Removal of Exemption for Certain Pseudoephedrine Products Marketed Under the Federal Food, Drug, and Cosmetic Act (FD&C Act)

This rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to remove the exemption for certain products containing pseudoephedrine (which are lawfully marketed under the Federal Food, Drug, and Cosmetic Act) from the regulatory chemical control provisions of the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act. This rule finalizes a Notice of Proposed Rulemaking (NPRM) published in the Federal Register on October 31, 1995 (60 FR 55348). Due to the large scale utilization of over-the-counter (OTC) pseudoephedrine products for the clandestine manufacture of controlled substances, the DEA has determined that certain products should be subject to recordkeeping, reporting, registration and notification requirements of the CSA to prevent their diversion. Such products include OTC tablets, capsules and powder packets containing pseudoephedrine alone or in combination with antihistamines, guaifenesin or dextromethorphan. This action also reduces the threshold for pseudoephedrine to 48.0 grams pseudoephedrine base. Such a threshold is sufficient to permit the purchase of up to a 244 day supply of OTC pseudoephedrine drug products without the application of regulatory requirements. In addition, the cumulative threshold requirement for multiple transactions of pseudoephedrine drug products in a calendar month will not apply to sales for personal use. To further ensure the availability of pseudoephedrine products to legitimate consumers at the retail level, this action also waives the registration requirement for retail distributors of regulated pseudoephedrine products.