01-20-2015 08:52 PM
Is it required for our employees who compound hazardous products to sign type of "waiver" to acknowledge the risks of handling such items? Or is have documented required education on the topic sufficient?
01-20-2015 09:31 PM
The chapter says: "Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs." Education and training are also requirements of USP 797 and the proposed USP 800 chapter. I have attached a sample form that was developed by Clinical IQ for your consideration. Hope this information helps.
09-29-2017 10:59 AM
USP 800 does not define the legality of a wet vs. electronic signature. Based on my experience, electronic signatures are legally binding, assuming that there are adequate controls on the signature integrity.