APPLY FOR YOUR STATE DHHS (North Carolina DEA office) LICENSE:

• Complete North Carolina Department of Health and Human Services (NC DHS) form 225.   This form is a available for download as the NC DHHS Form, 225 on the Duke Animal Program Web Site.

• Paying for the state license:   The licensing fee may be paid from departmental or personal funds (you cannot use direct grant funds). The recommended method is to use the Duke issued Credit Card for license fee payment, and then IR the funds to the appropriate department account. When paying by credit card, FAX a copy of the DHHS form 225 with the credit card information below to Christina Baker @ FAX number 919.334.1271:

  • Visa or Mastercard

  • Credit card number

  • Expiration date on the card

  • Name on the card

  • Phone number of the card holder (just in case there is a problem)

• For specific questions, call 919.334.1201 and ask for Christina Baker. She handles the processing of license applications. 

• Submit NC DHHS Form 225 to the address listed on the form. 

• Site Inspection by NC DHHS Agent:

  • Schedule I agents:  Requires a physical inspection of the site prior to issuing a license.

  • Schedule II - V agents:  The NC DHHS may forgo a physical inspection if pictures accompany the license application which adequately demonstrate appropriate storage and security measures for the controlled substances.  What pictures should you send with your state application? We suggest providing one photo of the open cabinet; a second photo showing the cabinet location and the 'first lock' security; and a third proto showing the 'second lock' security. 

• Wait for the North Carolina State License number BEFORE filing for a federal license!  The feds WILL NOT grant a federal license until the state has granted a state license.

APPLY FOR YOUR FEDERAL DEA LICENSE:

• Complete 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

• Site Inspection:

  • Schedule I agents:  Requires a physical inspection of the site prior to issuing a license.  May (or may not) be conducted at the time of the state inspection.

  • Schedule I - V agents:  A physical inspection by the Federal DEA is not usually required for schedule II-V controlled substances prior to issuing a license number. In most instances the Federal DEA will accept the NC DHHS approval.

• Wait for the federal DEA license

INPUT YOUR CONTROLLED MANAGEMENT INFORMATION:

• Go to the Duke Controlled Substance Wed Database.  Log your list of controlled agents The web address is: http://www.safety.duke.edu/ControlledSubstances/ControlledSubstances/DEASubstances.aspx  at your convenience, prior to 1 March, please enter the information as requested.

• Update annually or when changes occur.

ORDER YOUR CONTROLLED SUBSTANCES:

• Order your controlled substances through DLAR, a DEA licensed public vendor, or the federal supplier.  if you order controlled substnaces through DLAR, then ... 

  • For Schedule II:  Requires an IR AND the DEA form 222 (example available here)

  • For Schedule III-V, Requires an IR (example available here). 

• Order your controlled substances through any DEA licensed vendor or federal supplier.

MAINTAIN RECORDS:  Keep records in close proximity to the controlled substances.

• Schedule I:

  • Schedule I controlled substance records need to be maintained in a permanently bound notebook. 

  • The records should include the following information: Name of the drug; Source (vendor source or DLAR); Date of Expiration of the drug; Date of receipt; Date of use (or withdrawn for use); Protocol (or project) for which it is being used; Animal (or group of animals) for which it is being used; Person dispensing the medication from the cabinet; Quantity (cc or ml or grams) of agent dispensed; Quantity remaining in the vial / bottle / box; Unique identification number for the bottle.

• Schedule II:

  • Schedule II-V controlled substance records can be maintained in a three-holed loose leaf binder. A suggested template for a Controlled Substance Use Log is available for use.

  • The records should include the following information: Name of the drug; Source (vendor source or DLAR); Date of Expiration of the drug; Date of receipt; Date of use (or withdrawn for use); Protocol (or project) for which it is being used; Animal (or group of animals) for which it is being used; Person dispensing the medication from the cabinet; Quantity (cc or ml or grams) of agent dispensed; Quantity remaining in the vial / bottle / box; Unique identification number for the bottle.

• Purchase Log:  Maintain a Purchase Log of drugs as you receive them.  This specific log is not mandatory, but if you choose not to use this document, then something similar is necessary to properly track purchases.

• Use Log: Maintain a Use Log for each controlled substance.

  • If you purchase controlled substances from DLAR, they will give you individual log sheets for each uniquely numbered bottle.  Use this log sheet, and keep a copy in your records when you return the bottle to DLAR pharmacy.

  • If you purchase controlled substances from a DEA approved vendor (not DLAR), then uniquely number the bottles when you receive them and maintain your own log sheets (select the link for Use Log above for a suggested template). 

• Quarterly Audit Log:  Perform internal audits of inventory at least quarterly using the Quarterly Audit Log or any similar document to track your auditing of controlled substance use. 

PROPER DRUG DISPOSAL:

• Schedule I:

  • Empty and 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 continue discarding down the drain for liquid agent, mixing powders with liquid and then discarding, and discarding of bottles in the sharps container.

  • 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 continue discarding down the drain for liquid agent, mixing powders with liquid and then discarding, and discarding of bottles in the sharps container.

• Schedule II-V:

  • Empty bottles:

    • If you have emptied a bottle that was purchased from DLAR, return the bottle and the log sheet to DLAR pharmacy, but maintain a copy of the log sheet for your records.

    • If you have emptied a bottle that was purchased from an outside vendor, place the empty vial in the sharps container, and maintain the log sheet for your records.

  • Expired substances:  If you have expired drugs (regardless of where they were purchased), return them to the DLAR pharmacy.

    • If you purchased them from DLAR, return the log sheet with the bottle while maintaining a copy of the log sheet for your records.

    • If you did not purchase the agents from DLAR pharmacy, then give the DLAR pharmacy the expired drug and a copy of the log sheet' keep a copy of the log sheet in your record book.  Both you and the DLAR technician receiving the controlled substance will sign verifying the volume transferred.

  • Controlled drug wastage (i.e. excess drug removed for experimental purposes but not needed) and loss (i.e. broken vials etc) need to be logged on the log sheet and initialed by a witness. Excess drug should be wasted by empting the syringe into the sharps container (do not place syringe with drug in the sharps container, but rather squirt drug into the container).

  • 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.

  NOTE:  To access ALL Duke, state, and federal forms required for controlled substance licensure, please go to  Index of Controlled Substance Forms