By Diane Colabello, Senior Health & Safety Specialist, Matthew Domser, Hazardous Materials Manager, & Christopher Moore, Controlled Substance Program Manager
The Drug Enforcement Administration (DEA) highly regulates scheduled substances from the point of purchase to disposal. During all stages of a registrant’s protocol, scheduled substances, dilutions, and waste must be logged to maintain an accurate use record. It is the registrant’s responsibility to maintain these logs, which are subject to inspection by state and/or federal authorities at any time. This can come in the form of an announced or unannounced inspection by the NYS Department of Health (DOH) or DEA. Inaccuracies in a registrant’s logs can lead immediately to a stoppage of work and include significant civil and criminal penalties.
All Weill Cornell researchers who currently work with controlled substances or intend to will be required to obtain and maintain individual licensure from both NYS DOH and the DEA.
- It should be noted that this process can take up to several months and requires significant investment in security infrastructure.
- Additional licensing and storage requirements are required for researchers seeking to work with schedule I substances.
- Prior to issuance of any license, laboratories and storage areas must be inspected by agents from the NYS Bureau of Narcotics Enforcement and the DEA.
Controlled Substance Program Manager
Christopher Moore has been appointed as the Controlled Substance Program Manager to assist individuals in all aspects of scheduled substance use in research. He will be available to assist investigators during the application process and aid in regulatory compliance, including security and records maintenance. Please contact Christopher at chm4035@med.cornell.edu.
The DOH and DEA have updated their licensing forms and requirements as of 2023.
In response, EHS has:
- Created a list of Controlled Substances FAQs.
- Updated our Security of Controlled Substances guidance.
- Developed a DEA Application Instructions guidance document that helps summarize the licensure process.
All internal, state, and federal guidance documents should be read thoroughly prior to applying for use of controlled substances.
Please reach out to EHS at (646) 962-7233 or email at ehs@med.cornell.edu:
- Prior to applying for any license,
- Prior to submitting an amendment, or
- For any questions related to the use of controlled substances in research at WCM.