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The rockefeller university

Controlled, Restricted and Permit Only Materials

I. Alcohol (100%[absolute] or 95% ethanol)-Updated 12/23/2013 – Alcohol obtained from the University Storeroom may be used for laboratory research and research support purposes only, in line with regulations governing the permit issued to the University by the New York State Liquor Authority. Alcohol will be dispensed only in approved containers to approved users and only after receipt of appropriate requisition forms. End users must maintain records of alcohol use, using the “Record of distribution” form, available from the Storeroom (catalog number 526000). More detailed guidelines are provided below:

  • Heads of Laboratory must identify and request approval for members of the Laboratory to sign for and pick up alcohol from the Storeroom, using the Authorization to Retrieve Alcohol & Controlled Substances Form (http://formspolicies.rockefeller.edu/getfile.php?type=Form&file=MM_controlled_pdf).
  • To obtain alcohol, complete an Oracle iProcurement requisition and complete a corresponding hardcopy of the appropriate alcohol request form. The hardcopy alcohol request form and the “Record of Distribution Form,” both signed by the Head of Laboratory, must be presented by a person approved as above, at the Storeroom in order to pick up the alcohol.
  • For 100 % (Absolute) ethanol (catalog numbers 137000 or 138000): Complete the red alcohol request form. These forms are available from the Storeroom (catalog number 525000).
  • For 95% ethanol (catalog number 139000): Complete the black alcohol request form. These forms are available from the Storeroom (catalog number 527000).
  • Alcohol may be dispensed only to approved safety cans. The maximum approved safety can volume is 5 gallons. For information about safety cans, contact LS&EH or Purchasing. Pint volume containers of 100% ethanol (catalog number 137000) are also available from the Storeroom.
  • Ethanol may not be transferred to or shared between Laboratories. Ethanol cannot be removed from University premises for any purpose.
  • Record of Distribution forms (Catalog number52600) must be maintained in the Laboratory. As noted above, to obtain more alcohol from the Storeroom, a copy of this form, signed by the Head of Laboratory, must be presented to Storeroom staff at the time of pick up.
  • Storeroom personnel are prohibited from distributing ethanol except in accordance with the guidelines outlined above.
  • Any misuse of alcohol and/or theft of alcohol must be reported immediately to the Director of Materials Management & Chief Procurement Officer and/or the Assistant Director of eProcurement and Inventory Control.

II. Controlled Substances- Updated 12/23/2013: Materials Management SOP for the procurement, receipt and dispensing of controlled substances for University Research Purposes

  • The controlled substances carried by the University Stockroom (Nembutal and Ketamine) are requisitioned by the end user through Oracle iProcurement and are processed as a Stockroom Sales Order (SO).   All other controlled substances are processed as a Purchase Order (PO).
  • The University maintains this inventoried supply of Nembutal and Ketamine within a double locked and alarmed safe for use in approved Institutional Animal Care and Use Committee (IACUC) animal (in vivo) animal protocols and/or in vitro (non-animal) research purposes.
  • All other in vivo studies requiring the use of any other controlled substance not carried by the University Stockroom  also requires an approved IACUC Protocol and is to be requisitioned through iProcurement (Non-Catalog Request) and processed as a University (PO).
  • Any controlled substance requisition is subject to review by the Department or Laboratory hierarchy within the Oracle iProcurement Module and subject to further review by the Director and CPO of Materials Management prior to order placement.
  • If the controlled substances are being used for in vitro purposes, the Head of Department/Laboratory (HOD/HOL) must submit a memorandum detailing the requirement and intended use of the controlled substance for in vitro use to the Director and CPO of Materials Management for review.
  • The use of controlled substances for University research purposes is controlled by the University in accordance with the requirements of the University certificates issued by the U.S. Drug Enforcement Agency and University licenses issued by the New York State Department of Health and these agencies’ regulations. More information on the requirements for use and storage of controlled substances is provided in the University’s Controlled Substances Policy.
  • Controlled substances may be requisitioned, received and used only by users approved by their Head of Laboratory and by the Director and CPO of Materials Management. This approval must be provided in writing (http://formspolicies.rockefeller.edu/getfile.php?type=Form&file=MM_controlled_pdf) by the Head of Laboratory to the Director and CPO of Materials Management.  The end user must submit a fully executed and approved memorandum of intended use for in vivo experiments as required by CBC (http://formspolicies.rockefeller.edu/getfile.php?type=Form&file=MM_invivocontrolled_sub_pdf).
  • Once the requisition for the controlled substance(s) has been reviewed and approved by the Director and CPO of Materials Management, a PO is assigned and depending upon the schedule of the controlled substance (i.e. in addition to a copy of the applicable DEA License, Controlled Substance–I require a DEA 222 Form), the applicable required documentation is provided with the PO to the vendor for order processing.  The vendor receives the vendor copy and DEA copy of the DEA 222 form and the Director and CPO of Materials Management retains the Purchasing Copy and notes the date and amount of the controlled substance received on the Purchasing Copy of the DEA 222 form in addition to receiving data from the scanned inbound University Receiving Module which references the physical receipt date by the Director and CPO of Materials Management.  The controlled substances are shipped by the vendor to the address on the license (The Rockefeller University-1230 York Avenue-New York,NY 10065).  These materials are immediately sent to the office of the Director and CPO of Materials Management by the Mailroom or Receiving Departments.
  • In the case of Stockroom requisitions for Nembutal and Ketamine, these requisitions will become a SO through the Oracle Order Management Module, and the end-users must request an appointment with the Director and CPO of Materials Management for receipt of these items. These controlled substances are not warehoused within the Stockroom or distributed by the Stockroom Staff.
  • All Controlled Substances will be released to the approved end user directly by the Director and CPO of Materials Management. The end user will be contacted by the Director and CPO of Materials Management upon receipt of the controlled substance to report to FRS 516 with the green Controlled Substance Special Requisition and Record of Distribution (along with any empty or partially used controlled substances) if applicable.
  • Upon receipt of a controlled substance, the Director and CPO of Materials Management will notify the end user to report to FRS 516 immediately, so that these controlled substances can be released to the end user (if the end user is unable to report, then the substance will be held on the applicable shelf within the double locked alarmed safe within FRS 516; the end user has 2 business days to report, otherwise, the order is returned to the vendor).
  • The Director and CPO of Materials Management will open and inspect the seal of the controlled substance in the presence of the end user, and will match the description and quantity of the physical item and the corresponding PO and vendor packing slip. Upon approval of inspection, the end user will sign the Purchase Order, the Controlled Substance Special Requisition Form, and the packing slip from the vendor. Empty or partial vials must be returned to the Director and CPO of Materials Management.  The empty vials will be transferred to Laboratory Safety & Environmental Health (LS&EH) for disposal in accordance with NYS-DOH and/or DEA guidelines.
  • As part of the annual Stockroom Inventory and Audit, the stocks of the Stockroom-based Nembutal and Ketamine will be inventoried and audited.  In addition, a biennial inventory of all controlled substances will be conducted by the Director and CPO of Materials Management.  The results of this inventory will be stored in the physical file along with all PO and SO-related controlled substance documentation in FRS 516.  This inventory also will be stored on the Purchasing shared drive in electronic format. Controlled substance-based SO andPO’s are subject to monthly review of receipt date and stock inventories are also conducted on a monthly basis.
  • Instruction to the authorized end user in receiving Controlled Substances for Research Purposes from the Director and CPO of Materials Management:
    • Fill out the Controlled Substance Special Requisition form and the Record of Distribution form-if complete or controlled substances for discard (these are green-colored forms, see Controlled Substances Policy on information for ordering).
    • Completed SO for controlled substance may be obtained from the Office of the Director and CPO of Materials Management, located in Room 516 of Founder’s Hall.
    • Before picking up a newly arrived order of controlled substances, complete the Controlled Substance Authorization and Record of Distribution forms. Both forms must be signed by the Head of Laboratory.
    • Bring the completed and signed forms to the office of the Director and CPO of Materials Management. Please note that only the Director and CPO of Materials Management will release the controlled substances by appointment, only.
    • The bottles are numbered (SO items receive three digit #, external vendor items are numbered based on lot#) and recorded in the Controlled Substances Record Ledger (located in FRS 516). The end user must sign the applicable green Controlled Substances form and the SO or PO and packing slip(s) in the presence of the Director and CPO of Materials Management. The Director and CPO of Materials Management will sign the SO as Issuer of the controlled substance from the Stockroom.

 

Select Agents – (Updated 12/23/13) Select agents may only be acquired with the express approval of the CDC Select Agent Program and Laboratory Safety & Environmental Health. The University is currently NOT approved for possession and/or use of select agents. If you plan to conduct work with select agents, please contact the office of Laboratory Safety & Environmental Health (tel. #: 212-327-8324).