Comprehensive Methamphetamine Control Act of 1996; Registration Fees

DEA is waiving a portion of the registration fee for non- retail distributors of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products. Under the Comprehensive Methamphetamine Control Act of 1996 (MCA), wholesale distributors of these drug products are subject to the existing List I chemical registration and fee requirements. However, because the drug products are distributed in substantially different channels than other List I chemicals, the existing pre-registration investigation procedures, which were established primarily with respect to the handlers of chemicals, as opposed to drug products, are not necessarily applicable to the new type of applicant. DEA will be reviewing the pre- registration investigation procedures to determine what changes will be necessary to account for the different manner of distribution of the drug products. Recognizing that changes are likely to be made in the pre-registration process, thus causing changes to the fees assessed, DEA is waiving a portion of the fee at this time, rather than requiring that new applicants pay a fee that would not be consistent with the resources actually expended in the issuance of the registration.