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Prescription Drugs: Strategic Framework Would Promote Accountability and Enhance Efforts to Enforce the Prohibitions on Personal Importation

NCJ Number
Date Published
September 2005
76 pages
This report sought to answer questions on how Federal agencies are addressing the importation of prohibited prescription drugs through international mail and carrier facilities, by reviewing current Federal laws, available studies and reports on the importation of prescription drugs and controlled substances, U.S. Customs Border Protection (CBP) and Food and Drug Administration (FDA) procedures and practices related to prescription drugs and controlled substance importation, and applicable importation volume and safety data.
The information currently available on the safety of illegally imported prescription drugs is limited, and neither U.S. Customs Border Protection (CBP) nor Food and Drug Administration (FDA) systematically collect data on the volume of these imports. Nevertheless, both CBP and FDA officials state that, based on their own observations and limited information collected, the volume of prescription drugs imported into the United States is substantial and increasing. The FDA has issued new procedures to standardize practices for selecting packages for inspection and making admissibility determinations. In addition, CBP has also implemented new procedures to interdict and destroy certain imported controlled substances. Three factors have been identified that have complicated Federal enforcement of laws prohibiting the personal importation of prescription drugs. First, volume has strained limited Federal resources at the mail facilities. Second, Internet pharmacies can operate outside the United States regulatory system and evade Federal law enforcement actions. Third, current law requires FDA to give addressees of packages containing unapproved imported drugs notice and the opportunity to provide evidence of admissibility regarding their imported items. Recently CBP organized a task force to coordinate Federal agencies’ activities to enforce the laws prohibiting the personal importation of prescription drugs. The task force efforts appear to be steps in the right directions. Enhancements to these efforts should include: establishment of a strategic framework to define the scope of the problem at mail and carrier facilities; determine resource needs; establish performance measures; and evaluate progress.