Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances

In accordance with the Controlled Substances Act (CSA), every DEA registrant must make a biennial inventory and maintain, on a current basis, a complete and accurate record of each controlled substance manufactured, received, sold, delivered, or otherwise disposed of. 21 U.S.C. 827 and 958. These records must be maintained separately from all other records of the registrant or, alternatively, in the case of non-narcotic controlled substances, be in such a form that required information is readily retrievable from the ordinary business records of the registrant. 21 U.S.C. 827(b)(2). The records maintained by registrants must be kept and be available for at least two years for inspection and copying by officers or employees of the United States as authorized by the Attorney General. 21 U.S.C. 827(b)(3). On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act (CARA) of 2016 into law as Public Law 114-198, which included amending the CSA to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. 21 U.S.C. 829(f). Upon filling a prescription for a partial fill of a schedule II controlled substance, a pharmacy will have to create and maintain certain records relating to the partial fill.

The latest form for Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances expires 2026-10-31 and can be found here.