The licensee/registrant must maintain applicable, accurate records in a secure storage location for two (2) years from the date of last transaction. All records must be readily available for audit purposes to NYSDOH BNE, or DEA Diversion Investigators.
The tables below list each record by its type (e.g., security) with a description of its use.
Record template | Use |
|---|---|
Authorized Personnel Log | List each person (e.g., PI, lab personnel) allowed to handle controlled substances for research use as an authorized agent or authorized personnel. |
Record template | Use | Example |
|---|---|---|
Record controlled substances at a new storage location (including transfers and changes of address) immediately upon receipt of a DEA registration.
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DEA Biennial Inventory | List all of the controlled substances currently stored at the DEA registered location. Perform every two (2) years after initial inventory. Keep the compelted biennial inventory with the controlled substance records. Tip: If the timing coincides, the DEA biennial inventory can be performed at the same time as the SOM annual inventory. |
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Summarize the usage of a controlled substance from the time of acquisition to the end of use (e.g., administration and/or disposal), including recording expired or damaged controlled substances. Also called "perpetual inventory," this log is likely used in conjunction with other usage records that fully detail the use of the controlled substance (e.g., multiple dose log, dilution log). | General Inventory Example | |
Reverse Distributor Inventory List | Submit inventory of all expired, unwanted or damaged controlled substances to be picked up by Occupational and Environmental Health & Safety (OES) as part of the reverse distribution process. |
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Closing Inventory Log
| List the controlled substances stored at a registered location upon the closing of that location. May use the General Inventory Log, but circle "Closing Inventory." |
Record template | Use | Example |
|---|---|---|
Document the details for each use of any controlled substance amount removed from its original container, including the:
| Multiple Dose Log Example | |
Document the usage details for a controlled substance that has been withdrawn from its original container and mixed with a solution to dilute the concentration, including the:
| Diluted Solution Log Example |
Record template | Use |
|---|---|
Record controlled substances that are wasted on site (i.e., in the laboratory) by the DEA registrant or authorized personnel in the course of normal controlled substance administration or container breakage/spillage. Complete online, print and file with controlled substance paperwork for a minimum of two (2) years. Do not waste expired, unwanted or significant quantities of damaged controlled substances on site. Contact OES for pick up through the reverse distribution process. | |
Submit an online report within one (1) day of significant loss/theft.
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