The determination of the medical and annual needs of ephedrine, pseudoephedrine and phenylpropanolamine as required by the enactment of the Combat Methamphetamine Epidemic Act of 2005 (CMEA)

The CMEA was enacted on March 9, 2006 and it amended the Controlled Substances Act (CSA) by adding provisions to the regulatory control of ephedrine (EPH), pseudoephedrine (PSE), and phenylpropanolamine (PPA). EPH, PSE, and PPA are List I chemicals which can be used as precursor chemicals in the illicit manufacture of certain controlled substances, e.g. methamphetamine and amphetamine. CMEA required DEA to establish quotas for these List I chemicals and to prevent the use of these chemicals in the clandestine manufacture of methamphetamine. DEA obtained assistance from a private independent contractor, IMS Health Government Solutions (IMS), to develop the proposed initial estimate of the medical needs of EPH and PSE for the U.S. For this analysis, IMS utilized the following types of data: (1) sales to retail establishments, (2) sales to patients, and (3) medical insurance claims. A weighted average of the three individual estimates was used to derive the final estimates of medical need. The weighted average was determined based on IMS’ confidence in each individual estimate. The medical needs of EPH and PSE were determined to be 5,998 kg and 350,700 kg, respectively. After DEA considered the medical needs of the EPH and PSE, and PPA (veterinary products) the assessment of annual needs was determined using other required factors. The methodology used to determine these estimates will be discussed.