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Research Involving Controlled Substances - Quick Guide to Getting Started. The Office of Research Compliance v. Jan 2013. Introduction.
Quick Guide to Getting Started
Animal, human or in vitro research involving the use and possession of controlled substances is highly regulated and requires central notification at our Health System as well as appropriate registration and licensing from state and federal agencies.
It is important to be familiar with our institutional policies and process not only to ensure compliance with the various regulatory requirements, but to ensure that your study can be conducted smoothly and in a timely fashion.
This presentation will cover basic information about this process to get you started and direct you to the appropriate contact depending on the type of research you plan to conduct.
In general it will familiarize you with the following:
How to access our Health System’s Research Policy governing research using controlled substances
NY State license requirements and application form
Federal DEA registration requirements and application form
Other key requirements
There are 5 schedules:
Schedule I: High potential for abuse with no currently accepted medical use in the U.S. (e.g. heroin, marijuana, LSD)
Schedule II: High potential for abuse with severe psychic or physical dependence liability. (e.g. morphine, codeine, methadone, methylphenidate, amphetamine)
Schedule III: Potential for abuse less than those in schedule I and II with compounds containing limited quantities of certain narcotic and non-narcotic drugs (e.g. ketamine)
Schedule IV: Potential for abuse less than those in schedule III (e.g. phenobarbital, chloral hydrate, and diazepam (Valium))
Schedule V: Potential for abuse less than those in schedule IV and consist of preparations containing limited quantities of certain narcotic drugs.
You can find drug schedules listed in NYS Article 33
You should familiarize yourself with our institutional policy, which you can access through HealthPort by:
Clicking on the Policies tab
Then click on the “Research Policies” tab under your site
Scroll down to the section: “Use of Drug and Investigational Products”
Then click on “GR050: Use of Controlled Substances in Research”
Notification that controlled substances will be used in research is required, which you can do by submitting a notification form to:
For human research: [email protected] (regardless of which IRB you use)
For animal research: [email protected]
For in vitro research: [email protected]
The notification form should be completed prior to initiating any research and making any changes to your research related to controlled substances being used or personnel handling the substances.
Notification of the Office of Research Compliance that controlled substances will be used in research is also required, which you can do by scanning license and registrations to:
ORC Mailbox: [email protected] or 516-562-2019
Key things to know:
Researchers require separate state licenses and DEA registrations to engage in research with controlled substances even if one already has a clinical or professional license
Licenses are issued by the NYS Bureau of Narcotic Enforcement and must be renewed every two years
The NYS license must be obtained before the DEA registration
Outpatient prescriptions require use of official NYS prescription forms
Mandatory reporting of dispensed controlled substances to NYS is required electronically every month
Step 1: Download the license application form (DOH 4330) and instructions online at: http://www.health.state.ny.us/professionals/narcotic/forms.htm
Step 2: Determine your license classification:
Schedule I researchers should apply for a Class 7individual license
Schedule II-V researchers should apply for a Class 4individual license
Contact the Office of Research Compliance for institutional license matters for schedule II-V.
Step 3: Read instructions for the following:
Required information to be submitted with the application
Minimum security requirements including safe specifications
Note: Researchers conducting human subject research must submit IRB approval correspondence with the application
NYS Bureau of Narcotic Enforcement Web Site
For further information, forms and guides for physicians and pharmacists: http://www.health.ny.gov/professionals/narcotic/
NYS Laws and Regulations
Access Article 33 to look up schedules of drug and Title 10 Part 80 for regulations governing this activity:
Please take the time to read the “Dear Researcher” letter from NYS:
Key Things to Know:
Investigators must be registered as a DEA Researcher; researchers require annual renewal of registration
Each separate site of activity must be DEA registered
Federal registration does NOT overrule state restrictions
Additional Requirements for Schedule I & II:
Supply must be requested using DEA Form 222
Researchers conducting research with Schedule I substances must:
Hold a separate Federal Research DEA Registration
(For Clinical Investigations): Submit to FDA a “Notice of Claimed Investigational Exemption for New Drug (IND)” (from: www.fda.gov)
Submit proof of Institutional (and IRB for human studies) approval
You must register as a researcher by following the steps below:
Step 1: Download the DEA application form 225 (or complete it online) and access instructions by going to: http://www.deadiversion.usdoj.gov/drugreg/reg_apps/225/225_instruct.htm
Step 2: Determine your business activity:
Researcher with Schedule I OR Researcher with Schedule II-V
Note that each activity requires a separate application
You will need to include your NYS license number
Step 3:See page 4 (or click on “Attachments”) for:
Required attachments for Schedule I researchers
DEA Web Site for Registration
For further information, tools and resources: http://www.deadiversion.usdoj.gov/drugreg/index.html#1
Federal Laws and Regulations
The Controlled Substance Act, regulations, Q&A, and legal information:
Section 1301.18 Pertaining to Research Protocols & Schedule I
License/Registration holders must do the following:
Limit access only to employees or agents under their supervision who require handling of controlled substances issued to them as part of the research.
Formally authorize employees or agentsby performing appropriate screening of each user and maintain a list of authorized users.
Use the Authorized User of Controlled Substances in Research Screening Form (available through HealthPort under Research Policies)
Work with HR to handle any issues related to screening and store forms in a secure location
Note that any additional prescribers must obtain their own separate license/registration.
License/Registration holders are ultimately responsible and accountable for adherence to policies and regulations including authorized personnel.
Key things to know:
Supply should be stored in a locked, secure area with limited access and appropriate security measures to prevent theft or diversion
There are minimum storage requirements for main and working stocks depending on the schedule of drug
(see specifications in the NYS application instructions)
Applicants are subject to an on-site inspection by NYS
Do not store drug in a locked box that can easily be lifted or an unlocked desk drawer.
Documentation must be maintained that clearly tracks the chain of custody of controlled substances from receipt to final disposition, and be made 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
Records for receipt and use (including dispensing)
Disposal, theft and loss records
Inventory records (including required biennial inventory)
Documentation must be attributable (e.g. identifies the individual recording the information and represents what actually occurred).
We recommend returning unused drug to the original distributor/manufacturer or disposing it off-site through an approved reverse distributor that is licensed/registered by the State and DEA.
See approved Reverse Distributor list at: http://www.health.state.ny.us/professionals/narcotic/pharmacies/surrender_to_independent_companies.htm
On-site destruction is not recommended and requires prior authorization by NYS. Please contact the appropriate office listed at the end of this presentation for assistance.
This should be promptly reported to the Office of Research Compliance and Corporate Security for investigation and required actions.
Formal reporting to NYS and the DEA may be required, and should be done in conjunction with the Office of Research Compliance.
NYS Loss of Controlled Substances Report: http://www.health.state.ny.us/professionals/narcotic/forms.htm
DEA Theft or Loss of Controlled Substances:http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html
The DEA requires reporting knowledge of drug diversion by employees or colleagues to the responsible security official
Allow time to obtain proper licenses & registrations, particularly if separate approvals are required
Have pharmacy store and dispense drug
Check expirations dates of drug regularly
Place a reminder in your calendar for license/registration renewals
Provide education for all personnel involved in handling controlled substances
Be prepared for routine or for case audits or investigations by documenting well and ensuring that records are organized