Objectives: This study is to examine the public health implications associated with personal imports of medicines via internet brokers.
Methods: Unapproved but popular medicines were purchased via the internet through internet brokers. Their visual features, authenticity, approval status in the countries where they were manufactured, package inserts and Japanese leaflets, site information, custom declarations, and contents of active ingredients were examined.
Results and consideration: 166 samples of PROZAC®, POSTINOR® and Nootropil®/ Nootropyl® and their generic versions were purchased in 2007 from 27 overseas distributors via 66 internet brokers. Same-brand products show multiple manufacturing/marketing countries and packages. They contained 85-118% of the labeled contents of active ingredients. Four samples claiming to be PROZAC in unlabeled generic containers were packaged without authorization. Piracetam sent from US as a dietary supplement had been excluded from its definition under 21 U.S.C. 321(ff)(3)(B) Prescriptions were never required. Only 72% of products contained a package insert, all of which were in foreign languages, such as English, French, Spanish, Thai or Chinese. Among branded products, 33% contained anonymous Japanese leaflets which were not translations of the original inserts. In violation of the Pharmaceutical Affairs Law, 65 brokers showed brand names and effectiveness of unapproved products on their sites, while two distributors dispatched the unapproved medicines domestically. Product origins, inclusion of Japanese leaflets, subdivision of packages, and customs declaration varied, depending on the distributors.
Purchase of medicines via internet brokers has various negative public health implications. International distributors play a key role in the situation.

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