Controlled Substance - FAQ

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?

State of Iowa: Download application from Iowa Board of Pharmacy Examiners (IBPE) website. 

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

DEA: Apply online

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.

• Include all Licenses and Certificates with the name, number and expiration date that are related to the research registration requested. Be prepared to provide a copy of all licenses.

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.

• Name 
• Title
• 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.

• Name
• Title
• 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.

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

• Contact name
• Address
• Telephone number
• DEA License number

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.

Explain in detail, the process for handling controlled substances from the time removed from storage until used in research.

Explain in detail, the procedures for preventing theft or loss of controlled substances; this could include limiting access, securing in a vault, perpetual inventory.

Provide a detailed description of the storage location for the controlled substances (including 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
• Security

 Provide a list of controlled substances including: the drug codes and the quantity of each controlled substance to be ordered and stored initially.

Could I be subject to an inspection?

Yes. Both the DEA and IBPE have the authority to oversee and inspect facilities before and after registration approval. Typically the DEA field office in Des Moines will conduct an announced inspection.

How do I order controlled substances? 

PIs with a ‘Researcher’ license or their authorized agents must determine the need for the controlled substances and sign all requisitions for controlled substances, regardless of dollar value. Manufacturers, suppliers or distributors require that all purchase orders for Schedule I and Schedule II substances be submitted using a DEA form 222.

Do I need to submit all orders for controlled substances via mail?

Please check with your distributor. For ordering Schedule I and Schedule II controlled substances, a copy of the licensed researcher’s DEA number and her/his registration must be submitted using a signed DEA form 222. DEA forms 222 are provided to the individual licensed researchers by DEA upon an online request. Purchase orders for Schedule III-V drugs should be placed by providing a copy of the investigator’s DEA registration to the distributor.

A controlled substance is backordered by Sigma-Aldrich and my current supply will not be sufficient for my ongoing studies. What should I do?

Proper attention to the inventory of controlled substances in a laboratory should typically prevent shortages from occurring. If a controlled substance is backordered at Sigma-Aldrich, for example, the licensed researcher or an Authorized Agent of the licensed researcher should contact the DEA to obtain permission to order the controlled substance from an alternate distributor. Be aware that borrowing a controlled substance from other licensed researchers who are not part of the research project is against DEA regulations.

Can I transfer controlled substances to another authorized PI at the UI?

Yes, but only after receiving approval from the DEA and only if the following criteria are met: (1) the authorized PI who is to receive the substance(s) (purchaser) must first receive DEA approval for any Schedule I and II transfers, and (2) both parties maintain proper documentation for any approved transfers (including Form 222 for Schedule I and II drugs). The transfer process is very similar to the purchase of controlled substances from an authorized distributor.

The “purchaser” must first complete an Initial Inventory Form if this will be the first time the drug is obtained; the amount should be “0”.

For all Schedule I and II drugs:

• The Purchaser must order the DEA Form 222.
• The Purchaser must complete DEA Form 222 and list any Schedule I and II drugs that are to be transferred. The PI who will transfer the drugs is considered the vendor/source/supplier.
• DEA Form 222 is sent to the address on the Form.

For Schedule III, IV, and V drugs:

• The Purchaser must create a purchase invoice that lists at a minimum: (1) schedule of drug, (2) name of drug, (3) strength of drug, (4) form (liquid, powder, tablet), (5) number of full and partial containers – if partial, then known or estimated amount remaining, and (6) date drugs are acquired.
• The invoice does not get submitted to the DEA. It should be stored with the other controlled substance records for a minimum of 2 years.
• Within 24-hours after the transfer occurs, the Purchaser must complete the Annual Inventory Form and maintain the record for 2 years.

Can I transfer controlled substances to an individual at another University or institution? 

Such transfers are not recommended. A better way for such transfers is via reverse distributors who ensure the proper paperwork and documentation for physical transfers. Principal Investigators needing to perform such a transfer must contact the DEA in advance; Investigators will be responsible for ensuring proper documentation is maintained and all procedures are followed.

What specific records must be maintained after obtaining IBPE license and DEA registration for receiving, storing, and administering controlled substances?

To achieve compliance with IBPE and DEA mandated regulations, the PI or an authorized agent must oversee the processes described below.

Each registrant must have the following documents:

• Initial Inventory: New registrants - record 0 for the inventory, as no inventory should be on hand when the new registrant receives approval. Record must be maintained for the first two years.
• Annual Inventory: Upon receipt of the first purchase of controlled substances, record this new inventory. Annual inventory is required by the IBPE while the DEA is biennial; however, DEA is currently enforcing the IBPE requirement.
• Purchase invoices
• Record of Distribution/Use: each controlled substance should be logged on a separate form.
• Disposal records: when controlled substances have been disposed/destroyed.
• For Registrants using controlled substances for animal studies:
  • A standard operating procedure that states how controlled substances will be transported through public spaces from the storage area to the procedural area(s).
  • A copy (could be electronic) of each Animal Protocol for which the registrant provides controlled substances.

NOTE: example documents of all bolded items can be found within the Controlled Substances Manual.

What are the elements of inventory requirements for controlled substances?

Each licensed researcher is responsible for his/her own annual inventory. Typical inventory checks involve: 1) hands-on inventory count; 2) completed in a single business day, i.e., before the start of the work day or at the end of the work day; 3) at least two authorized personnel (licensed researcher and authorized agent or two authorized agents); and 4) use of an in-house developed inventory form and dispensation/disposal records.

Do I need to keep separate logs for aliquoting a controlled substance?

This practice is highly recommended. Once a controlled substance is used to make a dilution, it is important to track the usage, disposition and disposal of the new dilution which contains a controlled substance. An appropriate entry should be recorded on the original stock bottle's controlled substance aliquot log and a new dilution log. The stock vial must be trackable from purchase through disposal.

How long do I keep the copies of my controlled substance usage logs?

You must keep these for two years after the final disposition of the controlled substance. The logs must be readily available for review by IBPE and/or DEA.