fsu.edu | controlled substance licensing information

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 Health (DOH) regulates prescription medicines and legend drugs and requires an exemption from state licensing for researchers. This is acquired by writing a letter asking for the research exemption. The Department of Environmental Health & Safety (EH&S) will write the letter for you, and submit it to the appropriate DOH office, using the information you provide in the "Controlled Substance Request for Registration" form. Once we write the letter, obtain your signature, and send it to DOH, you should receive an exemption number in 2-3 weeks. 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 DOH due to the abuse potential associated with these compounds. Controlled Substances are classified as Schedule I, Schedule II…to Schedule V based on their potential for abuse. Most researchers will be required to have both a DOH exemption and a DEA license. EH&S will aid each Principle Investigator (PI) in obtaining his/her licenses 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. EH&S will use this information to write the DOH letter requesting a research exemption, print out the letter on your departmental letterhead, obtain your signature and submit to DOH for approval of exemption.

EH&S will also fill out the initial DEA form requesting a controlled substance license, obtain your signature and submit it to the DEA.

Step 2: Fill out the "Security Screening Form", if you need a DEA schedule I-V drug license. EH&S will submit this information to the local DEA District office.

Step 3: Make certain that you are in compliance with security issues as stated in your registration forms.

Have the proper security (locked cabinet or safe, alarm system) installed in your facility.
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 controlled substance inventory.
Make sure that you have the appropriate inventory forms (these can be obtained from EH&S).
A DEA and/or DOH agent will meet with you and inspect your facility and security measures. If approved, DEA/DOH will provide you with a license number that will enable you to possess controlled substances.

Please note that additional information and forms are available at our website at www.safety.fsu.edu/substancemanual.html.

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


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	Controlled Substance Licensing Information


Laboratory Safety Issues Tools and Information Controlled Substance Registration Controlled Substance License Renewal Research Animal Allergens Memo on Eating and Drinking in Laboratories Disposable Glove Selection Nanosafety Program Lab Guardian Laboratory Safety Links Forms Controlled Substance Request for Registration Security Screening Form Employee Questionnaire for Controlled Substance Access Controlled Substance Order/Receipt Log Controlled Substance Use Log Controlled Substance Spill Record Chemical Inventory pdf format doc format pdf format doc format pdf format doc format pdf format doc format pdf format doc format pdf format doc format xls format Policies Training Laboratory Manager Safety Presentation Laboratory Safety Training Lab Safety for your Research Anesthetic Gas Safety Training	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 Health (DOH) regulates prescription medicines and legend drugs and requires an exemption from state licensing for researchers. This is acquired by writing a letter asking for the research exemption. The Department of Environmental Health & Safety (EH&S) will write the letter for you, and submit it to the appropriate DOH office, using the information you provide in the "Controlled Substance Request for Registration" form. Once we write the letter, obtain your signature, and send it to DOH, you should receive an exemption number in 2-3 weeks. 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 DOH due to the abuse potential associated with these compounds. Controlled Substances are classified as Schedule I, Schedule II…to Schedule V based on their potential for abuse. Most researchers will be required to have both a DOH exemption and a DEA license. EH&S will aid each Principle Investigator (PI) in obtaining his/her licenses 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. EH&S will use this information to write the DOH letter requesting a research exemption, print out the letter on your departmental letterhead, obtain your signature and submit to DOH for approval of exemption. EH&S will also fill out the initial DEA form requesting a controlled substance license, obtain your signature and submit it to the DEA. Step 2: Fill out the "Security Screening Form", if you need a DEA schedule I-V drug license. EH&S will submit this information to the local DEA District office. Step 3: Make certain that you are in compliance with security issues as stated in your registration forms. Have the proper security (locked cabinet or safe, alarm system) installed in your facility. 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 controlled substance inventory. Make sure that you have the appropriate inventory forms (these can be obtained from EH&S). A DEA and/or DOH agent will meet with you and inspect your facility and security measures. If approved, DEA/DOH will provide you with a license number that will enable you to possess controlled substances. Please note that additional information and forms are available at our website at www.safety.fsu.edu/substancemanual.html. 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 (form EHS 9-2) Employee Questionnaire for Controlled Substance Access (form EHS 9-3) Possession and Use of Ether, Prescription or Legend Drugs, and Controlled Substances (OP-G-1.5.1)