Prescription medicines and legend drugs are those that have printed on the label "Rx only" or "Caution: not to be dispensed except by prescription." The State of Florida Department of Business and Professional Regulation (DBPR) regulates prescription medicines and legend drugs and requires that these drugs be ordered using a valid license, which EH&S has obtained. The license requires EH&S to collect information from researchers wishing to purchase Rx drugs using the license, and this information may be provided through the "Controlled Substance Request for Registration" form. Researchers who do not wish to order prescription drugs using the EH&S license may establish their own veterinary supply accounts and order prescription drugs directly from vendors. Researchers who choose to order prescription drugs directly from vendors must first obtain a license exemption for prescription drugs from the Department of Business and Professional Regulation. Prescription drugs must be kept in a secure location and a detailed use log must be kept.

Controlled Substances are drugs and chemicals that are regulated by the U.S. Drug Enforcement Administration (DEA) and DBPR due to the abuse potential associated with these compounds. Controlled Substances are classified as Schedule I, and Schedule II to Schedule V based on their potential for abuse. EH&S will aid each Principle Investigator (PI) in obtaining his/her license for the purchase of controlled drugs. Security requirements are more rigorous for Schedule I drugs, but all controlled substances must be kept in a secure location and a detailed use log must be kept.

Step 1: Fill out the "Controlled Substance Request for Registration" form to register for purchase of prescription drugs or controlled substances. The prescription drug registration is accomplished simply by filling out the form. The controlled drug registration is accomplished by filling out the form in two parts and submitting other information requested.

Using the information provided, EH&S will fill out an online DEA form requesting a controlled substance license.

Step 2: Make certain that you are in compliance with security issues as stated in your registration forms. EH&S can provide you with information to ensure you maintain compliance.

• Have the proper security (locked cabinet or safe, alarm system) installed in your facility. Contact EH&S for guidance on what to buy and how to install it.
• Make certain that each graduate student and employee who will handle controlled substances fills out the "Questionnaire for Employees or Affects Who will have access to Substances Regulated by the Drug Enforcement Administration ." Provide a copy of this form to EH&S and keep the original with your controlled substance inventory.
• Make sure that you have the appropriate inventory forms (these are provided upon transfer of the drug from EH&S to the researcher, or can be obtained from EH&S).
• A DEA agent will meet with you and inspect your facility and security measures. If approved, the DEA will provide you with a license number that will enable you to possess controlled substances. (You may wish to first meet with EH&S to review the information that the DEA will discuss in their applicant interview.)

Please note that additional information is available here.

Please notify EH&S for further instructions if any of the following apply

• Controlled substances will be administered to human subjects

• Investigator intends to manufacture or import a controlled substance

• Registrant desires to increase amount of controlled substance beyond the amount already approved by the DEA in a registered protocol

• Registrant desires to conduct research using controlled substances beyond the variation provided for in the registrant's approved protocol

• Registrant desires to dispose of unused quantities of any controlled substance

• Registrant intends to possess/purchase = 2.5gal Diethyl Ether

Controlled Substance Request for Registration
(form EHS 9-1)

Security Screening Form [doc]
Security Screening Form [pdf]
(form EHS 9-2)

Employee Questionnaire for Controlled Substance Access
(form EHS 9-3)

Drug Order Worksheet
(form EHS 9-8)

Safety Manual Information on Regulated Drugs, Pharmaceuticals, and Ether