Administration of non approved FDA drugs

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

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.

Can you cite Federal law stating what you just claimed?

A drug cannot be labeled to cure or treat a disease that it has not been proven to cure or treat by the FDA. Does not have to have been proven to be on the market. Look at the silly HCG drug around, still on th shelves although it has been proven time and time again not to work plus has a warning label saying that it does not work.

Just because something is not FDA approved does not mean it cannot be administered nor does it mean it cannot be sold or remain on the shelves.

I think you are misunderstanding Federal law and the intent of the FDA.

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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.

Are all your medications FDA approved to be given for the reasons why your giving them? I know only 80% of all the drugs I have given in LTC were.

Being a RN vs LPN makes no difference unless your Nurse Practice Act is very very unique. What State are you in? I have many different States NPAs and SoPs, never come across administration of FDA approved vs non.

Besides, rules are different in LTC vs Acute Care. They are not patients, they are residents and we are obligated, usually by State law or HHS guidelines, to create an environment as close to home as possible. If grandma Phyllis wants to take Ju Ju Root to cure her Arthritis because that is what she has done for the past 40 years, then that is her right and our obligation to assist her.

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Specializes in Psych/CD/Medical/Emp Hlth/Staff ED.
Can you cite Federal law stating what you just claimed?

.

The FD&C act of 1938 as well as it's subsequent ammendments define the requirements that drugs must meet to be sold or dispensed in the US. It also defines the requirements for homeopathics, cosmetics, food supplements, etc., all of which are also regulated by the FDA.

A drug is defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g).

Homeopathics don't have to show efficacy, since if they were to make a claim of efficacy then it would be considered a drug, which would then require proof of efficacy. Even without having to prove efficacy they still have to meet safety requirements and must be listed in the Homeopathic Pharmacopoeia and are regulated by the FDA. (FD&C act section 201 and 501).

Even the soap you use to wash your hands in the hospital must be FDA approved (under the FDA's Federal Insecticide, Rodentciacide, and Fungicide Regulatory Act).

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Specializes in Psych/CD/Medical/Emp Hlth/Staff ED.
Look at the silly HCG drug around, still on th shelves although it has been proven time and time again not to work plus has a warning label saying that it does not work.

Ever wonder why it has a disclaimer saying it doesn't work? It's because the FDA has placed this requirement on them, without that disclaimer they would not carry FDA approval and therefore could not be sold.

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Specializes in L&D RN.

Sooo, this is my GREAT delima.... I am a nursing supervisor for a home health agency and have a client with a M.D. order for a drug that is not FDA approved yet, they are getting it from Canada. Is it legal for an RN to administer this drug? I am not able to find any documentation on the rules and regulations for administering non FDA approved drugs in the U.S.A. But yet I do understand that as an RN administering any medication, you are required to be able to determine if the patient is experiencing any adverse side effects and must know in detail the full spectrum of any and all adverse effects any drug may have to protect each individual patient. How is this possible if it is not FDA approved?

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Ever wonder why it has a disclaimer saying it doesn't work? It's because the FDA has placed this requirement on them, without that disclaimer they would not carry FDA approval and therefore could not be sold.

EXACTLY! The drug can still be sold, still be dispensed even though it DOES NOT have FDA approval.

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The FD&C act of 1938 as well as it's subsequent ammendments define the requirements that drugs must meet to be sold or dispensed in the US. It also defines the requirements for homeopathics, cosmetics, food supplements, etc., all of which are also regulated by the FDA.

A drug is defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g).

Homeopathics don't have to show efficacy, since if they were to make a claim of efficacy then it would be considered a drug, which would then require proof of efficacy. Even without having to prove efficacy they still have to meet safety requirements and must be listed in the Homeopathic Pharmacopoeia and are regulated by the FDA. (FD&C act section 201 and 501).

Even the soap you use to wash your hands in the hospital must be FDA approved (under the FDA's Federal Insecticide, Rodentciacide, and Fungicide Regulatory Act).

I just read through the FD&C Act, Chapter 5; Subchapter A, Sec 502, 503 and Subchapter E, Sec 561

I have not found anywhere it specifically states it is illegal for a licensed person under the supervision of the physician to dispencse homeopathic or off label use medications.

Can you please cite the Chapter, Subchapter, Section and paragraph where you think it does bar off label medications?

The FD&C Act DOES require all medications to be labeled and does require the medications to be safe, doesn't say you can't give it.

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Sooo, this is my GREAT delima.... I am a nursing supervisor for a home health agency and have a client with a M.D. order for a drug that is not FDA approved yet, they are getting it from Canada. Is it legal for an RN to administer this drug? I am not able to find any documentation on the rules and regulations for administering non FDA approved drugs in the U.S.A. But yet I do understand that as an RN administering any medication, you are required to be able to determine if the patient is experiencing any adverse side effects and must know in detail the full spectrum of any and all adverse effects any drug may have to protect each individual patient. How is this possible if it is not FDA approved?

There is a difference between not being FDA approved for the treatment it is being prescribed for and being actually banned from being sold in the United States.

You would have to look upthat specific drug and find out what the FDA's position on it is.

Is insurance providing the drug or is the family purchasing it themselves? Remember that rules are different for patients not in acute care, patients have the right to self determination and we are obligated to assist them.

If the insurance company is paying for it or at least the MD is ordering it I see no legal objection to administering it. In fact there are several provisions in the FD&C that specifically state that a physician may order certain drugs if they feel it to be necessary.

I found those provisions mostly under the clinical trial/experimental sections.

If you actually look at the drugs we give and what we are actually giving them for you will see only certain amount of the drugs we give are FDA proven for the problems they are being given for.

The basics of the FDA law basically states a few things, (Is the drug safe? ie is there Hg in a bottle sold as aspirin, you can't sell a drug that is benig marketed to cure a disease when it has not been proven to do so, and the drug must be labeled with its contents and what they are being used for.)

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Specializes in Psych/CD/Medical/Emp Hlth/Staff ED.
EXACTLY! The drug can still be sold, still be dispensed even though it DOES NOT have FDA approval.

As I pointed out earlier, the FDA defines a drug as something that makes a claim of efficacy, the example here not only doesn't claim any efficacy, but as you point out it specifically denies any efficacy, meaning it is not a drug.

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

Can you please cite the Chapter, Subchapter, Section and paragraph where you think it does bar off label medications?

The FD&C Act DOES require all medications to be labeled and does require the medications to be safe, doesn't say you can't give it.

There is a difference between giving an FDA approved medication "off label" and giving a medication that is not FDA approved at all. Giving a medication for off label use means you are giving a medication for one indication that was approved for another indication. As I stated earlier, there is nothing wrong with off label use (legally at least). The original question was whether or not we can give "drugs" that carry no FDA approval whatsoever.

There are many different categories of FDA regulation; drugs, homeopathics, food coloring, etc all regulated by the FDA, although the requirements vary depending on what category the substance falls into.

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As I pointed out earlier, the FDA defines a drug as something that makes a claim of efficacy, the example here not only doesn't claim any efficacy, but as you point out it specifically denies any efficacy, meaning it is not a drug.

How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm

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There is a difference between giving an FDA approved medication "off label" and giving a medication that is not FDA approved at all. Giving a medication for off label use means you are giving a medication for one indication that was approved for another indication. As I stated earlier, there is nothing wrong with off label use (legally at least). The original question was whether or not we can give "drugs" that carry no FDA approval whatsoever.

There are many different categories of FDA regulation; drugs, homeopathics, food coloring, etc all regulated by the FDA, although the requirements vary depending on what category the substance falls into.

Not necessarily true.

If a drug has been deemed "unsafe" and totally taken off the market then I would agree.

If the drug has not gone through trials or is in trials currently then under the supervision of a physician it can be administered.

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