DBPR – Pharmaceutical Products
| NOTE : There is currently a backlog with the FL Department of Business and Professional Regulation (DBPR) in issuing exemption letters for research involving pharmaceutical products and controlled substances. This delay has ranged from 3-9 months once applications are submitted. If you are planning on (a) conducting research with pharmaceutical or controlled substances or (b) any current exemption’s expiration date. We highly encourage you to start the DBPR application process as soon as possible. |
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. 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 will expire in two (2) years. Once close to expiration, re-application is required to maintain status for another two years.
- Upload DEA/DBPR Records
- How to use DBPR-DEA upload form guide
Applications are accepted either by mail or the online portal. Applications are NOT accepted via email or fax. Online Applications however are preferred and can be completed here: http://www.myfloridalicense.com/DBPR/drugs-devices-and-cosmetics/exemption-letter-research-teaching-testing/
- 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.
- 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.