FAQ -Managing Controlled Substances in Research

Registration

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.

DEA schedule numbers and corresponding DEA codes.
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
Buprenorphine III 9064
Diazepam IV N 2765
Ketamine III N 7285
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 I 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
Drug Division
400 S.W. Eighth Street, Suite E
Des Moines
Iowa 50309-4688.
Phone: (515) 281-5944

US-DEA:
Apply online
Process Guide

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.
  • To minimize the need for transferring controlled substances between multiple registrations held by a single licensed researcher, they should order the controlled substances that they will need 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?

Clinical practitioners must maintain a separate ‘Researcher’ category license to conduct nonclinical research.

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 i 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.

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. Your supervisor is required to place her or his signature on Item #10 in the DEA registration form as an assurance of your employment. Note: your registration is not transferable to another institution.
http://www.deadiversion.usdoj.gov/drugreg/categories.htm#research

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 via a personal check. Credit cards and departmental vouchers are not accepted. The current biennial registration fee is $100 per application. 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.

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
Drug Division
400 S.W. Eighth Street, Suite E
Des Moines
Iowa 50309-4688.
Phone: (515) 281-5944

For DEA registration change requests: Use the online registration change form for change of address requests. http://www.deadiversion.usdoj.gov/drugreg/change_requests/index.html

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. 

Background Screening

Who must undergo a security screening, and how does the screening process work?

As part of the DEA registration, every ’Researcher’ category registrant is required to undergo a DEA background check/screening. No additional screening is required by the University. Staff members working under a licensed researcher are not required to complete a DEA background/security screening.

Do research investigators applying for DEA registration(s) undergo background screening through University Human Resources?

No. As part of the application for registration, a background check/screening is conducted by the DEA when the application is submitted. For any questions related to background checks of University employees, please contact the following University of Iowa administrative officers:

  • Judie Hermsen, Director of UI Administrative Services in Central Human Resources; phone 335.3553
  • James Jorgensen, Deputy Counsel in the Office of the General Counsel; phone 335.0400

I am a Principal Investigator (PI) 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) and your application will be screened by the DEA. As the licensed researcher, you have the primary 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.

Do au​thorized agents and authorized laboratory personnel (known as daily users) undergo a DEA background check or screening?​

No. Authorized agents and authorized laboratory personnel are not required to go through a DEA background check or screening. Licensed researchers are ultimately responsible for the management of controlled substances acquired under their DEA registration or license. 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 officers:
Judie Hermsen, Director of UI Administrative Services in Central Human Resources; phone 335.3553
James Jorgensen, Deputy Counsel in the Office of the General Counsel; phone 335.0400.

I am​ a licensed researcher with the DEA. Do my trainees or graduate students need a DEA background check?​

No. Any individual employed in research studies conducted in the licensed researcher’s laboratory who has access to the controlled substance(s) must be approved by the licensed researcher. Licensed researchers are ultimately responsible for checking each staff’s credentials for handling the controlled substances.

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. However, licensed researchers are ultimately responsible to ensure the security of the controlled substances under their license and maintain an up-to-date inventory.

A​uthorized 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?

Maybe. 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.

Wh​o oversees the controlled substances program at the University?​

Both the DEA and the State of Iowa - Iowa Board of Pharmacy Examiners (IBPE) oversee controlled substances. No UI office oversees the program. EHS provides information and resources to assist researcher investigators in their management of their registrations with the DEA and IBPE.

Purchasing Controlled Substances

H​ow 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 such as Sigma-Aldrich require that all purchase orders for schedule I and schedule II substances be submitted using a DEA form 222.

I ​am attempting to order antibiotics from a distributor, but they need a “verification documentation” to prove that I am authorized to receive the drugs. How do I obtain this verification documentation?​

Controlled substances distributors can be a chemical supplier, pharmaceutical vendor, or drug manufacturer. Licensed researchers must work directly with the distributor and provide the necessary information to establish that s/he is indeed authorized to receive controlled substances or drugs and that the research activities are within the scope of a DEA approved research protocol. A licensed distributor must exercise due diligence and obtain verification documentation from licensed researchers to ensure controlled substances are shipped only to individuals authorized for such access by the licensed researcher.

D​o 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. An example of a properly completed DEA form 222 can be accessed from the University of Michigan EHS website. 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 is against DEA regulations.

Can you provide names and addresses of controlled substance sources for purchase?

The distributor list can be downloaded from the DEA website. A brief list below is provided as an example for planning purposes only:

Burns Veterinary Supply Fort Dodge Laboratories JA Webster Vortech Pharmaceutical
3400 West Lake Ave 800 5th Stree, Northwest 86 Leominster Road 6851 Chase Road
Glenview Fort Dodge Sterling Dearborn
IL  60025 IA  50501-0518 MA  01564-2198 MI  48126
800-922-8767 800-685-5656 800-225-7911 800-521-4686
Butler Schein, Inc Butler Schein, Inc. Sigma-Aldrich, Inc. Diamondback Drugs
135 Duryea Road 3820 Twin Creeks Dr 3050 Spruce Street 7901 East McDowell Road
Melville, NY 11747 Columbus, OH  43204 St. Louis, MO  63103 Scottsdale, AR  85257
800-483-8329 800-552-8387 800-325-3010 866-578-4420


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) must first receive DEA approval for the transfer, and (2) both parties maintain proper documentation for any approved transfers. The transfer process is very similar to the purchase of controlled substances from an authorized distributor.

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

No. Such transfers are not allowed under any circumstances. Controlled substances procured under a specific research investigator’s DEA registration cannot be transferred to another individual who is not registered with DEA. A better way for such transfers is via reverse distributors who ensure the proper paperwork and documentation for physical transfers.

What special procedures are required to purchase class 2 DEA controlled substances?

Class 2 DEA controlled substances are the same as schedule II controlled substances (class 2 = schedule II). To purchase schedule II controlled substances, the DEA registration holder must provide original copies of a DEA form with the order, which requires that all purchase orders that list schedule II controlled substances must be mailed (not faxed) to the supplier. Instructions for ordering DEA form 222
An example of a properly completed DEA form 222 can be accessed via the University of Michigan’s EHS website.

Storage and Security

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

This means that two locks must be in place to adequately secure the controlled substances. A laboratory door that is locked when authorized personnel (the licensed researcher, authorized agent(s) of the licensed researcher, or authorized lab personnel) are absent can serve as one of the “locks.” Within the laboratory, controlled substances must be secured within a locked cabinet or safe that cannot be moved or transported.

  • Schedule I and schedule II controlled substances must be secured within a specific type of safe or steel cabinet. The DEA regulations provide specifications regarding such enclosures
  • A narcotics cabinet (double lock, double door, which must be bolted to a wall) is recommended for drug storage.  The safe or cabinet must remain locked at all times when controlled substances are not being dispensed from or returned to storage. Details regarding security requirements can be found in 21CFR Section 1301.71.

Please discuss with the IBPE representative (see IBPE contact information in Q21), prior to installing a safe or cabinet for storing the 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?

You can find standard “narcotic cabinets” through Health Care Logistics Inc
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 contr​olled substances?​

Controlled substances must be stored securely. Controlled substances should 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. Please review the DEA requirements at http://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_75.htm

How do I stor​e controlled substances during field work?​

Controlled substances must be stored in a locked box either under direct control of an authorized agent or authorized lab personnel or in a locked building or vehicle when not in use during field work. An example of field work could be when the authorized work is performed in a fume hood located in a different room within the building or in an animal research area on a different floor of the same building.

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

No. 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.

How​ do I report if I discover a loss or theft?​

Authorized personnel are expected to report missing controlled substances to their supervisor, and the University of Iowa Public Safety Office as soon as the loss is discovered. Public safety and law enforcement officials will investigate the diversion, loss, or theft of controlled substances. If any imminent safety threat exists, contact Public Safety directly at 911.
In addition, upon discovery of the theft of significant 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.

I suspe​ct that 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 to the attention of the UI Public Safety office and to the DEA Field Office (515-284-4700 or ext. 4709). Notification to the DEA should include the licensed researcher promptly completing a DEA form 106.

What are ​the consequences of engaging in illicit activities?​

It is the position of the DEA that employees who possess, sell, use or divert controlled substances will subject themselves not only to a State or Federal prosecution for any illicit activity, but shall also immediately become 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.

What 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.

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, and (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 key security 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 those who passed the background check by the DEA and their authorized personnel and are used only for legitimate research purposes. Order and store only the minimum amount of controlled substances necessary for planned experiments.

Spill

I dropped a bottle containing DEA regulated substances and all of the material spilled. What paperwork do I need to fill out, and do I have to use a reverse distributor to dispose of materials used to clean up the spill?

You must document, in the respective drug accountability record, the volume of the DEA-controlled substance that was lost, and submit a DEA form 106 detailing the loss to the DEA.  You do not need to use a reverse distributor to dispose of the materials used to clean up the spill.

Materials from such a spill should be packaged for collection by EHS as a chemical waste spill (hazardous waste). Please contact EHS at 335-8501 (or Jim Pyrz at 335-4625) for more information.

Disposal

How do I dispose of partially used, unused or expired injectable vials containing controlled substances (injectable veterinary medicine)?

Any amount of controlled substance waste must be destroyed by a member of the IBPE or an approved agent of IBPE. The destruction will be witnessed by the licensed researcher. An “Inventory of Drugs Destroyed or Surrendered” (Form 41) must be completed and signed by an agent of IBPE. Disposal information must include: (a) DEA registration number, (b) controlled substance name, (c) Vendor, (d) quantity (controlled substance content of each unit described in the container, number of containers and size of the containers), and (e) user's name and campus address including the room number where the substance was being used. One copy will be made available to IBPE and one copy must be retained by the licensed researcher. Please contact Curtis Gerhold, Compliance Monitor for Johnson County regarding controlled substances, at curtis.gerhold@iowa.gov to schedule a time when he can perform a disposition of expired controlled agents. To reach the Iowa Board of Pharmacy Examiners, call 515-281-5944 or via the website.

Is there any difference in the procedures for discarding empty vials (injectable drugs) of controlled substances vs. residual quantities of expired controlled substances?

Empty vials of controlled substances (injectable drugs) can be disposed of in red bag biohazardous waste containers, although the label should be removed or rendered unreadable. In addition, the disposal of the empty vial must be recorded in the respective controlled substances accountability record.

Expired containers of controlled substances (with any contents remaining) must be separated from non-expired containers of controlled substances, and must be clearly labeled as being expired. The expired containers of controlled substances must remain in the locked controlled substances cabinet or safe. The licensed researcher must request permission from the IBPE /Regional DEA representative (in the Des Moines office) to dispose of the remainder of the expired controlled substance. The expired drug cannot be destroyed until permission is obtained from IBPE or the DEA.

Final disposition of the expired quantity of the controlled substance must be documented in the respective controlled substance accountability record. The IBPE representative will visit your lab, render expired drugs and unused injectable solutions unusable per their approved procedure, bag them in a plastic bag and dispose of them in regular trash.
Please contact EHS at 335-8501 (or Jim Pyrz at 335-4625) for more information.

Who are the ‘reverse distributors’?

Reverse distributors (third party companies) are registered with DEA and are authorized to receive out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including unwanted bulk controlled substances samples from DEA/IBPE licensed researchers and dispose of the waste(s) by appropriate DEA procedures.

How do I dispose of my controlled substance?

You may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a third party company who is authorized to receive such materials. These commercial operators are referred to as reverse distributors (see Q54). Schedule I and schedule II controlled substances should be transferred via the DEA form 222, while schedule III–V substances may be transferred via invoice. The licensed researcher must maintain copies of the records documenting the transfer and disposal for a period of at least 2 years after disposal of a controlled substance. There is a charge for the use of a reverse distributor. The cost of waste disposal depends on the type and quantity of the substance. You may also try contacting the manufacturer to request authorization to return the controlled substances directly to them. Licensed researchers wanting to dispose of controlled substances that are mixed with hazardous chemical waste should contact EHS at 335-8501 (or Jim Pyrz at 335-4625) to ensure compliance with RCRA regulation.

I obtain​ed a reagent that contains a controlled substance but it was sold to me without having to provide a DEA registration number? How can this be?​

A manufacturer or distributer of certain reagents may apply to DEA for exemption from the requirements of DEA registration. These are typically research or analytical reagents that contain very small amounts of the controlled substance. A list of currently exempted substances

I want to dis​pose of an exempt substance. Do I have to go through a reverse distributor?

No. Since the substance is exempt EHS can take possession and will properly dispose of the substance. However, it must be verified that the reagent is on the DEA exempted list.

Can I charge the disposal of the controlled substances to my grants?​

Yes. The disposal costs (via, external vendors known as reverse distributors) can be charged as a direct cost to a sponsored project.

W​ill EHS's Environmental Management section take custody and dispose of my DEA regulated material as a hazardous waste?

No. It is against the IBPE/DEA rules for EHS to take possession of any DEA regulated substances from your research lab. The DEA strictly regulates all purchases, storage, dispensing and disposal of expired, unwanted or any other schedule I, II, III, IV and V controlled substances or drugs. Only individual licensed researchers who have submitted an application and are assigned a DEA registration number are allowed to purchase and possess DEA regulated controlled substances. The EHS office will assist PIs who need to dispose of DEA regulated substances. Please call EHS at 335-8501 (or Jim Pyrz at 335-4625) for technical assistance with disposal process.

Th​e DEA informed me that I need to discard my expired drugs via a reverse distributor. How do I do this?​

EHS can assist PIs in locating a reverse distributor. Please contact EHS at 335-8501 (or Jim Pyrz at 335-4625) for further information.

An example list of reverse distributors used by the University of Iowa Facilities and UIHC includes:

Clean Harbors national Pharmaceutical Returns, Inc. EXP Pharmaceutical Services Corp.
42 Longwater Drive 4164 NW Urbandale Dr 48021 Warm Springs Boulevard
Norwell Urbandale Fremont
MA 02061-9149 IA 50322 CA 94539
800-282-0058 800-470-7725 510-476-0909 Ext 429
www.cleanharbors.com www.npreturns.com www.expworld.com


Disposal of Orphan Controlled Substances

H​ow can I dispose of controlled substances left behind by a previously- licensed researcher or other investigator?​

It is the responsibility of DEA- licensed researchers to dispose of all controlled substances before they leave the University. If the original licensed researcher is not available and DEA is not able to determine who in your department is registered, then you, the current owner, are responsible for contacting EHS office. The EHS office can assist you to surrender the controlled substances to a DEA approved reverse distributor for the proper disposal of “orphaned” controlled substances. Please contact EHS at 335-8501 (or Jim Pyrz at 335-4625) for further information.

How do I dispose o​f an orphaned controlled substance?

Please refer to the responses to the previous questions. If your laboratory discovers a controlled substance and the registrant is not known to you or your department, please contact EHS at 335-8501 (or Jim Pyrz at 335-4625) for recommendations. Indicate you discovered an orphaned controlled substance in your laboratory that needs to be properly disposed of. EHS will help you obtain the information needed for surrendering the controlled substances, and to get the IBPE/DEA approval for their proper disposal. Please be aware it is against the DEA regulations for EHS to pick up the controlled substances from your laboratory or provide you with a temporary storage; therefore, EHS cannot accept a controlled substance or controlled substance bearing waste. The pickup and disposal of orphan drugs must be properly handled through reverse distributors, only after you have obtained IBPE/DEA approval.

Is it p​ossible for EHS personnel to become a licensed researcher, which would then allow them to collect and segregate controlled substances from researchers around campus prior to disposal, either orphaned substances or the hazardous waste solvents containing controlled substances, and then ship the solvent waste off-site for thermal destruction?​

No. The above described process is not an acceptable solution, as confirmed by IBPE. Therefore, EHS is not allowed to collect, store or ship off site any controlled substances. Please contact a reverse distributor. However, licensed researchers wanting to dispose of controlled substances that are mixed with hazardous chemical waste must contact EHS at 335-8501 (or Jim Pyrz at 335-4625) to ensure compliance with RCRA regulation.

Is the​re a preferred disposal method available to dispose of orphan controlled substances?​

No.

  • As per IBPE, the correct process for the licensed researcher is to legally dispose of any controlled substances under the ownership and control of the licensed researcher when these substances are no longer needed or prior to the licensed researcher leaving the facility.
  • Proper disposal could be through a sale or transfer of the controlled substances to another licensed researcher authorized to possess the substances (only if authorized to do so by DEA) or, if the controlled substances are to be destroyed, the licensed researcher must take arrangements for that destruction and dispose of them through a licensed reverse distributor.
  • Reverse distributors are licensed by the IBPE and registered with DEA to accept the controlled substances from licensed researchers for appropriate destruction or other means of disposal.

Occasionally licensed researchers leave the University, and they may leave behind small numbers of orphaned controlled substances that are listed as a schedule II, III, IV or V substance. Usually, ​EHS f​acilitates a process that is time consuming, so I’m looking for a better way. Are these “orphaned” substances something IBPE can accept for disposal/reverse distribution?

No.

  • Neither IBPE nor EHS are authorized to accept the orphaned chemicals for disposal.
  • Licensed researchers should be aware that they are responsible for not only ordering, handling, and recordkeeping, but also making sure that timely proper disposal methods are accomplished.
  • If the “licensed researcher” and responsible personnel are no longer available to authorize the disposal of these substances, EHS does not have the authority to destroy the controlled substances.
  • The only legal means of destroying those orphaned controlled substances is to get the approval from the DEA and IBPE and properly dispose of them through the reverse distributors.

I understand that at some institutions in other states, the EHS Office was given permission to accept controlled substances and blend them with hazardous waste solvents to be shipped for incineration. Is it acceptable at UI?

No. The above described process would not be appropriate in the State of Iowa. If the IBPE accepts or receives such substances into their possession, then IBPE would have to either petition the DEA for the authority to destroy them or petition a court for an order of abandonment and destruction. University of Iowa IBPE/DEA-licensed researchers must take responsibility, not only for the ordering and use of controlled substances in research projects, but also for the appropriate disposal of unneeded or expired controlled substances when the project is completed and before the licensed researcher leaves the university.

Recordkeeping and Inventory

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.

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

It is imperative that each licensed researcher adheres to all IBPE and DEA record keeping requirements to ensure proper security controls are in place and complied with. To achieve compliance with all mandated regulations, the PI or an authorized agent must oversee the processes described in Q69.

What are the elements of inventory requirements for controlled substances?

Each licensed researcher is responsible for his/her own annual inventory. Typical inventory checks include: 1) hands-on counting inventory and not a database check; 2) must be 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 authorized lab personnel); and 4) use of an in-house developed initial inventory form, dispensation/disposal records, monthly inventory checks and annual inventory form.

Is it true that I need to keep separate logs for aliquoting a controlled substance?

Yes. 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. A separate controlled substance aliquot log should be generated and maintained by the investigator to record activities associated with the diluted aliquot.

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

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

What is the biennial inventory?

Every two years, each licensed researcher and their authorized agent must inventory the controlled substances under their possession during a one-day institutional inventory at either the opening or close of business (21 CFR 1304.11(b))

Listed Chemicals

Wh​at are “listed” chemicals and “precursor” chemicals?​

Certain chemicals and solvents can be used to manufacture a controlled substance. There are two DEA regulated lists, List I and List II, which differ by import/export/sales reporting thresholds.  The list I typically represents precursor reagents. The list II represents the solvents that are used in the synthesis and purification steps.

Are i​ndividuals who use DEA “listed” chemicals or “precursor” chemicals included in the DEA controlled substance registration?​

No. The requirements of the controlled substance program apply only to DEA “scheduled” drugs.

H​ow do I order listed/precursor chemicals, such as iodine?​

Contact your purchasing representative for assistance. Store managers in Chemistry and BioChem stores may also be able to help you with this process. To meet the specific vendor requirements for the purchase of chemicals above the reporting thresholds, you will need to receive a registration form from your vendor, complete the form with appropriate authorization/approval signature from your departmental officer and then mail a hardcopy or email as a pdf attachment to the vendor. Fax copies may not be accepted by your vendor.

How do I​ store the listed/precursor chemicals?​

Listed/precursor chemicals must be stored according to hazard class, following the EHS hazardous material storage requirements. These chemicals must not be stored with controlled substances.

Reference Documents

Why did EHS creat​e the guidance document for handling controlled substances?​

  • The DEA and the IBPE regulations are designed to assure that PIs (owners of registrations) have written policies and procedures to use controlled substances and prevent the inappropriate diversion or inadvertent access to controlled substances.
  • EHS has been developed guidelines as a resource for research personnel. Laboratory Guideline for Managing Controlled Substances in Research Laboratories (CSG) clarifies the roles and responsibilities of the individual PIs (‘Researcher’ category DEA registration) with access to controlled substances in their research projects and describes proper disposal of partially used and expired substances, or orphan controlled substances, and the wastes containing controlled substances.
  • The EHS guidance document helps to ensure compliance with the Federal and State regulations; therefore, the guidance document is an important resource with regard to safety and security of controlled substances stored in research labs.

Which laws and regulations must be followed regarding controlled substances used for research purposes at the University of Iowa?

Federal: Controlled Substance Act of 1970 and the Code of Federal Regulations (21 CFR, part 1300 to end).

State of Iowa: 2009 Iowa Code Chapter 124 - Iowa Controlled Substances Act. See paragraphs 205.11 – 205.13 for additional provisions relating to administration and enforcement. Also see chapter 124A. For more information, refer to the State of Iowa Regulations  and Iowa Administrative code (Pharmacy Board) 657 I.A.C. Chapter 10 - Controlled Substances.

Who should I contact for questions regarding the use of controlled substances for research purposes at UI?

The Office of the Vice President for Research (OVPR) has designated the EHS as a resource to assist in matters relating to controlled substances guidance. EHS staff will provide guidance for laboratories attempting to dispose of orphan DEA regulated materials. Please call EHS at 5-8501 (or Jim Pyrz at 335-4625) for assistance.