FDA cracks down on ‘misleading’ compounded GLP-1s by telehealth companies

[cheaperseeker]

You know what's misleading? Articles like this.

I know the compounding pharmacies are just in it for the money, but they aren't lying when they say they have the same active ingredient as Ozempic or Zepbound. It's quite a leap to equate this to "FDA Approved".

"FDA Approved" does not mean, "everything else is bunk or poison". Just about every supplement inside of a GNC or Vitamin Shoppe is not FDA approved, but nobody's trying to shut them down. Why? Because Big pharma isn't trying to sell the same things for $1,200/month, and FDA committee members often have ties to the pharmaceutical industry.

FDA cracks down on 'misleading' compounded GLP-1s by telehealth companies

The FDA has sent 30 warning letters to telehealth companies for falsely marketing compounded GLP-1s, which are not FDA-approved and can pose risks to patients.

www.wishtv.com

 

[QueenMuntha]

Yeah, they have effectively stopped all of the 503B Compounding Pharmacies from mass compounding the GLP1s. The 503A pharmacies are ok FOR NOW.

Assholes. What are poorer people who want to get healthy going to do?

 

[tubby]

You know what's misleading? Articles like this.

I know the compounding pharmacies are just in it for the money, but they aren't lying when they say they have the same active ingredient as Ozempic or Zepbound. It's quite a leap to equate this to "FDA Approved".

"FDA Approved" does not mean, "everything else is bunk or poison". Just about every supplement inside of a GNC or Vitamin Shoppe is not FDA approved, but nobody's trying to shut them down. Why? Because Big pharma isn't trying to sell the same things for $1,200/month, and FDA committee members often have ties to the pharmaceutical industry.

FDA cracks down on 'misleading' compounded GLP-1s by telehealth companies

The FDA has sent 30 warning letters to telehealth companies for falsely marketing compounded GLP-1s, which are not FDA-approved and can pose risks to patients.

www.wishtv.com

My understanding of this is that this is mostly a legal distinction. The FDA approved not just a specific molecule, but rather a specific manufacturing process to produce that specific molecule. That means when Novo builds a manufacturing facility to specification and uses that facility to produce semaglutide, that is defined as semaglutide. When another lab produces the same API (but through a somewhat different process) that's not semaglutide.

As long as the compounding pharmacy sources from a producer of high quality API the customer probably doesn't care, but it's technically a different product the same way that a really high quality replica of an item is legally a different thing from the original item.

I think this distinction is probably more relevant when it comes to generic VS brand name drugs where substances like the inert filler can vary from branded to generic, which won't matter for most people, but every once in a while actually does matter.

 

[Rolltide61]

Just about every supplement inside of a GNC or Vitamin Shoppe is not FDA approved, but nobody's trying to shut them down. Why? Because Big pharma isn't trying to sell the same things for $1,200/month, and FDA committee members often have ties to the pharmaceutical industry.

I heard on a podcast Sunday that pharma owns about 90-95% of the supplement products. Don't know if that is true but may explain why they could care less about GNC.

 

[cheaperseeker]

My understanding of this is that this is mostly a legal distinction. The FDA approved not just a specific molecule, but rather a specific manufacturing process to produce that specific molecule. That means when Novo builds a manufacturing facility to specification and uses that facility to produce semaglutide, that is defined as semaglutide. When another lab produces the same API (but through a somewhat different process) that's not semaglutide.

As long as the compounding pharmacy sources from a producer of high quality API the customer probably doesn't care, but it's technically a different product the same way that a really high quality replica of an item is legally a different thing from the original item.

I think this distinction is probably more relevant when it comes to generic VS brand name drugs where substances like the inert filler can vary from branded to generic, which won't matter for most people, but every once in a while actually does matter.

That makes sense.

Still, the author seems to be implying that anything other than brand name is a scam, or otherwise dangerous. Yet somehow it's not when there's a national shortage?

We all know from EndoJEEP '26 that there are sometimes batches that could make people sick, but this is also true of legitimate pharmaceutical companies. Not to mention recalls after finding out years later that the medication causes cancer or some other disease.

I just get annoyed by these articles, because they lead the general population to believe the only safe way to be healthy is to pay, or have their insurance to pay, massive amounts of money to big pharma.

 

[Rolltide61]

Not to mention recalls after finding out years later that the medication causes cancer or some other disease.

And we wouldn't even know that if it wasn't for commercials with lawyers inviting you into a class action lawsuit against a certain drug.

 

[RoadRash]

Yeah, they have effectively stopped all of the 503B Compounding Pharmacies from mass compounding the GLP1s. The 503A pharmacies are ok FOR NOW.

Assholes. What are poorer people who want to get healthy going to do?

Grey market. It's been working for me.

 

[randompersonrandom]

The people in r/Tirzepatidecompound sound so scared. I feel bad for them. I WAS one of them during the last "they're gonna shut down" compound freakout, which is how I wound up over here; because absolutely not, I'm not living that scared.

 

[cheaperseeker]

It is sad. I want to tell everyone about gray, but I know I have to protect it by keeping quiet. Except for close family members.

 

[Turbo-Farmer]

Compounded Retatrutide

 

[ochoseis]

The people in r/Tirzepatidecompound sound so scared. I feel bad for them. I WAS one of them during the last "they're gonna shut down" compound freakout, which is how I wound up over here; because absolutely not, I'm not living that scared.

They are scared. And it sucks because so many of them are just never going to feel comfortable moving away from compound because that was already a very hard step for them.

One of my family members lost coverage for sema over a year ago. He is not in a financial position to pay out of pocket. He was finally at a place, at freaking 70 years old, where his diabetes was controlled, he was at a normal BMI and was getting to live the life he deserved and should have gotten sooner. I can't count how many times I was scared he was going to die in my life over diabetes or diabetes related problems.

He stopped Ozempic and regained like 30lbs super quick, glucose all over the place, had to go back on insulin. I started compounded tirz and gently nudged him into compounded sema because he was def not willing to do compounded + different medication. It was such a battle, so much hand holding to walk him through a telehealth intake.

There is no chance in hell I will get him on this if he loses compounding access even if I did everything for him. He will 100% take compounding getting stopped as proof it's dangerous and this will be even worse/scarier and I will probably lose him. So I'm scared & pissed.

 

[Good-Heart6425]

eli lilly stock is up on the news

FDA Proposes to Exclude Semaglutide, Tirzepatide, Liraglutide From 503B Bulks List​

10:56 AM EDT, 04/30/2026 (MT Newswires) -- The US Food and Drug Administration said Thursday it is proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound the drugs from bulk substances.

Novo Nordisk ( NVO ) manufactures semaglutide, marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, and liraglutide, under the brand name Victoza for type 2 diabetes and Saxenda for chronic weight management. Eli Lilly ( LLY ) manufactures tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for chronic weight management.

Normally, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance is on the 503B bulks list or the compounded drug is on the FDA's drug shortage list at the time of compounding, distribution, and dispensing, the FDA said.

Novo Nordisk ( NVO ) and Eli Lilly ( LLY ) didn't immediately reply to requests for comment from MT Newswires.

Price: 42.48, Change: +2.19, Percent Change: +5.44MT Newswires

 

[5byfive]

Look like this just reinforces the status quo. Nothing is changing. They are currently not on the bulks list. Continue at your current level of panic.

 

[timfa]

View attachment 20897Compounded Retatrutide

lmao these ppl are just profiting off of middle aged people who saw something on TikTok

 

[spanky2026]

I AM one of those reddit folks who are scared, why do you think im over here reading every day? I'm a senior on a fixed income, if I had to pay Lily prices I just could not. I have about 1.5 years of Tirz compounded right now, and my first kit of gray Tirz is sitting in my freezer. I paid Nexaph pricing (I know, I know) because of comfort level and ease of purchase, and honestly when the time comes I'll likely do the same again, I'm just not comfortable guessing who is/isn't safe or deciphering the veiled hieroglyphics to figure that out. But it's just insane that literally MILLIONS of people's health is being threatened because El Lilly isn't happy with 50 billion a year, it needs to be 60. Honestly, we have the most fucked up excuse for health care on the planet.

 

[randompersonrandom]

I AM one of those reddit folks who are scared, why do you think im over here reading every day? I'm a senior on a fixed income, if I had to pay Lily prices I just could not. I have about 1.5 years of Tirz compounded right now, and my first kit of gray Tirz is sitting in my freezer. I paid Nexaph pricing (I know, I know) because of comfort level and ease of purchase, and honestly when the time comes I'll likely do the same again, I'm just not comfortable guessing who is/isn't safe or deciphering the veiled hieroglyphics to figure that out. But it's just insane that literally MILLIONS of people's health is being threatened because El Lilly isn't happy with 50 billion a year, it needs to be 60. Honestly, we have the most fucked up excuse for health care on the planet.

oh, just to be really clear, nobody here has contempt for how scared the compound people are. Y'all are right to be scared. I'm glad for any of you who make it over here and get to a point where you feel comfortable and safe navigating "all this" because I hate for people to have to navigate all that looming dread.

 

[Calm Logic]

An upcoming option for those with Medicare Part D (even with a Medicare Advantage plan) is the Medicare GLP-1 Bridge program, starting in July, even if only for maintenance with currently normal BMI:

Medicare Bridge Program that will offer GLP-1s to Seniors for $50

https://formblends.com/articles/glp1-hub/medicare-glp1-bridge-program-july-2026 Medicare GLP-1 Bridge program starts July 2026: what seniors need to know Medicare GLP-1 Bridge program launches July 1, 2026. Early access to Wegovy, Foundayo, Zepbound KwikPen before full Part D coverage in 2027...

glp1forum.com

Medicare GLP-1 Bridge program launches July 1, 2026. Early access to Wegovy, Foundayo, Zepbound KwikPen before full Part D coverage in 2027.

Medicare GLP-1 Bridge | CMS

Centers for Medicare & Medicaid Services (CMS) announced the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model and a separate short-term demonstration (now called the “Medicare GLP-1 Bridge”)

www.cms.gov

For a beneficiary to qualify for the Medicare GLP-1 Bridge, a provider must submit a prior authorization request that attests the beneficiary meets the following criteria:

• The beneficiary is prescribed the requested drug to reduce excess body weight and maintain weight reduction in combination with current and ongoing lifestyle modification including structured nutrition and physical activity consistent with the applicable FDA approved label, AND
  • The beneficiary is at least eighteen (18) years of age and has a BMI greater than or equal to thirty-five (≥35) at the time of initiation of GLP-1 therapy, or
    
    
  • The beneficiary is at least eighteen (18) years of age and has a BMI greater than or equal to thirty (≥30) at the time of initiating GLP-1 therapy with a diagnosis of one or more of the following: (A) heart failure with preserved ejection fraction, (B) uncontrolled hypertension (defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg, despite concurrent treatment with two antihypertensive medications), or (C) chronic kidney disease stage 3a or above, or
    
    
  • The beneficiary is at least eighteen (18) years of age and has a BMI greater than or equal to twenty-seven (≥27) at the time of initiating GLP-1 therapy with a diagnosis of one or more of the following: (A) pre-diabetes (as defined by American Diabetes Association guidelines), (B) previous myocardial infarction, (C) previous stroke, or (D) symptomatic peripheral artery disease.

Eligible beneficiaries must meet the clinical criteria at the time of GLP-1 therapy initiation. This includes beneficiaries who initiated therapy prior to enrolling in Medicare Part D and/or prior to the July 1, 2026 launch of the Medicare GLP-1 Bridge.

For example, if a beneficiary initiated GLP-1 therapy in September 2024 with a body mass index (BMI) of 37 and has a BMI of 34 at the time of a July 2026 prior authorization request, the prescribing provider should attest that the beneficiary met the BMI ≥35 criterion at the time therapy was initiated.

 

[tubby]

An upcoming option for those with Medicare Part D (even with a Medicare Advantage plan) is the Medicare GLP-1 Bridge program, starting in July, even if only for maintenance with currently normal BMI:

Medicare GLP-1 Bridge | CMS

Centers for Medicare & Medicaid Services (CMS) announced the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model and a separate short-term demonstration (now called the “Medicare GLP-1 Bridge”)

www.cms.gov

It looks like the way the program is structured is that the manufacturers get to charge the government $245/month with the participant paying $50 of that, which honestly isn't that unreasonable. Back when GLPs were $1000/month, the idea of the government/insurance covering everyone was fiscally ridiculous (if one wanted to keep private insurance plans even remotely affordable to those paying the premiums).

I wonder how many obese people will be filling grandma's pockets up with rocks before she gets weighed in at her next physical in hopes of taking advantage of the pricing and then using grandma's meds. They get cheap GLPs and grandma gets more frequent visits from her favorite grandchild. LOL

 

[Loscar]

Rich get richer. Those who can afford it won’t bat an eye.

Those who lose access will keep the processed food industry in business, and get back on all the drugs and doctors visits again.

Let them eat cake.

It’s disappointing.

 

[JoonyO]

You know what's misleading? Articles like this.

I know the compounding pharmacies are just in it for the money, but they aren't lying when they say they have the same active ingredient as Ozempic or Zepbound. It's quite a leap to equate this to "FDA Approved".

"FDA Approved" does not mean, "everything else is bunk or poison". Just about every supplement inside of a GNC or Vitamin Shoppe is not FDA approved, but nobody's trying to shut them down. Why? Because Big pharma isn't trying to sell the same things for $1,200/month, and FDA committee members often have ties to the pharmaceutical industry.

FDA cracks down on 'misleading' compounded GLP-1s by telehealth companies

The FDA has sent 30 warning letters to telehealth companies for falsely marketing compounded GLP-1s, which are not FDA-approved and can pose risks to patients.

www.wishtv.com

Right! 🙄 ONE "person's" anecdotal experience is pushed as proof that all compounded glps/telehealth providers are crap. OH MY! 😱 Uh huh. I believe the article. The science is settled on compounded glps. Not. smh
The article is crap imo.
I'd like to know how this "team" found this Ms Frankl or vice versa.