Controlled Substances & Pharmaceutical Products

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  • Occupational Safety & Risk Management
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  • It has come to our attention that the Florida Department of Business and Professional Regulation (DBPR) research exemption letter applications are taking up to 3 months to process. To avoid any disruptions with your research or DEA registration, we highly encourage you to start the DBPR application process at least 90 days before either (a) initiating new research, or (b) any current exemption’s expiration date. Also, please ensure it is completed using the online application. http://www.myfloridalicense.com/DBPR/drugs-devices-and-cosmetics/exemption-letter-research-teaching-testing/

    NOTE: Applications are accepted either by mail or the online portal.  Applications are not accepted via email or fax.  Online applications however are preferred.

    If your exemption has expired, it will not be considered “valid” for purchase, possession or for use of the drug products you may be using in your research. There is no extension or grace period, even if DBPR has not processed your application. Therefore, you may want to order ahead to stock up on needed supplies.

    Lastly, remember that in addition to the state’s DBPR exemption process, researchers must also comply with Federal DEA requirements if you use controlled substances. The DEA will not conduct their process until you either possess an approved DBPR exemption or, in the case of a renewal, that it has been submitted to the state.

    If you have any questions or concerns, please reach out to us at labsafety@ehs.ufl.edu.

    The Florida Department of Business & Professional Regulation (DBPR) enforces regulations related to the preparation, manufacture, repackaging, or distribution of prescriptions drugs, medical gases, active pharmaceutical ingredients, medical devices, and cosmetics. The Federal Drug Enforcement Administration (DEA) enforces regulations related to the importation, manufacture, distribution, possession, and use of controlled substances.To conduct research at UF involving any of these substances, Principal Investigators must:

    DEA Controlled Substances RequirementsAs an active DEA registration, you must:

    • Properly screen and document, using the Authorized Personnel Log and Questionnaire, the laboratory staff who will use the controlled substances for research under your registration.
    • Properly store controlled substances per DEA regulations.
    • Maintain all records for a period of 3 years (minimum)
    • Renew the DEA registration on an annual basis.
    • Properly dispose of unwanted or expired controlled substances through a reverse distributor. The PI must maintain a valid DEA registration to dispose of any controlled substance.
    • Report any theft or unaccounted significant losses to DEA (within 24 hours) using Form DEA-106 and to UPD.

    Required DocumentationDisposalUnwanted or expired controlled substances must be disposed of through a reverse distributor. The following is a list of DEA-registered reverse distributors in Florida:

    • Cavu Medical Products & Services LLC DBA Pharmatech Services: (813) 749-7113
    • Clean Harbors Florida LLC: (863) 519-6331
    • Express RX Returns: (954) 589-2386
    • PharmaLink: (800) 257-3527
    • Rx Return Services: (727) 754-7848
    • Rx Reverse Distributors Inc.: (772) 388-1212
    • Woodfield Distribution LLC: (561) 998-3885

    Resources

    Category Form/Template Notes/Requirements
    Category Form/Template Notes/Requirements
    Personnel Authorized User Questionnaire Certify each person (e.g., PI, lab personnel) who will handle controlled substances as part of a research protocol.  Registrants may chose to conduct a background check.
    Personnel Authorized User Log List each person (e.g., PI, lab personnel) allowed to handle controlled substances for research use as an authorized agent or authorized personnel.

     

    Include a date range for the authorization.

    Purchasing Form 222

     

    For Schedule I & II only – click here to order the form from the DEA.

    For Schedule I & II only

     

    Complete Part 1 & Part II of Form-222 and make a copy before ordering. Order your controlled substance and give the original Form-222 to the supplier. Retain the copy for your own records. Upon receipt of the substances, complete Part 5 with the date and amount received.

    Purchasing Invoices and Packing Slips Ensure invoice contains:

    • Name, address, and DEA registration number of registrant.
    • Controlled substance name, concentration, dosage form, and quantity.
    • Include signature of authorized personnel receiving the substance and date received.
    Inventory Initial Inventory Record controlled substances at a new storage location (including changes of address) immediately upon receipt of a DEA registration. Under inventory type, select “Initial.”

     

    If you have yet to store controlled substances at that location indicate, “Zero inventory – no controlled substances at present location.”

    Inventory Biennial Inventory List all of the controlled substances currently stored at the DEA registered location.

     

    Perform every two (2) years after receiving the DEA registration.  Keep the completed biennial inventory with the controlled substance records.

    Usage Records General Use Log Summarize the usage of a controlled substance from the time of acquisition to the end of use (e.g., administration and/or disposal), including recording expired or damaged controlled substances.
    Usage Records Diluted Solution Log Document the usage details for a controlled substance that has been withdrawn from its original container and mixed with a solution to dilute the concentration, including the:

    • Amount withdrawn
    • Waste amount (if applicable), and
    • Remaining balance through final disposal
    Disposal/Destruction Form 41 To be completed and filed with controlled substances paperwork when substance is destroyed. Unwanted or expired controlled substances must be disposed of through a reverse distributor or destroyed through EH&S on a scheduled controlled substances destruction day.
    Theft/Loss Form 106 Submit an online report within one (1) day of significant loss/theft. Must be completed by the DEA registrant.