Testimony 

Before the Permanent Subcommittee on 

Investigations, Committee on Governmental

Affairs, U.S. Senate

United States Government Accountability Office

GAO

For Release on Delivery 

Expected at 9:00 a.m. EDT 

Thursday, July 22, 2004 PRESCRIPTION DRUGS

Preliminary Observations 

on Efforts to Enforce the 

Prohibitions on Personal 

Importation 

Statement of Richard M. Stana, Director 

Homeland Security and Justice Issues 

GAO-04-839T 
www.gao.gov/cgi-bin/getrpt?GAO-04-839T.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Richard Stana 

at (202) 512-8777 or Stanar@gao.gov. 

Highlights of GAO-04-839T, a testimony 

before the Permanent Subcommittee on 

Investigations, Committee on 

Governmental Affairs, U.S. Senate 

July 22, 2004

PRESCRIPTION DRUGS 

Preliminary Observations on Efforts to 

Enforce the Prohibitions on Personal 

Importation 

CBP and FDA officials said that the volume of imported adulterated, 

misbranded, or unapproved prescription drugs is large and increasing, but 

complete data do not exist to document these observations. FDA officials 

said that they cannot assure the public of the safety and quality of drugs 

purchased from foreign sources that are largely outside the U.S. regulatory 

system. GAO’s recent report on a sample of drugs purchased from Internet 

pharmacies echoed these concerns. 

CBP and FDA officials at mail and private carrier facilities inspect and 

interdict some packages that contain prescription drugs. However, 

according to officials, because of resource constraints, many other packages 

containing prescriptions drugs are either not inspected and are released to 

addressees or are released after an inspection. CBP and FDA target certain 

packages for inspection based on the packages’ countries of origin and 

whether the packages are suspected of containing certain prescription 

drugs. However, packages that are not targeted typically bypass inspection 

and are released to addressees without an assessment of their contents or 

admissibility. FDA officials have acknowledged that tens of thousands of 

packages, containing drug products that may violate current laws and pose 

health risks to consumers, have been released. They said that timeconsuming processing requirements and resource constraints limit their 

ability to perform more inspections. 

Agency efforts to deal with imported prescription drugs are evolving. Two 

interagency task forces were established to study prescription drug 

importation and address related law enforcement issues, respectively. Also, 

to overcome differences in the way officials target and interdict shipments of

unapproved prescription drugs at various mail and private carrier facilities, 

FDA has begun implementing new procedures to promote more uniformity 

across facilities. It is too soon to tell if these efforts are sufficient to address 

various health, safety, and law enforcement issues associated with the 

importation of prescription drugs. 

Packages suspected of containing imported prescription drugs awaiting FDA review 

Source: GAO with permission of CBP and FDA.

American consumers are 

increasingly drawn to the 

convenience, privacy, and cost 

advantages that might be accrued 

by purchasing prescription drugs 

over the Internet. However, there is 

growing concern about the safety 

of the drugs and the lawfulness of 

shipping the drugs into the United 

States through international mail 

and private carriers. Under current 

law, the importation of prescription 

drugs for personal use is illegal, 

with few exceptions. All 

prescription drugs offered for 

import must meet the requirements 

of the Federal Food, Drug, and 

Cosmetic Act, and those that are 

controlled substances also must 

meet the requirements of the 

Controlled Substances Import and 

Export Act. According to the 

agencies responsible for enforcing 

these laws, prescription drugs 

imported for personal use generally 

do not meet these requirements. 

The Department of Homeland 

Security’s U.S. Customs and Border 

Protection (CBP) and the 

Department of Health and Human 

Service’s Food and Drug 

Administration (FDA) are 

responsible for inspecting and 

interdicting unapproved 

prescription drugs that are being 

illegally imported via the U.S. mail 

or private carrier. 

This testimony reflects our 

preliminary observations from 

ongoing work to assess federal 

efforts to enforce the prohibitions 

on personal importation of 

prescription drugs. 
Page 1 GAO-04-839T 

Mr. Chairman and Members of the Subcommittee: 

I appreciate the opportunity to be here today to participate in this hearing 

on prescription drug importation. American consumers are increasingly 

drawn to the convenience, privacy, and cost advantages that might be 

accrued by purchasing over the Internet such prescription drugs as 

Valium, cholesterol-lowering drugs, and Viagra. However, there is growing 

concern, reported in the media and elsewhere, that persons who purchase 

prescription drugs from Internet pharmacies, particularly those 

pharmacies located in foreign countries, run the risk of taking drugs that 

may be compromised or not the authentic product they intended to 

purchase. Thus, American consumers may be exposed to potential health 

and safety risks. Furthermore, consumers may also be violating the law, 

unknowingly or intentionally, by having these drugs shipped into the 

United States through the international mail and private carriers. 

Under current law, the importation of prescription drugs for personal use 

is illegal, with few exceptions. Two acts specifically regulate the 

importation of prescription drugs into the United States. That is, all 

prescription drugs offered for import must meet the requirements of the 

Federal Food, Drug, and Cosmetic Act and those that are controlled 

substances, as defined in the Controlled Substances Act,1

 also must meet 

the requirements of the Controlled Substances Import and Export Act. 

Prescription drugs imported for personal use generally do not meet these 

requirements. 

My testimony today reflects our preliminary observations from ongoing 

work to assess federal efforts to enforce the prohibitions on personal 

importation of prescription drugs, which was requested by the Chairman 

and Ranking Minority Member of this Subcommittee and the Ranking 

Member of the House Energy and Commerce Committee. Much of our 

work to date has focused on the efforts of the Department of Homeland 

Security’s U.S. Customs and Border Protection (CBP) and the Department 

of Health and Human Service’s Food and Drug Administration (FDA) to 

 1

The Controlled Substances Act establishes a classification structure for certain drugs and 

chemicals that are designated as controlled substances. This structure places controlled 

substances in one of five schedules, based on their medicinal value, risk to public health, 

and potential for abuse and addiction, among other factors. Schedule I is reserved for the 

most dangerous drugs that have no currently accepted medical use, such as heroin and 

ecstasy. Prescription drugs that are also controlled substances, such as Valium or codeine, 

fall in schedules II through V. 
Page 2 GAO-04-839T 

inspect and interdict prescription drugs that are being imported via the 

U.S. mail or private carrier, such as FedEx or DHL, for personal use. In 

this statement, I make the following points: 

• CBP and FDA officials said that the amount of unapproved prescription 

drugs illegally entering the country is large and increasing. The overall 

healthfulness and safety of these imported drugs is not assured, and 

limited testing showed that some of these drugs pose risks to 

consumers. 

• CBP and FDA interdict some packages that contain prescription drugs, 

but many other packages containing these drugs are released to 

addressees—either not inspected and released or released after 

inspection. According to CBP and FDA officials, this is because of 

resource and other constraints. 

• CBP and FDA officials told us that their respective requirements for 

inspecting and processing violative materials can be time-consuming 

and in some cases hamper their enforcement efforts. 

• Agency efforts to address issues concerning the importation of 

prescription drugs are evolving, but it is still too early to tell whether 

these efforts will adequately address every aspect of the law 

enforcement and safety issues associated with the importation of these 

drugs. 

My testimony is based on our ongoing review of federal laws and agency 

policies, procedures, and practices related to personal importation of 

prescription drugs; visits to three international mail facilities operated by 

the U.S. Postal Service and two private carrier facilities; and interviews 

with officials from CBP, FDA, the Department of Justice’s Drug 

Enforcement Administration (DEA), the U.S. Postal Service, and the 

Department of Homeland Security’s U.S. Immigration and Customs 

Enforcement. We did the work reflected in this statement from March to 

July 2004 in accordance with generally accepted government auditing 

standards. We plan to finish our work and issue a report later this year. 

Additional information on our scope and methodology can be found in 

appendix I. 

All international mail and packages entering the United States through the 

U.S. Postal Service and private carriers are subject to potential CBP 

inspection at the 13 International Mail Branches (IMBs) located at U.S. 

Background 
Page 3 GAO-04-839T 

Postal Service international mail facilities and 29 express consignment 

carrier facilities operated by private carriers located around the country. 

CBP inspectors can target certain packages for inspection or randomly 

select packages for inspection. CBP inspects for, among other things, 

illegally imported controlled substances, contraband, and items—like 

personal shipments of prescription drugs—that may be inadmissible. CBP 

inspections can include examining the outer envelope of the package, 

using x-ray detectors, or opening the package to physically inspect the 

contents. Each year the IMBs and carrier facilities process hundreds of 

millions of pieces of mail and packages. Among these items are 

prescription drugs ordered by consumers over the Internet, the 

importation of which is prohibited under current law, with few exceptions. 

Two acts—the Federal Food, Drug, and Cosmetic Act and the Controlled 

Substances Import and Export Act—specifically regulate the importation 

of prescription drugs into the United States. Under the Federal Food, 

Drug, and Cosmetic Act, as amended, FDA is responsible for ensuring the 

safety, effectiveness, and quality of domestic and imported drugs and may 

refuse to admit into the United States, any drug that appears to be 

adulterated, misbranded, or unapproved for the U.S. market as defined in 

the act.2

 Under the act and implementing regulations, this includes foreign 

versions of FDA-approved drugs because, for example, neither the foreign 

manufacturing facility nor the manufacturing methods and controls were 

reviewed by FDA for compliance with U.S. statutory and regulatory 

standards. The act also prohibits reimportation of a prescription drug 

manufactured in the United States by anyone other than the original 

manufacturer of that drug. According to FDA, prescription drugs imported 

by individual consumers typically fall into one of these prohibited 

categories. However, FDA has established a policy that allows local FDA 

officials to use their discretion to permit personal importation of 

prescription drugs that do not contain controlled substances under 

specified circumstances, such as importing for treatment of a serious 

condition a small quantity, generally not more than a 90-day supply, of a 

 2

An unapproved drug includes one that has not been demonstrated to be safe and effective 

and for which the manufacturing facility, methods, and controls have not been shown to 

meet FDA standards. Failure to meet other statutory and regulatory standards relating to 

labeling, handling, and packaging may result in a drug being considered adulterated or 

misbranded. See 21 U.S.C. §§ 811, 812 §§ 351, 352, 355. 
Page 4 GAO-04-839T 

drug not available domestically.3 The importation of unapproved foreign 

versions of prescription drugs like Viagra (an erectile dysfunction drug) or 

Propecia (a hair loss drug), for example, would not qualify under the 

personal importation policy because approved versions are readily 

available in the United States. 

In addition, the Controlled Substances Import and Export Act, among 

other things, generally prohibits personal importation of those 

prescription drugs that are also controlled substances, such as Valium or 

codeine. (See app. II for general description of controlled substances.) 

Under the act, the importation of controlled substances is prohibited 

unless the importer is registered with DEA, and such registration is 

generally not available for importation for personal use. The act and 

implementing regulations permit an individual traveler under certain 

circumstances to carry a personal use quantity of a controlled substance 

(except a substance in Schedule I) across the U.S. border, but they do not 

make a similar exception for importation by mail or private carrier.4

CBP inspects packages for prescription drugs on behalf of DEA and FDA. 

Upon inspection, CBP is to seize illegally imported controlled substances 

on behalf of DEA.5

 CBP may take steps to destroy the seized and forfeited 

substance or turn the seized substance over to other federal law 

enforcement agencies for further investigation.6

 CBP is to turn over 

 3

According to the policy, other conditions should be met as well, such as (1) provision of 

the name and address of the doctor licensed in the United States responsible for the 

importer’s treatment with the product or evidence that the product is for continuation of 

treatment begun in a foreign country and (2) the absence of any known commercialization 

or promotion to persons residing in the United States by those involved in the distribution 

of the product at issue. Alternatively, in the case of a drug that is not for a serious 

condition, the policy also permits FDA officials to use their discretion to allow importation 

of that drug if the intended use is identified, and the product is not known to represent a 

significant health risk. A complete description of FDA’s personal importation policy can be 

found in chapter 9 of FDA’s Regulatory Procedures Manual, which is available on the 

agency’s web site. 

4

21 U.S.C. 956(a), 957(b)(1)(C); 21 C.F.R. 1301.26. The controlled substance must be in the 

original container in which it was dispensed to the individual. The individual must declare 

that it is possessed for personal use or for an accompanying animal and provide the trade 

or chemical name and schedule of the substance. If the traveler is a U.S. resident, he or she 

may bring no more than 50 dosage units of the substance without a prescription. 

5

19 USC § 1595a(c)(1)(B); 19 C.F.R. §§ 162.23, 145.59, 145.58, 12.36. Schedule I and II 

controlled substances are subject to summary forfeiture. 

6

19 CFR §§ 162.31, 162.32, 162.45, 162.45a, 162.46, 162.47, 162.63. 
Page 5 GAO-04-839T 

packages suspected of containing prescription drugs that are not 

controlled substances to FDA.7

 FDA investigators may inspect such 

packages and hold those that appear to be adulterated, misbranded, or 

unapproved, but must notify the addressee and allow that individual the 

opportunity to present evidence as to why the drug should be admitted 

into the United States.8

 If the addressee does not provide evidence that 

overcomes the appearance of inadmissibility, then the item is refused 

admission. 

Figure 1 illustrates the two acts that specifically govern the importation of 

prescription drugs into the United States. It also presents the roles of FDA, 

DEA, and CBP in implementing those acts. 

 7

 21 U.S.C. § 381(a); 19 C.F.R. §§ 12.1(a), 145.57; see also Chapter 9 of FDA’s Regulatory 

Procedures Manual, Subchapter Coverage of Personal Importations, “Mail Shipments” 

http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html. Downloaded May 18, 

2004. 

8

 21 U.S.C. § 381(a); 21 CFR §1.94. 
Page 6 GAO-04-839T 

Figure 1: Acts Governing the Personal Importation of Prescription Drugs into the United States and FDA, DEA, and CBP Roles 

Implementing Those Acts 

Prohibits importation of any drug that appears to 

be adulterated, misbranded, or unapproved and 

reimportation of a drug manufactured in the U.S. 

by anyone other than the original manufacturer

U.S. Customs and Border Protection 

receives international mail and 

packages for possible inspection.

The Food and Drug Administration 

may inspect and hold prescription 

drugs that appear adulterated, 

misbranded or unapproved, but 

must notify and allow addressee 

opportunity to present evidence as 

to why drug should be admitted 

into the United States.

While the Act permits a traveler 

under certain circumstances to 

carry a small quantity of certain 

controlled substances across the 

border, there is no similar 

exception for importation by mail.

FDA policy allows local FDA officials 

to use their discretion to permit 

personal importation of unapproved 

drugs that are not controlled 

substances, under specified 

circumstances.

U.S. Customs and Border Protection 

turns over prescription drugs 

imported for personal use that are 

not controlled substances.

On behalf of the Drug Enforcement 

Administration, U.S. Customs and 

Border Protection is to seize illegally 

imported controlled substances.

Federal Food, Drug,

and Cosmetic Act

FDA

Exception by policy

Source: GAO analysis of 19 U.S.C. § 1595a(c); 21 U.S.C. §§ 381, 956, 957; U.S. Food and Drug Administration, Regulatory Procedures Manual, Chapter 9, Subchapter: Coverage of Personal Importations.

No exception by statute or policy

CBP for

DEA

Prohibits importation of controlled substances by 

persons other than those registered with the Drug 

Enforcement Administration

Controlled Substances

Import and Export Act

Mail

suspected of

containing a

prescription

drug

?

Not a controlled substance Controlled substance
Page 7 GAO-04-839T 

CBP and FDA officials said that the volume of unapproved prescription 

drugs illegally imported through the IMBs or carrier facilities is large and 

steadily increasing. However, complete data do not exist to document this 

observation. During special operations, CBP and FDA have attempted to 

determine the volume of imported prescription drugs entering through 

selected IMBs. Generally, these were one-time, targeted efforts to identify 

and tally all of the packages containing prescription drugs at certain time 

periods. The limited data collected have shown wide variations in volume. 

For example, CBP officials at one IMB estimated that approximately 3,300 

packages containing prescription drugs entered the facility in one week. In 

2004, CBP officials at another IMB determined that 4,300 packages 

containing prescription drugs entered the facility in one day. While these 

data may provide estimates regarding the volume entering selected IMBs 

for certain time periods, the data may not be representative of other time 

periods or projectable to other locations. 

FDA officials have stated that they cannot provide assurance to the public 

regarding the safety and quality of drugs purchased from foreign sources, 

which are largely outside of their regulatory system. Additionally, FDA 

officials indicated that consumers who purchase prescription drugs from 

foreign-based Internet pharmacies are at risk of not fully knowing the 

safety or quality of what they are importing. FDA officials also have stated 

that while some consumers may purchase genuine products, others may 

unknowingly purchase counterfeit products, expired drugs, or drugs that 

were improperly manufactured. 

CBP and FDA have conducted special operations to do limited 

assessments of the nature of some imported prescription drugs, and these 

operations have raised questions about the safety of some of the drugs 

analyzed. For example, during an operation undertaken in 2003 at four 

IMBs, CBP and FDA inspected 1,153 packages that contained prescription 

drugs.9

 According to a CBP report, 1,019, or 88 percent, of the drug 

products were violative because they were prohibited for import, 

including Lipitor (a cholesterol-lowering drug), Viagra, and Propecia. A 

CBP laboratory analyzed 180 drug samples. This analysis showed that the 

majority of the drugs were never approved by FDA. Furthermore, the 

operation showed that many of the unapproved drugs could pose safety 

 9

According to CBP officials, packages shipped through four IMBs were examined over a 3-

day period. Approximately 100 parcels (each of which may have contained multiple drug 

products) per day per facility were selected based upon their country of origin and 

historical experience. 

Volume of 

Prescription Drug 

Imports Is Said to be 

Large and Increasing, 

and the Health and 

Safety of these Drug 

Imports is Not 

Assured 
Page 8 GAO-04-839T 

risks. The samples included drugs that were withdrawn from the U.S. 

market for safety reasons; animal drugs not approved for human use; and 

drugs that carry risks because they require careful dosing, initial 

screening, or periodic patient monitoring. In addition, other drugs tested 

were found to contain controlled substances prohibited for import, and 

some of the drugs contained no active ingredients. Figure 2 illustrates the 

results of the CBP laboratory analysis. 

Figure 2: Results of CBP’s Laboratory Analysis of 180 Imported Drugs 

In a recent report and testimony before this Subcommittee, we found that 

prescription drugs ordered from some foreign-based Internet pharmacies 

posed safety risks for consumers.10 Specifically, we identified several 

problems associated with the handling, FDA approval status, and 

authenticity of 21 prescription drugs samples purchased from Internet 

pharmacies located in several foreign countries—Argentina, Costa Rica, 

Fiji, Mexico, India, Pakistan, Philippines, Spain, Thailand, and Turkey. Our 

work showed that most of these drug samples, all of which we received via 

consignment carrier shipment or the U.S. mail, were unapproved for the 

 10See U.S. General Accounting Office, Internet Pharmacies: Some Pose Safety Risks for 

Consumers, GAO-04-820 (Washington, D.C.: June 17, 2004) and U.S. General Accounting 

Office, Internet Pharmacies: Some Pose Safety Risks for Consumers and Are Unreliable 

in Their Business Practices, GAO-04-888T (Washington, D.C.: June 17, 2004). 

5%

28%

67%

Drugs with no active ingredients

Drugs that contained controlled substances

prohibited for import

Drugs that were not FDA approved

Source: GAO analysis of CBP information.
Page 9 GAO-04-839T 

U.S. market because, for example, the labeling11 or the foreign 

manufacturing facility, methods, and controls were not reviewed by FDA. 

Of the 21 samples: 

• None included dispensing pharmacy labels that provided instructions 

for use, and only about one-third included warning information. 

• Thirteen displayed problems associated with the handling of the drug; 

three samples that should have been shipped in a temperaturecontrolled environment arrived in envelopes without insulation; and 

five samples contained tablets enclosed in punctured blister packs, 

potentially exposing them to damaging light or moisture. 

• Two were found to be counterfeit versions of the products we ordered, 

and two had a significantly different chemical composition than that of 

the product we had ordered. 

We found fewer problems among 47 samples purchased from U.S. and 

Canadian Internet pharmacies. Although most of the drugs obtained from 

Canada were of the same chemical composition as that of their U.S. 

counterparts, most were unapproved for the U.S. market. We stated that it 

was notable that we identified numerous problems among the samples 

received despite the relatively small number of drugs we purchased, 

consistent with problems recently identified by state and federal 

regulatory agencies. 

Our work thus far shows that while CBP and FDA interdicted some 

packages that contain prescription drugs, other similar packages were 

released—either not inspected and released or released after inspection. 

CBP officials told us that certain packages were targeted for inspection. 

However, packages that were not targeted typically bypass inspection and 

are released to the addressee without an assessment of their contents or 

admissibility. Many packages that were held by CBP officials for FDA at 

the IMBs were also subsequently released to the addressee. FDA has 

acknowledged that tens of thousands of packages have been released, 

although they may contain drug products that violate current laws and 

pose health risks to consumers. FDA officials at the IMBs said that the 

 11The 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). 

Some Packages 

Containing 

Prescription Drugs 

Are Interdicted, but 

Others Are Released 
Page 10 GAO-04-839T 

packages were released to the addressee because FDA investigators were 

unable to process the volume of packages turned over to them. FDA 

headquarters officials told us that this occurred because of limited 

available resources relative to the volume of unapproved prescription 

drugs entering the country. 

According to CBP and FDA officials at the IMBs we visited, CBP and FDA 

use various approaches to target certain incoming international mail 

packages for inspection. These include targeting packages from certain 

countries and/or packages suspected of containing certain prescription 

drugs. For example, at one IMB we visited, FDA provided CBP with a list 

of targeted countries—the composition of which changed periodically. A 

recent list targeted seven countries and specific areas in one other 

country. FDA officials asked that CBP hold the packages they suspected of 

containing prescription drugs that were from the targeted countries. 

Typically, CBP officials told us that when packages containing 

prescription drugs were detected, but were not from one of the targeted 

countries, they were released to the addressee without an assessment of 

their admissibility. Accordingly, CBP officials stated that packages 

containing prescription drugs unapproved for import were released daily 

without FDA review. 

According to CBP and FDA officials at the carrier facilities we visited, 

packages containing prescription drugs sent through these facilities may 

also be released without inspection. Unlike packages at IMBs, packages 

arriving at carrier facilities we visited were preceded by advance manifest 

information, which included the shipper’s declaration describing the 

contents and its value. CBP and FDA officials review the manifest 

information to target packages for inspection before their arrival. Agency 

officials at two carrier facilities we visited told us that FDA officials were 

not typically on-site and electronically reviewed the manifests and 

targeted incoming packages declared as prescription drugs. FDA officials 

noted that packages containing prescription drugs could potentially avoid 

their review if the manifest information was not accurate. CBP and FDA 

officials told us there were no assurances that the shipper’s declarations 

were accurate. For example, CBP and FDA officials at the carrier facility 

found eight packages containing a human growth hormone—unapproved 

for import—that were inaccurately manifested as glassware. 

FDA officials said that some packages that were inspected and determined 

to contain prescription drugs at the IMBs were released because they 

could not process them. For example, at one IMB, CBP officials held 16 

bins containing roughly 3,000 packages for FDA investigators on a weekly 

Packages Not Targeted for 

Inspection and Released 

Packages Released after 

Inspection 
Page 11 GAO-04-839T 

basis. However, the FDA officials estimated that in one week, they could 

open and fully inspect about 140 packages. In making the decision 

regarding what to inspect, two FDA investigators considered whether the 

packages contained prescription drugs considered to be an enforcement 

priority, including injectable drugs and certain controlled substances, such 

as steroids. The FDA officials told us that they typically released packages 

that did not contain a priority drug, even though the packages were 

believed to contain other prescription drugs that were not approved for 

import. Figure 3 shows bins containing packages of suspected prescription 

drugs being held for FDA review and possible inspection. 

Figure 3: Bins Containing Packages of Suspected Prescription Drugs Being Held 

for FDA Review and Possible Inspection. 

Source: GAO with permission of CBP and FDA.
Page 12 GAO-04-839T 

At another IMB, CBP officials said that they usually released packages 

containing prescription drugs that appeared to be a 90-day supply or less—

in line with one of the criteria in FDA’s personal importation policy.12 For 

example, after viewing an x-ray image of a package, CBP performed a 

visual inspection of the outer container of a medication, labeled as a 

treatment for ulcers,13 determined that it appeared to contain 90 pills, and 

released it. At this same facility, FDA officials told us that every week CBP 

turned over to FDA hundreds of packages. CBP told us that these 

packages contained quantities of prescription drugs that appeared to be 

more than a 90-day supply. However, the FDA officials stated that they 

were able to process a total of approximately 20 packages per day. As a 

result, the FDA officials told us they returned many of the packages to 

CBP, citing an inability to process every package. The CBP officials said 

that most of the returned packages were released to the addressees. For 

example, CBP officials told us that several packages suspected of 

containing generic Viagra, unapproved for import, were returned by FDA 

and were released. 

FDA officials told us that for packages found to contain prescription 

drugs, processing requirements are time-consuming and can hamper their 

ability to process all of the packages that are detained by CBP. FDA 

processing requirements include identifying the drugs, measuring the 

volume, entering this information into a FDA database, taking pictures of 

the drugs, preparing the drugs for temporary storage, and sending 

notification to the addressees to provide evidence regarding the 

admissibility of the drug. Processing time varies depending on the quantity 

and variety of drugs in the package. 

In addition, processing time increases if research is required to determine 

the drug type. For example, FDA officials at one IMB stated that some 

prescription drugs are not immediately identifiable, particularly when 

shipped without labels or with labels in a foreign language. Figure 4 

illustrates an example of drugs that was sent without labeling. 

 12For a description of some of the other criteria in FDA’s personal importation policy, see 

note 3 and the accompanying text. 

13This medication was labeled as a Canadian drug, although it had a New Zealand return 

address. 

Officials Said Process 

Requirements Are 

Time-Consuming and 

Can Hamper 

Enforcement Effort 
Page 13 GAO-04-839T 

Figure 4: Drugs Sent without Labeling. 

FDA officials at the IMBs we visited stated that considering these many 

factors, processing a single package can take anywhere from a few 

minutes to several hours. FDA officials who are responsible for reviewing 

manifest information for drugs shipped through the private carriers stated 

that it can take several days to process a package, particularly if they need 

to obtain additional information regarding the shipment. 

FDA headquarters officials said that packages that contain prescription 

drugs that appear to be unapproved for import cannot be automatically 

refused and returned because of the statutory requirement that FDA hold 

the package and give the addressee the opportunity to provide evidence of 

admissibility. Officials said that this requirement applies to all drug 

imports with few exceptions. According to FDA investigators, in most 

instances, the addressees did not present evidence to support the drugs’ 

admissibility, and the drugs were ultimately provided to CBP or the U.S. 

Postal Service for return to sender. 

CBP officials at two IMBs told us that they could not turn over all 

packages they suspected of containing prescription drugs because FDA 

officials were not able to process all of the packages. FDA officials at one 

IMB stated that the processing time affected the number of packages they 

could inspect and was the reason many of the packages that were held up 

by CBP were ultimately released to the addressee without inspection. A 

FDA headquarters official stated that considerable storage space is needed 

to hold the detained packages, while the notice, opportunity to respond, 

and the agency’s decision are pending. For example, one FDA IMB official 

told us that space limitations have affected the number of packages they 

Source: FDA.
Page 14 GAO-04-839T 

are able to store, including those packages held on-site awaiting a 

response from the addressee. Figure 5 shows drugs stored at one IMB as 

they pass through FDA’s process, including those awaiting addressees’ 

responses. 

Figure 5: Drugs in Storage as They Pass through FDA’s Process at One IMB 

Processing requirements for controlled substances can also be 

burdensome if an IMB receives a high volume of controlled substances in 

the mail. According to CBP officials, the seizure process requires that CBP 

inspectors record the contents of each package—including the type of 

drugs and the number of pills or vials in each package—before it is turned 

over to seized property staff for possible investigation by Immigration and 

Customs Enforcement, forfeiture, and eventual destruction. CBP officials 

at one IMB told us that in recent months they have observed substantial 

increases in the volume of prescription drugs containing controlled 

substances being sent through the international mail because, in their 

view, of the increased incidence of consumers ordering drugs over the 

Internet. Although CBP officials had been seizing substantially more of 

these drugs in recent months, they had also accumulated a sizable backlog 

Source: FDA.
Page 15 GAO-04-839T 

of controlled substances awaiting seizure because, according to officials, 

they did not have the resources to begin the seizure process. By June 2004, 

CBP at this IMB had accumulated 123 bins of mail, containing over 40,700 

packages of Schedule IV controlled substances—including the tranquilizer 

Valium, antidepressants, and painkillers. Figure 6 shows some of the bins 

of controlled substances that were being held awaiting formal seizure, as 

of May 14, 2004. 

Figure 6: Controlled Substances Accumulated and Awaiting Seizure at One IMB 

According to CBP officials at this facility, as the controlled substances 

continued to accumulate, they became concerned that they would not be 

able resolve the backlog. In June, a CPB official said that CBP IMB 

officials asked CBP headquarters for permission to send the products back 

to the senders as an alternative to seizure, and to keep these drugs from 

entering U.S. commerce. According to this official, CBP’s headquarters 

office granted them permission to send most of the drugs back to the 

Source: GAO with permission of CBP and FDA.
Page 16 GAO-04-839T 

sender because the backlog would have taken months to resolve.14 One 

CBP official said that the ability to return the controlled substances 

enabled CBP to clear the backlog in two to three weeks rather than the 

one to two years they projected it would have taken had CBP been 

required to begin seizure proceedings for each item. Officials at the facility 

said that they are now seizing controlled substances as they arrive at the 

facility. 

Our preliminary work revealed a number of efforts, including interagency 

initiatives that are being undertaken in response to concerns raised about 

the importation of prescription drugs. For example, the Medicare 

Prescription Drug, Improvement, and Modernization Act of 2003 directed 

the Secretary of Health and Human Services, in consultation with 

appropriate government agencies, to conduct a study of the importation of 

drugs into the United States and submit a report to Congress (P.L. 108-

173). The conference report (House Report 108-391) enumerated questions 

to be addressed in this study including, among other things: 

• assessing the scope, volume, and safety of unapproved drugs, including 

controlled substances, entering the United States via mail shipment; 

and 

• estimating agency resources, including additional field personnel, 

needed to adequately inspect the current amount of pharmaceuticals 

entering the country. 

In February 2004, the Secretary of Health and Human Services appointed a 

task force, chaired by the Surgeon General, on drug importation. It 

included members representing the department, CBP, DEA, Department of 

Justice trial attorneys, and the Office of Management and Budget. Between 

March and May, the task force held public hearings to gather information 

to address the questions posed by Congress. According to an FDA official, 

as of July 2004, the task force staff was reviewing the testimony from the 

public hearings and the comments sent to the Federal Register docket to 

answer the questions posed in the conference report. The official said that 

the task force report is expected to be completed by this fall so that the 

 14According to a CBP official, most of the drugs returned were Schedule IV controlled 

substances. They said that a small number of the packages contained nonschedule 

prescription drugs that were referred to FDA. Also, CBP seized a small number of items 

that did not have a return address. 

Agency Efforts to 

Address the 

Importation of 

Prescription Drugs 

Are Evolving 
Page 17 GAO-04-839T 

Secretary of Health and Human Services can meet his December 2004 

deadline for reporting to Congress. 

In addition, a CBP official told us that CBP is leading an interagency 

pharmaceutical task force, established in January 2004 to address various 

law enforcement issues related to the importation of prescription drugs 

and miscellaneous pharmaceuticals. The task force, which includes 

managers and senior managers from CBP, FDA, DEA, the Office of 

National Drug Control Policy, U.S. Immigration and Customs 

Enforcement, as well as legal counsel from the Department of Justice and 

other agencies, meets every two months. According to the CBP official, the 

task force has established five interagency working groups designed to 

tackle specific issues identified by the task force. The working groups, 

which meet more frequently, are focused on improving information 

sharing and law enforcement targeting criteria, increasing public 

awareness of potential dangers of imported pharmaceuticals, reviewing 

and enhancing mail and express mail consignment procedures, working 

cooperatively with industry, and legal issues. The groups report the results 

of their enforcement efforts to the task force, which makes suggestions for 

future efforts. 

Our preliminary discussions with CBP about the activities of the working 

groups revealed initiatives currently under way by two of the groups. In 

one instance, the working group on mail and express mail consignment 

procedures has been involved in recent interagency enforcement 

operations at selected international mail facilities. During these 

operations, the interagency group targeted and found mail containing 

nonscheduled prescription drugs as well as controlled substances. 

According to the CBP official, these operations resulted in investigations 

of commercial shipments of the prescription drugs by agents from the task 

force and working group and helped the law enforcement agencies 

identify Internet addresses for purposes of future investigations. The CBP 

official told us that, in another instance, the working group focused on 

increasing public awareness of the potential dangers of imported 

pharmaceuticals had developed public service announcements that are to 

be posted on the Internet. Appendix III shows one of these 

announcements that was recently posted on the CBP web site. 

Individual agencies are also taking steps to enhance their ability to deal 

with inspection and interdiction issues associated with imported 

prescription drugs. As discussed earlier, during our visits to the three 

IMBs, we noted that CBP and FDA officials at those facilities had adopted 

different approaches for targeting and interdicting prescription drugs. FDA 
Page 18 GAO-04-839T 

headquarters officials also recognized this and in response indicated that a 

more uniform approach was needed. According to these officials, FDA has 

drafted a set of standard operating procedures that will apply to the 

handling of imported prescription drugs consistently across the 13 

International Mail Branches. FDA officials said that these procedures have 

been developed to apply to the handling of prescription drugs nationwide, 

but will also give officials at individual facilities some flexibility to adopt 

procedures that address uniquely local conditions. FDA headquarters 

officials told us they have begun implementing the procedures at selected 

IMBs and plan to implement them at more locations. FDA officials also 

said that they were developing a similar set of standard operating 

procedures that would apply to the inspection and interdiction of 

imported prescription drugs at the consignment carrier facilities. CBP 

officials told us that CBP expects that these guidelines will also discuss 

CBP responsibilities for handling imported prescription drugs. 

In closing, Mr. Chairman, it has been discussed in the media and elsewhere 

that American consumers are purchasing prescription drugs for 

importation in increasing numbers. Our preliminary observations indicate 

that CBP and FDA face considerable challenges inspecting and 

interdicting these drugs to help ensure compliance with current law. 

Currently data are unavailable to estimate the volume of prescription 

drugs entering the country, and the overall health and safety risks of these 

drugs are unknown. CBP and FDA are inspecting and interdicting some of 

the unapproved prescription drugs that are entering the country, but 

others bypass inspection and are sent to consumers who purchased them, 

often because, according to CBP and FDA officials, time-consuming 

processing requirements and staffing constraints limit their ability to 

perform more inspections. Although agencies like CBP, FDA, and DEA 

have begun initiatives to deal with various aspects of the drug importation 

issue, it is too early to tell whether these efforts will adequately address 

every dimension of the law enforcement and safety issues associated with 

the importation of prescription drugs. 

This concludes my prepared statement. In the next several weeks we plan 

to follow up with CBP and FDA officials on their plans to enhance their 

enforcement activities. I would be pleased to answer any questions you 

and the Subcommittee members may have. 
Page 19 GAO-04-839T 

For further information about this testimony, please contact Richard 

Stana, Director, Homeland Security and Justice Issues, on (202) 512-8777 

or at stanar@gao.gov. Major contributors to this testimony included 

John Mortin, Yelena Harden, Barbara Stolz, Frances Cook, and 

James Russell. 

GAO Contacts and 

Staff 

Acknowledgments 
Page 20 GAO-04-839T 

To understand importation restrictions and enforcement requirements, we 

reviewed current federal laws on the importation of prescription drugs 

and controlled substances. We reviewed current CBP and FDA policies, 

procedures, and guidance related to prescription drugs and controlled 

substance importation. We reviewed applicable importation and 

interdiction data from CBP and FDA. We conducted interviews with 

officials at CBP, FDA, U.S. Postal Service, U.S. Immigration and Customs 

Enforcement, and DEA. 

To understand inspection procedures, we visited three IMBs in Chicago, 

Los Angeles, and New York and two carrier facilities in Cincinnati (for the 

DHL Corporation) and in Memphis, (for the FedEx Corporation). We 

judgmentally selected these facilities based on the overall number of 

packages processed at the facilities and their geographic dispersion. At 

these locations, we observed inspection and interdiction practices; met 

with CBP and FDA management, inspectors, and investigators to discuss 

issues related to inspection, manifest reviews, and pharmaceutical 

importation volume; and reviewed relevant documents on inspection and 

interdiction procedures. At the IMBs we also met with officials from the 

U.S. Postal Service regarding mail handling and processing procedures. 

We did the work reflected in this statement from March to July 2004 in 

accordance with generally accepted government auditing standards. 

Appendix I: Scope And Methodology 
Page 21 GAO-04-839T 

The drugs and drug products that come under the Controlled Substances 

Act are divided into five schedules. A general description and examples of 

the substances in each schedule are outlined below in table 1. 

Table 1: General Description of Controlled Substance Schedules I-V 

Schedule Description of substances in the schedule Examples 

I Substances that have no accepted medical use in the United 

States and have a high potential for abuse. 

Heroin, lysergic acid diethylamide (LSD), marijuana, 

and gama hydroxybutyric acid (GHB) 

II Substances that have a high potential for abuse with severe 

psychic or physical dependence liability—certain narcotic, 

stimulant, and depressant drugs. 

Opium, morphine, codeine, methadone, and 

meperidine (Demerol) 

III Substances that have a potential for abuse that is less than those 

in Schedules I and II and include compounds containing limited 

quantities of certain narcotic drugs and non-narcotic drugs. 

Anabolic steroids; derivatives of babituric acid 

(except those listed in another schedule); 

benzphetamine; and any compound, mixture, 

preparation or suppository dosage form containing 

amobarbital, secobarbital, or pentobarbital 

IV Substances that have a potential for abuse that is less than those 

listed in Schedule III. 

Barbital, alprazolam (Xanax), Cathine— constituent 

of the “Khat” plant, and Diazepam (Valium) 

V Substances that have a potential for abuse that is less than those 

listed in Schedule IV and consist primarily of preparations 

containing limited quantities of certain narcotic and stimulant 

drugs. 

Pyrovalerone (Centroton, Thymergix) 

Source: GAO analysis of Drug Enforcement Administration information 

Note: Schedule I substances are not the subject of this report. 

Appendix II: General Description of the 

Controlled Substance Schedules I-V 
Page 22 GAO-04-839T 

Appendix III: CBP Public Service 

Announcement Posted on the Internet 

(440331) 
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