Drug Enforcement Administration September 2008 – Federal Register Recent Federal Regulation Documents

DEA is withdrawing a proposed rule that was published in the Federal Register on September 24, 2007 (72 FR 54226) and is terminating the rulemaking. The proposed rule would have revised the DEA regulations with respect to the listing in schedule III of a synthetic isomer of tetrahydrocannabinols (THC) contained in a specific formulation of a drug product approved by the U.S. Food and Drug Administration (FDA). Specifically, the proposed rule would have revised the DEA regulation so that it would also include generic drug products approved by the FDA under section 505(j) of the Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 355) that cite the drug product currently listed in schedule III as the reference listed drug. In view of the comments DEA received in response to the proposed rule, DEA has decidedin lieu of finalizing the proposed ruleto proceed with the process set out in 21 U.S.C. 811 for transferring each such generic drug individually to schedule III.

This notice proposes the initial year 2009 assessment of annual needs for certain List I chemicals in accordance with the Combat Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006. The Act required DEA to establish production quotas and import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. The enactment of the CMEA places additional regulatory controls upon the manufacture, distribution, importation, and exportation of the three List I chemicals.