This procedure is in place to ensure that IPFW is in compliance with both State and Federal regulations concerning the use and handling of controlled substances. This procedure applies to Purdue University staff who utilize controlled substances while teaching or conducting research. Compliance will be accomplished by proper licensing with the State and the U.S. Department of Justice Drug Enforcement Administration (DEA), record keeping, inventory, and handling by University research staff.
Monitoring and Inspection
Radiological & Environmental Management (REM) is responsible for monitoring the record keeping, inventory, security, and disposal of controlled substances. Inspections will be conducted on an annual basis to assist you with controlled substances handling procedures and to assure University compliance with DEA regulations. If you have questions concerning controlled substances either contact REM or the Regional DEA Office located in Merrillville, IN, at 219-681-7000.
How to Register
Individuals must first notify REM of their intentions and then register with the State of Indiana for the use of controlled substances prior to registering with the DEA using the following links to instructions and forms:
Indiana State Board of Pharmacy Instructions and Forms:
DEA Registration Form:
- Ensure the information that you are providing is legible. We suggest that you complete the DEA registration online and then print your submission copy. (This site is listed on our DEA Controlled Substances web page)
- Obtain your Indiana Controlled Substance Registration (CSR) first. Make sure you remind the Indiana State Board of Pharmacy inspector to include your name on the CSR. This inspector will make a site visit to your lab prior to issuing the State CSR.
Note: The State does not inform the DEA Office when you are registered. You must attach a copy your State CSR card with the DEA registration form.
- Make sure you have the proper controlled substance schedule listed for the drug(s) you will be using. Also make sure you have listed the proper drug codes. They must coincide with the schedules requested.
CAUTION: The Indiana controlled substance schedules are the reverse of the Federal schedules! The drug schedule license you apply for on the Federal application must correspond to the drug schedule you are licensed for in Indiana (e.g. if your Indiana license shows you are licensed for Schedule 2N you would request a Schedule 2 license on the Federal application).
- When completing the DEA registration form, make sure the name and address are identical to those on the Indiana State license.
- Schedule 1 Controlled Substances registrations require specific application instructions: Contact Robert Golden at 41496 for instructions.
- Complete the "Fee Exemption" Section (section 10) on the DEA 225 form. Exemption from payment of application fee is limited to federal, state or local government operated hospitals, institutions and officials. The applicant's superior (i.e. your Department Head) or agency officer must certify exempt status. The signature, authority title, and telephone number of the certifying official (other than the applicant) must be provided.
- FAX 62572 or send your DEA application form to Robert Golden REM/CIVL. After REM has reviewed the DEA 225 form, the registrant will send the application form to:
Drug Enforcement Administration
United States Department of Justice
P.O. Box 28083
Washington , D.C. 20038-8083
Note: Every package sent to the DEA Washington location, especially bulky application packets, is subjected to a hazard analysis scan process. This Department of Justice security measure can add up to six weeks to your approval time frame. Send only the printed application; do not include other required information (see section 8 below) at this time .
- Once your application request has been entered into the DEA database, an agent from the Merrillville Regional DEA Office will contact you to request that you mail or fax to them the additional required documentation that will include:
- Controlled Substance Authorized User Signature List listing all staff who will have access to controlled substances
- Copy of your research protocol and/or a completed DEA research protocol information sheet
- Curriculum vitae
- Narrative covering how you will secure the controlled substances and how you will conduct inventories.
- Send all forms and documentation by registered mail. Keep a copy for your records.
DEA License Scope
Practitioner means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other institution or individual licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in Indiana.
A non-practitioner, in Indiana, would be anyone that performs research and does not have a practitioner's license. A researcher is classified as a non-practitioner and can only be registered as such. A non-practitioner cannot dispense or write prescriptions with a researcher registration, but can purchase and/or administer controlled substances. A researcher works under a protocol, which directs the specific actions and the specific drugs that may be used in the research protocol.
Agents are authorized employees or lab staff who act on behalf of the registrant. The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his/her business or employment.
Power of attorney; any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his/her behalf by executing a power of attorney for each such individual. The authorization forms and further information can be found in Title 21Code of federal Regulations Section 1305.07 (21 CFR 1305.07).