    Internet Pharmacies: Some Pose Safety Risks for Consumers
    (17-JUN-04, GAO-04-820).

    As the demand for and the cost of prescription drugs rise, many
    consumers have turned to the Internet to purchase drugs. However,
    the global nature of the Internet can hinder state and federal
    efforts to identify and regulate Internet pharmacies to help
    assure the safety and efficacy of products sold. Recent reports
    of unapproved and counterfeit drugs sold over the Internet have
    raised further concerns. GAO was asked to examine (1) the extent
    to which certain drugs can be purchased over the Internet without
    a prescription; (2) whether the drugs are handled properly,
    approved by the Food and Drug Administration (FDA), and
    authentic; and (3) the extent to which Internet pharmacies are
    reliable in their business practices. GAO attempted to purchase
    up to 10 samples of 13 different drugs, each from a different
    pharmacy Web site, including sites in the United States, Canada,
    and other foreign countries. GAO determined whether the samples
    contained a pharmacy label with patient instructions for use and
    warnings on the labels or the packaging and forwarded the samples
    to their manufacturers to determine whether they were approved by
    FDA and authentic. GAO also confirmed the locations of several
    Internet pharmacies and identified those under investigation by
    regulatory agencies.
    -------------------------Indexing Terms-------------------------
    REPORTNUM:   GAO-04-820
        ACCNO:   A10540
      TITLE:     Internet Pharmacies: Some Pose Safety Risks for Consumers
         DATE:   06/17/2004
      SUBJECT:   Drugs
    	     Internet
    	     Investigations by federal agencies
    	     Labeling law
    	     Safety regulation
    	     Safety standards
    	     Testing

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    GAO-04-820

    United States General Accounting Office

    GAO	Report to the Chairman, Permanent Subcommittee on Investigations,

                     Committee on Governmental Affairs, U.S. Senate

    June 2004

    INTERNET PHARMACIES

                          Some Pose Safety Risks for Consumers

                                           a

    GAO-04-820

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

    As the demand for and the cost of prescription drugs rise, many consumers
    have turned to the Internet to purchase drugs. However, the global nature
    of the Internet can hinder state and federal efforts to identify and
    regulate Internet pharmacies to help assure the safety and efficacy of
    products sold. Recent reports of unapproved and counterfeit drugs sold
    over the Internet have raised further concerns.

    GAO was asked to examine (1) the extent to which certain drugs can be
    purchased over the Internet without a prescription; (2) whether the drugs
    are handled properly, approved by the Food and Drug Administration (FDA),
    and authentic; and (3) the extent to which Internet pharmacies are
    reliable in their business practices. GAO attempted to purchase up to 10
    samples of 13 different drugs, each from a different pharmacy Web site,
    including sites in the United States, Canada, and other foreign countries.
    GAO determined whether the samples contained a pharmacy label with patient
    instructions for use and warnings on the labels or the packaging and
    forwarded the samples to their manufacturers to determine whether they
    were approved by FDA and authentic. GAO also confirmed the locations of
    several Internet pharmacies and identified those under investigation by
    regulatory agencies.

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

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

    June 2004

    INTERNET PHARMACIES

    Some Pose Safety Risks for Consumers

    GAO obtained most of the prescription drugs it targeted from a variety of
    Internet pharmacy Web sites without providing a prescription. GAO obtained
    68 samples of 11 different drugs-each from a different pharmacy Web site
    in the United States, Canada, or other foreign countries, including
    Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain,
    Thailand, and Turkey. Five U.S. and all 18 Canadian pharmacy sites from
    which GAO received samples required a patient-provided prescription,
    whereas the remaining 24 U.S. and all 21 foreign pharmacy sites outside of
    Canada provided a prescription based on their own medical questionnaire or
    had no prescription requirement. Among the drugs GAO obtained without a
    prescription were those with special safety restrictions and highly
    addictive narcotic painkillers.

    GAO identified several problems associated with the handling, FDA approval
    status, and authenticity of the 21 samples received from Internet
    pharmacies located in foreign countries outside of Canada. Fewer problems
    were identified among pharmacies in Canada and the United States. None of
    the foreign pharmacies outside of Canada included required dispensing
    pharmacy labels that provided instructions for use, few included warning
    information, and 13 displayed other problems associated with the handling
    of the drugs. For example, 3 samples of a drug that should be shipped in a
    temperature-controlled environment arrived in envelopes without
    insulation. Manufacturer testing revealed that most of these drug samples
    were unapproved for the U.S. market; however, manufacturers found the
    chemical composition of all but 4 was comparable to the product GAO
    ordered. Four samples were determined to be counterfeit products or
    otherwise not comparable to the product GAO ordered. Similar to the
    samples received from other foreign pharmacies, manufacturers found most
    of those from Canada to be unapproved for the U.S. market; however,
    manufacturers determined that the chemical composition of all drug samples
    obtained from Canada were comparable to the product GAO ordered.

    Some Internet pharmacies were not reliable in their business practices.
    Most instances identified involved pharmacies outside of the United States
    and Canada. GAO did not receive six orders for which it had paid. In
    addition, GAO found questionable entities located at the return addresses
    on the packaging of several samples, such as private residences. Finally,
    14 of the 68 pharmacy Web sites from which GAO obtained samples were found
    to be under investigation by regulatory agencies for reasons including
    selling counterfeit drugs and providing prescription drugs where no valid
    doctorpatient relationship exists. Nine of these were U.S. sites, 1 a
    Canadian site, and 4 were other foreign Internet pharmacy sites.

    In commenting on a draft of this report, FDA generally agreed with its
    findings and conclusions.

    Contents

      Letter

    Results In Brief
    Background
    Most of the Targeted Prescription Drugs Were Purchased from

    Multiple Internet Pharmacies Without Providing a Prescription Most
    Problems Identified among Drug Samples Received fromOther Foreign Internet
    Pharmacies Some Internet Pharmacies Were Not Reliable in Their Business

    Practices Concluding Observations Agency and External Comments

    1 5 8

    11

    14

    21 23 23

    Appendixes
                   Appendix I: Comments from the Food And Drug Administration  26
                  Appendix II:      GAO Contact and Staff Acknowledgments      29
                                                 GAO Contact                   29
                                               Acknowledgments                 29
                                  Table 1: Prescription Drugs Selected for
         Tables                            Purchase from Internet
                                                 Pharmacies                     3
                                   Table 2: Prescription Drugs Ordered and
                                           Received from Internet
                                                 Pharmacies                    11
                                    Table 3: Prescription Requirements of
                                          Pharmacies from which We
                                              Obtained Samples                 13
                                Table 4: Problems Observed Among Prescription
                                                Drug Samples
                                                  Received                     15
        Figures                  Figure 1: Drug Sample Received Without Any
                                          Warnings or Instructions             16
                                 Figure 2: Drug Sample Received Without Any
                                               Instructions in
                                                   English                     17
                                  Figure 3: Drug Sample Shipped Improperly     18
                                      Figure 4: Drug Samples Shipped in        19
                                          Unconventional Packaging
                                  Figure 5: Drug Sample Received in Damaged    20
                                                  Packaging

    Contents

    Abbreviations

    DEA Drug Enforcement Administration
    FDA Food and Drug Administration
    FDCA Federal Food, Drug, and Cosmetic Act
    NABP National Association of Boards of Pharmacy
    VIPPS Verified Internet Pharmacy Practice Sites

    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.

    A

    United States General Accounting Office Washington, D.C. 20548

    June 17, 2004

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

    Dear Mr. Chairman:

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

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

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

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

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

    You asked us to assess:

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

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

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

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

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

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

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

    Table 1: Prescription Drugs Selected for Purchase from Internet Pharmacies

    Prescription drug Condition treated Remarks

                         Accutane(R)             Acne          Has special safety
                                                                    restrictionsa
                         Celebrex(R)        Arthritis                          --
                         Clozaril(R)    Schizophrenia          Has special safety
                                                                    restrictionsa
                         Combivir(R)              HIV                          --
                         Crixivan(R)              HIV                          --
                           Epogen(R)           Anemia        Has special handling
                                                                     requirements
                        Humulin(R) N         Diabetes        Has special handling
                                                                     requirements
                          Lipitor(R) High cholesterol                          --
                        OxyContin(R)             Pain      Schedule II controlled
                                                              substance, narcotic
                         Percocet(R)             Pain      Schedule II controlled
                                                              substance, narcotic
                           Viagra(R)      Male sexual                          --
                                          dysfunction
                                                 Pain     Schedule III controlled
              Vicodin(R)/hydrocodone                                   substance,
                                                                         narcotic

    Zoloft(R) Depression

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

    aDue 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.

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

    6 We determined the location of Internet pharmacies from which we received
    drug samples based on information contained in the pharmacy Web sites and
    the return addresses and postmarks on the packages we received. Throughout
    this report, we refer to Internet pharmacies from countries other than the
    United States or Canada as "other foreign Internet pharmacies."

    providers of prescription drugs.7 To identify the Internet pharmacies, we
    relied upon a list of Internet pharmacy Web sites compiled by a private
    consultant and provided to us by FDA; used Internet search engines,
    including Google, Yahoo, and Excite; and joined Internet pharmacy
    members-only Web sites, which provide enrolled members with lists of Web
    sites selling various prescription drugs. Because the universe of Internet
    pharmacies is not known, and because we obtained only one drug sample8
    from each pharmacy, our findings cannot be generalized.

    To assess whether the drug samples we received were handled properly, we
    identified whether the samples contained a pharmacy label9 with patient
    instructions for use and whether warnings were included on the labels or
    along with the packaging. We define handling as the manner in which
    Internet pharmacies labeled, packaged, and shipped the prescription drug
    samples we received. In addition, we made other observations about the
    manner in which the drugs were handled and the condition of the
    packaging.10 To assess whether the drug samples we received were
    FDAapproved and authentic products, we forwarded the samples to
    manufacturers of the drugs that we ordered to make these determinations11
    and identify any other safety concerns associated with the drugs or their

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

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

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

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

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

    handling.12 Where manufacturers commented on the adequacy of patient
    instructions for use or warnings, we relied upon their assessments rather
    than our own judgment. We did not disclose to the manufacturers
    information concerning the source of the drug samples we purchased,
    including whether the pharmacy purported to be located in the United
    States, Canada, or in another foreign country.

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

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

    Results In Brief	We were able to obtain the majority of prescription drugs
    we targeted for purchase from a wide variety of domestic and foreign
    Internet pharmacies without providing a prescription. We obtained a total
    of 68 drug samples- each from a different pharmacy in the United States,
    Canada, or other foreign countries-representing 11 of the 13 drugs we
    targeted for purchase.13 Drug samples received from other foreign
    pharmacies came from Argentina, Costa Rica, Fiji, India, Mexico, Pakistan,
    Philippines, Spain, Thailand, and Turkey. The samples included drugs with
    special

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

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

    safety restrictions and addictive narcotic painkillers. Among the Internet
    pharmacies from which we obtained drugs, 5 U.S. and all 18 Canadian
    pharmacies required the patient to provide a prescription, whereas the
    remaining 24 U.S. and all 21 other foreign Internet pharmacies issued
    prescriptions based on their own medical questionnaires or had no
    prescription requirements. The availability and ease with which the drugs
    could be purchased varied by drug type. Top selling drugs such as
    Celebrex, Lipitor, Viagra, and Zoloft were readily available from multiple
    Internet pharmacies. Other drugs, such as those with special safety
    restrictions-Accutane and Clozaril-and narcotic painkillers-Percocet,
    OxyContin, and Vicodin-were offered for sale by fewer Internet pharmacies
    or were otherwise more difficult to obtain.

    We identified several problems associated with the handling, FDA-approval
    status, and authenticity of the 21 drug samples received from other
    foreign Internet pharmacies, but fewer problems among the U.S. and
    Canadian Internet pharmacies. None of the 21 samples from other foreign
    pharmacies included dispensing pharmacy labels that provided instructions
    for use, and only about one-third included warning information. Thirteen
    of the 21 samples displayed other problems associated with the handling of
    the drugs. For example, 3 samples of a drug that should be shipped in a
    temperature-controlled environment arrived in envelopes without
    insulation, and 5 samples contained tablets enclosed in punctured blister
    packs, potentially exposing the tablets to damaging light or moisture.
    Finally, manufacturers reported that most of the drug samples from other
    foreign pharmacies (19 of 21 samples) were unapproved for the U.S. market
    because, for example, the labeling14 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

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

    ingredient, and 2 samples had a significantly different chemical
    composition than that of the product we had ordered.15 In contrast, all 47
    of the drug samples we received from U.S. and Canadian Internet pharmacies
    included dispensing pharmacy labels that generally provided patient
    instructions for use, 41 included warning information, and none displayed
    evidence of mishandling. Like the samples received from other foreign
    pharmacies, most of those from Canada were also unapproved for the U.S.
    market; however, manufacturers determined that the chemical composition of
    all were comparable to the product we had ordered. Finally, manufacturer
    testing identified 1 sample from a U.S. pharmacy that was inappropriately
    removed from the sealed manufacturer container and dispensed in a pharmacy
    bottle.

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

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

    15 Under federal law, counterfeit drugs include those sold under a product
    name without proper authorization, which falsely purport or are
    represented to be a particular product. See 21 U.S.C. S: 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.

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

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

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

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

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

    The FDCA requires that drugs be dispensed with labels that include the
    name of the prescriber, directions for use, and cautionary statements,
    among other things. A drug is considered misbranded if its labeling or
    container is misleading, or if the label fails to include required
    information. Prescription drugs dispensed without a prescription are also
    considered misbranded. In addition, if a drug is susceptible to
    deterioration and must, for example, be maintained in a
    temperature-controlled environment, it must be packaged and labeled in
    accordance with regulations and manufacturer standards. Drugs must also be
    handled to prevent adulteration, which may occur, for example, if held
    under unsanitary conditions leading to possible contamination.

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

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

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

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

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

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

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

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

    We were able to obtain the majority of prescription drugs we targeted for
    purchase from a wide variety of domestic and foreign Internet pharmacies
    without providing a prescription. Five U.S. and all 18 Canadian pharmacies
    from which we obtained drug samples required a patient-provided
    prescription, whereas the remaining 24 U.S. and all 21 other foreign
    pharmacies from which we obtained samples either provided a prescription
    based on an online medical questionnaire or had no prescription
    requirement. Although we obtained samples of most of the drugs we targeted
    for purchase, some drugs, such as those with special safety restrictions
    and narcotics, were available from fewer sources or were more difficult to
    obtain.

        Samples of 11 of 13 Targeted Drugs Obtained from Internet Pharmacies

    We obtained 1 or more samples of 11 of the 13 drugs we targeted, both with
    and without a patient-provided prescription. In total, we placed 90
    orders-each with a different Internet pharmacy in the United States,
    Canada, and other foreign countries-and received 68 samples. Drug samples
    we received from other foreign pharmacies came from Argentina, Costa Rica,
    Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey.
    Most of the drugs-45 of 68-were obtained without a patientprovided
    prescription. These included drugs for which physician supervision is of
    particular importance due to the possibility of severe side effects, such
    as Accutane, or the high potential for abuse and addiction, such as the
    narcotic painkiller hydrocodone. (See table 2.)

    Table 2: Prescription Drugs Ordered and Received from Internet Pharmacies

                                      Drug ordered

    Orders placeda

    Drug samples receivedb

             Drug samples obtained without a prescription provided by the patient

                          Accutane       10              6c
                          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

    (Continued From Previous Page)

    Orders placeda

    Drug samples receivedb

             Drug samples obtained without a prescription provided by the patient

    Drug ordered

                                     Percocet        0                          0
                                       Viagra        10                         9
                          Vicodin/hydrocodone        10                      9c,d
                                       Zoloft        10                         9
                                        Total        90                        68

    Source: GAO.

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

    aDoes 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.

    bWe 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.

    cIncludes one sample we could not link to an order we placed.

    dAlthough 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
    patientprovided prescription, prescription requirements varied. Five U.S.
    and all 18 Canadian pharmacies from which we obtained drug samples
    required the patient to provide a prescription. The remaining 24 U.S.
    pharmacies generally provided a prescription based on a general medical
    questionnaire filled out online by the patient. Questionnaires requested
    information on the patient's physical characteristics, medical history,
    and condition for which drugs were being purchased. Several pharmacy Web
    sites indicated that a U.S.-licensed physician reviews the completed
    questionnaire and issues a prescription. The other foreign Internet
    pharmacies we ordered from generally had no prescription requirements, and
    many did not seek information regarding the patient's medical history or
    condition. The process for obtaining a drug from many of these pharmacies
    involved only selecting the desired medication and submitting the
    necessary billing and shipping information. (See table 3.)

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

                                Prescription requirement

    U.S. Internet pharmacies

                   Canadian Internet pharmacies Other foreign Internet pharmacies

                          Prescription from patient's
                           physician must be provided       5                  18
                       Web site provides prescription
                               based on questionnaire      24                   0
                             No prescription required       0                   0
                                         Source: GAO.

        The Availability and Ease of Purchase Varied by Drug

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

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

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

    requirements prevented it from dispensing the drug to patients outside of
    Canada.

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

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

    We identified several problems associated with the handling, FDA-approval
    status, and authenticity of the 21 drug samples we received from other
    foreign Internet pharmacies. None included required pharmacy labels that
    provided patient instructions for use, and few provided warning
    information. Thirteen were shipped improperly, were packaged
    unconventionally, or arrived damaged. Manufacturers reported that most of
    the samples they reviewed at our request from other foreign pharmacies
    were not approved by FDA for the United States-although most had a
    comparable chemical composition to the product we ordered-and 4 were
    either counterfeit products or otherwise not comparable to the product we
    ordered. While most of the samples received from Canadian Internet
    pharmacies were unapproved for the U.S. market, they otherwise had a
    comparable chemical composition, and the samples from U.S. and Canadian
    pharmacies exhibited few problems otherwise. Table 4 summarizes the
    problems we identified among the 68 samples we received.

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

          Table 4: Problems Observed Among Prescription Drug Samples Received

              No pharmacy                                                          Counterfeit
                                                                                            or
               label with             Improperly                          Not        otherwise
                                                                          approved         not
             instructions No warning  shipped or Unconventional   Damaged for U.S.  comparable
                                                                                            to
    Pharmacy      for use information  dispensed      packaging packaging   market     product
                                                                                       ordered
    location              (21         (4                        (5        (35
             (23 samples) samples)    samples)      (6 samples) samples)  samples) (4 samples)

    Canadian              Celebrex (2)                            Accutane (3)
                                    Zoloft (2)                       Combivir (3)
                                                                     Crixivan (3)
                                                                    Humulin N (1)
                                                                      Lipitor (2)
                                                                       Viagra (1)
                                                                       Zoloft (3)

    Other   Accutane Accutane  Humulin  Accutane  Accutane Accutane   Accutane
                    (3) (2)       N (3)       (1)    (2)         (2)          (1)
      foreign  Celebrex Celebrex            Celebrex Celebrex Celebrex  OxyContin
                    (3) (3)                      (1) (1)         (3)          (1)
               Combivir  Crixivan           Crixivan Crixivan Combivir     Viagra
                    (1)       (2)                (2)      (1)    (1)          (2)
               Crixivan   Lipitor          OxyContin  Lipitor Crixivan
                    (2)       (3)             (1)         (1)    (1)
              Humulin N OxyContin             Viagra          Humulin N
                    (3) (1)                      (1)          (3)
                Lipitor    Viagra                               Lipitor
                    (3)       (2)                                   (3)
              OxyContin    Zoloft                             OxyContin
                    (1)       (2)                             (1)
                 Viagra                                          Viagra
                    (2)                                             (2)
                 Zoloft                                          Zoloft
                    (3)                                             (3)
    U.S.    Celebrex   Lipitor Crixivan
                    (1)       (1)   (1)
                 Zoloft    Zoloft
                    (1)       (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.

        All Drug Samples Received from Other Foreign Pharmacies Exhibited Problems
        Associated with Their Handling

    None of the 21 prescription drug samples we received from other foreign
    Internet pharmacies included a dispensing pharmacy label that provided
    patient instructions for use, and only 6 of the samples came with warning
    information.25 Lack of instructions and warnings on these drugs leaves
    consumers who take them at risk for potentially dangerous drug
    interactions or side effects from incorrect or inappropriate use. For
    example, we received 2 samples purporting to be Viagra, a drug used to
    treat male sexual dysfunction, without any warnings or instructions for
    use. (See fig. 1.) According to its manufacturer, this drug should not be

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

    prescribed for individuals who are currently taking certain heart
    medications, as it can lower blood pressure to dangerous levels.
    Additionally, 2 samples of Roaccutan, a foreign version of Accutane,
    arrived without any instructions in English. (See fig. 2.) As noted,
    possible side effects of this drug include birth defects and severe mental
    disturbances. Compounding the concerns regarding the lack of warnings and
    patient instructions for use, none of the other foreign pharmacies ensured
    patients were under the care of a physician by requiring that a
    prescription be submitted before the order is filled.

    Figure 1: Drug Sample Received Without Any Warnings or Instructions

    Source: GAO.

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

    Figure 2: Drug Sample Received Without Any Instructions in English

    Source: GAO.

    Note: Sample of Roaccutan(R), a foreign version of Accutane(R), 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,
    three samples of Humulin N were not shipped in accordance with
    manufacturer handling specifications. Despite the requirement that this
    drug be stored under temperature-controlled and insulated conditions, the
    samples we received were shipped in envelopes without insulation. (See
    fig. 3.) Similarly, 6 samples of other drugs were shipped in
    unconventional packaging, in some instances with the apparent intention of
    concealing the actual contents of the package. For example, the sample
    purporting to be OxyContin was shipped in a plastic compact disc case
    wrapped in brown packing tape-no other labels or instructions were
    included, and a sample of Crixivan was shipped inside a sealed aluminum
    can enclosed in a box labeled "Gold Dye and Stain Remover Wax." (See fig.
    4.) Additionally, 5

    samples we received were damaged and included tablets that arrived in
    punctured blister packs, potentially exposing pills to damaging light or
    moisture. (See fig. 5.) One drug manufacturer noted that damaged packaging
    may also compromise the validity of drug expiration dates.

    Figure 3: Drug Sample Shipped Improperly

    Source: GAO.

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

    Figure 4: Drug Samples Shipped in Unconventional Packaging

    Source: GAO.

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

    Source: GAO.

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

    Figure 5: Drug Sample Received in Damaged Packaging

    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.26 For example, the manufacturer
    of one drug noted that 2 samples we received of that drug were packaged
    under an alternate name used for the Mexican market. The manufacturer of
    another drug found that 3 samples we received of that drug were
    manufactured at a facility unapproved to produce drugs for the U.S.
    market. In all but 4 instances, however, manufacturers determined that the
    chemical composition of the samples we received from other foreign
    Internet pharmacies was comparable to the chemical composition

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

                                      Source: GAO.

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

        Most Drug Samples Received from Other Foreign Pharmacies Were Unapproved,
        Four Were Not Authentic

    of the drugs we had ordered. Two samples of one drug were found by the
    manufacturer to be counterfeit and contained a different chemical
    composition than the drug we had ordered. In both instances the
    manufacturer reported that samples had less quantity of the active
    ingredient, and the safety and efficacy of the samples could not be
    determined. Manufacturers also found 2 additional samples to have a
    significantly different chemical composition than that of the product we
    had ordered.

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

    All 47 of the prescription drug samples we received from Canadian and U.S.
    Internet pharmacies included labels from the dispensing pharmacy that
    generally provided patient instructions for use and 87 percent of these
    samples (41 of 47) included warning information. Furthermore, all samples
    were shipped in accordance with special handling requirements, where
    applicable, and arrived undamaged. Manufacturers reported that 16 of the
    18 samples from Canadian Internet pharmacies were unapproved for sale in
    the United States, citing for example unapproved labeling and packaging.
    However, the samples were all found to be comparable in chemical
    composition to the products we ordered. Finally, the manufacturer found
    that 1 sample of a moisture-sensitive medication from a U.S. pharmacy was
    inappropriately removed from the sealed manufacturer container and
    dispensed in a pharmacy bottle.

    Some Internet We observed questionable characteristics and business
    practices of some

    of the Internet pharmacies from which we received drugs. Most, but
    notPharmacies Were Not all, involved other foreign pharmacies. These
    included pharmacies that Reliable in Their accepted payment but did not
    provide the drugs ordered, shipments of Business Practices drugs with
    questionable return addresses, pharmacies that obscured

    details about the drugs sold, and pharmacies that were under investigation

    by regulatory agencies.

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

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

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

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

    28We 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.

    About 21 percent of the Internet pharmacies from which we received drugs
    (14 of 68) were under investigation by regulatory agencies. The reasons
    for the investigations by DEA and FDA include allegations of selling
    controlled substances without a prescription; selling adulterated,
    misbranded, or counterfeit drugs; selling prescription drugs where no
    doctor-patient relationship exists; smuggling; and mail fraud. The
    pharmacies under investigation were concentrated among the U.S. pharmacies
    that did not require a patient-provided prescription (9) and other foreign
    (4) pharmacies. One Canadian pharmacy was also included among those under
    investigation.

    Concluding	Consumers can readily obtain many prescription drugs over the
    Internet without providing a prescription-particularly from certain U.S.
    and

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

    Agency and External	In commenting on a draft of this report, FDA generally
    agreed with our findings and conclusions and made suggestions to clarify
    or expand upon

    Comments	its contents (see app. II). FDA commented that, while the draft
    report noted Internet pharmacy Web sites purported or appeared to be from
    various countries, the draft did not demonstrate that the drug samples we
    received were actually sent from those countries, such as by discussing

    return addresses and postmarks on the samples. FDA suggested we indicate
    the methods we used to determine the samples' origins. We modified the
    report to indicate that we determined the location of the Internet
    pharmacy Web sites from which we received drug samples based on
    information contained in the pharmacy Web sites and the return addresses
    and postmarks on the packages we received. FDA also commented that our
    finding that certain unapproved drugs were chemically equivalent to the
    brand name products we ordered was misleading. FDA noted that chemical
    equivalence testing may not always determine whether a drug is comparable
    in all respects to the FDAapproved drug and therefore fully
    therapeutically equivalent. We relied on manufacturers to determine
    whether the drug samples we received were comparable to their own
    FDA-approved brand name version of the drug, and manufacturers conducted a
    range of tests to make this determination. Nevertheless we modified the
    final report to note the potential limitations to chemical equivalence
    testing. FDA also made several observations about the practices of
    Internet pharmacies and provided technical comments, which we incorporated
    where appropriate.

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

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

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

    Please call Marcia Crosse at (202) 512-7119 or Robert Cramer at (202)
    5127455 if you have any questions. Another contact and other major
    contributors are listed in appendix I.

    Sincerely yours,

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

    Robert J. Cramer Managing Director, Office of Special Investigations

    Appendix I

    Comments from the Food And Drug Administration

    Appendix I
    Comments from the Food And Drug
    Administration

    Appendix I
    Comments from the Food And Drug
    Administration

    Appendix II

                         GAO Contact and Staff Acknowledgments

    GAO Contact Randy M. DiRosa, (312) 220-7671

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

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