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UNIVERSITY OF SOUTHERN MAINE
Office of Research Integrity & Outreach
Procedure #:
Date Adopted:
Last Updated:
Prepared By:
Reviewed By:
Procedure Title:
01-008
7/28/2003
8/18/2011
Sarah Gilliam, Animal Facilities Manager
USM IACUC Committee
DEA Scheduled Drug Storage & Control
1.0 Purpose: To ensure that all schedule II & III drugs are used, kept, and accurately
recorded in accordance with all applicable regulations. It is also intended to ensure
that no expired drugs are used on any animal within USM IACUC approved
protocols.
2.0 Responsibility: It is the responsibility of the investigator, technician, or student
performing the task to follow the procedures established in this document.
3.0 Applicable Documents or Information Sources:
3.1 Drug Enforcement Agency
3.2 Controlled Substances Act (21 USC § 801 et seq.)
3.3 Food & Drug Administration
3.4 Any information inserts include with pharmaceutical drugs
3.5 University of Southern Maine DEA License
4.0 Location:
4.1 All controlled substances are to be kept in a double lock box located either in
the procedure room or the animal facilities manager’s office.
4.1.1 Controlled substances involved in field studies are to be stored in a
mobile lock box, with an approved individual signing out keys,
drug(s), and the lock box.
5.0 Procedures:
5.1 All controlled substances & other regulated drugs will be stored in a double
locked box unless there is a need for refrigeration. If a substance needs to be
refrigerated then a double lock refrigerator will be supplied & located in an
appropriate area.
5.2 The animal facilities manager and one other assigned individual will hold
keys.
5.2.1 If keys are missing, the animal facility manager will notify the
appropriate individuals.
5.2.2 If keys are missing for longer than 72 hours, then the locks will be
changed.
5.3 A controlled substance access log will be kept and maintained by the Animal
Facilities Manager. This access log will list all individuals authorized to sign
out controlled substances. If the individual requesting the substance is not
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named on the access log, then they will not be allowed access to the requested
substance.
5.3.1 Authorized individuals are: those named in IACUC approved
protocols, those that hold a professional license, those that must
handle controlled substances via job function(s), and those allowed
by law.
5.3.1.1 Any person convicted of a felony or misdemeanor
involving narcotics, fraud, or theft must be removed from
the list.
5.3.1.2 Any individual can have their access revoked for failure to
follow IACUC approved protocols, for non-compliance
with this SOP, or for serious misconduct as defined in the
USM Policy on Misconduct.
5.4 Narcotic inventory records will be kept up to date with the amounts of each
substance available and the amounts of each substance used.
5.4.1 These narcotic inventory sheets will be kept in the appropriate
storage container until fully filled out, and then they will be kept
on file at the animal facilities manager’s office.
5.5 To obtain a drug for use in an IACUC approved protocol, the Animal
Facilities Manager must be notified ahead of time (preferably 24 hours). This
allows the manager to be sure that one of the two approved people will be
available to open the storage container and disperse the requested drug.
5.5.1 The person requesting the substance must record the amount used,
the amount remaining, and account for any discrepancies between
the two amounts.
5.5.2 If there are any unexplained discrepancies, then the Animal
Facilities Manager will follow steps 5.7.2 through 5.7.3.
5.6 Using controlled substances in field studies:
5.6.1 The investigator will sign out the mobile lock box, keys, and
needed substance from the Animal Facilities Manager (or assigned
individual) within 24 hours of when the drug is needed.
5.6.2 The controlled substance will be kept in the mobile lock box up
until it is needed and then returned immediately to the lock box
after it is used.
5.6.3 The investigator will record the drug used, the amount used, and
the patient information on the mobile lock box log.
5.6.4 The lock box, keys, and controlled substance must be returned to
the Animal Facilities Manager or assigned individual no later than
48 hours after signing out the lock box.
5.6.4.1 If a substance needs to be kept longer, then previous
arrangements should be made and noted in writing when
the substance is signed out.
5.6.4.2 If for some reason the lock box, keys, and substance cannot
be returned at the previously arranged time, then the
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Animal Facilities Manager (or designee) should be notified
as soon as possible and new arrangements made.
5.6.4.3 Any loss, theft, or destruction of the lock box, keys, and/or
substance should be reported to the Animal Facilities
Manager (or designee) immediately and documented. The
Animal Facilities Manager will then notify the appropriate
authorities and follow steps outlined in section 5.7.3.
5.6.5 Upon return, the remaining controlled substance will then be
logged back into the permanent double lock box located within the
Animal Facilities Manager’s office.
5.7 Once a month, the animal facilities manager will check the contents of each
lock box or storage container.
5.7.1 Any substance that is found to be expired will be clearly marked
‘DO NOT USE’.
5.7.1.1 As appropriate, the animal facilities manager will arrange
to have expired substances disposed of properly, in
accordance with DEA regulations.
5.7.2 All narcotic record sheets will be periodically checked for
accuracy.
5.7.3 If the narcotic sheets show any inconsistency, the animal facility
manager will try to reconcile the discrepancy.
5.7.3.1 If the discrepancy can be reconciled, no further action is
necessary.
5.7.3.2 If the discrepancy cannot be reconciled, the manager will
notify the IACUC Chair or designee and other appropriate
individuals (such as the USM Police). The manager will
also follow the procedures established in the
Incident/Injury Reporting section of the USM Policies &
Procedures for Biosafety.
01-008