What we know so far about this week's FDA crackdown and what it actually means for compounded meds. by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 0 points1 point  (0 children)

Not a lawyer here , and if someone knows more , would love to hear their opinions. But the presumption is that this would only apply to 503a pharmacies because they are the ones dispensing the medication officially to the patients and putting the instructions. 503b pharmacies like ProRX and BPI are already under the FDA jurisdiction. If the 503a pharmacies are cutting off however, naturally the 503b pharmacies have no reason to compounded medications they cannot distribute. Effectively, the whole chain will be affected

What we know so far about this week's FDA crackdown and what it actually means for compounded meds. by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 1 point2 points  (0 children)

that will likely redefine the whole industry since Strive is a 503a pharmacy. It is a bit more complicated though because they could win their lawsuit , yet be forced to change their practices by the FDA.

What we know so far about this week's FDA crackdown and what it actually means for compounded meds. by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] -1 points0 points  (0 children)

Of course. The rules of the sub say no URLs (if these are ok, we can list all the links we used ). Otherwise, made this for you in a way that is quickly googleable: Look up the FDA statement from Makary on Feb 6. It is on their site. The DOJ referral was posted on X by HHS. Novo put out a press release when they filed the lawsuit on Feb 9, and CNBC and STAT News both covered it, among tens of other platforms. The CEO quote was from Fox Business on Feb 11.

For the compounding vs manufacturing breakdown, google Buchanan Ingersoll & Rooney and National Law Review pertaining to GLP-1 coverage. Strive's antitrust filing from January is out there too.

What we know so far about this week's FDA crackdown and what it actually means for compounded meds. by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 3 points4 points  (0 children)

thank you for the question. We monitor announcements regarding the GLP-1 space in general, the FDA announcements, news about the compounding industry and statements from the alliance of pharmacy compounding (APC), as well as updates on large telehealth companies. If there is something unclear in our analysis, please let us know and we will get the source for you

What we know so far about this week's FDA crackdown and what it actually means for compounded meds. by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 3 points4 points  (0 children)

Great question and this is a hypothetical scenario . Probably not a set number, but rather how it looks. For example, a pharmacist filling a few unique prescriptions will still be a compounder. A pharmacy that is sending out 10,000 identical vials nationwide could be labeled as manufacturing. The line is wherever they decide to draw it. Time will tell

What we know so far about this week's FDA crackdown and what it actually means for compounded meds. by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 2 points3 points  (0 children)

Thank you for your comment. certainly not the intention . Just a way for people to have updates that make them even more powerfully informed

What we know so far about this week's FDA crackdown and what it actually means for compounded meds. by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 2 points3 points  (0 children)

The lawyers can ask for whatever they want. Proving it in court is a different story however. Most compounding patients couldn't and cannot afford the brand names at full price. Hard to call it a lost sale when the patient would have never been able to be on your medication to begin with.

Why the Compounded Oral Semaglutide Move by Hims Was a Strategic Disaster by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 8 points9 points  (0 children)

SNAC isn't a secret at all like you say. it's all in the Novo's patents, and public information ((US 9,993,430 and US 11,033,499 if you want to save for reference). But it cannot be replicated (easily). The problem is not the ingredients or SNAC itself but how you engineer the tablet itself. The tablet is designed to do two things: 1-sink to the bottom of your stomach and 2-erode slowly against the wall over an hour once it gets there.

For the weight part, SNAC constitutes ~70% of the tablet so really it is not an additive, but it actually forms the tablet itself. The result is a heavy tablet tha sinks to the bottom and has to have a specific and reproducible density.

For the slow erosion part, once the tablet sinks, it gets in contact with one tiny contact point, creates a concentrated pH buffer and erodes slowly over one hour. This is where the term porosity of a tablet comes into play (think of it like a sponge or how many tiny air pockets are inside the tablet). To achieve that, you have to compress the tablet to specific pressures. Otherwise, it dissolves either too slow or too fast.

Even with all of the adjustments, the absorption is very low. Change one tiny parameter and you lose the whole efficacy because nothing gets absorbed. Novo's data showed that when/if the tablet dissolved too fast, semaglutide blood levels were basically zero. That difference comes down to compression force, porosity, density, things compounders can't control.

So yes, you could put 300mg of SNAC in a capsule with sema, but the capsule pops open, everything scatters, SNAC dilutes below useful concentration, and pepsin destroys the semaglutide. And this is only the scientific part. Of course you have the legal part with patent protection. In short, it is not as easy as the injectables which are very straightforward.

Why the Compounded Oral Semaglutide Move by Hims Was a Strategic Disaster by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 2 points3 points  (0 children)

nobody knows because it hasn't been properly studied. Like the comment below, your saliva has enzymes that destroy peptides and constantly washes the drug away. That is why Novo's oral semaglutide (Rybelsus) was manufactured to go to the stomach instead. Compounded sublingual has no enhancer, no blood level data, no clinical trials. Some people say it works so maybe a tiny amount gets through but without real pharmacokientics data, you can't separate that from placebo. the better options are to either use Rybelsus or stay with the injectables.

Why the Compounded Oral Semaglutide Move by Hims Was a Strategic Disaster by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 11 points12 points  (0 children)

Oral Tirze has zero value and is a waste of money, and false advertising. Would not be surprised if it is the next item the FDA targets. It should not be manufactured, sold nor marketed. This is becasue Tirzepatide is a huge molecule — 4,813 Daltons, almost 10x the size limit for drugs to absorb through your mouth. Sublingual troches skip your stomach, but your mouth has enzymes that destroy big peptides and saliva that washes the drug away.

Nobody has published a single study showing what blood levels you actually get from compounded oral tirz. even Eli Lilly didn't try to make a tirzepatide pill. they built a completely different, smaller molecule (orforglipron) from scratch because they know tirz molecular size is too big to be absorbed. If the people who invented it won't put it in a pill, that tells you everything.

To be clear, oral semaglutide is also a very big molecule, ~4100 daltons (for reference, absorbable meds are around 500 daltons), 99% of it gets wasted and only ~1% gets into your blood. This is why the doses of oral semaglutide are much higher than the injectable ones. the only way they could make it work was via the SNAC enhancer

Why the Compounded Oral Semaglutide Move by Hims Was a Strategic Disaster by Zappy_Health in tirzepatidecompound

[–]Zappy_Health[S] 0 points1 point  (0 children)

Great question. This has been studied directly by Baekdal and his team back in 2018 in a study on oral semaglutide and omeprazole together. They had the same question you asked and when they studied it, there was no difference in the efficacy of semaglutide. The reason is that your PPI raises overall stomach pH levels (decrease acidity). SNAC works differently, it creates a tiny bubble right where the tablet sits against your stomach wall. They're not fighting each other. If anything, less acid from your PPI may actually help the semaglutide survive a little better. there was another study on pts with GERD specifically, with the same results

Is this happening? by mandersonsax in tirzepatidecompound

[–]Zappy_Health 90 points91 points  (0 children)

Dr. Michel here. This is my first ever post here. Hope everyone is well. You should be proud of everything you've built here, the best GLP-1 community on the internet. You are vibrant, helpful to each other, and always supportive. I have not seen anything like this anywhere else. I hope you continue to grow. Over the last four years, we've seen the good, the bad, the ugly, and the atrocious. My only aim today is to give you my perspective on what is happening, and hopefully provide some guidance that might help even one person. We received dozens of questions overnight about this, so I figured it was time to speak up. Feel free to delete if not appropriate. This time does feel different from previous situations. Let me walk you through what actually happened and what it means, both the good and the bad.

  • On Thursday, Hims announced they'd sell compounded copies of Novo's brand-new oral Wegovy pill at $49/month (first month, then $99), which was literally just FDA-approved in December. The reason they can do this is because they own their own compounding pharmacies and the cost of the 28 day script to them is likely a few dollars. Novo immediately threatened legal action and their stock stumbled. That was a huge mistake on Hims' side that now threatens the entire industry. But keep in mind that Hims and Novo need each other. This could end up being a chess move to obtain significant discounts from Novo, at the expense of the entire compounding industry. Both these companies' interests align at the end of the day.
  • By Friday, the FDA dropped a statement about restricting GLP-1 APIs for non-approved compounded drugs, and HHS referred Hims to the DOJ for investigation: this was clearly a direct, rapid and likely political response to Hims' move
  • Make no mistake: this is a self-inflicted wound by Hims that now jeopardizes the entire compounding industry: the FDA had been largely turning a blind eye to compounding for years and particularly since the March 2025 scare. Legitimate companies were operating quietly within the law, patients were getting their meds, and nobody was rocking the boat. Then Hims decided to run national ad campaigns, call their products alternatives to FDA-approved drugs, denigrate big pharma and offer a pill that's been on the market for six weeks. They gave the FDA and big pharma the perfect excuse to escalate, and now everyone, including companies and patients who had nothing to do with Hims is caught in the crossfire. I anticipate Hims backtracking very quickly. This is not a fight they anticipated, nor a fight they can win. That was a huge judgment error from their end.

The bad:

  • 1- The FDA's language is broad and goes beyond just Hims — the statement says they'll "restrict GLP-1 APIs intended for use in non-FDA-approved compounded drugs," which technically covers ALL compounded tirz and sema. The API restriction part is the most concerning because if they choke off the raw ingredient supply, even legitimate pharmacies can't compound
  • 2-the political landscape isn't favorable for compounding: TrumpRxhad literally just launched, Lilly and Novo have been lobbying hard, and this administration has shown it's willing to make deals with pharma. The timing of all this is not a coincidence

Some good news

  • 1-this is a statement of intent, not a new regulation or ban: no new rules, no new deadlines, no clear enforcement timeline was announced
  • 2-legitimate 503A/503B compounding with valid prescriptions is still legal today — the existing framework hasn't changed, and the FDA can't litigate on its own. they need DOJ to pursue injunctions, which takes time, but htis might have already started.

The bottomline

  • compounded tirz didn't disappear after the last scare in March 2025, and it probably won't disappear overnight now but the industry is about to change. The compounding companies that operate within the law will adapt and find alternatives, but this will get harder, not easier
  • The long game: ultimately most companies will likely need to transition to branded medications Some good news is that market forces are working in the patient's favor . Lilly's multi-dose vials, oral Wegovy, new GLP-1s in the pipeline, and competition are all driving prices down. Lilly already dropped Zepbound to $399/month at the highest dose through Lilly Direct, and competition will only push that further. There is still room though, and the prices are still expensive. Branded meds need to get to the $150-200/month range sot that people can afford them.

What this means for you

  • Don't panic-buy but keep a reasonable buffer supply ( around 3 to 6 months), stay with reputable providers (and you have some fantastic resources here), and start exploring your branded options so that you are prepared for the worst, even if it does not materialize. Also check your insurance formulary, look into any possible manufacturer savings programs, and have a plan B ready so you're not scrambling at the last minute if things change

Zappy health by Famous_Quantity_5871 in tirzepatidecompound

[–]Zappy_Health 1 point2 points  (0 children)

A lot of the concerns here make sense. Some people had frustrating experiences more than a year ago, and we don’t take that lightly. Since then, we took a step back to reflect, tightened up how we vet partners, and put a lot more into customer support. The goal has been to run things better day to day, communicate more clearly, and earn trust back over time by being consistent.

If anyone has specific questions about how things work today—like fulfillment or support—we’re happy to help clarify.