Contents of Records and Reports

The interim rule published by the Deputy Administrator of the Drug Enforcement Administration (DEA) to clarify what records shall be adequate to satisfy recordkeeping requirements for Listed Chemical transactions under provisions of the Controlled Substances Act (CSA) as amended by the Chemical Diversion and Trafficking Act of 1988 (CDTA) and the Domestic Chemical Diversion Control Act of 1993 (DCDCA) is adopted without change. Specifically, the amendment clarifies that for prescription drug products, prescription and hospital records shall be adequate to satisfy recordkeeping requirements. In addition, this final rule clarifies that for the distribution of these products to hospitals, pharmacies and other entities, normal business records shall be considered adequate if they meet the requirements of 21 CFR 1310.06 (a) and (b).