DEA Controlled Substance Recordkeeping Guide

DEA Controlled Substance Recordkeeping Requirements

The DEA recordkeeping requirements for Controlled Substances are as follows:

  • All records must be kept for a minimum of two years so that auditors have access to them when needed

    • DEA auditors can come to facilities where controlled substances are used and perform unannounced inspections

      • Typically, this is done to verify that the facility is compliant with the Controlled Substance Act. Violation of regulations included in the Controlled Substance Act can result in increasing levels of penalty, including:

        • Letter of Admonition

        • $10,000 fine for each individual violation

        • Suspension or revocation of registration

        • Prison sentence

  • Controlled substance logs should be stored separately from other records not related to the DEA

  • Records must specify which staff member interacted with each particular controlled substance, the quantity used, the date and time of the interaction, and the specific destination of the substance (patient, etc.)

    • The DEA-compliant records should consistently indicate the running totals of each controlled substance from transaction to transaction

    • The records should also be securely stored and not easily accessed

      • Risks of tampering are always a concern when dealing with paper records

  • Daily counts of the controlled substances should be witnessed by another staff member

    • The witness should be recorded

  • Wasting and disposal of controlled substances should also be witnessed, with that witness on record as well

  • If records indicate that some controlled substances are not accounted for, submitting DEA Form 106 to authorities might be necessary

  • We always suggest consulting your pharmacy partner or the DEA to ensure you are informed and fully compliant

Eliminate Your DEA Recordkeeping Headaches…

MedServe’s controlled substance management solution automatically generates DEA-compliant records as staff interact with controlled substances stored in MedServe cabinets. These records are tamper-proof and can be accessed from any computer or tablet. MedServe allows you as a busy administrator to not have to worry about any changes to the DEA’s recordkeeping requirements, as our software continues to be updated and evolve with the DEA’s recordkeeping requirements.