Quick Regulatory Guide to Getting Started Research Involving Controlled Substances Office of Research Compliance

Introduction Laboratory, animal and human research involving the use and possession of controlled substances is highly regulated and requires: Notification of research administrative offices NYS research license DEA registration Other federal agencies as required

Learning Objectives This short presentation will cover basic information about regulatory requirements to get you started and direct you to the appropriate contacts depending on the type of research you plan to conduct.

Schedules of Controlled Substances Schedule I: No currently accepted medical use in the US, a lack of accepted safety for use under medical supervision, and a high potential for abuse. [e.g., heroin, LSD, marijuana (cannabis)] Schedule II: A high abuse potential with severe psychological or physical dependence liability. (e.g., morphine, codeine, methadone, amphetamine, methylphenidate, fentanyl and any products containing Hydrocodone) Schedule III: An abuse potential less than those in Schedules I and II. (e.g., ketamine and buprenorphine) Schedule IV: An abuse potential less than those listed in Schedule III. [e.g., phenobarbital, chloral hydrate, and diazepam (Valium)] Schedule V: An abuse potential less than in Schedule IV and preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes. You can find drug schedules in NYS Article 33

What is Northwell Health's Policy? You should familiarize yourself with institutional policy, which can be accessed through the intranet under Research Policies: GR050: Use of Controlled Substances in Research Notification that controlled substances will be used in research is required to the following: The Human Research Protection Program (HRPP) for human or clinical research (regardless of which IRB you use) through the electronic submission system The Institutional Animal Care and Use Committee (IACUC) for laboratory animal research through the protocol submission process Research Administration for laboratory or in vitro research by emailing Feinsteinadministration@northwell.edu

What are NY State Requirements? Key things to know: Researchers are required to obtain separate state research licenses to use controlled substances in research. Licenses are issued by the NYS Department of Health Bureau of Narcotics Enforcement and must be renewed every two years. The NYS research license must be obtained before the DEA registration.

What are NY State Requirements? Additional requirements for clinical researchers: Only licensed individuals in NYS to practice medicine with a valid DEA registration may prescribe and dispense controlled substances to subjects in clinical research studies. All prescriptions for controlled substances must be issued as required by NYS (e.g. official or electronic prescription). Researchers who dispense controlled substances (Schedule II-V) to human research subjects are required to report dispensing information to NYS DOH electronically by the 15th of the month following in which the controlled substance was dispensed. NYS DOH may waive this reporting requirement for certain investigational products. During the NYS DOH research license application process, consult a Bureau of Narcotic Enforcement (BNE) inspector. Any dispensing of Schedule 1 controlled substances is not reportable unless the dispensing is from a NYS registered Medical Marijuana Dispensary.

How Do I Apply for a NYS License? Step 1: Download the license application form (DOH 4330), instructions and applicable appendix online at: https://www.health.ny.gov/professionals/narcotic/licensing_and_certification/ Step 2: Determine your license classification: Schedule I researchers should apply for a Class 7 individual license. Schedule II-V researchers should apply for a Class 4 individual license. Step 3: Read instructions for the following: Required information to be submitted with the application. Minimum security requirements for main and working stock including safe specifications.

How Do I Obtain a DEA Registration? You must register by following the steps below: Step 1: Download the DEA application form (or complete it online) and instructions at: https://www.deadiversion.usdoj.gov/drugreg/ Step 2: Determine your business activity: Researcher with Schedule I OR Schedule II-V. Include your NYS license number. Note that each activity & location requires a separate application. Step 3: Include required information: Schedule I research requires additional attachments.

How Do I Authorize Staff to Handle Controlled Substances? License/registration holders must do the following: Limit the access of controlled substances to employees or agents who must handle them as part of the research. This should be done under the holder’s direct supervision. Authorize and screen users and maintain a list of authorized users Use the Authorized User of Controlled Substances in Research Screening Form (available on the intranet under the research policy). Work with HR to handle any issues related to screening and store forms in a secure location. Update authorized users lists to accurately reflect current employees (e.g. removing terminated staff from the authorized users list). Additional prescribers must have their own DEA registration and obtain separate research license as applicable.

Storage and Security Requirements Key Things to Know: There are minimum storage requirements for main and working stocks depending on the schedule of drug. See specifications in the NYS license application instructions. Supply should be stored in a locked, secure area with limited access and appropriate security measures (e.g., card reader to enter room, camera, etc.) to prevent theft or diversion. Do not store drug in a locked box that can easily be lifted or in an unlocked desk drawer. Applicants are subject to an on-site inspection by NYS & DEA. Report any suspected and/or confirmed loss, theft or diversion of drug immediately.

Record Keeping Requirements Documentation must be maintained that clearly tracks the chain of custody of controlled substances from receipt to final disposition, and should be readily available upon inspection. The following must be maintained for at least 5 years: Applications, issued license/registration, authorized user screening and any other relevant forms Purchase orders and forms Orders, prescriptions Records for receipt and use (including dispensing) Disposal, theft and loss records (including NYS Official Prescription Forms, if applicable) Inventory records (including required annual inventory) Documentation must be attributable (e.g. identifies the individual recording the information and represents what actually occurred)

How Do I Dispose of Unused Drug? Unused drug should either be returned to the original distributor/manufacturer/sponsor or to an authorized reverse distributor that is licensed/registered by the State and DEA. See approved reverse distributor list: https://www.health.ny.gov/professionals/narcotic/licensing_and_certification/surrender_to_independent_companies.htm

What Should I Do in the Case of Suspected Diversion, Theft or Loss? This should promptly be reported to the Office of Research Compliance and Corporate Security. Formal reporting to NYS and DEA may be required. NYS DOH Loss of Controlled Substances Report (Form 2094): https://www.health.ny.gov/professionals/narcotic/forms.htm DEA Theft or Loss of Controlled Substances (Form 106): https://www.deadiversion.usdoj.gov/21cfr_reports/theft/ Reporting knowledge of drug diversion by employees or colleagues to a responsible security official is required.

Helpful Tips Allow time to obtain licenses & registrations. Check sponsor or sponsoring agency specific requirements, if any. Budget appropriately for license/registration fees, storage and security requirements and pharmacy services. Regularly monitor substances by checking accountability and expiration dates of drugs. Place a reminder in your calendar for license/registration renewals and annual inventories. Ensure all personnel involved in handling controlled substances have been screened and trained. Be prepared for audits or inspections by having good documentation practices and organized records.

Where Can I Find More Info? NYS DOH Bureau of Narcotic Enforcement Web Site: https://www.health.ny.gov/professionals/narcotic/ For further information, forms and guides for practitioners and pharmacists Access Article 33 to look up schedules of drug and Title 10 Part 80 for regulations governing this activity DEA Web Site Resources: https://www.deadiversion.usdoj.gov/Resources.html For practitioner and pharmacist manual Title 21 Controlled Substances Act ORC web site: www.northwell.edu/orc for templates and tools

Contact Us for More Information Office of Research Compliance Email: orc@northwell.edu General Line: (516) 321-2101