A Review: Research Using Controlled Substances  by Christopher Pettinato

The acquisition, use and disposal of controlled substances are highly regulated by both the New York State Department of Health (NYS DOH) and the United States Drug Enforcement Agency (US DEA) to prevent their diversion.  Among other things, the regulations detail requirements for licensure and registration; detailed recordkeeping; and secure storage of controlled substances.  Columbia’s “Policy for Acquisition, Use and Disposal of Controlled Substances in Research” addresses these requirements for in vivo and in vitro research. The Policy, FAQs and other resources are available at http://www.ehs.columbia.edu/ControlledSubstances.html This policy does not apply to human subject research.

To purchase, synthesize or use controlled substances for non-human research, an individual must obtain a license from the NYS DOH and subsequently must register with the US DEA.  Typically, the principal investigator (PI) of a laboratory using controlled substances for research obtains the license and registration, and may also authorize others within the laboratory to use controlled substances for research. The PI however, retains overall responsibility for meeting all regulatory requirements.   
To acquire a controlled substance, a requisition must be processed through the Purchasing Department using commodity code 5845 and be accompanied by a copy of a valid DEA registration certificate (which is furnished to the vendor).  Purchases cannot be made by EZ-PO, P-Card, Credit Card or any other method unless approved by Purchasing.
Licensed individuals must maintain complete and accurate records, including initial receipt, use, inventory and disposal logs, which must be retained for at least five years and are subject to inspection by NYS DOH and US DEA.  Record-keeping requirements while significant, are essential in preventing diversion and documenting compliance.  Suspected loss or theft of controlled substances must be reported immediately to Public Safety, and to the NYS DOH and to the US DEA upon discovery.
To help prevent loss or theft, controlled substances must be securely stored in accordance with the regulations.  In many cases, a narcotics locker is sufficient to meet security requirements.  However, researchers who store larger amounts may need a higher level of security.  Columbia University has established a preferred pricing agreement with a local vendor that is available to all researchers.
To assist researchers in understanding and complying with the Policy, the University’s Controlled Substances Working Group has created a webpage that includes a number of resources, including the Policy, record-keeping templates, and information on selecting a narcotic locker, http://www.ehs.columbia.edu/ControlledSubstances.html
In addition, a Rascal-based training program is available for individuals engaged in research with controlled substances.  Training includes step-by-step instruction for initiating applications, procuring, recordkeeping, reporting loss or theft, and disposal. Refresher training will be required triennially when renewing a DEA registration.

Smoke Detectors

Did you change your batteries and test your smoke detector?  Local FDNY Engine 67 was present on the CUMC campus on October 30 distributing 9 volt batteries and reminding people to change the batteries in their smoke detector when they turned back their clocks. REMEMBER, SMOKE DETECTORS SAVE LIVES!

FDNY fdny

Emergency Contact Number

Recently, Columbia Public Safety placed an emergency call after normal working hours to EH&S because the temperature alarm on a walk-in cold room was sounding. There was no name or contact number on the door of the cold room, so that Public Safety was not able to obtain information that would allow for an appropriate response.  Fortunately, after an extensive search of University research documentation, EH&S was able to provide Public Safety with a contact number (from a research protocol).  Public Safety was then able to contact the responsible party and the situation was addressed without research losses.

Equipment failures and accidents can occur any time of day or night. Information about hazardous materials and equipment in the laboratory is critical for enabling first responders to safely take appropriate actions.  All doors to labs and  environmental and equipment rooms must have an after-hours name and emergency contact number for the person(s) to be called in the event of a spill, equipment alarm or other incident.

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