Record Retention and Storage
Main Requirements for Controlled Substance Recordkeeping
- All records (inventory, usage or administration, invoices, packing slips, transfers, and disposal) of controlled substances listed in Schedules I- II shall be maintained separately from all of the records of the registrant.
- Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.
- All records must be maintained for at least 2 years from the date of such inventory or records and be readily retrievable for immediate inspection and copying by authorized employees of the DEA and Michigan Bureau of Health Investigations. Five years is recommended for record retention.
- Records must be readily retrievable which means that certain records are kept in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.
- Records and all DEA 222 forms (executed, voided, and unused) must be stored in a secure location at the registered site preferably locked in a cabinet or safe.
- Separate files or binders should be used for schedule I-II controlled substances and schedule III-V controlled substances. If a single binder is used for all records, Schedule I-II controlled substance records must be physically separated from Schedule III-V controlled substances records by using a divider.
- Inspectors must be able to trace a controlled substance from a purchasing record to its administration in a research study or its disposal.
The following records must be maintained and readily available:
- DEA Certificate of Registration 223
- State of Michigan controlled substance license
- Authorized Agent Log
- Authorized Agent Screening Statement
- Acquisition and ordering invoices
- Completed and signed copies of Researcher Request Forms
- Signed and dated supplier invoices or packing slips
- DEA Form 222s
- Used, voided, and unused DEA Form 222s
- *The DEA must be notified of lost or missing Form 222s*
- Inventory records
- Usage and administration records
- Transfer records of controlled substances transferred between registrants
- Disposal records (reverse distributor or OSEH-Hazardous Materials Management
- Inventory or Drugs Surrendered for Disposal (DEA Form 41)
- DEA Form 106 - Report of Loss or Theft