FDA says semaglutide is no longer in shortage

[Heywood Jablowme]

Shares of Hims & Hers tumble 26% after FDA says semaglutide is no longer in shortage
Published Fri, Feb 21 2025, 12:56 PM EST

https://www.cnbc.com/2025/02/21/hims-hers-shares-fall-after-fda-says-semaglutide-no-longer-in-shortage.html

• The FDA said the shortage of semaglutide injection products such as Novo Nordisk’s Ozempic and Wegovy has been resolved.
• The agency said it will start taking action against compounders, which are allowed to produce custom-made alternatives to brand-name drugs during shortages, for violations in the next 60 to 90 days.
• The FDA said Friday that it will start taking action against compounders for violations in the next 60 to 90 days, depending on the type of facility, in order to “avoid unnecessary disruption to patient treatment.”

In other news, my research for vendors intensifies...

 

[Heywood Jablowme]

The Ozempic Shortage Is Over
By Kate Knibbs and Emily Mullin, Feb 21, 2025 10:58 AM

The Ozempic Shortage Is Over

The semaglutide shortage has officially ended in the US—which means the GLP-1 drug industry is about to undergo massive changes.

www.wired.com

At the end of October, the FDA changed the status of all dosages of Ozempic and Wegovy to “available,” signaling that the end of the official shortage was likely in sight. It took until today, nearly four months later, for regulators to conclude that the drug was widely available enough to remove it from the shortage list.

The FDA is giving “503A” compounders, typically state-licensed pharmacies or physician compounders that run smaller operations, until April 22 to cease producing the drug. It is giving “503B” compounders, which are larger outsourcing facilities that follow stricter manufacturing guidelines, until May 22.

 

[ruisenor]

Shares of Hims & Hers tumble 26% after FDA says semaglutide is no longer in shortage
Published Fri, Feb 21 2025, 12:56 PM EST

https://www.cnbc.com/2025/02/21/hims-hers-shares-fall-after-fda-says-semaglutide-no-longer-in-shortage.html

In other news, my research for vendors intensifies...

FDA is most concerned with protecting Eli Lilly shareholders

 

[nonyabizznez]

FDA is most concerned with protecting Eli Lilly shareholders

Novo in this case.

 

[chmuse]

We'll see how long it lasts. If everyone on compound all of a sudden gets a legit rx, they're going to be on shortage again very quickly.

I think the big issue will be a pharmacies ability to keep it in stock; their fridges tend to be rather small.

 

[keangkong]

Of course there is no shortage. I can buy it from a multitude of Chinese vendors.

 

[nonyabizznez]

We'll see how long it lasts. If everyone on compound all of a sudden gets a legit rx, they're going to be on shortage again very quickly.

I think the big issue will be a pharmacies ability to keep it in stock; their fridges tend to be rather small.

If it can be ordered regardless of how long it takes it will be considered available and I don't foresee them hitting the shortage list again.

Pharmacy's don't need to have the product available, just the ability to order it. Many of the people reporting the shortage to the FDA were expecting walk-in coolers behind the counter full of all the doses in multiples refreshed like a Golden Corral Buffet. They left the pharmacy empty-handed and were greeted by an Internet with links all over to report to the FDA.

I'm not defending or excusing Lilly/Novo. Just saying I'm on many scripts that aren't stocked and have to be ordered.

 

[touringsedan]

I am more concerned with them all selling 6 month supplies in prefilled syringes. Seems a bit risky for harm.

 

[chmuse]

If it can be ordered regardless of how long it takes it will be considered available and I don't foresee them hitting the shortage list again.

Pharmacy's don't need to have the product available, just the ability to order it. Many of the people reporting the shortage to the FDA were expecting walk-in coolers behind the counter full of all the doses in multiples refreshed like a Golden Corral Buffet. They left the pharmacy empty-handed and were greeted by an Internet with links all over to report to the FDA.

I'm not defending or excusing Lilly/Novo. Just saying I'm on many scripts that aren't stocked and have to be ordered.

Fair enough. It'll be interesting to see how it plays out. I've seen that some pharmacies won't even stock it because patients go feral when they can't get it on time.

 

[nonyabizznez]

Fair enough. It'll be interesting to see how it plays out. I've seen that some pharmacies won't even stock it because patients go feral when they can't get it on time.

Yeah, I was trying a soft response since we're being accused of being condescending Jack-offs... But since you're opening the gate...

I alluded to it with the Golden Corral reference. Some pharmacists have said GLP-1 customers are the absolute worst, worse than addicts being denied sched 2 drugs. They clog their phones, berate associates and confront customers who are having scripts filled after ordering the conventional way. They've had to modify their phone procedures and obscure windowed visi coolers from customer view to prevent customers seeing GLP boxes in the cooler awaiting customer pickup. Some demand substitutions based on inventory in dosage and even brand Mounjaro for Zepbound. Some have multiple scripts and berate the pharmacist or tech to contact their insurance despite a line and a known outcome.

I live nextdoor to my pharmacy where I get everything except Mounjaro. I get that mail order from Centerwell (Humana) because I don't want to add to their stress and I've seen that thanks to PBMs there's no profit for them anyway.

I managed to get all that out w/o saying "Karen"

 

[Morbius]

There is a brief discussion of this on Reddit.

https://www.reddit.com/r/medicine/comments/1iv6y8h/fda_declares_end_to_wegovy_and_ozempic_shortage

So far no one seems sure what to expect for the future of compounding.

 

[nonyabizznez]

I am more concerned with them all selling 6 month supplies in prefilled syringes. Seems a bit risky for harm.

Who's doing that? I know some spas were doing that monthly. Are you talking about the script injection devices? (that have BUDs over a year out)

 

[nonyabizznez]

There is a brief discussion of this on Reddit.

https://www.reddit.com/r/medicine/comments/1iv6y8h/fda_declares_end_to_wegovy_and_ozempic_shortage

So far no one seems sure what to expect for the future of compounding.

Semaglutide belongs to Novo for the short term and Tirzepatide belongs to Lilly for the long term (many years).

There will be no more compounding. Not with an additive not for a unique dose. Telehealth will try to sell you something else. Already the much reduced advertising emphasizes blue pills and hair growth over weight loss.

 

[chmuse]

Yeah, I was trying a soft response since we're being accused of being condescending Jack-offs... But since you're opening the gate...

I alluded to it with the Golden Corral reference. Some pharmacists have said GLP-1 customers are the absolute worst, worse than addicts being denied sched 2 drugs. They clog their phones, berate associates and confront customers who are having scripts filled after ordering the conventional way. They've had to modify their phone procedures and obscure windowed visi coolers from customer view to prevent customers seeing GLP boxes in the cooler awaiting customer pickup. Some demand substitutions based on inventory in dosage and even brand Mounjaro for Zepbound. Some have multiple scripts and berate the pharmacist or tech to contact their insurance despite a line and a known outcome.

I live nextdoor to my pharmacy where I get everything except Mounjaro. I get that mail order from Centerwell (Humana) because I don't want to add to their stress and I've seen that thanks to PBMs there's no profit for them anyway.

I managed to get all that out w/o saying "Karen"

Yeah, I was also tempering my words. We get people coming to the ER because their pharmacy was out and they want an emergency refill. Absolutely, 100% serious.

 

[Morbius]

There will be no more compounding.

Next question is... Will the people cut off from compounding realize there is a grey market, and would an influx of noobs be bad for seasoned peptide pros like ourselves?

 

[chmuse]

Next question is... Will the people cut off from compounding realize there is a grey market, and would an influx of noobs be bad for seasoned peptide pros like ourselves?

I found grey while debating buying compound and decided to skip the middleman, so it's not like it's all that hidden that it's an option.

 

[Morbius]

Nope, it really isn't that hidden. Things could get interesting.

 

[nonyabizznez]

Next question is... Will the people cut off from compounding realize there is a grey market, and would an influx of noobs be bad for seasoned peptide pros like ourselves?

Yes

Unless you're over seasoned... I've got more vials in my freezer than ice cubes and I've got a big ice bin!

 

[m100568]

Next question is... Will the people cut off from compounding realize there is a grey market, and would an influx of noobs be bad for seasoned peptide pros like ourselves?

I think most people cut off from compound will not go grey, at least on a percentage basis. Still, even if 5% go grey, that is a lot of desperate people who will flood in and have no idea what they are doing. STG is a great resource for them, but they are already struggling with 7,700 people. The message boards are almost unreadable. I don't know how they will manage another 50,000 people, or more.
There really aren't the resources in the community to deal with the upcoming tidal wave. I fear that some people are really going to hurt themselves, and that will draw attention to the grey market and give all of us a bad name.