Drug Enforcement Administration July 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.

In March 2006, Congress enacted the Combat Methamphetamine Epidemic Act of 2005, which mandates that DEA establish total annual requirements, import quotas, individual manufacturing quotas, and procurement quotas for three List I chemicalsephedrine, pseudoephedrine, and phenylpropanolamine. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements.

This rulemaking changes the regulation of the listed chemical iodine under the chemical regulatory provisions of the Controlled Substances Act (CSA). The Drug Enforcement Administration (DEA) believes that this action is necessary to remove deficiencies in the existing regulatory controls, which have been exploited by drug traffickers who divert iodine (in the form of iodine crystals and iodine tincture) for the illicit production of methamphetamine in clandestine drug laboratories. This rulemaking moves iodine from List II to List I; reduces the iodine threshold from 0.4 kilograms to zero kilograms; adds import and export regulatory controls; and controls chemical mixtures containing greater than 2.2 percent iodine. This rulemaking establishes regulatory controls that will apply to iodine crystals and iodine chemical mixtures that contain greater than 2.2 percent iodine. This regulation therefore controls iodine crystals and strong iodine tinctures/solutions (e.g., 7 percent iodine) that do not have common household uses and instead have limited application in livestock, horses, and for disinfection of equipment. Household products such as 2 percent iodine tincture/solution and household disinfectants containing iodine complexes will not be adversely impacted by this regulation. Additionally, the final rule exempts transactions of up to one-fluid-ounce (30 ml) of Lugol's Solution. Persons handling regulated iodine materials are required to register with DEA, are subject to the import/export notification requirements of the CSA, and are required to maintain records of all regulated transactions involving iodine regardless of size.