Testimony 

Before the Permanent Subcommittee on 

Investigations, Committee on 

Governmental Affairs, U.S. Senate

United States General Accounting Office 

GAO

For Release on Delivery 

Expected at 9:00 a.m. EDT 

Thursday, June 17, 2004 INTERNET PHARMACIES

Some Pose Safety Risks for 

Consumers and Are 

Unreliable in Their Business 

Practices 

Statement of Marcia Crosse 

Director, Health Care—Public Health 

 and Military Health Care Issues 

GAO-04-888T 
www.gao.gov/cgi-bin/getrpt?GAO-04-888T.

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. 

Highlights of GAO-04-888T, a testimony 

before the Permanent Subcommittee on 

Investigations, Committee on 

Governmental Affairs, U.S. Senate 

June 17, 2004

INTERNET PHARMACIES 

Some Pose Safety Risks for Consumers 

and Are Unreliable in Their Business 

Practices 

GAO obtained most of the prescription drugs it sought 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 dispensing pharmacy labels 

that provide 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 temperaturecontrolled environment arrived in envelopes without insulation. 

Manufacturer testing revealed that most of these drug samples were 

unapproved for the U.S. market because, for example, the labeling or the 

facilities in which they were manufactured had not been approved by FDA; 

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 doctorpatient relationship exists. Nine of these were U.S. sites, 1 a Canadian site, 

and 4 were other foreign Internet pharmacy sites. 

As the demand for and the cost of 

prescription drugs rise, many 

consumers have turned to the 

Internet to purchase them. 

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. 

This testimony summarizes a GAO 

report: Internet Pharmacies: 

Some Pose Safety Risks for 

Consumers, GAO-04-820 (June 17,

2004). 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 assessed 

the condition of the samples it 

received and forwarded the 

samples to their manufacturers to 

determine whether they were 

approved by FDA, safe, and 

authentic. GAO also confirmed the 

locations of several Internet 

pharmacies and undertook 

measures to examine the reliability 

of their business practices. 
Page 1 GAO-04-888T 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today as you discuss the safety of prescription 

drugs sold by Internet pharmacies.1

 As both the demand for and the cost of 

prescription medications have increased, the Internet has emerged as a 

growing marketplace for their purchase. Various types of pharmacies offer 

prescription drugs over the Internet, including those that require a patient 

to provide a physician’s prescription and are sometimes associated with 

traditional chain drug stores, and other pharmacies that issue a 

prescription based on an online medical questionnaire or have no 

prescription requirement. 

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. Federal agencies 

have also taken steps to stop illegal Internet sales of prescription drugs, 

including by prosecuting Internet pharmacies that dispense medications 

without a valid prescription. 2

 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. 

My testimony will summarize findings of a report we are releasing today 

that examines issues surrounding the availability and safety of 

prescription drugs sold over the Internet and the business practices of 

certain Internet pharmacies.3

 In a separate testimony, we are providing 

 1

Throughout this testimony, each Internet Web site selling prescription drugs is referred to 

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

U.S. General Accounting Office, Internet Pharmacies: Some Pose Safety Risks for 

Consumers, GAO-04-820 (Washington, D.C.: June 17, 2004). 
Page 2 GAO-04-888T 

further details about our purchases of narcotics from Internet 

pharmacies.4

 At your request, Mr. Chairman, we examined (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. We 

attempted to place up to 10 orders for each of 13 targeted prescription 

drugs, each from a different Internet pharmacy.5

 (See table 1.) We 

generally attempted to purchase each of the 13 drugs both with and 

without a prescription, from a range of Internet pharmacies that purported 

or appeared to be located in the United States, Canada, and other foreign 

countries.6

 4

See U.S. General Accounting Office, Internet Pharmacies: Hydrocodone, An Addictive 

Narcotic Pain Medication, Is Available Without a Prescription Through the Internet, 

GAO-04-892T (Washington, D.C.: June 17, 2004). 

5

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. 

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 testimony, Internet pharmacies 

from countries other than the United States or Canada are referred to as “other foreign 

Internet pharmacies.” 
Page 3 GAO-04-888T 

Table 1: Prescription Drugs Selected for Purchase From Internet Pharmacies 

Prescription drug Condition treated Remarks 

 Accutane® Acne Has special safety restrictionsa

 Celebrex® Arthritis -- 

 Clozaril® Schizophrenia Has special safety restrictionsa

 Combivir® HIV -- 

 Crixivan® HIV -- 

 Epogen® Anemia Has special handling requirements 

 Humulin® N Diabetes Has special handling requirements 

 Lipitor® High cholesterol -- 

 OxyContin® Pain Schedule II controlled substance, 

narcoticb

 Percocet® Pain Schedule II controlled substance, 

narcoticb

 Viagra® Male sexual dysfunction -- 

 Vicodin®/hydrocodone Pain Schedule III controlled substance, 

narcoticb

 Zoloft® Depression -- 

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. 

b

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 identified whether the samples we received contained a pharmacy 

label7

 with patient instructions for use and whether warnings were 

included on the labels or along with the packaging and made other 

observations about the manner in which the drugs were handled and the 

condition of the packaging. We forwarded the samples to the 

manufacturers of the drugs to determine whether they were FDA-

 7

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). 
Page 4 GAO-04-888T 

approved and authentic products, and identify any other safety concerns 

associated with the drugs or their handling.8

 We also undertook measures 

to examine the reliability of Internet pharmacy business practices, such as 

attempting to confirm the locations of certain Internet pharmacies and 

identifying the pharmacy sites currently under investigation by federal 

agencies. 

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. 

In summary, we were able to obtain the majority of prescription drugs we 

targeted for purchase from a wide variety of 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. 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 as 

addressed in our companion statement, we were also able to obtain 

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. 

We identified several problems associated with the handling, FDAapproval status, and authenticity of the 21 drug samples received from 

other foreign Internet pharmacies, but fewer problems among the 47 

samples received from 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 onethird included warning information. Thirteen of the 21 samples displayed 

other problems associated with the handling of the drugs, such as 3 

samples of a temperature-sensitive drug sent in envelopes without 

insulation, and 5 samples containing tablets enclosed in punctured blister 

packs, potentially exposing the tablets to damaging light or moisture. 

 8

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. 
Page 5 GAO-04-888T 

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 labeling9

 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.10 In contrast, all 47 of the drug samples we received from 

U.S. and Canadian Internet pharmacies included dispensing pharmacy 

labels, 41 included warning information, and none displayed evidence of 

mishandling. Like the samples 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. 

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 the Drug 

Enforcement Administration (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. 

 9

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). 

10Under 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. 
Page 6 GAO-04-888T 

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. 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. 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 gain approval for the U.S. market, 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 foreignmade 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. Failure to meet 

these standards could result in a drug being considered illegal for sale in 

the United States. 

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. 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. 

Background 
Page 7 GAO-04-888T 

We obtained 1 or more samples of 11 of the 13 drugs we targeted, both 

with and without a patient-provided prescription. 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.11 (See table 2.) 

 11We purchased generic hydrocodone because it was much more readily available than the 

brand name drug Vicodin. 

Most of the Targeted 

Prescription Drugs 

Were Purchased from 

Multiple Internet 

Pharmacies Without 

Providing A 

Prescription 
Page 8 GAO-04-888T 

Table 2: Prescription Drugs Ordered and Received from Internet Pharmacies 

Drug ordered Orders placeda

Drug samples 

receivedb

Drug samples 

obtained without a 

prescription provided 

by the patient

Accutane 10 6c 3

Celebrex 10 9 7

Clozaril 9 0 0

Combivir 6 5 1

Crixivan 6 6 2

Epogen 1 1 0

Humulin N 7 4 3

Lipitor 10 9 6

OxyContin 1 1 1

Percocet 0 0 0

Viagra 10 9 7

Vicodin/hydrocodone 10 9c,d 9

Zoloft 10 9 6

Total 90 68 45

Source: GAO. 

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

couriers (2). Payments were made using Visa and MasterCard credit cards. 

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. 

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 
Page 9 GAO-04-888T 

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 

U.S. Internet 

pharmacies

Canadian Internet 

pharmacies 

Other foreign 

Internet pharmacies

Prescription from 

patient’s physician must 

be provided 5 18 0

Web site provides 

prescription based on 

questionnaire 24 0 3

No prescription required 0 0 18

Source: GAO. 
Page 10 GAO-04-888T 

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 these samples came with 

warning information.12 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, two samples of Roaccutan, a foreign version of Accutane, 

arrived without any instructions in English. (See fig. 2.) 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. 

 12One of the samples we received from other foreign pharmacies included a dispensing 

pharmacy label; however, this label lacked patient instructions for use. 

Most Problems 

Identified among 

Drug Samples 

Received from Other 

Foreign Internet 

Pharmacies 
Page 11 GAO-04-888T 

Figure 1: Drug Sample Received Without Any Warnings or Instructions 

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

Source: GAO.
Page 12 GAO-04-888T 

Figure 2: Drug Sample Received Without Any Instructions in English 

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

English. 

We observed other evidence of improper handling among 13 of the 21 drug 

samples we received from other foreign Internet pharmacies. For example, 

3 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 

Source: GAO.
Page 13 GAO-04-888T 

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 

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. 

Source: GAO.
Page 14 GAO-04-888T 

Figure 4: Drug Samples Shipped in Unconventional Packaging 

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.” 

Source: GAO.

Source: GAO.
Page 15 GAO-04-888T 

Figure 5: Drug Sample Received in Damaged Packaging 

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

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.13 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 

 13The 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. 

Source: GAO.
Page 16 GAO-04-888T 

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 

ordered. 

In contrast to the drug samples received from other foreign Internet 

pharmacies, 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 moisturesensitive medication from a U.S. Internet pharmacy was inappropriately 

removed from the sealed manufacturer container and dispensed in a 

pharmacy bottle. 

Table 4 summarizes the problems we identified among the 68 samples we 

received. 
Page 17 GAO-04-888T 

Table 4: Problems Observed Among Prescription Drug Samples Received 

Pharmacy 

location 

No pharmacy 

label with 

instructions 

for use 

(23 samples) 

No warning 

information 

(21 samples) 

Improperly 

shipped or 

dispensed

(4 samples)

Unconventional 

packaging

(6 samples)

Damaged 

packaging 

(5 samples) 

Not approved 

for U.S. 

market

(35 samples)

Counterfeit or 

otherwise not 

comparable to 

product 

ordered

(4 samples)

Canadian Celebrex (2) 

Zoloft (2) 

 Accutane (3)

Combivir (3)

Crixivan (3)

Humulin N (1)

Lipitor (2)

Viagra (1)

Zoloft (3)

Other 

foreign 

Accutane (3) 

Celebrex (3) 

Combivir (1) 

Crixivan (2) 

Humulin N (3) 

Lipitor (3) 

OxyContin (1) 

Viagra (2) 

Zoloft (3) 

Accutane (2) 

Celebrex (3) 

Crixivan (2) 

Lipitor (3) 

OxyContin (1) 

Viagra (2) 

Zoloft (2) 

Humulin N (3) Accutane (1)

Celebrex (1)

Crixivan (2)

OxyContin (1)

Viagra (1)

Accutane (2) 

Celebrex (1) 

Crixivan (1) 

Lipitor (1) 

Accutane (2)

Celebrex (3)

Combivir (1)

Crixivan (1)

Humulin N (3)

Lipitor (3)

OxyContin (1)

Viagra (2)

Zoloft (3)

Accutane (1)

OxyContin (1)

Viagra (2)

U.S. Celebrex (1) 

Zoloft (1) 

Lipitor (1) 

Zoloft (1) 

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. 

We observed questionable characteristics and business practices of some 

of the Internet pharmacies from which we received drugs. 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.14 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 

 14The National Association of Boards of Pharmacy has also reported receiving complaints 

from consumers who state they have provided payment to various Internet pharmacies, but 

have not received the products ordered. 

Some Internet 

Pharmacies Were Not 

Reliable in Their 

Business Practices 
Page 18 GAO-04-888T 

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.15

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 (nine) and 

other foreign (four) pharmacies. One Canadian pharmacy was also 

included among those under investigation. 

 15We 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. 
Page 19 GAO-04-888T 

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 with special safety restrictions, for which patients should be 

monitored for side effects, and narcotics, 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. 

Mr. Chairman, this concludes my prepared statement. I would be pleased 

to respond to any questions you or other Members of the Subcommittee 

may have at this time. 

For future contacts regarding this testimony, please call Marcia Crosse at 

(202) 512-7119. Other individuals who made key contributions include 

Randy DiRosa, Margaret Smith, and Corey Houchins-Witt. 

Concluding 

Observations 

Contacts and 

Acknowledgments 

(290388) 
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