Is it legal for hospitals to use a drug that is not FDA approved?

Answer 1

While there are several preliminary levels of approval, including research and compassionate use, but the basic answer is no, it's illegal.

HOWEVER, more importantly, once a drug is released for any reason, a licensed practitioner is allowed to use off label, at his/hers -- and the recipient's-- risk.

Answer 2

Only if approved for investigational use - then you'd have to sign an informed consent.

The question is how a non-approved drug was available at all. It's illegal to distribute medications in the US that have not been approved by the FDA. Under the FD&C Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes importation--bringing drugs from a foreign country into the United States.

However, once a drug is approved for use by the FDA, doctors can prescribe it as they deem appropriate. In the United States, FDA regulations permit physicians to prescribe approved medications for other than their intended indications. Marketing information for the drug will list one or more indications, i.e., illnesses or medical conditions for which the drug has been shown to be both safe and effective. Pharmaceutical companies are not allowed to promote a drug for any other purpose without formal FDA approval.

However, once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective; they are not limited to its official, FDA-approved indications. This off-label prescribing is most commonly done with older, generic medications that have found new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, there is usually extensive medical literature to support the off-label use.

Hope this helps.

Rick the Pharmacist

Answer 3

Even if you do find a website that will sell you the real thing, it's going to be a hell of a lot more expensive than going to a doctor. If he can't afford a trip to the doctor, he can't afford to buy meds online. It costs an arm and a leg, and if he get sbad stuff or it's a placebo, who does he go to to get his money back? It's illegal. The only legal way to do it are the sites that require you to send in your medical records, have a phone consult with a doctor, and have someone come to your house to do a physical exam. All that runs you around 250 or more dollars. Then IF the doc decides you need the meds, it's another 100-200 plus shipping for the medication. Sometimes you find websites where can get Ultram without a prescription, but again, it's around 100-200 dollars plus shipping. Seeing a doc, even without insurance would be cheaper. There are programs and free clinics for people without insurance, he should look into that and get to a pain clinic.

Answer 4

Yes. Aspirin was never approved by the FDA.

Answer 5

NO. there's no way around it! you have to have extensive research before you even think of using a non-approved drug on a patient.

Answer 6

Not sure if it depends on where the hospital is located, try contacting the AMA.

Answer 7

illegal inside USA

Answer 8

No, its illegal