14.0 Recordkeeping

The controlled substances tracking requirements are available at http://www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_22.htm.

Controlled Substances Log: a controlled substances log will be maintained at each location where controlled substances are stored.  Dedicated notebooks are strongly recommended for maintaining records for all controlled substances.  A separate page shall be maintained for each controlled substance.  Inventories and records for Schedule I and II drugs must be kept separate from all other records maintained by the licensed researcher.  Records for Schedule III-V drugs must be kept separate from all other records. Alternatively, a folder for controlled substances records can be created so they are easily and “readily retrievable” from other records. 

Basic record keeping includes:

  • Records of receipt
  • Records of use (including loss or theft)
  • Records of disposal of controlled substances
  • Biennial inventory (an example of a biennnial inventory form can be found in Appendix B7)

The following information will be kept in the receiving log:

  • The date the substance was received at the storage location
  • The substance name assigned by the manufacturer
  • The manufacturer of the substance or vendor
  • The quantity and strength of the substance added to the storage area
  • Name of individual adding product to the inventory

Dispensing controlled substances: whenever drugs are dispensed either for teaching purposes, research or surrendered for disposal the following information must be logged.

  • Date used or disposal of waste
  • Quantity dispensed for aliquots, dilution
  • Strength dispensed (concentration and volume)
  • Name of person (authorized user)
  • Quantity remaining in inventory

Labeling Containers: for controlled substances that are removed from their original packaging and compounded, diluted or combined, must be labeled with a new control number, the final concentration, the amount per container and the expiration date.

Inventory Audits: the licensed researcher must maintain a complete and accurate accounting of all controlled substances, from the time they are ordered until they are used up or disposed of.  

  • These inventories and records should be kept at the location where the licensed activity is conducted, and must be readily available for inspections.
  • Chemical inventories of controlled substances are up-to-date and discrepancies reconciled at least annually.
  • All records of inventories and logs of controlled substances shall be kept a minimum of two years and be available for inspections and for copying by a member of DEA or IBPE, if requested.
  • The licensed researcher should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of at least two years.