Three types of Internet pharmacies selling prescription drugs directly to consumers have emerged in recent years. First, some Internet pharmacies operate much like traditional drugstores or mail-order pharmacies: they dispense drugs only after receiving prescriptions from consumers or their physicians. Other Internet pharmacies provide customers medication without a physical examination by a physician. In place of the traditional face-to-face physician/patient consultation, the consumer fills out a medical questionnaire that is reportedly evaluated by a physician affiliated with the pharmacy. If the physician approves the questionnaire, he or she authorizes the online pharmacy to send the medication to the patient. This practice tends to be largely limited to “lifestyle” prescription drugs, such as those that alleviate allergies, promote hair growth, treat impotence, or control weight. Finally, some Internet pharmacies dispense medication without a prescription. Regardless of their methods, all Web sites selling prescription drugs are governed by the same complex network of laws and regulations at both the state and federal levels that govern traditional drugstores and mail-order drug services. In the United States, prescription drugs must be prescribed and dispensed by licensed health care professionals, who can help ensure proper dosing and administration and provide important information on the drug’s use to customers. To legally dispense a prescription drug, a pharmacist licensed with the state and working in a pharmacy licensed by the state must be presented a valid prescription from a licensed health care professional. Every state requires resident pharmacists and pharmacies to be licensed. The regulation of the practice of pharmacy is rooted in state pharmacy practice acts and regulations enforced by the state boards of pharmacy, which are responsible for licensing pharmacists and pharmacies. The state boards of pharmacy also are responsible for routinely inspecting pharmacies, ensuring that pharmacists and pharmacies comply with applicable state and federal laws, and investigating and disciplining those that fail to comply. In addition, 40 states require out-of-state pharmacies—called nonresident pharmacies—that dispense prescription drugs to state residents to be licensed or registered. Some state pharmacy boards regulate Internet pharmacies according to the same standards that apply to nonresident pharmacies. State pharmacy boards’ standards may require that nonresident pharmacies do the following: maintain separate records of prescription drugs dispensed to customers in the state so that these records are readily retrievable from the records of prescription drugs dispensed to other customers; provide a toll-free telephone number for communication between customers in the state and a pharmacist at the nonresident pharmacy and affix this telephone number to each prescription drug label; provide the location, names, and titles of all principal corporate officers; provide a list of all pharmacists who are dispensing prescription drugs to customers in the state; designate a pharmacist who is responsible for all prescription drugs dispensed to customers in the state; provide a copy of the most recent inspection report issued by the home provide a copy of the most recent license issued by the home state. States also are responsible for regulating the practice of medicine. All states require that physicians practicing in the state be licensed to do so. State medical practice laws generally outline standards for the practice of medicine and delegate the responsibility of regulating physicians to state medical boards. State medical boards license physicians and grant them prescribing privileges.In addition, state medical boards investigate complaints and impose sanctions for violations of the state medical practice laws. While states have jurisdiction within their borders, the sale of prescription drugs on the Internet can occur across state lines. The sale of prescription drugs between states or as a result of importation falls under the jurisdiction of the federal government. FDA is responsible for ensuring the safety, effectiveness, and quality of domestic and imported pharmaceutical products under the FDCA. Specifically, FDA establishes standards for the safety, effectiveness, and manufacture of prescription drugs that must be met before they are approved for the U.S. market. FDA can take action against (1) the importation, sale, or distribution of an adulterated, misbranded, or unapproved drug; (2) the illegal promotion of a drug; (3) the sale or dispensing of a prescription drug without a valid prescription; and (4) the sale and dispensing of counterfeit drugs. If judicial intervention is required, Justice will become involved to enforce the FDCA. Justice also enforces other consumer protection statutes for which the primary regulatory authorities are administrative agencies such as FDA and FTC. FTC has responsibility for preventing deceptive or unfair acts or practices in commerce and has authority to bring an enforcement action when an Internet pharmacy makes false or misleading claims about its products or services. Finally, Justice’s DEA regulates controlled substances, which includes issuing all permits for the importation of pharmaceutical controlled substances and registering all legitimate importers and exporters, while Customs and the Postal Service enforce statutes and regulations governing the importation and domestic mailing of drugs. The very nature of the Internet makes identifying all pharmacies operating on it difficult. As a result, the precise number of Internet pharmacies selling prescription drugs directly to consumers is unknown. We identified 190 Internet pharmacies selling prescription drugs directly to consumers, 79 of which dispense prescription drugs without a prescription or on the basis of a consumer’s having completed an online questionnaire (see table 1). Also, 185 of the identified Internet pharmacies did not disclose the states where they were licensed to dispense prescription drugs, and 37 did not provide an address or telephone number permitting the consumer to contact them if problems arose. Obtaining prescription drugs from unlicensed pharmacies without adequate physician supervision, including an examination, places consumers at risk of harmful side effects, possibly even death, from drugs that may be inappropriate for them. Estimates of the number of Internet pharmacies range from 200 to 400. However, it is difficult to determine the precise number of Internet pharmacies selling prescription drugs directly to consumers because Internet sites can be easily created and removed and some Internet pharmacies operate for a period of time at one Internet address and then close and reappear under another name. In addition, many Internet pharmacies have multiple portal sites (independent Web pages that connect to a single pharmacy). We found 95 sites that at first appeared to be discrete Internet pharmacies but were actually portal sites. As consumers click on the icons and links provided, they are brought to an Internet site that is completely different from the one they originally visited. Consumers may be unaware of these site changes unless they are paying close attention to the Internet site address bar on their browser. Some Internet pharmacies had as many as 18 portal sites. About 58 percent, or 111, of the Internet pharmacies we identified told consumers that they had to provide a prescription from their physician to purchase prescription drugs. Prescriptions may be submitted to an Internet pharmacy in various ways, including by mail or fax and through contact between the consumer’s physician or current pharmacy and the Internet pharmacy. The Internet pharmacy then verifies that a licensed physician actually has issued the prescription to the patient before it dispenses any drugs. Internet pharmacies that require a prescription from a physician generally operate similarly to traditional drugstore or mail-order pharmacies. In some instances, the Internet site is owned by or affiliated with a traditional drugstore. We identified 54 Internet pharmacies that issued prescriptions and dispensed medications on the basis of an online questionnaire. Generally, these short, easy-to-complete questionnaires asked about the consumer’s health profile, medical history, current medication use, and diagnosis. In some instances, pharmacies provided the answers necessary to obtain the prescription by placing checks next to the “correct” answers. Information on many of the Internet sites indicated that a physician reviews the questionnaire and then issues a prescription. The cost of the physician’s review ranged from $35 to $85, with most sites charging $75.Moreover, certain illegal and unethical prescribing and dispensing practices are occurring through some Internet pharmacies that focus solely on prescribing and dispensing certain “lifestyle” drugs, such as diet medications and drugs to treat impotence. We also identified 25 Internet pharmacies that dispensed prescription drugs without prescriptions. In the United States, it is illegal to sell or dispense a prescription drug without a prescription. Nevertheless, to obtain a drug from these Internet pharmacies, the consumer was asked only to complete an order form indicating the type and quantity of the drug desired and to provide credit card billing information. Twenty-one of these 25 Internet pharmacies were located outside the United States; the location of the remaining 4 could not be determined. Generally, it is illegal to import prescription drugs that are not approved by FDA and manufactured in an FDA-approved facility.Obtaining prescription drugs from foreign-based Internet pharmacies places consumers at risk from counterfeit or unapproved drugs, or drugs that were manufactured and stored under poor conditions. The Internet pharmacies that we identified varied significantly in the information that they disclosed on their Web sites. For instance, 153 of the 190 Internet pharmacies we reviewed provided a mailing address or telephone number (see table 1). The lack of adequate identifying information prevents consumers from contacting Internet pharmacies if problems should arise. More importantly, most Internet pharmacies did not disclose the states where they were licensed to dispense prescription drugs. We contacted all U.S.-based Internet pharmacies to obtain this information.We then asked pharmacy boards in the 12 states with the largest numbers of licensed Internet pharmacies (70 in all) to verify their licensure status. Sixty-four pharmacies required a prescription to dispense drugs; of these, 22, or about 34 percent, were not licensed in one or more of the states in which they had told us they were licensed and in which they dispensed drugs. Internet pharmacies that issued prescriptions on the basis of online questionnaires disclosed even less information on their Web sites. Only 1 of the 54 Internet pharmacies disclosed the name of the physician responsible for reviewing questionnaires and issuing prescriptions. We attempted to contact 45 of these Internet pharmacies to obtain their licensure status; we did not attempt to contact 9 because they were located overseas.