In addition, if a drug is susceptible to deterioration and must,  for example, be maintained in a temperature-controlled environment, it  must be packaged and labeled in accordance with regulations and  manufacturer standards. FDA-approved drugs manufactured in foreign countries, including those  sold over the Internet, are subject to the same requirements as domestic  drugs. Most of the Targeted Prescription Drugs Were Purchased from Multiple Internet Pharmacies Without Providing A Prescription

We obtained 1 or more samples of 11 of the 13 drugs we targeted, both  with and without a patient-provided prescription. Drug samples we  received from other foreign pharmacies came from Argentina, Costa Rica,  Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey. Most of the drugs—45 of 68—were obtained without a patient-provided  prescription. Five U.S.  and all 18 Canadian pharmacies from which we obtained drug samples  required the patient to provide a prescription. The remaining 24 U.S.  pharmacies generally provided a prescription based on a general medical  questionnaire filled out online by the patient. Most Problems Identified among Drug Samples Received from Other Foreign Internet Pharmacies

None of the 21 prescription drug samples we received from other foreign  Internet pharmacies included a dispensing pharmacy label that provided  patient instructions for use, and only 6 of these samples came with  warning information. Among the 21 drug samples from other foreign pharmacies, manufacturers  determined that 19 were not approved for the U.S. market for various  reasons, including that the labeling or the facilities in which they were  manufactured had not been approved by FDA. In all but 4 instances, however, manufacturers determined  that the chemical composition of the samples we received from other  foreign Internet pharmacies was comparable to the chemical composition  of the drugs we had ordered. Two samples of one drug were found by the  manufacturer to be counterfeit and contained a different chemical  composition than the drug we had ordered. In both instances the  manufacturer reported that samples had less quantity of the active  ingredient, and the safety and efficacy of the samples could not be  determined. In contrast to the drug samples received from other foreign Internet  pharmacies, all 47 of the prescription drug samples we received from  Canadian and U.S. Internet pharmacies included labels from the  dispensing pharmacy that generally provided patient instructions for use  and 87 percent of these samples (41 of 47) included warning information. Manufacturers reported that 16 of the 18 samples from Canadian Internet  pharmacies were unapproved for sale in the United States, citing for  example unapproved labeling and packaging. However, the samples were  all found to be comparable in chemical composition to the products we  ordered. Table 4 summarizes the problems we identified among the 68 samples we  received. Some Internet Pharmacies Were Not Reliable in Their Business Practices

We observed questionable characteristics and business practices of some  of the Internet pharmacies from which we received drugs. We ultimately  did not receive six of the orders we placed and paid for, suggesting the  potential fraudulent nature of some Internet pharmacies or entities  representing themselves as such. Finally, the return addresses on samples of Humulin N and Zoloft were  found to be private residences in Lahore, Pakistan. About 21 percent of the Internet pharmacies from which we received  drugs (14 of 68) were under investigation by regulatory agencies. The  reasons for the investigations by DEA and FDA include allegations of  selling controlled substances without a prescription; selling adulterated,  misbranded, or counterfeit drugs; selling prescription drugs where no  doctor-patient relationship exists; smuggling; and mail fraud. Concluding Observations

Consumers can readily obtain many prescription drugs over the Internet  without providing a prescription—particularly from certain U.S. and  foreign Internet pharmacies outside of Canada. Drugs available include  those with special safety restrictions, for which patients should be  monitored for side effects, and narcotics, where the potential for abuse is  high. In addition to the lack of  prescription requirements, some Internet pharmacies can pose other  safety risks for consumers.
Why GAO Did This Study

As the demand for and the cost of prescription drugs rise, many consumers have turned to the Internet to purchase them. However, the global nature of the Internet can hinder state and federal efforts to identify and regulate Internet pharmacies to help assure the safety and efficacy of products sold. Recent reports of unapproved and counterfeit drugs sold over the Internet have raised further concerns. This testimony summarizes a GAO report: Internet Pharmacies: Some Pose Safety Risks for Consumers, GAO-04-820 (June 17, 2004). GAO was asked to examine (1) the extent to which certain drugs can be purchased over the Internet without a prescription; (2) whether the drugs are handled properly, approved by the Food and Drug Administration (FDA), and authentic; and (3) the extent to which Internet pharmacies are reliable in their business practices. GAO attempted to purchase up to 10 samples of 13 different drugs, each from a different pharmacy Web site, including sites in the United States, Canada, and other foreign countries. GAO assessed the condition of the samples it received and forwarded the samples to their manufacturers to determine whether they were approved by FDA, safe, and authentic. GAO also confirmed the locations of several Internet pharmacies and undertook measures to examine the reliability of their business practices.

What GAO Found

GAO obtained most of the prescription drugs it sought from a variety of Internet pharmacy Web sites without providing a prescription. GAO obtained 68 samples of 11 different drugs--each from a different pharmacy Web site in the United States, Canada, or other foreign countries, including Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey. Five U.S. and all 18 Canadian pharmacy sites from which GAO received samples required a patient-provided prescription, whereas the remaining 24 U.S. and all 21 foreign pharmacy sites outside of Canada provided a prescription based on their own medical questionnaire or had no prescription requirement. Among the drugs GAO obtained without a prescription were those with special safety restrictions and highly addictive narcotic painkillers. GAO identified several problems associated with the handling, FDA-approval status, and authenticity of the 21 samples received from Internet pharmacies located in foreign countries outside of Canada. Fewer problems were identified among pharmacies in Canada and the United States. None of the foreign pharmacies outside of Canada included dispensing pharmacy labels that provide instructions for use, few included warning information, and 13 displayed other problems associated with the handling of the drugs. For example, 3 samples of a drug that should be shipped in a temperature-controlled environment arrived in envelopes without insulation. Manufacturer testing revealed that most of these drug samples were unapproved for the U.S. market because, for example, the labeling or the facilities in which they were manufactured had not been approved by FDA; however, manufacturers found the chemical composition of all but 4 was comparable to the product GAO ordered. Four samples were determined to be counterfeit products or otherwise not comparable to the product GAO ordered. Similar to the samples received from other foreign pharmacies, manufacturers found most of those from Canada to be unapproved for the U.S. market; however, manufacturers determined that the chemical composition of all drug samples obtained from Canada were comparable to the product GAO ordered. Some Internet pharmacies were not reliable in their business practices. Most instances identified involved pharmacies outside of the United States and Canada. GAO did not receive six orders for which it had paid. In addition, GAO found questionable entities located at the return addresses on the packaging of several samples, such as private residences. Finally, 14 of the 68 pharmacy Web sites from which GAO obtained samples were found to be under investigation by regulatory agencies for reasons including selling counterfeit drugs and providing prescription drugs where no valid doctor-patient relationship exists. Nine of these were U.S. sites, 1 a Canadian site, and 4 were other foreign Internet pharmacy sites.