Controlled Substances in Research

Researchers wishing to work with Schedule II-V drugs must obtain IACUC approval to grant institutional oversight. Upon approval, they must obtain their own individual Researcher License. The process is outlined on this page and a full guide can be found in the sidebar.

Obtain Approval and Licensing 

  1. Complete Training Module.
  2. Submit an IACUC Protocol.
  3. Obtain a Controlled Substances Registration from the New York State Department of Health.
    1. License Application to Engage in a Controlled Substance Activity (DOH-4330)
    2. Appendix A1: Class 4 & 7 Individual Researcher Protocol
    3. emailed applications to: bnelicensing@health.ny.gov
  4. Obtain a Controlled Substances Registration from the Drug Enforcement Agency. This is all online.
  5. Set up an account with a Reverse Distributor

Purchase and Inventory substances

  1. Obtain a logbook from the department. Inventory log instructions can be found here
  2. Meet with LAR or EHS to discuss storage location
  3. Instructions for filling out the DEA 222 form

Ongoing Maintenance:

  1. Renew your approvals/license
    1. DEA- Every 1 year (a reminder email should be sent)
    2. NYSDOH- Every 2 years
    3. IACUC approval every 3 years
  2. Complete biennial inventory every 2 years
  3. Participate in institutional inspections every 6 months
  4. Make sure new members of your lab are filling out their screening form and submitting it to you.

Reverse Distribution:

Licensees are responsible for removal and disposal of their expired or excess controlled substances. These materials can NOT be disposed of through the Hazardous Waste Management Program. 

Frequently Asked Questions

What address should I put on my license?

The address where the material will be used must appear on the license, and must match where the material will be shipped to. On Main campus this address is:

4400 Vestal Parkway East
Science 5 Building
Binghamton, NY, 13901 
Does everyone working with Controlled Substances need to be listed as an Authorized User?

Yes, anyone working directly with controlled substances must be listed as an "Authorized User" on your log sheet. This confirms the dates they are allowed to work under your license, and that they have received appropriate training.

Can Controlled Substances be transferred to another licensee or University Official?

No, you cannot transfer ownership of your materials to anyone else. This includes disposal, which must be handled by a Reverse Distributor.

Do I need to hand the screening statement in?

No, that should be kept with with the License holders secure records.

Do dilutions need to be inventoried?

Yes, dilutions and transferrals from the main stock should be labelled with a unique ID and inventoried appropriately

Can the existing locking wall cabinets be used?

Not for main stock, but dilutions and amounts that will be used within 3 days can be stored there.

Are we exempt from DEA or DOH fees?

You can claim exemption from DEA fees by clicking you are part of a state agency. There is no exemption for DOH.

How long must records be kept? 

The NYSDOH requires the registrant to maintain records for 5 years. Even though the DEA is only 2 years, we follow the more stringent rule to avoid confusion. 

Does the DOH License need to be displayed?

Yes, it must be displayed on the site in which it applies.

Does the DEA License need to be displayed?

The DEA only states it must be readily accesible on site for inspection.