceutical admissibility contact number: (301) 443-6553

DEA contact number on the importation of a controlled substance: (202) 307-2414

CBP's notice of FDA's enforcement policy available athttp://www.cbp.gov/xp/cgov/travel/alerts/medication_drugs.xml

FDA's Regulatory Procedures Manual, including the Chapter 9 subchapter on Coverage of Personal Importations (currently undergoing revision), available at http://www.fda.gov/ora/compliance_ref/rpm/default.htm

GAO testimony entitled, Prescription Drugs: Preliminary Observations on Efforts to Enforce the Prohibitions on Personal Importation (GAO-04-839T, dated 07/22/04) available at http://www.gao.gov/cgi-bin/getrpt?GAO-04-839T