Drug Enforcement Administration November 12, 2008 – Federal Register Recent Federal Regulation Documents

DEA is proposing that chemical mixtures that are 70 percent or less gamma-butyrolactone (GBL), by weight or volume, be automatically exempt from regulatory controls under the Controlled Substances Act (CSA). DEA is seeking through this rulemaking to exempt only those chemical mixtures that do not represent a significant risk of diversion. If finalized as proposed, this regulation would result in GBL chemical mixtures, in concentrations greater than 70 percent, becoming subject to List I chemical regulatory requirements of the CSA, except if exempted through an existing categorical exemption. DEA is taking this action because there is a serious threat to the public safety associated with the ease by which GBL is chemically converted to the schedule I controlled substance gamma-hydroxybutyric acid (GHB). DEA recognizes that concentration criteria alone cannot identify all mixtures that warrant exemption. As a result, 21 CFR 1310.13 provides for an application process by which manufacturers may obtain exemptions from CSA regulatory controls for those GBL chemical mixtures that are not automatically exempt under the concentration criteria.