Controlled Substances Program

Recordkeeping and Inventory

  • Most current version must be maintained onsite and available for inspection
    • The DEA requires Registrants to maintain all financial and shipping records (e.g., invoices, packing slips) as official records of receipt.
    • These records must include the drug name, strength, dosage form, quantity received, and the initials or signature of the individual who received the shipment. When multiple documents (e.g., an invoice and a packing slip) collectively provide the required information, they must be kept together and maintained as a single complete record.
    • UTMB Form may be used: Record of Receipts: Procured Controlled Substances
  • The following inventory and usage log records must be maintained for at least two years.

    Initial Inventory

    • eCFR :: 21 CFR 1304.11 -- Inventory requirements. …“Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances..”. “In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.”
    • If nothing on hand record “0”.
    • Form: Controlled Substance Initial and Biennial Inventory

    Biennial Inventory

    • After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.
    • If nothing on hand record “0”.
    • Form: Controlled Substance Initial and Biennial Inventory

    Usage log

    • A separate usage log must be maintained for each individual controlled substance container.
    • Any dilution, mixture, or secondary preparation must be documented on a separate usage log.
    • Form: Controlled Substance Usage Log
  • Personnel Access to Controlled Substances (CSs)

    • A Registrant may authorize members of their research staff, collaborators, or administrators to access CSs. The Registrant must complete and maintain an up-to-date Controlled Substances Authorized Personnel Log that lists the names of all AIs granted permission to access CSs under the Registrant’s DEA license and registration.
    • All Authorized Personnel must complete required training Use of Controlled Substances in Animal Research in Learn. See Required Training for further details.

    Exception
    The following personnel should not have access to CSs:

    • Any person convicted of a felony offense related to CSs.
    • Any person who has been denied a DEA registration;
    • Any person whose DEA registration has been revoked;
    • Any person who has surrendered a DEA registration for cause.
  • Transfer Between DEA Registrants

    Facilitate compliant transfers of controlled substances between authorized DEA-registered entities.

    ⚠ Transfer Restriction

    The 5% Rule: Researchers are limited to transferring 5% of their inventory per calendar year, with appropriate documentation (DEA Form 222 for Schedule II and invoices for Schedules III–V).

     21 CFR 1307.11 -- Distribution by dispenser to another practitioner.

     

  • Steps to dispose of unused or expired controlled substances.

    1. Request Disposal

    2. Schedule disposal

    • EPM will reach out and schedule the disposal/pick date and time. The DEA license holder and one member of the lab must be present.

    3. Day of Disposal

    Note: Keep each Disposal Records (EHS Chain of Custody and DEA Form 41)  for at least 2 years