DEA Controlled Substances

Controlled substances are drugs or chemicals that have the potential to be addictive or habit-forming. The United States Drug Enforcement Agency (DEA) divides controlled substances into 5 categories called Schedules based upon substances’ potential for abuse and addictiveness and its’ usefulness in medicine. The Drug Scheduling document can be viewed on the DEA website.

In Massachusetts, controlled substances are also regulated by the MA Department of Public Health (DPH). The MA DPH regulates the DEA Schedules I-V and adds a Schedule VI for prescription medicines that are not covered in Schedules I-V.

The compliance requirements for obtaining controlled substances and for managing their possession vary based on their schedule. Below is a discussion of the different Schedules:

Schedule I

• Have no current accepted medical use in the United States
• Lack of accepted safety for use under medical supervision
• Have a high potential for abuse
• Examples: marijuana and all cannabinoid derivatives, GHB, peyote, ecstasy, LSD, heroin
• Note: Although marijuana has been legalized in some states, the DEA continues to regulate marijuana and cannabinoid derivatives as Schedule I controlled substances

Schedule II

• Have a high potential for abuse
• May lead to severe psychological or physical dependence
• Are only used in medicine under special circumstances and under severe restrictions
• Examples: cocaine, morphine, opium, Adderall, codeine, Nembutal (pentobarbital)

Schedule III

• Have a lower potential for abuse than Schedule I and II substances
• Abuse may lead to low to moderate physical dependence or high psychological dependence
• Are widely used in medicine as pain killers
• Have less stringent restrictions than Schedule I and II substances
• Examples: anabolic steroids, buprenorphine, ketamine, telazol

Schedule IV

• Have a low potential for abuse
• Are widely accepted in medical use
• Examples: Diazepam, Alprazolam, Midazolam

Schedule V

• Have lower potential for abuse than Schedule IV substances
• Consist primarily of preparations containing limited quantities of certain narcotics
• Very widely accepted in medical use
• Examples: Robitussin AC with codeine, Phenergan with codeine

Schedule VI

• Includes all prescription medications not already covered in DEA Schedules I-V
• Pharmaceuticals and other materials included in Schedule VI may or may not require a state registration
• The MA DPH does not publish a list of these substances
• For help determining if a substance is controlled by Schedule VI, contact EHS (bsp@mit.edu)
• Examples: penicillin, Dilantan, Meloxicam

Researchers and PI’s who work with DEA Controlled Substances are responsible for understanding and following applicable regulations. PIs are ultimately responsible for ensuring their labs are compliant with Federal, State, and Institutional policies and guidelines. These include procedures for obtaining and maintaining a DEA and Mass DPH license and registration, following procedures for ordering the substances, properly securing the substances and restricting access only to authorized users, maintaining and retaining all required documentation, completing all required EHS training, and disposing of expired, unused, or unnecessary DEA Controlled substances in an appropriate manner. The specific sections of this guidance page give details for each of these topics. Additional information can be found in the EHS SOP

The nature of your research will determine whether you need your own License and Registration. PI’s conducting animal research and only using commonly used analgesics or sedatives may be able to receive certain controlled substances through the DCM Pharmacy using the DCM Registration. Please contact DCM pharmacy managers for more information (617-324-5444 or 617-253-3089)

PI’s who are not conducting animal research or those who plan to use substances that are not available through the DCM Pharmacy must have their own License and Registration. A Commonwealth of Massachusetts license is required for all schedules including Schedule VI. A Federal DEA registration is also required for research with Schedule I-V substances.

PI’s are responsible for complete their own applications and paying the associated fees. Registrations must be renewed on an annual basis.

Registration Process:

For Schedule I-V substances:

• Submit an application to the Commonwealth of Massachusetts.
• After obtaining your state license, complete the DEA new registration form #225 or apply for a new DEA registration online.
• Inform the EHS DEA Controlled Substance manager of the new registration.
• DEA registrations must be renewed on an annual basis. This can be done online at the DEA website.
• Licenses must be renewed on an annual basis. The renewal application can be found at the federal and state links above.

Schedule VI substance:

• Investigators must submit an application to only the Commonwealth of Massachusetts.
• Licenses must be renewed on an annual basis. Please visit the Commonwealth of Massachusetts link above for more information.

DCM is able to provide materials for commonly used Schedule II-V substances in animal research if an approved CAC protocol is on file. Please contact DCM pharmacy managers for more information (617-324-5444 or 617-253-3089).

Registration holders may order controlled substances through the following process.

Note: Controlled substances may not be purchased using an MIT P-Card.

Ordering:

• All orders for controlled substances must be placed through the Buy-to-Pay system in Atlas
• DO NOT use your MIT P-card or other credit cards to purchase controlled substances

The ordering process varies slightly by Schedule.

Schedule I or II

• Attach copies of DEA and MA DPH licenses
• Select the Commodity “Pharmaceuticals and Controlled Substance” for each substance ordered
• Enter a Notes to Buyer indicating whether this is a Schedule I or Schedule II substance
• Check the Approval Chain to be sure the EHS approval group is listed
• Submit the requisition
• Financial approval is required
• B2P will route the requisition to EHS for review
• Hand deliver additional paperwork to EHS
• Contact EHS to arrange a convenient time to deliver the forms (bsp@mit.edu)
• Deliver 1 copy of MA DPH and DEA current licenses
• Deliver 2 copies of the DEA form 222 that have been handwritten in ink to demonstrate the document authenticity (both copies are sent to the supplier
• PI should retain copies of all documents for their own records
• Once a PO# is generated and all paperwork is in order, EHS will send hard copies of the paperwork to the supplier via Federal Express to place the order.
• EHS cannot release the order to the supplier until we receive this paperwork
• Once the drug is received, the registrant must annotate their copy of the DEA form #222 with:
• The date the substance was received
• The amount of substance received
• DEA form #222

Schedule III, IV, or V

• Attach copies of DEA and MA DPH licenses
• Select the Commodity “Pharmaceuticals and Controlled Substance” for each substance ordered
• Check the Approval Chain to be sure the EHS approval group is listed
• Submit the requisition
• Financial approval is required
• B2P will route the requisition to EHS for review and approval
• B2P emails the PO to the supplier once EHS approval given

Schedule VI

• Attach a copy of MA DPH licenses
• Select the Commodity “Pharmaceuticals and Controlled Substance” for each substance ordered
• Check the Approval Chain to be sure the EHS approval group is listed
• Submit the requisition
• Financial approval is required
• B2P emails the PO to the supplier once EHS approval given

Access to Controlled Substances is restricted to authorized personnel only. Authorized personnel is defined as individuals who have been given access to controlled substances for research approved by the PI. Secure storage prevents unauthorized access to controlled substances which could be used for illicit or illegal purposes.

The kind of secure storage depends on the Schedule of the substance stored.

Schedule I substances specific requirements:

• Schedule I substances must have a drug safe that weighs at least 750 lb. safe or drug safe bolted or cemented to the floor or wall in such a way that it cannot be easily removed
• In some cases, the drug safe mush be equipped with an alarm system, depending upon the quantity of substance it stores
• The DEA will visit to inspect and determine if security is adequate

Schedule II-V substances specific requirements:

• Schedule II-V substances must be securely stored in one of the following ways:
  • Inside of a double-locked safe
  • Inside a securely locked box that is tethered or attached to the inside of a substantially constructed, locked drawer or locked cabinet
  • No bicycle locks, clasp locks, or any other locking structure that can be easily cut off the cabinet can be used

Schedules VI substances specific requirements:

• Schedule VI substances are not regulated by the DEA
• These substances may be stored in a chemical storage unit or at a lab bench located within a secured lab where doors are locked when unoccupied

General Considerations

• Access to storage and use areas must be strictly limited to the authorized individuals assigned by the PI.
• When the areas might be accessed by unauthorized individuals, such as cleaning and maintenance staff, the drugs will be secured.
• All controlled substances must be under the control of a designated, authorized individual.
• The storage cabinet or safe must be adequately sized to maintain stock containers and waste materials.
• Controlled Substances should never be given to non-registrants without proper designation from the DEA.
• Transfer of drugs obtained from DCM is not permissible between PIs
• Contact EHS (BSP@mit.edu/617-452-3477) for more information.

Record keeping that is accurate, up-to-date, and complete is a critical component to DEA compliance. Failure to maintain proper documentation is the most common cause of a DEA inspection violation. The following records must be maintained by the PI and Lab as identified on the registration. Record retention requirements vary slightly depending on how the substance was obtained.

Substances obtained from the DCM Pharmacy:

All records must be kept for at least 2 years from the date of record (the date on which you received the substance)

• DCM continuous inventory
  • DCM provides an inventory template when dispensing the substance
  • Entries are made when the substance is dispensed and are hand-written in ink
  • Inventory forms must be on file in the lab where the substance is used
  • Continuous inventories are compared against DCM logs when substances are returned for disposal
  • The CAC inspects inventory and security in labs receiving drugs from DCM
• DEA Lab Specific SOP  for DEA Controlled Substance Use and record of training completions (Course 290C) must be on file.

Substances obtained by PI Registration:

All records must be kept on hand for at least 2 years from the date of record (the date on which you received the substance).

• All completed order forms
• Inventory forms:
  • DEA Continuous Inventory Record.
  • A Biennial Inventory Form.
  • Entries are made when the substance is dispensed and are hand-written in ink
  • All inventory forms must be kept on file in the lab where the substance is used
• Record of the destruction of a lab’s DEA materials will be recorded by the DEA program manager on the Federal Form 41. This form will be sent to the DEA regional manager and a copy sent to the individual PI.
• DEA Lab Specific SOP for DEA Controlled Substance Use and record of training completions (Course 290C) must be on file.

If a portion of the substance was accidentally spilled or if you suspect your Controlled Substances has been lost or stolen:

• Notify EHS 617-452-3477 / BSP@mit.edu immediately.
• If the substances were obtained from DCM, notify DCM and EHS immediately.
• EHS will work with the registrant to perform an initial investigation to determine if the event is a suspected theft, a significant loss, or an insignificant loss.
• EHS must report suspected thefts or significant losses to the DEA within one business day.
• EHS will also notify the MIT Police of investigations.
• The license holder must then submit DEA Form 106 within 60 days of the reported loss. EHS can assist in the completion and submission of this form.
• DEA form 106 can be found here

Prior to working with a controlled substance, researchers are required to complete Controlled Substances Use in Lab (EHS00290C)) and lab-specific SOP training.

Controlled Substances Use in Lab Training can be completed online through the Atlas Learning Center.  This training must be refreshed every 3 years.

Lab Specific DEA Controlled Substance SOP training is provided by the Established Lab Representative and includes a review of the lab-specific SOP.

Once training is complete, researchers sign and date the training log that is kept with the DEA Controlled Substance SOP.

Visit BSP training page

DEA controlled substances must be disposed of and witnessed by authorized personnel.

• Only select MIT EHS personnel are authorized to dispose of a DEA controlled substance
• Never dispose of the controlled substance yourself
• Controlled substances cannot be “red-tagged” and sent out through the regular hazardous waste stream

The method for disposing of controlled substances depends on where they were obtained:

For substances that originated in DCM:

• All unused controlled substances must be returned to DCM for proper disposal.
• DCM coordinates with EHS to have the substances destroyed
• DCM maintains all destruction records

For registration holders:

• Please contact the DEA Controlled Substances Manager in the EHS Biosafety Office at bsp@mit.edu to arrange for disposal of expired or unused controlled substances
• EHS authorized personnel will render the controlled substance unrecoverable by chemical inactivation
• EHS will witness the destruction and submit DEA form #41
• A copy of DEA form #41 will be given to the PI and lab for local record retention

A PI terminates their DEA and MA DPH registration when the research no longer requires the use of the controlled substance.

• Notify EHS of intent to close out the registration
• Return to the DEA all remaining blank DEA form #222s
• Return to the DEA the original DEA license
• Return to the MA DPH the original MA DPH license
• Please contact EHS for the mailing address for both the DEA and DPH.
• If there is remaining inventory of the substance, contact the MIT DEA Controlled Substances Manager to determine how to dispose of it (bsp@mit.edu)
• Arrange for a record retention within the Department, Lab, or Center (DLC). Please contact EHS to confirm the records transfer. Records should be kept on hand for 2 years.

The DEA can conduct routine, unannounced inspections for your lab to determine if controlled substances are securely stored and if all required records are available, accurate, and up-to-date. Inspectors should show proper identification when they arrive, but you may and should ask to see proper identification if it is not presented.

DEA inspectors will ask to speak with the license holder (PI). Authorized users may be asked to provide Social Security Number (SSN), phone number, address, date of birth (DOB), and job title. DEA inspectors will only ask for documentation from the previous 2 years, which may include:

• Notify EHS of intent to close out the registration
• Copies of the PI’s DEA and MA DPH licenses
• Executed order forms (222 forms) for Schedule I or Schedule II substances
• Invoices for controlled substances
• Floor plan of facility/location of controlled substance storage
• Drug safe specifications including serial number
• SOP and distribution records/dispensing (log sheets)
• DEA-Form 41 (record of destruction from EHS)
• Any DEA-1066 Theft or Loss Reports

Your role during an inspection is to ensure the smooth execution of the inspection. To do this:

• Be courteous and cooperate
• Answer only the questions that the inspectors ask
• If a DEA inspector knocks on your door, contact EHS immediately at 617-452-3477
• EHS can assist with the inspection process

The mission of DEA’s Chemical Control Program is to disrupt the illicit production of controlled substances by preventing diversion of chemicals used to manufacture controlled substances. The production of illegal drugs such as methamphetamine, cocaine, heroin, and MDMA (ecstasy) requires enormous quantities of precursor and essential chemicals. The Chemical Control Program seeks to minimize the regulatory burden on the legitimate chemical industry while instituting effective anti-diversion policies. DEA registration, record keeping and suspicious order reporting requirements apply to importers, exporters, manufacturers, distributors and certain retailers of 50 listed chemicals.  List I and II chemicals.

No regulatory burden exists on the MIT researcher unless they are importing or distributing listed chemicals above threshold values as determined by the DEA and International regulatory bodies. Chemical distributors (e.g. Sigma-Aldrich) may request a completed Authorized Purchaser form. Both the person placing the order and the PI need to sign this form and return it to the chemical distributor (e.g. Sigma-Aldrich). Chemical distributors (e.g. Sigma-Aldrich) will call or email the PI before the order will be released. Here is a sigma authorized purchaser form

Regarding the use of DEA Listed Chemicals, please refer to the MIT Chemical Hygiene Plan, or contact the Industrial Hygiene Program (IHP) for information pertaining to the safe handling of these chemicals. According to the MIT Chemical Hygiene Plan, access to all hazardous chemicals, including toxic substances, should be restricted. Specifically, these materials should be stored in laboratories or storerooms that are kept locked when laboratory personnel are not present.