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. 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. 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. 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.