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36 Cal. W. Int'l L.J. 77 (2005-2006)
Drug Quality, Safety Issues and Threats of Drug Importation

handle is hein.journals/calwi36 and id is 85 raw text is: DRUG QUALITY, SAFETY ISSUES AND THREATS

OF DRUG IMPORTATION
MARV SHEPHERD, PH.D.*
ABSTRACT
Until the last decade, the U.S. Food and Drug Administration
(FDA) had tight control over drug importation; principally, drug
manufacturers were the only entities which could legally import
pharmaceuticals. However, in the last ten years, the FDA's tight con-
trol has weakened. The number of U.S. residents who personally im-
port prescription medications has increased dramatically. For exam-
ple, in 2004, over two million U.S. residents purchased over twelve
million prescriptions from Canada alone. The number of prescriptions
purchased from other countries is unknown, but it is estimated that
Americans buy $800 million in drugs from Mexico. Additionally,
drug products are entering the United States from across the globe.
Drug importation not only affects the economy; importation presents
serious drug safety issues for the public. One problem is that some
pharmacy Web sites where individuals obtain their prescription drugs
are rogue, fraudulent sites, with many selling substandard, counterfeit
drug products. Furthermore, many pharmacy Web sites do not require
a prescription and thus some sites are shipping a plethora of narcotic
and non-narcotic drugs to Americans. Thus, medical supervision by
licensed health care practitioners is missing. Some imported products
are of poor quality and are counterfeit. The imported drugs have no
active ingredients, wrong active ingredients, or are poorly labeled and
packaged. However, some imported drug products are FDA-approved
and are the same quality as products from U.S. pharmacies. The prob-
lem is distinguishing the good products from the substandard prod-
ucts. However, documentation of the adverse effects from imported,
Director, Center for Pharmacoeconomic Studies, College of Pharmacy, University of
Texas, Austin, Texas 78712. Email: marvshepherd@mail.utexas.edu.

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