Boston University
Controlled Substance Program
February 2008
PREFACE:
The Boston University Office of Environmental Health and Safety (OEHS) is responsible for the
establishment and continuing review of an adequate controlled substance program at the University. The
purpose of the program is to provide faculty and laboratory directors with the training and resources
necessary to obtain federal and state approval required to work with controlled substances, and to ensure that
each laboratory properly manages all aspects of the work in compliance with federal, state, and local
regulations as well as BU policies. All users of controlled substances must be registered with the Office of
Environmental Health and Safety.
Ronald Slade, the Assistant Director for the Charles River Campus Office of Environmental Health and
Safety, serves as the Controlled Substance Administrator (CSA). The CSA is responsible for providing the
services outlined in this program. Copies of the Boston University Controlled Substance Program, as well as
the required forms and helpful links, are available through the OEHS at the following web page:
www.bu.edu/ehs.
Please call the Office of Environmental Health and Safety at 353-9734 with any questions concerning the
Controlled Substances Program.
Controlled Substance
A controlled substance is a drug or other substance that is specifically designated under the Comprehensive
Drug Abuse Prevention and Control Act of 1970 (21 USC 801 et. seq.). Controlled substances are listed on
five separate Drug Enforcement Administration (DEA) lists (Schedules), primarily by the substance’s
propensity to become addictive. The DEA also assigns a unique Code Number to each substance.
DEA controlled substances schedules are available at:
www.deadiversion.usdoj.gov/schedules/schedules.htm
Regulations
Two regulatory agencies, the United States Drug Enforcement Administration (DEA) and the Massachusetts
Department of Public Health, Food and Drug Division (DPH) govern the use of controlled substances for
research purposes. Boston University’s controlled substance program is designed to comply with all
applicable regulations, found in 21 CFR 1300 (DEA) and 105 CMR 700 (DPH). Copies of these regulations
are available in the Office of Environmental Health and Safety (OEHS). Important aspects of the rules
include:
 Controlled substances can only be purchased or obtained by registered users (both the supplier and
the purchaser must have State and Federal registrations).
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All use and storage must conform to the information reported to the DEA and DPH in the registrant’s
application. Use must be at the reported location.
Transfers of controlled substances are allowed only between registered parties, and each must be
authorized to possess the Schedule that is transferred. For example, a person who is registered for
Schedules III through V cannot accept Schedule I or II material from a registered colleague.
The BU Office of Environmental Health and Safety must be notified of all purchases and internal
transfers.
Disposal must be documented, and performed by a DEA authorized entity. BU OEHS will help
coordinate disposals.
Security and oversight are integral to the process. DEA and DPH inspectors make unannounced
inspections.
Controlled Substances Registration Process
Principal Investigators (PIs) who wish to use controlled substances must apply for and obtain registrations
from DEA and DPH. Registrations from each agency must be renewed annually. Regulations require strict
adherence to protocol for use of controlled substances in research. OEHS will assist PIs with the application
process.
Controlled Substances Registration Instructions:
Complete all of the following forms and then call the BU OEHS. The OEHS will schedule an appointment
with you to review the forms for accuracy prior to submittal of the applications. This will help to avoid
common errors that will result in processing delays. Registrants are responsible for maintaining copies of all
documentation with their records.
1. INFORMATION FOR DEA CONTROLLED SUBSTANCE APPLICATION
This allows OEHS to establish a file for the Controlled Substance user. OEHS will schedule periodic
inspections of the lab. This form is available through OEHS at
http://www.bu.edu/ehs/cs/pdf/Controlled_Substance_InformationSheet.pdf as well as in Appendix 1.
Submit completed forms to OEHS, located at 704 Commonwealth Avenue, 2nd Floor, Boston, MA
02215. Annual updates are required.
2. CONTROLLED SUBSTANCE PROGRAM RELEASE
This form must be completed by all lab personnel who will be permitted to have access to controlled
substances. Complete this/these form(s) and forward to OEHS. This authorizes Boston University to
conduct a background check on employees who have access to controlled substances. This form is
available through OEHS at http://www.bu.edu/ehs/cs/pdf/Controlled_Subtance_Program_Release.pdf
and in Appendix 2.
3. DEA CONTROLLED SUBSTANCE REGISTRATION APPLICATION (DEA FORM 225)
NEW AND RENEWAL
These forms are completed on-line, printed and then submitted by mail.
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For NEW Applications, go to the web site below and select ‘To Apply for New Applications for
Registration On-Line’. Select ‘DEA-225’ from the table for NEW applications. Complete the DEA
Form 225 ‘Interactive version’.
www.deadiversion.usdoj.gov
After OEHS review, send the completed form to DEA with a check for $184.00.
For RENEWAL Applications, go to the web site above and select ‘To Apply for Renewal
Applications for Registration On-Line’. Select ‘Log-in to Begin Renewal Process’
OEHS need not review your renewal application. Submit the renewal application with a $184.00 fee
either by mail or on-line.
4. APPLICATION FOR MASSACHUSETTS CONTROLLED SUBSTANCES REGISTRATION
TO USE CONTROLLED SUBSTANCES AND INVESTIGATIONAL NEW DRUGS IN
RESEARCH”.
This form is available on-line at www.state.ma.us/dph/dcp/dcpmcsr.htm. Go to Quick Links,
Registration Application Forms, Applications for Massachusetts Controlled Substances Registration,
Researcher or ctrl click on
http://www.mass.gov/Eeohhs2/docs/dph/quality/drugcontrol/app_researcher.pdf.
Complete the form and submit to OEHS for review. After OEHS review, send the completed form to
the Massachusetts Department of Public Health with a check for $150.00.
BU OEHS will assist in identifying security needs such as a safe or steel cabinet for Controlled
Substance users. You may also refer to the section following on “Security”. Contact Ron Slade,
Controlled Substances Administrator at:
rslade@bu.edu
BU Office of Environmental Health and Safety
704 Commonwealth Avenue, 2nd Floor
Phone 617 353-9734 Fax 617 353-5646
Summary of Submittals
The following bulleted lists are provided to summarize the documentation that should be prepared and
submitted as a part of the registration process:
1. Documentation for the Controlled Substance Administrator, OEHS
 Information for DEA Controlled Substance Regulation
 Controlled Substance Program Release
 Complete DEA initial registration package
 Complete MDPH initial registration package
 Initial registration certificates (State and Federal) when received
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
Annual renewal is the responsibility of the Registrant. A copy of a current State and Federal
registration must be attached to each drug order form submitted to OEHS for approval.
2. Documentation for the DEA
 DEA form 225 Application
 Check for $184.00
 Principal Investigator’s Curriculum vitae (short version)
 IACUC approval letters (not detailed Protocols)
 Documentation of method of security (safe or narcotics cabinet)
 Floor plan showing lab layout and storage location
3. Documentation for the MDPH
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MDPH Application
Check for $150.00
Principal Investigator’s Curriculum vitae (short version)
IACUC approval letters (not detailed Protocols)
Documentation of method of security (safe or narcotics cabinet)
Floor plan showing lab layout and storage location
Acquisition
Controlled substances must be ordered using either BU’s orange-colored Laboratory Requisition form and
include the Registration Holder’s signature. Orders for Schedules I and II substances must also include
accurately completed DEA Form 222s. Forms needed to complete a purchase include:
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BU Controlled Substance Protocol Order Form – Complete and sign (available in Appendix 3 and at
http://www.bu.edu/ehs/cs/pdf/Controlled_Substance_Protocol_Order_Form.pdf )
DEA Form 222 – Must be completed for Schedule I and II purchases (sample available in Appendix
4 and at https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp)
Standard BU Requisition Form with PI signature
Valid MA DPH and DEA registrations – Copy of each must be included with purchase requisition
form
All orders must be reviewed and approved by OEHS prior to submission to the Office of Purchasing
Services. OEHS will route requests to Office of Purchasing Services. Allow two weeks for order processing.
Electronic authorizations are available and will expedite the ordering process.
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Internal Transfers
Internal transfers of controlled substances between Registration Holders are allowed providing that each
holds a current registration with appropriate Schedule. The internal transfer is conducted using the same
procedure as a purchase, except that the BU Requisition form is not needed. OEHS will help to coordinate al
transfers. Remember:
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Complete all forms except BU Requisition forms
All transfers must be reviewed and approved by BU OEHS
Ensure that all inventory records are reconciled upon the transfer by both the sender and receiver
DEA Form 222 must be used when transferring Schedule I and II substances. (sample available in
Appendix 4 and at https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp)
Security
Depending on the quantities and type of controlled substances, security must include a safe or steel cabinet,
which follow DEA specifications. Access must be strictly limited. Controlled substances in use must be
under the direct supervision of a designated, responsible individual (e.g., Principal Investigator). OEHS will
help define specific lab requirements. General requirements include:
 All controlled substances must be kept in a double locked enclosure. Minimum requirement is a
double locked steel cabinet (drug box).
 Schedule I substances must have 750 lb safe (or safe bolted to floor) with central station alarm
 Access to storage and use areas must be strictly controlled
 All controlled substances must be under the control of a designated, responsible individual.
 Storage cabinet or safe must be adequately sized to maintain stock containers and waste materials.
One example of a TL15 compliant safe (resistant to burglary & radiological techniques) is shown below. It is
available in sizes from 1 cubic foot of storage (DXE 1212) and larger from Boston Lock and Safe (617-7873400, http://www.bostonlockandsafe.com/ ). This model, or an equivalent, is recommended.
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Record keeping
Registration holders must maintain the following records in a readily retrievable manner and submit certain
records to regulatory agencies as specified below. Records must be available for unannounced inspection.

Physical Inventories:
o Inventories must be current at all times.
o DEA requires biennial inventory reports
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Standard “Bound Book” Dispensing Log
o Numbered pages
o List of contents and page numbers
o Drug Name, how supplied, date, purpose of use
o Quantity on hand, quantity deducted or added to inventory
o Signature of individual authorized researcher for each transaction
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Receipts:
o Official order forms (Form 222) for Schedules I and II; invoices from wholesaler/supplier for
Schedules III through V.
o Blank Form 222s must be kept in safe.
Animal Protocols:
o Written animal protocols and approval letters from the Institutional Animal Care and Use
Committee (IACUC) are required if controlled substance use involves the use of animals.
o Otherwise, the Registration Holder or applicant must include a letter justifying the need for
the controlled substance in his/her research (included in application materials).
Personnel:
o Current records of personnel who have access to the security container(s) and personnel who
have access only to controlled substances.
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Disposal
Unwanted or outdated controlled substances must be sent to a DEA-registered disposal firm for destruction.
Contact OEHS for assistance.
Empty containers (using normal means) are disposed of as biohazard waste by OEHS during audits.
Registrants are not authorized to dispose of controlled substance containers.
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Keep your empty containers in security containment until the annual OEHS audit.
Make sure inventory is “zeroed” out
OEHS will inspect empty containers and documentation prior to defacing the labels and disposing of the
containers via the bio-hazardous waste stream.
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Termination
Registration Holders who wish to terminate registrations must dispose or transfer any controlled substances
in inventory, in accordance with applicable regulations, prior to termination. Actions to take include:
 Notify OEHS
 Send all remaining blank 222s and registration certificate to DEA
 Transfer inventory to BU registered user(s) or arrange for disposal
 Arrange for record retention
Reporting
Unexplained losses or thefts of controlled substances must immediately be reported to DEA and DPH upon
discovery. Contact the OEHS who will assist with the reporting requirement. Learn more here:
http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html
Training
OEHS will provide training for all current and future registration holders. Training will include an overview
and update of the regulatory requirements, including an explanation of each element of the controlled
substance program. OEHS will notify all Registrants of scheduled training programs.
Audit
OEHS performs periodic program audits including visits to each laboratory, interviews with the requisition
holders, and a review of recordkeeping. Recommendations for program improvements are developed and
implemented.
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APPENDIX 1
INFORMATION FOR DEA CONTROLLED SUBSTANCE
APPLICATION
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INFORMATION FOR DEA CONTROLLED SUBSTANCE APPLICATION
1. Principal Investigator:
Full Name:
Title:
Social Security #:
Date of Birth:
Mailing Address:
Telephone:
Home Address:
Telephone:
2. Describe where the controlled substances will be secured.
a. Address:
b. Room No. or Lab Name:
c. Floor:
d. Describe security to be used (e.g., safe, narcotic control cabinet, other steel cabinet)
e. Describe (and attach documentation if possible) of safe and/or cabinet.
f. Describe any other security provisions ( e.g., alarm, room locked off master, etc.)
3. Attach floor plan(s), noting location of all security provisions, such as a safe, alarm, etc.
4. List all information below regarding people who will have access to the security container(s):
Name
Title or
Position
Local Home Address
Social Security
(No P.O. Boxes)
Number
Date of Birth
5. List all information below regarding people who will have access to the controlled substance(s):
Name
Title or
Position
Local Home Address
Social Security
(No P.O. Boxes)
Number
Date of Birth
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6. List for each controlled substance (attach separate sheet if necessary):
a. Name of controlled substance
b. Purpose or use of controlled substance
c. Brief summary of nature of research
d. Maximum amount of raw stock to be possessed at any one time
e. Maximum amount of any diluted solutions to be possessed at any one time
F. the Boston University Institutional Animal Care and Use Committee approved protocol
number(s)
for the Principal Investigator’s research on
(date).
g. Grants from
support this research.
7. List the source(s) of supply.
a. Name of vendor(s) or institution(s)
b. Address(es)
c. Telephone number(s)
d. Name, address and telephone # of person(s) in charge of supplier(s) or point(s) of contact.
8. Attach a copy of the state controlled substance license issued by the Department of Public Health.
9. Signature of DEA license applicant____________________________ Date_______________
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APPENDIX 2
CONTROLLED SUBSTANCE PROGRAM RELEASE
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Controlled Substance Program Release
Federal and state laws relating to controlled substance licenses encourage employers to take all reasonable steps to reduce the
risk of drug security breaches. The United States Drug Enforcement Administration has issued regulations encouraging
employers to screen employees with access to controlled substances in order to reduce the risk, or likelihood, of criminal
activity or other unauthorized use of controlled substances.
Therefore, Boston University requests that you answer the following questions and execute the
release set forth below.
1.
Within the past five years, have you been convicted of a felony?
Yes
2.
No
Within the past two years, have you been convicted of a misdemeanor?
Yes
No
If the answer to either of Questions 1 or 2 is “Yes,” please furnish the details of the charge or
conviction, the offense, the location, the date, and the sentence, if any. Do not include references to any
traffic violations, juvenile offenses, or military convictions, except by General Court Martial.
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3.
Within the past three years, have you ever knowingly used narcotics, amphetamines, or
barbiturates, other than those prescribed to you by a physician?
Yes
No
If the answer to Question 3 is “Yes,” please furnish the details of your use of these substances.
Release
I,
[name],
authorize Boston University, pursuant to my work in an area where
access to controlled substances exists, to make inquiries of courts and law enforcement agencies for charges
or convictions, pursuant to 21 C.F.R. § 1301.90 and Massachusetts General Laws, c. 94C § 42. I understand
that the information disclosed or discovered as a result of any inquiry will not necessarily preclude
employment or continued employment, but will be considered as part of an overall evaluation of my
qualifications. I understand that any false information or omission of information will jeopardize my
position with Boston University.
I recognize that Boston University will treat the results of such inquiries in confidence, consistent
with fair employment practices and my right of privacy.
Date:
By:
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APPENDIX 3
BU CONTROLLED SUBSTANCE PROTOCOL ORDER FORM
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CONROLLED SUBSTANCE PROTOCOL ORDER FORM (for research only)
ONE FORM PER CONTROLLED SUBSTANCE ORDERED
This form MUST be typed
Date:
1
Principal Investigator (Last name, First name):
2.
Department:
3.
Building:
4.
Phone:
5.
Name of Controlled Substance Ordered:
6.
Schedule Number:
7.
Amount:
8.
Reason for use - Describe briefly, in the space below, the reason for ordering
(e.g. anesthesia)
9.
Grant Title:
10.
Place of Storage (Building; Room):
11.
Type of Storage (Safe):
I am fully knowledgeable of the rules and regulations promulgated by the Drug
Enforcement Administration (DEA) pertaining to the safe - keeping of controlled
substances scheduled 1,2,3,4, and 5 and agree to abide by them.
SIGNATURE OF P.I. ___________________________________________________________
SIGNATURE OF LICENSE HOLDER: ____________________________________________
Send this completed form to the Office of Environmental Health and Safety,
704 Commonwealth Avenue, 2nd Floor, with a completed requisition form
(and Form 222, if applicable).
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APPENDIX 4
INSTRUCTIONS FOR ORDERING CONTROLLED SUBSTANCES,
INCLUDING THOSE THAT REQUIRE A
DEA FORM 222
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Boston University
Office of Environmental Health and Safety
Instructions for Ordering Controlled Substances
In order to expedite the delivery of your DEA Controlled Substances, we have created this reference
document regarding information necessary to place orders for DEA Controlled Substances. Much of this
information was obtained from the 2006-2007 Sigma Catalog, pages 18-20.
Orders for controlled substances must be placed in writing on an official purchase order. Please note the
"ship to" address must exactly correspond to your name and address on the DEA registration. Your DEA
registration number must also be included on your purchase order (on initial order you must submit a copy of
your DEA registration for our files).
Orders for Schedule I and II DEA items
Orders for these items must include a complete DEA Form 222 (see sample below). We are not permitted to
fill orders in altered or incomplete order forms. The address on the Form 222 must match the address on your
DEA registration certificate. Remember to keep the bottom (blue) copy of Form 222 with your records and
follow its instructions.
Orders for Schedule III, IV, & V DEA items
Orders for these items must include a copy of your DEA registration number with your official purchase
order.
For All Orders:
1.
2.
3.
4.
5.
Complete and sign BU “Controlled Substance Protocol Order Form”
Attach completed form 222 for Schedule I and II
Attach copies of valid MA DPH and DEA registrations
Attach completed standard BU Requisition Form with PI signature
Forward to BU Office of Environmental Health and Safety:
Ron Slade, Controlled Substances Administrator
rslade@bu.edu
617 353-9734
BU Office of Environmental Health and Safety
704 Commonwealth Avenue, 2nd Floor
Fax 617 353-5646
Following is a list of the most common reasons that we are unable to process a DEA order upon
receipt. Please double check these items before submitting your order to Sigma-Aldrich, Inc.
1. The "No. of lines completed" is not filled out or filled out correctly (Remember it is the number of
lines on the form used, not the number of bottles you are ordering.)
2. Two lines on the 222 form are used for 1 product. (Remember you are only to use 1 line per
product.)
3. The date is not filled out.
4. DEA and/or DPH registration(s) have expired. (Remember to submit copies of your current
registrations to OEHS.)
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FORM 222
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No order form may be issued for Schedule I and II substances unless a
completed application form has been received, (21 CFR 1305.04).
See Reverse of PURCHASERS
Copy for Instructions
TO: (Name of Supplier)
CITY and STATE
L
I
N
E
N
o
1
2
3
4
5
6
7
8
9
10
3
OMB APPROVAL
No. 1117-0010
STREET ADDRESS
DATE
TO BE FILLED IN BY SUPPLIER
SUPPLIERS DEA REGISTRATION NO.
 Today's Date
TO BE FILLED IN BY PURCHASER
No. of
Packages
Size of
Package
1
2
2
250 mg
1g
10 mg

NO. OF LINES
COMPLETED
Date Issued
MM/DD/YY
Schedules
1, 2, 3, 3N, 4, 5
Registered as a
RESEARCHER
Name of Item
National Drug Code
Packages
Shipped

Cocaine hydrochloride
Thebaine
Phencyclidine hydrochloride
SIGNATURE OF PURCHASER OR

HIS ATTORNEY OR AGENT
DEA Registration No.
Name and Address of Registrant
AB1234567

YOUR INSTITUTUON
1 MAIN STREET
TOWN, STATE ZIP
No. of the Order Form
123456789
DEA Form - 222
(June 1983)
U.S. OFFICIAL ORDER FORMS - SCHEDULES I & II
DRUG ENFORCEMENT ADMINISTRATION
SUPPLIERS COPY
40147948
Instructions appear on the back of the form. Keep blue copy and send the tan and green copy and carbons to supplier.
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Date
Shipped
Fill in name and address of supplier
Fill in today's date
Fill in columns marked "No. of Packages", "Size of Package" and
"Name of Item". Use only one line per item ordered.




Supplied by the DEA. Do not change
Supplied by the DEA. Do not change
Sign with your Authorized Signature
Do not fill in. For Supplier only.
Fill in "No. of lines completed"
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