Controlled Substance Use in Research at Cornell University

Transcription

Research Use of Controlled
Substances
Written
Program
Research Use of Controlled Substances
Program
Table of Contents
1 Purpose......................................................................................................................................... 4
2 Up-Front Information................................................................................................................... 4
3 Scope ............................................................................................................................................ 5
3.1 Weill Cornell Medical College ............................................................................................. 5
3.2 Clinical/Hospital Medical, Pharmaceutical and Veterinary Practice.................................... 5
3.3 Human Subjects’ Research ................................................................................................... 5
4 Roles and Responsibilities ........................................................................................................... 5
4.1 Cornell University EH&S ..................................................................................................... 5
4.2 Cornell University Police...................................................................................................... 5
4.3 Cornell University Hospital for Animals Pharmacy ............................................................. 6
4.4 Licensee ................................................................................................................................ 6
4.5 Individual Licensee ............................................................................................................... 6
4.6 Institutional Licensee ............................................................................................................ 7
4.7 Oversight Committee (Institutional Licensee) ...................................................................... 7
4.8 Signatory – Applicant or Officer of the Applicant and Authorized Representative ............. 7
4.9 Supervisor of Controlled Substance Activity/Responsible Individual ................................. 8
4.10 Material Manager ................................................................................................................ 8
4.11 Authorized User .................................................................................................................. 9
4.12 Senior Authorized User (Institutional Licensee) ................................................................ 9
5 Disclaimer .................................................................................................................................... 9
6 Laws and Regulations ................................................................................................................ 10
6.1 Federal ................................................................................................................................ 10
6.2 State .................................................................................................................................... 10
7 Licensing and Registration – Initial Application ....................................................................... 10
7.1 DEA Registration (Federal) ................................................................................................ 11
7.1.1 DEA Specific Research Requirements ........................................................................ 11
Approved by: James Grieger
Last revised by: Joanna Lynch
Revision date: 2/4/13
Controlled_Substances_Guidance
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The most recent version of this document is available electronically at EH&S Website: http://sp.ehs.cornell.edu/lab-researchsafety/research-safety/constrolled-substances/Documents/Controlled_Substances_Guidance.pdf
7.2 NYSDOH Licensure (State) ............................................................................................... 12
7.2.1 NYSDOH Specific Research Requirements ................................................................ 12
7.2.2 Individual State License ............................................................................................... 13
7.2.3 Institutional State License ............................................................................................ 13
7.2.4 License Amendments ................................................................................................... 17
8 Licensing and Registration – Renewal ...................................................................................... 18
8.1 DEA Registration Renewal (required yearly) ..................................................................... 18
8.2 NYSDOH License Renewal (required every 2 years) ........................................................ 19
9 Definition and Schedules of Controlled Substances .................................................................. 19
9.1 Controlled Substances. Definition ...................................................................................... 19
9.2 Schedules of Controlled Substances. Definitions ............................................................... 19
9.2.1 Schedule I..................................................................................................................... 19
9.2.2 Schedule II ................................................................................................................... 19
9.2.3 Schedule III .................................................................................................................. 19
9.2.4 Schedule IV .................................................................................................................. 20
9.2.5 Schedule V ................................................................................................................... 20
9.3 Schedules of Controlled Substances. Lists ......................................................................... 20
9.3.1 Federal Controlled Substance Schedule List ............................................................... 20
9.3.2 State Controlled Substance Schedule List ................................................................... 20
9.4 Exempt Amounts ................................................................................................................ 21
10 Lists I and II Chemicals (Precursors)....................................................................................... 21
11 Guidelines ................................................................................................................................ 22
11.1 Registration and Licensing ............................................................................................... 22
11.1.1 Displaying .................................................................................................................. 22
11.2 Training ............................................................................................................................. 22
11.3 Purchasing ......................................................................................................................... 22
11.3.1 Purchasing Schedule I and II Substances ................................................................... 23
11.3.2 Cornell University Hospital for Animals Pharmacy .................................................. 23
11.4 Receiving .......................................................................................................................... 23
11.5 Inventory & Recordkeeping.............................................................................................. 23
11.5.1 Record of Receipt ...................................................................................................... 24
11.5.2 Record of Use and Disposal ....................................................................................... 24
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11.5.3 Inventory .................................................................................................................... 25
11.5.4 Record Templates ...................................................................................................... 25
11.6 Storage .............................................................................................................................. 26
11.6.1 Vault or GSA Class 5 Rated Safe/Cabinet ................................................................. 27
11.6.2 Cabinet, Double Locked ............................................................................................ 27
11.6.3 Cabinet ....................................................................................................................... 27
11.7 Access Restrictions ........................................................................................................... 27
11.8 Personnel Screening .......................................................................................................... 27
11.9 Diversion, Loss or Theft ................................................................................................... 28
11.10 Spill Procedures .............................................................................................................. 28
11.10.1 Not Recoverable - DEA Procedure .......................................................................... 28
11.10.2 Not Recoverable - NYSDOH Procedure ................................................................. 28
11.11 Import/Export.................................................................................................................. 29
11.12 Transfer between Research Groups ................................................................................ 29
11.13 Disposal .......................................................................................................................... 29
11.13.1 Licensees Holders .................................................................................................... 29
11.13.2 Abandoned Substances ............................................................................................ 29
11.13.3 Outdated or Unneeded Controlled Substances ........................................................ 30
12 Appendices ............................................................................................................................... 30
12.1 Appendix. Quick Links .................................................................................................... 31
12.2 Appendix. Example: Personnel Screening Questionnaire ............................................... 34
12.3 Appendix. Example: Record of Receipt Log for an Individual Licensee ........................ 35
12.4 Appendix. Example: Record of Use Log for an Individual Licensee .............................. 36
12.5 Appendix. Schedules for Many Controlled Substances Used for Research at CU.......... 37
12.6 Appendix. Example: Storage Cabinets Double Door, Double Lock ............................... 39
12.7 Appendix. Procedures Specific to Analytical Laboratories ............................................. 40
12.8 Appendix. Procedures Specific to Instruction (Teaching) ............................................... 42
12.9 Appendix. Flow Chart: Individual Controlled Substance Research License: Initial
Application Schedule II-V ........................................................................................................ 44
12.10 Appendix. Flow Chart: Institutional Controlled Substance Research License: Initial
Application Schedule II-V ........................................................................................................ 45
12.11 Appendix. Biennial Inventory1, 2 (Individual Licensee, Multiple Drugs, Single Storage
Location)
46
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12.12 Appendix. Outdated or Unneeded Controlled Substances............................................. 47
1 Purpose
Research use of controlled substances and precursor chemicals is regulated by New York
State Department of Health (NYSDOH), Bureau of Narcotic Enforcement (BNE) and the
Federal Drug Enforcement Agency (DEA). A “controlled substance” broadly means a
substance that is addictive, illegal or can be abused. Use and possession of controlled
substances requires:
•
NYSDOH licensing
•
DEA registration
•
Adherence to all controlled substances rules and regulations
This document is intended to outline the roles and responsibilities for use of controlled
substances in research at Cornell University and to provide guidance and resource
information to users.
2 Up-Front Information
Sometimes, when confronted with detailed guidance such as is provided in this document,
important points can be missed. The following is therefore abstracted for emphasis:
•
All applicants should contact EH&S before applying for Controlled Substance
Licensure.
•
All Licensees and users under Licensees should take the EH&S on-line training
course “Controlled Substance Use in Research”. This course is available on the
EH&S Controlled Substances webpage
•
Researchers must apply for a NYSDOH license BEFORE they apply for a DEA
registration.
•
Controlled substances for research CAN NOT (and must not) be obtained using a
prescription or from a pharmacy (including the CU Hospital for Animals Pharmacy).
•
Disposal of unused/expired controlled substances MUST be arranged by the
researcher (license holder) through a reverse distributor or by returning the material to
the supplier. The cost of doing this is the responsibility of the Licensee.
•
A schematic of the licensing and registration process for the most common licensing
situations (research, schedules II-V) is given in Appendix 12.9 (Individual Licensee)
and Appendix 12.10 (Institutional Licensee).
•
Analytical Laboratories: Specifics on controlled substance use and licensing for
analytical laboratories is covered in Appendix 12.7.
•
Instructional Activities (Teaching): Specifics on controlled substance use and
licensing for teaching is covered in Appendix 12.8.
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3 Scope
This document applies to the use of controlled substances in research, instruction and
analytical laboratories at Cornell University excluding:
3.1 Weill Cornell Medical College
3.2 Clinical/Hospital Medical, Pharmaceutical and Veterinary Practice
These exclusions include Gannett Health Services, Gannett Pharmacy, the Cornell University
Veterinary Hospital and Out-Patient Clinic, and individual practitioners in the course of their
medical or veterinary practice. The University Hospital for Animals Pharmacy is considered
in this document only in regard to their role in supplying controlled substances for research
animals registered as patients at the Cornell University Hospital for Animals.
3.3 Human Subjects’ Research
Research involving the use of controlled substances and human subjects is not currently
conducted on the Cornell Campus (excluding Weill Cornell Medical College). Additional
considerations need to be taken into account if this type of research is proposed and is outside
the scope of the current document.
4 Roles and Responsibilities
In order to conduct research involving the use of controlled substances, researchers must
have or work under a NYSDOH license and DEA registration. It is important to be aware
that anyone holding a NYSDOH license/DEA registration is ultimately responsible and
accountable for understanding and adhering to all the federal and state controlled substances
rules and regulations. Cornell University itself does not hold an institutional license.
Note that NYSDOH licensing/DEA registration for research use of controlled substances is
separate and independent of any professional NYSDOH license/DEA registration that allows
for the use of controlled substances in the course of a professional practice (such as
veterinary medicine).
4.1 Cornell University EH&S
Cornell University EH&S is responsible for developing and maintaining the Research Use of
Controlled Substances Program and providing guidance to individuals and campus units on
licensing and registration, procurement, use, record keeping, storage, security and disposal of
controlled substances used in research, teaching and analytical testing. EH&S will maintain
a record of all researchers, teaching units, analytical laboratories that hold DEA registration
at Cornell University. EH&S will report or refer any known loss, theft or diversion of
controlled substances to the Cornell University Police. It remains the responsibility of the
Licensee to notify both the DEA and NYSDOH BNE of any loss, theft and diversion
(Section 11.9).
4.2 Cornell University Police
Cornell University Police are responsible for investigating all matters regarding the loss, theft
or diversion of controlled substances used in research, teaching or analytical work. Cornell
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University Police will notify EH&S of any known loss, theft or diversion and enlist their
assistance as necessary. It remains the responsibility of the Licensee to notify both the DEA
and NYSDOH BNE of any loss, theft and diversion (Section 11.9).
4.3 Cornell University Hospital for Animals Pharmacy
The Cornell University Hospital for Animals Pharmacy (CUHA pharmacy; “Vet School
Pharmacy”) provides controlled substances to registered patients of the hospital under a Class
3 Institutional Distributor license. The Pharmacy cannot supply controlled substances for
research purposes to the Cornell Community because it is not within the scope of their
licensure.
4.4 Licensee
A Licensee, as defined in this document, is a person, department or organization unit that
holds both a NYSDOH license and DEA registration to work with controlled substances.
There are two types of licensees: Individual (Section 4.5) and Institutional (Section 4.6). The
Licensee is ultimately responsible and accountable for understanding and adhering to all
federal and state controlled substances rules and regulations as well as any specific
University and department/unit requirements. Responsibilities include, but are not limited to:
granting Authorized User (Section 4.11) or Senior Authorized User (Section 4.12) status to
persons under their supervision, having all users working with controlled substances fill out a
Personnel Screening Questionnaire (Section 11.8), training users in the proper use (both
safety and regulatory) of controlled substances, providing adequate oversight and
supervision, maintaining current licensure/registration, working within the scope of the
current license/registration, understanding and complying with all federal and state laws,
maintaining required records, reporting any theft or loss of controlled substances (to CU
police, EH&S, NYSDOH BNE, and DEA. See Section 11.9), properly ordering, storing and
disposing of controlled substances, and preparing biennial controlled substance inventories.
Please note that NYSDOH does not allow any “mixing and matching” of licenses and
registrations. Researchers with projects involving the use of controlled substances must either
work under their own individual research NYSDOH license and corresponding individual
research DEA registration, or (if available) their department’s institutional research
NYSDOH license and department research DEA registration. Similarly, NYSDOH requires
a separate license and registration for each independent activity (e.g., research, teaching,
analytical). This is different from the DEA, which does allow professional practitioners (e.g.
DVM and MD) to conduct research and instructional activities as coincident activities under
their professional DEA registration. However, NYS law (Article 33) does not specifically
allow for coincident activities and this is interpreted to mean that that a separate NYSDOH
license and corresponding DEA registration must be obtained (personal communication with
NYSDOH, 5/12/11).
4.5 Individual Licensee
An Individual Licensee is a faculty or senior staff member that holds an Individual NYSDOH
license and corresponding DEA registration. An Individual Licensee assumes all the
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responsibilities of a Licensee. Controlled substance activities are limited to the scope of the
protocols approved by and submitted to NYSDOH.
4.6 Institutional Licensee
An Institutional Licensee is a department or unit that holds a NYSDOH Institutional license
and a DEA registration to work with controlled substances. The responsibilities of an
Institutional Licensee are similar to that of an Individual Licensee except that protocols are
approved by an Oversight Committee (Section 4.7) rather than direct submission to
NYSDOH (although NYSDOH must be sent information on each approved protocol). Under
an institutional license, specific roles must be assigned to designated individuals. At Cornell
University, the department chair or unit head serves the key roles of chair of the Oversight
Committee (Section 4.7), Signatory (Section 4.8) and Supervisor (Section 4.9).
Institutional research licenses are covered briefly in Article 33, 3325 of the NYS Controlled
Substance Act and on in the application instructions for a NYSDOH license. EH&S has
worked with NYSDOH to clarify the specifics, and recommendations in this guidance
document reflect these discussions.
See Section 7.2.3 of this document for more information on the responsibilities and
administration of an Institutional Licensee.
4.7 Oversight Committee (Institutional Licensee)
An Oversight Committee is a committee established within a department or unit for
approving, supervising and evaluating protocols under an institutional license. The
Oversight Committee also appoints a Supervisor of Controlled Substance Activity (Section
4.9). At Cornell University, the department chair or unit head should serve as the chair of the
Oversight Committee and Supervisor of the Controlled Substance Activities. The Oversight
Committee has the authority to appoint Senior Authorized Users (Section 4.12) and a
Material Manager (Section 4.10). The Oversight Committee shall meet regularly and as
necessary to fulfill the committee's responsibilities to approve, supervise, and evaluate
project. An up-to-date record of approved protocols, Senior Authorized Users and any
actions taken by the Committee should be maintained. The Oversight Committee has the
responsibility to take appropriate action in cases where an individual (Senior Authorized
User, Authorized User, Material Manager or any other) is not in compliance with controlled
substance federal or state laws and regulations, the conditions of the NYSDOH license or
DEA registration, or the policies of the Licensee or Cornell University.
4.8 Signatory – Applicant or Officer of the Applicant and Authorized Representative
NYSDOH license application, DEA registration and DEA Form 222 (for procurement of
schedule I and II substances) require an authorized signature.
For an Individual Licensee, this is the applicant’s signature.
For an Institutional Licensee, this is the Department Chair or Unit Head, acting as the Officer
of the Applicant (when signing DEA paperwork) and Authorized Representative (when
signing NYSDOH paperwork). This signatory also acts as the Supervisor of Controlled
Substance Activity (Section 4.9).
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A Power of Attorney is required for a Chair or Unit Head to obtain signature authority to sign
a DEA application for an Institutional Licensee (therefore acting as the Officer of the
Applicant). The DEA addresses POA in CFR 1301.13. EH&S can help facilitate this
assignment through the University Counsel’s office.
4.9 Supervisor of Controlled Substance Activity/Responsible Individual
The term “Supervisor of Controlled Substance Activity” is used by NYSDOH and the term
“Responsible Individual” is used by DEA. They have similar meanings. For the purpose of
this guidance document, the term “Supervisor” will be used to refer to either.
The Supervisor is responsible for all controlled substances obtained through this registration,
including recordkeeping and security of the controlled substances at the address located on
the application. For research, analytical and teaching licensure at Cornell, the applicant (for
an Individual Licensee) or department chair/unit head (for an Institutional Licensee) serves as
the Supervisor. In both cases, this is the same person that signs the license and registration
applications.
The Supervisor has operational and oversight responsibilities for the NYSDOH license and
DEA registration activities. Responsibilities include:
•
•
•
•
Establishing and overseeing operation in accordance with NYSDOH and DEA rules,
regulations and best practices.
Signature authority (Section 4.8) for an individual license or on behalf of the
Institutional Licensee, including but not limited to license and registration
applications, renewals, amendments, procurement forms (including DEA Form 222),
order approval, disposal forms, and appointing Senior Authorized Users (Institutional
Licensee) and Authorized Users (Individual Licensee).
Serving as chair of the Oversight Committee (Institutional Licensee Only) (Section
4.7).
Appointing, overseeing and supervising a Material Manager (Section 4.10)
responsible for managing and implementing specified day-to-day activities conducted
under the Licensure. The Supervisor is not relieved of his/her responsibility to detect
and correct any diversion or mishandling of controlled substances or for
understanding and adhering to all federal and state controlled substances rules and
regulations by a delegation of responsibility. Appointment of a Material Manager is
not required if the Supervisor personally assumes these day-to-day activities and does
not delegate them.
4.10 Material Manager
The Material Manager is responsible for the day-to-day activities associated with Licensure.
A Material Manager may be appointed by either an Individual or Institutional Licensee.
Appointment of a Material Manager is not required if the Supervisor (Section 4.9) personally
assumes the day-to-day activities associated with Licensure and does not delegate them. The
Material Manager should be a staff or faculty member at Cornell University (not a student)
and the role of Material Manager should be part of the employee’s official job description.
The appointment should be formalized in writing and the Material Manager should read and
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understand this guidance document as well as complete EH&S on-line training. The Material
Manager should complete a Personnel Screening Questionnaire (Section 11.8). The role of
Material Manager may include procuring controlled substances (although they cannot sign
DEA form 222), distribution to Authorized Users or Senior Authorized Users (within the
scope of the approved projects), record keeping, security, arranging for proper disposal, and
reporting any knowledge or suspicion of loss or diversion to the Supervisor. If working
under an institutional license, the Material Manager should be a member of the Oversight
Committee. The Material Manager cannot be given signature authority for license and
registration applications, renewals, amendments, DEA Form 222 or approval of Senior
Authorized or Authorized Users (specific power-of-attorney is required by DEA for any
delegation of signature authority regarding applications, renewals and DEA Form 222. See
CFR 1301.13, CFR 1305.05, CFR 1305.11, CFR 1305.12).
4.11 Authorized User
An Authorized User is a faculty or laboratory member (staff, graduate student, or visiting
scientist) who is authorized by a Licensee or Senior Authorized User to possess or use
controlled substances in the course of their research. Authorized Users must fill out a
Personnel Screening Questionnaire (see Section 11.8 of this document). Authorized Users are
responsible for understanding and complying with all federal and state laws regarding the use
of controlled substances as well as adhering to University and department/unit requirements.
Authorized Users may work only within the scope of the registration/license/protocol for
which they are authorized.
4.12 Senior Authorized User (Institutional Licensee)
A Senior Authorized User is a faculty member or senior staff member who is authorized
under an institutional license by the Oversight Committee to possess or use controlled
substances in the course of their research. Senior Authorized Users must submit protocols to
the Oversight Committee for approval. Upon approval, Senior Authorized Users may work
only within the scope of the protocol for which they are authorized. Controlled substance
ordering and disposal must be done by the Licensee, not the Senior Authorized User. Senior
Authorized Users must fill out a Personnel Screening Questionnaire (Section 11.8). Senior
Authorized Users may also appoint members of their research group as Authorized Users
(Section 4.11) and must assure that they receive appropriate training. Senior Authorized
Users are responsible for understanding and complying with all federal and state laws
regarding the use of controlled substances as well as adhering to University, institutional
license and department/unit requirements.
5 Disclaimer
The guidance, links, references and excerpts regarding the NYSDOH and DEA controlled
substance programs provided in this document are for informational purposes only and are
not guaranteed to be current and complete. It is the responsibility of each Licensee (not
EH&S) to fully understand and comply with the most current NYSDOH and DEA mandates.
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6 Laws and Regulations
Controlled substances are regulated at both the federal and state levels. The laws, regulations
and additional information can be found at:
6.1 Federal
Administered by the Drug Enforcement Administration (DEA), Office of Diversion Control:
Office of Diversion Control (Home page)
(http://www.deadiversion.usdoj.gov/)
Title 21 CFR, Part 1300-1399 (The regulation)
(http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html)
Title 21 United States Code (USC) Controlled Substances Act (The law)
(http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html)
6.2 State
Administered by New York State Department of Health (NYSDOH), Bureau of Narcotic
Enforcement (BNE):
Bureau of Narcotic Enforcement (Home page)
(http://www.health.state.ny.us/professionals/narcotic/)
Part 80 Rules and Regulations on Controlled Substances (The regulation)
(http://www.health.state.ny.us/regulations/controlled_substance/part/80/docs/80.pdf)
Article 33. Controlled Substances (The law)
(http://www.health.state.ny.us/regulations/public_health_law/article/33/docs/33.pdf)
7 Licensing and Registration – Initial Application
Licensing means getting both a NYSDOH license and federal DEA registration. Researchers
without a NYSDOH license and DEA registration who are, or intend to, work with controlled
substances need to obtain these credentials or work as an Authorized User or Senior
Authorized User under a Licensee.
A schematic of the licensing and registration process for the most common licensing
situations (research, schedules II-V) is given in Appendix 12.9 (Individual Licensee) and
Appendix 12.10 (Institutional Licensee). Analytical laboratories and instructional activities
are covered in Appendix 12.7 and 12.8, respectively.
The following points should be noted:
•
A NYSDOH license must be obtained before applying for DEA registration.
•
The activities and controlled substances used are limited to those described in the
protocol(s) approved in the Individual NYSDOH license and DEA registration or by
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an Oversight Committee within the scope of the Institutional NYSDOH license and
DEA registration.
•
Research and teaching use of schedule I controlled substances requires specific
licensing and registration that is not directly covered in this document. Please contact
EH&S for further information if use of schedule I drugs is anticipated: askEHS.
7.1 DEA Registration (Federal)
Federal registration is issued by the DEA (a NYSDOH license must be obtained FIRST).
New applicants may be subject to an on-site facility inspection. There are 4 application
categories with various subcategories within the registration forms. Researchers and
analytical laboratories use form DEA Form 225. Departments or units with instructional
activities use DEA Form 224. Experience suggests that it may take between 1-2 months from
the time of application for a registration to be issued.
Note! The DEA application does not have a specific category for institutional research
license. For specific information in completing a DEA registration when operating under a
NYS institutional research license, see Section 7.2.3.2.
DEA links for registration are:
Registration program website:
http://www.deadiversion.usdoj.gov/drugreg/index.html
Application can either be on paper:
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/pdf_apps.htm
Or on-line:
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm
Researchers and analytical laboratories fill out DEA Form 225; departments or units with
instructional activities fill out DEA Form 224:
http://www.deadiversion.usdoj.gov/drugreg/index.html#1
For information on categories and fees, see:
http://www.deadiversion.usdoj.gov/drugreg/categories.htm
The address of the DEA field office servicing Tompkins County is:
Syracuse Resident Office/DEA
500 Plum Street, Suite 700
Syracuse, NY 13204
315-477-1700
7.1.1 DEA Specific Research Requirements
After the DEA application is submitted, it gets referred to the Syracuse DEA field office
and assigned to a DEA official. The process after this point is variable. Sometimes they
issue a registration without further follow-up (recognizing that a site inspection and
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application review as already been conducted by NYSDOH before the NYSDOH license
was issued). At other times, however, they perform their own on-site inspection and/or
submit detailed questions to the applicant, including and in addition to that which was
submitted to NYSDOH.
7.2 NYSDOH Licensure (State)
NYSDOH licenses are issued by the Bureau of Narcotic Enforcement (BNE). New
applicants are subject to an on-site facility inspection. Experience suggests that it may take
between 2-3 months from the time of application for a license to be issued.
License program website:
http://www.health.state.ny.us/professionals/narcotic/forms.htm
Researchers, analytical laboratories and departments with instructional activities fill out form
DOH-4330:
http://www.health.state.ny.us/forms/doh-4330.pdf
Important instructions on form DOH-4330:
http://www.health.state.ny.us/forms/instructions/doh-4330_instructions.pdf
Fee structure is given in form DOH-4330. Applicants working for Cornell Contract Colleges
can request a fee exemption in their application cover letter. There are 11 classes of licenses
and various sub-categories. The ones most applicable to research/teaching/analytical are:
•
Class 4
Researcher (Schedules II-V) (Individual and Institutional)
•
Class 5
Instructional Activities (Schedules II-V)
•
Class 7
Research and Instructional Activities (Schedule I) (Individual and
Institutional)
•
Class 8
Analytical Laboratory
The address of the DEA field office servicing Tompkins County is:
New York State Department of Health
Bureau of Narcotic Enforcement
Riverview Center
150 Broadway
Albany, New York 12204
1-866-811-7957 (Option #3)
7.2.1 NYSDOH Specific Research Requirements
NYSDOH has outlined specific current and future licensing requirements in a letter on
the NYSDOH website: “Dear Researcher Licensee Letter - Obtaining a Controlled
Substance License”,
http://www.health.state.ny.us/professionals/narcotic/facilities/letters/2008-0801_controlled_substance_license.htm. Some changes proposed in this letter have not yet
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been fully implemented but are still planned. Researchers planning to use controlled
substances should read this letter.
7.2.2 Individual State License
In order for an individual to apply for a state licensure, proof must be submitted that the
applicant and its managing officers are of good moral character, the applicant possesses
or is capable of acquiring facilities, staff and equipment sufficient to carry on properly
the proposed project, is able to maintain effective control against diversion and is able to
comply with state and federal regulations (Article 33, 3325). The applicant must submit
(for a license or amendment) a detailed protocol setting forth the nature of the proposed
project, controlled substances to be used (including supplier and supplier’s DEA
registration number), proposed quantities, the qualifications and competence of applicant,
provisions for safe administration, and any papers filed with the BNE, FDA or any other
federal /state governmental agency as it relates to the proposed activity. The activities of
an Authorized User working under a Licensee are limited to those described in the
protocol.
An Individual Licensee acts as both the Signatory and Supervisor of Controlled
Substance Activity. The optional Supervisor section in the NYSDOH application does
not need to be filled out because the Supervisor is the applicant. An Individual Licensee
may appoint a Material Manager (Section 4.10).
EH&S can provide assistance in license application.
7.2.3 Institutional State License
Cornell University does not hold an institutional license (Section 4.6). The
responsibilities of administering an institutional license are not insignificant. If a
department or unit is considering applying for an institutional license, they must, among
other requirements, establish an Oversight Committee (whose membership credentials are
submitted to the state. See Section 4.7) to approve, supervise and evaluate specific
protocols, and appoint a Supervisor of Controlled Substance Activity (Section 4.9). As
described in Article 3326 and “Dear Researcher Licensee Letter” (NYSDOH 2008),
upon approval of each protocol, the department or unit holding the license must forward
to NYSDOH a description of the protocol, the names and qualification of the individuals
working thereon and of those individuals designated to supervise each individual protocol
(Senior Authorized Users, Section 4.12). The department or unit holding the license must
also forward periodic progress reports and evaluations as well as amendments to each
protocol. As the Licensee, the department or unit is responsible for all controlled
substance activities conducted under the license, including record keeping, ordering,
disposal, security (e.g. an approved safe or vault in an area with minimal access for
holding main stock, packages, and substances for disposal), and reporting knowledge or
suspicion of loss, theft or diversion.
The chair of the department or unit should serve as the chair of the Oversight Committee
(Section 4.7), Signatory (Section 4.8), and Supervisor of the Controlled Substance
Activity (Section 4.9). These roles include (1) establishing and overseeing operation of
the Controlled Substance Activities in accordance with NYSDOH and DEA rules,
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regulations and best practices, (2) signature authority (which cannot be delegated AND,
for DEA, must be assigned by POA), and (3) managing and implementing the day-to-day
activities conducted under the license. The chair can, if desired, appoint a Material
Manager to implement specific and defined day-to-day activities (Section 4.10).
7.2.3.1 NYSDOH Application – Institutional Research License
The following instructions clarify some of the specifics of filling out the NYSDOH
application form DOH-4330 for a Class 4 Institutional Research License:
Applicant’s Name
The name of the department or unit should go in the Applicant Name box as
follows: strike the d/b/a and have the legal name read "Cornell University c/o
Department of ____________________.
Contact Information
The chair’s name should go in the Contact Information box.
License Classification
Check the box “Class 4 Researcher (Schedules II-V).
Also check the box “Institutional”
(Contact EH&S if a license is needed for Schedule I. Special procedures apply)
Exemption from Fee
The NYS application form states that “New York State, county and municipal
agencies are exempt from licensing fees”. Applicants in the Contract Colleges at
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Cornell are exempt from the NYS fee. If applying for an exemption, include this
request in the cover letter. Applicants in the Endowed Colleges are not exempt
from the fee.
Drug Schedules
Check all drug schedules that could be anticipated (except schedule I). An
institutional applicant with varied research protocols should check all boxes
(except schedule I).
Supervisor of Controlled Substance Activity
The section of the application that asks for the Supervisors name should either be
left BLANK (because the chair, as the Authorized Representative for the Licensee
is acting as the Signatory and Supervisor) or be filled in with the chair’s name. A
Material Manager, even if appointed, is not the Supervisor and their name should
not go here.
Applicant’s Signature
The chair should sign the form as the Authorized Representative.
7.2.3.2 DEA Application – Research Institutional
The DEA application does not have specific category for institutional research
license. The following instructions clarify some of the specifics of filling out the DEA
Form 225 application for a department/unit holding a NYSDOH Class 4 Institutional
Research License
Section 1 – Applicant Identification
Check the box saying this is a Business registration. The name of the department
or unit should go in the 1st line of Section 1 under “Name 1”.
The name of the chair (as the “Responsible Party) should go in the 2nd line under
“Name 2”:
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The chair’s name should go in the section on “Point of Contract”:
Section 2 - Business Activity
Check the box “Researcher w/Sched II-V”
(contact EH&S if a license is needed for Schedule I. Special procedures apply)
Section3, Part A – Drug Schedules
Check all drug schedules that could be anticipated. (except schedule I). An
Institutional applicant with varied research protocols should check all boxes
(except schedule I). Regardless of what boxes are checked, actual purchasing and
use is limited to the scope of the NYSDOH license and approved protocols.
Note! If the drug schedule II is selected, do not forget to check the bottom box
indicating that you require official order forms (DEA Form 222).
Section 3, Part C – Drug Codes
Drug codes for research use involving schedules II-V ARE NOT required unless
the drugs are being manufactured or imported.
Section 6 - Exemption from Applicant Fee
Applicants from both the Endowed and Contract Colleges at Cornell must pay the
DEA applicant fee (personal communication with the DEA, Syracuse Resident
Office, 3/1/12). Federal employees (e.g. USDA) performing official duties at
Cornell are exempt.
Section 8. Applicant Signature
A POA is required for a Chair or Unit Head to obtain signature authority to sign a
DEA application for an Institutional Licensee (therefore acting as the Officer of the
Applicant). See Section 4.8.
The chair of the department or unit, as the Officer of the Applicant, should sign
here.
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7.2.3.3 Before Applying for an Institutional Research License
A department or unit considering obtaining a NYSDOH institutional license MUST:
1. Contact EH&S. EH&S will provide guidance and information on NYSDOH
requirements for holding an institutional license.
2. Prepare the application and submit it to EH&S. EH&S will review the application
for completeness and accuracy.
3. Upon EH&S approval, the department or unit should submit the application to
NYSDOH and provide a copy of the final submission to EH&S.
4. After receiving the NYSDOH license, the department or unit should complete an
application for DEA registration. A Department Chair (acting as the Head of the
Oversight Committee), will need a POA in order to sign the application. EH&S
can help facilitate this assignment through the University Counsel’s office.
5. Submit the application to EH&S for approval. EH&S will review the application
for completeness and accuracy.
6. Upon EH&S approval, the department or unit should submit the application to
DEA and provide a copy of the final submission to EH&S.
7. The department or unit should provide EH&S with copy of the NYSDOH license
and DEA registration once they have been issued. EH&S will maintain a record of
all researchers, analytical laboratories and departments with instructional
activities that hold DEA registration at Cornell University.
7.2.4 License Amendments
A NYSDOH license may be amended to add further activity or add substances or
schedules to a project. Such an amendment may incur an additional fee. There is a box
on the DOH-4330 application form specific for applying for an amendment.
Adding a new schedule is considered a license amendment. A copy of the approved
amendment should be sent to EH&S.
Adding a new protocol is considered “keeping the license up-to-date”. It is not an
amendment (personal communication with NYSDOH 11/3/11). Individual Licensees
must submit all new protocols to NYSDOH. A record of submittal should be maintained.
In addition, the supplier/manufacturer (and their DEA registration number) of the
controlled substances to be purchased must be submitted to NYSDOH in the initial
application.
If the Licensee wishes to change to a different supplier/manufacturer after the license is
granted, then the Licensee must notify NYSDOH. Notification at the time of license
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renewal is generally considered sufficient (personal communication with NYSDOH
11/3/11).
Although technically not an amendment, the Institutional Licensee must forward
information on each project upon approval by the Oversight Committee (emphasis is
from NYSDOH). See Article 3326 and “Dear Researcher Licensee Letter”. As
described in the “Dear Researcher Licensee Letter”, the following information is
requested:
In the above, the Principle Investigator and the Project Supervisor should be the same
person (the Senior Authorized User for the protocol). The Project Supervisor, in this
context, is assumed to refer to the specific project (it does not refer to the Supervisor of
Controlled Substance Activity, Section 4.9).
Changes to a DEA registration (e.g. schedule additions, address changes) can be made at
http://www.deadiversion.usdoj.gov/drugreg/change_requests/index.html.
8 Licensing and Registration – Renewal
Researchers or departments/units already possessing licensure must renew their NYSDOH
license every two years and DEA registration every year.
8.1 DEA Registration Renewal (required yearly)
Researchers and analytical laboratories fill out form DEA Form 225a; departments or units
with instructional activities fill out DEA Form 224a:
Renewal can only be done on line. See:
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms.htm.
Researchers and analytical laboratories fill out form DEA Form 225a; departments or units
with instructional activities fill out DEA Form 224a:
http://www.deadiversion.usdoj.gov/drugreg/index.html#1
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For information on categories and fees, see:
A copy of the renewal should be sent to EH&S.
8.2 NYSDOH License Renewal (required every 2 years)
Prior to the license expiration date, licensees are provided with the materials necessary for
renewal by the state. Renewal is done by filling out the appropriate sections of form DOH4330, as described in Section 7.2 of this document.
A copy of the renewal should be sent to EH&S.
9 Definition and Schedules of Controlled Substances
9.1 Controlled Substances. Definition
The federal definition of a controlled substance (Title 21, Section 802) is: “… a drug or other
substance, or immediate precursor, included in schedule I, II, III, IV, or V …”. New York
State provides a similar definition (NYS Article 33. 3302 (5). Note that hypodermic syringes
and needles, although regulated by NYS Article 33, are not defined as controlled substances.
Cornell University has a policy on use of hypodermic syringes and needles:
http://www.policy.cornell.edu/Syringe_and_Needle_Control.cfm.
9.2 Schedules of Controlled Substances. Definitions
There are five schedules of controlled substances (I-V), ranging from the most stringently
controlled (schedule I; primarily illegal drugs) to the least restrictive (schedule V):
9.2.1 Schedule I
A drug or other substance that has a high potential for abuse and which has no currently
accepted medical use in treatment in the United States. There is a lack of accepted safety
for use of the drug or other substance under medical supervision.
9.2.2 Schedule II
A drug or other substance that has a high potential for abuse and has a currently accepted
medical use in treatment in the United States or a currently accepted medical use with
severe restrictions. Abuse of the drug or other substances may lead to severe
psychological or physical dependence.
9.2.3 Schedule III
A drug or other substance that has a potential for abuse less than the drugs or other
substances in schedules I and II. The drug or other substance has a currently accepted
medical use in treatment in the United States. Abuse of the drug or other substance may
lead to moderate or low physical dependence or high psychological dependence.
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9.2.4 Schedule IV
A drug or other substance that has a low potential for abuse relative to the drugs or other
substances in schedule III. The drug or other substance has a currently accepted medical
use in treatment in the United States. Abuse of the drug or other substance may lead to
limited physical dependence or psychological dependence relative to the drugs or other
substances in schedule III.
9.2.5 Schedule V
A drug or other substance that has a low potential for abuse relative to the drugs or other
substances in schedule IV. The drug or other substance has a currently accepted medical
use in treatment in the United States. Abuse of the drug or other substance may lead to
limited physical dependence or psychological dependence relative to the drugs or other
substances in schedule IV.
9.3 Schedules of Controlled Substances. Lists
There are both federal and state lists of controlled substances. Schedules for some of the
more common controlled substances used in research at Cornell University are given in
Appendix 12.5.
9.3.1 Federal Controlled Substance Schedule List
The five established federal schedules of controlled substances (I-V) are updated and
republished annually by the DEA (USC Title 21, Section 812). These lists describe the
basic or parent chemicals and do not describe the salts, isomers and salts of isomers,
esters, ethers and derivatives which may be controlled substances. These DEA lists are
intended as general references and are not comprehensive (for example, sodium barbital
is not listed but barbital is. Clearly, sodium barbital is also a controlled substance). A
link to the federal schedule list is at: http://www.deadiversion.usdoj.gov/schedules/.
9.3.2 State Controlled Substance Schedule List
In general, the NYS controlled substances list reflects the federal classifications.
There are exceptions, however. For example, human chorionic gonadotropin (HCG)
is not a controlled substance at the federal level, but is a schedule III controlled
substance on the state list. As a result, researchers must have a NYSDOH license (and
follow all applicable rules and regulations) to purchase and use HCG in New York State.
Another example is anabolic steroids (e.g. testosterone). Testosterone and most other
anabolic steroids are schedule III controlled substances at the federal level and a
schedule II at the NYS level. Thus, in NYS, testosterone must be purchased and
handled as a schedule II drug. However, because anabolic steroids are a DEA schedule
III, DEA Form 222 is not required.
When NYS and DEA schedules do not agree, applying for a DEA registration can be
complicated. The DEA and NYSDOH handles this on a case-by-case basis. For
example, a researcher who obtains a schedule II Class 4 NYSDOH research license for
testosterone will need to apply for a schedule III DEA research registration. The DEA
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may deny to registration because of the mismatch between the NYSDOH license
schedule (II) and the requested DEA registration (III). In cases such as this, NYSDOH
will (upon request) write a letter to the DEA (personal communication with NYSDOH
11/3/11).
The listing of NYS scheduled substances can be found in the NYS regulations, Section
3306 of Article 33:
http://www.health.state.ny.us/regulations/public_health_law/article/33/docs/33.pdf. It is
easiest to use the Adobe search function to find specific substances within this regulation
since the NYS list is not as user friendly as the DEA.
DEA and NYS schedules for some of the more common controlled substances used in
research at Cornell University are given in Appendix 12.5.
If in doubt, EH&S can be contacted for assistance.
9.4 Exempt Amounts
In NYS, there is no licensing exemption for research/teaching/analytical use of controlled
substance in any amount (personal communication with NYSDOH 2/21/12; also see Part 80
Rules and Regulations on Controlled Substances).
This is different from the DEA, which allows certain analytical standards, preparations and
products to be purchased and used without the need for the user to have DEA registration
(http://www.deadiversion.usdoj.gov/schedules/#exempt). Analytical laboratories in NYS using
only analytical standards in the exempt DEA list do not need to obtain a DEA registration.
However, they still must apply for and receive a NYSDOH Class 8 Analytical License.
Licensees with a Class 4 Researcher license can conduct chemical analysis with the controlled
substances authorized by the license if the analytical activities are part of the licensed activity.
In this case, separate analytical licensure is not required.
10 Lists I and II Chemicals (Precursors)
The Chemical Diversion and Trafficking Act (CDTA) and subsequent amendments were
enacted to provide a system of regulatory controls and criminal sanctions to address both
domestic and international diversion of important chemicals. The CDTA created two
categories for these chemicals: List I and List II. There are currently (as of 5/2011) 40
chemicals on these lists in total.
The mission of the DEA Chemical Control Program is to disrupt the illicit production of
controlled substances by preventing diversion of chemicals used to make drugs. As such, the
program applies DEA registration, record keeping and suspicious order reporting
requirements to List I and List II chemicals. The regulatory requirements generally apply
importers, exporters, manufacturers, distributors and certain retailers and do not have a direct
impact on researchers at the present time although researchers may be asked by the supplier
to fill out a letter of intended use for purchase of chemicals on List I (such as iodine). These
letters ask the researcher to confirm they are the end-user of the chemical and do not intend
to distribute or resell the chemical.
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Information on List I and List II chemicals can be found at:
http://www.deadiversion.usdoj.gov/chem_prog/34chems.htm.
11 Guidelines
The following are guidelines and expectations to aid the researcher in complying with
controlled substance rules and regulations, with specific references to procedures at Cornell
University. However, it is the responsibility of the Licensee and all Senior Authorized Users
and Authorized Users working under the Licensee to be familiar with and adhere to all
federal and state controlled substances rules and regulations.
11.1 Registration and Licensing
The use and purchase of controlled substances at Cornell University for research, analytical
and teaching purposes must be conducted under the appropriate licensure. All Licensees,
Senior Authorized Users and Authorized Users must operate within the scope of their
applicable NYSDOH license/DEA registration. Unlicensed non-authorized users may not
work with or have access to controlled substances. Licensees must keep their license and
registration current.
11.1.1 Displaying
The NYSDOH license must be permanently displayed in the place to which it applies
(Part 80, Section 80.5). The DEA registration must be maintained at the registered
location in a “readily retrievable” manner (CFR 1301.35). EH&S recommends that the
DEA registration also be displayed along with the NYSDOH license.
11.2 Training
All Licensees and persons working under the Licensee are responsible for being familiar with
and adhering to all federal and state controlled substances rules and regulations. Licensees, or
their designees, must provide appropriate training to all Authorized Users/Senior Authorized
Users working under the license. It is recommended that training (1) include a review of this
guidance document and (2) be documented in writing. Training should also include safety
information specific to the substance and application.
EH&S has an on-line training course on “Controlled Substance Use in Research” that will
assist Licensees in meeting training requirements. The course is available on the EH&S
Controlled Substances webpage. There is a quiz associated with the training that can be
accessed through CU learn (the training PowerPoint will direct the user to the right location).
The associated quiz must be taken in order for the user to get credit for the course in their
training records. Licensees should assure that users working under their Licensure take the
course.
11.3 Purchasing
All purchases of controlled substances must be accompanied by registration and license
information. Obtaining drugs for research using a prescription is NOT ALLOWED by
NYSDOH. Ordering of controlled substances for research must be done through approved
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distributors or manufacturers, not pharmacies. In addition, the distributor or manufacturer
must be approved to distribute controlled substances in NYS. EH&S can provide assistance
in identifying acceptable suppliers – contact ask EHS.
The supplier/manufacturer (and their DEA registration number) of the controlled substances
to be purchased must be supplied to NYSDOH in the initial application. If the Licensee
wishes to change to a different supplier/manufacturer after the license is granted, then the
Licensee must notify NYSDOH.
A record of all deliveries must be maintained (Section 11.5). Delivery must be made to the
address on the DEA registration (Part 80, Section 80.6(a)).
11.3.1 Purchasing Schedule I and II Substances
Orders for schedule I and II controlled substances must be accompanied by DEA Form
222. These forms are available only through the DEA. See:
http://www.deadiversion.usdoj.gov/faq/dea222.htm. Upon completion of the form, the
Licensee should submit Copy 1 and 2 to the supplier and retain Copy 3. Take care when
filling out the form – an order that shows any alteration, erasure or change in description
will be rejected (CFR 1305.15). Void any forms with corrections and keep them on file
with the rest of the DEA Form 222 records (do not throw them out. All DEA Form 222s
must be accounted for).
11.3.2 Cornell University Hospital for Animals Pharmacy
The CUHA Pharmacy (CUHA; “Vet School Pharmacy”) provides controlled substances
to registered patients of the hospital under a Class 3 Institutional Distributor license. The
Pharmacy cannot supply controlled substances for research purposes to the Cornell
Community because it is not within the scope of their licensure.
11.4 Receiving
Delivery can only be made to the Licensee at the address on the DEA registration (Part 80,
Section 80.6(a))
11.5 Inventory & Recordkeeping
The Licensee must maintain complete and accurate accounting of all controlled substances,
from the time they are ordered until they are used up or disposed of. These inventories and
records should be kept at the premises where the licensed activity is conducted, and be
readily available for inspections. Inventories and records for schedule I and II drugs must be
kept separate from all other records maintained by the Licensee. Records for schedule III-V
drugs should be kept separate from all other records or in such as form that they are “readily
retrievable” from other records (CRF 1304.04).
New York requires that inventory and records be kept for a period of 5 years from the date of
transaction (Part 80, Section 80.100; Section 80.112).
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EH&S strongly recommends dedicated note books be maintained for all controlled substance
records, that they be kept in the area where the controlled substances are stored, and that
there be separate binder sections for schedules I-II and III-V.
Basic record keeping includes (1) records of receipt, (2) records of use (including disposal,
loss or theft), and (3) biennial inventory. Examples of record forms and binder sections for
Individual Licensees are available at: http://sp.ehs.cornell.edu/lab-research-safety/researchsafety/constrolled-substances/Documents/CS_Individual_License_Record_Keeping.pdf.
Examples of record forms for Institutional Licensees are more involved and can be obtained
by contacting the EH&S Controlled Substance Program directly at askEHS.
11.5.1 Record of Receipt
A record of all controlled substances received must include date of receipt, name and
address of vendor, and the type and quantity of the controlled substance (Part 80, Section
80.37). A duplicate invoice or separate itemized list furnished by the vendor is sufficient
provided it contains all the information required and is maintained in a separate file (that
is, a file specific for receipt records of controlled substances). Invoices for schedules I
and II should be maintained separately from schedules III-V. In addition (for schedules I
and II), a copy of the executed DEA Form 222 (Copy 3 of the triplicate form) should be
maintained and kept separate from all other records (CFR 1305.17).
It is highly advised, especially for Institutional Licensees or Individual Licensees with
multiple projects and drugs, that each commercial unit of controlled substance be given a
tracking number and that a Controlled Substance Receipt Log be maintained (in addition
to maintaining actual invoices and DEA Form 222 copies). An example of a Controlled
Substance Receipt Log for an Individual Licensee is given in Appendix 12.3.
11.5.2 Record of Use and Disposal
A record of all controlled substances used must include the name of the person authorized
to control and use such drugs, the date, type and quantity of the drug and signature of the
user (Part 80, Section 80.37). An example of a Controlled Substance Use Log for an
Individual Licensee is given in Appendix 12.4. Records must also include, for each
controlled substance:
11.5.2.1 Name of the Substance.
11.5.2.2 Form
Each finished form (such as 10 mg, tablet, or concentration), the number of units or
volume in each commercial container, and the number of containers.
11.5.2.3 Amount
The amount of finished form dispensed, including the name and address of the person
to whom it was dispensed, the date of dispensing, and the name or initials of the
individual who dispensed or administered the substance. For research activities, the
Use Record should include the protocol for which the drug was dispensed (e.g.
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protocol ID #) and purpose (if non-animal) or species/animal ID number (e.g. rat
#16).
11.5.2.4 Loss, Spills, Disposal, Destruction
The volume or amount of the finished form and/or commercial containers disposed of
in any manner by the researcher, including the date and manner of disposal. This
includes:
• Substances lost or stolen (see Section 11.9 for reporting)
• Substances spilled (see Section 11.10)
• Substances disposed of (unused or expired. See Section 11.13.1)
• Substances destroyed (See Section 11.13.1).
11.5.2.5 Stock and Working Solutions
In some applications, a stock controlled substance will be used to make a solution. In
these cases, records must be kept for both the diluted solution as well as the stock.
11.5.3 Inventory
A biennial (once every 2 years) inventory needs to be performed (this is both a NYSDOH
and DEA requirement). The inventory information should include each kind of substance
or preparation, number of packages and total content of all the packages as of the
inventory date. An example of a Controlled Substance Biennial Inventory for an
Individual Licensee is given in Appendix 12.4.
An initial inventory must be taken when “… a person commences business” (CFR
1304.11(b)). It is advised that this be done when the Licensee receives their initial DEA
registration. Since no controlled substances should be on hand, the Licensee should
complete the initial inventory indicating this fact (CFR 1304.11(b)).
After an initial inventory is taken, the inventory should be taken on any date within two
years of the previous inventory (CFR 1304.11(c)). For consistency and ease of
remembering, EH&S suggests that this inventory be done at the time the NYSDOH
license renewal is submitted (which is every 2 years).
There should be an inventory for schedules I and II and a separate inventory for
schedules III-V (CFR 1304.04(g)). A copy of the inventory must be retained for at least
5 years. The inventory should be kept on file with the other controlled substances records.
11.5.4 Record Templates
A basic concept behind record keeping, besides adhering to the specifics of the regulatory
requirements, is accounting for controlled substances from cradle to grave. As a result,
record keeping may be relatively simple and straight forward for an Individual Licensee
working with a single controlled substance on a single protocol but will be more complex
– and require more forms - for Institutional Licensees working with multiple Senior
Authorized Users and multiple projects.
EH&S strongly recommends dedicated note books be maintained for all controlled
substance records and that they be kept in the area where the controlled substances are
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stored. The DEA requires that all records be “readily retrievable” (CFR 1304.04) and
specific documents (such as inventory) be maintained at the registered location (CFR
1304.11). Electronic records of required documents are not acceptable for all practical
purposes – they can be altered and do not allow for signatures.
Examples of recommendations for organizing a binder for keeping controlled substance
records, and templates for record keeping are available at:
Individual Licensee Record Keeping (Binder Tabs, Authorized User List,
Receipt, Use and Disposal Forms):http://sp.ehs.cornell.edu/lab-researchsafety/research-safety/constrolledsubstances/Documents/CS_Individual_License_Record_Keeping.pdf.
Institutional Licensee Record Keeping: Contact EH&S directly at askEHS.
Not all of the binder tabs will be applicable to all Licensees. For example, a license
holder who does not use schedule II substances would not be need to keep schedule II
records and a license holder who has no Authorized Users (that is, only the Licensee
controls and uses the substances in research) would not need the section on Authorized
Users. Similarly, a tracking number may not be necessary for an Individual Licensee
who possesses just one container of one controlled substance.
11.6 Storage
Storage requirements depend on the type of license, registration, and schedule of the drug,
and whether the drug is being stored as a main (reserve) or a working stock.
For Individual Licensees and Senior Authorized Users (using working stocks under an
institutional research license), a simple recommendation to meet regulations for storing main
or reserve stocks of schedules III-V and working stocks of schedules I-V is to use a stainless
steel, stationary (bolted to a wall or fixed surface), double door cabinet. Both cabinet doors
must have key-locked doors with separate keys. These cabinets are often referred to as
“Drug Boxes” or “Narcotics Cabinets” (although the correct type must be selected, based on
the specifications in Section 11.6.2). These can be obtained from many of the laboratory
suppliers on e-Shop. See Appendix 12.6 for examples.
Main or reserve stocks of schedule I and II controlled substances have more substantial
storage requirements (vault or GSA class 5 rated safe or cabinet). Most Institutional
Research Licensees will need this type of vault or safe to stored received packages, main
stocks and controlled substances awaiting disposal.
Individual Licensees and Senior Authorized users can not share drug boxes or safes (Personal
communication with NYSDOH 11/15/11). It can cause problems with security and
responsibility.
A detailed description of minimum storage requirements is given in the NYSDOH licensing
application instructions http://www.health.state.ny.us/forms/instructions/doh4330_instructions.pdf and in NYSDOH Part 80, Section 80.50. These requirements are
summarized below:
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11.6.1 Vault or GSA Class 5 Rated Safe/Cabinet
Minimum requirement for main stocks of schedules I and II. A vault must be of
substantial masonry and have a multiple position combination lock, relocating device (or
equivalent) and a door having a thickness of steel plate of at least ½ inch. If the vault is
newly constructed, it must have walls, floors and ceilings constructed of at least 8”
reinforced concrete. Vaults must be six-sided or have floor constructed as described
above. For a GSA Class 5 safe/cabinet, the door must contain a multiple-position
combination lock, a relocking device (or equivalent) and a steel plate having a thickness
of at least ½ inch. Safes or cabinets weighing less than 750 lbs. must be bolted or
cemented to the floor. The acronym GSA stands for General Services Administration (an
independent agency of the United States government).
11.6.2 Cabinet, Double Locked
Minimum requirement for working stocks of schedules I, II, III and IV. Unit must
be a stationary, locked, double cabinet. Both cabinets must be key-locked doors with
separate keys. Spring locks or combination dial locks are not acceptable. Cabinet must be
made of steel or other approved metal.
11.6.3 Cabinet
Minimum requirement for main stocks of schedules III, IV and V, and working stock of
Schedule V. Cabinet must be stationary, securely locked, and of substantial construction
(metal).
11.7 Access Restrictions
Access to controlled substances must be given to a minimum of personnel. Keys (or
combination, if vault or GSA class 5 safe or equivalent) need to be kept by the license holder
or Material Manager.
11.8 Personnel Screening
In addition to the screening that is part of licensing and registration for Licensees, users
(Authorized Users, Senior Authorized Users, Material Managers) working with controlled
substances under the authorization of a license holder must be screened (CFR 1301.90). At a
minimum this requires the user to answer 2 specific written questions and a record of these
answers needs to be kept by the Licensee. The questionnaire should be kept on file in a
secure location by the Licensee.
An example of a suitable questionnaire is in Appendix 12.2.
If the answer to either of the 2 questions is “yes”, the Licensee should contact the Office of
University Counsel for advice on how to proceed: http://counsel.cornell.edu/. For general
questions on filling out the form (for example, is marijuana considered a narcotic,
amphetamine or barbiturate? The answer is no), contact the EH&S Controlled Substance
Program through askEHS.
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11.9 Diversion, Loss or Theft
Loss, theft and diversion requires notification of the proper authorities (Cornell University
Police, 255-1111, EH&S 255-8200) and submission of specific forms to the DEA (Form
DEA-106, http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html) and NYSDOH
(Form DOH-2094, http://www.health.state.ny.us/forms/doh-2094.pdf).
DEA notification must be immediate (one business day) and in writing (such as a FAX)
although submission of the actual DEA-106 form is not immediately necessary if the
Licensee needs additional time to investigate the circumstances regarding the loss or theft. To
notify the DEA, see the contact information:
http://www.deadiversion.usdoj.gov/offices_n_dirs/fielddiv/newyork.htm. (Note: Tompkins
County will be covered by the DEA office in Syracuse, with the Investigator located in
Binghamton. This update should take place in June 2011 but is not reflected on the webpage
as of this writing). Updates should be provided to the DEA if the investigation takes more
than 2 months. See http://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0812.htm and
http://www.deadiversion.usdoj.gov/fed_regs/rules/2003/fr0708.htm for more information.
Similarly, NYSDOH should be immediately notified. Contact information for reporting is at:
http://www.health.state.ny.us/professionals/narcotic/contact.htm.
If an order is loss in transit from the supplier to the Licensee, it is the supplier’s responsibility
to notify NYSDOH and DEA, and to submit the forms. If the Licensee uses a reverse
distributor or manufacturer to return unused or expired controlled substances and the
shipment is lost in transit, it is the Licensee’s responsibility to notify NYSDOH and DEA,
and to submit the forms.
11.10 Spill Procedures
When a spill occurs and there is recoverable material, it must be disposed of according to
NYSDOH and DEA requirements (Section 11.13.1). This should be recorded in the use and
disposal records.
However, if the material is not recoverable, things are a bit less straight forward.
Breakage/spillage of non-recoverable controlled substances constitutes a “loss” under NYS
(Part 80.110; personal communication with NYSDOH, 11/3/11) but not federal (CFR Part
1301, Rules 2003) regulations. Separate actions must be taken to satisfy both regulatory
bodies if a spill occurs that results in non-recoverable material:
11.10.1 Not Recoverable - DEA Procedure
The registrant must document the circumstances in the inventory and use records. Two
individuals who witnessed the breakage must sign both of these records (CFR Part 1301,
Rules 2003).
11.10.2 Not Recoverable - NYSDOH Procedure
The Licensee must report the spill to NYSDOH using form DOH-2094. A copy of the
completed (and mailed) DOH-2094 form should be kept for 5 years. The license should
also document the circumstances of loss in the use record – this is already part of the
DEA Procedure Section 11.10.1 above.
Page 28 of 48
11.11 Import/Export
Special procedures, authorization and reporting forms are required. This may include
interstate activities. Researchers intending to engage in these activities must thoroughly
research applicable procedures and requirements and submit a written proposal to EH&S
before proceeding. Information (DEA) on import/export of controlled substances for
scientific purposes can be found at: http://www.deadiversion.usdoj.gov/imp_exp/index.html.
11.12 Transfer between Research Groups
Controlled substances may not be transferred from one research Licensee to another (or
between Senior Authorized Users) at Cornell University.
11.13 Disposal
11.13.1 Licensees Holders
All license holders must arrange to return all unused or expired controlled substances to
the original distributor or manufacturer, or contract disposal through a reverse distributor.
A list of NYS approved reverse distributors can be found at:
http://www.health.state.ny.us/professionals/narcotic/pharmacies/surrender_to_independe
nt_companies.htm. The CUHA and Gannett pharmacy use Guaranteed Returns, so
Guaranteed Returns is familiar with Cornell University procedures
http://www.guaranteedreturns.com/FAQ.aspx (this is not an endorsement, just
informational). The cost of disposal (typically around $150, primarily because there is a
minimum charge) is the researcher’s responsibility.
Controlled substances are not considered hazardous waste, biological waste or regulated
medical waste so they CANNOT be disposed of through EH&S or the biological/medical
waste program.
Although NYSDOH has procedures for allowing on-site destruction, this is not a method
intended for routine disposal. On-site destruction requires prior EH&S and NYSDOH
approval. NYSDOH approval for on-site destruction is limited and given on a case-bycase basis. Cost saving is not one of these circumstances. Procedures and forms for
submitting a request to NYSDOH for onsite destruction are at:
http://www.health.state.ny.us/forms/instructions/doh-2340_instructions.pdf (instructions);
http://www.health.state.ny.us/forms/doh-2340.pdf (form DOH-2340). The official
NYSDOH inventory form for disposal, DOH-166, is at:
http://www.health.state.ny.us/forms/doh-166.pdf.
11.13.2 Abandoned Substances
Occasionally controlled substances will be found in the process of cleaning out
abandoned laboratories. Sometimes these substances were purchased before they were
classified as controlled substances. EH&S will aid the department or unit in disposal of
these types of substances
Controlled substances left by a Licensee (even if their license is expired or if they have
left Cornell) are still (legally) the Licensee’s responsibility. The Licensee’s department
should make every effort to contact the Licensee. If that is unsuccessful, EH&S will
Page 29 of 48
provide guidance to the department as to their options. Any associated costs may be
borne by the department or unit.
11.13.3 Outdated or Unneeded Controlled Substances
Advice for managing outdated or unneeded controlled substances is given in Appendix
12.12.
12 Appendices
12.1
12.2
12.3
12.4
12.5
12.6
12.7
12.8
12.9
12.10
12.11
12.12
Quick Links
Personnel Screening Questionnaire (Example)
Record of Receipt Log for an Individual Licensee (Example)
Record of Use Log for an Individual Licensee (Example)
Schedules (DEA and NYS) for Many Controlled Substances Used for Research at
CU
Storage Cabinets (Examples)
Analytical Laboratories (Procedures Specific to)
Instructional Activities Teaching (Procedures Specific to)
Flow Chart – Individual (Class 4 Research Initial Application)
Flow Chart – Institutional (Class 4 Research Initial Application)
Biennial Inventory (Example)
Outdated or Unneeded Controlled Substances
Page 30 of 48
12.1 Appendix. Quick Links
Quick Links
Federal Program
Office of Diversion Control (Home page)
http://www.deadiversion.usdoj.gov/
Title 21 CFR, Part 1300-1399 (The regulation)
http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html
Title 21 United States Code (USC) Controlled Substances Act (The law)
http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html
State Program
Bureau of Narcotic Enforcement (Home Page)
http://www.health.state.ny.us/professionals/narcotic/
Part 80 Rules and Regulations on Controlled Substances (The regulation)
http://www.health.state.ny.us/regulations/controlled_substance/part/80/docs/80.pdf
Article 33. Controlled Substances (The law)
http://www.health.state.ny.us/regulations/public_health_law/article/33/docs/33.pdf
Federal Registration
Form DEA Form 225 (research and analytical), DEA Form 224 (teaching) initial
applications and renewals:
Application (initial) - paper:
Application (initial) – online
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm
Application (renewal) – online
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms.htm
Categories and fees:
Registration Changes:
http://www.deadiversion.usdoj.gov/drugreg/change_requests/index.html
State Licensing
License program website:
http://www.health.state.ny.us/professionals/narcotic/forms.htm
Form DOH-4330 (license and amendments)
Application Instructions
Dear Researcher Licensee Letter
Page 31 of 48
http://www.health.state.ny.us/professionals/narcotic/facilities/letters/2008-0801_controlled_substance_license.htm
Schedules
Federal
http://www.deadiversion.usdoj.gov/schedules/
State (pages 12-28):
http://www.health.state.ny.us/regulations/public_health_law/article/33/docs/33.pdf
Ordering
DEA Form 222 (schedules I and II)
http://www.deadiversion.usdoj.gov/faq/dea222.htm
DEA Controlled Substance Ordering System
http://www.deaecom.gov/csosmain.html.
Loss, Theft or Diversion
Federal DEA, report verbally to Binghamton Division (Binghamton Division is new and
will not be on website until June 2011. Until it appears on the website below, use the
Albany Division)
http://www.deadiversion.usdoj.gov/offices_n_dirs/fielddiv/newyork.htm
Form DEA-106
https://www.deadiversion.usdoj.gov/webforms/dtlLogin.jsp
State, NYSDOH, report verbally to:
http://www.health.state.ny.us/professionals/narcotic/contact.htm
Form DOH -2094
Disposal
Reverse Distributors
http://www.health.state.ny.us/professionals/narcotic/pharmacies/surrender_to_independe
nt_companies.htm
NYSDOH Onsite destruction Instructions
Form DOH-2340 (NYSDOH Onsite destruction)
Form DOH-166 (Inventory of drugs for destruction)
Addresses
DEA Tompkins County Field Office
Syracuse Resident Office/DEA
500 Plum Street, Suite 700
Syracuse, NY 13204
315-477-1700
NYSDOH BNE
New York State Department of Health
Bureau of Narcotic Enforcement
Page 32 of 48
Riverview Center
150 Broadway
Albany, New York 12204
1-866-811-7957 (Option #2)
Page 33 of 48
12.2 Appendix. Example: Personnel Screening Questionnaire
EXAMPLE
PERSONNEL SCREENING QUESTIONAIRE – AUTHORIZED USER or SENIOR AUTHORIZED USER
Questionnaire for Cornell University Personnel Who Will Have Access to Substances Regulated by the U.S. Drug
Enforcement Agency or New York State Department of Health
Cornell University at Ithaca, version 3/30/11
To comply with federal Drug Enforcement Agency guidance, Cornell University requires that all persons who will have access to
controlled substances during work or research activities answer the following questions. By signing below, you authorize inquiries of
courts and law enforcement agencies for possible pending charges or convictions. Any false information, omission of information, or
misuse of controlled substances will jeopardize your position with the University. Information included herein will not preclude
employment, but will be considered as part of the overall evaluation of qualifications in the application. The protection of an
individual’s right to privacy will be upheld in all confidential inquiries.
Name: __________________________
Circle one:
Faculty
Staff
Student
Other _______________
Lab/Office location: ____________________________________
Phone: _____________________________
E-mail address: ______________________
Net ID: _________________________
Authorization (circle one):
Senior Authorized User (for PI under Institutional License only)
Authorized User
Material Manager
(a Material Manager may also be an Authorized or Senior Authorized User)
1) Within the past five years, have you been convicted of a felony, or within the past two years of any misdemeanor,
or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations,
juvenile offenses, or military convictions, except by general court-martial.) If the answer is yes, furnish details of
conviction, offense, location, date, and sentence on an additional page.
□ Yes
□ No
2) In the past three years, have you ever knowingly used any narcotics, amphetamines, or barbiturates, other than
those prescribed to you by a physician? If the answer is yes, furnish details on an additional page.
□ Yes
□ No
Applicant signature: _________________________________
Date: _________________________
Licensee or Senior Authorized User (Senior Authorized Users may only sign for Authorized Users) authorization
for the person (identified above) to handle controlled substances:
Licensee/Senior Authorized User signature: _____________________
Date: ________________________
Licensee/Senior Authorized User signature: _____________________
NYSDOH License Number: ________________________
DEA Registration Number: ________________________
Page 34 of 48
The most recent version of this document is available electronically at EH&S Website: http://sp.ehs.cornell.edu/lab-research-safety/researchsafety/constrolled-substances/Documents/Controlled_Substances_Guidance.pdf
12.3 Appendix. Example: Record of Receipt Log for an Individual Licensee
Receipt Log1 (Individual Licensee, Multiple Drugs, Single Storage Location)
VENDOR invoices and DEA Form 222 (schedule I & II only) should be kept along with this record.
Individual License Holder:
Net ID:
Storage Cabinet (room/building):
Schedules1:
Rec’d
(date)
Rec’d by
(print)
Rec’d by
(sign)
DEA registration #:
NYSDOH License #:
_____________________
_____________________
_____________________
_____________________
Source
(vendor)
Drug &
Concentration
Amt per
unit
Order #
# of
Units
_______________________________
_______________________________
Tracking #
Accounted
for2
(date)
1
Receipt Logs for schedules I & II must be maintained separately from schedules III-V. Invoices and copies of DEA Form 222 should be retained with receipt records.
Date when drug accounting is complete (Use Log complete and substance used up or any unused portions disposed of).
2
Page 35 of 48
The most recent version of this document is available electronically at EH&S Website: http://sp.ehs.cornell.edu/lab-research-safety/research-safety/constrolledsubstances/Documents/Controlled_Substances_Guidance.pdf
12.4 Appendix. Example: Record of Use Log for an Individual Licensee
Use Log1 (Individual Licensee, Multiple Drugs, Single Storage Location)
Authorized Users:
Item:
Strength:
Unit # (if
applicable)
Name: _____________________
Name: _____________________
_____________
_____________
Date Dispensed
_____________________
_____________________
Tracking #:
# Units:
Protocol #
_______
_______
Species & ID #
(or purpose, if nonanimal)
DEA registration #:
NYSDOH License #:
Protocol #:
Protocol #:
_______________________________
_______________________________
________________
________________
Amount/unit: __________
Total amount: __________
Start amount &
Unit # (if more
than 1 unit)
Amount
Dispensed
Balance2
Dispensed by
(print)
Dispensed by
(signature)
1
A separate log sheet must be completed for each Tracking # (except multiple units of a single order may be on the same log sheet). If the material is converted or diluted, start
a new log form to track that usage; reference the original tracking #.
2
If balanced amount is “0” because of disposal, indicate date disposed, route of disposal (reverse distributor name or other route), and record disposal details in disposal log.
Page 36 of 48
The most recent version of this document is available electronically at EH&S Website: http://sp.ehs.cornell.edu/lab-research-safety/research-safety/constrolledsubstances/Documents/Controlled_Substances_Guidance.pdf
12.5 Appendix. Schedules for Many Controlled Substances Used for Research at CU
Schedules (DEA and NYS)
Below is a list of controlled substances along with the corresponding DEA and NYS schedules
for many of the controlled substances used in research at Cornell University. Contact EH&S to
suggest other controlled substances to add or report any errors. This information cannot be
guaranteed to be current and complete. It is the responsibility of each Licensee to fully
understand and comply with the most current NYSDOH and DEA mandates.
Materials
4-Dihydrotestosterone (17betahydroxyandrostan-3-one)
Barbital
Barbital Sodium
Barbituric acid derivative
Buprenorphine
Butorphanol
Chloral Hydrate
Diazepam
Etorphine
Etorphine hydrochloride
Fentanyl
Human Chorionic Gonadotropin
Hydromorphone
Ketamine
Ketamine/Xylazine combinations
Methyl testosterone
Mibolerone (7alpha,17alpha-dimethyl17beta-hydroxyestr-4-en-3-one)
Midazolam
Alternative Name(s)
Anabolex, Andractim,
Pesomax, Stanolone
Veronal, Plexonal, barbitone
2-Thiobarituric acid
Buprenex, Temgesic,
Subutex, Suboxone
Torbugesic, Stadol, Stadol
NS, Torbutrol
Noctec
Valium, Diastat
M 99
Duragesic, Oralet, Actiq,
Sublimaze, Innovar
Chorulon, HCG, Chorionic
Gonadotripin
Hydromorphon, Dilaudid,
dihydromorphinone
Ketaset, Ketalar, Special K, K
Ketamine/Xylzine
Cheque, Matenon
Morphine
Nalorphine
Oxymorphone
Versed
MS Contin, Roxanol,
Oramorph, RMS, MSIR
Nalline
Numorphan
Pentobarbital
Nebutal, Fatal Plus
NYSDOH
Schedule
(if different
from DEA)
DEA
Sche
dule
Narc
otic?
III
IV
No
No
IV
III
No
No
II
same as DEA
same as
DEA1
same as DEA
III
Yes
same as DEA
IV
IV
IV
I
II
No
No
No
yes
Yes
same as DEA
same as DEA
same as DEA
same as DEA
same as DEA
II
Yes
same as DEA
None
No
III
II
III
III
III
Yes
No
No
No
same as DEA
same as DEA
same as DEA
II
III
IV
No
No
II
same as DEA
II
III
II
Yes
Yes
Yes
same as DEA
same as DEA
same as DEA
II &
No
same as DEA
Page 37 of 48
III2
Pentobarbital & non-controlled active
ingredients
Pregnant Mare Serum Gonadotropin
Remifentanil
Telazol
Testosterone (17beta-hydroxyandrost-4-en3-one)
Testosterone Propionate
Thiopental
1
FP-3, Euthasol
PMSG, Equine Chorionic
Gonadotropin
Ultiva
Tiletamine & Zolazepam
Combination Product
Android-T, Androlan,
Depotest, Delatestryl
III
No
same as DEA
None
II
No
Yes
III
same as DEA
III
No
same as DEA
III
III
No
No
II
II
Pentothal
III
No
same as DEA3
Not specifically listed by NYS but assumed to be the same as barbital
2
Schedule II - parenteral and oral
Schedule III - rectal
3
Not specifically listed by NYS but assumed to be covered under barbituric acid derivatives
Page 38 of 48
12.6 Appendix. Example: Storage Cabinets Double Door, Double Lock
Suitable for storing main or reserve stocks of schedules III-V and working stocks of
schedules I-V
Manufacturer: Lakeside
Model: 3822MAW
Double door, double lock cabinet
http://elakeside.thomasnet.com/ite
m/tegories-healthcare-narcoticcabinets-autumn-white/arenarcotic-cabinets-autumn-whitenarcotics-boxes/3822maw-2?
Available from VWR and other
suppliers
Page 39 of 48
12.7 Appendix. Procedures Specific to Analytical Laboratories
Analytical laboratories using controlled substances must obtain a NYSDOH Class 8 analytical
license and analytical laboratory DEA registration.
State Licensure
Application for a NYSDOH analytical license (DOH-4330) is similar to that as an
Individual Researcher (Section 7.2.2) except for license classification:
Analytical laboratories do not need separate licensing registration for schedule I and
schedule II-V use. When filling out the section on controlled substances to be utilized,
check all schedules that apply to analyses anticipated:
Analytical Laboratories should submit a protocol to the state outlining the purpose and
scope of their activities.
DEA Registration
When completing the DEA registration (DEA Form 225), the box for analytical
laboratory (Section 2 of the application “business activity”) should be checked:
The applicant should check the boxes (Section 3 of the application “A. Drug Schedules”)
for all drug schedules and types (narcotic/non-narcotic) that they anticipate using.
Analytical laboratories do not need to fill in drug codes on the DEA application.
Page 40 of 48
Specific Details
The administrative head of the laboratory is responsible for the proper safeguarding and
handling of controlled substances within the facility, and, as with the chair of a
department administering an institutional research license, the administrative head of the
laboratory serves as the responsible party, Signatory (Section 4.8), and Supervisor of the
Controlled Substance Activity (Section 4.9). These roles include (1) establishing and
overseeing operation of the Controlled Substance Activities in accordance with
NYSDOH and DEA rules, regulations and best practices, (2) signature authority (which
cannot be delegated), and (3) managing and implementing the day-to-day activities
conducted under the Licensure. The administrative head of the laboratory can, if desired,
appoint a Material Manager to implement specific and defined day-to-day activities
(Section 4.10). An administrative head is not relieved of his responsibility to detect and
correct any diversion or mishandling of controlled substances by a delegation of
responsibility (Part 80. 80.6).
Other than the licensing and registration specifics described above, Analytical
Laboratories are subject to and must follow the same procedures as researchers described
in this document.
________________
Regulatory note: Although federal regulations do not require, for chemical analysis,
records of controlled substances used (CFCR 1304.23) or inventory of most controlled
substances < 1 kg (CFR 1304.11), NYS does (Part 80, Section 80.39 and 80.112). Thus,
the stricter interpretation (NYS) applies.
Page 41 of 48
12.8 Appendix. Procedures Specific to Instruction (Teaching)
Instructional (teaching) activities using controlled substances are considered institutional (not
individual) activities. For all practical purposes at Cornell, an instructional license/registration is
held by a department or unit, not an individual.
The possible exception is if instruction with schedule I substances is anticipated. Please contact
EH&S (askEHS) before proceeding with a schedule I Instructional application – special
procedures apply and are not addressed below.
NYSDOH Licensure
Departments or units with instructional activities using schedule II-V controlled substances apply
for a Class 5 instructional license.
Application for a NYSDOH analytical license (DOH-4330) is similar to that as an Institutional
Research (Section 7.2.3) except for license classification and the need for an Oversight
Committee. An Oversight Committee is NOT required for an Class 5 instructional license.
When filling out the section on controlled substances to be utilized, check all schedules that
apply:
When submitting the application, the applicant should submit the class syllabus(es), describe the
controlled substances (and their source) and associated activities, and provide the name and
qualifications of the instructor(s).
As is described for an institutional research license, the department chair or unit should serve as
the Signatory and Supervisor of the Controlled Substance Activities. Individual Instructors may
be appointed as Senior Authorized Users. A Material Manager may also be appointed (a Senior
Authorized User may also serve as a Material Manager). Thus, if a department has just a single
instructor involved with teaching responsibilities using controlled substances, they can be
appointed to use them in teaching (as a Senior Authorized User) and to manage most handling
activities (as a Material Manager). In that case, the primary role of the chair would be providing
Page 42 of 48
supervision, oversight and signature authority (and ultimate responsibility for assuring that a
regulatory rules and regulations are adhered to).
DEA Registration
CONTRARY TO researchers and analytical laboratories, INSTRUCTIONAL DEA
registration requires the applicant to fill out DEA Form 224 (for access, go to:
http://www.deadiversion.usdoj.gov/drugreg/index.html). The application process is
primarily done on-line.
PLEASE NOTE that EH&S has not had direct experience with applying for a DEA
instructional registration or with DEA Form 224. Please contact EH&S (ask EHS) before
applying for a DEA instructional registration so that appropriate guidance can be given as
the application is filled out.
Specific Details
As previously mentioned, the chair of the department or unit is responsible for the proper
safeguarding and handling of controlled substances under an instructional license, and
serves as the responsible party, Signatory (Section 4.8), and Supervisor of the Controlled
Substance Activity (Section 4.9). These roles include (1) establishing and overseeing
operation of the Controlled Substance Activities in accordance with NYSDOH and DEA
rules, regulations and best practices, (2) signature authority (which cannot be delegated),
and (3) managing and implementing the day-to-day activities conducted under the
Licensure. The chair may appoint Individual Instructors as Senior Authorized Users. A
Material Manager may also be appointed (a Senior Authorized User may also serve as a
Material Manager). The chair is not relieved of his responsibility to detect and correct
any diversion or mishandling of controlled substances by a delegation of responsibility
(Part 80. 80.6).
Other than the licensing and registration specifics described above, Instructional
Licensees are subject to and must follow the same procedures as Institutional Research
Licensees described in this document.
Page 43 of 48
12.9 Appendix. Flow Chart: Individual Controlled Substance Research License: Initial
Application Schedule II-V
Training “Research Use of Controlled Substances”
Become Familiar with the Process (all persons
with a role under the license)
Take on-line training
Review guidance document
Understand responsibilities
Contact EH&S for initial consult
EH&S document “Research Use of Controlled Substances”
Licensee is ultimately responsible for understanding &
complying with all state & federal controlled substances
rules & regulations
askEHS
Obtain Proper Storage
Type (vault, safe, double lock cabinet, single lock
cabinet) depends on drug schedule & main or working
stock storage.
Obtain Supporting Documentation
-
CV
Research protocol (including drug type,
amount, drug supplier DEA #)
If animal use: species, #, dose regimen, route
of administration (IACUC protocol)
Submit (by mail) to NYSDOH
Form DOH 4330 – Class 4 License
Form DOH 4330 & Instructions
(including supporting documentation & application fee)
NYSDOH On-Site Visit (at discretion of NYSDOH)
Submit Additional Protocols to NYSDOH (ongoing)
-
Receive NYSDOH License (~ 2-3 months)
Submit (mail or on-line) to DEA
Form 225
(including NYSDOH license number & application fee)
Provide Supporting Information
As requested by DEA (varies)
DEA On-Site Visit (at discretion of DEA)
Receive DEA Registration & (if schedule II) DEA
Form 222s (~ 1-2 months)
[Type text]
-
Research protocol (including drug type, amount, drug
supplier DEA #)
If animal use: species, #, dose regimen, route of
administration (IACUC protocol)
Form DEA Form 225
12.10 Appendix. Flow Chart: Institutional Controlled Substance Research License: Initial
Application Schedule II-V
Become Familiar with the Process (all persons
Learning “Research Use of Controlled Substances”
with a role under the license)
-
Take on-line training
Review guidance document
Understand responsibilities
EH&S document “Research Use of Controlled Substances”
Licensee is ultimately responsible for understanding &
complying with all state & federal controlled substances
rules & regulations
Contact EH&S for initial consult
askEHS
Formalize Roles
Oversight Committee
To approve, supervise and evaluate projects
Chair/Unit Head
Chair of Oversight Committee, Supervisor of
Controlled Substance Activity, Signatory
Material Manager (optional; designated staff member)
Senior Authorized Users (PIs with approved protocols)
Chair/Unit must obtain POA to sign
DEA forms – askEHS for assistance
Evaluate Initial Protocols
-
Oversight committee evaluates starting protocols (if any)
Appoint PI as Senior Authorized User upon approval
Obtain Proper Storage - PI
Obtain Proper Storage – Department
-
For receiving packages, main stocks & disposal
Vault or GSA Class 5 safe in most cases
-
For Senior Authorized User working stocks
Double door, double lock cabinet in most cases
Obtain Supporting Documentation
-
Description of Oversight Committee & how it functions
CV & qualifications Oversight Committee Members
Current approved research protocols & associated information
Submit (by mail) to NYSDOH
Form DOH 4330 – Class 4 License
Form DOH 4330 & Instructions
(including supporting documentation & application fee)
NYSDOH On-Site Visit (at the discretion of NYSDOH)
Receive NYSDOH License (~ 2-3 months)
Submit (mail or on-line) to DEA
Form 225
(including NYSDOH license number & application fee)
Provide Supporting Information
As requested by DEA (varies)
DEA on-site visit (at discretion of DEA)
Receive DEA Registration & (if schedule II) DEA
Form 222s (~ 1-2 months)
[Type text]
Evaluate and Submit Additional Protocols (ongoing)
-
Oversight Committee must:
Evaluate new protocols (including new PI storage)
Appoint PI as Senior Authorized User upon approval
Submit to NYSDOH upon approval
Form DEA Form 225
12.11 Appendix. Biennial Inventory1, 2 (Individual Licensee, Multiple Drugs, Single Storage Location)
___________________
DEA registration #:
_______________________________
___________________
NYSDOH License #:
_______________________________
*******************************************************************************************************************
Name of Person Completing Form:
___________________
Signature:
_______________________________
Date Inventory Performed:
___________________
Title:
_______________________________
Controlled
Substance Name
Strength/Dosage Form
Number of units or volume
of each finished form in each
commercial container3
Number of commercial containers of
each finished form
Total Amount
Current Use
Example:
10 mg tablet
or
10 mg powdered solid
or
10 mg/mL liquid
100 tablets per bottle
or
100 mg per bottle
or
100 mL per bottle
4 bottles
400 tablets
or
400 mg
or
400 mL
Currently in use
or
Awaiting for disposal (expired, not
needed, defective)
or
Kept for quality control
1.
2.
3.
4.
5.
Page _____ of _____
Inventory for schedule I & II must be maintained separately from schedules III-V.
2
For references, see CFR 1304.11, 1304.04 and NYS Part 80, Section 80.100.
3
If substance is Schedule I or II, make exact count or measure of contents. If substance is Schedule III-V, make estimated count or measure, unless the container holds more
than 100 tablets or capsules in which case an exact count must be made (CFR 1304.11).
1
[Type text]
12.12 Appendix. Outdated or Unneeded Controlled Substances
Outdated or Unneeded Controlled Substances held by Licensees
Recommended Practices for Items Awaiting Reverse Distribution
Neither the state nor federal controlled substance laws or regulations specifically address a time
frame for disposal of outdated or unneeded controlled substances by individuals or institutions
holding research licensure. EH&S advises licensees to dispose of controlled substances (expired
or unneeded) on a regular, periodic basis commensurate with their activities and needs1. In most
situations, we recommend the licensee use a reverse distributor2. For example, Guaranteed
Returns is the reverse distributor that both Gannett and CUHA pharmacies use; they allow
returns to be sent via the postal service. Guaranteed Returns charges a base fee of around $150
and an additional cost per weight of material returned (typically less than $10/lb). The licensee
is responsible for the cost of the returns.
EH&S is aware that the cost of disposal, while relatively small for a business, may be viewed as
an unwelcome expense by a single researcher. For on-going controlled substance research use,
we recommend timely and periodic disposal at intervals (minimum of annually) that reflects the
amount of substances on hand. An individual licensee that has a single project using a small
quantity of a single controlled substance might arrange for disposal annually for the duration of
the project (concluding with full disposal when the project ends); an institutional licensee with
considerable activity within their department may wish to arrange for disposal more often –
every 4 months for example.
Controlled substances awaiting disposal are still subject to the same security controls as
controlled substances in active use. They must be stored in the same storage area (locked cabinet
or safe) approved and specified on their license. It is good practice to isolate substances slated
for reverse distribution from those in active use. Individual and institutional licensees, however,
have different options for how this might be done.
Individual licensees can place the materials for disposal in a plastic bag or box and label it
something like “Expired Materials – Scheduled for Reverse Distribution on mm/yy”. Adding an
intended disposal date indicates to an inspector that the disposal is regularly scheduled and
materials are not just accumulating. Reverse distribution should be at least annually; more if
necessary. If the locked box becomes “too small” to fit all the materials, it is a clear indication
that a reverse distribution is in order.
Institutional licensees typically have a main department central safe for storage of incoming
packages, stock materials and materials awaiting disposal. Controlled substances in use,
Page 47 of 48
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C:\Users\llc29\Desktop\Junk\Controlled_Substances_Guidance.doc
however, are kept in the individual lock boxes under the control of Senior Authorized Users.
Senior Authorized users who have outdated or unneeded materials should return these materials
to central storage (along with their User Log) – there is no need for Senior Authorized Users to
keep these materials (in fact, Senior Authorized Users are NOT permitted to dispose of
controlled substances on their own). The Material Manager for the Institutional license should
segregate these materials in the central safe as described above for an individual licensee – bag
or box them and label them something like “Expired Materials – Scheduled for Reverse
Distribution mm/yy”. The frequency of reverse distribution for an institutional licensee holder
should be often enough to ensure unusable material does not accumulate. Annual reverse
distribution is recommended as minimum – quarterly may be more appropriate for active
departments.
1
EH&S advices licensees to dispose of controlled substances (expired or unneeded) on a regular, periodic
basis commensurate with their activities and needs for the following reasons:
1. Excess accumulation of unusable or unneeded controlled substances increases the diversion risk.
2. Timely disposal of unusable or unneeded substances can be a matter of practicality since
approved secure storage areas are often limited in size.
3. Licensed researchers are authorized to use controlled substances only as described in their
approved protocols – which includes specific substances and estimated amounts. If these
amounts are exceeded in appreciable quantities (such as excessive accumulation of expired
substances) or kept on-hand after the research study has been completed, it might be viewed as a
violation of the approved conditions of licensure.
4. An inspector (DEA or NYSDOH BNE) may view accumulation of excess unusable or unneeded
controlled substances unfavorably which may jeopardize the license/registration.
5. Controlled substances that are held by an unlicensed person (as will occur if the licensure expires
and controlled substances are still present) are illegal to possess and very difficult to get rid of.
2
Complete information on controlled substance disposal for licensees, including reverse distribution2 and
NYS approved reverse distributors, is available in Section 11.3 of http://sp.ehs.cornell.edu/lab-researchsafety/research-safety/constrolled-substances/Documents/Controlled_Substances_Guidance.pdf
Page 48 of 48

Controlled Substance Use in Research at Cornell University

Transcription

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