I. Introduction
The purpose of this guidance document is to assist campus personnel in obtaining, storing, record
keeping and disposing of controlled substances by providing information on these items.
Improper storage, recordkeeping, dispensing, or disposal of controlled substances can result
in civil penalties up to $50,000.00, arrest and incarceration, or license suspension/revocation.
Information found in this guide:
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Controlled Substance Definitions
Campus Unit, and DEA Registrant Responsibilities
Controlled Substance Registration
Authorized Use
Ordering
Record Keeping Requirements
Security
Disposal
Abandoned Controlled Substances
Comprehensive list of DEA controlled substances
Employee Questionnaire (for employees of DEA registrants that will work with DEA
controlled substances)
II. Controlled Substance Definitions
Controlled Substances are drugs or other chemicals that have the potential to be addictive or
habit forming. The Drug Enforcement Administration (DEA) has divided the Controlled
Substances into 5 schedules based on their potential to be habit forming and usefulness in
medicine as a drug. Click here for the comprehensive DEA schedule. Below is the criteria
established by the DEA to determine appropriate schedules for narcotic and non-narcotic
controlled substances.
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Schedule I
 Drugs or other substances that have a high potential for abuse; no currently
accepted medical use in the United States and have a lack of accepted safety
for use under medical supervision. (examples - Heroin, Marijuana)
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
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Schedule II
 Drugs or other substances that have a high potential for abuse; currently have an
accepted medical use in treatment in the United States, or have a currently
accepted medical use with severe restrictions; abuse may lead to severe
psychological or physical dependence. (examples - Methamphetamine, pure
Pentobarbital)
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Schedule III
 Drugs or other substances that have a potential for abuse less than Schedule I or
II; currently have an accepted medical use in treatment in the United States; abuse
may lead to moderate or low physical and high psychological dependence.
(examples - Beuthanasia Solution, Ketamine, Testosterone)
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Schedule IV
 Drugs or other substances that have a low potential for abuse relative to those
listed in Schedule III; currently have an accepted medical use in the United States;
abuse may lead to limited physical or psychological dependence relative to those
in schedule III. (examples - Valium, Butorphanol)
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Schedule V
 Drugs or other substances that have a low potential for abuse relative to Schedule
IV; currently have an accepted medical use in the United States; abuse may lead
to limited physical or psychological dependence relative to those in Schedule IV.
(example - Pregabalin, Not more than 100mg of Opium per 100ml, or per 100g)
III. Responsibilities
DEA and State Board of Pharmacy Registrants
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
1. Be in compliance with Federal and State Laws. (state laws can supersede federal laws to
make them more restrictive)
2. Have employees working with Controlled Substances fill out an employee questionnaire.
(See section V-“Employee Questionnaire”)
3. Assure Controlled Substances ordered through the department are stored in a way that
will not lead to theft or misuse.
4. Maintain proper record keeping for Controlled Substances.
5. Report any theft or loss of Controlled Substances.
6. Properly dispose of Controlled Substances.
IV. Controlled Substance Registration
Controlled Substance use in Washington requires registration with both:
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The Federal Drug Enforcement Administration
Washington State Department of Health Board of Pharmacy
Federal Drug Enforcement Administration
Every person that engages in research with Controlled Substances must be registered with the
Drug Enforcement Administration (DEA) or be an authorized user under a registrant. In some
instances, the registrant may be a unit or department. There are different activities that require
different registration types. Further, one registration type may not cover two different activities,
such as research with controlled substances and dispensing of controlled substances. The
required forms and detailed instructions are available on the DEA website:
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html
The following is a list of some types of registration for the Federal DEA:
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Research
For conducting research on, or with, narcotic and non-narcotic controlled substances in
Schedules II-IV. Mark the “Request Fee Waiver” box, then there should be no annual
registration cost. The DEA form # 225 is submitted for this type of registration, with the
following information required:
o Investigator - Name, address, institution, state license, and a qualifications
statement including a curriculum vita with bibliography for each investigator in
the research project.
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
o
Project - Title, statement of purpose, controlled substance name and amount
needed, location of research, security statement and a technical description of the
substance use.
Form #225A is used to renew this registration.
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Laboratory Chemical Analysis
DEA form # 225 provides authorization to conduct analysis with controlled substances
listed in any schedule. Form #225A is used to renew this registration.
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Dispenser of Controlled Substances- For Clinical Research
DEA form # 224 is used by private practitioners (physicians, dentists, veterinarians, nurse
practitioners, hospitals, and pharmacies) for clinical and hospital use. Form #224A is
used to renew this registration.
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Instructional Activity
DEA form # 224 is used to obtain a new instructional registration for instructional
activity only, and covers schedule II-V Controlled Substances. Form #224A is used to
renew this registration.
Washington State Department of Health Board of Pharmacy
In addition to registering with the Federal Drug Enforcement Agency, applicants in the State of
Washington must also register with the Washington State Department of Health Board of
Pharmacy. There is an annual registration fee (currently $40.00). The State fee cannot be
waived. Like the DEA, there are different registrations for different activities involving
controlled substances. Click here for Washington State controlled substance registration.
V. Authorized Use
The registrant is responsible for managing the controlled substances in accordance with the
requirements of the regulations including inventory, record keeping and security provisions.
Agents (designated employees) of the registrant may engage in approved activities under the
direction of the registrant. The registrant is strongly encouraged to screen employees prior to
authorization of work with controlled substances.
Employee Screening
DEA recommends that inquiries concerning employees' criminal records be made as follows:
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Local inquiries: Inquiries should be made by name, date and place of birth, and other
identifying information, to local courts and law enforcement agencies for records of
pending charges and convictions. Local practice may require such inquiries to be made in
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
person, rather than by mail, and a copy of an authorization from the employee may be
required by certain law enforcement agencies.
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DEA inquiries: Inquiries supplying identifying information should also be furnished to
DEA Field Division Offices along with written consent from the concerned individual for
a check of DEA files for records of convictions. The Regional check will result in a
national check being made by the Field Division Office.
Employee Questionnaire
The following questions should be included on a questionnaire* as part of the screening process
(21 CFR, 1301.90):
1. Within the past five years, have you been convicted of a felony, or, within the past two
years, any misdemeanor, or, are you presently charged with committing a criminal
offense?
2. In the past 3 years, have you knowingly used narcotics, amphetamines, or barbiturates
other than those prescribed to you by a physician?
Fill out one questionnaire for each employee who is authorized by the Principal Investigator (PI)
to handle DEA controlled substances under that PI's supervision. Make copies of the form as
needed for each employee who will be working with these substances.
Keep these questionnaires on file at the registered location. Keep a blank copy of this form in
your files for new hires to be completed before they are allowed to handle DEA controlled
substances. An example can be found here. (Click on “appendix B”)
*The questionnaire is recommended, but providing access to persons who would answer
“yes” to either or both questions is a violation.
VI. Ordering
Schedule I or II
Any person registered to conduct research with Controlled Substances in Schedule I or II must
send, in triplicate, DEA order form # 222. Contact the drug supplier when ordering a Schedule I
or II drug. The supplier will fax a copy of DEA form #222. After filling out the form, fax it back,
and the order will be filled. Instructions for ordering DEA form #222 can be found at:
http://www.deadiversion.usdoj.gov/faq/dea222.htm.
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
Schedule I that is not commercially available
Requests to obtain Schedule I Controlled Substances not commercially available must be made
to the National Institute on Drug Abuse (301-443-1124) or http://www.nida.nih.gov/).
Schedule III-IV
Obtaining Schedule III-V Controlled Substances may be handled by invoicing normal records.
Please assure that registration numbers for supplier and recipient are included on invoice.
*All invoices for controlled substances must be identified with a red letter “C”, no less than one
inch high on the bottom right corner of the invoice document.
VII. Record Keeping Requirements
The following records should be maintained at the registrant's location (as identified on the
registration):
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Employee questionnaire and authorization records
Executed order forms
Inventory records (must be kept a minimum of two years from date of record)
Drug dispensing records (must be kept a minimum of two years from the date of record)
If the registrant wishes to maintain records at a central location other than the registered location,
a notification must be sent to the DEA. More information regarding the information that will
need to be submitted in the notification can be found at 21 CFR (code of federal regulations)
1304.04.
Controlled Substance Tracking (an example tracking sheet follows this section)
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Records must be kept to track each container of Controlled Substances as well as records
that detail each time a Controlled Substance was used.
Every ml or mg of a controlled substance should be accounted for in the dispensing
records.
The tracking record must be bound and have sequentially numbered pages, and each
controlled substance should have its own record.
The drug tracking record must have an entry for each time any material was removed
from the container, including any quantity wasted or disposed, and initials of the user.
Records for Schedule I and II must be maintained separately from records for schedule
III-V.
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
Please note that it is a felony to provide a controlled substance to a person who is not
registered with the DEA, or is not one of your authorized users. All transfers of controlled
substances can only occur between two DEA registrants. Transfers of schedule I or II
controlled substances must be accompanied by a DEA form 222 completed by the registrant
receiving the substance(s).
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
Drug Control Record
Drug:
Bottle Serial No.:
Date Issued:
Date
Amount
Used
Vol.
Amount
Left
Animal ID No.
Investigator:
Procedure
User Initials
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
Inventory Procedures
Each person registered to handle Controlled Substances must complete an inventory annually as
required by the Washington Board of Pharmacy. The inventory should be:
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Maintained at the registered location (unless a notification has been sent to DEA
notifying that records will be maintained at a specified central location).
Available for 2 years after the substance is used or is disposed.
Updated on the effective date of a rule (from the DEA) when a substance is added to the
Schedule (list of controlled substances).
The inventory should have the following information:
For Controlled Substances in finished form (i.e. commercially bought)
An exact count of the dosage units must be made. Schedule I and II substances must be separated
from other substances on the inventory. The inventory shall include the following:
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2.
3.
4.
Name, address, and DEA registration number.
Date the inventory was taken.
Name of substance.
The form of the substance (i.e., 10-milligram tablet or 10-milligram concentration per
fluid ounce or milliliter);
5. The number of units or volume of each commercial container (i.e., 100-tablet bottle or 3milliliter vial);
6. The number of commercial containers of each substance form;
7. Sign and date form.
For each substance not listed above (i.e. damaged, defective or impure substances)
An exact count of the dosage units must be made, or the container must be graduated to reflect
its content. Inventory shall include the following:
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Name, address, and DEA registration number;
Date the inventory was taken.
Name of substance.
Total volume of substance or total number of units (i.e. 50 10mg tablets);
Reason for the substance being maintained by the researcher
Sign and date form.
An example of a Controlled Substance Inventory form can be found here
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
VIII. Security
Researchers are generally permitted to keep Controlled Substances in a substantially constructed,
double locked cabinet or safe.
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Schedules III-V, the Controlled Substance must be in a substantially constructed, double
locked cabinet or safe.
Schedules I and II, the Controlled Substance must in a substantially constructed, double locked
cabinet, with the cabinet secured to a wall or otherwise not removable.It has been
generally deemed acceptable to have the substances in a locked cabinet within a locked
room to satisfy “Double Lock”. However, final determination of acceptability would be
up to the field agent.
It is unacceptable to have the keys to the cabinet left in the lab. Keys allowing access to
the controlled substances must be in the possession of authorized individuals.
If there is a theft or loss of controlled substances, The Washington State University Police must
be notified as soon as the theft or loss is discovered. A DEA form 106 must be submitted to the
DEA and the State Administrator must be notified within 10 days of the discovery of the theft or
loss. DEA form 106 can be found at:
http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html.
IX. Disposal
When a DEA registrant has controlled substances that are expired or unwanted the registrant
must submit DEA Form 41 to the DEA prior to destruction (disposal) with the following
information:
1. Name, address of the facility wishing to dispose of the controlled substance
2. Name, address and DEA registration number
3. DEA Form-41, listing:
a. Inventory of drugs to be destroyed
b. Name of drug with strength
c. Quantity of drug
d. Technical name of controlled substance
e. Signature of DEA notification
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.
After submission of the DEA Form-41, use the EH&S Chemical Collection Request (CCR) to
arrange for the disposal of the substance. Be sure to indicate on the CCR that the substance is a
registered controlled substance. Contact EH&S at 335-9564 for additional assistance or questions
about controlled substance disposal.
X. Abandoned Controlled Substances
Under no circumstances are controlled substances to be abandoned by a DEA registrant.
However, occasionally, faculty will leave without appropriately disposing or transferring all
controlled substances from their lab. Sometimes the faculty acquired the controlled substance(s)
before registration was required. Under these circumstances, the department responsible for the
lab will need to contact EH&S to arrange for appropriate disposal. Depending on the situation,
one of two procedures will be followed:
If the faculty was a DEA registrant and it can be determined that the controlled substance(s)
were acquired through their registration, the department will need to complete a DEA Form 41
with a cover letter providing all the information required for disposal (see section IX), in addition
to explaining the circumstances as to why the registrant did not complete the Form 41. The
department should contact EH&S to arrange for disposal. If the substance is also regulated by
EPA or DOE, it will be disposed as prescribed by EPA or DOE.
If the faculty was not registered with the DEA, and/or the controlled substance(s) was
acquired prior to registration requirements (pre-1970 for many substances), the department
should contact EH&S for disposal. If the substance is also regulated by the Environmental
Protection Agency (EPA) or Department of Ecology (DOE), it will be disposed as prescribed by
EPA or DOE.
Any person who is registered with the DEA who violates record-keeping requirements or
abandons controlled substances will be subject to the civil penalties outlined in the United
States Code (USC): 21 USC Sec. 842. Please note that abandoning substances is equivalent
to distributing a controlled substance to an unauthorized person.
Disclaimer: This is an interpretation of State and Federal regulations under CFR 21, RCW 69, and WAC 246. Individual agents of
the Drug Enforcement agency (DEA) and Washington State Board of Pharmacy reserve the right to use their own discretion
when addressing the information contained herein.