Drug Enforcement Administration March 10, 2020 – Federal Register Recent Federal Regulation Documents

On November 21, 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application for XCOPRI (cenobamate) tablets. Cenobamate is chemically known as [(1R)-1-(2-chlorophenyl)-2-(tetrazol- 2-yl)ethyl] carbamate. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place cenobamate in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing cenobamate, including its salts, in schedule V of the CSA.

The Drug Enforcement Administration (DEA) published a document in the Federal Register on November 22, 2019, concerning a notice of application. As that document correctly indicated, the applicant, S&B Pharma, Inc., DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702-3232 applied to be registered as a bulk manufacturer of a number of controlled substances, to include applying for authorization in order to synthetically manufacture using drug code 7360 (marihuana). However, on the notice of application published, drug code 7360 was inadvertently identified and listed as Gamma Hydroxybutyric Acid instead of Marihuana.