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Quick Outline
for
Controlled Substance Licensure
and Management Process |
The use of controlled substances
is a highly regulated activity. To assist Duke researchers and trainers
with maintaining compliance, the following outline is provided. For
questions with this process, please call the OAWA @ 668.6720.
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REGISTER AT DUKE FOR USE OF CONTROLLED SUBSTANCES IN ANIMALS:
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FILE FOR A NORTH CAROLINA PERMIT:
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STEP 1: Complete North Carolina Department
of Health and Human Services (NC DHS) form 225. Submit NC DHHS Form 225
to the address listed on the form. Questions concerning the sate DEA
application should be directed to Ms. Jo Baker (919.733.1765). This form
is available for download from the Duke Animal Program Web Site:
http://vetmed.duhs.duke.edu/documents/controlled_substances/State_DEA_Form.pdf
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STEP 2: The licensing fee may be paid from
departmental or personal funds. You cannot use grant funds to pay for
this license! For specific questions, call 919.334.1218 and ask for
Evelyn Johnson. Ms. Johnson handles the processing of license
application fee payments. When paying by credit card, FAX a copy of the
DHHS form 225 with the credit card information below to Ms. Evelyn
Johnson (FAX number 919.334.1271):
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STEP 3: An agent of the NC DHHS will
contact the registrant and schedule an inspection of the proposed
holding site. The registrant can call Duke OAWA (919.668.6720) prior to
the scheduled physical inspection by the state agent and arrange a
pre-visit by Duke OAWA staff. This will assist the registrant with
location security or common DHHS concerns with controlled substance
management. If there are concerns noted by the DHHS agent during the
physical visit, you may request the agent accept photographs of the
corrected item, rather than requiring a return physical inspection.
STEP 4: Update the Duke registration database at the link
above.
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FILE
FOR A FEDERAL DEA LICENSE:
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STEP 1: Wait for the North Carolina State
License number BEFORE proceeding! The federal DEA WILL NOT
process a federal license until the state has granted a state
license. It may take many weeks to schedule an inspection by the
state agents, so PLEASE apply EARLY!
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STEP 2: Complete the Federal 225 form.
This form can be filed either on-line or hard copy. The DEA
preferred option is to file on-line. The link for filing on-line is:
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm
STEP 3: The federal agents require a physical
inspection for all Schedule I agents. Physical inspections for
Schedule II-V controlled substances may or may not be required.
STEP 4: Update the Duke registration database at the
link above.
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FEES: The cost of maintaining state and federal
registrations is the responsibility of the researcher using the
controlled substances. Fees are currently:
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NCHHS (state):
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DEA (federal):
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ORDER YOUR CONTROLLED SUBSTANCES:
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Schedule I:
These controlled substances are not available through DLAR. The
Schedule I registrant will legally procure these substances through
federally approved public vendors.
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Schedule II:
These controlled substances may be purchased through DLAR or a
public vendor. A DEA Form 222 is required to purchase these
substances from either DLAR or licensed public vendors.
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Schedule III – V:
Controlled substances for animal studies may be purchased from the
DLAR Pharmacy or licensed public vendors.
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MAINTAIN RECORDS: Keep records
in close proximity to the
controlled substances.
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Schedule I:
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Schedule II:
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Any written (paper) recording system may be used for
maintaining dispensing data, which includes:
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Name of the drug (may be in page
header)
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Source (may be in page header)
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DEA Catalog Number (4 digit DEA code
may be in page header)
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Date of expiration of the drug (may
be in page header)
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Date of receipt (may be in page
header)
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Unique identification number for the
bottle (may be in page header)
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Date of use
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Protocol (or project) for which it is
being used
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Animal (or group of animals) for
which it is being used
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Person dispensing the medication from
storage
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Person administering the medication
to the animal (s)
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Quantity (cc / ml / grams) of agent
dispensed
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Quantity remaining in the vial
/ bottle / box
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Purchase Log: Maintain a
Purchase Log
of drugs as you receive them. This specific log is not
mandatory, but a system of tracking purchases should be employed.
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Use Log: Maintain a
Use Log for each
controlled substance.
This specific log is not mandatory, but a system of tracking use
should employed.
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Quarterly Audit Log: Perform internal audits of inventory at least quarterly
using the
Quarterly Audit Log.
This specific log is not mandatory, but a system of tracking audits
should be employed.
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PROPER DRUG DISPOSAL:
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Schedule I:
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Expired drugs: The state and federal DEA
are presently re-evaluating their position of proper methods of
discarding these items. Until a new decision is reached,
please mix liquid agents with 'kitty litter' and discard in the
trash, discarding
of bottles in the sharps container.
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Controlled drug wastage /loss:
The state and federal DEA
are presently re-evaluating their position of proper methods of
discarding these items. Until a new decision is reached,
please mix liquid agents with 'kitty litter' and discard in the
trash, discarding
of bottles in the sharps container.
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Schedule II-V:
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Empty Bottles: All bottles should flushed
with water to prevent illegal use of minimal amounts in an empty
bottle.
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When purchased from DLAR: Empty bottles and a
copy of the log tracking sheet should be returned to DLAR
pharmacy.
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When purchased form a licensed pubic vendor:
Empty Schedule I substance bottles will disposed by the
registrant according to federal DEA requirements. Empty Schedule
II-V bottles may be disposed of via standard sharps/glass
disposal systems.
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Partial Filled Bottles (e.g. expired, waste,
or contaminated): The remaining material may be mixed with
an absorbent (e.g. kitty litter) and then disposed in standard
trash.
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Terminal amount in a syringe: For
controlled substances dispensed but not used for the reason they
were dispensed (e.g. 1 ml left over after the surgeries are
complete), the controlled substance agent may be disposed of (or
discarded) by any approved route, including denaturation,
dissolution, or dispersion. Disposal of unused product must be
witnessed by a second individual. The individual disposing of
the substance and the witness must both sign the controlled
substance log book. The log entry should include what was
discarded, when it was discarded, how much was discarded, and
who (printed name) discarded and who (printed name) witnessed
the disposal.
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Patches: The state and federal DEA are
presently re-evaluating their position of proper methods of
discarding these items. Until a new decision is reached, please
continue discarding patches in the sharps container.
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Reverse Distributors:
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For quantities of controlled substance (bottles
of expired agent or Schedule I substances), contact a DEA
certified reverse distributor for disposal. In North
Carolina, the approved reverse distributors are:
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ANNUAL RENEWALS WITH THE STATE OF NORTH CAROLINA:
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All Duke researchers are in the state system for
'Durham County.' This county has an annual renewal cycle of 1
November to 31 October. In approximately September of each
year, you should receive a reminder notice from NC DHHS to renew
your state license. If you have questions (or miss your
September notice), contact Ms. Joi Baker @ 919.733.1765.
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The annual renewal fee for the NC DHHS at present is
$125.00. This fee is payable by credit card or check, but must
be received prior to October 31 (for Duke researchers). You
will submit payment (check or credit card) to Ms. Evelyn Johnson.
For questions, contact Ms. Johnson's voice phone at 919.334.1218.
Documents and payment information may be FAXed to 919.334.1271.
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Required documents for renewal:
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Ms. Johnson will accept a phone call at 919.334.1218
for the credit card information, but a copy of the registration
certificate must be FAXED or mailed.
NOTE: To access ALL Duke, state, and
federal forms required for controlled substance licensure, please go
to
Index of Controlled Substance Forms
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UNIVERSITY
AND MEDICAL CENTER
