Recordkeeping and Inventory

All DEA Registrants at USC are required to maintain accurate usage records and inventories for controlled substances per terms of their DEA licenses. Inaccurate, incomplete, or missing logs may result in suspension of the license as well as DEA-imposed penalties (Controlled Substances Act – Control and Enforcement). This section describes recordkeeping and inventory requirements for controlled substances at USC. Please refer to the Controlled Substances -Recordkeeping & Inventory Guide Sheet for a summary of the information below.

Controlled Substance Recordkeeping

All controlled substance records are required to be retained for two years following controlled substance disposal. These records include purchasing and shipping records, inventories, usage and disposal logs and disposal paperwork. Records must be readily retrievable for immediate inspection by EH&S and DEA inspectors. If records are copied for an inspection, they must be kept for an additional two years from the date of copying (21 CFR 1304.04, 1304.11, 1304.21 and 1304.22). It is recommended that all records be retained for a minimum of five years as they must be kept for an additional two years following controlled substance disposal. Records for Schedule I-II controlled substances must be maintained and stored separately from records for Schedule III-IV controlled substances. Ensure that all records are appropriately stored and secured along with the controlled substances as described in the Storage and Security of Controlled Substances section.

Usage and Disposal Log

  1. Generate a usage and disposal log for each controlled substance container, including dilutions. Appropriate Usage & Disposal Logs are needed for each vial in your possession, regardless of current use.
    • CS Form B- Controlled Substance Usage & Disposal Log
    • CS Form B-1- Controlled Substance Dilution Usage & Disposal Log
  2. A usage and disposal log must contain the following information:
    • DEA Registrant
    • Approved IACUC Protocol #’s
    • CS Name
    • CS Stock Container ID #
      • All individual CS containers must have a unique alphanumeric ID
    • CS Storage Location
    • Amount Received
    • Date of Receipt
    • Expiration Date
    • Physical State (e.g., liquid, tablet, or powder)
    • Concentration (e.g., mg/liter solution)
  3. Record each use of controlled substance.
    1. Record amount used, transferred, and/or disposed of, and remaining balance after each use.
      • Ensure date of use/transfer/disposal is recorded and proper units are noted.
      • Authorized User name must accompany each entry.
      • Physical amount in container must match the usage and disposal logs AT ALL TIMES.
      • Store CS usage and disposal logs with physical CS inventory.
    2. Each error must be struck-through once and initialed by the Authorized User.
  4. Document transfer of CS into and out of inventory.

Controlled Substance Inventory

A physical inventory of all controlled substances in possession, under a DEA registrant’s license, must be completed and submitted to EH&S each calendar year to document the amount of controlled substances on hand. This document fulfills the requirement for receipt of the DEA Biennial Controlled Substance Inventory.

In addition, the DEA requires that an initial physical inventory be completed of all stocks of controlled substances on hand on the date the DEA registrant first engages in the manufacture, distribution, or dispensing of controlled substances as outlined in Title 21 CFR, Part 1304.11. Ensure these records are appropriately maintained and stored with your other controlled substance paperwork.

DEA registrants must ensure that inventories of their controlled substances are complete and accurate; list all controlled substances and dilutions in your possession at time of recording. If no controlled substances are in your possession at time of recording, during initial or annual physical inventory, indicate this accordingly.

NOTE: The DEA requires inventory be taken either at opening of business or at close of business on the inventory date (see Title 21 CFR, Part 1304.11). Please indicate the date and time of recording on your inventory forms.

Precursor Chemical Recordkeeping and Inventory

Principal Investigators are responsible for maintaining appropriate purchase records for precursor chemicals (DEA List I & II; California List) used in their research at the University. All records must be kept for two years and be available for inspection by the DEA and EH&S.

Inventory Records