Drug Enforcement Administration July 25, 2007 – Federal Register Recent Federal Regulation Documents

This Interim Rule removes the Controlled Substances Act (CSA) exemptions for chemical mixtures containing ephedrine and/or pseudoephedrine with concentration limits at or below five percent. The Combat Methamphetamine Epidemic Act of 2005 (CMEA) added additional controls on ephedrine and pseudoephedrine and mandated that DEA limit the domestic production and importation of materials containing ephedrine and pseudoephedrine to quantities necessary for medical, scientific and other legitimate purposes (21 U.S.C. 952(a)(1) as amended). DEA is eliminating exemptions for these chemical mixtures. As such, all ephedrine and pseudoephedrine chemical mixtures, regardless of concentration and form, shall be subject to the regulatory provisions of the CSA. DEA is not prohibiting the importation, exportation, manufacture, or distribution of chemical mixtures containing ephedrine or pseudoephedrine in concentrations less than or equal to five percent. Rather, DEA is regulating the importation, exportation, manufacture, and distribution of these chemical mixtures by requiring persons who handle these chemical mixtures to register with DEA, maintain certain records common to business practice, and file certain reports, regarding these chemical mixtures. Chemical mixtures containing the List I chemicals ephedrine and pseudoephedrine will still be available for use.