United States Senators Vitter, Salazar, Thune and Demint have proposed legislation to amend and expand the “Importation of Prescription Drugs” statute found at 21 U.S.C. §384. The Importation of Prescription Drugs statute, which became effective December 8, 2003, allows for the importation of prescription drugs from Canada to pharmacists or wholesalers in the United States.

The statute calls for the Secretary to promulgate regulations under the provisions of the statute to guide such importation by pharmacists and wholesalers. Additionally, the statute allowed the Secretary of DHHS to grant by regulation or waiver a permit for individuals to import into the United States a prescription drug, approved by the Secretary under the Federal Food Drug and Cosmetic Act (“FDCA”), for personal use, in quantities that do not exceed a 90-day supply. Under this statute, individuals are granted waivers on a case-by-case basis; however, the Secretary is directed to publish guidance that accurately describes circumstances in which the Secretary will consistently grant such waivers.

One of the major expansions of the current statute proposed by Senator Vitter, et al, is to allow importation of prescription drugs from not only Canada but from any “permitted countries”. The term “permitted country” means a country, union, or economic area listed as an eligible country for export. In other words, any country listed, i.e., Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa or in the European Union, as an approved country for export purposes with the United States would qualify to import prescription drugs into the United States under this new legislation. Moreover, the new legislation grants the Secretary the authority to add or delete a country from this list if he determines that they do or do not have a “substantially equivalent or superior pharmaceutical infrastructure” to the United States.

The proposed legislation also changes the language in the statute and in the Food Drug and Cosmetic Act (“FDCA”) from “prescription drugs” to “qualifying drugs”. Qualifying drugs under the proposed legislation include those prescription drugs approved under the FDCA’s new drug application and approval regulations minus those drugs requiring refrigeration or those that are photoreactive or are manufactured through a biotechnology process. The proposed legislation also removes the requirement for individuals to obtain waivers by the Secretary in order to import prescriptions for personal use. Instead, the new legislation permits individuals to import a drug from a permitted country to the U.S., as long as “it is a qualifying drug; imported from a licensed pharmacy or qualifying internet pharmacy; for personal use by an individual or family member; in a quantity not to exceed a 90-day supply during a 90-day period; and accompanied by a copy of a valid prescription for the drug issued by a practitioner authorized to administer prescription drugs”. The proposed legislation also allows individuals to import a drug from a country that is not a permitted country if it was dispensed to the individual while the individual was in that country and it was dispensed according to the laws and regulations of such country, as long as the drug is approved for commercial distribution in the country in which the drug was obtained. The drug cannot appear to be adulterated and the quantity of the drug cannot exceed a 14-day supply.

In order to accomplish the goals of the proposed legislation, the government, would have to create an entire infrastructure for inspections and registrations of importing countries to maintain the public safety. Additionally, the internet would be used as a primary source for individuals wishing to import drugs for personal use. This would greatly impact local pharmacies and pharmacists and create further concerns of internet privacy and consumer safety.