In 2003, U.S. consumers bought more than $1 billion in prescription drugs from Canada—twice as much as the year before, by some estimates. Although the 2004 and 2005 increases slowed, congressional efforts to allow American consumers to buy prescription drugs from foreign sellers did not. Many U.S. residents use the Internet or mail-order pharmacies; others simply go to a drug store when they travel outside the United States, especially to Canada or Mexico. The reason is clear. Brand-name prescription drugs often cost less abroad—particularly for the uninsured and many of the elderly who pay retail prices. Under current law, only the manufacturer of a prescription drug may legally bring it into the United States. The law allows U.S. pharmacists and wholesalers to do so only if the Secretary of Health and Human Services (HHS) first certifies that those drugs would be safe and that the program lowered drug costs for U.S. consumers. After issuing that certification, the Secretary must issue regulations allowing individuals to import prescription drugs. Because no HHS Secretary has ever taken that step, consumers, pharmacists, and wholesalers are prohibited from importing prescription drugs. Given the difference between prices in the United States and elsewhere, many Americans, including some Members of Congress, want legislation eliminating the restrictions on imports. This report does not address whether drug prices are too high or unfair. It does focus on the issues recent legislative proposals raise in attempting to help U.S. consumers—themselves or through importing pharmacists and wholesalers—gain access to safe and less expensive Food and Drug Administration (FDA)-approved prescription drugs from abroad. The report begins with an overview of the domestic drug distribution system and how Congress has handled prescription drug importation. It then discusses the current situation following its upsurge in the volume of drug imports, state and local government initiatives, the drug industry and FDA's reactions, and the legislative proposals introduced to consider this issue. It goes on to examine three broad sets of issues surrounding importation. The first involves ensuring drug safety and effectiveness, by attending to product integrity and appropriate use. The next set explores whether a drug import program would be feasible administratively and in the context of international trade and pharmaceutical research and development. The report concludes by discussing the likelihood that a drug import program would save U.S. consumers money. (A separate CRS report provides a detailed side-by-side comparison of current law and selected major importation bills introduced but not passed during the 109 th Congress. Other CRS reports focus in more detail on legal and drug price issues. ) Since 1938, the Federal Food, Drug, and Cosmetic Act (FFDCA, P.L. 75-717) has required that drugs sold to U.S. consumers be safe. With its 1962 Kefauver-Harris Amendments (P.L. 87-781), all drugs had to be proven effective as well. The FFDCA is the major law that set up the current U.S. system of drug regulation; subsequent legislation amends it. In the last 17 years, congressional and FDA actions have addressed the importation of prescription drugs by, in turn, limiting imports, establishing exceptions to those restrictions, and attempting to broaden access to imports. FDA supervises the approval, production, and distribution of prescription drugs. It works to prevent unsafe, ineffective, subpotent or adulterated drugs from reaching retail pharmacies in the United States—whether on purpose or inadvertently. Before it approves a prescription drug for sale, FDA requires that a manufacturer demonstrate that its product is safe and effective for its intended use, that directions on the label are clear and appropriate, and that the drug has been manufactured in specific production lines that have been registered and approved by FDA. After approval, the manufacturer must continue production according to FDA-approved "good manufacturing processes." The drug companies must periodically open their production facilities to rigorous FDA inspection. After production, the manufacturer sends the drug to FDA-registered U.S. drug wholesalers or secondary drug wholesalers for further distribution. States license or authorize the pharmacists and wholesalers who sell and distribute pharmaceuticals within their borders and also license the physicians and dentists who prescribe the drugs. The structure of today's distribution system is based on changes made in the 1980s when Congress determined that the drug distribution system was not sufficiently "closed" to prevent abuse of drug samples. The Prescription Drug Marketing Act of 1987 (PDMA, P.L. 100-293 ) banned the sale, trade, and purchase of drug samples; mandated storage, handling, and accounting standards for drug samples; and required that drug wholesalers be licensed by the states. To enforce the law, the FDA drafted regulations that would require drug companies to maintain a detailed "chain of custody" (known as a pedigree) for every pharmaceutical product sold in this country. By imposing strict recordkeeping requirements, FDA hoped, among other things, to ensure the safety and quality of all drugs that are exported and later imported back into the country. The recorded pedigree would allow manufacturers to trace back suspected counterfeit shipments. However, the law excluded manufacturers' authorized distributors from this recordkeeping requirement. Because most drugs are sold from authorized distributors into secondary drug wholesale distribution markets (not authorized distributors of record), the recordkeeping requirement created a dilemma. Because secondary distributors (authorized and unauthorized) receive no records or pedigree with the drugs they purchase, they do not have the information necessary to show a chain of custody. For that reason, when FDA published final regulations to implement this section of the PDMA in December 1999, the Small Business Administration petitioned the agency, arguing that enforcement of the provision would drive 4,000 or more secondary distributors out of business. Subsequently, FDA delayed the effective date of this provision's enforcement repeatedly, most recently because it believed that industry voluntary conversion to an electronic pedigree was imminent, in which case the rule would be superfluous. In 2006, seeing that industry's progress toward the technology change was slow, FDA announced and then finally implemented the rule on December 1, 2006. One week later, a court issued a preliminary injunction to prohibit FDA's implementing key pieces of the rule. For the past few years, Members have tried to use the agriculture appropriations bill (which includes FDA) to get around administrative blocks to prescription drug importation. The House-passed FY2007 agriculture appropriations bill would prohibit FDA from using funds to prevent individuals, pharmacists, or wholesalers from importing prescription drugs that comply with the core requirements of the FFDCA. The Senate-reported bill contains no similar provision. Importation's supporters had more success in applying this strategy to the Department of Homeland Security FY2007 appropriations bill that became law. It prohibits the use of those funds by CBP to prevent "individuals not in the business of importing a prescription drug" from importing a prescription drug that complies with the FFDCA. The Senate Committee on Commerce, Science, and Transportation of the 109 th Congress reported its Federal Trade Commission (FTC) reauthorization bill ( S. 1392 ) and included the text of Senator Dorgan's separate drug importation bill ( S. 334 ). Although the bill did not see further activity in that Congress, the Congressional Budget Office (CBO) issued cost estimates of the import provisions that provide additional data for the ongoing debate. The PDMA limits importation of a prescription drug into the United States to the manufacturer. Further, when importing a drug, the manufacturer must present records indicating that the product is the same as an FDA-approved drug being distributed in the United States, that the imported product was handled properly and, if necessary, is re-labeled for the U.S. market. When drugs are imported into the United States—whether they are shipped commercially, carried by travelers, or arrive by mail—the Bureau of Customs and Border Protection (CBP) (formerly the U.S. Customs Service) and the FDA have broad authority to detain and deny products that "appear" to violate U.S. law or regulatory standards. Since the PDMA's restrictions went into effect, the FDA has chosen to leniently enforce that ban and has allowed individuals to bring into the United States a small amount (i.e., a 90-day supply) of non-FDA-approved drugs for personal use. This FDA enforcement policy requires that those individuals affirm in writing that the drugs are for their own use, and provide the name and address of their treating physician. When FDA's personal use import policy began, it was not envisioned as a way for consumers to bring lower-priced prescription drugs into the United States. According to FDA's policy statement on importing drugs for personal use: ... the intent of the personal use importation guidance is to save FDA resources and to generally permit, through the exercise of enforcement discretion, medical treatments sought by individuals that are not otherwise available in the United States (where such treatments are not promoted/commercialized in the United States). Thus foreign-made chemical versions of drugs available in the United States are not intended to be covered by the policy. But where the policy once compassionately let a few people import—for personal use—cancer or AIDS drugs that were not available for sale in the United States, today that policy is used by consumers seeking lower foreign prices for FDA-approved drugs available in the United States. The U.S. Customs and Border Protection (CBP) is responsible for enforcing the FFDCA prohibition on prescription drug importation. Hence, despite FDA's continuing "exercise of enforcement discretion" regarding personal-use importation by individuals, from November 2005 until October 2006, CBP could implement a policy to detain prescription drugs entering U.S. international mail branches. In a notification letter, CBP would ask the intended recipient to choose between abandoning the shipment or requesting "an admissibility determination from the FDA."