GUIDANCE FOR THE USE OF CONTROLLED SUBSTANCES
ORDERING CONTROLLED SUBSTANCES
All orders for controlled substances must be placed by the Registrant or an Authorized User. Schedule I and Schedule II controlled substances must be ordered and received by the Registrant. Schedule III-V controlled substances can be ordered and received by the Registrant or an Authorized User. A listing of Schedule I-V Controlled Substances can be found in the DEA Orange Book.
Registered Investigators are required to establish accounts with the appropriate vendors of Controlled Substances. Once an account has been set up, Registered Investigators must complete their Purchase Requisition through Mass General Brigham eBuy in Peoplesoft.
Sample DEA Schedules
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin and marijuana (cannabis)
Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are cocaine, oxycodone, hydromorphone, fentanyl, and Fatal Plus.
Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are ketamine, buprenorphine, testosterone, Telazol and Euthsol.
Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are lorazepam, diazepam and tramadol
Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are cough preparations containing codeine, Lomotil and pregabalin.
In the State of Massachusetts all prescription drugs not included in the first five Schedules are considered schedule VI-controlled substances. Examples of schedule VI-controlled substance are isoflurane, xylazine, carprofen and antibiotics.
STORAGE OF CONTROLLED SUBSTANCES
All Schedule I-V Controlled Substances must be stored in a secure, permanently affixed, substantially constructed double-locked drug cabinet or safe. Schedule I & II substances can be stored in the same safe or locked cabinet as Schedule III-V substances as long as access to that cabinet is restricted to individuals who are authorized to access the highest Schedule of drug maintained.
Schedule VI Controlled Substances must be stored in a limited access area out of the public eye, but not in the Controlled Substance cabinet.
Access to drug cabinets and safes must be restricted to only Registered Investigators and Authorized Users who are listed on the registration applications submitted to DPH and DEA. Authorized User logs should be reviewed and updated regularly. Keys and combinations to drug cabinets or safes should be secured in a locked cabinet or drawer in an office. Only the Registrant and Authorized Users should have access. Keys should never be left unattended in an unsecure location.
All Schedule I-V Controlled Substances should be maintained in the locked storage location except for the actual time required for Authorized Users to remove, legitimately work with, and replace the Controlled Substances. No Controlled Substance should be left unattended at any time.
DISPOSAL OF CONTROLLED SUBSTANCES
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. Please visit your individual hospital’s SOP for disposal guidance.
THEFT OR LOSS OF CONTROLLED SUBSTANCES
Any loss of a Controlled Substance, including theft, suspected theft, unauthorized use, or other loss must be reported immediately in iLog or directly to Research Compliance at your hospital.
If you are unsure as to whether a loss has occurred, contact Research Compliance for consultation. Research Compliance will collaborate with others as needed to determine if the concern is a reportable event and ensure external reporting requirements are met.
- USDEA requires reporting within (1) business day of discovery by completing the DEA Form 106
- We must immediately report the incident by telephone to the MA Drug Control Program (DCP) at (617) 973-0800 and then must follow up with a written report within 7 days of discovery.
In addition, any unauthorized persons who gain access to Controlled Substances for the purpose of diversion or theft must be reported to hospital security and the local Police Department and may be subject to disciplinary action.