Controlled Substances are drugs or chemicals that have the potential to be addictive or habit forming. The US Drug Enforcement Administration (DEA) has divided the Controlled Substances into 5 schedules (I-V) based on their potential to be habit forming and usefulness in medicine as a drug. The Drug Scheduling document can be viewed at http://www.usdoj.gov/dea/pubs/scheduling.html.
Every person that engages in research with Controlled Substances must be registered with the U.S. Drug Enforcement Administration (DEA). In addition, use of Controlled Substances in Massachusetts also requires registration with the Commonwealth of Massachusetts Department of Public Health (DPH).
While there is no institute-wide license to use controlled substances, researchers at MIT may obtain certain controlled substances through DCM as outlined in their approved CAC protocol. Principal Investigators (PI’s) must apply for registration as a researcher to order controlled substances directly from a distributor or vendor.
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 Controlled Substances: Requirements for Acquisition, Use and Disposal in Laboratories SOP (EHS-0093).
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: Monica Siddalls (firstname.lastname@example.org) or Morgan Jamiel (email@example.com).
PI’s who are not conducting animal research or those who plan to use substances which 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 1-V substances.
PI’s are responsible for complete their own applications and paying the associated fees. Registrations must be renewed on an annual basis.
- 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: Monica Siddalls (firstname.lastname@example.org) or Morgan Jamiel (email@example.com).
Registration holders may order controlled substances through the following process.
Note: Controlled substances may not be purchased using an MIT P-Card.
- The registrant must submit an electronic requisition and reference the correct material group for controlled substances
- To expedite the approval process, pertinent documents may be scanned and attached electronically to the requisition
- For Schedule I and II only: hard copies of all pertinent documents must be hand delivered to the EHS office at N52-496
- Attachment of scanned documents does not preclude the requirement to send hard copies to EHS
- Additional Forms for purchasing Schedule I and II substances:
- Three copies of completed and signed DEA form #222 (Please note: A separate #222 form for Schedule I material is required!)
- One copy is kept in the lab for record
- Two copies are carried to EHS and forwarded to the drug supplier
- The supplier will keep one copy and send the other to the DEA as a record of distribution
- Additional Forms for purchasing Schedule I and II substances:
- EHS will review and approve the electronic requisition based upon the documents provided by the requestor
- Procurement will then process the purchase order
- EHS will use the PO generated by the purchasing system to put together the order and will send hard copies of all document to the vendor
- 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 can be found at: http://www.deadiversion.usdoj.gov/faq/dea222.html
- To order Schedule III-V controlled substances, the PI must submit an electronic requisition as usual; there is no need to fill out or attach DEA form #222, but the registration number still must be provided
- Schedule VI substances may not require any documentation and will be vendor specific; please contact the vendor prior to placing an order for a Schedule VI material for clarification
- Controlled substances may not be purchased using an MIT P-Card!
The following records must be maintained by the PI and Lab as identified on the registration. PI’s receiving materials from the DCM pharmacy are only required to keep a continuing inventory record and the Lab Specific SOP (bullet points 2 and 6 below).
- All completed order forms
- A Continuing Inventory Record must be kept a minimum of two years from date of record
- A Biennial Inventory Form must be kept by PI’s with their own registrations for a minimum of two years
- Record of 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; destruction of DCM materials are also recorded and federal forms sent to the DCM pharmacy managers
- Drug dispensing records must be kept a minimum of two years from the date of record
- A Lab Specific SOP for DEA Controlled Substance Use and record of training completions (Course 290C) must be on file
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.
- All controlled substances must be kept in a double locked enclosure. Minimum requirement is a locked cabinet stored within a locked room. A lockbox tethered to the primary enclosure is required.
- Schedule I substances specific requirements:
- Schedule I substances must have a 750 lb. safe (or safe bolted to floor) with central station alarm control; please note the central station alarm requirement is on a case by case basis and will determined during the DEA site visit
- Schedule II substances specific requirements:
- Schedule II substance storage may be in any built in case work of lab benches with sufficient locking structures
- May be stored in a securely locked box within a substantially constructed locked drawer or cabinet tethered to the inside or a double locked safe
- No bicycle locks, clasp locks or any other locking structure that can be easily cut off the cabinet should be used
- If any schedule II materials will be stored with schedules III-V, a double lock security system must be in place
- However, if many personnel only need access to schedule III-V substances, then it is prudent to store schedule II materials separately from other schedules in order to maintain strict access control
- Schedules III, IV, and V substances specific requirements:
- May be stored in locked box within a substantially constructed drawer or cabinet; the lockbox must be tethered to the inside
- 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 for more drug storage information or to request a lockbox and security cable
If you suspect your Controlled Substances has been lost or stolen:
- Notify EHS immediately of the potential theft or loss
- 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 will also notify MIT Police of investigations
- Suspected thefts or significant losses must be reported to DEA within one business day. EHS will perform this notification; the license holder must then submit DEA Form 106 within 60 days of the reported loss and EHS can assist in completion and submission of this form
- DEA form 106 can be found at: http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html
- For substances that originated from DCM, please notify DCM and EHS
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 provided by an Established Lab Representatives who have previously received initial training by EHS, or this training can also be provided through the Biosafety Program
- 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
- The Lab Representative send copies of the training record to EHS
- Credit for Controlled Substances Use in Lab training will be assigned to the researcher in the Atlas Learning Center
- Established lab representatives can download the training slides here
- Please see the BSP training page for more information
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.
- 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 Michele Miele in the EHS Biosafety Office at (617) 253-8409 or via email at firstname.lastname@example.org to arrange for disposal of expired or unused controlled substances
Before a registration can be terminated, registration holders must dispose or transfer any controlled substances currently in their inventory in accordance with applicable regulations.
- Notify EHS of intent to close out the registration
- Send all remaining blank DEA form #222s (See link below for link to DEA form #222) and the registration certificate to DEA
- Return the state registration certificate to Massachusetts DPH
- Please contact EHS for the mailing address for both the DEA and DPH
- Transfer inventory to other registered user(s) or the MIT DEA Controlled Substances Manager (Michele Miele, (617) 253-8409, email@example.com) to arrange for disposal
- Arrange for record retention within the Department, Lab, or Center (DLC); please contact EHS to confirm records transfer - records should be kept on hand for 2 years
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 40 Listed 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 distributers (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 distributer (e.g. Sigma-Aldrich). Chemical distributers (e.g. Sigma-Aldrich) will call or email the PI before the order will be released. Here is an Example Sigma-Aldrich Authorized Purchaser Form.
Regarding 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.