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?

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 Susan Klatt, University Secretary.  Her phone number is: 319-335-5084 and email: susan-klatt@uiowa.edu

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 the Iowa Board of Pharmacy Examiners at the address below.

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.


Background Screening:


Who must undergo a security screening/background check and how does the screening process work?

As part of the DEA registration, every ’Researcher’ category registrant is required to undergo a background check/screening conducted by the DEA when the application is submitted.  No additional screening is required by the University.  

Staff members (authorized personnel/daily users) working under a licensed researcher are not required to complete a DEA background/security screening.  Therefore, each licensed researcher is responsible for checking staff’s credentials, authorizing specific roles, and providing required training for handling controlled substances. For any questions related to security screening checks of University employees, please contact the following University of Iowa administrative offices:

  • University Human Resources, 335-3558.
  • Deputy Counsel in the Office of the General Counsel, 335-0400.

 

Authorized agents and authorized laboratory personnel in my laboratory are employed by VA Medical Center and are not the University employees. Do they need a background check?

It depends on the VAMC’s employment policy. The University of Iowa DEA-licensed researcher is ultimately responsible for checking the individual credentials for handling the controlled substances.  Any individual (including authorized agents and/or authorized laboratory personnel and graduate students employed at VAMC) who handle controlled substances in University of Iowa laboratories under the direction of the licensed researcher must be authorized by the University of Iowa licensed researcher.

I am a Principal Investigator and will be identified as a ‘Researcher’ in the DEA application for a research study, but I don’t plan to personally use the controlled substances.  Do I still need to complete a DEA background check? 

Yes. If you are listed as the ‘Researcher’ in the DEA application you must answer all liability questions in the DEA application form (Section 5- Liability). As the licensed researcher, you have the overall responsibility for the research project and for overseeing the safety and security of all research materials; consequently, you must fully answer the liability questions in the initial and renewal applications. 

As the licensed researcher, do I need to notify anyone if an authorized agent or authorized laboratory personnel transfers to another lab or leaves the University?

No. There is no need to notify the DEA or EHS if an authorized agent or authorized laboratory personnel terminates employment with a given laboratory or with the University. Licensed researchers are ultimately responsible to ensure the security of the controlled substances under their license; therefore, keys/combinations for storage areas must remain secure and only known to current authorized agent(s).


Purchasing/Transferring Controlled Substances:


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.


Storage and Security:


The DEA says that I need to double-lock my controlled substances.  What does this mean?

Controlled substances must be behind two locks at all times. Within the laboratory, controlled substances must be secured within a locked cabinet or safe that cannot be moved or transported.  More detailed information can be found within the Controlled Substances Guideline on EHS’s website under: Chemical Safety/Controlled Substances. 

The University’s Work Control Center can help you install a locked cabinet or safe that is required to be bolted in a secured fashion.

Is there a supplier of double lock storage cabinets for controlled substances?

Standard “narcotics cabinets” can be purchased through a variety of resources, e.g. Health Care Logistics, Harloff, or Medicus Health.

Please be aware that DEA regulations require that the cabinet be secured.  DEA regional representatives will visit your lab as part of registration to ensure that the cabinet is bolted to the wall and that the interior double lock compartment is bolted to the main cabinet.

Can I charge the purchase of a new safe to my grant?

Yes. The costs of securing the controlled substance in a secured cabinet or lockbox could vary substantially between labs.  Please contact the Office of Sponsored Programs to address this issue on a case-by-case basis. Contact the University’s Work Control Center for scheduling someone to secure a cabinet in your laboratory. 

How do I store controlled substances?

Controlled substances must be stored securely.  Controlled substances must be separated from other drugs or other hazardous chemicals.  This practice will help to prevent loss by limiting access to only those who are assigned to work specifically with controlled substances. It is recommended that access be limited to a minimum number of approved personnel as possible. When in use, controlled substances should never be left unattended.  

My colleague and I have separate DEA registrations in a shared laboratory.  Can I share the drug locker of my colleague in the department?

No.  According to University of Iowa policy, each licensed researcher should maintain her or his own secured lockbox or other secured cabinet for storage of DEA-controlled substances that are permitted by the individual license.

What is ​the definition of ‘access to controlled substances’?

Anyone who has the ability to access or can gain access to controlled substances: a person who is responsible for (1) obtaining, assuring secure storage, managing the initial or annual inventory; (2) completing the aliquot logs and recordkeeping; (3) distributing controlled substances or a dilution thereof to other approved laboratory personnel; or (4) dispensing to an animal or disposing of controlled substances waste.

What ​are acceptable storage and security practices?

Regardless of the source of the controlled substance, materials must be securely locked. A two lock system must be in place. Existing casework may be sufficient to limit inappropriate access if a cabinet or drawer is locked in a non-glass cabinet or drawer integral to the casework. Controlled substances must be accessible only to the Registrant and their authorized agent(s) and are used only for legitimate research purposes. Order and store only the minimum amount of controlled substances necessary for planned experiments.

As a new DEA registrant, when can I expect a DEA inspector to visit my research lab for approval of my secure storage?

Yes.  For new applicants, a Des Moines DEA investigator will contact you and send a list of items that you will need prior to an on-site inspection. 

How do I report a loss or theft?

Authorized agents are expected to report a loss (includes a spill) or theft of a controlled substance to the registrant and if theft, also report to the Department of Public Safety.  Public Safety and law enforcement officials will investigate a theft of a controlled substance. If any imminent safety threat exists, contact Public Safety directly at 911. 

Upon discovery of the theft or loss of any controlled substance, licensed researchers must notify the DEA field office in Des Moines and complete DEA form 106 documenting the loss or theft. 

Staff must document, in the respective drug accountability record, the volume of the DEA-controlled substance that was lost.  You do not need to use a reverse distributor to clean a spill.  Materials from such a spill should be packaged for collection by EHS as a chemical waste spill (hazardous waste).  Please contact Bill Murray in EHS at 335-4624 for more information.

I suspect tha​t controlled substances have been stolen from the lab, but since I am not the licensed researcher or an authorized agent I can’t be sure. What should I do?

The licensed researcher is ultimately responsible for the oversight of controlled substances that are maintained or used under her/his direction.  Hence, any suspicion of possible diversion of a controlled substance should be initially brought to the attention of the licensed researcher, who must promptly report suspicion of drug loss or theft as described directly above.

What are the consequences of engaging in illicit activities?   

Employees who possess, sell, use or divert controlled substances will subject themselves not only to State or Federal prosecution for any illicit activity, but shall also immediately become the subject of independent action by the University regarding their continued employment. The University will assess the violation and determine whether to suspend, transfer, terminate or take other action against the employee. 

W​hat are the fines and penalties if I am non-compliant with either the IBPE or the DEA controlled substance regulations?

Actions may include administrative, civil, or criminal prosecution.  The DEA can fine a licensed researcher for each and every violation that it finds.  Loss or suspension of a controlled substance license and DEA registration could be catastrophic for a research investigator.


Disposal:

All information relating to disposal of controlled substances is maintained under the Waste/Environmental Section of EHS - Controlled Substances Waste.  Frequently asked questions regarding disposal can be found here.


Record Keeping and Inventory:


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:
    • 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.

 

Contact Information

Organization

Phone Number

Iowa Board of Pharmacy Examiners (IBPE)

(515) 281-5944

IBPE office ( IBPE rules and registration questions)

(515) 281-6676 

University of Iowa 'Certifying Official' (required for DEA registration form)
Susan Klatt

(319) 335-3552

DEA Office in Des Moines (for regarding online registration/ amendment questions)

(515) 284-4709

DEA Registration Information Call Center

(800) 882-9539

General questions on controlled substances use
Rick Byrum, EHS

(319) 335-9379

Expired, unwanted or orphaned controlled substance disposal - 
Bill Murray, EHS 

(319) 335-4624

University Human Resources

(319) 335-3558

Deputy Counsel Office, General Counsel
 

(319) 335-0400