Overview of Controlled Substances
Oversight
The Federal Drug Enforcement Agency (DEA) strictly regulates those substances that have the potential for abuse as well as their precursors. These substances are subject to licensing, registration, storage, security, use and disposal requirements. The Office of Research Compliance at Stony Brook University is committed to assisting researchers in negotiating these requirements.
Use of Controlled Substances within DLAR
If you plan to use controlled substances in research animals, please contact the Attending Veterinarian (Rachel.Brownlee@stonybrook.edu). Each PI is required to obtain their own BNE license and DEA registration prior to using controlled substances as listed in their animal use protocol. If you have animal welfare concerns that may require the use of controlled substances (pain medication), please do not hesitate to contact the on-call veterinarian at any time (631-263-7501).
Use of Controlled Substances in Patient Care Activities
The use of controlled substances will be in compliance with the institutional dispensing licenses held by the University Hospital, Dental Care Center and the University Health Service for patient care activities conducted within those sites only. Controlled substances for patient use may only be prescribed by faculty holding appropriate DEA and state registration.
Other Uses
The use of controlled substances not covered under the preceding sections requires coverage under an individual license. Contact the Office of Research Compliance for assistance with obtaining licensure from New York State and registration from the Drug Enforcement Administration. Once the license and registration is obtained, you can proceed with ordering a controlled substance.
New York State Department of Health (NYSDOH) - Application for Bureau of Narcotic Enforcement (BNE) License
United States Department of Justice Drug Enforcement Agency - Application for Drug Enforcement Administration (DEA) License
Please note: You cannot apply for your DEA registration until you have received your NYS license.
Stony Brook University Local Site Application - Class 4 & 7 Individual Researcher Application
If the proposed use requires individual or departmental licensure, registration is required with the Federal DEA.
Drug Enforcement Agency: 516-420-4531
If the proposed use requires individual or departmental licensure, licensure is required with the NYS Department of Health.
Department of Health: 718-526-2626
United States Drug Enforcement Agency
DEA Controlled Substance Inventory Form - The DEA requires inventory every two years. This inventory may be taken on any
date within two years of the previous date. Keep this record at the licensed-registered
location. Schedule I and II controlled substances must be on a separate form. Do Not submit this form to the DEA unless requested.
DEA Form 41 - required by investigators for returning controlled substances
DEA Researchers Manual
New York State Department of Health
Reverse Distributor List(updated 2/22/2024) - A list of independent companies currently licensed by the NYS DOH and registered with the DEA that will take surrendered controlled substances for disposal.
| Question | Answer | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| What are “controlled substances”? | Narcotic and non-narcotic drugs under the jurisdiction of the Federal Controlled Substances Act (CSA) including, but not limited to, those substances listed in 21 CFR parts 1308.11-1308.15. These are known as scheduled controlled substances or scheduled drugs under the CSA. | |||||||||||||||
| Are all drugs controlled substances?
|
No, most drugs are considered pharmaceuticals and are not controlled substances. Examples of drugs that are not controlled substances are Donepezil, Xylazine, and Atropine. | |||||||||||||||
| What are the Drug Enforcement Administration (DEA) schedules and code numbers for
controlled substances?
|
The DEA assigns each controlled substance a schedule number (I through V) according
to its medicinal value, harmfulness, and potential for abuse or addiction. A higher
schedule number indicates the substance has more medicinal value and less potential
for abuse or addiction. The most common controlled substances used in research and
respective schedule numbers and DEA codes are listed below. The DEA code is a four
digit code assigned to each controlled substance.Examples of Controlled Substances,
Schedule Numbers, and DEA Codes.
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| Could I be subject to an inspection? | Yes. The DEA has the authority to oversee and inspect facilities before and after registration approval. | |||||||||||||||
| What are the inventory requirements for controlled substances? | Each licensed researcher is responsible for his/her own annual inventory. Typical inventory checks include: 1) hands-on counting; 2) completed in a single business day, i.e., before the start of the workday or at the end of the workday; 3) at least two authorized personnel; and 4) use of a form to document the inventory. | |||||||||||||||
| I am relocating to Stony Brook University, how do I update my state license and DEA registration? |
Relocation requires changing your license to conform with the state of New York requirements. NYS DOH 4330 - The NYS BNE instruction and application form for DOH 4330 includes information for relocations. Check “change”, “address change” and “physical relocation”. This will start the process of changing your license. It will also mean a site inspection for your new space. DEA – Once the DOH inspection for New York State is complete and the relocation is approved, you can complete a “modification of registration” for your DEA registration. This is an on-line application form. |