The licensee/registrant must maintain applicable, accurate records in a secure storage location for two (2) years from the date of the last transaction. All records must be readily available for audit purposes to OSU EH&S or DEA Diversion Investigators.

The tables below list each record by its type (e.g., security) with a description of its use.

Blank templates and forms are available from the links in the Record Template columns.

Click the link to download or open.

Security Records

Record Template

Used to…

 

Authorized User Screening Form

Certify each person (e.g. PI, lab personnel) who will handle controlled substances as part of a research protocol.

 

Authorized Personnel Log

List each person allowed to handle controlled substances for research use as an authorized agent.

 

Inventory Records

Record Template

Used to…

Example

 

 

Initial Inventory

Record controlled substance at a new storage location (including transfers and changes of address) immediately upon receipt of a DEA registration

 

 

 

 

 

 

 

 

DEA Biennial Inventory

List all controlled substances currently stored at the DEA registered location.

 

Perform every two (2) years after initial inventory. Keep completed biennial inventory with the controlled substance records.

 

 

 

 

 

General Inventory

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 a “perpetual inventory”, this log is likely used in conjunction with other usage records that fully detail the use of the controlled substance (e.g. dilution log).

 

 

 

 

General inventory Example

Closing Inventory

List the controlled substances stored at a registered location upon the closing of that location.

 

 

 

Usage Records

Record Template

Used to…

Example

 

 

 

 

Multiple Dose Usage Log

Document the detail for each use of any controlled substance amount removed from its original container, including the:

  • Amount withdrawn
  • Waste amount, and
  • Remaining balance through final disposal

 

 

 

 

Multiple Dose Usage Log Example

 

 

Dilution Solution Log

Document the usage details for a controlled substance that has been withdrawn from its original container and mixed with a solution to dilute the concentration including the:

  • Amount withdrawn
  • Waste amount, and
  • Remaining balance through final disposal.

 

 

Dilution Solution Log Example

 

Purchasing, Transferring, Waste, & Theft/Loss Records

Record Template

Used to…

Example

 

Purchasing Log

 

DEA Form 222

Record the receipt of the controlled substance from the supplier including the signed and dated:

  • Invoices and packing slips
  • Executed DEA form 222

 

 

 

 

 

 

DEA Form 222

 

 

 

DEA Form 41 – Drugs Destroyed

Record controlled substances that are wasted on site (i.e., in the laboratory) by 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 two (2) years.

 

Do not waste expired, unwanted, or significant quantities of a damaged controlled substance on site. Contact EH&S for options.

 

Registration for Schedule I – DEA Form 225

 

Instructions

Applications for use of Schedule I drugs must be submitted as a hard copy and must attach 3 copies of protocol, including curriculum vitae.

 

Registrations for Schedule II-IV DEA Form 225

 

Instructions

Electronic submission of this form is preferred, except for Schedule I

 

 

Controlled Substances Discrepancy Report Form

 

 

DEA Form 106 Theft/Loss

Record and document a theft or significate loss of controlled substance.

 

  • Complete the Controlled Substances Discrepancy Report Form
  • Complete DEA Form 106

 

Transfer Log

To track the transfer of controlled substances from one authorized person or location to another.

 

 

Other Helpful Documents

Document

Used to…

Researcher Controlled Substance Checklist

Prepare for an Audit

SOP Template for Controlled Substance Use

Provides standard operating procedures for laboratory personnel

Oregon Board of Pharmacy Letter

Required for using controlled substances in research