Access to affordable prescription drug products is a serious challenge faced by millions of Americans. More than 40% of Americans take one or more prescription drugs; and a small, but increasing, number rely on drug importation to lower costs. Although some imported drugs are legal, a far greater number are unregulated within the U.S. drug distribution system and cannot be confirmed as safe and effective. Whether purchased online, from a storefront pharmacy, or during travel to another country, foreign prescription drugs pose risks to patient safety. The most serious risks include counterfeit potential, quality assurance concerns, presence of untested ingredients, and issues related to risk management and unsupervised use, labeling, language, and lack of information. Import blitz exams confirm that a wide variety of drug types entering the United States lack integrity in manufacturing, packaging, labeling, storage, or distribution. The FDA-initiated “Looks Can Be Deceiving” public information campaign educates American consumers about the dangers of buying unapproved foreign drugs, and current efforts to find and implement alternatives to such drugs seem promising. The FDA has been active in helping to accelerate access to generic drugs and exploring ways to lower drug development and manufacturing costs. Furthermore, the new Medicare prescription drug benefit will likely assist seniors in purchasing affordable and safe medications. The policies and regulations of the current, relatively “closed” U.S. drug distribution system maximize the safety and effectiveness of the domestic drug supply and serve as the model for systems around the world. Changes to the system, such as a legal commercial importation program, are not without costs and would require careful scrutiny before implementation. A personal importation system would likely result in an increased risk to American drug consumers.