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Controlled Substances - applicable for Subawardees

  • 1.  Controlled Substances - applicable for Subawardees

    Posted Tue September 23, 2014 08:54
    Dear all,

    I hope you are all doing fine.
    At the moment we are going through the NIH- Grants Policy statement and one question came up regarding "Controlled Substances" - see below.

    Does the obligation to register etc.. also apply to subawards outside the US?

    I would be thankful for your valuable input.
    Best regards from Switzerland,
    Agatha

    4.1.5 Controlled Substances

    If controlled substances are proposed to be administered as part of a research protocol or if research is to be conducted on the drugs themselves, applicants/grantees must ensure that the DEA requirements, including registration, inspection, and certification, as applicable, are met. Regional DEA offices can supply forms and information concerning the type of registration required for a particular substance for research use. The main registration office in Washington, DC may be reached at 800-882-9539. Information also is available from the National Institute on Drug Abuse at 301-443-6300.


    -------------------------------------------
    Agatha Keller
    Co-Director EU GrantsAccess
    ETH Zurich | University of Zurich
    Zurich
    414-463-45350
    -------------------------------------------


  • 2.  RE: Controlled Substances - applicable for Subawardees

    Posted Wed September 24, 2014 13:28
    This is not an NIH regulation. Rather, it's a reminder to grantees that inclusion of a controlled substance protocol within a grant application does not satisfy the U.S. government requirement to register the allowed possession/use of controlled substances with DEA.
     
    I believe DEA's authority to control possession only applies within the U.S. Therefore, I would assume that there would be no need to register possession with DEA if that possession occurred solely outside the U.S. Of course, you would still need to be compliant with your own country's regulations on controlled substances.
     
    Note that this is purely conjecture on my part and I would recommend that Agatha contact the DEA's Office of Diversion Control with this question.
     
    David
     
     
    David J. Mayo
    Director of Sponsored Research
    Mail Code 201-15
    California Institute of Technology
    1200 E. California Blvd.
    Pasadena, CA 91125 USA
    +1-626-395-6219 (voice)
    +1-626-795-4571 (fax)




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