[Virtual Presenter] We are pleased to present to you a comprehensive overview of the legal use of controlled substances in research. In this presentation, we will delve into the various categories of controlled substances, explore the functions of those responsible for managing them, and examine the Eight Elements of Controlled Substance Management. Our aim is to equip you with the necessary knowledge to handle controlled substances in your research with utmost care and efficiency.. 

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CONTROLLED SUBSTANCES USE AND MANAGEMENT IN RESEARCH TRAINING

Jovan Gonzalez Office of Environmental Health & Safety jovan.gonzalez@downstate.edu 718-221-5212

DOWNSTATE
HEALTH SCIENCES UNIVERSITY
Office of Environmental Health & Safety
718.270.1216

[Audio] We are pleased to present to you a training module on the use and management of controlled substances in research. This module has been designed to provide University personnel with the information they need to legally acquire, use, synthesize, secure, inventory, and dispose of these substances. It is crucial for University personnel to understand and comply with regulations to ensure the safety of themselves, their colleagues, and the public. In the next slide, we will discuss the requirements for obtaining a controlled substance license in New York State.. 

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This training module is designed to provide University personnel who use or synthesize controlled substances in research with the information to legally acquire, use, synthesize, secure, inventory and dispose of these substances. 
 Acquisition, use, and disposal of controlled substances in New York State are strictly regulated by the:
 New York State Department of Health (DOH) Bureau of Narcotic Enforcement United States Department of Justice Drug Enforcement Administration (DEA)

[Audio] We provide training on the use and management of controlled substances in research. Some examples of controlled substances include ketamine, pentobarbital, buprenorphine, euthasol, human chorionic gonadotropin (hCG), and amphetamine. During our training, you will learn how to handle, store, and administer these substances safely and effectively in a research setting. By following these guidelines, you will help ensure the safety of both the research subjects and the personnel involved in the study.. 

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What is a controlled substance?
 A “controlled substance” is a drug or other substance, or immediate precursor, listed in:
 Schedules I - V of the Federal Controlled Substances Act (21 U.S.C. §§ 801-971) or The New York State Controlled Substances Act (Article 33 of the NYS Public Health Law)

Examples include: ketamine, pentobarbital, buprenorphine, euthasol, human chorionic gonadotropin (hCG-NYS only), amphetamine

[Audio] We are a research institution that offers training for the proper use, handling, and storage of controlled substances. Controlled substances are heavily regulated drugs due to their potential for abuse, physical and psychological dependence, and medical use in treatment. Our goal is to equip researchers and staff with the necessary knowledge and skills to handle controlled substances safely and in compliance with federal and state regulations.. 

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Controlled substances are divided into five categories, called Schedules, according to: Potential for abuse Where it is approved for medical use in treatment in the United States Potential for physical and psychological dependence
 Classification in a particular Schedule affects the licensing, recordkeeping, security & storage of drugs
 Schedules I & II subject to the most stringent regulations

[Audio] We are excited to present this slide deck on the roles and responsibilities of individuals involved in the use and management of controlled substances in research. Our focus will be on the Licensed Individual and the Authorized Individual. The Licensed Individual, typically the Principal Investigator (P-I---) of a research protocol, is responsible for obtaining and renewing both D-O-H and D-E-A license and registration. This individual is also responsible for ensuring that all acquisition, storage, security, inventory, disposal, and record-keeping requirements are met. The Authorized Individual is an individual the Licensed Individual has authorized to work with controlled substances under his/her license and registration. These individuals are responsible for following all regulations and guidelines set forth by the D-O-H and D-E-A-. It is important to note that both the Licensed Individual and the Authorized Individual have a responsibility to maintain the integrity and safety of controlled substances. Failure to comply with regulations can result in severe consequences, including fines, license revocation, and even criminal charges. Thank you for your attention to this important topic.. 

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Licensed Individual - Typically the Licensed Individual is the Principal Investigator (PI) of a research protocol
 The Licensed Individual is responsible for: Obtaining and renewing both DOH and DEA license and registration Assuring that all acquisition, storage, security, inventory, disposal and record-keeping requirements are met
 Authorized Individual – Individuals the Licensed Individual has authorized to work with controlled substances under his/her license & registration

Introduction:  Roles and Responsibilities

[Audio] We are here today to discuss the essential components of controlled substance management in research. Our presentation is intended to provide you with the knowledge and resources needed to efficiently manage controlled substances in your research setting. As a researcher, it is crucial that you comprehend the legal and regulatory requirements associated with the utilization of controlled substances in research. This includes acquiring the necessary licenses and registrations from the Department of Health and Human Services (D-O-H--) and the Drug Enforcement Administration (D-E-A--). Besides obtaining the necessary licenses and registrations, it is imperative to establish appropriate procedures for the procurement, storage, and security of controlled substances. This entails implementing recordkeeping systems to monitor usage and disposal, as well as reporting any losses, thefts, or unauthorized use. Proper training is also essential for effective controlled substance management. Our presentation will offer resources and references for training on controlled substance use and management in research. By understanding and implementing these essential components of controlled substance management, you can ensure that your research is conducted in a secure and compliant manner.. 

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Researcher Licensing & Registration:  Researcher licensing (DOH) Researcher registration (DEA) Procurement of Controlled Substances Storage & Security Recordkeeping Disposal Reporting Loss, Theft, or Unauthorized Use Training Resources & References

The Eight Elements of Controlled Substance Management

[Audio] We are discussing Element 1 of our presentation on controlled substance use and management in research. The focus of this element is on researcher licensing and registration. Specifically, we will discuss two key aspects of this topic: researcher licensing and registration. We will discuss researcher licensing, which is an important aspect of ensuring the safety and security of research involving controlled substances. The licensing process includes background checks, training, and certification. We will also discuss researcher registration, which is another critical aspect of controlled substance use and management in research. The registration process includes background checks, training, and reporting requirements. In conclusion, researcher licensing and registration are two important aspects of controlled substance use and management in research. By implementing these measures, we can ensure the safety and security of research involving controlled substances while also complying with regulatory requirements.. 

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Element 1:  Researcher Licensing & Registration

Researcher licensing (DOH) ii. Researcher registration (DEA)

[Audio] Our company provides training on the usage and management of controlled substances in research. We can assist you with the application process for obtaining a New York State Department of Health (NYS DOH) controlled substance license. It is crucial to obtain an NYS DOH controlled substance license if you don't already have a D-E-A registration. To apply for a Class 4 researcher license, visit the NYS DOH website and follow the instructions given. NYS DOH licenses must be renewed every two years, and the cost for an initial license and renewals is $40. Our training sessions cover all the necessary information and procedures for obtaining and managing a controlled substance license in research. Our experienced trainers will guide you through the process and answer any questions you may have. If you would like to learn more about our training sessions or schedule one, please contact us today. We are eager to help you obtain the necessary licenses and take your research to the next level.. 

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New York State Department of Health Controlled Substance License (NYS DOH)
 For those that do not currently possess a DEA registration that wish to use controlled substances in research, a NYS DOH controlled substance license must be obtained first. Submit application for Class 4 researcher license
 DOH licenses must be renewed every 2 years
 The cost for an initial DOH research license and for renewals is $40

[Audio] We are here today to discuss the significance of obtaining D-E-A registration for researchers in the United States. D-E-A registration is a vital requirement for researchers in the U S to legally handle and use controlled substances in their studies. Researchers must obtain D-E-A registration separate from the D-O-H license. To apply for D-E-A registration, researchers must submit the DEA 225 form under the researcher category. This form should be submitted annually to ensure that the registration remains valid. The cost of D-E-A registration is $244 per year. However, the cost of obtaining D-E-A registration may vary depending on the research study and the type of controlled substances being used. In conclusion, D-E-A registration is a crucial requirement for researchers in the United States. It enables researchers to legally handle and use controlled substances in their studies, and it must be obtained separately from the D-O-H license. We recommend that researchers become familiar with the D-E-A registration process and the requirements for obtaining and renewing D-E-A registration.. 

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U.S. Department of Justice Drug Enforcement Agency (DEA)
 A DEA researchers registration must be obtained after the DOH license has been issued Submit DEA 225 form under “researcher”. NOT practitioner  DEA registration must be renewed annually
 The cost is $244

[Audio] It is crucial to have all required licenses in place prior to carrying out any research with controlled substances. These licenses are imperative for the safety of researchers, participants, and the environment. By providing valid licenses, you are demonstrating your dedication to adhering to all regulations and guidelines. This not only safeguards your organization but also contributes to preserving the integrity of the scientific community as a whole.. 

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Valid DEA and NYSDOH licenses must be submitted to the Office of Environmental Health & Safety once obtained or renewed

[Audio] As researchers, it is crucial to understand the correct process for acquiring controlled substances. It is essential to follow proper procedures to guarantee the safety of all individuals involved in the research. Building relationships with reputable suppliers and maintaining proper documentation are necessary to ensure compliance with all regulations. Researchers must also be aware of the potential risks associated with the use of controlled substances, such as accidental exposure or theft. Proper safety measures, such as the use of personal protective equipment and proper storage of controlled substances, must be implemented.. 

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Element 2:  Procurement of Controlled Substances

[Audio] Good afternoon everyone, We are here to discuss the procurement of controlled substances in research. PIs need to obtain controlled substances from commercial vendors/distributors or government agencies for use in IACUC-approved protocols in animals under the PI’s controlled substance researcher registration. This may require the use of a D-E-A Form. PIs can also acquire controlled substances from the Division of Comparative Medicine (D-C-M--) for administration by D-C-M staff, fee for service. Such acquisition occurs under the PI’s license unless an analgesic is reviewed on a case by case basis. Finally, PIs can obtain Buprenorphine ER, a compounded analgesic, from the D-C-M veterinarian only by veterinary prescription, requiring specific animal ID, body weight, and species. It is crucial to adhere to regulations and laws governing controlled substances when procuring them. PIs should always seek guidance from appropriate resources when needed.. 

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PIs may source controlled substances for use in IACUC-approved protocols in animals from an outside commercial vendor/distributor or governmental agency.  Such acquisition occurs under the auspices of the PI’s controlled substance researcher registration, and may require the use of a DEA Form. Refer to DEA and BNDD resources on the EH&S webpage.
 PIs may source controlled substances from the Division of Comparative Medicine (DCM) for administration only by DCM staff, fee for service.  Such acquisitions by the PI occur under the auspices of their own license unless an analgesic reviewed on a case by case basis.
 PIs may source from the DCM veterinarian only for Buprenorphine ER, a compounded analgesic, by veterinary prescription.  Specific animal ID, body weight and species is required.

Note- For purchases of Schedule I or Schedule II controlled substances, the Licensed Individual must also complete and submit DEA Form 222 to purchase.

[Audio] We provide training on the proper use and management of controlled substances in research. Our presentation focuses on the correct procedures for handling controlled substances, including inventory and storage. It is essential for a D-E-A registrant to log the receipt of controlled substances for inventory and storage purposes. The “ship to” address for all controlled substances must match the address on the D-E-A registration, which is the physical location where the controlled substances will be securely stored.. 

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DEA registrant logs receipt of controlled substances for inventory and storage
 The “ship to” address for all controlled substances must match the address on the DEA registration (i.e., be the physical location where the controlled substances will be securely stored)
 When controlled substances are delivered, the Licensed Individual or Authorized Individual must:
 Immediately inventory the package to ensure that the order was accurately filled
 Prepare a Receipt Log to document the receipt of the order. If a discrepancy in the order is identified, immediately contact the distributor
 Secure the controlled substances in an appropriate narcotics cabinet

[Audio] We are pleased to welcome you to this presentation on the safe and proper use of controlled substances in research. Controlled substances are highly regulated substances that are used for research purposes. Proper storage and security of controlled substances are critical to ensuring the safety of researchers, lab personnel, and the public. In this presentation, we will be discussing best practices for storing and securing controlled substances in a research setting. We will be covering topics such as proper labeling and inventory management, physical security measures, access controls and monitoring, and training and education of lab personnel. We hope that this presentation will provide you with the information you need to ensure the safe and proper use of controlled substances in your research. Thank you for your attention, and we look forward to hearing your questions.. 

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[Audio] We're proud to offer training on controlled substances use and management in research. As a responsible organization, it is our duty to ensure that controlled substances are properly safeguarded and securely stored at all times. The level of security required for controlled substances storage varies depending on two factors: (a) storage for working stocks or reserve or main stocks; and (b) the Schedule of the controlled substance. To help you determine the appropriate storage unit, we've provided you with a Storage and Security Decision Tree and Specification Sheet. Proper storage and security of controlled substances is essential for maintaining the integrity of research and ensuring the safety of all involved. Thank you for selecting our training program.. 

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It is the Licensed Individual’s responsibility to ensure that controlled substances are properly safeguarded and securely stored at all times at the address on file with the DOH and DEA
 Security requirements vary depending on:  (a) whether storage is for working stocks or reserve or main stocks; and  (b) the Schedule of the controlled substance
 To determine the appropriate storage unit, Licensed Individuals should use the Storage and Security Decision Tree and Specification Sheet on the next slide

Will go over the Storage and Security Decision Tree and Specification Sheet used to determine storage requirements. Storage requirements are separated between the main stock, or reserve stock, and your working stock, the location where substances in use must be stored.  For Main or reserve stock, Schedules 1 & 2 must be stored in a G-S-A 5-rated cabinet or safe. Schedules 3, 4, and 5 must be in a securely locked cabinet of substantial construction. For working stocks, schedules 1, 2, 3, and 4 must be stored in a stationary, locked double cabinet. Schedule 5 substances can be stored in a securely locked cabinet of substantial construction.

 Use this decision tree to determine the information to be added to page 2 of DOH Application Form 4330 

*Note- It is anticipated that the working stock definition will apply in most research storage situations. 

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[image] Formulation of Controlled Substance to be stored
Main/ reserve stock
Select DEA schedule
Work ing stock*
Select DEA schedule
Schedulesl, II
GSA S-rated
cabinet or safe
Schedules Ill, IV, V
Secure ty- locked
cab inet of
substantial
construction
Schedules l, II, Ill, IV
Stationary, locked
double cabinet
Schedule V
Secu rely- locked
cabinetof
su bstan tial
construction
Use this decision tree to determine the information to be added to page 2 of DOH Application Form 4330
*Note- It is anticipated that the working stock definition will apply in most research storage situations

DOWNSTATE HEALTH SCIENCES UNIVERSITY. Element 4: Recordkeeping. 

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[Audio] Good afternoon everyone. Today, we will be discussing the importance of recordkeeping in the life cycle of controlled substances. Controlled substances are substances that are regulated by the government and are used for various purposes, such as medical treatment and research. When it comes to the use of controlled substances, significant recordkeeping is required at every point of the life cycle. This is because the proper tracking and recording of controlled substances is crucial for ensuring the safety and security of the substances, as well as for complying with government regulations. We will discuss the types of records that are required by licensed individuals to maintain proper recordkeeping of controlled substances, including receipt logs, use logs, and biennial inventory records. These records are used to track the movement and usage of controlled substances, and are an important tool in the prevention of theft, loss, and diversion. Proper recordkeeping is not only a legal requirement, but also a best practice for ensuring the safety and security of controlled substances. In conclusion, the proper tracking and recording of controlled substances is essential for ensuring the safety and security of the substances, as well as for complying with government regulations.. 

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Significant recordkeeping is required at every point of the life cycle of the controlled substance, including initial receipt, use, and disposal   Licensed individuals must maintain the following records: Receipt log Use log Biennial inventory Disposal and reverse distribution records If applicable, theft and loss records

[Audio] We will be discussing the importance of proper controlled substances use and management in research today. As researchers, it is crucial to understand the regulations and guidelines that govern the use of controlled substances. Before an order of controlled substances is received, it must be recorded in the Receipt Log. This is a vital step in ensuring that the controlled substances are used properly and in compliance with all regulations. The Receipt Log must be maintained by the Authorized or Licensed Individual. This means that a unique internal ID number must be assigned to each container received in the order. This helps to track the use of the controlled substances and ensure that they are used in a controlled and safe manner. In addition to the Receipt Log, D-E-A official order forms, such as D-E-A Form 222, and invoices must be maintained. This helps to ensure that all transactions involving controlled substances are properly documented and audited. It is important to note that separate Receipt Log templates are required for Schedule I-II and Schedule III-V controlled substances. This helps to ensure that the proper regulations are followed and that the controlled substances are used in a safe and controlled manner. In conclusion, proper controlled substances use and management in research is critical for the safety of researchers and the public. By following the regulations and guidelines, researchers can ensure that controlled substances are used in a safe and controlled manner, and that all transactions involving controlled substances are properly documented and audited. Thank you for your attention.. 

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Every time an order of controlled substances is received, it must be recorded in the Receipt Log
 Separate Receipt Log templates are required for Schedule I-II and Schedule III-V
 A unique internal ID number created by the Authorized or Licensed Individual must be assigned to each container received in the order
 DEA official order forms, such as DEA Form 222, and invoices must be maintained

[Audio] Our training emphasizes the importance of proper use and management of controlled substances in research. We provide comprehensive training on the use and management of controlled substances in this field. Our training covers the use of a separate Use Log to keep track of all use and disposal of substances. This log must be maintained and updated regularly to ensure compliance with regulations. We believe that accurate and complete recordkeeping is crucial for ensuring the safe and ethical use of controlled substances in research. Our training is designed to help researchers understand the importance of maintaining accurate and complete records, and to provide them with the tools and resources they need to do so.. 

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A separate Use Log must be maintained for each container
 The unique internal ID number created by the Authorized or Licensed Individual at the time of receipt, must be recorded on each Use Log

[Audio] We will provide you with the knowledge and skills needed to handle controlled substances in research. It is crucial to maintain accurate records of all controlled substances in order to meet regulatory requirements and prevent any unauthorized use or theft. Our training program will walk you through the proper procedures for taking inventory and recording all controlled substances in storage.. 

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After initial inventory is taken, the Licensed or Authorized Individual must:
 Take inventory of all current controlled substances in storage every 2 years using the Biennial Inventory Log. This is essentially a snapshot of the controlled substance inventory at that time.

[Audio] We cover all aspects of recordkeeping for controlled substances in research settings. Our training includes record-keeping procedures, record retention, and record destruction. We also provide guidance on how to properly handle and store controlled substances, as well as how to dispose of them safely and securely. Compliance with the Public Health Law is critical for ensuring the safety and security of controlled substances in research settings. Proper recordkeeping can help prevent theft, loss, and unauthorized access to controlled substances. Our training is designed to help researchers maintain a safe and secure research environment.. 

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Receipt, Use and Biennial Inventory Log records must be maintained for 5 years
 If applicable, a copy of the “Loss of Controlled Substances Report” must also be maintained for 5 years in accordance with Section 3370 of the Public Health Law

DOWNSTATE HEALTH SCIENCES UNIVERSITY. Element 5: Disposal. 

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[Audio] As a research scientist,. 24. If controlled substances expire or otherwise require disposal the Licensed Individual must: Contact an approved Reverse Distributor and arrange for the documented return of the controlled substances. Reach out to EH&S for assistance finding an approved vendor. It is strictly prohibited to discard controlled substances into a drain or sharps container, or to use any other method, other than using a Reverse Distributor The only exception is Buprenorphine ER, through DCM veterinarian prescription. Disposal is done by chemical destruction, via the Rx Destroyer. Contact EH&S for guidance.. 

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If controlled substances expire or otherwise require disposal the Licensed Individual must:
 Contact an approved Reverse Distributor and arrange for the documented return of the controlled substances. Reach out to EH&S for assistance finding an approved vendor.
 It is strictly prohibited to discard controlled substances into a drain or sharps container, or to use any other method, other than using a Reverse Distributor  The only exception is Buprenorphine ER, through DCM veterinarian prescription. Disposal is done by chemical destruction, via the Rx Destroyer.  
 Contact EH&S for guidance.

[Audio] Afternoon. Today, we will be discussing the reporting of loss, theft, or unauthorized use of controlled substances in research. Proper reporting mechanisms are critical to ensure the safety and security of both the substances and those involved in the research. Our organization recognizes the significance of this issue and has developed a reporting system to address any incidents that may occur. Our reporting system is designed to be user-friendly and accessible to all members of the research community. We encourage all individuals to report incidents as soon as possible to enable us to investigate and resolve them quickly, minimizing any potential harm to individuals or substances. Any reports of loss, theft, or unauthorized use must be in writing and should include as much detail as possible to help us better understand the incident and take appropriate action. In addition to our reporting system, we provide training on proper handling and management of controlled substances. This training aims to educate individuals about the risks associated with these substances and how to minimize them. Our organization takes the safety and security of our research community very seriously and is committed to providing the best support and training to all members. Thank you for your attention, and we welcome any questions you may have.. 

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Element 6:  Reporting Loss, Theft or Unauthorized Use

[Audio] We offer training on the appropriate handling, storage, and disposal of controlled substances in research. It is crucial for responsible researchers to have a proper understanding of these topics to prevent accidents, minimize the risk of diversion, and maintain compliance with all relevant laws and regulations. In the event of a controlled substance loss, theft, or unauthorized use, we strongly advise immediate action. We suggest contacting the licensed individual and University Police to report the incident. Furthermore, we recommend preparing the following documents within one business day of discovery: * Use New York D-O-H Form 2094 “Loss of Controlled Substances Report” to report all losses due to diversion (unknown, suspected, or possible) * Online D-E-A Form 106, as applicable By following these steps, you can ensure that your research is conducted in a safe and compliant manner. We hope that you find this training informative and valuable in your work. Thank you for your attention.. 

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CONTACT THE LICENSED INDIVIDUAL & University Police IMMEDIATELY!
 Prepare the following documents within one business day of discovery:
 Use New York DOH Form 2094 “Loss of Controlled Substances Report” to report all losses of controlled substances due to diversion (unknown, suspected, or possible) Online DEA Form 106, as applicable

Reporting Loss, Theft or Unauthorized Use

[Audio] We are here to discuss the controlled substances research S-O-P and the useful resources available on the Downstate EH&S website. It is crucial for researchers to understand the proper handling and management of controlled substances to ensure the safety of themselves and others in the laboratory.. 

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The Controlled Substances in Research SOP, as well as other helpful resources are available on the Downstate EH&S website:
 https://www.downstate.edu/about/our-administration/facilities-management-development/environmental-safety.html 
 Review the controlled substance SOP

[Audio] We are thrilled to see your comprehension of the subject matter. To evaluate your knowledge and determine whether you are ready to receive the Training Certificate, we have created a quiz. You must answer 8 of 10 questions correctly to pass the quiz. We hope you found the presentation enlightening and captivating, and we wish you the best of luck on your quiz. Thank you for participating in our session.. 

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You have come to the end of the course material  
 You can now take quiz (answer 8 of 10 correctly  to pass and receive the Training Certificate)

 Jovan Gonzalez Office of Environmental Health & Safety jovan.gonzalez@downstate.edu 718-221-5212

slide1-hotlink3

We are pleased to present to you a training module on the use and management of controlled substances in research. This module has been designed to provide University personnel with the information they need to legally acquire, use, synthesize, secure, inventory, and dispose of these substances. It is crucial for University personnel to understand and comply with regulations to ensure the safety of themselves, their colleagues, and the public. In the next slide, we will discuss the requirements for obtaining a controlled substance license in New York State.

avatar

We provide training on the use and management of controlled substances in research. Some examples of controlled substances include ketamine, pentobarbital, buprenorphine, euthasol, human chorionic gonadotropin (hCG), and amphetamine. During our training, you will learn how to handle, store, and administer these substances safely and effectively in a research setting. By following these guidelines, you will help ensure the safety of both the research subjects and the personnel involved in the study.

 What is a controlled substance?
 A “controlled substance” is a drug or other substance, or immediate precursor, listed in:
 Schedules I - V of the Federal Controlled Substances Act (21 U.S.C. §§ 801-971) or The New York State Controlled Substances Act (Article 33 of the NYS Public Health Law)  


slide3-hotlink6

We are a research institution that offers training for the proper use, handling, and storage of controlled substances. Controlled substances are heavily regulated drugs due to their potential for abuse, physical and psychological dependence, and medical use in treatment. Our goal is to equip researchers and staff with the necessary knowledge and skills to handle controlled substances safely and in compliance with federal and state regulations.

We are excited to present this slide deck on the roles and responsibilities of individuals involved in the use and management of controlled substances in research. Our focus will be on the Licensed Individual and the Authorized Individual.
                                    
The Licensed Individual, typically the Principal Investigator (P-I---) of a research protocol, is responsible for obtaining and renewing both D-O-H and D-E-A license and registration. This individual is also responsible for ensuring that all acquisition, storage, security, inventory, disposal, and record-keeping requirements are met.
                                    
The Authorized Individual is an individual the Licensed Individual has authorized to work with controlled substances under his/her license and registration. These individuals are responsible for following all regulations and guidelines set forth by the D-O-H and D-E-A-.
                                    
It is important to note that both the Licensed Individual and the Authorized Individual have a responsibility to maintain the integrity and safety of controlled substances. Failure to comply with regulations can result in severe consequences, including fines, license revocation, and even criminal charges.
                                    
Thank you for your attention to this important topic.

We are here today to discuss the essential components of controlled substance management in research. Our presentation is intended to provide you with the knowledge and resources needed to efficiently manage controlled substances in your research setting.                                     As a researcher, it is crucial that you comprehend the legal and regulatory requirements associated with the utilization of controlled substances in research. This includes acquiring the necessary licenses and registrations from the Department of Health and Human Services (D-O-H--) and the Drug Enforcement Administration (D-E-A--).                                     Besides obtaining the necessary licenses and registrations, it is imperative to establish appropriate procedures for the procurement, storage, and security of controlled substances. This entails implementing recordkeeping systems to monitor usage and disposal, as well as reporting any losses, thefts, or unauthorized use.                                     Proper training is also essential for effective controlled substance management. Our presentation will offer resources and references for training on controlled substance use and management in research.                                     By understanding and implementing these essential components of controlled substance management, you can ensure that your research is conducted in a secure and compliant manner.

We are discussing Element 1 of our presentation on controlled substance use and management in research. The focus of this element is on researcher licensing and registration. Specifically, we will discuss two key aspects of this topic: researcher licensing and registration. We will discuss researcher licensing, which is an important aspect of ensuring the safety and security of research involving controlled substances. The licensing process includes background checks, training, and certification. We will also discuss researcher registration, which is another critical aspect of controlled substance use and management in research. The registration process includes background checks, training, and reporting requirements. In conclusion, researcher licensing and registration are two important aspects of controlled substance use and management in research. By implementing these measures, we can ensure the safety and security of research involving controlled substances while also complying with regulatory requirements.

Our company provides training on the usage and management of controlled substances in research. We can assist you with the application process for obtaining a New York State Department of Health (NYS DOH) controlled substance license. It is crucial to obtain an NYS DOH controlled substance license if you don't already have a D-E-A registration. To apply for a Class 4 researcher license, visit the NYS DOH website and follow the instructions given. NYS DOH licenses must be renewed every two years, and the cost for an initial license and renewals is $40. Our training sessions cover all the necessary information and procedures for obtaining and managing a controlled substance license in research. Our experienced trainers will guide you through the process and answer any questions you may have. If you would like to learn more about our training sessions or schedule one, please contact us today. We are eager to help you obtain the necessary licenses and take your research to the next level.

We are here today to discuss the significance of obtaining D-E-A registration for researchers in the United States. D-E-A registration is a vital requirement for researchers in the U S  to legally handle and use controlled substances in their studies.  
                                     Researchers must obtain D-E-A registration separate from the D-O-H license. To apply for D-E-A registration, researchers must submit the DEA 225 form under the researcher category. This form should be submitted annually to ensure that the registration remains valid.                                                                            The cost of D-E-A registration is $244 per year. However, the cost of obtaining D-E-A registration may vary depending on the research study and the type of controlled substances being used.                                                                            In conclusion, D-E-A registration is a crucial requirement for researchers in the United States. It enables researchers to legally handle and use controlled substances in their studies, and it must be obtained separately from the D-O-H license. We recommend that researchers become familiar with the D-E-A registration process and the requirements for obtaining and renewing D-E-A registration.

It is crucial to have all required licenses in place prior to carrying out any research with controlled substances. These licenses are imperative for the safety of researchers, participants, and the environment. By providing valid licenses, you are demonstrating your dedication to adhering to all regulations and guidelines. This not only safeguards your organization but also contributes to preserving the integrity of the scientific community as a whole.

As researchers, it is crucial to understand the correct process for acquiring controlled substances. It is essential to follow proper procedures to guarantee the safety of all individuals involved in the research. Building relationships with reputable suppliers and maintaining proper documentation are necessary to ensure compliance with all regulations. Researchers must also be aware of the potential risks associated with the use of controlled substances, such as accidental exposure or theft. Proper safety measures, such as the use of personal protective equipment and proper storage of controlled substances, must be implemented.

Good afternoon everyone,                                     We are here to discuss the procurement of controlled substances in research. PIs need to obtain controlled substances from commercial vendors/distributors or government agencies for use in IACUC-approved protocols in animals under the PI’s controlled substance researcher registration. This may require the use of a D-E-A Form.                                     PIs can also acquire controlled substances from the Division of Comparative Medicine (D-C-M--) for administration by D-C-M staff, fee for service. Such acquisition occurs under the PI’s license unless an analgesic is reviewed on a case by case basis.                                     Finally, PIs can obtain Buprenorphine ER, a compounded analgesic, from the D-C-M veterinarian only by veterinary prescription, requiring specific animal ID, body weight, and species.                                     It is crucial to adhere to regulations and laws governing controlled substances when procuring them. PIs should always seek guidance from appropriate resources when needed.

We provide training on the proper use and management of controlled substances in research. Our presentation focuses on the correct procedures for handling controlled substances, including inventory and storage. It is essential for a D-E-A registrant to log the receipt of controlled substances for inventory and storage purposes. The “ship to” address for all controlled substances must match the address on the D-E-A registration, which is the physical location where the controlled substances will be securely stored.

We are pleased to welcome you to this presentation on the safe and proper use of controlled substances in research. Controlled substances are highly regulated substances that are used for research purposes. Proper storage and security of controlled substances are critical to ensuring the safety of researchers, lab personnel, and the public. In this presentation, we will be discussing best practices for storing and securing controlled substances in a research setting. We will be covering topics such as proper labeling and inventory management, physical security measures, access controls and monitoring, and training and education of lab personnel. We hope that this presentation will provide you with the information you need to ensure the safe and proper use of controlled substances in your research. Thank you for your attention, and we look forward to hearing your questions.

We're proud to offer training on controlled substances use and management in research. As a responsible organization, it is our duty to ensure that controlled substances are properly safeguarded and securely stored at all times. The level of security required for controlled substances storage varies depending on two factors: (a) storage for working stocks or reserve or main stocks; and (b) the Schedule of the controlled substance. To help you determine the appropriate storage unit, we've provided you with a Storage and Security Decision Tree and Specification Sheet. Proper storage and security of controlled substances is essential for maintaining the integrity of research and ensuring the safety of all involved. Thank you for selecting our training program.

Good afternoon everyone. Today, we will be discussing the importance of recordkeeping in the life cycle of controlled substances. Controlled substances are substances that are regulated by the government and are used for various purposes, such as medical treatment and research. When it comes to the use of controlled substances, significant recordkeeping is required at every point of the life cycle. This is because the proper tracking and recording of controlled substances is crucial for ensuring the safety and security of the substances, as well as for complying with government regulations. We will discuss the types of records that are required by licensed individuals to maintain proper recordkeeping of controlled substances, including receipt logs, use logs, and biennial inventory records. These records are used to track the movement and usage of controlled substances, and are an important tool in the prevention of theft, loss, and diversion. Proper recordkeeping is not only a legal requirement, but also a best practice for ensuring the safety and security of controlled substances. In conclusion, the proper tracking and recording of controlled substances is essential for ensuring the safety and security of the substances, as well as for complying with government regulations.

We will be discussing the importance of proper controlled substances use and management in research today. As researchers, it is crucial to understand the regulations and guidelines that govern the use of controlled substances. Before an order of controlled substances is received, it must be recorded in the Receipt Log. This is a vital step in ensuring that the controlled substances are used properly and in compliance with all regulations. The Receipt Log must be maintained by the Authorized or Licensed Individual. This means that a unique internal ID number must be assigned to each container received in the order. This helps to track the use of the controlled substances and ensure that they are used in a controlled and safe manner. In addition to the Receipt Log, D-E-A official order forms, such as D-E-A Form 222, and invoices must be maintained. This helps to ensure that all transactions involving controlled substances are properly documented and audited. It is important to note that separate Receipt Log templates are required for Schedule I-II and Schedule III-V controlled substances. This helps to ensure that the proper regulations are followed and that the controlled substances are used in a safe and controlled manner. In conclusion, proper controlled substances use and management in research is critical for the safety of researchers and the public. By following the regulations and guidelines, researchers can ensure that controlled substances are used in a safe and controlled manner, and that all transactions involving controlled substances are properly documented and audited. Thank you for your attention.

Our training emphasizes the importance of proper use and management of controlled substances in research. We provide comprehensive training on the use and management of controlled substances in this field. Our training covers the use of a separate Use Log to keep track of all use and disposal of substances. This log must be maintained and updated regularly to ensure compliance with regulations. We believe that accurate and complete recordkeeping is crucial for ensuring the safe and ethical use of controlled substances in research. Our training is designed to help researchers understand the importance of maintaining accurate and complete records, and to provide them with the tools and resources they need to do so.

We will provide you with the knowledge and skills needed to handle controlled substances in research. It is crucial to maintain accurate records of all controlled substances in order to meet regulatory requirements and prevent any unauthorized use or theft. Our training program will walk you through the proper procedures for taking inventory and recording all controlled substances in storage.

We cover all aspects of recordkeeping for controlled substances in research settings. Our training includes record-keeping procedures, record retention, and record destruction. We also provide guidance on how to properly handle and store controlled substances, as well as how to dispose of them safely and securely. Compliance with the Public Health Law is critical for ensuring the safety and security of controlled substances in research settings. Proper recordkeeping can help prevent theft, loss, and unauthorized access to controlled substances. Our training is designed to help researchers maintain a safe and secure research environment.

Afternoon. Today, we will be discussing the reporting of loss, theft, or unauthorized use of controlled substances in research. Proper reporting mechanisms are critical to ensure the safety and security of both the substances and those involved in the research. Our organization recognizes the significance of this issue and has developed a reporting system to address any incidents that may occur. Our reporting system is designed to be user-friendly and accessible to all members of the research community. We encourage all individuals to report incidents as soon as possible to enable us to investigate and resolve them quickly, minimizing any potential harm to individuals or substances. Any reports of loss, theft, or unauthorized use must be in writing and should include as much detail as possible to help us better understand the incident and take appropriate action. In addition to our reporting system, we provide training on proper handling and management of controlled substances. This training aims to educate individuals about the risks associated with these substances and how to minimize them. Our organization takes the safety and security of our research community very seriously and is committed to providing the best support and training to all members. Thank you for your attention, and we welcome any questions you may have.

We offer training on the appropriate handling, storage, and disposal of controlled substances in research. It is crucial for responsible researchers to have a proper understanding of these topics to prevent accidents, minimize the risk of diversion, and maintain compliance with all relevant laws and regulations. In the event of a controlled substance loss, theft, or unauthorized use, we strongly advise immediate action. We suggest contacting the licensed individual and University Police to report the incident. Furthermore, we recommend preparing the following documents within one business day of discovery:  * Use New York D-O-H Form 2094 “Loss of Controlled Substances Report” to report all losses due to diversion (unknown, suspected, or possible) * Online D-E-A Form 106, as applicable  By following these steps, you can ensure that your research is conducted in a safe and compliant manner. We hope that you find this training informative and valuable in your work. Thank you for your attention.

 CONTACT THE LICENSED INDIVIDUAL & University Police IMMEDIATELY!
 Prepare the following documents within one business day of discovery:
 Use New York DOH Form 2094 “Loss of Controlled Substances Report” to report all losses of controlled substances due to diversion (unknown, suspected, or possible) Online DEA Form 106, as applicable 























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We are here to discuss the controlled substances research S-O-P and the useful resources available on the Downstate EH&S website. It is crucial for researchers to understand the proper handling and management of controlled substances to ensure the safety of themselves and others in the laboratory.

We are thrilled to see your comprehension of the subject matter. To evaluate your knowledge and determine whether you are ready to receive the Training Certificate, we have created a quiz. You must answer 8 of 10 questions correctly to pass the quiz. We hope you found the presentation enlightening and captivating, and we wish you the best of luck on your quiz. Thank you for participating in our session.