Although this report is intended to focus on legal analysis, policy issues are also addressed because they are closely linked. For a more complete analysis of policy issues, see CRS Report RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook , by [author name scrubbed]. Issues associated with the risks posed by some online pharmacies and prescription drug sales over the Internet will no longer be addressed in this report, but are rather addressed in CRS Report RS21711, Legal Issues Related to Prescription Drug Sales on the Internet , by [author name scrubbed]. Introduction

High prescription drug prices have increased consumer interest in purchasing less costly medications abroad by means of either commercial or personal (consumer) imports. The debate about drug importation continues. On the one hand, some policymakers remain opposed to allowing prescription drugs to be imported from foreign countries. On the other hand, importation proponents, who claim that importation would result in an increased supply of prescription drugs that could result in significantly lower prices for U.S. consumers, say that safety concerns are overblown and would recede if additional precautions were implemented. Bills introduced in the 110 th Congress include H.R. 194 , H.R. 380 , H.R. 1218 , H.R. 2638 , H.R. 2900 , H.R. 3161 , H.R. 3580 , S. 242 , S. 251 , S. 554 , and S. 1082 . At the state level, state boards of pharmacy regulate pharmacy practice, and state medical boards oversee the practice of medicine. In addition, this section contains a discussion of other legal areas that may affect prescription drug importation, including antitrust law, trade law, and patent law. In response to concerns about the rising costs of prescription drugs, however, Congress adopted importation amendments to the FFDCA in 2000. For further information on the subject, see CRS Report RL32400, Patents and Drug Importation , by [author name scrubbed].
High prescription drug prices have increased consumer interest in purchasing less costly medications abroad. Policymakers opposed to allowing prescription drugs to be imported from foreign countries argue that the Food and Drug Administration (FDA) cannot guarantee the safety or effectiveness of such drugs. Importation proponents, who claim that importation would result in significantly lower prices for U.S. consumers, say that safety concerns are overblown and would recede if additional precautions were implemented. The importation debate continues.
In response to concerns about prescription drug imports, lawmakers have introduced multiple bills in this and previous Congresses. Bills introduced in the 110th Congress include H.R. 194, H.R. 380, H.R. 1218, H.R. 2638, H.R. 2900, H.R. 3161, H.R. 3580, S. 242, S. 251, S. 554, and S. 1082. In recent years, appropriations bills have contained restrictions on the use of funds by Customs and Border Protection (CBP) to prevent certain individuals from importing Canadian prescription drugs; however, such provisions appear to have limited effect.
The following federal and state agencies are involved in regulating aspects of prescription drug importation: FDA, CBP, the Drug Enforcement Agency (DEA), state boards of pharmacy, and state medical boards. This report, originally written by [author name scrubbed], Legislative Attorney, CRS, focuses on legal aspects of prescription drug importation, including antitrust law, international trade law, and patent law issues. However, policy issues are also addressed because they are closely linked. For a more complete analysis of policy issues, see CRS Report RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook, by [author name scrubbed]. For more information regarding Internet pharmacies, see CRS Report RS21711, Legal Issues Related to Prescription Drug Sales on the Internet, by [author name scrubbed].