Controlled Substances FAQs

Can you work with a controlled substance outside of the schedules or substances authorized by your registration?

No. Researchers may only conduct controlled substance activities authorized by their current DEA registration and applicable New York State controlled substance license.

A DEA registrant may apply to modify an existing registration to add controlled substances or schedules, when permitted. Research involving Schedule I controlled substances is subject to additional DEA registration and research protocol requirements and is treated separately from Schedule II-V research.

Do not obtain, store, or use a controlled substance that is not covered by your current authorizations. Contact Research Safety before adding a new controlled substance or schedule to determine whether DEA and NYSDOH amendments or additional registrations are required.

21 CFR 1301.13 - Application for registration 
21 CFR 1301.51 - Modification in registration 

Can a New York State Department of Health Class 4 license be transferred or amended to another faculty member?

No. NYSDOH controlled substance licenses are name- and address-specific and are not transferable. For example, an individual Class 4 license issued to a retiring faculty member cannot be transferred to another principal investigator.

Before a successor begins controlled substance research, the successor must have the appropriate NYSDOH authorization and corresponding DEA registration for the activity and location. NYSDOH permits certain amendments to existing licenses, but an amendment cannot be used simply to substitute one individual license holder for another.

Contact Research Safety before transferring controlled substances, responsibility for a research program, or controlled substance activities to another investigator.

NYSDOH Controlled Substance License Application Instructions 

Does the New York State controlled substance license need to be issued before DEA registration?

Yes. A researcher must have the required New York State authority before DEA can issue the corresponding controlled substance registration. For Cornell researchers, this generally means obtaining the applicable NYSDOH controlled substance license before completion of the DEA registration process.

NYSDOH Controlled Substance License Application 

Are separate DEA registrations required for separate locations?

A separate DEA registration is generally required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed, unless an exception in DEA regulations applies.

Storage of controlled substances at another location does not, by itself, always require a separate DEA registration. DEA regulations contain specific exceptions, including certain qualifying storage locations.

Because the federal requirements depend on the activity and location, researchers must contact Research Safety before storing, using, administering, dispensing, or otherwise conducting controlled substance activities at a location that is not already covered by the applicable registration.

21 CFR 1301.12 - Separate registrations for separate locations 

Is a separate NYSDOH controlled substance license required for a separate location?

New York State licensing requirements are separate from DEA registration requirements. NYSDOH generally requires controlled substance activities to be conducted at the location authorized by the applicable license, and a separate application may be required for an additional location.

Do not move controlled substances or begin controlled substance activities at a new location until Research Safety has reviewed the proposed change and confirmed whether a new or amended NYSDOH license and DEA registration are required.

10 NYCRR 80.5 - Licenses 
NYSDOH Controlled Substance License Application 

Does the NYSDOH controlled substance license need to be displayed?

Yes. New York State requires a controlled substance license to be permanently displayed in the place to which the license applies.

10 NYCRR 80.5 - Licenses 

Does the DEA Certificate of Registration need to be displayed?

No. DEA does not require the Certificate of Registration to be permanently displayed. The registrant must maintain the certificate at the registered location in a readily retrievable manner and make it available for inspection by authorized federal, state, or local officials.

21 CFR 1301.35 - Certificate of registration 

How long must controlled substance records be kept?

Cornell researchers must retain controlled substance records for at least five years to satisfy New York State record-retention requirements. DEA generally requires records maintained under 21 CFR Part 1304 to be retained for at least two years. The longer New York State retention period therefore applies to records subject to both requirements.

Records must be complete, accurate, readily retrievable, and available for inspection as required by applicable federal and state regulations.

10 NYCRR 80.100 - Records 
21 CFR 1304.04 - Maintenance of records and inventories