Administration of non approved FDA drugs

Nurses General Nursing

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Is it legal for an RN to administer non FDA drugs to patients if ordered by an MD?

Specializes in L&D RN.

:yeah:finally somewhat of an answer today! i just spoke with our local executive officer of pharmacy and nursing who informed me that the nursing practice act does not state nurses are allowed or not allowed to administer a drug that has not yet been fda approved. she highly advised against giving this medication and stated, "why would any nurse want to risk their license to give a non fda approved drug"? she said ultimately, it is up to each individual nurse but with a very high risk. she than advised me to contact the fda directly 888-463-6332 for their position on this subject, which i will have to do tomorrow because they are closed for the day! mahalo for everyone's input, this opened my eyes to a lot!

Specializes in Psych/CD/Medical/Emp Hlth/Staff ED.

Although it probably doesn't apply to your LTC residents, Clobazam was granted "orphan drug" status by the FDA, which means it can be prescribed for specific conditions (no off label use allowed). The condition that clobazam is approved for is for a severe form of childhood epilepsy.

Fascinating that your state Board representative stated it is a decision of the individual nurse. Although new and naive about nursing at the time, I intuitively knew there was a blank good reason why the agency told me specifically to leave all mention of the unapproved activity off their charting. Thank you for providing the official stand. Now, decades later, I can make better decisions based upon the nurse practice act. Now, out of curiosity, to see if my state's practice act states the same.

Specializes in L&D RN.

Please post your state's response...curious to see if it is universal across the states~~

Specializes in L&D RN.

Latest info on Kauai. So after contacting the Narcotic Enforcement Division along with the FDA and the Executive Officer of Pharmacy and Nursing, my agency has come to the conclusion it is not safe for a nurse to administer a non approved FDA drug. All three agencies pretty much said the same thing, ultimately if something goes wrong witht he client due to the medication, the nurse would be liable. It is illegal to administer an illegal drug and according to them Cobazam is illegal in the US. Interesting stuff!

Thanks for everyone's input!

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