BFAD ADMINISTRATIVE ORDER NO. 1, S. 2000

: The main purpose is to ban and withdraw all drug products containing Trovafloxacin (Trovan) from the Philippine market due to safety concerns, especially serious hepatic events.
: It was adopted on January 3, 2000.
: The World Health Organization released information about the risks posed by Trovafloxacin, including serious and unpredictable hepatic events, some leading to death or requiring liver transplantation.
: The order mandates that all drug products containing Trovafloxacin shall no longer be registrable, and the registration of all such products is recalled and cancelled.
: The National Drug Committee (NDC) of the Department of Health recommended the ban.
: All stocks must be withdrawn immediately from all drug distribution channels.
: The withdrawal is based on new scientific information concerning the drug’s safety and the risk it poses to consumer health.
: While this specific order focuses on banning and withdrawal, non-compliance generally may lead to sanctions under the Food, Drug, and Cosmetic Act and related implementing rules and regulations.
: The DOH, through agencies like BFAD, regulates, monitors, and enforces laws ensuring the safety, efficacy, and quality of drugs and health products to protect consumers.