The following should be considered informal and for 'ease of reference' only. IU hosts a page on the IU controlled substance program here: https://protect.iu.edu/environmental-health/laboratory-safety/controlled-substances.html
Note, however, that the drugs we use are via a DEA license in Ehren's name, not the University. Should any drugs be found missing or unaccounted for, it will be Ehren who is directly liable. The university plays an advisory role only and does not assume any responsibility for our drugs.
We use the following substances:
Ketamine - This is part of an anesthetic cocktail used during surgery. It is a Schedule 3 non-narcotic substance.
Buprenorphine - This is part of the peri-surgical analgesia treatment. It is a Schedule 3 narcotic.
Because these substances are controlled, we are held accountable for every last drop that comes into our possession. Because of this, we must formally acknowledge receipt of each new shipment, thereby taking legal responsibility for caring for the drug. Once in our custody, every drop used or wasted must be logged and signed for by the user, and, in some cases, a witness. If the drug reaches its expiration before fully used, it must be formally destroyed through a formal process of handing off the drug to IU authorities.
To receive new shipments of drugs, the lab manager (and only the lab manager, unless special circumstances have been cleared with Ehren in advance) must meet the courier to accept the package. This means going down to the main office to meet the UPS driver (or whichever courier is handling the shipment). The office will be instructed to NOT accept shipments for our lab from the relevant vendors without the lab manager accepting the package personally. When accepting the package, it is essential to do the following before the courier leaves:
Open the package
Verify that all items on the packing slip are present
Initial after each item
Verify that no items have been tampered with or are damaged
If anything is damaged or tampered with, do not accept the package. The courier must take it with them.
If all is present and intact, sign and date the bottom of the packing slip
Once signed and dated, the invoice must be stored in the controlled substance invoice binder away from the drugs.
The drugs should be taken directly to the safe and log sheets created for each bottle received.
All use of the drugs must be strictly logged. Remember, not a drop can be unaccounted for.
There are two primary types of use -
Dilution of stock solution into usable concentrations;
Use of diluted solutions with the animals.
Both must be logged every time.
There are log sheets in the safe with the drugs. A new sheet should be started for each bottle of drug to be used. This means there will be one sheet for the use of the stock solution while making the diluted solutions and a new sheet for each bottle of diluted solution made. The PDF of the log sheet is included at the bottom of this page ('BLANKUSAGELOG.PDF'). It is important that each of these sheets include a way to uniquely identify which bottle they refer to.
Bottles will be named according to the following naming scheme according to the day received / created:
SS-YYMMDD_n
SS - the first two letters of the substance (e.g., ke for ketamine; bu for buprenorphine)
YY - the last two numbers of the year (e.g., 18 for 2018)
MM - the two digit number of the month (e.g., 02 for Feb)
DD - the two digit number of the day (e.g., 09 for the 9th)
n - a number indicating which bottle among those received / created that day this is. This starts at 1 each day, and will go to N where N is the number of bottles received/created in a single day. (e.g., 1,2, & 3 for three bottles of ketamine stock solution received in a single shipment).
This number should be applied via a sticker or by writing on the label of each bottle and should match exactly one log sheet.
When starting a log sheet, complete all fields at the top of the page.
For stock solutions, indicate the invoice number the bottle was received under.
For dilutions, indicate the ID # of the stock solution bottle it was created from.
When using drugs, complete all fields in the table on the log sheet.
When creating diluted solutions, indicate the number of the dilution bottle created in the central column for 'Identification of usage'. This should match the number of the new log sheet you will have created in making this new bottle of diluted drug.
When using the drug for surgery, indicate the rat name in the central column for 'Identification of usage'. This should match the name on the surgery log sheet for maximal transparency.
Care should be taken to never spilled or waste the drugs as it is so carefully controlled. If any substance is ever spilled or wasted (e.g., due to spillage or contamination) however this must be logged. In this case it is important that two people sign the log sheet - the person who was working with the drug when spilled or wasted and a witness. If no witness was present, it is important to find another person and explain to them the circumstances of the loss. When they are comfortable with their understanding of what happened, they must also sign.
Diluted bottles expire at the sooner of either the manufacturer's expiration or six months from the time of being mixed.
If either stock or diluted bottles expire:
Place the expired drug into the container in the safe labeled 'Expired, not for use'
Complete a "form 41" available at http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/41_form.pdf
Inform IUEHS when the DEA Form 41 has been completed and is ready for review;
https://protect.iu.edu/environmental-health/labnotes/fall2019/Controlled%20Substances.html
The IUEHS contact for your respective campus will forward a copy of this form to the DEA with a projected two week disposal date;
At the end of the waiting period arrangements will be made for an IU Police Officer and the IUEHS contact for your respective campus to be present to witness the disposal, verify the DEA Form 41 and inventory shown on the form. The DEA registrant or their authorized agent must bring the controlled substance to the disposal site. IUEHS will not take possession of controlled substances at any point in the disposal process;
Practically, EHS says this means: "Our hazardous waste team (Rex Howard and Rick Peterson) will take the vial, use pliers to open it up and pour the liquid into a 55-gallon solvent drum. Rex will sign the Form 41. The police officer present will also sign the form. I will mail it along with a cover letter to the DEA indicating that the controlled substance was destroyed. I will send you, Rex, and Police Chief Jill Lees an email with the letter and completed Form 41 attached."
IUEHS contact will forward two copies of the DEA Form 41 to the Agent in Charge of the regional office of the DEA, and provide one copy to the researcher for their inventory records.
Attn: Agent in Charge, Diversion
Drug Enforcement Administration
Indianapolis District Office
575 N. Pennsylvania, Room 408
Indianapolis, IN 46204
We are obligated to perform internal inventory checks every two years.
Inventory checks involve comparing invoices to usage logs to ensure all bottles received either have completed logs (i.e., used until volume was marked as zero), have form 41's if expired, or still exist.
The state of Indiana will conduct inspections every 18 - 24 months. They will want to see:
Security - that the drugs are kept in the safe and the cabinet is locked
Record keeping - usage logs are up to date and complete; invoices are signed and dated and NOT kept with the drugs; DEA license; evidence of inventory checks such as in the form of a reconciliation of the drugs received and used as would.