Drug Enforcement Administration January 18, 2008 – Federal Register Recent Federal Regulation Documents

The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which was enacted on March 9, 2006, requires DEA to establish an assessment of annual need for the importation and manufacture of ephedrine, pseudoephedrine, and phenylpropanolamine. Because of the new CMEA mandates for importation, import quotas, and production quotas for these chemicals, DEA must revise its registration provisions. The changes made by the CMEA render current DEA regulations inadequate for two reasons. First, although DEA registers bulk manufacturers of the three chemicals in the United States and importers of the bulk chemicals, some of those chemicals are distributed to non-registered companies that process them into prescription drugs. Under the Controlled Substances Act, section 826, production quotas are available only to registered manufacturers. DEA cannot meet the CMEA mandate to establish annual need and import quotas, and then issue individual quotas for each of the chemicals unless all manufacturers manufacturing or procuring the chemicals and manufacturing drug products that contain the chemicals are registered as manufacturers, even if the distribution of the final drug products is not regulated. DEA also must know the quantity of prescription drug products containing the three chemicals being imported. Without this information, DEA would not be able to determine an assessment of annual need for these chemicals. Any person importing prescription drug products containing any of the three chemicals must register although the distribution of these products would not be subject to DEA regulation. Second, persons currently registered to import, distribute, or dispense controlled substances who manufacture drug products using ephedrine, pseudoephedrine, or phenylpropanolamine, are not necessarily registered to do so. This must also be changed so that controlled substance registrants will only receive a waiver from the requirement of separate chemical registration if they engage in the same activity for both lawfully marketed drug products containing List I chemicals and controlled substances (as is already the case for bulk manufacture, imports, and exports.) In this way, any registrant that must obtain a quota to manufacture or procure one or more of the chemicals will be a registered manufacturer, as required by the CSA. Were DEA not to issue this rule, it would have no mechanism to issue production or import quotas for persons handling prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine. If these persons were not required to register, there would be no mechanism by which they would be permitted to apply for production or import quotas. Therefore, these persons would have no means by which to acquire the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine necessary for them to conduct business. Accordingly, DEA is proposing to amend its registration regulations to ensure that every location that manufactures or imports one of these chemicals or drug products that contain ephedrine, pseudoephedrine, or phenylpropanolamine is a DEA registered manufacturer or importer. These amendments will make it possible to establish the system of quotas and assessment of annual needs for the manufacturing that Congress mandated for ephedrine, pseudoephedrine, and phenylpropanolamine.