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24th Jan 2012, 05:17 PM
#1
IV IMP labelling requirements
Dear all
Does anyone know if IV IMPs are exempt from requiring 'use as directed' or similar directions if they are administered by nurses within the hospital? All our trial specific prescription proformas have the specific administration details that the nurses follow.
The labelling section of annex 13 guidance does state the information should be included on labels unless its absence can be justified - does inclusion of admin details on the prescription justify its absence?
Thanks
Vicky
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25th Jan 2012, 09:45 AM
#2
I would venture to say that the requirements of Annex 13 are still required to be met. I don't consider separate instructions on doing provided to nurses as adequate. The main exemption being health care provider and hospital based is only that re-packaging does not require QP release.
HTH
Graham
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27th Jan 2012, 09:22 AM
#3
HI Vicky
If it is an IMP then Annex 13 should still be met - if there was a justification for absence then this needs to be detailed in the CTA application.
Susie
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