Working with Controlled Substances requires specific procedures and documentation practices in accordance with federal and state regulations. Three categories of documents must be maintained: records associated with the application process; records of Authorized Users; and records of use.
The usage documentation must demonstrate a closed system of distribution wherein each Controlled Substance is accounted for from acquisition through to use and disposal (or destruction) and the chain of custody and usage must be documented. Typical categories include: acquisition (ordering or purchasing), receiving, administration (use), inventory, and disposal.
The Using Controlled Substances in Research at the University of Virginia manual refers to the sample forms below. The use of these forms is not required; however, the templates incorporate all of the required elements from the applicable regulations. Any format used must meet the requirements of all pertinent regulations. Registrants should determine a consistent documentation process to ensure best compliance practices.
Authorized User records must be kept for two years. Usage records must be maintained for two (2) years after the depletion or destruction of the Controlled Substance.
Personnel Forms for Authorized Users
Everyone identified by the Registrant as being an Authorized User must complete the screening process and complete several forms prior to the Registrant authorizing the individual to work with Controlled Substances. The forms must be kept by the Registrant in a separate, secured file for two years after the departure of the Authorized User.
- Personnel Screening form
- Personnel with Access to Controlled Substances -Specific to the DEA, Schedules I -V.
Notebook and Recordkeeping Forms and Logs
Controlled Substance Notebooks must be maintained and contain all relevant documents demonstrating the chain of custody and closed system of distribution. The sections below are strongly encouraged and each contains the relevant logs and forms needed. Documentation for Schedules III – V can be maintained together in one notebook. Refer to the CS manual for guidance on separating documentation based on Schedule.
1. Background Information (optional)
- Copy of current in-date DEA Registration, VBP Registration Certificate, and any amendments to Registration(s)
- Copy of completed UVA Controlled Substance Research Protocol including theft procedures
- DEA Form 106-Significant Loss or Suspected Theft
2. Authorized Users (required)
- Authorized User Signature form specific to Schedules in Registration(s)
- Schedule II–VI
- Schedule I
- Copy of Power of Attorney (for Schedule II only)
3. Inventory (required)
4. Acquisition/Purchasing (required)
- Purchasing Log/Tracking–Recommended form used to track acquisition, numbering/tracking system, and disposal.
- Packing slips (signed and dated)
- Copy of completed DEA Form 222 Required for Schedule II purchases.
5. CS Usage and Disposal Log forms (required)
- Schedule II – V Usage and Disposal form (required). Use this form for all Schedule II – V substances. Do not use this form for Schedule VI substances
- Schedule VI – Usage and Disposal form (required for isoflurane, sevoflurane, and propofol). Use this form as indicated, and good practice for other Schedule VI substances but not required
- Stock (Bulk form) vial log - Every vial must have a unique tracking number and Usage/Disposal log
- Compounded/Dilution (Finished form) vial log – each compounded vial created must have a usage log. The compounded vial must have a unique tracking number that links it to the original Stock/Bulk vial number.
6. Reverse Distribution (required)
- Maintain copies of Reverse Distribution confirmation Reverse Distribution Instructions
- DEA Form 41 Instructions
- DEA Form 41
7. Completed Transactions (optional)
After the stock (bulk) vial and all associated compounded/diluted solution vials have been used/emptied/destroyed, it may be useful to collect all associated documents related to the transaction and place them together within the stock vial’s plastic sheet protector pocket (or other method).