Transcript NS-LIJ Powerpoint Template - The Feinstein Institute for Medical

Research Involving Controlled Substances Quick Guide to Getting Started
The Office of Research Compliance
v. Jan 2013
Introduction
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.
Learning Objectives
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:
1) How to access our Health System’s Research Policy governing
research using controlled substances
2) NY State license requirements and application form
3) Federal DEA registration requirements and application form
4) Other key requirements
Schedules of Controlled Substances
There are 5 schedules:
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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
What is our Health System Policy?
You should familiarize yourself with our institutional policy, which you
can access through HealthPort by:


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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]
More about the Notification Form
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
What are NY State Requirements?
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
How Do I Apply for a NY State License?
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 7 individual license
• Schedule II-V researchers should apply for a Class 4 individual 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
Where Can I Find More NYS Information?
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:
http://www.health.ny.gov/professionals/narcotic/laws_and_regulations.htm
Please take the time to read the “Dear Researcher” letter from NYS:
http://www.health.ny.gov/professionals/narcotic/facilities/letters/2008-0801_controlled_substance_license.htm
What are Federal Requirements?
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
How Do I Obtain a DEA Registration?
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:
• Additional instructions
• Required attachments for Schedule I researchers
Where Can I Find DEA Information?
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:
http://www.deadiversion.usdoj.gov/Resources.html
Section 1301.18 Pertaining to Research Protocols & Schedule I
http://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_18.htm
How Do I Authorize Staff to Handle
Controlled Substances?
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 agents by 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.
Storage and Security Requirements
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.
Record Keeping Requirements
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
• Orders/prescriptions
• 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).
How Do I Dispose of Unused Drug?
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/surr
ender_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.
What Should I Do in the Case of
Theft or Loss?
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/in
dex.html
The DEA requires reporting knowledge of drug diversion by
employees or colleagues to the responsible security official
Helpful Tips
• 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
Contacts Us for
Questions or Assistance
Animal
Research
IACUC
P(516) 562-1274
Email: [email protected]
Human
Research
Office of Research Compliance
P(516) 562-2019 or 0339
Email: [email protected]
In Vitro
Research
Research Administration
P(516) 562-3467 or 1093
Email: [email protected]