SECOBARBITAL INTERNATIONAL CONTROLS TRANSFER FROM SCHEDULE III TO II

Executive Summary

SECOBARBITAL INTERNATIONAL CONTROLS TRANSFER FROM SCHEDULE III TO II is being proposed by the U.S. government, FDA announced in an Oct. 27 Federal Register notice. The agency, noting that secobarbital has been in Schedule II in the U.S. since 1972, stated that "the time has come for the international community to consider similiar actions." FDA said the U.S. government "has informed the Secretary-General of the United Nations" that it believes the drug should be rescheduled under the Controlled Substances Act. FDA cited a September 1985 secobarbital trafficking report which concluded that "substantial quantities of secobarbital are being diverted from international commerce for illicit purposes." According to the report, secobarbital is being substituted for methaqualone in illicit pharmaceutical products which often originate from Mexican or European sources. Large amounts of these secobarbital products have been seized in Africa and in the Middle East, the notice said. The agency asserted that present international Schedule III controls are "inadequate to address the rapidly rising levels of diversion." FDA said the added controls of Schedule II would enable governments to "scrutinize import requests prior to shipment, and determine whether the products serve legitimate needs." Schedule II products require separate import or export authorization. Five other barbiturate-type sedative and/or hypnotic drug substances are also being recommended for rescheduling by the World Health Organization. Allobarbital, butobarbital, secbutabarbital, and vinylbital are recommended for Schedule IV while butalbital is recommended for inclusion in Schedule III. FDA said in a separate Oct. 27 Federal Register notice that the drugs are or are "likely to be abused so as to constitute a public health and social problem warranting placing [them] under international control."