What are “controlled substances?”
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.
What does the controlled substance program include?
The major elements of the controlled substance program include project registration, procurement, storage and security, usage and disposal of unused, expired and waste containing controlled substances, and inventory procedures.
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 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. The DEA schedules and corresponding DEA numbers can also be found in the DEA orange book. The most common controlled substances used in research and respective schedule numbers and DEA codes are listed below.
|Controlled Substance||Schedule||DEA Code|
|Pentobarbital (e.g., Nembutal)||II N||2270|
Who is considered a Licensed Researcher?
‘Licensed Researcher’ refers to the Principal Investigator (PI) throughout this document and is someone who possesses a ‘Researcher’ category license through the DEA and IBPE.
Who is an Authorized Agent?
An Authorized Agent is an individual who has the complete trust of a DEA registered individual (licensed researcher). An authorized agent (with authorization from the licensed researcher) may oversee the ordering, dispensing and management of the controlled substances in the absence of the licensed researcher. To minimize the risk of drugs being diverted, only 1-2 individuals in a laboratory should be provided the status of an authorized agent. Licensed researchers are ultimately responsible for the management of controlled substances acquired under their DEA registration or license. Only the licensed researcher and authorized agents can have a key or the combination to access a safe or locked cabinet where controlled substances are stored. Only authorized agents are permitted to know the licensed researcher’s respective registration number and order controlled substances on her/his behalf.
Who are Authorized Laboratory Personnel?
Authorized Laboratory Personnel are research staff, including graduate students and postdoctoral scholars that work under the direct supervision of a licensed researcher. In addition to the licensed researcher and authorized agents, the authorized laboratory personnel (also known as daily users) may participate in working with controlled substances as part of the approved experiments or treatments involving research animals. Authorized laboratory personnel can perform these functions without keys or combination access to the safe or cabinet where bulk quantities of controlled substances are stored. Licensed researchers or their authorized agent must take responsibility for dispensing limited quantities of controlled substances to authorized laboratory personnel for daily use and maintaining unused substances in the safe or locked cabinet for proper storage. Licensed researchers are ultimately responsible for the management of controlled substances acquired under their DEA registration or license.
What type of Iowa registration and DEA registration should a non-practitioner researcher apply for if schedule II-V controlled substances are needed for research purposes?
A non-practitioner researcher must first acquire a State of Iowa ‘Researcher’ category license for using schedule II-V substances by applying to the IBPE. After an IBPE license is acquired (anticipate 4 to 8 weeks 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?
State of Iowa: Download application from Iowa Board of Pharmacy Examiners (IBPE) website.
Or contact IBPE address listed below.
Iowa Board of Pharmacy Examiners
400 S.W. Eighth Street, Suite E
Phone: (515) 281-5944
I have an office in the UIHC, but my laboratory is located in University Research Park. What should I use as the address for my DEA registration?
- The DEA regulations require that licensed researchers have a separate DEA registration for each location where controlled substances are received, stored or used.
- If you are using DEA controlled substances in different rooms within the same building, but only storing controlled substances at one location within a specified building, then your registration need only reflect the storage location.
- If you are planning to receive, store or use DEA controlled substances in more than one building or you are storing DEA controlled substances in more than one location within the same building, then you must have a separate DEA registration for each building and storage location. Registrants should arrange to have secured storage boxes in each location, storage locations included on their DEA registration, and maintain records at each location where substances are used/stored that document the inventory, dispensing and using of substances, etc.
- To minimize the need for transferring controlled substances between multiple registrations held by a single licensed researcher, the researcher should order the controlled substances that will be needed for each separate building/building location under the appropriate registration for such building/building location.
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?
While a DEA registration held by a practitioner may permit research use of the specified DEA controlled substance(s), the DEA registration is specific to a certain location where the controlled substances are received and stored. If you do not store controlled substances at your practice location, you may be able to maintain the single registration for the research location where the chemicals are received and stored. However, controlled substances acquired under the ‘Researcher’ category license must not be used in clinical practice. Note, 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.
When a researcher is registered as a clinician through DEA form 224 and no storage location is declared, the registration must be amended to add this information. This can be done online; for any questions about amending the form, contact the DEA office in Des Moines at 515-284-4709. Do not call the federal or regional office!!
If the storage location is not specified prior to an audit by DEA agents, you could face penalties. You will avoid such penalties by amending your registration online to declare the storage location. Please note that the storage location does not have to be the same as the mailing address. In addition, note that you must maintain your controlled substance records at the location where the substances are stored.
Do I qualify for the fee exemption for DEA registration as a research investigator?
Yes. As an employee of a state university, you are qualified for 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 Susan Klatt, University Secretary. Her phone number is: 319-335-3552 and email: email@example.com
Do I qualify for the fee exemption for the IBPE registration for controlled substances?
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. You should contact Terry Witkowski at the IBPE office (phone: 515-281-6676) for questions on IBPE rules and registration.
Can you confirm that research investigators are 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?
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. For registering with IBPE, 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. However, you are ultimately responsible to maintain the up-to-date inventory of controlled substances after each purchase and disposal of chemicals. Licensed researchers are encouraged 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 date. 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 protocol I was working on last year which has now ended. Can I just renew my registration in case I start another protocol 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. It is against the IBPE and DEA rules and regulation to share or transfer the controlled substances to ‘other research investigators’ without the prior DEA approval. Other research investigators include faculty members in different collaborative projects working within your building, department or college. Similarly, licensed researchers must not store or use the controlled substances purchased under another investigator’s license without a DEA approved transfer.
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 her or his own registration(s) or can a designated departmental investigator obtain registration(s) on behalf of many other 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. Please 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.
If two different principal investigators are using the same controlled substances for the specified purpose as stated in the registration and the substances are used within the building and stored in a single location within that building, then the primary licensed researcher can assign the other investigator as the authorized agent, if the usage falls within the work described in the DEA application.
Can I charge the IBPE registration fees to my grants, if any?
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.
How do I change the address on my current address listed in controlled substance license and the DEA registration?
For IBPE registration changes requests: Use the Iowa registration change form 48.
You can also contact the Iowa Board of Pharmacy Examiners at the address below.
Iowa Board of Pharmacy Examiners
400 S.W. Eighth Street, Suite E
Phone: (515) 281-5944
For DEA registration change requests:
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.
- Licenses and Certificates include the name, number and expiration date that are related to the research registration requested. Please provide a copy of all licenses.
Provide a list of individuals who have access and or will be conducting research with the controlled substances. Registrant must include the following information for each individual.
- Work address
- Work telephone Number
- Date of birth
- Social security number
- Place of birth
Provide a list of individuals responsible for controlled substance ordering, receiving, and record keeping. Registrant must include the following information for each individual.
- Work address
- Work telephone Number
- Date of birth
- Social security number
- Place of birth
Do you have any employee screening or do any background checks?
- If the DEA application is new, answer "No" The DEA will do a background check, if needed.
Provide a description of the main points of the Research Protocol in letter format.
What is 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
- Contact name
- Telephone number
- DEA License number
Who will receive the controlled substances at your location?
What are your hours of operation?
Who are going to be your customers?
- Examples include:
- I am going to use ketamine for anesthetizing animals for experiments.
- I am going to use as a reference standard in analysis of environmental samples or biological specimens.
Will someone besides you, Secretary, Receptionist, or other employee be receiving packages? If so, the investigator will need all information as reported under the question number 2 of this investigator checklist
Explain in detail the process of handling Controlled Substances from the time removed from storage and used during research.
Explain in detail the procedures for preventing theft or loss of Controlled Substances, such as limiting access, secured in a vault, perpetual inventory (these are typical).
Provide a Detailed description of the storage location for the controlled substances such as storage room, vault, locker, etc.
- Room number
- Square footage of storage location
- Square footage of research location
- Construction material of vault
- What security devices are installed? (contact switches, motion detectors, cameras, etc.?)
- What is the type of lock on the door?
- What is the construction of the storage unit where controlled substances are stored?
- What type of lock will the storage unit have on it?
- What type, model, serial number, and name of safe/cabinet which is used to store controlled substances?
- List the name, address, and contact information for the security company or campus police?
Do you have an alarm system?
- Unless your controlled substances are stored in a vault (e.g., UIHC Pharmacy), the typical answer would be "NO" However, you can provide additional information, such as, limited access to the room where controlled substances will be stored in a locked drug cabinet, padlocked refrigerator, etc.
List the first and last name of responsible person for:
- Ordering controlled substances (DEA 222 forms)
- Record keeping
Provide a list of Controlled substances including: the drug codes, and the quantity of each controlled substance to be ordered and stored initially.
Provide incorporation documents and/or a list of corporate officers if applicable.