Who is required to obtain Controlled Substance Licensing?
Non-clinical researchers who plan to utilize controlled substances will need to obtain both a NYS Dept. of Heath License to Engage in a Controlled Substance Activity for Individual Researchers as well as a DEA Registration for Controlled Substance use in Research.
Which drugs are controlled substances?
Not all drugs used in research are controlled substances. The most commonly used controlled substances in research are buprenorphine, fentanyl, ketamine, and pentobarbital. The DEA has a complete List of Controlled Substances with their assigned schedules. Additionally, please see the list of exempt items.
Who oversees controlled substances regulations?
New York State Department of Health (DOH), Bureau of Narcotics Enforcement (BNE) monitors and regulates controlled substances through its issuance of licenses to manufacturers, distributors, hospitals, and researchers. BNE Narcotic Agents investigate suspected drug diversion involving theft, forgery, and illegal sales.
U.S. Department of Justice, Drug Enforcement Administration (DEA) enforces the controlled substances laws and regulations of the United States and supports non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.
What legislation applies to controlled substance use?
- The Controlled Substances Act (21U.S.C. §801-971)
- Chapter II of the Code of Federal Regulation (21C.F.R. §1300-1321)
- New York State Controlled Substances Act (PBH Article 33 §3300-3397)
- The Rules and Regulations on Controlled Substances (Title10 NYCRR Part 80).
Can I continue to buy the necessary controlled substances from RARC?
No, unfortunately the DEA has been phasing out the use of Institutional Licenses. After 2024, researchers who wish to continue working with C.S. without any interruption to their studies, must apply individually for their own licensing and registration. It is best to apply early as the application and approval process can take about 6 months.
How do I apply for licensing? What is involved in the licensing process?
To begin the application process, please contact EHS.
Licensing Overview:
- Finalize laboratory storage and security for C.S.
- Apply for a License to Engage in a Controlled Substance Activity from NYS Dept. of Health
- Inspection by NYS Bureau of Narcotics Enforcement
- Apply for a Registration under Controlled Substances Act from Drug Enforcement Administration
- Inspection by DEA Agents
- Register with vendor & order controlled substances
Are there any resources to assist in the application process and for controlled substance handling?
Yes, please see:
Environmental Health & Safety: Security of DEA Controlled Substances
Environmental Health & Safety: Applying for the Use of DEA Scheduled Substances
New York State Dept. of Health: Instructions for License Application
Drug Enforcement Administration: Researcher’s Manual
Additionally, please contact EHS with any questions. The Controlled Substances Program Specialist will assist you through the application and inspection process.
Do I need to obtain multiple licenses/registrations for my different laboratory locations?
Yes, the DEA stipulates that each location must have its own registration. You must file for separate NYS DOH licenses and DEA registrations for each laboratory location you plan on storing controlled substances.
I have a DEA Practitioner Registration, do I still need to apply for any licensing?
Practitioners who wish to work with controlled substances to perform in vitro or in vivo research still need to apply for a NYS DOH License. However, after receiving an approved NYS DOH License, they may use their DEA Practitioner Registration for research instead of applying for a DEA Individual Researcher Registration.
Please note, the address on your DEA Practitioner Registration must match the exact address on your NYS DOH License. If you are unable to change your DEA Practitioner Registration address, you will need to apply for a DEA Individual Researcher Registration.
Do I need a different license or registration for different drugs I plan on using?
Researchers are required to specify Schedule(s) I or II-V on their NYS DOH License and DEA Registration. If you require use of drugs that fall into both Schedule I as well as Schedules II-V then you will need to obtain two separate licenses (Class 7 for Schedule I & Class 4 for Schedules II-V) from NYS DOH and two separate registrations from the DEA.
If I have approval for Ketamine, can I order buprenorphine (or other schedule III drugs) too?
No, all controlled substances you plan on using must be specified on your application to NYS DOH. If you only listed ketamine, you can only legally purchase and use ketamine regardless of the schedule of other drugs you wish to use. An amendment detailing additional controlled substances must be made to NYS DOH. Additionally, you may need to update your DEA Registration (after your amendment is approved) depending on the schedules of controlled substances listed on your registration.
What type of security requirements are required for storage of my controlled substances?
Please see the EHS Update Security of DEA Controlled Substances for a detailed description of storage requirements.
Can storage locations be shared amongst researchers in neighboring labs?
No, each registrant is responsible for the security of their controlled substances and must have storage locations independent of other laboratories.
Who is allowed to access and use controlled substances in my lab?
Only a Supervisor of C.S. Activity and approved Authorized Users are allowed to use controlled substances purchased under your DEA Registration. Labs cannot borrow from or share controlled substances with other labs regardless of their NYS DOH License or DEA Registration status.
Can Authorized Users in my lab take C.S. whenever they need for experimentation?
Only the Registrant & Supervisor of C.S. Activity are allowed to access the main inventory of controlled substances. Authorized Users are generally allowed to work with C.S. that have been diluted and dispensed to them.
To allow experimentation to continue on off-hours or weekends, a Registrant or Supervisor may dispense C.S. to a working stock lockbox for up to 72 hours. Authorized Users can be given open access to the working stock lockbox provided that C.S. are only placed in there for specific occasions of use.
What can be stored in my lockbox or safe?
No materials other than controlled substances and dilutions/solutions can be stored in your lockbox or safe. Diluents or other non-controlled materials used for solutions such as saline or xylazine must be stored separately.
Your records may be kept together as a set in your safe; however, if it does not easily fit, binders may be stored elsewhere provided they are safe and easily accessible.
Are there any preferred methods for storage of keys?
Yes, using a wall mounted key box with a combination code is the preferred method of key storage. Unlike a locked drawer, a key box allows multiple authorized individuals to have access and the combination can be reprogrammed to update access at any time.
Additionally, using wall mounted key boxes gives a lab’s authorized users the most flexibility to perform experimentation with C.S. when the registrant or supervisor may not be on-site to dispense: Authorized users may have open access to a key box containing only the keys to the working stock lockbox, but security is maintained as the registrant/supervisor places specific quantities of materials in the working stock for up to 72 hours for AU to use.
How do I apply for a New York State Dept. of Health License?
Researchers will need to complete form DOH-4330 and an Appendix A1 for each research project/IACUC protocol. Please see the full instructions provided by NYS DOH and EHS’ application guide for detailed information on additional requirements.
Send completed application drafts to EHS for review before submission. The EHS Controlled Substances Program Specialist will need to be listed as an additional point of contact on the application and in the submission email.
What address should I list on my NYS DOH application?
The address listed on your application should be the location of your controlled substances lockbox or safe as each license is address specific. During inspection, agents from the Bureau of Narcotics Enforcement will check a lab’s storage location against that listed on the license.
How do I pay the application fee for NYS BNE?
The application fee for the NYS DOH License must be paid by check or money order. A photocopy/scan of the check can be attached to your application when submitted by emailed to bnelicensing@health.ny.gov.
What is a Supervisor of Controlled Substance Activity (Supervisor)?
A DEA registrant may designate an individual as Supervisor who undertakes responsibilities including ordering, receiving, inventory, recordkeeping, disposal, and dispensing to authorized users on behalf of the registrant. The Supervisor must be listed on form DOH-4330 and complete the ‘Applicant Acknowledgments’ in order to take on these responsibilities.
However, to take on these roles with controlled substances Schedules I & II, a Supervisor of C.S. activity must also be a Power of Attorney.
What is the Name, DEA registration & NYS controlled substance license of suppliers?
The recommended vendor is Covetrus (DEA Registration: RB0394940, NYS BNE: 02A-1099). All controlled substances they supply are pharmaceutical grade as required by IACUC.
Please double check that they carry all the controlled substances you are applying to use. For controlled substances not listed on their website, you will need to find another vendor. Trusted vendors should be able to easily provide their DEA Registration Number & NYS BNE License Number.
You will not be able to purchase controlled substances through a vendor unless it is listed on your application. To add a vendor, an amendment will be required.
Do I need to list multiple research projects if I have multiple IACUC protocols?
Yes, each research project/IACUC protocol needs its own Appendix A1 detailing the use of controlled substances in that project. If ketamine is to be used on 2 different projects, both appendices will need to list ketamine. Additionally, ketamine should be purchased and tracked independently for each project.
How do I apply for a DEA Registration?
Researchers may complete an application for Registration under the Controlled Substances Act (Form 225a) on the DEA’s Diversion Control Division Registration Page.
Detailed information on additional requirements for the application can be found here. Additionally, the DEA Researcher’s Manual is an excellent resource.
Can I store my C.S. records with all my other lab papers?
No, the DEA specifies that all C.S records must be kept independent from other laboratory records. Records should be kept organized in a binder meant only for controlled substances. Additionally, records for Schedule I&II activity must be kept separate from records for Schedules III-V.
How often do I need to take inventory of my controlled substances?
The DEA requires that you complete a Biennial Inventory every two years at minimum. However, the DEA generally chooses to audit all records dating back to the most recent inventory (either initial or biennial). For this reason, labs are strongly encouraged to complete biennial inventories at least every 6 months even though it is not required by the DEA.
How long do I need to keep my records?
The DEA requires all registrants to keep records for a minimum of 2 years. However, the NYS BNE requires that records be kept for a minimum for 5 years. Therefore, registrants must adhere to the stricter state requirements and keep all records for 5 years at minimum.
How can I dispose of unused or expired controlled substances?
Registrants are responsible for the proper disposal of all controlled substances. Abandonment, disposal along with other hazardous waste, destruction, or any method besides reverse distribution is strictly forbidden. Contact EHS for assistance in facilitating reverse distribution of all controlled substances.
How often do I need to renew my NYS DOH License & DEA Registration?
NYS DOH Licenses require renewal every 2 years with a $40 fee. DEA Registrations require renewals annually with a $296 fee.
How do I renew my NYS License?
To submit a renewal, use Form DOH-4330. All materials from the ‘New License Application Checklist’ application should be attached along with the $20 renewal fee. You may utilize your most recent renewal or new application to complete your renewal application provided that your research protocol has not changed.
How do I renew my DEA registration?
Renewal applications and the $296 renewal fee must be submitted on the Diversion Control Division registration page. Schedule I researchers must certify with a signed and dated statement that there are no changes in the approved.
My license/registration has expired, is there a grace period to submit renewal applications?
If your NYS DOH License OR DEA Registration expires, contact EHS as all C.S. activity in your laboratory must cease immediately.
Researchers with an expired license or registration may apply for a renewal within the grace period:
- 60 days from the expiration date for NYS DOH License
- 30 days from the expiration date for DEA Registration
However, even if a renewal has been submitted, C.S. activity may not resume until the expired license and/or registration has been reinstated.
My lab has had changes in our Authorized Users, do I need to make an amendment to my license?
You do not need to submit an official amendment, but you should email an updated Authorized User List to NYS DOH.
I would like to perform new research or add controlled substances. How can I make that change?
You must make an amendment to your license for any change in research protocol that requires the addition or removal of a controlled substance, change in storage, change in Supervisor of C.S. Activity, or any other change in approved C.S. activity.
How do I submit an Amendment to my NYS-DOH License?
Use form DOH-4330 and check ‘Amendment’ under Application Type. List a brief description of changes that need to be made in the same row, and attach an additional page describing the necessary changes. Additional documents like Appendix A1 and a complete research protocol may be necessary depending on the changes you wish to make. EHS can help determine what materials will be needed for each amendment.
How do I make changes to my DEA Registration?
You must update your registration for name changes, schedule changes, and drug code changes. The corrections can be made once an amendment to your NYS DOH License has been approved. No fee is required for these changes.
To submit a modification, visit the DEA Diversion Control Division registration page and select ‘Make Changes to my DEA Registration.’ Complete any changes as necessary.
I need to change the location of my storage. Can I just submit an amendment?
If you need to change your storage location, contact EHS as soon as possible. Modifications need to be submitted and approved before any drugs can be moved. Moving C.S. to a new unapproved storage location is considered diversion.
NYS DOH requires a new license application be submitted for changes to official name, address, or ownership. An on-site inspection will be required by NYS BNE, and, after approval of the application, a new license number may be issued.
The DEA allows updates to a business address without requiring a new registration. However, before any changes can be made to your registration, you must obtain a NYS DOH License with the updated address. The DEA may wish to inspect your new storage location before granting approval.
What should I do if I discover theft or loss of Controlled Substances?
Registrants should notify Environmental Health and Safety immediately to report any loss/theft of controlled substances regardless of the amount. EHS will help registrants complete the necessary reporting steps for both the NYS BNE & DEA.
NYS Article 33 of Public Health Law requires prompt notification to the NYS DOH & Bureau of Narcotics Enforcement of any incident or alleged incident of theft, loss, or possible diversion of controlled substances. Form DOH-2094 must be filled out and submitted within one business day.
The DEA requires researchers to notify the local DEA Diversion Field office in writing within one business day of the discovery of theft or significant loss of any controlled substance. Additionally, the registrant must complete DEA Form 106 to document the actual circumstances of the left or loss within 15 days.
A vial of controlled substances broke. What should I do?
In the event of any accidental spillage or breakage, do not attempt to clean up the spill, and contact EHS immediately.
What type of diversion applies to Researcher Registrations?
Theft, transporting controlled substances to a new location without DEA approval, forging records, and using materials of purposes other than originally disclosed in your registration (unapproved location locations or protocols) are all examples of diversion.
I have been contacted by NYS BNE/DEA Agents. How do I know if this is legitimate?
Before sharing any personal or controlled substance related information, you must confirm the identity of DEA/NYS BNE agents. Please contact EHS for assistance.
To verify the identity of DEA or NYS BNE agents if you receive a call, ask them to verify your case #, given when an application is submitted, or personal information contained within your application
If DEA or BNE Agents appear in your lab for an unplanned inspection, check their identification. All agents will have official governmental ID and will be able to share their contact information or business card. Additionally, DEA agents will present a Notice of Inspection (DEA Form 82) which acts as informed consent and must be signed by the registrant.