21 CFR 1304.21 - General requirements for continuing records.
(a) Every registrant required to keep records pursuant to § 1304.03 shall maintain, on a current basis, a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him/her, and each inner liner, sealed inner liner, and unused and returned mail-back package, except that no registrant shall be required to maintain a perpetual inventory.
(b) Separate records shall be maintained by a registrant for each registered location except as provided in § 1304.04 (a). In the event controlled substances are in the possession or under the control of a registrant at a location for which he is not registered, the substances shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.
(c) Separate records shall be maintained by a registrant for each independent activity and collection activity for which he/she is registered or authorized, except as provided in § 1304.22(d).
(d) In recording dates of receipt, distribution, other transfers, or destruction, the date on which the controlled substances are actually received, distributed, otherwise transferred, or destroyed will be used as the date of receipt, distribution, transfer, or destruction (e.g., invoices or packing slips, or DEA Form 41). In maintaining records concerning imports and exports, the registrant must record the anticipated date of release by a customs official for permit applications and declarations and the date on which the controlled substances are released by a customs officer at the port of entry or port of export for return information.
(e)Record of destruction. In addition to any other recordkeeping requirements, any registered person that destroys a controlled substance pursuant to § 1317.95(d), or causes the destruction of a controlled substance pursuant to § 1317.95(c), shall maintain a record of destruction on a DEA Form 41. The records shall be complete and accurate, and include the name and signature of the two employees who witnessed the destruction. Except, destruction of a controlled substance dispensed by a practitioner for immediate administration at the practitioner's registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized), shall be properly recorded in accordance with § 1304.22(c), and such record need not be maintained on a DEA Form 41.
Title 21 published on 19-May-2018 03:57
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1304 after this date.