OR011 Safety of multi-dose immunotherapy vials after routine use

Recent proposed changes to US Pharmaceutical General Chapter <797> (USP <797>) have prompted discussion regarding the safety of multi-dose immunotherapy extract vials after routine use. We present evidence to support the argument that currently accepted aseptic protocols for handling and administration of multi-dose immunotherapy extract maintenance vials during routine patient care does not result in risk of microbial growth and that changes as suggested by the proposed USP <797> guidelines are not needed.

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