Controlled Substances

The DEA regulates Schedules I-V.  Any drug not categorized as Schedule I-V by the DEA, the Commonwealth of MA classifies as Schedule VI.

A listing of Schedule I-V controlled substances can be found in the DEA Orange Book.

Samples of schedules are below:

• Policy
  
• Appendix A: Standard Operating Procedures for the Use of Controlled Substances in Non-Human Research
  
• Appendix B:Controlled Substances Transportation Form 

Researchers using controlled substances in non-human research must be registered with the Department of Public Health (DPH) and the Drug Enforcement Agency (DEA). These are referred to as “researcher registrations.”

If you plan to use schedule I-V controlled substances in non-human research, you must have a researcher registration from both the Massachusetts Department of Public Health (DPH researcher registration) and the Drug Enforcement Agency (DEA).  Schedule VI medications in Massachusetts are all prescription medications not listed on Schedules I-V. Note that if you are only using Schedule VI controlled substances a DEA research registration is not required.

• Please click here for the state application
• Please click here for the federal application
  

Researcher registrations must be renewed annually.  Researchers are responsible for ensuring that DPH and DEA researcher registrations are updated and current. The registrant will be required to register on the MGH Controlled Substance Registrant web page / app.

MA DPH revised their regulations for controlled substances in November 2018.  Click here for a memo distributed to the research community outlining key pieces of that regulation along with a FAQ document to help assist you with incorporating these changes into your use of controlled substances for research. 

Contact the Research Compliance Office if you have questions about the state or federal registration applications, are applying for Schedule I controlled substances, determining the schedule designation of a controlled substance, or security, storage, and access to controlled substances. Research Compliance must be present for all DEA interviews.

The MGH Pharmacy does not supply any controlled substances for non-human research use. Most schedule I-V controlled substances can be purchased from McKesson or a veterinary supply company such as Patterson Veterinary Supply or Butler Schein (now known as Covetrus).

Please note: You must set up your own accounts with vendors because the order is linked directly to your registrant numbers. 

McKesson does not carry any animal-specific medications. You should continue to use Patterson/Webster or Butler-Schein (Covetrus) for these medications. For in silico or in vitro (bench) research, Sigma-Aldrich will continue to provide chemical supplies.

Ordering from McKesson: Account Set-up:

Once you have your researcher registration(s), complete and send the following documents to Paul W. Donahue (pwdonahue@partners.org) in Materials Management:

1. Account set up form (one time only, some fields are pre-populated)
   *Please remember, the shipping address must be the same as the address on your DEA Registration.
2. McKesson DEA questionnaire (one time only, some fields are pre-populated
3. Copies of your state and federal controlled substances research registrations (one time only)
4. Ordering medications from McKesson: Video tour of the ordering process. (You do not need a username and password to access a tour of the ordering process. Under “Options”, click on “Take a Tour”. A new screen will pop up and a video will play to walk you through the ordering process.)
5. Step-by-step ordering instructions
   *You must enter your fund number into the PO field when placing your order.

Please click here for approved vendors. 

Researchers are required to maintain a usage log of controlled substances in Schedules I-V under their possession by using the MGH Controlled Substance Accountability Logbook.

The registrant is required to document authorized users, disposition of controlled substances, and biennial audits. All forms are located in the MGH Controlled Substance Accountability Logbook. 

In addition to the MGH Controlled Substance Accountability Logbook, registration holders must keep the following:

• DEA 222 Forms: The DEA Controlled substance order form (DEA 222) for schedule 1 and 2 controlled substances may be ordered using the following link: https://apps.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp or by calling the DEA Headquarters Registration Unit toll free at 1-800-882-9539 or the nearest DEA Registration Field Office. The forms will be mailed within 3 working days.
• Receipts, invoices, and packing slips.
• DEA 106 Form: Report of Theft or Loss forms (DEA Form-106).
• DEA 41 Form: Inventory of Drugs Surrendered for Disposal (DEA Form-41).
• DEA registration certificate.
• State registration certificate.

All records relating to controlled substances must be kept and maintained by the registrant for two years.

Controlled substances must not be transported from one location to another as your registration is location specific.  The ONLY exception for this requirement is if you are transporting animals from a MGH animal housing area where you DO NOT have an office or lab space to maintain a controlled substance registration to another MGH location to perform a procedure/surgery where you maintain your registration and controlled substance cabinet.  Controlled substances can only be used to sedate the animal for transport.  In this instance, you may transport controlled substances under the following requirements:

• Only transport as much controlled substance as is required to sedate the animal(s).
• Do not exceed the maximum amount defined on the Controlled Substance Transportation Form. If you require additional Controlled Substance, you must have approval from the Director of Research Compliance and a Security escort may be required at the discretion of the Director for Research Compliance.
• All Controlled Substances are to be transported from the registrant’s Controlled Substance cabinet inventory in an approved locking transport bag. After use, any residual or remaining controlled substances must be returned to the registered controlled substance cabinet and logged as appropriate as described in this SOP.  Empty syringes should be disposed of in an approved sharps container. 
• Purchasing information for Controlled Substance transportation bag:
  • An approved medication bag is available from global Industrial Equipment: Click here
  • Please enter a special request using the eBuy Plus quick guide for supplier ID: 0000640252. You will need to enter the part number and description from the link, and it would be best to paste the link in the comments.
• Controlled substances must be transported by the registrant or an authorized user.
• A Controlled Substance Transportation Form, Appendix B, must be completed and stored with the MGH Controlled Substance Accountability Logbook when not in use. Otherwise, the transportation form should be on-hand when transporting Controlled Substances
• For new registrations, this process must be described to the DEA agent during the initial interview.

For storage of Schedule I controlled substances, contact the Director of Research Compliance for DEA requirements.

For schedule II-V controlled substances should be stored as follows:

• Stored in a securely locked, substantially constructed double-locked cabinet or safe in locations where access is limited, except when in use by authorized personnel. 
• Safe weighing less than 750 pounds must be bolted to wall or floor.
• Access must be restricted to authorized users who are listed on the registration applications submitted to DPH and the DEA authorized user log.
• The smallest amount needed should be logged out for use and never left unattended.
• Keys to storage cabinets or safes should be secured and only available to authorized users.

Schedule VI – must be stored in a limited access area out of the public eye, but not in the Controlled Substance cabinet.

Refrigerator storage:  Controlled substances that must be refrigerated should be stored in a locked box within a locked refrigerator and the refrigerator should be behind a locked door.

Please click here for a list of approved vendors.

Researchers, who have completed DEA’s registration process, are responsible for the proper disposal of expired or unwanted controlled substances.  It is important for every registrant to maintain all waste disposal records to allow for the accurate and complete accounting of DEA controlled substances.

When disposal of controlled substances is needed, the registrant must contact the MGH Environmental Health and Safety (EH&S). EH&S chemical waste managers arrange for onsite destruction and disposal. 

Contact information: 

If a theft, loss, or unauthorized use of a controlled substance is known or suspected, the following steps must be taken:

1. Safety Reporting: Report immediately through the MGH Safety Reporting System.

Accessing the Direct Link to the MGH Safety Reporting System     

1.) Click on the “Controlled Substance” icon to start entering information into your report.

 2. Contact Research Compliance Immediately.

• Research Compliance will assist you with your regulatory reporting requirements. Regulators must be notified within 24 hours. 
  1. DEA Reporting: DEA regulations require the registrant to report any theft or significant loss. 
  2. DPH Reporting: The registrant must report to the designated agent of the DPH Commissioner by telephone theft or loss, and submit a copy of DEA Form 106, within seven days. 

Contact Information:

If you need an MGH Controlled Substances Accountability Book, please contact:

Kelé Piper, Director, Research Compliance
kkpiper@mgh.harvard.edu or 617-726-2111

• DPH Authorized User Modification Letter
• DPH Application Question 14