Among these items are  prescription drugs ordered by consumers over the Internet, the  importation of which is prohibited under current law, with few exceptions. Two acts—the Federal Food, Drug, and Cosmetic Act and the Controlled  Substances Import and Export Act—specifically regulate the importation  of prescription drugs into the United States. Under the Federal Food,  Drug, and Cosmetic Act, as amended, FDA is responsible for ensuring the  safety, effectiveness, and quality of domestic and imported drugs and may  refuse to admit into the United States, any drug that appears to be  adulterated, misbranded, or unapproved for the U.S. market as defined in  the act. II for general description of controlled substances.) Volume of Prescription Drug Imports Is Said to be Large and Increasing, and the Health and Safety of these Drug Imports is Not Assured

CBP and FDA officials said that the volume of unapproved prescription  drugs illegally imported through the IMBs or carrier facilities is large and  steadily increasing. However, complete data do not exist to document this  observation. FDA officials have stated that they cannot provide assurance to the public  regarding the safety and quality of drugs purchased from foreign sources,  which are largely outside of their regulatory system. We found fewer problems among 47 samples purchased from U.S. and  Canadian Internet pharmacies. Some Packages Containing Prescription Drugs Are Interdicted, but Others Are Released

Our work thus far shows that while CBP and FDA interdicted some  packages that contain prescription drugs, other similar packages were  released—either not inspected and released or released after inspection. However, packages that were not targeted typically bypass inspection and  are released to the addressee without an assessment of their contents or  admissibility. FDA has  acknowledged that tens of thousands of packages have been released,  although they may contain drug products that violate current laws and  pose health risks to consumers. Packages Not Targeted for Inspection and Released

According to CBP and FDA officials at the IMBs we visited, CBP and FDA  use various approaches to target certain incoming international mail  packages for inspection. These include targeting packages from certain  countries and/or packages suspected of containing certain prescription  drugs. Officials said that this requirement applies to all drug  imports with few exceptions. Agency Efforts to Address the Importation of Prescription Drugs Are Evolving

Our preliminary work revealed a number of efforts, including interagency  initiatives that are being undertaken in response to concerns raised about  the importation of prescription drugs. CBP and FDA are inspecting and interdicting some of  the unapproved prescription drugs that are entering the country, but  others bypass inspection and are sent to consumers who purchased them,  often because, according to CBP and FDA officials, time-consuming  processing requirements and staffing constraints limit their ability to  perform more inspections. Although agencies like CBP, FDA, and DEA  have begun initiatives to deal with various aspects of the drug importation  issue, it is too early to tell whether these efforts will adequately address  every dimension of the law enforcement and safety issues associated with  the importation of prescription drugs. Postal Service, U.S. Immigration and Customs  Enforcement, and DEA.
Why GAO Did This Study

American consumers are increasingly drawn to the convenience, privacy, and cost advantages that might be accrued by purchasing prescription drugs over the Internet. However, there is growing concern about the safety of the drugs and the lawfulness of shipping the drugs into the United States through international mail and private carriers. Under current law, the importation of prescription drugs for personal use is illegal, with few exceptions. All prescription drugs offered for import must meet the requirements of the Federal Food, Drug, and Cosmetic Act, and those that are controlled substances also must meet the requirements of the Controlled Substances Import and Export Act. According to the agencies responsible for enforcing these laws, prescription drugs imported for personal use generally do not meet these requirements. The Department of Homeland Security's U.S. Customs and Border Protection (CBP) and the Department of Health and Human Service's Food and Drug Administration (FDA) are responsible for inspecting and interdicting unapproved prescription drugs that are being illegally imported via the U.S. mail or private carrier. This testimony reflects our preliminary observations from ongoing work to assess federal efforts to enforce the prohibitions on personal importation of prescription drugs.

What GAO Found

CBP and FDA officials said that the volume of imported adulterated, misbranded, or unapproved prescription drugs is large and increasing, but complete data do not exist to document these observations. FDA officials said that they cannot assure the public of the safety and quality of drugs purchased from foreign sources that are largely outside the U.S. regulatory system. GAO's recent report on a sample of drugs purchased from Internet pharmacies echoed these concerns. CBP and FDA officials at mail and private carrier facilities inspect and interdict some packages that contain prescription drugs. However, according to officials, because of resource constraints, many other packages containing prescriptions drugs are either not inspected and are released to addressees or are released after an inspection. CBP and FDA target certain packages for inspection based on the packages' countries of origin and whether the packages are suspected of containing certain prescription drugs. However, packages that are not targeted typically bypass inspection and are released to addressees without an assessment of their contents or admissibility. FDA officials have acknowledged that tens of thousands of packages, containing drug products that may violate current laws and pose health risks to consumers, have been released. They said that time-consuming processing requirements and resource constraints limit their ability to perform more inspections. Agency efforts to deal with imported prescription drugs are evolving. Two interagency task forces were established to study prescription drug importation and address related law enforcement issues, respectively. Also, to overcome differences in the way officials target and interdict shipments of unapproved prescription drugs at various mail and private carrier facilities, FDA has begun implementing new procedures to promote more uniformity across facilities. It is too soon to tell if these efforts are sufficient to address various health, safety, and law enforcement issues associated with the importation of prescription drugs.