January 2009

Treatment for Inferior Medicine

The total of 90 cases have been received by the KPA¡¯s reporting centre for impure/inferior drugs: 40 cases of destroyed drugs, 19 cases of insufficient amount, 4 cases of finding impurities and 8 cases of deterioration. As this has been reported by pharmacies, it is anticipated more inferior drugs are in distribution.

In order to distribute safe drugs, KPA came up with guidance to receive reporting on inferior drugs for extermination of such goods.

The guidance requires replying to the reporter within 20 days of reporting date when information regarding the cases of distribution of illegal drugs, inferior packaging, mixed with impurities and drugs that are closed to/already expired after checking whether it violated the pharmacist law. Also, if violation is confirmed, a request for special observation at a corresponding jurisdiction¡¯s FDA. If not violated, adjustment would be required to the corresponding pharmaceutical company.

As scope for illegal/inferior drugs, standard for treatment and detailed provisions of different cases are presented, the guidance will establish order for safe drug distribution.