How to Use the Controlled Substances Notebook
Section 1: Registrations and Licenses
Keep all registration and license applications, certificates, correspondence, and documentation from the Drug Enforcement Agency (DEA) and the Massachusetts Department of Public Health Drug Control Program in this section. A page sleeve has been provided for your convenience.
Section 2: Authorized Users
This section contains a list of authorized users that must be kept perpetually in the lab. Authorized Users are individuals 21 years of age or older and have completed controlled substances training, submitted the Authorized User and Authorized Trainee Application Form to the Controlled Substances Office, and have been approved by the Office for work with controlled substances. Similarly, Authorized Trainees are individuals either 18, 19, or 20 years of age and have completed the training,submitted the Application Form, and been approved by the Office. Both Authorized Users and Trainees must be added to the Authorized User Log, with the entry signed by both the License Holder and the User or Trainee.
All completed Application Forms and approvals (essentially emails) for Authorized Users and Authorized Trainees issued by the Controlled Substances Office must be kept in this section. A page sleeve has been provided for this purpose.
Only those individuals listed in the authorized user log may have access to controlled substances, and only for the responsibilities as designated in the log.
Section 3: Usage Logs
This section contains the usage logs that must be perpetually kept for each controlled substance. Each newly received vial of a controlled substance, and each substance or mixture (two or more controlled substances combined together such as a Ketamine/Xylazine mixture) used in a procedure must be recorded in a separate log sheet. An Index of Usage Log is used when a controlled substance is received, and a Usage Log is begun when a vial of a drug or a mixture is used in a procedure for the first time.
Upon receipt of a controlled substance by an Authorized User in the laboratory,the package must be opened,the contents inspected to ensure that what was ordered is what was received, and each bottle is checked for any damage. The packing slip must be kept in the plastic sleeve in this section. The Authorized User must then enter the controlled substance information into the Index of Usage Log, thus adding to the list of all received drugs. All completed Index of Usage Logs must be kept for two years and be available for inspection.
Each time a controlled substance or a mixture is used, the Usage Log Form must be completed with the date, the type of procedure, amount of drug used, and amount of drug remaining. Only authorized users and trainees may use controlled substances, and the users and trainees must sign out the amounts in the usage log. All completedUsage Logs must be kept for two years and be available for inspection.
If a controlled substance is spilled or wasted, the amount must also be noted in the Usage Log. In the case of a spill, please write a brief explanation with details of the spill, sign it, date it, and have any other witness to the spill co-sign. Attach this document to the Usage Log and notify the Controlled Substances Office of the spill.
If theft of a controlled substance is discovered, the Controlled Substance Office must be informed IMMEDIATELY. The Controlled Substance Office will work with you to report the theft to Campus Public Safety and the appropriate Federal and State agencies.
Section 4: Disposal
When a controlled substance has expired or is no longer needed, please contact the Director of Environmental Health and Safety (EH&S), Andrew Finn (firstname.lastname@example.org or 781-736-4262), for disposal. The disposal of the controlled substance must be noted on the Disposal Log and in the Usage Log. All expired controlled substances must be disposed of through EH&S.
Section 5: Inventory
The Controlled Substance Office will work with each lab to conduct an inventory of all controlled substances biannually, usually during the IACUC semiannual review. All completed inventories are emailed to the PI or lab contact and must be kept in the Notebook for two years.