Approved by Animal Institute Committee: 2/21/2001
The policy shall cover all drugs classified as controlled substances by the Federal Government and the State of New York, including drugs in classes I - V. Class I controlled substances, such as “ecstasy” have no medicinal value but may be used in studies in experimental animals, while drugs in classes II - V are used in animals as anesthetics and analgesics.
The Principal Investigator (PI), as named on the Animal Use Protocol Form, will be responsible for controlled substances used in animals listed under his/her protocols. The PI is responsible for oversight of purchasing, storage, use and disposal of controlled substances for his/her laboratory. The PI is responsible for training new employees, although he/she may gain assistance and advice from members of the Animal Institute Committee (AIC) or the Institute for Animal Studies (IAS). A segment of the Orientation to Animal Use small-group lecture will discuss the purchase, use, storage and disposal of controlled substances.
Each PI must obtain and maintain appropriate registration to purchase and use controlled substances. Each PI with a M.D. degree or with an M.D. degree plus a Ph.D. must be registered with the Federal D.E.A. Each PI with a Ph.D. degree or a D.V.M./V.M.D. degree without a M.D. degree must be registered with the Federal D.E.A and the N.Y. State DOH. Information for obtaining a DEA and/or the NYSDOH registration will be provided by the IAS. Forms and information are available at www.deadiversion.usdoj.gov. (form DEA-22) and www.health.state.ny.us/nysdoh/newlaw.htm.
Controlled substances being purchased using University funding (University funds, grant funds, Montefiore intecharge, etc.) must be purchased through Yeshiva University Purchasing Department. After an order for controlled substances has been placed with Purchasing, the order must be approved by a representative of the AIC or IAS (Ms. Eileen Fillweber or Dr. Lawrence Herbst) prior to placement of the order. To speed this process, it will be done electronically whenever possible. Purchasing will obtain and provide the approved Animal Use Protocol Number at the time the order is placed, and will convey it to the IAS to allow the IAS to confirm that the use of this drug is part of an approved protocol. Purchasing will track all purchases of controlled substances for use in animals and will provide a monthly report to Dr. Herbst, who will then confirm that all purchases were in accordance with approved protocols. He will also identify laboratories ordering controlled substances which may not have appropriate storage locations and will contact the PI to confirm that an appropriate storage location is being used.
Regulations require that controlled substances must be stored under double locks at all times except when drugs are being withdrawn from containers. The preferred location for storage is a double-lock drug box or a locked safe in a locked room. Locations for storage of controlled substances will be inspected twice yearly by members of the AIC as they inspect laboratories utilizing animals
Each PI is responsible for maintaining appropriate records of acquisition, use and disposal of controlled substances, as required by Federal and New York laws and regulations. These records will be inspected twice yearly by members of the AIC as they inspect laboratories utilizing animals.
Sharing and Borrowing
Sharing and borrowing of controlled substances between staff or between laboratories is prohibited because sharing compromises the process of selecting eligible investigators and compromises the process by which drugs are distributed. An exception will be laboratories involved in the same animal protocol as collaborators, where animal drugs may be appropriately shared.
Purchase from the IAS
As of January 20, 2003, purchasing controlled substances from the IAS is no longer allowed at Albert Einstein College of Medicine as per Drug Enforcement Agency Rules and Regulations.
Disposal of Controlled Substances
Expired or unneeded controlled substances must be discarded or returned as dictated by federal and state laws and regulations.
Reporting of Mishaps
The PI will promptly report any mishaps with controlled substances to the Director of Security of the Resnick Campus, to the Chairman of the AIC and to Risk Management (Yeshiva University, Mr. Paul Goldschmidt). Reportable mishaps will include, but are not limited to: losses, discrepancies in written records, disappearances of written records, or suspected dilution.
Review of This Policy
This policy, once enacted, will be reviewed twice yearly by the AIC as part of semi-annual program and facility evaluations.