DEA Controlled Substances

Updated January 31, 2012

Controlled Substances are drugs or chemicals that have the potential to be addictive or habit forming. The 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 DEA. Use of Controlled Substances in Massachusetts requires registration with both the U.S. Drug Enforcement Administration and the Commonwealth of Massachusetts. 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 CAC protocol.  PI’s must become registered to order controlled substances directly from a distributer or vendor.

Basic Requirements for PIs ordering drugs through Division of Comparative Medicine:

Record Keeping Requirements:
The following records should be maintained at the registrant's location as identified on the registration:

Security:

  • Schedule II controlled substances must be stored in a “double lock” drug safe or a lockbox that is securely fastened with a security cord within a locked, substantially constructed cabinet. 
  • Schedules III, IV, and V are stored in a securely locked, substantially constructed drawer or cabinet.  
  • 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.
  • If there is a theft or loss of Controlled Substances, please notify DCM. A DEA form 106 must be submitted to the DEA and the State Administrator must be notified within 10 days of the discovery of the theft or loss. DEA form 106 can be found at: http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html
  • Controlled Substances should never be given to non-registrants without proper designation from the DEA.
  • Contact EHS for more drug storage information or to request a lockbox and security cable.

Disposal:

  • All unused controlled substances should be returned to DCM for proper disposal.

Basic Requirements for PIs that are registered:

Registration and Ordering

  • To use controlled substances in Schedules I-V, investigators must first submit an application to the Commonwealth of Massachusetts and then complete the DEA new registration form #225.
  • To use controlled substances in Schedule VI, investigators must submit an application to the Commonwealth of Massachusetts only.
  • DEA new registration form # 225 and DEA annual renewal form #225a are available on the DEA website: http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html
  • The Commonwealth of Massachusetts application can be found at: http://www.mass.gov/eohhs/docs/dph/quality/drugcontrol/app-researcher.pdf.
  • Ordering Schedule I or II controlled substances-the registrant must provide two copies of the DEA form #222 to the drug supplier and keep one for record. The supplier will keep one copy and send the other to the DEA as a record of distribution. Attach (staple) two copies of the completed and signed Form 222 to a completed and approved MIT requisition form on which the DEA Registration Number is clearly indicated, and submit to a Procurement Office.  Once the drug is received, the registrant must annotate the kept copy of the DEA form #222 with the amount and date received. DEA form #222 can be found at: http://www.deadiversion.usdoj.gov/faq/dea222.htm
  • Ordering Schedule III-V-Obtaining Schedule III-V Controlled Substances may be handled by invoicing normal records. The registration number still must be provided on requisition forms.

Record Keeping Requirements:
The following records should be maintained at the registrant's location as identified on the registration:

Security:

  • Schedule I controlled substances must be stored in a drug safe that weighs at least 750 lbs or if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and is equipped with an alarm system.  Schedule I substances may not be stored with schedule II-V substances.
  • Schedule II controlled substances must be stored in a “double lock” drug safe or a lockbox that is securely fastened with a security cord within a locked, substantially constructed cabinet. 
  • Schedules III, IV, and V are stored in a securely locked, substantially constructed drawer or cabinet.  
  • 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.
  • If there is a theft or loss of controlled substances, a DEA form 106 must be submitted to the DEA and the State Administrator must be notified within 10 days of the discovery of the theft or loss. DEA form 106 which can be found at: http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html
  • Controlled Substances should never be given to non-registrants without proper designation from the DEA.
  • Contact EHS for more drug storage information or to request a lockbox and security cable.

Disposal: Please contact the Environment Health and Safety Office at 617-45(617) 452-3477 for instructions on how to properly dispose of unused or unwanted controlled substances.

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Continuous Inventory Record.doc43.5 KB