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 were able to obtain the majority of prescription drugs we targeted for  purchase from a wide variety of domestic and foreign Internet pharmacies  without providing a prescription. Five U.S. and all 18 Canadian pharmacies  from which we obtained drug samples required a patient-provided  prescription, whereas the remaining 24 U.S. and all 21 other foreign  pharmacies from which we obtained samples either provided a  prescription based on an online medical questionnaire or had no  prescription requirement. Although we obtained samples of most of the  drugs we targeted for purchase, some drugs, such as those with special  safety restrictions and narcotics, were available from fewer sources or  were more difficult to obtain. In total, we placed 90  orders—each with a different Internet pharmacy in the United States,  Canada, and other foreign countries—and received 68 samples. Drug  samples we received from other foreign pharmacies came from Argentina,  Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and  Turkey. Despite extensive searching of Internet pharmacy  sites, we found few that sold these drugs without a prescription. Most Problems Identified among Drug Samples Received from Other Foreign Internet Pharmacies

We identified several problems associated with the handling, FDA-approval  status, and authenticity of the 21 drug samples we received from other  foreign Internet pharmacies. Manufacturers reported that most  of the samples they reviewed at our request from other foreign pharmacies  were not approved by FDA for the United States—although most had a  comparable chemical composition to the product we ordered—and 4 were  either counterfeit products or otherwise not comparable to the product we  ordered. All Drug Samples Received from Other Foreign Pharmacies Exhibited Problems Associated with Their Handling

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 the samples came with warning  information. 1.) 2.) 3.) Most Drug Samples Received from Other Foreign Pharmacies Were Unapproved, Four Were Not Authentic

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. However, the samples were all found to be comparable in chemical  composition to the products we ordered. 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. 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. One Canadian pharmacy was also included among those  under investigation. 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. Agency and External Comments

In commenting on a draft of this report, FDA generally agreed with our  findings and conclusions and made suggestions to clarify or expand upon  its contents (see app. We  modified the report to indicate that we determined the location of the  Internet pharmacy Web sites from which we received drug samples based  on information contained in the pharmacy Web sites and the return  addresses and postmarks on the packages we received.
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 drugs. 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. 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 determined whether the samples contained a pharmacy label with patient instructions for use and warnings on the labels or the packaging and forwarded the samples to their manufacturers to determine whether they were approved by FDA and authentic. GAO also confirmed the locations of several Internet pharmacies and identified those under investigation by regulatory agencies.

What GAO Found

GAO obtained most of the prescription drugs it targeted 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 required dispensing pharmacy labels that provided 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; 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. In commenting on a draft of this report, FDA generally agreed with its findings and conclusions.