Part 3
Using, Transferring, Disposing
Using Controlled Substances
The University policy mandates the following about the use and record-keeping of controlled substances for research:
- Only Unit Registrants, Location Registrants and Authorized Users may use controlled substances in the lab.
- The person using the controlled substances must be the one to initial and date the disposition record for the particular action performed.
Record-keeping for Use of Controlled Substances
Every activity with controlled substances must be recorded on the disposition record, which is the primary record of all activities with controlled substances used for research. The recording requirements vary by the type of drug being used:
- For C-III, C-IV and C-V drugs, the total volume used on a daily basis may be recorded on the disposition record. For instance, if ten animals were given 0.3 ml of a substance on a specific day, the total in the disposition record could read 3.0 ml. However, the individual use must be recorded in a surgical, anesthetic or other research record that is accessible.
- The regulations for use of C-II controlled substances (e.g. pentobarbital) are more stringent. Each individual dose must be recorded in the disposition record.
- In the instance of an animal surgery, the individual recorded dose can be the total per animal per anesthetic episode. If an animal was given 1.0 ml of a substance and boosted with 0.5 ml three times during the surgery, the total individual dose would be recorded as 2.5 ml.
- The University of Minnesota has developed controlled substance disposition records that contain all the required elements. They are available on the Forms page of the controlled substances website, http://www.research.umn.edu/riop/forms/Disposition_Record.pdf. If the recommended forms are not used, all required elements must be included in a modified form.
Note that the disposition records are dedicated exclusively to tracking all controlled substances activities. The actual use of the controlled substances must be demonstrated by recording it in surgical, anesthetic, post operative or other experimental record. This would be analogous to a hospital pharmacy dispensing a drug and a clinician writing the use of the drug in the medical record.
Example: Using the Disposition Record for C-II Controlled Substances
This example uses sodium pentobarbital, a C-II controlled substance, to demonstrate the more stringent record-keeping requirements. For a C-II controlled substance, remember that the total use for each animal must be recorded individually. For C-II drugs, do not combine the total use per day in multiple animals, as you can for C-III through C-V drugs.
The disposition record is used to track all activities:
- Receiving
- Using
- Diluting or combining
- Disposing of
- Transferring
This section will introduce the form, and demonstrate how each activity is recorded.
Research Controlled Substances Disposition Record
Online Version of Form
The recommended disposition record contains the required elements from the DEA regulations, which are included at the top and bottom of the form:
- Name of controlled substance
- Concentration or strength
- Form or type
- Amount per container
- Unit (DEA) and Location Registrant’s names
- Lab Location
- Sequential page numbers
Line 1:
Receiving controlled substances
Information to be recorded in the spaces provided on disposition record:
- Date: Date of activity
- Quantity Received: Number of containers received
- Received From: Name and address of source
- Lab Ref #: Lab reference number, if your laboratory assigns a number to each bottle
- Initials: Initials of Authorized User who received the drug
*Date and initial each activity.
*Cross out unused columns and lines.
Lines 2-4:
Using controlled substances
In this example, Lines 2-4 represent the use of sodium pentobarbital in three animals, each recorded individually. The first two animals, Rat 214 and 215, received 0.8 ml of drug. Rat 216 received 1.0 ml of sodium pentobarbital.
The lines referring to the receipt of controlled substances are crossed out.
Each activity is dated and initialed by the person using the controlled substance.
In the “Use Information” column, write enough specific information so that you can go to the lab notebook or surgical sheet where that use of the controlled substance is recorded. Writing only “mouse” or “rat” may not be enough information if your laboratory is conducting several projects using controlled substances.
Line 5:
Diluting or combining controlled substances
When controlled substances are diluted or combined, it must be recorded on the disposition record. When a drug combination is used, track the combination use separately from the stock bottle use.
In Line 5 of the disposition record, 0.5 ml of sodium pentobarbital is used from the stock bottle and diluted 5-fold to make 2.5 ml total volume to use in mice.
When diluting (as in this example using sodium pentobarbital) or combining drugs (when using ketamine-xylazine or other drug combinations), it is necessary to record the amount used from the stock bottle(s) AND to record the amount of diluted or combined drugs used.
A sterile container and pharmaceutical grade diluent must be used when diluting or combining controlled substances for use in animals. The diluted or combined controlled substance expires after 30 days.
In Line 5, the 0.5 ml is the stock bottle amount used. The 2.5 ml of diluted sodium pentobarbital (new concentration of 10 mg/ml) is the diluted amount of controlled substances that must also be tracked.
In the example, this 2.5 ml diluted sodium pentobarbital will also be recorded on the Controlled Substances Single Drug Disposition Record.
Controlled Substances Single Drug Disposition Record
Using the Single Drug Disposition Record is convenient when multiple animals are used and/or when other experimental information, e.g., animal weight, is needed. It is important to remember that with a C-II controlled substance like sodium pentobarbital you are required to record the drug use for each animal separately.
Controlled Substances Single Drug Disposition Record
Online Version of Form
The following example demonstrates how to complete the Single Drug Disposition Record.
This example demonstrates how to complete the Single Drug Disposition Record.
Complete the required information at the top of the Controlled Substances Single Drug Disposition Record.
In the body of the record, the columns on the left side pertain to use of the controlled substance and the columns on the right side could be used to record information relevant to your research.
In this example with diluted sodium pentobarbital, each of 10 mice received 0.2 ml, which leaves 0.5 ml diluted sodium pentobarbital remaining.
As noted on this disposition form, the 0.5 ml was put in the slurry bottle for disposal. The volume placed in the slurry bottle must also be recorded on the disposal form. More information on the use of the disposal form and slurry bottle is presented below.
When large numbers of animals are used and the information is the same (e.g. euthanizing a large number of animals with the same dosage of drug), this record could be prefilled on the Single Drug Disposition Record which is an Excel spreadsheet. If this is done, the record must be printed and signed or initialed by the person performing the activity.
In addition, to save time or minimize duplication of recording, researchers may choose to use the Controlled Substances Single Drug Disposition Record as a surgical or procedure record by adding other research elements to the record. If this is done, file the original record with your research records and a copy in your controlled substances records.
If your laboratory uses only the Single Drug Disposition Record as a controlled substance record, it is very important to clearly record all the controlled substances activities (receiving, using, diluting or combining, disposing and transferring) on the form.
Returning to the Research Controlled Substances Disposition Record
Line 6 and 7:
Using and disposing of controlled substances
Line 6 records the use of 0.8 ml of sodium pentobarbital 3/12/09 in Rat #217 for perfusion.
Line 7 records the disposal of 0.2 ml that was contaminated in the syringe. The 0.2 ml is placed in the slurry bottle and recorded on the disposal form.
By recording the amount you put in the slurry bottle on both the disposition record and disposal record, you can easily track the controlled substance. More information on disposal is provided below.
Line 8: Transferring controlled substances
Although it is not advised, it is possible to transfer controlled substances to another DEA registration. Only transfer unopened bottles of controlled substances so that both parties are certain of the amount being transferred. Both the receiving and the supplying laboratories must record the transfer in their disposition records.
In this example, Line 8 records the transfer of one 50 ml bottle of sodium pentobarbital to another laboratory. The receiving laboratory must record the 50 ml bottle in their disposition records, who they received it from and the DEA number. Because sodium pentobarbital is a C-II substance, a Form 222 order form must be used to make the transfer.
Disposing of Controlled Substances
The University's Department of Environmental Health and Safety (DEHS) has a DEA registration allowing them to pick up and dispose of expired, contaminated or excess controlled substances. Individual labs may NOT dispose of controlled substances themselves, but must have controlled substances disposed of by DEHS. Substances to be disposed of must be kept in the safe until picked up by DEHS.
Dispose of expired and excess controlled substances in the original bottle. Mark the container “Expired” and segregate, if possible, from other controlled substances in your safe.
Collect and dispose of small amounts of contaminated or waste controlled substances (i.e. in a syringe) in the “slurry bottle.”
A slurry bottle is a bottle that contains a contaminant. Slurry bottles can be obtained free by contacting DEHS at hazwaste@umn.edu or 612-626-1859. Multiple types of waste controlled substances can be put in the slurry bottle. The slurry bottle must be kept in the safe.
Slurry bottle
The DEHS website contains specific directions for the proper disposal of controlled substances. Use this link to review the instructions: http://www.dehs.umn.edu/hazwaste_consub_dispos.htm
- Transfer controlled substances to DEHS using the disposal form (see link to form below)
- Complete the disposal form and fax to DEHS
- Pick-up of controlled substances is arranged by DEHS
- File a copy of the disposal form in the controlled substances records
Record-keeping for Controlled Substances Disposal
Each disposal into the slurry bottle must be recorded on the disposal form, which is used to record amounts of expired or waste controlled substances for disposal. It is also recommended that the amount placed in the slurry bottle is recorded on the disposition record.
The two-page Controlled Substances Disposal Form is required by University policy and is available on the Department of Environmental Health and Safety (DEHS) website.
Controlled Substances Disposal Form
Online Version of Form
This form is used to record the disposal of expired, excess or contaminated controlled substances, using the system that has been established by DEHS.
To dispose of controlled substances using the Controlled Substances Disposal Form:
- Enter the DEA address as it appears on the DEA registration. The DEA number and signature of the DEA registrant should be entered at the time that you request disposal by DEHS. You do not want everyone in the lab to have access to your DEA number.
- All C-II through C-V controlled substances can be put in the same slurry bottle. DEHS is not registered to dispose of C-I controlled substances. You must use an outside vendor to dispose of C-I controlled substances. Contact Kathy Fox at foxxx005@umn.edu for more information.
- The disposal form for the slurry bottle must have the total amount of each controlled substance contained in the slurry bottle. Keep adding to the slurry bottle until it is full. Remember to store your slurry bottle in the safe.
- You can use more than one disposal form for one slurry bottle as long as you number each page in order.
- To request the disposal and pick up of controlled substances, fax the disposal forms to the DEHS fax number on the form, providing a contact name, phone number and laboratory address. DEHS will arrange the pick-up.
The following example shows how to record the disposal of sodium pentobarbital used previously.
Line 1 of the disposal form records the slurry bottle entry of the 0.5 ml diluted (10 mg/ml) of sodium pentobarbital from our previous example.
Line 2 records the 0.2 ml of 50 mg/ml sodium pentobarbital from the syringe in the previous example. This drug is contaminated in the syringe because it was used to inject 0.8 ml into a rat.
If you have expired drugs for disposal, use a separate disposal form and request that DEHS pick them up immediately.
Part 3 has covered the use of the disposition record to track all activities using controlled substances for research:
- Receiving
- Using
- Diluting or combining
- Disposing of
- Transferring
Part 3: Knowledge Check
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