Legal Nuances Surrounding Personal Medication Imports

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The FDA provides a clearly stated policy on the personal importation of prescription medications into the United States.

Buying Prescription Medications From Canada or Other Countries

As described on the page providing background on the controversial pricing policies of the pharmaceutical industry (see “Background to the Online Prescription Drug Controversy”), consumers in the United States pay a great deal more for prescription medications than those in most other parts of the world. As a result, increasing numbers of Americans are buying discount drugs online — including from suppliers in Mexico, Canada, and other countries apart from the United States. U.S. residents who choose to do this should be aware of the legal context surrounding personal importation of prescription medications.

FDA Personal Importation Policy

Whether for personal use or not, importing prescription medication into the United States is technically illegal. Despite this, in practice, individual Americans are rarely prevented from importing medicines for private personal use.

The FDA’s Personal Importation Policy is as follows, reproduced verbatim from a recent statement before the Subcommittee on Health of the Committee on Energy and Commerce in the House of Representatives:

Under FDA’s personal importation policy, as described in guidance to the Agency’s field personnel, FDA inspectors may exercise enforcement discretion in limited circumstances to permit the importation of certain unapproved prescription medication for personal use.

First adopted in 1954, the policy was last modified in 1988 in response to concerns that certain potentially effective treatments for AIDS patients were not available in the U.S. but were available in other countries. The Agency expanded the guidance for humanitarian purposes to allow individuals suffering from serious medical conditions to acquire medical treatments legally available in foreign countries but not approved in the U.S.

The policy is articulated in guidance to FDA field personnel and is not a license for individuals to import unapproved, and therefore illegal, drugs for personal use into the United States. Because the policy does not apply to medications that are already available in the U.S., even if sold under the same name, only a very few drug products available from foreign sources, especially Canada and Mexico, meet the personal importation criteria.

The current personal importation policy permits the exercise of enforcement discretion to allow entry of an unapproved prescription drug only if the intended use is for a serious condition for which effective treatment may not be available domestically; the product is considered not to represent an unreasonable risk; the product is for personal use; there is no known commercialization or promotion to U.S. residents by those involved in the distribution of the product; and the individual seeking to import the product affirms in writing that it is for the patient’s own use and provides the name and address of the U.S. licensed doctor 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.

FDA’s personal importation policy, as written, is difficult to implement with respect to mail shipments of drugs. This is due, at least in part, to the difficulty faced by Customs or FDA inspectors, or even health care practitioners, in identifying a medicine simply by its appearance or its labeling, which may falsely identify a product. From a practical standpoint, FDA inspectors cannot visually examine drug products contained in a mailed parcel and accurately determine their identity or the degree of risk posed to the individual who will receive these drugs. Also, largely due to the advent of Internet sites selling prescription drugs from all points around the globe, the volume of parcels containing prescription drugs has increased dramatically, beyond the ability of Customs and FDA staff to efficiently process.

Due to the huge volume of drug parcels entering the U.S. through the international mail and courier services, the requirements for notice and hearing, and our limited resources, it is difficult for FDA to detain and refuse mail imports for personal use. As a consequence, tens of thousands of parcels that FDA does not review are eventually released by Customs and sent on to their addressees, even though the products contained in these parcels may violate the FD&C Act and pose a health risk to consumers. We do not believe this is an acceptable public health outcome.

A few individual states — including Arizona, Minnesota, North Dakota and Rhode Island — have recently passed legislation requiring pharmacies shipping drugs to their residents to be licensed to do so within that state. The apparent intent is to block imports from Canada, one of the most popular sources for deeply discounted drugs.

Because of the legal issues surrounding the importation of drugs into the United States, it may be safer for consumers to use U.S.-based online pharmacies. In fact, prices for generic drugs are often cheaper from U.S.-based online discount pharmacies due to the higher level of competition within the U.S. market. Finally, note that the importation of controlled substances such as narcotics is flatly illegal and will not be overlooked in the way that imports of common prescription drugs may be.

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