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Report to the Chairman, Permanent Subcommittee on Investigations, 
Committee on Governmental Affairs, U.S. Senate: 

June 2004: 

INTERNET PHARMACIES: 

Some Pose Safety Risks for Consumers: 

GAO-04-820: 

GAO Highlights: 

Highlights of GAO-04-820, a report to the Chairman, Permanent 
Subcommittee on Investigations, Committee on Governmental Affairs, 
U.S. Senate 

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.

www.gao.gov/cgi-bin/getrpt?GAO-04-820.

To view the full product, including the scope and methodology, click on 
the link above. For more information, contact Marcia Crosse at (202) 
512-7119 or Robert J. Cramer at (202) 512-7455.

[End of section]

Contents: 

Letter: 

Results In Brief: 

Background: 

Most of the Targeted Prescription Drugs Were Purchased from Multiple 
Internet Pharmacies Without Providing a Prescription: 

Most Problems Identified among Drug Samples Received from Other Foreign 
Internet Pharmacies: 

Some Internet Pharmacies Were Not Reliable in Their Business Practices:  

Concluding Observations: 

Agency and External Comments: 

Appendixes: 

Appendix I: Comments from the Food And Drug Administration: 

Appendix II: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Acknowledgments: 

Tables: 

Table 1: Prescription Drugs Selected for Purchase from Internet 
Pharmacies: 

Table 2: Prescription Drugs Ordered and Received from Internet 
Pharmacies: 

Table 3: Prescription Requirements of Pharmacies from which We Obtained 
Samples: 

Table 4: Problems Observed Among Prescription Drug Samples Received: 

Figures: 

Figure 1: Drug Sample Received Without Any Warnings or Instructions: 

Figure 2: Drug Sample Received Without Any Instructions in English: 

Figure 3: Drug Sample Shipped Improperly: 

Figure 4: Drug Samples Shipped in Unconventional Packaging: 

Figure 5: Drug Sample Received in Damaged Packaging: 

Letter June 17, 2004: 

The Honorable Norm Coleman: 
Chairman: 
Permanent Subcommittee on Investigations:
Committee on Governmental Affairs: 
United States Senate: 

Dear Mr. Chairman: 

As both the demand for and the cost of prescription medications have 
increased, the Internet has emerged as a growing marketplace for the 
purchase of prescription drugs. Internet pharmacies offer benefits for 
consumers, such as the convenience of shopping from home 24 hours a day 
and the ability to compare prices offered by multiple vendors. Various 
types of pharmacies offer prescription drugs over the Internet, 
including pharmacies that sell a wide range of drugs, require a patient 
to provide a prescription, and are sometimes associated with 
traditional chain drug stores, and other pharmacies that issue a 
prescription based on an online medical history questionnaire or have 
no prescription requirement.[Footnote 1]

Like traditional pharmacies, Internet pharmacies are subject to state 
and federal statutes and regulations designed to ensure the safety and 
efficacy of the medications they dispense. However, the global nature 
of the Internet poses challenges for regulators. States have identified 
Internet pharmacies that do not comply with state pharmacy laws, but 
have reported difficulty locating, investigating, and taking action 
against the pharmacies when they are located beyond state 
borders.[Footnote 2] Federal agencies have also taken steps to stop 
illegal sales of prescription drugs through Internet pharmacies, 
including by prosecuting Internet pharmacies that dispense medications 
without a valid prescription. The Food and Drug Administration (FDA) 
recently reported instances of drugs sold over the Internet that were 
improperly handled, such as improperly packaged drugs, drugs that were 
unapproved, and drugs that were not the authentic products consumers 
intended to purchase. Consumer complaints: 

regarding the business practices of some Internet pharmacies have 
raised further concerns associated with the use of Internet pharmacies 
to obtain prescription drugs.

You asked us to assess: 

1.the extent to which certain prescription drugs can be purchased over 
the Internet without a prescription;

2.whether drugs sold by Internet pharmacies are handled properly, are 
FDA-approved, and authentic; and: 

3.the extent to which Internet pharmacies are reliable in their 
business practices.

To determine the extent to which certain prescription drugs can be 
purchased over the Internet, we attempted to place up to 10 orders for 
each of 13 drugs, each from a different online pharmacy. The 13 
targeted drugs included top selling drugs, drugs with special safety 
restrictions or handling requirements, drugs that have been 
counterfeited in the past, and narcotics.[Footnote 3],[Footnote 4] (See 
table 1.) We generally attempted to purchase each of the 13 drugs with 
and without a prescription and produced our own prescriptions to enable 
us to do so.[Footnote 5]

Table 1: Prescription Drugs Selected for Purchase from Internet 
Pharmacies: 

Prescription drug: Accutane®; 
Condition treated: Acne; 
Remarks: Has special safety restrictions[A].

Prescription drug: Celebrex®; 
Condition treated: Arthritis; 
Remarks: --.

Prescription drug: Clozaril®; 
Condition treated: Schizophrenia; 
Remarks: Has special safety restrictions[A].

Prescription drug: Combivir®; 
Condition treated: HIV; 
Remarks: --.

Prescription drug: Crixivan®; 
Condition treated: HIV; 
Remarks: --.

Prescription drug: Epogen®; 
Condition treated: Anemia; 
Remarks: Has special handling requirements.

Prescription drug: Humulin® N; 
Condition treated: Diabetes; 
Remarks: Has special handling requirements.

Prescription drug: Lipitor®; 
Condition treated: High cholesterol; 
Remarks: --.

Prescription drug: OxyContin®; 
Condition treated: Pain; 
Remarks: Schedule II controlled substance, narcotic.

Prescription drug: Percocet®; 
Condition treated: Pain; 
Remarks: Schedule II controlled substance, narcotic.

Prescription drug: Viagra®; 
Condition treated: Male sexual dysfunction; 
Remarks: --.

Prescription drug: Vicodin® /hydrocodone; 
Condition treated: Pain; 
Remarks: Schedule III controlled substance, narcotic.

Prescription drug: Zoloft®; 
Condition treated: Depression; 
Remarks: - -. 

Source: GAO analysis of information from drug manufacturers and the 
Drug Enforcement Administration.

[A] Due to health risks associated with using this drug, there are 
special safety restrictions imposed on its use and distribution in the 
United States, such as a requirement that patients undergo certain 
medical tests and restrictions on the distribution of this drug to 
physicians with special training or expertise. Because of the health 
risks, FDA advises consumers not to purchase this drug over the 
Internet.

[End of table]

We purchased drugs from Internet pharmacies that purported or appeared 
to be located in the United States, Canada, and other foreign 
countries.[Footnote 6] We purchased drugs from Internet pharmacies with 
varying prescription requirements--some required purchasers to provide 
a prescription; some required purchasers to fill out an online medical 
history questionnaire, based on which a physician affiliated with the 
pharmacy issued a prescription; and some had no prescription 
requirement. We also purchased drugs from Internet pharmacies that are 
licensed online: 

providers of prescription drugs.[Footnote 7] To identify the Internet 
pharmacies, we relied upon a list of Internet pharmacy Web sites 
compiled by a private consultant and provided to us by FDA; used 
Internet search engines, including Google, Yahoo, and Excite; and 
joined Internet pharmacy members-only Web sites, which provide enrolled 
members with lists of Web sites selling various prescription drugs. 
Because the universe of Internet pharmacies is not known, and because 
we obtained only one drug sample[Footnote 8] from each pharmacy, our 
findings cannot be generalized.

To assess whether the drug samples we received were handled properly, 
we identified whether the samples contained a pharmacy label[Footnote 
9] with patient instructions for use and whether warnings were included 
on the labels or along with the packaging. We define handling as the 
manner in which Internet pharmacies labeled, packaged, and shipped the 
prescription drug samples we received. In addition, we made other 
observations about the manner in which the drugs were handled and the 
condition of the packaging.[Footnote 10] To assess whether the drug 
samples we received were FDA-approved and authentic products, we 
forwarded the samples to manufacturers of the drugs that we ordered to 
make these determinations[Footnote 11] and identify any other safety 
concerns associated with the drugs or their handling.[Footnote 12] 
Where manufacturers commented on the adequacy of patient instructions 
for use or warnings, we relied upon their assessments rather than our 
own judgment. We did not disclose to the manufacturers information 
concerning the source of the drug samples we purchased, including 
whether the pharmacy purported to be located in the United States, 
Canada, or in another foreign country.

To examine the reliability of the business practices of Internet 
pharmacies, we contacted Internet pharmacy customer service staff and 
several of the processing centers or brokers that handled the 
transactions. We also compared the return addresses of some drug 
samples received against the business addresses provided by the 
processing centers or brokers and listed on the Internet Web sites. 
Where the packaging of the drug samples received from foreign Internet 
pharmacies raised questions, we coordinated with Drug Enforcement 
Administration (DEA) to obtain information about the physical entity 
located at the return address on the package and the tenants or owners 
of the property. Finally, we obtained information from DEA and FDA 
regarding their ongoing investigations of organizations associated with 
the Internet pharmacies from which we purchased drugs.

We conducted our work from January through June 2004 in accordance with 
generally accepted government auditing standards and in accordance with 
the standards of the President's Council on Integrity and Efficiency.

Results In Brief: 

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. We obtained a total of 68 
drug samples--each from a different pharmacy in the United States, 
Canada, or other foreign countries--representing 11 of the 13 drugs we 
targeted for purchase.[Footnote 13] Drug samples received from other 
foreign pharmacies came from Argentina, Costa Rica, Fiji, India, 
Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey. The samples 
included drugs with special safety restrictions and addictive narcotic 
painkillers. Among the Internet pharmacies from which we obtained 
drugs, 5 U.S. and all 18 Canadian pharmacies required the patient to 
provide a prescription, whereas the remaining 24 U.S. and all 21 other 
foreign Internet pharmacies issued prescriptions based on their own 
medical questionnaires or had no prescription requirements. The 
availability and ease with which the drugs could be purchased varied by 
drug type. Top selling drugs such as Celebrex, Lipitor, Viagra, and 
Zoloft were readily available from multiple Internet pharmacies. Other 
drugs, such as those with special safety restrictions--Accutane and 
Clozaril--and narcotic painkillers--Percocet, OxyContin, and Vicodin--
were offered for sale by fewer Internet pharmacies or were otherwise 
more difficult to obtain.

We identified several problems associated with the handling, FDA-
approval status, and authenticity of the 21 drug samples received from 
other foreign Internet pharmacies, but fewer problems among the U.S. 
and Canadian Internet pharmacies. None of the 21 samples from other 
foreign pharmacies included dispensing pharmacy labels that provided 
instructions for use, and only about one-third included warning 
information. Thirteen of the 21 samples 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, and 5 samples contained 
tablets enclosed in punctured blister packs, potentially exposing the 
tablets to damaging light or moisture. Finally, manufacturers reported 
that most of the drug samples from other foreign pharmacies (19 of 21 
samples) were unapproved for the U.S. market because, for example, the 
labeling[Footnote 14] or the facilities in which they were manufactured 
had not been approved by FDA; however, they reported that the chemical 
composition of all but 4 of the other foreign samples was comparable to 
the product we had ordered. Among the 4 exceptions, 2 samples were 
found to be counterfeit versions of the product we had ordered, 
containing a lesser amount of the active ingredient, and 2 samples had 
a significantly different chemical composition than that of the product 
we had ordered.[Footnote 15] In contrast, all 47 of the drug samples we 
received from U.S. and Canadian Internet pharmacies included dispensing 
pharmacy labels that generally provided patient instructions for use, 
41 included warning information, and none displayed evidence of 
mishandling. Like the samples received from other foreign pharmacies, 
most of those from Canada were also unapproved for the U.S. market; 
however, manufacturers determined that the chemical composition of all 
were comparable to the product we had ordered. Finally, manufacturer 
testing identified 1 sample from a U.S. pharmacy that was 
inappropriately removed from the sealed manufacturer container and 
dispensed in a pharmacy bottle.

Some Internet pharmacies--mostly other foreign pharmacies--were not 
reliable in their business practices. We did not receive six of the 
orders we placed and paid for, five of which were placed with other 
foreign Internet pharmacies and one of which was placed with a pharmacy 
whose location we could not determine. Also, we determined that several 
of the drug samples were sent from locations that raise questions, such 
as from private residences. We also observed Internet pharmacies that 
obscured details about the drugs sold, such as other foreign pharmacies 
from which we ordered brand name drugs, but then received a generic or 
foreign version of the drug. Finally, about 21 percent of the Internet 
pharmacies that sent us samples were found to be under investigation by 
DEA or FDA. Reasons for the investigations included allegations of 
selling adulterated, misbranded, or counterfeit drugs and providing 
prescription drugs where no valid doctor-patient relationship exists. 
Nine of these pharmacies were from the United States, one from Canada, 
and four from other foreign countries.

We provided a draft of this report to FDA, which generally agreed with 
our findings and conclusions. We provided a draft of this report to DEA 
for a technical review and it informed us it had no comments. We also 
provided each manufacturer with segments of this draft report that 
related to its product(s). They provided technical comments, which we 
incorporated where appropriate.

Background: 

Three general types of Internet pharmacies sell prescription drugs 
directly to consumers. First, some Internet pharmacies operate much 
like traditional drugstores, selling a wide range of prescription drugs 
and requiring consumers to submit a prescription from their physicians 
before their orders are filled. In some instances, these Internet 
pharmacies are affiliated with traditional chain drug stores. Second, 
other Internet pharmacies may sell a more limited range of drugs, often 
specializing in certain lifestyle medications, such as those that treat 
sexual dysfunction or assist in weight control. These Internet 
pharmacies typically require consumers to fill out an online medical 
history questionnaire in place of a traditional examination by a 
physician, and issue a prescription after a physician affiliated with 
the pharmacy reviews the questionnaire. Still other Internet pharmacies 
dispense drugs without a prescription.

In the United States, the practice of pharmacy is regulated by state 
boards of pharmacy, which establish and enforce standards intended to 
protect the public. State boards of pharmacy also license pharmacists 
and pharmacies.[Footnote 16] To legally dispense a prescription drug, a 
licensed pharmacist working in a licensed pharmacy must be presented a 
valid prescription from a licensed health care professional.[Footnote 
17] The requirement that drugs be prescribed and dispensed by licensed 
professionals helps ensure patients receive the proper dose, take the 
medication correctly, and are informed about warnings, side effects, 
and other important information about the drug.

Under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended, FDA 
is responsible for ensuring the safety, effectiveness, and quality of 
domestic and imported drugs. To do so, FDA establishes standards for 
the safety, effectiveness, and manufacture of drugs that must be met 
before they are approved for the U.S. market. To gain approval, a drug 
manufacturer must demonstrate that a drug is safe and effective, and 
that the manufacturing methods and controls that will be used in the 
specific facility where it will be manufactured meet FDA standards. The 
same drug manufactured in another facility not approved by FDA--such as 
a foreign-made version of an approved drug--may not be sold legally in 
the United States. Drugs are subject to other statutory and regulatory 
standards relating to purity, labeling, manufacturing, and 
packaging.[Footnote 18] Failure to meet these standards could result in 
a drug being considered adulterated or misbranded and therefore illegal 
for sale, which could result in FDA enforcement action.[Footnote 19]

The FDCA requires that drugs be dispensed with labels that include the 
name of the prescriber, directions for use, and cautionary statements, 
among other things. A drug is considered misbranded if its labeling or 
container is misleading, or if the label fails to include required 
information. Prescription drugs dispensed without a prescription are 
also considered misbranded. 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. Drugs must also be handled 
to prevent adulteration, which may occur, for example, if held under 
unsanitary conditions leading to possible contamination.

FDA-approved drugs manufactured in foreign countries, including those 
sold over the Internet, are subject to the same requirements as 
domestic drugs.[Footnote 20] Further, imported drugs may be denied 
entry into the United States if they "appear" to be unapproved, 
adulterated, or misbranded, among other things. While the importation 
of such drugs may be illegal, FDA has allowed individuals to bring 
small quantities of certain drugs into the United States for personal 
use under certain circumstances.[Footnote 21]

Internet pharmacies pose challenges for regulators. State boards of 
pharmacy in many states have reported difficulty identifying Internet 
pharmacies located outside of their borders and have limited ability 
and authority to investigate and act against pharmacies that do not 
comply with state pharmacy laws when they are identified. In 2000, 
nearly half of the state boards had identified consumer complaints 
against Internet pharmacies or reported problems with Internet 
pharmacies not complying with state pharmacy laws. Additionally, state 
medical boards have reported receiving complaints about physicians 
prescribing drugs over the Internet without performing an examination 
of the patient.[Footnote 22] Federal agencies have taken steps to stop 
the illegal sales of prescription drugs and other substances by 
Internet pharmacies. For example, FDA has taken enforcement actions 
against Internet pharmacies; the Department of Justice has prosecuted 
Internet pharmacies and physicians for dispensing medications without a 
valid prescription; and DEA has investigated Internet pharmacies for 
illegal distribution of controlled substances.

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.

Samples of 11 of 13 Targeted Drugs Obtained from Internet Pharmacies: 

We obtained 1 or more samples of 11 of the 13 drugs we targeted, both 
with and without a patient-provided prescription. 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. Most of the drugs--45 of 68--were obtained 
without a patient-provided prescription. These included drugs for which 
physician supervision is of particular importance due to the 
possibility of severe side effects, such as Accutane, or the high 
potential for abuse and addiction, such as the narcotic painkiller 
hydrocodone. (See table 2.): 

Table 2: Prescription Drugs Ordered and Received from Internet 
Pharmacies: 

Drug ordered: Accutane; 
Orders placed[A]: 10; 
Drug samples received[B]: 6[C]; 
Drug samples obtained without a prescription provided by the patient: 
3.

Drug ordered: Celebrex; 
Orders placed[A]: 10; 
Drug samples received[B]: 9; 
Drug samples obtained without a prescription provided by the patient: 
7.

Drug ordered: Clozaril; 
Orders placed[A]: 9; 
Drug samples received[B]: 0; 
Drug samples obtained without a prescription provided by the patient: 
0.

Drug ordered: Combivir; 
Orders placed[A]: 6; 
Drug samples received[B]: 5; 
Drug samples obtained without a prescription provided by the patient: 
1.

Drug ordered: Crixivan; 
Orders placed[A]: 6; 
Drug samples received[B]: 6; 
Drug samples obtained without a prescription provided by the patient: 
2.

Drug ordered: Epogen; 
Orders placed[A]: 1; 
Drug samples received[B]: 1; 
Drug samples obtained without a prescription provided by the patient: 
0.

Drug ordered: Humulin N; 
Orders placed[A]: 7; 
Drug samples received[B]: 4; 
Drug samples obtained without a prescription provided by the patient: 
3.

Drug ordered: Lipitor; 
Orders placed[A]: 10; 
Drug samples received[B]: 9; 
Drug samples obtained without a prescription provided by the patient: 
6.

Drug ordered: OxyContin; 
Orders placed[A]: 1; 
Drug samples received[B]: 1; 
Drug samples obtained without a prescription provided by the patient: 
1.

Drug ordered: Percocet; 
Orders placed[A]: 0; 
Drug samples received[B]: 0; 
Drug samples obtained without a prescription provided by the patient: 
0.

Drug ordered: Viagra; 
Orders placed[A]: 10; 
Drug samples received[B]: 9; 
Drug samples obtained without a prescription provided by the patient: 
7.

Drug ordered: Vicodin/hydrocodone; 
Orders placed[A]: 10; 
Drug samples received[B]: 9[C,D]; 
Drug samples obtained without a prescription provided by the patient: 
9.

Drug ordered: Zoloft; 
Orders placed[A]: 10; 
Drug samples received[B]: 9; 
Drug samples obtained without a prescription provided by the patient: 
6.

Drug ordered: Total; 
Orders placed[A]: 90; 
Drug samples received[B]: 68; 
Drug samples obtained without a prescription provided by the patient: 
45. 

Source: GAO.

Note: The samples were shipped by FedEx (24), UPS (3), the U.S. Postal 
Service (39), and other couriers (2).

[A] Does not include attempted orders that were not accepted. We did 
not reach our goal of placing 10 orders for each drug because we could 
not always locate 10 sources from which we could purchase the drugs in 
a manner consistent with our methodology's protocols.

[B] We did not receive a drug sample for every order placed. Reasons 
included the drug being out of stock, a requirement that physicians 
prescribing certain drugs be part of a registry, and pharmacy requests 
for follow-up information we could not provide. In several instances, 
we could not determine why an order placed was not received.

[C] Includes one sample we could not link to an order we placed.

[D] Although we placed orders for Vicodin, we did not receive any 
samples of the brand name version of the drug; all nine samples 
received were of the generic equivalent hydrocodone.

[End of table]

Although most of the samples we received were obtained without a 
patient-provided prescription, prescription requirements varied. 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. Questionnaires 
requested information on the patient's physical characteristics, 
medical history, and condition for which drugs were being purchased. 
Several pharmacy Web sites indicated that a U.S.-licensed physician 
reviews the completed questionnaire and issues a prescription. The 
other foreign Internet pharmacies we ordered from generally had no 
prescription requirements, and many did not seek information regarding 
the patient's medical history or condition. The process for obtaining a 
drug from many of these pharmacies involved only selecting the desired 
medication and submitting the necessary billing and shipping 
information. (See table 3.): 

Table 3: Prescription Requirements of Pharmacies from which We Obtained 
Samples: 

Prescription requirement: Prescription from patient's physician must be 
provided; 
U.S. Internet pharmacies: 5; 
Canadian Internet pharmacies: 18; 
Other foreign Internet pharmacies: 0.

Prescription requirement: Web site provides prescription based on 
questionnaire; 
U.S. Internet pharmacies: 24; 
Canadian Internet pharmacies: 0; 
Other foreign Internet pharmacies: 3.

Prescription requirement: No prescription required; 
U.S. Internet pharmacies: 0; 
Canadian Internet pharmacies: 0; 
Other foreign Internet pharmacies: 18.

Source: GAO.

[End of table]

The Availability and Ease of Purchase Varied by Drug: 

While we obtained samples of most of the drugs we targeted for purchase 
on the Internet, certain drugs were more widely available and easier to 
purchase than others. The top selling drugs Celebrex (a pain reliever), 
Lipitor (a cholesterol-lowering drug), Viagra (a medication for male 
sexual dysfunction), and Zoloft (an antidepressant) were available from 
multiple pharmacies. We placed 10 orders for each of these four drugs 
with little difficulty.

Other drugs were available from fewer sources or were more difficult to 
obtain. Some of our orders for drugs with special safety restrictions 
were more closely scrutinized. For example, one order we placed for 
Accutane was declined by a U.S. pharmacy. Accutane is an acne 
medication that may cause birth defects and serious mental disturbances 
leading to suicide among some users. The pharmacy indicated that it 
declined our order because the physician was not included on a national 
registry of qualified prescribers.[Footnote 23] Similarly, one U.S. and 
one Canadian Internet pharmacy declined our order for Clozaril. 
According to its manufacturer, patients taking Clozaril, an 
antipsychotic medication, must have ongoing blood tests to monitor for 
the development of a fatal blood disorder that can occur during 
treatment. The U.S. pharmacy that declined our order indicated that 
Clozaril should not have been offered for sale on its Web site, and the 
Canadian pharmacy indicated that more stringent prescription 
requirements prevented it from dispensing the drug to patients outside 
of Canada.

Narcotic pain medications--OxyContin, Percocet, and Vicodin--were also 
less readily available. Despite extensive searching of Internet 
pharmacy sites, we found few that sold these drugs without a 
prescription. Other factors also hindered our ability to purchase these 
drugs. For example, some pharmacies that advertised the narcotics did 
not actually sell them. Rather, they attempted to substitute a 
different, often less potent and nonnarcotic drug once the order was 
placed. In addition, several pharmacies that offered narcotics required 
payment by means that were beyond our scope, such as check, bank 
transfers, or "e-gold" exchanges.[Footnote 24] We were able to place 
orders for the generic version of Vicodin at several U.S. pharmacies; 
however, some of these pharmacies required not only an online medical 
questionnaire, but also a telephone consultation with a pharmacy-
designated physician in order to obtain a prescription. Finally, we 
were able to place only one order for a drug purporting to be 
OxyContin, and only after locating the source by paying a membership 
fee and joining an Internet pharmacy drug club, which referred us to 
the site.

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. None included required pharmacy 
labels that provided patient instructions for use, and few provided 
warning information. Thirteen were shipped improperly, were packaged 
unconventionally, or arrived damaged. 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. While most of the samples received from 
Canadian Internet pharmacies were unapproved for the U.S. market, they 
otherwise had a comparable chemical composition, and the samples from 
U.S. and Canadian pharmacies exhibited few problems otherwise. Table 4 
summarizes the problems we identified among the 68 samples we received.

Table 4: Problems Observed Among Prescription Drug Samples Received: 

Pharmacy location: Canadian; 
No warning information: (21 samples): Celebrex (2); Zoloft (2); 
Not approved for U.S. market: (35 samples): Accutane (3); Combivir (3); 
Crixivan (3); Humulin N (1); Lipitor (2); Viagra (1); Zoloft (3). 

Pharmacy location: Other foreign; 
No pharmacy label with instructions for use: (23 samples): Accutane 
(3); Celebrex (3); Combivir (1); Crixivan (2); Humulin N (3); Lipitor 
(3); OxyContin (1); Viagra (2); Zoloft (3); 
No warning information: (21 samples): Accutane (2); Celebrex (3); 
Crixivan (2); Lipitor (3); OxyContin (1); Viagra (2); Zoloft (2); 
Improperly shipped or dispensed: (4 samples): Humulin N (3); 
Unconventional packaging: (6 samples): Accutane (1); Celebrex (1); 
Crixivan (2); OxyContin (1); Viagra (1); 
Damaged packaging: (5 samples): Accutane (2); Celebrex (1); Crixivan 
(1); Lipitor (1); 
Not approved for U.S. market: (35 samples): Accutane (2); Celebrex (3); 
Combivir (1); Crixivan (1); Humulin N (3); Lipitor (3); OxyContin (1); 
Viagra (2); Zoloft (3); 
Counterfeit or otherwise not comparable to product ordered: 
(4 samples): Accutane (1); OxyContin (1); Viagra (2).

Pharmacy location: U.S.; 
No pharmacy label with instructions for use: (23 samples): Celebrex 
(1); Zoloft (1); 
No warning information: (21 samples): Lipitor (1); Zoloft (1); 
Improperly shipped or dispensed: (4 samples): Crixivan (1). 

Source: GAO and drug manufacturers.

Notes: 

Drug names indicated are those that GAO ordered. The samples we 
received were not the brand name drugs we ordered in all instances.

Drug samples do not add to 68 because some samples exhibited more than 
one problem.

[End of table]

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.[Footnote 25] Lack of instructions and warnings on 
these drugs leaves consumers who take them at risk for potentially 
dangerous drug interactions or side effects from incorrect or 
inappropriate use. For example, we received 2 samples purporting to be 
Viagra, a drug used to treat male sexual dysfunction, without any 
warnings or instructions for use. (See fig. 1.) According to its 
manufacturer, this drug should not be prescribed for individuals who 
are currently taking certain heart medications, as it can lower blood 
pressure to dangerous levels. Additionally, 2 samples of Roaccutan, a 
foreign version of Accutane, arrived without any instructions in 
English. (See fig. 2.) As noted, possible side effects of this drug 
include birth defects and severe mental disturbances. Compounding the 
concerns regarding the lack of warnings and patient instructions for 
use, none of the other foreign pharmacies ensured patients were under 
the care of a physician by requiring that a prescription be submitted 
before the order is filled.

Figure 1: Drug Sample Received Without Any Warnings or Instructions: 

[See PDF for image] 

Note: Sample purporting to be Viagra® arrived without any warning 
information or instructions for use.

[End of figure] 

Figure 2: Drug Sample Received Without Any Instructions in English: 

[See PDF for image] 

Note: Sample of Roaccutan®, a foreign version of Accutane®, arrived 
without instructions for use in English.

[End of figure] 

We observed other evidence of improper handling among 13 of the 21 drug 
samples we received from other foreign Internet pharmacies. For 
example, three samples of Humulin N were not shipped in accordance with 
manufacturer handling specifications. Despite the requirement that this 
drug be stored under temperature-controlled and insulated conditions, 
the samples we received were shipped in envelopes without insulation. 
(See fig. 3.) Similarly, 6 samples of other drugs were shipped in 
unconventional packaging, in some instances with the apparent intention 
of concealing the actual contents of the package. For example, the 
sample purporting to be OxyContin was shipped in a plastic compact disc 
case wrapped in brown packing tape--no other labels or instructions 
were included, and a sample of Crixivan was shipped inside a sealed 
aluminum can enclosed in a box labeled "Gold Dye and Stain Remover 
Wax." (See fig. 4.) Additionally, 5 samples we received were damaged 
and included tablets that arrived in punctured blister packs, 
potentially exposing pills to damaging light or moisture. (See fig. 5.) 
One drug manufacturer noted that damaged packaging may also compromise 
the validity of drug expiration dates.

Figure 3: Drug Sample Shipped Improperly: 

[See PDF for image] 

Note: Despite the requirement that Humulin®N be stored under 
temperature-controlled and insulated conditions, samples we received 
were shipped in an envelope without insulation.

[End of figure]  

Figure 4: Drug Samples Shipped in Unconventional Packaging: 

[See PDF for image] 

Note: Sample purporting to be OxyContin® was shipped in a plastic 
compact disc case wrapped in brown packing tape--no other labels or 
instructions were included.

Note: Sample of Crixivan® was shipped inside a sealed aluminum can 
enclosed in a box labeled "Gold Dye and Stain Remover Wax.": 

[End of figure] 

Figure 5: Drug Sample Received in Damaged Packaging: 

[See PDF for image] 

Note: Sample of Crixivan®, a moisture sensitive drug, arrived in 
punctured blister packs. 

[End of figure] 

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.[Footnote 26] For 
example, the manufacturer of one drug noted that 2 samples we received 
of that drug were packaged under an alternate name used for the Mexican 
market. The manufacturer of another drug found that 3 samples we 
received of that drug were manufactured at a facility unapproved to 
produce drugs for the U.S. market. 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. Manufacturers also found 2 additional samples to 
have a significantly different chemical composition than that of the 
product we had ordered.

Drugs Received from Canadian and U.S. Internet Pharmacies Exhibited 
Fewer Problems: 

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. Furthermore, all 
samples were shipped in accordance with special handling requirements, 
where applicable, and arrived undamaged. 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. Finally, the 
manufacturer found that 1 sample of a moisture-sensitive medication 
from a U.S. pharmacy was inappropriately removed from the sealed 
manufacturer container and dispensed in a pharmacy bottle.

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. Most, but not 
all, involved other foreign pharmacies. These included pharmacies that 
accepted payment but did not provide the drugs ordered, shipments of 
drugs with questionable return addresses, pharmacies that obscured 
details about the drugs sold, and pharmacies that were under 
investigation by regulatory agencies.

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.[Footnote 27] The six 
orders were for Clozaril, Humulin N, and Vicodin, and cost over $700 in 
total. Five of these orders were placed with non-Canadian foreign 
pharmacies and one was placed with a pharmacy whose location we could 
not determine. We followed up with each pharmacy in late April and 
early May of 2004 to determine the status. Three indicated they would 
reship the product, but as of June 10, 2004, we had not received the 
shipments. Three others did not respond to our inquiry.[Footnote 28]

We determined that at least eight of the return addresses included on 
samples we received from other foreign Internet pharmacies were shipped 
from locations that raise questions about the entities that provided 
the samples. For example, we found a shopping mall in Buenos Aires, 
Argentina, at the return address provided on a sample of Lipitor. 
Authorities assisting us in locating this address found it impossible 
to identify which, if any, of the many retail stores mailed the 
package. The return address for a sample of Celebrex was found to be a 
business in Cozumel, Mexico, but representatives of that business 
informed authorities that it had no connection to an Internet pharmacy 
operation. Finally, the return addresses on samples of Humulin N and 
Zoloft were found to be private residences in Lahore, Pakistan.

Certain practices of Internet pharmacies may render it difficult for 
consumers to know exactly what they are buying. Some non-Canadian 
foreign Internet pharmacies appeared to offer U.S. versions of brand 
name drugs on their Web sites, but attempted to substitute an 
alternative drug during the order process. In some cases, other foreign 
pharmacies substituted alternative drugs after the order was placed. 
For example, one Internet pharmacy advertised brand name Accutane, 
which we ordered. The sample we received was actually a generic version 
of the drug made by an overseas manufacturer.

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. The pharmacies under investigation were concentrated among the 
U.S. pharmacies that did not require a patient-provided prescription 
(9) and other foreign (4) pharmacies. 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. Drugs available include 
those for which patients should be monitored for side effects or where 
the potential for abuse is high. For these types of drugs in 
particular, a prescription and physician supervision can help ensure 
patient safety. In addition to the lack of prescription requirements, 
some Internet pharmacies can pose other safety risks for consumers. 
Many foreign Internet pharmacies outside of Canada dispensed drugs 
without instructions for patient use, rarely provided warning 
information, and in four instances provided drugs that were not the 
authentic products we ordered. Consumers who purchase drugs from 
foreign Internet pharmacies that are outside of the U.S. regulatory 
framework may also receive drugs that are unapproved by FDA and 
manufactured in facilities that the agency has not inspected. Other 
risks consumers may face were highlighted by the other foreign Internet 
pharmacies that fraudulently billed us, provided drugs we did not 
order, and provided false or questionable return addresses. It is 
notable that we identified these numerous problems despite the 
relatively small number of drugs we purchased, consistent with problems 
recently identified by state and federal regulatory agencies.

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. II). FDA commented that, while the draft report 
noted Internet pharmacy Web sites purported or appeared to be from 
various countries, the draft did not demonstrate that the drug samples 
we received were actually sent from those countries, such as by 
discussing return addresses and postmarks on the samples. FDA suggested 
we indicate the methods we used to determine the samples' origins. 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. FDA also commented 
that our finding that certain unapproved drugs were chemically 
equivalent to the brand name products we ordered was misleading. FDA 
noted that chemical equivalence testing may not always determine 
whether a drug is comparable in all respects to the FDA-approved drug 
and therefore fully therapeutically equivalent. We relied on 
manufacturers to determine whether the drug samples we received were 
comparable to their own FDA-approved brand name version of the drug, 
and manufacturers conducted a range of tests to make this 
determination. Nevertheless we modified the final report to note the 
potential limitations to chemical equivalence testing. FDA also made 
several observations about the practices of Internet pharmacies and 
provided technical comments, which we incorporated where appropriate.

We also provided a draft of this report to DEA for technical comments 
and to ensure information we reported did not compromise its ongoing 
investigations. The agency responded that it had no comments.

Finally, we provided segments of the draft report to the manufacturer 
of each drug sample we received. Each manufacturer reviewed the 
segments of the draft report relating to its own product(s), and 
provided technical comments, which we incorporated as appropriate.

As agreed with your office, unless you publicly announce this report's 
contents, we plan no further distribution until 30 days after its issue 
date. At that time, we will send copies to the Acting Commissioner of 
FDA, the Administrator of DEA, and others upon request. In addition, 
this report will be available at no charge at the GAO Web site at 
[Hyperlink, http://www.gao.gov].

Please call Marcia Crosse at (202) 512-7119 or Robert Cramer at (202) 
512-7455 if you have any questions. Another contact and other major 
contributors are listed in appendix I.

Sincerely yours,

Signed by: 

Marcia Crosse: 
Director, Health Care--Public Health and Military Health Care Issues: 

Signed by: 

Robert J. Cramer: 
Managing Director, Office of Special Investigations: 

[End of section]

Appendixes: 

Appendix I: Comments from the Food And Drug Administration: 

DEPARTMENT OF HEALTH & HUMAN SERVICES:

Food and Drug Administration 
Rockville MD 20857:

June 4, 2004:

Marcia Crosse:

Director, Health Care-Public Health and Military Health Care Issues: 
United States General Accounting Office:
441 G Street, N.W.
Washington, D.C. 20548:

Dear Ms. Crosse:

Please find the enclosed comments from the Food and Drug Administration 
on the GAO draft report entitled INTERNET PHARMACIES: Some Pose Safety 
Risks for Consumers (GAO-04-820). The Agency provided technical 
comments directly to your staff.

We appreciate the opportunity to review and comment on this draft 
report before its publication as well as the opportunity to work with 
your staff in finalizing this report.

Sincerely,

Signed by: 

Lester M. Crawford, D.V.M., Ph.D. 
Acting Commissioner of Food and Drugs:

Enclosure:

General Comments by the Department of Health and Human Services' Food 
and Drug Administration on GAO's Draft Report, INTERNET PHARMACIES: 
Some Pose Safety Risks for Consumers (GAO-04-820):

The FDA appreciates the opportunity to review and comment on GAO's 
draft report. FDA concurs with the overall conclusions contained in 
this report that many imported prescription drugs appear to be of poor 
quality, are mishandled, have questionable authenticity and approval 
status, and that these drugs are readily available and can be easily 
purchased by consumers via Internet pharmacies. Our general comments 
follow:

1. The report repeatedly states that the Internet sites "purported" or 
"appeared" to be from Canada, the U.S., or other foreign countries. The 
study does not demonstrate with any certainty, particularly for the 
U.S. or Canadian websites, that the products were sent from or 
manufactured for use in those countries. It also does not discuss 
return address labels, post marks or other indicators of the origin of 
the packages. If Congress were to legalize importation of prescription 
drugs, we anticipate a proliferation of websites claiming to be 
Canadian pharmacies and entry of unscrupulous individuals into the 
marketplace. It is easy to design a fraudulent Canadian website that 
looks completely legitimate. We request that GAO make clear in its 
report how they determined the origin of the products they purchased. 
Further, when GAO refers to a "Canadian Internet pharmacy," how is that 
defined? Even if Canadian drugs are absolutely reliable, American 
consumers would still need a way to make sure that the medicines they 
order are actually coming from Canada and not simply transshipped 
through the country.

2. Many Canadian Internet Pharmacies market specifically to U.S. 
citizens seeking lower drug prices. The numerous storefront Canadian 
pharmacy operations in the U.S. are a direct offshoot of these business 
initiatives.

3. In several places throughout the report, GAO comments that, while 
"unapproved", the drugs obtained from abroad were chemically equivalent 
to FDA-approved drugs. We think this claim is misleading. Whether a 
foreign product contains the same active ingredient is no guarantee 
that it is identical to the FDA-approved product. For example, the 
foreign drug may contain different inactive ingredients (to which some 
persons may be allergic), and there is no guarantee that the foreign 
and FDA-approved drugs are bioequivalent.

Because two drug products are "chemically equivalent" does not make 
them therapeutically equivalent. Most of a generic drug's application 
review is directed to demonstrating its bioequivalence to the innovator 
drug.

Drug products are considered to be therapeutic equivalent only if they 
are pharmaceutical equivalents and if they can be expected to have the 
same clinical effect and safety profile when administered to patients 
under the conditions specified in the labeling.

4. The report does not mention the fact that criminal enforcement of the 
FD&C Act as it relates to the "online questionnaire" used in most 
domestic sites selling non-controlled prescription pharmaceuticals 
depends on individual States interpretation of what constitutes a valid 
prescription. This, in turn depends on their interpretation of what 
constitutes an adequate "doctor/patient relationship". Some states do 
not require a "face to face" medical evaluation. Where this is the 
case, FDA is deprived of the "misbranding" charge that results from the 
allegation that a prescription based solely on review of an online 
questionnaire is not valid.

5. Many U.S. Internet pharmacy sites selling drugs through the use of an 
online questionnaire do not offer lower prices, but cater to persons 
seeking so called "lifestyle" drugs, or to others wanting to avoid a 
doctor's visit or those intent on self-prescribing. These sites sell 
such drugs as Viagra, Zenical, Propecia and minor tranquilizers usually 
at a higher price than in a traditional brick and mortar or Internet 
pharmacy.

6. Sites that sell controlled substances do so usually at substantial 
mark up. For example, the AWP for generic Percocet is $11 but it sells 
for $265 per hundred on the Internet. These Internet sites are often 
sought out by drug abusers. Sites that are identified in the report as 
operating legally, like traditional drug stores, do not sell controlled 
substances because of DEA restrictions. FDA has found an increased 
number of controlled substances in the two "port blitzes" it did in 
2003. In 2004 the large volume of controlled substances coming into the 
U.S. continues.

7. The sampling GAO conducted is extremely small when viewed in the 
context of the vast number of Internet sites offering prescription 
drugs for sale. Although the size of the study demonstrates the gravity 
of the situation regarding "other foreign" Internet sites, a much 
larger study that has statistical significance should be considered. 

[End of section]

Appendix II: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Randy M. DiRosa, (312) 220-7671: 

Acknowledgments: 

Major contributors to this report were Margaret Smith, Corey Houchins-
Witt, Andrew O'Connell, Ramon Rodriguez, Julian Klazkin, Helen 
Desaulniers, Robert Copeland, and Harold Lewis.

(290339): 

FOOTNOTES

[1] Throughout this report, we refer to each Internet Web site selling 
prescription drugs as an Internet pharmacy. 

[2] See U.S. General Accounting Office, Internet Pharmacies: Adding 
Disclosure Requirements Would Aid State and Federal Oversight, GAO-01-
69 (Washington, D.C.: Oct. 19, 2000). 

[3] One of the drugs, Humulin N, is prescribed by physicians and is 
also available without a prescription. We included it among the drugs 
we ordered because of its special handling requirements.

[4] The Controlled Substances Act established a classification 
structure for drugs and chemicals used in the manufacture of drugs that 
are designated as controlled substances. Controlled substances are 
classified into five schedules on the basis of their medicinal value, 
potential for abuse, and safety or dependence liability. Schedule I is 
reserved for the most dangerous drugs that have no recognized medicinal 
use, while Schedule V is the classification used for the least 
dangerous drugs. We attempted to purchase Schedule II and Schedule III 
narcotics. See 21 U.S.C. §§ 811 and 812.

[5] Due to the heightened regulation of controlled substances, we did 
not attempt to purchase narcotics from pharmacies that required 
patients to submit a prescription from their physicians. 

[6] We determined the location of Internet pharmacies 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. Throughout this report, we refer to Internet pharmacies from 
countries other than the United States or Canada as "other foreign 
Internet pharmacies."

[7] We selected these Internet pharmacies from among those associated 
with large drugstore chains and those certified as Verified Internet 
Pharmacy Practice Sites (VIPPS) by the National Association of Boards 
of Pharmacy (NABP). VIPPS certification is voluntary and indicates that 
the pharmacy meets applicable state licensure requirements and certain 
other criteria established by NABP.

[8] This report uses the word "samples" to refer to our purchases of 
drugs from Internet pharmacies rather than to those drugs provided to 
practitioners and others for the purpose of promoting drug sales. See 
21 U.S.C. § 353(c)(1)(2000). 

[9] The Federal Food, Drug, and Cosmetic Act defines "label" as the 
display of written, printed, or graphic matter upon the immediate 
container of any article and information required to be on the label 
must also be included on the outside container or wrapper, if any, of 
the retail package. See 21 U.S.C. § 321(k). 

[10] We did not conduct a comprehensive review of the pharmacies' 
compliance with all applicable federal and state laws and regulations. 

[11] FDA has noted that chemical analysis of prescription drug samples 
may not always detect slight changes in the manufacturing process or 
different types or amounts of inactive ingredients, which can affect 
the comparability and thus therapeutic equivalence of drug samples. 

[12] We sent samples of the generic drug hydrocodone to the 
manufacturer of Vicodin for testing.

[13] We did not obtain samples of 2 of the 13 drugs we targeted for 
purchase. We placed nine orders for one of the drugs but received none, 
and we identified no source from which to purchase the other drug in a 
manner consistent with our methodology's protocols. 

[14] The term "labeling" is broader than the term "label" and includes 
all labels and other written, printed, or graphic matter upon an 
article or its container or wrapper, or that accompanies the article. 
See 21 U.S.C. § 321(m). 

[15] Under federal law, counterfeit drugs include those sold under a 
product name without proper authorization, which falsely purport or are 
represented to be a particular product. See 21 U.S.C. § 321(g)(2). 
Counterfeit products may include products without the active 
ingredient, with an insufficient quantity of the active ingredient, or 
with the wrong active ingredient. 

[16] Most states also license out-of-state pharmacies that dispense 
drugs to state residents, and some states regulate Internet pharmacies 
in a similar manner. See GAO-01-69. 

[17] States also license health care professionals, grant them 
prescribing privileges, and outline standards of practice in state 
medical practice laws.

[18] See, e.g., 21 U.S.C. §§ 351(b), 352(g), 352(h), 352(p), 355(d); 21 
C.F.R. pts. 201 and 210 (2003). Additional requirements apply to 
controlled substances under the Controlled Substances Act and DEA's 
implementing regulations. 

[19] Other federal agencies also play a role with respect to the 
regulation of prescription drugs under various circumstances. See GAO-
01-69. GAO is currently reviewing available data on the volume of 
prescription drugs entering the United States through the Postal 
Service and private couriers and the policies and practices of federal 
agencies charged with preventing unapproved prescription drugs from 
entering the country. 

[20] The recently enacted Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 directed the Secretary of Health and Human 
Services to create a system for the importation of prescription drugs 
from Canada upon certification that the implementation of the program 
would (1) pose no additional risk to the public's health and safety and 
(2) result in a significant reduction in the cost of covered products 
to the American consumer. The act directed the Secretary to complete a 
study on drug importation from Canada within 1 year of enactment. See 
Pub. L. No. 108-173, §§ 1121, 1122, 117 Stat. 2066, 2464-69 (to be 
codified at 21 U.S.C. §§ 384, 384 note).

[21] FDA guidelines indicate that agency officials may use their 
discretion to allow importation if (1) the intended use is identified, 
is not for a serious condition, and the product is not known to 
represent a significant health risk; or (2) if the intended use is 
unapproved and for a serious condition for which effective treatment 
may not be available domestically, and other conditions are also met. 
See Chapter 9 of FDA's Regulatory Procedures Manual. http://
www.fda.gov/ora/compliance_ref/rpm/default.htm. Downloaded June 10, 
2004.

[22] In 2000, 39 of 45 state medical boards responding to our survey 
indicated that a physician who issued a prescription on the basis of an 
online questionnaire would not satisfy the standard of good medical 
practice required under their states' laws. SeeGAO-01-69.

[23] Risk management protocols developed by the manufacturer in 
agreement with FDA prohibit U.S. pharmacies from accepting electronic 
prescriptions for this drug.

[24] "e-gold" is a system where sellers and buyers can establish 
accounts and electronically exchange values or amounts of gold in order 
to complete Internet transactions.

[25] One of the samples we received from other foreign pharmacies 
included a dispensing pharmacy label; however, this label lacked 
patient instructions for use.

[26] The manufacturer of one of the remaining two samples determined it 
was approved for the U.S. market and the manufacturer of the other 
sample could not make a determination.

[27] NABP has reported receiving complaints from consumers who state 
they have provided payment to various Internet pharmacies, but have not 
received the products ordered.

[28] We received no notice from federal agencies indicating that our 
drug samples had been seized, nor did the Internet pharmacies we 
contacted about unreceived shipments indicate they had received such 
notification.

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