Administration of non approved FDA drugs

[Kauai RN]

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

[Asystole RN]

Yes.

Even legal to administer drugs for off label uses.

[Kauai RN]

Do you know where this is documented anywhere?

[NYRN05]

yep it is. i believe sotalol is one if you've ever given that...its non FDA approved. given for arrythmia prevention-afib patients. don't know where it would be documented but its been done. thats the only 1 i can think of at the moment.

[flashpoint]

Ooops...I am easily confused!

[Asystole RN]

Do you know where this is documented anywhere?

Are you asking if it is Federal law? No.

You would have to check your local State Revised Statutes or BONs/Dept of Health and Human Services position statement to determine if it is regulated.

Never heard nor could imagine it would be illegal. Have you ever noticed many drug books have a label under Indications called "off label uses?"

[Not_A_Hat_Person, RN]

Yes. I work in an ALF, and quite a few residents get supplements and homeopathic "medications", none of which are FDA-approved. They're listed in the MAR with the other medications.

[nyteshade, BSN]

Yes, we can give them. Honestly, just because something is FDA approved doesn't mean it's the greatest thing next to sliced bread (Vioxx, Bextra, "The patch") all come to mind.

[HamsterRN, ADN, RN]

Maybe I'm misunderstanding the question, but I think we're all a little off base. Unless it is in clinical trials, every medication we give needs to have FDA approval, and yes sotalol is FDA approved. This is because every drug sold in the US must have FDA approval, when a drug looses FDA approval, it is "pulled off the market". Even vitamins require FDA approval to be dispensed or sold, even food coloring for that matter.

If you are giving a medication that is in clinical trials, then the patient must provide informed consent and cannot be charged for the medication.

Medications can be given for off label use but need to be FDA approved for some purpose.

[CNL2B]

Post #8 -- that is my understanding as well. All of our medications are FDA approved by law.

Medications that are in clinical trials (not FDA approved yet) can be given by an RN. I do not believe LPN licensure allows this.

I'm a little bit befuddled by the homeopathic meds, etc. I've had doctors order them to be given on request of the patient from their own supply. I'm not sure exactly how the law applies to this situation.

[HamsterRN, ADN, RN]

Yes, homeopathic medications require FDA approval and are regulated (under section 201) and must be registered. Many medications that are lumped into the "homeopathic medicine" category are actually considered food supplements, but even those require FDA approval. Even bottled water requires FDA approval.

[blondy2061h, MSN, RN]

We occasionally get drug protocols, even phase 1s. It's always weird to give a drug labeled something like CX313413, having no idea what it is. I once saw a patient have a remarkable recovery after receiving such a drug. I haven't seen anything like it any other time.