Controlled Substance - FAQ

Controlled substances are narcotic and non-narcotic drugs under the jurisdiction of the Federal Controlled Substances Act (CSA) and the State of Iowa Controlled Substances Act, including, but not limited to, those substances listed in 21 CFR parts 1308.11-1308.15 . These are known as scheduled controlled substances or scheduled drugs under the CSA.

For the full set of regulations applicable to controlled substances, refer to 21 CFR Part 1300-END .

What are the DEA schedules or code numbers for the controlled substances?

The DEA assigns each controlled substance a schedule number (I through V) according to its medicinal value, harmfulness, and potential for abuse or addiction. A higher schedule number indicates the substance has more medicinal value and less potential for abuse or addiction. The letter "N" following the schedule number signifies the substance is non-narcotic (e.g. III N). The DEA drug code is a 4-digit number assigned to each controlled substance. Please check your registration information with IBPE and the DEA for the specific substances that are registered under your license. DEA controlled substances, schedule numbers, whether or not it is a narcotic and the 4-digit drug code number can also be found in the DEA orange book , (Google search “DEA drug code number”). The most common controlled substances used in research and respective schedule numbers and DEA codes are listed below.

Registration Related Questions:

What type of Iowa registration and DEA registration should a non-clinical researcher apply for if controlled substances are needed for research purposes?

According to University of Iowa policy, all non-clinical researchers must first acquire a State of Iowa ‘Researcher’ category license for using Schedule I-V substances by applying to the IBPE. After an IBPE license is acquired (anticipate up to 6 months for processing), submit your application for the DEA registration. Researchers must use the DEA Form 225 for classification as a licensed researcher. Please refer to 21 CFR Section 1301.18 for additional information on research protocols to conduct research with controlled substances.

Where can I find application information for registration of controlled substances?

Or contact IBPE at: Iowa Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E Des Moines, IA 50309-4688 Phone: (515) 281-5944

I am a licensed healthcare professional in UIHC and have a practitioner’s registration with the DEA. Can I use this registration to cover my non-clinical research that involves the use of DEA controlled substances, or should I obtain a separate DEA registration for research use?

Under University of Iowa policy, clinicians holding a clinical license must obtain a separate researcher license to perform non-clinical research using controlled substances.

Please note: controlled substances acquired under the ‘Researcher’ category license must not be used in clinical practice. This is the reason the Office of Animal Resources (OAR) cannot provide controlled substances to research staff. Please call the local DEA office (515-284-4700 or ext. 4709) if you need more guidance.

Do I qualify for the fee exemption for DEA or IBPE registration as a research investigator?

DEA Registration: Yes, as an employee of a state university, you qualify for a fee exemption. After answering this question, you will be asked to provide the name of the 'certifying official'. At the University of Iowa, that individual is the Sr. HR Leader for your Org/Department.

IBPE registration: No, neither practitioners nor research investigators are EXEMPT from registration fees. Research investigators are required to submit the registration fee for both an initial registration and renewal application, along with a check or money order payable to the Iowa Board of Pharmacy. Credit cards or cash are not acceptable forms of payment. The registrations must be renewed periodically. Contact the IBPE office (phone: 515-281-5944) for questions on IBPE rules and registration.

Can I charge the IBPE registration fees to my grant?

Yes. Controlled substance registration fees can be charged as a direct cost to a sponsored fund, if the licensed researcher’s sponsored project requires use of controlled substances.

Are research investigators required to obtain two separate registrations, one with the Iowa Board of Pharmacy Examiners and one with the DEA?

Yes. Research investigators are required to maintain registrations with both IBPE and the DEA.

I mistakenly entered my home address on Form 225. How do I correct this?

Information concerning the DEA registration process can be obtained from a DEA field office or by contacting the Registration Call Center at 1-800-882-9539. The DEA Registration Call Center is staffed from 8:30 a.m. to 6:00 p.m., Eastern Standard Time. During non-business hours, information is available through their automated Call Center menu.

Do I have to apply for separate registrations for Schedule I controlled substances and Schedule II-V Substances?

DEA Registration: Yes, research investigators must apply for a separate registration if the research involves both Schedule I and Schedule II-V controlled substances. For registration with DEA, separate applications must be submitted for Schedule I substances and Schedule II–V substances.

IBPE Registration: No, a single application should be sufficient for Schedule I and Schedule II-V substances.

Do I need to notify EHS prior to registration and registration renewal?

No. You are not required to notify EHS prior to your registration. The PI is ultimately responsible to maintain the required records. Licensed researchers may to maintain their controlled substances inventory within the EHS chemical inventory system and include the date of expiration. Utilizing this system will assist you in tracking when a drug is close to expiration. Be aware that in addition to maintaining your controlled substances inventory in the EHS chemical inventory system, you must also maintain records, as required by DEA.

How often do I need to renew my registration?

The DEA registration renewal is typically every year, based on the type of the activity (Title 21 Code of Federal Regulations (CFR) Part 1301.13). The IBPE registration must be renewed periodically or biennially, as required. The DEA and IBPE send renewal reminder letters to the licensed researcher.

I had an active DEA registration for a research project I was working on last year which has now ended. Can I just renew my registration in case I start another project which uses DEA regulated substances?

When licensed researchers are no longer conducting studies under an approved research protocol that authorizes use of DEA controlled substances, they should promptly surrender their respective DEA registration to the DEA to avoid potential civil or administrative penalties. DEA only approves registration to research investigators who have a current need to access controlled substances for use in their research. Similarly, you should keep the schedules of controlled substances specified on your DEA registration current with the DEA, and promptly remove any controlled substances that are not authorized in your on-going research.

Can a registration be transferred to someone else once a licensed researcher leaves the campus?

No. Registration and authority to use controlled substances are not transferable. Individuals who want to use a controlled substance in his/her research are required to be registered individually with the DEA and IBPE. DEA approval must be obtained prior to transferring any controlled substances to another research investigator. The transfer process is the same as one would use to purchase substances from an approved vendor or request a reverse distribution.

Must each individual research investigator obtain his/her own registration(s) or can a designated departmental investigator obtain registration(s) on behalf of several investigators within the same department?

Iowa registers individual researchers, not the department. Any research investigator that will be prescribing, administering, ordering, or dispensing controlled substances must individually register with the IBPE and with the DEA. Be aware that transfers of controlled substances between two licensed researchers are the same as the purchase of controlled substances from an approved vendor and therefore proper DEA procedures must be followed.

How do I change the address on my controlled substance license and the DEA registration?

IBPE registration: Contact IBPE at: Iowa Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E Des Moines, IA 50309-4688 Phone: (515) 281-5944

DEA registration: Use the online registration change form for change of address requests.

Note: you must first receive approval from IBPE for the new address before submitting a request to DEA. Also note that address change will become effective immediately upon DEA approval. Do not move the controlled substances from their current location to the new location until you have the approval from both IBPE and DEA.

What are the typical follow-up questions for which the DEA may require answers as part of its investigation prior to approving a “Researcher Application”?

Each Registrant should have the following information readily available and submit the information, if requested by a DEA investigating officer as part of the review of your application.

List all state and federal registrations.

Provide a list of individuals who have access (including who will receive the controlled substances) and/or will be conducting research with the controlled substances. Registrant must include the following information for each individual.

Provide a list of individuals responsible for controlled substance ordering, receiving, and record keeping. Registrant must include the following information for each individual.

Do you have any employee screening or do any background checks?

Provide a description of the main points of the Research Protocol in letter format.

Describe your experience in this field.

Provide a copy of your curriculum vitae or resume.

Describe your educational background and certifications.

Provide a List of all Suppliers

What are your hours of operation?

Who are going to be your customers?