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
  2. Meet with LAR or EHS to discuss storage location

Ongoing Maintenance:

  1. Renew your approvals/license
    1. DEA- Every 1 year
    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

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

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.