Legal Issues Related to Prescription Drug Sales on the Internet

^Pr^ep^ar^{ed f}^o^r^M^e^m^b^ers^an^d^Com^mⁱ^t^t^ees^of^C^ong^r^e^ss

This report provides a legal analysis of issues related to prescription drug sales on the Internet,
including issues involving online pharmacies and physicians who prescribe medications over the
Internet. Specifically, this report provides an overview of the various federal and state laws that
regulate this field, including laws and regulations covering prescription drugs, controlled ^th
substances, doctors, and pharmacies. Legislators have introduced the following bills in the 110
Congress: H.R. 194, H.R. 380, S. 242, S. 251, S. 554, S. 596, and S. 980. Additionally, in May
2007, the Senate passed S. 1082, which would create a new section addressing online sales of
prescription drugs in the Federal Food, Drug, and Cosmetic Act (FDCA). (Note: this report was
originally prepared by Jody Feder, Legislative Attorney.)

Many individuals have turned to online pharmacies to purchase prescription drugs, and increasing
numbers of physicians have incorporated the Internet and email into their medical practice. Use
of this technology has many advantages for both the doctor and the patient, including cost ¹
savings, convenience, accessibility, and improved privacy and communication. Although many
online pharmacies are legitimate businesses that offer safe and convenient services similar to
those provided by traditional neighborhood pharmacies and large chain drugstores, other online
pharmacies—often referred to as “rogue sites”—engage in practices that are illegal, such as ²
selling unapproved or counterfeit drugs or dispensing drugs without a prescription. Some rogue
sites operate in a legal gray area in which the online pharmacy, as mandated by federal law,
requires a prescription before dispensing prescription drugs, but allows patients to secure a
prescription by completing an online questionnaire that is reviewed by a doctor who never
examines or speaks to the patient. This practice, though potentially unsafe for patients who may
be diagnosed incorrectly, is not necessarily illegal.
The regulation of online pharmacies and doctors consists of a patchwork of federal and state laws ³
in an array of areas. At the federal level, the Food and Drug Administration (FDA) regulates
prescription drugs under the Federal Food, Drug, and Cosmetic Act (FDCA), which governs,
among other things, the safety and efficacy of prescription medications, including the approval, ⁴
manufacturing, and distribution of such drugs. The FDCA requires prescription drugs be ⁵
dispensed only with a valid prescription. The Drug Enforcement Agency (DEA) enforces the
Controlled Substances Act (CSA), which is a federal statute that establishes criminal and civil
sanctions for the unlawful possession, manufacturing, distribution, or importation of controlled ⁶
substances. State boards of pharmacy regulate pharmacy practice, and state medical boards ⁷
oversee the practice of medicine. Thus, some laws that govern online pharmacies and doctors
vary by state. Laws governing each of these areas are described below.
As noted above, the CSA is a federal statute that establishes criminal and civil sanctions for the ⁸
unlawful possession, manufacturing, distribution, or importation of controlled substances. The
primary purpose of the CSA is to facilitate the legal distribution of controlled substances for
legitimate medical purposes while preventing their diversion for illegal uses. Although the CSA is
generally known for prohibiting illegal drugs that have a high potential for abuse and no accepted

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medical use, such as heroin or cocaine, the statute also covers a range of other drugs that have a
lesser potential for abuse and an accepted medical use, including certain prescription drugs.
Although most prescription drugs are not controlled substances and therefore are not regulated
under the CSA, some prescription drugs, such as narcotics and opiates that are often used in the
treatment of pain, are regulated under the CSA because they have a greater potential for abuse
than other prescription drugs and may lead to physical dependence.
It is the latter category of prescription painkillers that appears to be among the drugs most heavily
dispensed by certain Internet pharmacies in accordance with prescriptions that are issued based ⁹
on online questionnaires. This practice has sometimes been abused by rogue sites that dispense
large quantities of addictive substances to customers apparently seeking access to prescription
painkillers, and it has led to instances of addiction, overdose, and death. In response to cases in
which online doctors have written thousands of prescriptions for controlled substances without
examining their patients, the federal government has begun prosecuting certain doctors under the ¹⁰
CSA by charging them with the illegal distribution of controlled substances. Penalties under the
CSA vary depending on the amount and type of substance involved but generally include ¹¹
monetary fines, forfeiture, and imprisonment.
As noted above, prescription drugs are also regulated by the FDA under the FDCA.¹² Although
state law also governs the prescribing of drugs, the FDCA covers certain aspects of the
prescribing process, including the requirement that prescription drugs may not be dispensed ¹³
without a valid prescription. The FDCA, however, does not define the meaning of
“prescription.” Rather, each state defines what constitutes a valid prescription under its pharmacy
laws. Because such definitions differ from state to state, there is no uniform, national definition of ¹⁴
the term “prescription.” Thus, certain activities, such as prescribing drugs without performing
an in-person examination, may be explicitly illegal in one state but of ambiguous legal status in
another (see below).
Concerned about reports of rogue online pharmacies, Congress has considered legislation to ¹⁵
establish a federal definition of what constitutes a valid prescription. For example, such
legislation has included proposals to establish a single federal standard for prescriptions or to
require online pharmacies to disclose information about themselves and about the doctors ¹⁶
approving prescriptions on their sites. Congress has also explored the possibility of limiting the
means by which allegedly rogue sites do business, namely by restricting their ability to advertise ¹⁷
on search engines, make credit card sales, and ship prescription drugs, and some companies

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have responded with their own proposals. Reportedly, Google, an Internet search engine, no
longer accepts advertising from unlicenced pharmacies and prohibits the use of certain controlled ¹⁸
substances as keywords for search purposes. Because federal and state regulators face many
legal barriers when attempting to exercise jurisdiction over rogue pharmacies based in foreign ¹⁹
countries, placing limits on the degree to which search engines, credit card companies, and
shipping entities enable rogue sites to sell prescription drugs may be one of the only ways to
control illicit sales by foreign online pharmacies.
Online prescription drug sales by both U.S.-based and foreign Internet pharmacies may raise ²⁰
additional legal questions involving drug importation. The FDCA prohibits anyone other than
the U.S. manufacturer from importing prescription drugs originally manufactured in the U.S., and
the FDA maintains that consumer imports of prescription drugs approved for sale in foreign
countries would almost certainly violate the FDCA, because such drugs are likely to be ²¹
mislabeled. Thus, online pharmacies that sell such drugs appear to violate the FDCA, as do
businesses that facilitate such sales. In addition, the CSA prohibits the unapproved importation of ²²
controlled substances, as well as causing such importation, so an individual or pharmacy that
uses the Internet in a way that causes controlled substances to be mailed or shipped into the U.S. ²³
may violate the CSA.
As noted above, state boards of pharmacy are primarily responsible for regulating pharmacy ²⁴
practice, although the FDA does provide some federal oversight of pharmacies. Because
virtually all states require a pharmacy that sells drugs in the state to be licensed with the state, a
state board of pharmacy traditionally may exercise regulatory authority over pharmacies located
within the state, as well as those that dispense drugs across state lines to citizens within the ²⁵
state. Since each state board of pharmacy sets its own policies with regard to both online and

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traditional pharmacies, state pharmacy laws differ from state to state. While some state laws
specify whether or not prescriptions based on online questionnaires are valid, other state laws do
not address the issue, thus rendering it difficult for some states to prosecute doctors who prescribe ²⁶
drugs without performing an in-person evaluation. Some critics of the current system have ²⁷
proposed establishing a federal definition of what constitutes a valid prescription.
In addition, some organizations have begun to promote uniform national standards for the
industry. For example, the National Association of Boards of Pharmacy (NABP) is an
organization that helps state boards by developing uniform standards on pharmacy practice. In
response to the proliferation of online pharmacies, NABP established the Verified Internet
Pharmacy Practice Sites (VIPPS) program, a certification program that “identifies to the public
those online pharmacy practice sites that are appropriately licensed, are legitimately operating via ²⁸
the Internet, and that have successfully completed a rigorous criteria review and inspection.”
According to NABP, the VIPPS program was developed in order to improve the safety of online
pharmacy practices and to “provide a means for the public to distinguish between legitimate and ²⁹
illegitimate online pharmacy practice sites.” Although NABP acknowledges that there are many
advantages to ordering drugs online, the Association specifically warns consumers against buying
prescription drugs online without obtaining an in-person examination and valid prescription from
a doctor. Like U.S. pharmacies, Canadian pharmacies may also be certified under the VIPPS ³⁰
program, but only if they do not export drugs to the U.S. However, NABP has indicated that it
may extend its VIPPS certification program to Canadian pharmacies that sell to U.S. consumers if
Congress approves drug importation or “if HHS does not stop the state and local governments ³¹
that already are reimporting drugs.”
Like pharmacy practice, the practice of medicine has historically been regulated at the state level
by state medical boards. According to the Federation of State Medical Boards (FSMB) “[t]he
primary responsibility and obligation of a state medical board is to protect consumers of health ³²
care through proper licensing and regulation of physicians.” Traditionally, states enact laws that
regulate the practice of medicine, and state medical boards implement and oversee state ³³
policies. If a doctor violates a state law or regulation, state medical boards generally have the

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authority to fine or otherwise discipline the doctor through modification, suspension, or
revocation of the doctor’s license to practice medicine in that state. In reality, however, laws
regarding medical practice vary widely in strength and effectiveness from state to state. While
some states have strong laws that explicitly prohibit activities such as prescribing drugs without
conducting an in-person examination, other states have weak laws, lax enforcement, or both.
Like NABP, FSMB has developed a specific policy with regard to online pharmacies and doctors
that prescribe drugs over the Internet. According to FSMB’s model guidelines on the subject,
electronic technology “should supplement and enhance, but not replace, crucial interpersonal ³⁴
interactions that create the very basis of the physician-patient relationship.” To that end, FSMB
guidelines declare that doctors who use the Internet as part of their medical practice should
conduct a physical evaluation of the patient before providing treatment. Although FSMB
recognizes the benefits of online pharmacies, the organization warns that “[t]reatment, including
issuing a prescription, based solely on an online questionnaire or consultation does not constitute ³⁵
an acceptable standard of care.” FSMB further urges that doctors who prescribe drugs on the ³⁶
Internet should be licensed in all states in which their patients reside, a practice that would ³⁷
subject doctors to the oversight of the medical boards in each state in which their patients lived.
These professional standards, however, are not legally enforceable in the absence of state laws
establishing such requirements.
The current legal framework for regulating online pharmacies and doctors is a patchwork of
federal and state laws regarding controlled substances, prescription drugs, pharmacies, and the
practice of medicine. Although many doctors and pharmacies who use the Internet prescribe and
dispense drugs in a safe and legal fashion, others have exploited gaps in the current system to
prescribe and dispense potentially dangerous quantities of highly addictive prescription drugs. To
combat such abuses, legislators and interest groups have proposed an array of solutions.
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