Could I be subject to an inspection?
Yes. Both the DEA and IBPE have the authority to oversee and inspect facilities before and after registration approval.
What specific records must be maintained after obtaining IBPE license and DEA registration for receiving, storing, and administering controlled substances?
It is imperative that each licensed researcher adheres to all IBPE and DEA record keeping requirements to ensure proper security controls are in place and complied with. To achieve compliance with all mandated regulations, the PI or an authorized agent must oversee the processes described below.
Each registrant must have the following documents:
- Initial Inventory (New registrants - record 0 for the inventory, as no inventory should be on hand when the new registrant receives approval.)
- Biennial Inventory (Upon receipt of the first purchase of controlled substances, record this new inventory.)
- Purchase invoices
- Daily distribution log (note: each controlled substance should be logged separately, e.g., Pentobarbital in one section, Ketamine in another, etc.)
- Disposal records (when controlled substances have been disposed/destroyed)
- For Registrants using controlled substances for animal studies:
- An SOP that states how controlled substances will be transported through public spaces from the storage area to the procedures area.
- A copy (could be electronic) of each Animal Protocol for which the registrant provides controlled substances.
What are the elements of inventory requirements for controlled substances?
Each licensed researcher is responsible for his/her own annual inventory. Typical inventory checks include: 1) hands-on counting inventory and not a database check; 2) must be completed in a single business day, i.e., before the start of the work day or at the end of the work day; 3) at least two authorized personnel (licensed researcher and authorized agent or authorized lab personnel); and 4) use of an in-house developed initial inventory form, dispensation/disposal records, monthly inventory checks and annual inventory form.
Is it true that I need to keep separate logs for aliquoting a controlled substance?
Yes. Once a controlled substance is used to make a dilution, it is important to track the usage, disposition and disposal of the new dilution which contains a controlled substance. An appropriate entry should be recorded on the original stock bottle's controlled substance aliquot log and a new dilution log. A separate controlled substance aliquot log should be generated and maintained by the investigator to record activities associated with the diluted aliquot.
How long do I keep the copies of my controlled substance usage logs?
You must keep these at least two years after the final disposition of the controlled substance. The logs must be readily available for periodic review by IBPE and/or DEA.
What is the biennial inventory?
Every two years, each licensed researcher and their authorized agent must inventory the controlled substances under their possession during a one-day institutional inventory at either the opening or close of business (21 CFR 1304.11(b)).