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Controlled Substance Information

 

Controlled Substance Guidelines


Guidelines for the Ordering and Use of Prescription Drugs and Devices and Controlled Substances for Non-Clinical Laboratory Research

Storage, Control and Accountability of Prescription Drugs and Devices and Controlled Substances:

  1. Prescription drugs and devices and controlled substances shall be stored within a limited access room (i.e., access limited primarily to the responsible principal investigator and his/her research and administrative staff; room locked during non-occupancy).
  • Schedule II-V controlled substances must be stored in a securely locked, substantially constructed cabinet located within the limited access room.
  • Schedule I controlled substances and carfentanil, etorphine hydrochloride and/or diprenorphine must be stored in a safe or steel cabinet (i.e., equivalent to a U.S. Government Class V security container) secured within the limited access room.
  • Access to the key or combination for the controlled substances cabinet and/or safe shall be limited to the principal investigator and the Authorized Agent(s) of the Principal Investigator.

 

  1. Control and accountability of prescription drugs and devices; other than controlled substances:
  • The principal investigator shall be ultimately responsible for the control and accountability of prescription drugs and devices stored and used within his/her research laboratory (laboratories); to include ensuring that these drugs and devices are used only for authorized laboratory research purposes.
  • The dispensing of prescription drugs or devices for use in laboratory research shall be under the direct control of the principal investigator or, in his/her absence, an Authorized Agent of the Principal Investigator
  • Suspected diversion of prescription drugs or devices for other than authorized laboratory research use shall be promptly reported to the University Police Department (412-624-4040).
  • Prescription drugs or devices that are expired, damaged, or no longer used shall be promptly removed from active laboratory research use and/or inventory and either returned to the supplier or disposed of in a proper manner.
  1. Control and accountability of controlled substances:
  • The principal investigator shall require that each member of his/her research or administrative staff who will have access to controlled substances or confidential controlled substance information (e.g., the principal investigator’s DEA registration number) must complete a DEA Screening Certification administered by University’s Office of Human Resources.
  • The original of the completed DEA Screening Certifications shall be maintained with the respective employees’ records by the University’s Office of Human Resources.  The University Office of Human Resources shall provide copies of the completed DEA Screening Certifications for Authorized Laboratory Personnel to the responsible principal investigator, who shall maintain these Certifications in such a manner that they are readily available for audit purposes.
  • The ability of any individual who responds affirmatively to a DEA screening question to have access to controlled substances or confidential controlled substance information shall be subject to approval of a Waiver Request1 by the DEA and any other requirements of the University.  In addition, an affirmative response to a DEA screening question may affect an employee’s job duties or job status.
  • The principal investigator shall be ultimately responsible for the control and accountability of controlled substances stored and used within his/her research laboratory (laboratories); to include ensuring that these substances are used only for authorized laboratory research purposes.
  • The dispensing of controlled substances for use in laboratory research of the principal investigator shall be under the direct control of the principal investigator or, in his/her absence, an Authorized Agent of the Principal Investigator.
  • Controlled substances for use in laboratory research of the principal investigator may only be dispensed to Authorized Laboratory Personnel.
  • The quantity of the controlled substance dispensed to Authorized Laboratory Personnel shall be limited to that which is estimated to be required to complete the experimental procedures scheduled for that day.
  • The principal investigator shall maintain detailed, accurate and up-to-date accountability records of the receipt, dispensing and corresponding laboratory research use of controlled substances.  At a minimum, the accountability record for a controlled substance shall be updated on each day that the substance is dispensed for laboratory research use.
  • The principal investigator shall ensure, on a routine basis (i.e., a minimum of quarterly or more frequently based on inventory and use levels), that the inventory of controlled substances reflected on the accountability records corresponds with the actual inventory on hand, and shall promptly investigate and reconcile any significant discrepancies.
  • The principal investigator shall notify, in writing, the local DEA field office within one business day of any report or discovery of theft or significant loss of controlled substances and shall complete, and submit to the local DEA field office, a DEA Form 1062 regarding such theft or loss.  The principal investigator shall also promptly notify the University Police Department (412-624-4040) of the report or discovery of theft or significant loss of controlled substances and shall provide this Office with a copy of all respective DEA reports.
  • When determining whether a loss is significant, the principal investigator shall consider, among others, the following factors:

-     the actual quantity of the controlled substance(s) lost in relation to the laboratory activities;

-     the specific controlled substances lost;

-     whether the loss of the controlled substance(s) can be associated with access to the substance(s) by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substance(s);

-     a pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses;

-     whether the specific controlled substance(s) that was (were) lost is a (are) likely candidates for diversion; and, if known,

-     local trends and other indicators of the diversion potential of the missing controlled substance(s).

  • Containers of controlled substances that are expired, damaged, or no longer used shall be promptly removed from active laboratory research use and/or inventory. If unused controlled substances remain in a container, it must be disposed of via DEA-Registered Reverse Distributor.
  • The University Environmental Health and Safety Department (412-624-9505) maintains contracts with DEA-registered Reverse Distributors and the principal investigator should contact this office for instructions, if applicable.
  • Transfer (e.g., to Reverse Distributor) or other authorized disposition of the controlled substance shall be promptly (i.e., same day) documented on the corresponding accountability record.

1http://www.deadiversion.usdoj.gov/faq/waiver_1301_76.htm

2 http://www.deadiversion.usdoj.gov/21cfr_reports/theft/