The IT Law Wiki
The IT Law Wiki

Definition[]

An Internet pharmacy is

a website that fulfills first-time orders of prescription drugs, regardless of whether the company that operates the website is licensed as a pharmacy.[1]

Overview[]

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 requiring a prescription.

Like brick-and-mortar pharmacies, Internet pharmacies are subject to federal and state statutes and regulations that are designed to ensure the safety, efficacy, and proper administration of medications.

The federal government plays a role in overseeing Internet pharmacy activity to the extent that these entities engage in interstate commerce or violate federal laws. However, states have traditionally regulated the practice of pharmacy and the practice of medicine. State boards of pharmacy license pharmacists and pharmacies, and state medical boards license physicians and set standards to ensure appropriate care, including standards for writing prescriptions. By violating federal and state laws, rogue Internet pharmacies threaten the public health.

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 patients with important information on the drug's use. To legally dispense a prescription drug, a pharmacist licensed by the state and working in a pharmacy licensed by the state must be presented a valid prescription from a licensed health care professional. In addition, most states require pharmacies located outside their state to obtain a nonresident pharmacy permit prior to dispensing prescription drugs to customers located in that state. Some states regulate Internet pharmacies according to the same standards that apply to nonresident pharmacies. Others require pharmacies to obtain a special license to dispense prescription drugs ordered online.

The regulation of the practice of pharmacy is rooted in state pharmacy practice acts and regulations enforced by state boards of pharmacy. 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.

Organizations such as the National Association of Boards of Pharmacy (NABP) and Federation of State Medical Boards (FSMB) have established and promoted uniform national standards related to Internet pharmacies for the consideration of state pharmacy and medical boards, as well as for consumers.

Rogue Internet pharmacies[]

Although the exact number of rogue Internet pharmacies is unknown, one estimate suggests that there were over 36,000 in operation as of February 2014, and these rogue sites violate a variety of federal laws. Most operate from abroad, and many illegally ship prescription drugs into the United States that have not been approved by the Food and Drug Administration (FDA), including drugs that are counterfeit or are otherwise substandard. Many also illegally sell prescription drugs with no prescription that meets federal and state requirements. Foreign rogue Internet pharmacies use sophisticated methods to evade scrutiny by customs officials and smuggle drugs into the country. Their operators also often violate other laws, including those related to fraud and money laundering.

Rogue Internet pharmacies are often complex, global operations, and federal agencies face substantial challenges investigating and prosecuting those involved. According to federal agency officials, piecing together rogue Internet pharmacy operations can be difficult because they may be composed of thousands of related websites, and operators take steps to disguise their identities. Officials also face challenges investigating and prosecuting operators because they are often located abroad in countries that are unable or unwilling to aid U.S. agencies. The Department of Justice (DOJ) may not prosecute such cases due to competing priorities, the complexity of these operations, and challenges related to bringing charges under some federal laws.

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