DEA Ends Exemption for Low-Concentration Ephedrine or Pseudoephedrine Mixtures

The Drug Enforcement Administration on Thursday finalized a July 2007 interim rule that removed the Controlled Substances Act exemptions for chemical mixtures containing ephedrine and/or pseudoephedrine at or below a 5 percent concentration limit. Effective Aug. 11, 2008, all ephedrine and pseudoephedrine chemical mixtures, regardless of concentration and form, are subject to the regulatory provisions of the act.

This change affects dietary supplements containing ephedrine or pseudoephedrine; in fact, FDA in April 2004 banned the sale of supplements containing ephedrine alkaloids such as ephedra, so they could not longer be lawfully sold. The FDA ban doesn't address the mixtures DEA is now addressing with this rule, which will require importers and suppliers of such materials to comply with DEA recordkeeping, registration, quota, import/export, and security requirements.

DEA said it received no comments when it published the interim rule.

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