WHO expert committee on drug dependence.

This report presents the recommendations of a WHO Expert Committee responsible for reviewing information on psychoactive substances to assess the need for their international control. The report contains a summary of the Committee's evaluations of gamma-hydroxybutyric acid (GHB) and ketamine. GHB was recommended to be rescheduled from Schedule IV to Schedule II of the Convention on Psychotropic Substances. The report also discusses the nine substances that were pre-reviewed: dextromethorphan, tapentadol, N-benzylpiperazine (BZP), 1-(3-trifluoromethylphenyl) piperazine (TFMPP), 1-(3-chlorophenyl)piperazine (mCPP), 1-(4-methoxyphenyl)piperazine (MeOPP), 1-(3,4-methylenedioxybenzyl)piperazine (MDBP), gamma-butyrolactone (GBL), and 1,4-butanediol (1,4-BD). Of these, tapentadol, BZP, GBL and 1,4-BD were recommended for critical review. Issues identified for consideration at future Expert Committee meetings are also listed. Furthermore, the report discusses the use of terms, the use of pharmacovigilance data for the assessment of abuse and dependence potential, balancing medical availability and prevention of abuse of medicines manufactured from controlled substances, and improving the process for substance evaluation.

WHO Expert Committee on Drug Dependence.

This report presents the recommendations of a WHO Expert Committee responsible for reviewing information on dependence-producing drugs to assess the need for their international control. The first part of the report contains a summary of the Committee's evaluations of seven substances (dronabinol, oripavine, buprenorphine, butorphanol, ketamine, khat and zopiclone). The report also discusses the substances that were pre-reviewed (gamma-hydroxybutyric acid and tramadol) and recommended gamma-hydroxybutyric acid for critical review at a future meeting. Two substances (gamma-butyrolactone and 1,4-butanediol) were identified for future pre-review). The second part of the report discusses the guidelines for the WHO review of dependence-producing psychoactive substances for international control. It includes sections on amending the current guidelines, interpretation of specific aspects of the guidelines and access to information necessary for the evaluation of substances. The final section considers other matters including activities of the EMCCDA, the use of pharmacovigilance data, promotion of education and information on the appropriate use of psychoactive drugs and the impact of international control on medical availability of substances.

Recordkeeping and reporting requirements for drug products containing gamma-hydroxybutyric acid (GHB). Final rule.

DEA is amending its regulations to require additional recordkeeping and reporting requirements for drug products containing gamma-hydroxybutyric acid (GHB) for which an application has been approved under the Federal Food, Drug, and Cosmetic Act. DEA makes these changes under section 4 of the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000." These additional requirements are necessary to protect against the diversion of GHB for illicit purposes.