Controlled Substances Frequently Asked Questions (FAQs)

EH&S – serve as consultants for researchers in relevance to DEA and NYS regulations. EH&S cannot provide guidance outside the scope of the University’s policy on controlled substances. Responsibilities include: 

• Review and advise on security provisions as outlined in the minimum-security requirements under New York State Public Health Law and in accordance with federal regulations under the Controlled Substances Act. 
• Assist registrant with pre-inspections in preparation for DEA/DOH site inspections. 
• Provide best practices for inventory management and record keeping.
• Advise on disposal via New York State licensed reverse distributors. 

Licensed Individual – typically the Principal Investigator of a research protocol. Responsibilities include: 

• Overall compliance with controlled substance research regulations.  
• Obtaining and renewing both federal DEA registration and NYS DOH license.  
• Ensuring all acquisition, storage, security, inventory, disposal, and record-keeping requirements are strictly met.  
• Fulfilling requirements of DEA/DOH applications and working with the respective licensure division to complete the registrant’s applications.  
• Attending site inspections for consultation with diversion investigators, and demonstrating competency in preventing illicit diversion of controlled substances. 

Authorization for acquisition of controlled substances for research is a two-step process: (a) licensing with the NYS DOH; and (b) registration with the US DEA. New applicants should obtain the New York State license before submitting a registration to the Drug Enforcement Agency. All Columbia University license holders are also required to take RASCAL course TC0502: Controlled Substances Use and Management in Research.

1. NYS DOH licensing application is available at https://www.health.ny.gov/forms/doh-4330.pdf. Instructions and additional information about licensing requirements are available at https://www.health.ny.gov/forms/instructions/doh-4330_instructions.pdf.
   • Use of substances in Schedules II-V requires a Class 4 license.
   • Use of substances in Schedule I requires a Class 7 license.
   • Use of substances in both Schedule I and Schedule II-V requires both licenses.
   • NYS DOH licenses must be renewed every two years. It is the responsibility of the Licensed Individual to ensure that this license does not lapse.
2. The US DEA registration requires inclusion of the licensee’s State license number and identification of the controlled substances used. The registration application, DEA Form 225 should be completed online here https://www.deadiversion.usdoj.gov/drugreg/index.html.
   • Registration procedures, including detailed instructions on form submission, are available here: https://apps.deadiversion.usdoj.gov/webforms/jsp/regapps/common/instructions.jsp  and https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-057)(EO-DEA217)_Researchers_Manual_Final_signed.pdf
   • DEA registration must be renewed annually. It is the responsibility of the Licensed Individual to ensure that this registration does not lapse.
3. Log in to RASCAL with your Columbia UNI and Password to take TC0502: Controlled Substances Use and Management in Research.

New applicants will be subject to an on-site facility inspection by the NY State Bureau of Narcotic Enforcement (BNE), which reviews information concerning the operation of the laboratory and inspects for compliance with security and storage requirements for controlled substances. Applicants may prepare for this inspection by referring to the pre-inspection checklist. 

Upon receipt of a DEA registration application, the DEA may schedule a telephone interview or an on-site inspection. New registrants must complete their initial inventory of controlled substances immediately upon receipt of their DEA registration, on the first day of business after registration. In most cases, this initial inventory will show zero quantities.

Please refer to Storage and Security Resource document storage decision tree.  

Yes, please see the Columbia University Policy for the Acquisition, Use and Disposal of Controlled Substances in Research. 

No, Columbia University does not possess an institutional license for controlled substance use. If you intend to apply for a DOH license for Class 4 researcher (Schedules 11-V) or a Class 7 researcher (Schedule 1) you must apply as an individual on the DOH 4330 application.

1. A DOH license holder can renew their DOH license “If there have been no changes to the licensee’s controlled substance activity, name (legal, trade or d/b/a), ownership (operator), address and approved controlled substance schedules.” (https://www.health.ny.gov/forms/instructions/doh-4330_instructions.pdf)
   • The NYS DOH 4330 form used for initial application must be filled out for a “Renewal” Application Type if the above criteria are met.
   • NYS DOH license must be renewed every two years.
2. A DEA registration holder can renew their DEA registration online at https://www.deadiversion.usdoj.gov/online_forms_apps.html  using the DEA Form 225a (Renewal Application for DEA Registration) and must have their information from DEA Form 223 to initiate the renewal process.
   • Schedule I Researcher Renewals require certification with “a signed and dated statement that there are no changes to their approved research protocol, drug codes, or amount of controlled substances listed on the registration renewal application.” https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-057)(EO-DEA217)_Researchers_Manual_Final_signed.pdf
   • DEA registration must be renewed annually.

EH&S cannot accept controlled substances for disposal. Expired or unwanted controlled substances must be handled by a reverse distributor for disposal.

Reverse distribution companies are licensed to do both “reverse distribution” and “destruction”. Based on the status of your controlled substances, you can either request reverse distribution or destruction of the product. Reverse distribution will be for any unopened, sealed product you have (including expired materials). Destruction will be for any opened, aliquoted, or prepared dilutions of the product. You can determine which service you need before contacting the company to ensure they understand the services you are requesting.

For details on the procedures for these services, please contact the companies directly. A list of reverse distributor vendors here: https://www.health.ny.gov/professionals/narcotic/licensing_and_certification/docs/reverse_distributor.pdf

Recordkeeping must also reflect the disposal of controlled substances. The New York Codes, Rules and Regulations require records for the initial receipt of CS, inventory on hand every two years (biennial inventory), along with logs depicting container specific use and disposal.

As such records for initial receipt, biennial inventory, use logs, and any inventory list for disposal or P.O.'s generated from the reverse distribution should be kept on file, due to the record retention period of 5 years from the date of purchase, use, and transfer of any controlled substances under (NYS Title section 80.112 (b))

Under the New York Codes, Rules and Regulations (NYCRR) VOLUME A-1a (Title 10), Part 80 - Rules And Regulations On Controlled Substances, Title: Section 80.51, The Recordkeeping requirements for any controlled substances for disposal must include:

(i) date of return or destruction.

(ii) name, form, quantity of the substance returned or destroyed.

(iii) name, address, applicable registry numbers (DOH/DEA number) of the person making the return.

(iv) name, address, registry number of the supplier or manufacturer to whom the substances are returned

1. The NYS DOH will allow amendments to the DOH license for the addition of controlled substances outside the initial approved schedule or for changing the scope of the research protocol. The NYS DOH Form 4330 that is used for the initial application must be filled out for an “Amendment” Application Type and a narrative outlining the specific changes requested must be attached to the application. If you are relocating, please see the FAQ, “I am relocating...” question below.
2. The US DEA will allow modification of registration for change of address, name change, change in drug schedules, and addition of new drug codes.

Relocation requires a change to the NYS DOH license, followed by a modification to the federal DEA registration.

1. NYS DOH 4330: Please refer to the NYS BNE instruction and application form for DOH 4330. There is now an update on the application form for relocations: the applicant would check off “change” and the “address change” and “physical relocation”. This will initiate a site inspection in the new space.
2. DEA modification: Once the DOH inspection is complete and the relocation is approved, the PI can then complete a “modification of registration” for their DEA license (please see pg. 23). This is an online application form.
3. Storage: At the new location, the storage unit (e.g. double door cabinet or safe), should be present, installed properly, and should NOT contain any controlled substances. If a PI will be moving their storage unit from one location to the other, their current inventory must be reverse distributed.