Controlled Substances & Pharmaceutical Products
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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:
- Obtain a State of Florida exemption to use pharmaceutical grade substances or medical gases for research. The registration form can be filed on-line with the Florida Department of Business and Professional Regulations (DBPR). There is no fee for this exemption. The exemption letter must be renewed every two (2) years and an updated copy sent to email@example.com.
- File a DEA registration for controlled substances once the Florida DBPR exemption number is received. Registrations can be completed online using the 225 application. UF researchers are exempt from the DEA registration fees. Please enter the PI’s department chair or dean’s name under the “Official’s Name” on the application. Submit a copy of the registration to firstname.lastname@example.org.
DEA Controlled Substances Requirements
As 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 and submit the updated registration to email@example.com.
- 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.
|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.
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:
|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:
|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.|