Reply to Will a doctor prescribe Ozempic for weight loss?

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[quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous]No.  Ozempic is for those who are diabetics or pre-diabetics. It's only given to a certain dose, I think 1mg.  Saxenda/Wegovy is the same medication, but is approved for weight loss, and given up to 2.4mg.  Doctors are not going to prescribe Ozempic for weight loss, as that's not what it is approved for.[/quote]

You are very wrong. I and many others without diabetes are prescribed Ozempic off label for weight loss. It is approved for up to 2.0 mg. [/quote]

It is not approved for weight loss only in any dose. It's approved indication is only for management of Type 2 diabetes. Wegovy is approved for weight managment, but only for those that are clinically obese or for those struggling with weigh-related health conditions. It is not approved for vanity weight loss.

Am I an expert in drug policy? Yes. Is off-label prescribing legal? Yes. It is ethical for what amounts to cosmetic reasons when the drug is in shortage? No. Is it legal for a pharmacy to compound this? No. Compunding pharmacies by law cannot compound "copies" of FDA-approved medications. Is getting it from Canada legal? No, its not.

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Not sure about the compounding pharmacies, but a lot of them are openly offering compounded semaglutide so I don’t think it’s illegal.

It’s definitely not illegal to use a Canadian pharmacy as an American. That’s where I’ve been getting my Ozempic for 8 months now. [/quote]

Which Canadian pharmacy do you use?[/quote]

It definitely is illegal. Its not well policed, but its not legal.

From the FDA website (Ozempic does not qualify under the exceptions, BTW):

Can I purchase or bring drug or device products from a foreign country to the U.S.?

U.S. Citizens:
In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S. If a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import.

The FDA cannot ensure the safety and effectiveness of medicine purchased over the Internet from foreign sources, storefront businesses that offer to buy foreign medicine for you, or during trips outside the U.S. For these reasons, the FDA recommends only obtaining medicines from legal sources in the U.S.

Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?

The FDA has guidance for personal importation of drug or device products.  Below provides information regarding situations for which this might be allowed:

Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); or

Product is for the treatment of a serious condition ( Prescription Drug Products):
-The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
-There is no known commercialization or promotion of the product to persons residing in the U.S.
-The product does not represent an unreasonable risk.
-The consumer affirms in writing that the product is for personal use.
-The quantity is generally not more than a three month supply and either:
-Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
-Provide evidence that the product is for the continuation of a treatment begun in a foreign country.

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I don’t think you understand what what you posted, Based on what you posted, why would it be illegal to purchase ozempic from Canada?[/quote]

I don't think you understand what I posted. Under which exemption do you think Ozempic falls? Its not without serious health risks, meaning its not OTC, etc and does not qualify under the first exemption. It also doesn't fall under the exemptions for treating a serious condition....which from a policy perspective are aimed at providing availability to those with serious conditions for which there are no approved available treatments in the US. I get that, to a lay person, they think they understand these policies, but you obviously do not. Like I said, its not well polices/enforced, which is why pharmacies ship in, but it is also not legal. There were some attempts by the Trump administration folks to create a new pathway to allow for important of drugs into the US from Canada by allowing states to set up importation programs, but no state has done so that I am aware and Canada signaled their complete unwillingness to participate. [/quote]

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