Drug Enforcement Administration 2008 – Federal Register Recent Federal Regulation Documents

This notice establishes initial 2009 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA).

On March 9, 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005, which mandates that DEA establish total annual requirements, and individual import, manufacturing, and procurement quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. DEA issued an Interim Final Rule establishing procedures for applying for individual import, manufacturing, and procurement quotas. DEA is finalizing the rule with one change, to extend the authority to sign certifications to persons granted power of attorney to do so by the registrant.

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.