Prescription Drugs: Preliminary Observations on Efforts to Enforce the Prohibitions on Personal Importation
Published: 2004-07-22T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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 time-consuming 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.

section_title: Letter
paragraphs: 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, 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  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.
subsections: section_title: Background
paragraphs: 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.
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. 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  drug not available domestically. 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.
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. 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. CBP is to turn over  packages suspected of containing prescription drugs that are not  controlled substances to FDA. 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. 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.
section_title: Volume of Prescription Drug Imports Is Said to be Large and Increasing, and the Health and Safety of these Drug Imports is Not Assured
paragraphs: 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. 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  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.
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. 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  U.S. market because, for example, the labeling 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 temperature- controlled 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.
section_title: Some Packages Containing Prescription Drugs Are Interdicted, but Others Are Released
paragraphs: 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  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.
subsections: section_title: Packages Not Targeted for Inspection and Released
paragraphs: 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.
section_title: Packages Released after Inspection
paragraphs: 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  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.
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. 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, 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.
section_title: Officials Said Process Requirements Are Time-Consuming and Can Hamper Enforcement Effort
paragraphs: 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.
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  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.
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  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.
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  sender because the backlog would have taken months to resolve. 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.
section_title: Agency Efforts to Address the Importation of Prescription Drugs Are Evolving
paragraphs: 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  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  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.
section_title: GAO Contacts and Staff Acknowledgments
paragraphs: 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.
section_title: Appendix I: Scope And Methodology
paragraphs: 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.
section_title: Appendix II: General Description of the Controlled Substance Schedules I-V
paragraphs: 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.
section_title: Appendix III: CBP Public Service Announcement Posted on the Internet
paragraphs: This is a work of the U.S. government and is not subject to copyright protection in the  United States. It may be reproduced and distributed in its entirety without further  permission from GAO. However, because this work may contain copyrighted images or  other material, permission from the copyright holder may be necessary if you wish to  reproduce this material separately.