EDIT: here is a statement and what the letter is about https://a4pc.org/2024-06/those-lilly-letters/ Anyone hear about this? I thought as long as there was a shortage compounding is legal, but with tirzepatide and other glp-s it’s a little more complex? Was over at r/peptidediscussion and one of the guys that runs precision Peptides posted this morning that they along with many others have received a cease and desist order from selling tirzepatide as it’s base ingredient has been copyrighted by Lilly. He said many if not all US based suppliers, compound pharmacies, and labs/shops will be getting these letters over the next few weeks. The salt form is safe from the cease and desist since its only ingredient is Tirzepatide that has been freeze dried in a vacuum. Tirzepatide it self can not be copyrighted, so it’s likely some compound pharmacies will switch to the salt form, but public opinion of the salt form is generally negative so it may not be worth the hassle for most places.
I agree with u Ardbert, it’d be horrible press to target the compound pharmacies that we had to turn to because BigPharma failed to put enough product into the supply line (in addition to their many problems, they also probably cause the shortage because they want to keep prices so high)
Imagine going after the customers only ability to get this medicine, we who need this medicine the most in the name of greed. 🤦🏻♀️
Shame on u BigPharma
I hope you're right!
Me too lol
I hope you're correct, but I read the letter, and it seems they're going after compounding pharmacies. Am I incorrect? I don't trust Big Pharma, particularly as I've worked for them. Is it too early to panic? Are they really able to shut down the compounding pharmacies compounding Tirzepatide? Wouldn't it take a big, lengthy lawsuit to do so?
The alliance for compounding responded to the letters, you might find it reassuring! They’re pushing back on Lilly’s claims
That is reassuring. Thank you. Big Pharma is all about profits and has got plenty of resources to create havoc to protect themselves. Like all big corporations, they’re often deceptive. I hope that no pharmacy serving our community becomes harassed and intimidated. We need Tirzepatide.
Reading this, it sounds like they're trying to poison the well on all products that aren't theirs. But it said they're only pursuing legal action against places that are selling products claiming to be their name brand medication. The rest is just fear mongering around compounded versions of the drug.
That letter is crazy. Literally says the compound versions won’t work or will only work poorly. Well in this group thousands have used compounded Tir and have had amazing success
Yea, it's an obvious scare tactic. The fact they're trying that angle makes me think they don't have a legal option to stop the legit compounders. So they're just going to try and smear the compounded pharmacies instead to try and keep people from going to them.
Most likely this is the plan. I agree. Hope this don’t backfire on them. Plenty of other places competing with Lilly are releasing their own GLP-1s next year and if they come across as low down they may lose a lot of customers to other companies soon.
Oddly I have never seen anywhere selling it under their trademark name have you?
I have on some real sketchy facebook/tiktok posts. They're selling them in the box with the pen for like $40 dollars. And I know some medspas were selling the compounded meds claiming they were name brand. I think those are the ones Lilly is going after.
Now that practice should be stopped. That is just straight fraud. But going after the ones selling pure tirzepatide is a stretch since they don’t own tirzepatide. Some scientists owns it. I’ll try and find the actual info for you, he was former Soviet Union scientist that discovered it, then in the 80s him and a few others figured out how to make it last longer thus creating the version we all know and love. I swear I should have book market that page, it’s really interesting
The guy that posted in peptide discussion is supplying the compound pharmacies….See how this rolls down hill?
Compounding pharmacies are supposed to be obtaining their peptides from FDA regulated manufacturers. There are only a few making tirzepatide and that guy isn’t one of them.
💯👊
You work for a supplier or pharmacy? I mean over at the peptide Reddit there are suppliers saying this will affect most of the telehealth places, but if you work for one or with the FDA please do elaborate further on the exact details.
I’ll believe it when I see it. Hallandale is shipping my order per usual today.
I highly doubt Hallandale would risk their license by using unapproved sources. There is probably little risk of them being affected by this.
I was considering Hallandale pharmacy for tirz via IVIM health and apparently Hallandale has a few FDA violations. It's public info so you can google it. Kind of scary IMO I decided to use a compounding pharmacy near me in NY.
Look at the comments below. It’s happening
What comment below? Share a link directly to the comment, because I see nothing in this thread. Please name an FDA source that received a letter.
No I don’t work for them, but you can see revoked licenses from compounding pharmacies for not using FDA approved sources. They are required, but I know that doesn’t mean they are. This is why I don’t trust the new pop up ones that don’t have much to lose that they didn’t have a few months ago, but pharmacies like Hallandale and Red Rock have a lot to lose. Weight loss drugs are only a small portion of their business.
I would think a larger percentage than we really know, at least this year! The profit margin I was told by the pharmacist I work for can be upwards of 150 to 200% per compounding patient. Just imagine the revenue stream these weight loss drugs have created virtually overnight!
They won’t get a cease and desist order but whomever they are getting Tirzepatide and the base ingredients from could very well get a cease and desist. Even if it’s an FDA approved place Lilly can still send the a letter. If challenged they got enough money to keep the challenge in legal limbo for as long as they want. Not saying they would go that far but they could if they wanted too since I’m guessing all these places are using the copyrighted base ingredients. Look at the comments below several people saying their supplier got a letter. Some are fda approved places
Whose supplier? What comments?
They weren’t specific unfortunately. I’m just passing along info after looking into it to make sure it’s real information. I’m just a messenger here. So you don’t have to down vote it. lol I don’t have a list of everyone FDA approved that’s getting a letter. I don’t even have a list of anyone getting it, but if you go through r/peptidediscussion you’ll see post popping up about it with different places named.
I see ONE tiny little post from the past week. ONE.
Here have another link
And no one is mentioning the stuff you say. Direct me where someone said they supply telemed companies or where they say an FDA one received it?
Which peptide Reddit are you referring to?
At this point, I feel like OP is making shit up. I can’t find anything OP keeps trying to refer to. Only one small post about one website getting shut down and those peptide sites get shut down all the time.
Link to the post please.
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Every single one of them? I assumed most compounding pharmacies would be using overseas suppliers to cut out the middle man entirely. Even if the seller is in the US all tirzpatide is made in China anyway. The Chinese sellers aren’t going to care about Lilly’s copyright
There are FDA approved suppliers in China that compounding pharmacies can get Tirzepatide from. I’m assuming this is only going to have a major effect on the sketchy telemed suppliers. Eventually it may trickle to the bigger players with the movement of customers, but I’m not worried about any shortages. It just might take an extra week or two for the pharmacy to ship it, so just plan ahead.
It’s not the Pharmacy it self getting orders I originally said pharmacies too but it’s the suppliers and manufacturers of tirzepatide who are getting the orders, and after spending some time digging around today I believe Lilly wants to stop all compounding of tirzepatide rather it is allowed to happen like that is a different story but that is what they aim to do.
Here smart a$$. See? They are going after FDA approved places too
Lol where is the post with the comments saying lilly sent them to fda approved sources? I asked for links to the post you were talking about and you still can’t send it to me because it doesn’t exist. You’re literally making up shit in your head.
It’s just the US peptide shops and the pharmacies being supplied by them according to a poster above. But the guy that posted the letter stated that most telehealth places will be affected
Well, I hope they can find some way around it. It’s gonna be a huge mess if not. The shortages are nowhere near over.
Some of the compounding pharmacies did get the letters also. I have read a letter sent out by the Alliance for Pharmacy Compounding. I can't seem to share it here but think you cutie look it up.
I messaged Emerge about the FDA rule yesterday. They get their tirzepatide from Hallandale. This was the response: "...we do not foresee slowing down anytime soon and have no plans on going anywhere. We hope to be a part of your health journey for as long as you need us. Have a great day!"
I'm not too concerned. Hallandale is an FDA lab.
Lol just messaged them with the same question, should have read this first. I hope we are safe.
I can’t find anything OP keeps referring to. It just seems like fear mongering to me.
Panic spreads fast.
Again I’m just passing along what I read in a different sub Reddit, no need to be so aggressive with me, go be aggressive in the subreddit I linked. I’m sure one of the suppliers there can give you everything nugget of detail you crave.
Please link to the post you’re talking about. Don’t like to the sub. I only see one little post which doesn’t line up with the allegations you’re making.
I was able to link it. Don’t be so extra and do your research. He is correct.
lol that’s not research. You linked to a website. If you read it again, I asked for him to link to the posts and comments he keeps mentioning.
Where is the comment saying they are “supplying the compounding pharmacies”? https://www.reddit.com/r/tirzepatidecompound/s/6Om6yhT0i0
Where is the comment saying most telemed will be affected? https://www.reddit.com/r/tirzepatidecompound/s/ikKxVbIoYC
There are more things OP said and cannot link to despite me asking multiple times. Until someone can link to it, it appears to all be shit pulled out of thin air. The only post in the subreddit that he linked to (and that post is now deleted) did not have any of these comments and the entire post is about a “research” peptide place which those get shut down all the time.
From Lilly Themselves They are going after everyone even the “approved” places everyone speaks of
You can google the letter.
I didn’t ask for the letter. I asked to be pointed to the comments and posts he keeps mentioning.
Maybe this will do you one better. From Lilly themselves from their website. They are going after everyone selling tirzepatide. Even the “approved” places claiming they are THE ONLY ones that have the fda approved versions and no one else has it.
So? That’s correct. Why do you keep deflecting from not being able to direct me to the comments and posts you mentioned?
I can’t find them anywhere anymore. And why did you say there are fda approved compound pharmacies when Lilly says they are the only ones that have and can produce the FDA approved version.
Compounding laboratories must obtain their APIs (aka their tirzepatide) from FDA registered manufacturers.
Eli Lilly has the only FDA approved tirzepatide medication.
A compounding pharmacy using tirzepatide from an FDA registered manufacturer and dispensing it in vials is not an FDA approved drug.
Well that letter makes it sound like if you didn’t get it from them, then it’s not approved and they will be taking legal actions on any manufacturer/pharmacy selling it. Is that how you read it too?
The letter to me makes it seem like Lilly is stating no other Tirzepatide has been approved to sell but the specific one only sold by them. They even say compounding is dangerous. Though as far as I know no true compounding pharmacy has gotten a cease and desist letter from them, however that doesn’t mean they aren’t going to take a different approach to stop sells for them. I have a feeling they are going to challenge the law itself. As they mention the dosages go in and out of shortage regularly right now and thus on and off the list so at the least sells should be on and off on a daily basis with those selling Tir under the guides of the compound laws and regulations is what they may try to achieve for the supposed very few places that have fda approval.
You realize tirzepatide is NOT FDA approved? Mounjaro and Zepbound are FDA approved. It’s a sum of the active ingredient, the inactive ingredients, and the packaging that receive approval. Changing anything in there requires FDA approval. That’s why Lilly got additional approval for single dose vials instead of pens. This is also why compounded medication is never FDA approved. Properly compounded medication is allowed by the FDA during shortages and Lilly can’t do anything about that. These “research peptides” have no business being on the market as they are not from FDA registered manufacturers and I can absolutely see Lilly shutting them down, but that shouldn’t affect compounding labs unless they are not following proper channels.
That letter doesn’t say that though, it says any compounding is dangerous. Yes of course I know Tir is not copyrighted, but what I was asking you is, does the wording of the letter make it seem like they would like you to believe only they have the rights to produce and sell the drug legally.
I understand they can’t do anything about compound laws, but they have enough money and the lawyers that can challenge that law. I think that’s coming next. The letter states compounding is molecularly same as their one and only FDA approved version. I’m willing to bet the next step is they will purchase from these places if they haven’t already and test their vials and send reports to the FDA to prove their claim that the fda approved pharmacies are changing the molecular structure by the very nature of compounding thus they can not possibly be selling the molecular structure accepted as tirzepatide by the FDA
My bad. Just trying to help.
I think mine is supposed to come from Hallandale
That's good to hear, but I don't trust anything I hear. First, Express Scripts said Zepbound would be on May 1, then June 1...it's never been stocked. Maybe Emerge doesn't want to scare anyone.
And I thought Eli Lilly wanted to help people’s health.
/s
In my own experience, not saying this is fact (for all the ninja downvoters out there) but I believe most if not all the big pharma companies are only interested in one thing, money. Otherwise if they really cared they would have developed a drug that would cure Obesity and not just stop its progression as long as you keep taking the drug.
Both patents and trademarks require active defense from potential infringement or they can be lost by the patent/trademark holder. This is why you see mom-and-pop businesses get cease-and-desist letters from big corporations with similar names, even though those big corporations know they’re not being confused with each other.
So I’m not at all surprised that Lilly is sending out letters like this. They could potentially lose their patent if it’s being infringed upon and they don’t take some kind of official action. And that would be a huge blow to their bottom line.
What they’re doing, though, goes a step beyond that, trying to actively discourage compounding pharmacies from continuing to dispense medications that are legally allowed under the ongoing shortages. They have some points correct, but on a very limited scale, and the FDA has taken action where appropriate. I’m sure they know they’re losing funding to legitimate compounding, both due to their production problems and to the lower cost of compound. The former they’re working to address so they can get the medications out of official shortage condition, and the latter they’re addressing with these letters.
The FDA has already told Lilly that it can’t quash compounding entirely at present. So, this is their next best option — intimidation. Are they technically legally correct in their assertions as worded? Maybe. Are they trying to imply things that are not entirely accurate? Probably. But that’s what lawyers do. So none of this surprises me. The compounding pharmacies as an industry won’t let Lilly bully them if they have the FDA on their side, and until the shortage is officially over, they do. The larger question is whether Lilly’s campaign to conflate bad actors in the compounding industry will keep patients from going to compound in any significant numbers, because that also seems to be a goal here. The compounding industry knows better, as does the FDA. But the patients may find these letters alarming if they hear about them without having deeper background on the legalities and safety of compounding. And that is also likely a part of Lilly’s game plan.
I imagine the biochemists and other research scientists and engineers working at big pharma companies are interested in helping people. Stockholders not so much.
To say nothing of the pharma companies that would lose money on all their drugs that treat illnesses related to obesity and actively want to keep people fat and sick.
A healthy bottom line for EL is what they care about.
Eli Lily is a for profit corporation and answers to shareholders and a board that expects ever increasing profits and return on investments.
No. There in it for profit. Could care less about people’s health.
They certainly are not helping our mental health with their monopoly shenanigans.
Oh, that's just Marketing. BigPharma cares about $$$$$
Missed the /s when I responded to your reply. Sorry!
A cease and desist is a type of letter that one person or entity sends to another, not a binding order. Nobody has to comply with it. It just says "cut it out or we will take you to court." EL is trying all manner of things to kill off the competition from compounding pharmacies, but so far none have succeeded. I am not worried.
I do hope you are correct. Having worked for BigPharma, I know how intimidating they can be, and they have lots of cash to protect their profits. I don't trust them at all, and my imagination envisions that they may even "pay off" some pharmacies to stop. Maybe that's crazy?
I don’t think they can stop the compounding pharmacies as long as there’s a shortage and as long as the pharmacies are not making exact copies of Lilly’s drug (adding B12, water, etc). Diabetics have to have access to these drugs. They’re not just for people trying to lose weight.
Could the FDA rule that you have to be diagnosed T2 to be eligible for the drug? Sure. But how do they do that without cutting the Wegovy and Zepbound profit machine? Those drugs are specifically approved for weight loss. I doubt Lilly and others want to fight that battle. My sense is they are mostly concerned with providers and pharmacies who are being misleading in how they’re marketing their compound. For example, I hear a lot of people claiming that compounded tirzepatide and semaglutide are merely “generic” forms of Zepbound and Wegovy, and that’s obviously not true.
When Novo Nordisk was sending out c&d letters, it was only to pharmacies advertising products using NN's brand names. So those pharmacies running IG ads saying like "same ingredient as Ozempic!" or "Generic Wegovy!" or whatever.
During the shortage there's no legal reason why Eli Lilly would be able to get legal compound pharmacies to stop compounding.
And im so pissed !! Greedy fkn pharmacy!! Precission Peptide changed my life , and always was pure !!! This is bullshit!!!
Yep. Lilly started sending out these letters last week. There has been a lot of panic buying in the pep community. Lilly has enough money to keep them tied in litigation even if what they're doing isn't actually illegal. So far it seems to be the ones who advertised on major platforms like facebook but it will no doubt trickle down to some of the more discreet vendors.
I suggest anyone who wants to go this route get comfortable with overseas vendors, btc and testing. Most domestic vendors had terrible pricing anyway but it still sucks to see this.
Yes. I chose overseas from the start, mainly because the prices are astronomically better and they don’t fall under a category that can lead to them having to stop production. Obviously as with anything like this, overseas has its own issues to look out for but at least it’s a stable market.
How do you find a good overseas supplier? My supplier here just posted they got the Lilly letter
My source is discontinuing as well
How can you find out if your source is listed in the EL letter?
I say you ask your source. I asked mine and confirmed they got the letter
Did they offer more than that? eg, they got the letter, but did they indicate if they may not be able to offer compounding in the future?
Why is the salt form considered undesirable? Are you thinking that the pharmacies won’t want to compound using the salt form because customers won’t like or buy it? Thank you.
Bad press and fear mongering. People not understanding the salt form is simply Tirzepatide without a base. Since it is a salt the base is just BAC water (99% water 1% alcohol) So technically it’s more pure than Lilly’s which uses a different base that contains preservatives and other ingredients to make it last longer in the fridge. Once the salt form is reconstituted you get 28 days in the fridge and that’s it. But un constituted it last 2 years stored at below 86 degrees, 3 years below 60 and up to 10 years in a freezer.
Wow. Good to know. The more I learn, the more it seems that compounding is the way to go. I don’t trust Big Pharma, as I worked for them and know how ruthless they can be when trying to protect their territory.
Looks like they are going after most every place selling Tirzepatide stating their only version of Tirzepatide the FDA approved of is theirs, and if it’s not made by them then it’s not approved and they aim to shut it down
I emailed Emerge. Here's their response: "The cease and desist is going after illegal online pharmacies, and counterfeit medications. 503A pharmacies are regulated by the FDA so our patients are in good hands! We have no concerns on not being able to continue prescribing the medication."
I emailed Emerge; here’s the reply: The cease and desist is going after illegal online pharmacies, and counterfeit medications. 503A pharmacies are regulated by the FDA so our patients are in good hands! We have no concerns on not being able to continue prescribing the medication.
However, I don’t trust Big Pharma and believe it’s not beyond them to intimidate and do whatever they can to protect what they see as “theirs”.
same for me - I will try to stcok up and put in the freezer
If you could PM about your oversees connect or suggestions, support, I’d appreciate it
This is not allowed by Reddit. It can get you banned and worse, the entire sub can be deleted. It has happened, and a lot of helpful information disappeared along with discussions on things which aren’t allowed.
Which part isn't allowed? Asking to be DM'ed or actually DMing people with info? What if someone messages me and I didn't ask for it? Do I still get in trouble? Can you link me to where I can read about this? My account is almost 13 years old and I'd be very sad to lose it.
Do you remember where the rules are posted? I can look but then I won’t be able to find my way back here LOL.
I find it very difficult to determine who is a trustworthy and safe overseas supplier. No idea how to go about this, sadly. If anyone is willing to share their wisdom, please PM me. :)
please remember that the rules for Reddit do not allow this discussion or asking for DM. The entire sub can be deleted because of this discussion of peptide sources and suggesting DM.
Thanks I’ll remove it
I don’t know where to start with overseas vendors, or I would switch ASAP.
It’s way more affordable.
Do you mind sharing your overseas supplier?
That cannot be discussed on this subreddit and will get you banned.
If you could PM a overseas vendor, I’d like to begin researching them
I would too. I have no idea how to find them though.
This is very interesting, and I really do appreciate you sharing it! Do you know if the "salt" is not as great to use because it just doesn't act the same way on glucose numbers and side effects such as weight loss? Anything you may have learned in the Peptide group, please feel free to share!' I have T2 diabetes and it is such a struggle right now keeping meds in the house that work with the Mounjaro that works for me hard to find! Thank you!
I think that EL is gearing up for the end of the shortage when it will come off of the FDA shortage report. Since they can go after these folks now (while it is still on the report) they are starting the cleanup.
I got an email from another company that said they are selling all their Tirz stock this week and then they will no longer sell it.
A company from which you were getting the compound? A compounding pharmacy will no longer provide it?
They are a peptide company, not a compounding pharmacy
Why is the salt form not so good?
They've been letting their customers down for months by not having enough product to match demand, and now they are going after the solution many customers have turned too during the shortage? It's not a cute look, nor is it a professional look.
You can't copyright medication. Copyright is for the creation of artwork/written word/etc. Think books, art pieces, maps, etc. They do have several patents for tirz and several trademarks (some pending, some approved) for Zepbound. Patents are for scientific discoveries/mechanisms/etc. and trademarks are for names/logos/brands/etc.
Lilly says it is trademarked/patented by Lilly. I don’t even know how they pulled that off because tirzepatide been around for years before they started developing it as a T2/obesity drug.
Trademark and patents are two different types of intellectual property. Trademark secures the name "Zepbound" not the scientific formula for tirz.
The patent is because they figured out how to make the GLP and GIP last longer in the body. It breaks down very fast otherwise and wouldn't be effective as a treatment.
They did not figure out how to make it last longer. Don’t ask how I know but it’s been available in long acting form since 2012 and sold for research use only.
This letter makes it seem like they will be challenging everyone that currently sales it as they claim all versions except the one they make is illegal
Chinese suppliers have been targeted now. Seen several that have been told to stop exporting tirz to the USA. It’s on discord, Pepys and FB. Could just be temporary but I have a bad feeling
I doubt they will actually stop selling it
I order from Precision Peptides and they sent out an email about this and how they have to stop selling Tirz (but they’re having a big sale on Tirz if anyone wants to grab some). Also Amino Research sent out an email they’re having a half off sale minutes after PP sent theirs. If you get yours from Research Labs I’d stock up! I bought 800mg for around $1700 yesterday.
Tirzepatide has a molecular patent by Eli Lilly. The compounding pharmacy can compound meds in a shortage but they have to use FDA certified manufacturers. My guess would be Eli Lilly wants to sue the compounding pharmacy’s to find the source. If Eli Lilly can prove they are not FDA certified manufacturers they can shut them down. If they are FDA certified manufacturers Eli Lilly now knows the manufacturer and can go after them. Since I would assume most of the peptides originate in China Eli Lilly could demand US FDA inspections ( most aren’t routinely FDA inspected) of the manufactures or appeal directly to the Chinese government .
Sad thing is no one cared about tirzepatide in 2016 when you could only get it for research. Now it’s a big deal and it seems Lilly wants it all for themselves
I just placed a 1 year supply order for me and my S.O. I'm slightly nervous right now. But, I have hope it will work out soon than later.
The actual letter Lilly has on their site
Most are salt forms
The salt form is so nice too! No fillers no nothing just pure Tirzepatide.
I'm glad I just reordered an additional three months and is shipping today.
How many months worth can one buy from lavender sky, anyone know?
According to their website, you can get 8 weeks of tirzepatide, or 10 weeks of semaglutide at a time. Unless you get their 3-month starter package, but that's 4 weeks of 2.5mg, and 8 weeks of 5mg
You also don't have to wait two months to reorder, so you can order a couple of weeks after you get a shipment if you want to stock up.
I didn’t know you could order 3 months worth. What company do you use? Thanks.
Thank you! I’m getting ready to start my second month of the three month starter pack and I’m planning on sticking with 2.5 or maybe going up to 3.5, so I’ll be able to stretch the 2nd and 3rd months a bit.
Shit I was planning to give me credit card a break the next couple months cuz I’m stocked until October with branded but damn I’m gonna grab a couple 3 month supplies I think from pharmacies with one year BUD dates
I am stocking up. I just placed another 3-month order and will do it again soon.
How do you place a 3 month order? It’s seems I’m only able to order 1 month at a time. Thank you.
Some states restrict the amount of Tirzepatide pharmacies are allowed to ship per order. You may live in one of those states. I use SlimDownRx. You can use the contact form on their website and ask how many months Ousia Pharmacy can ship to you.
Does it also depend if you get it in a vial or pen? It sounds most people get vials but I get 4 pens a month and they expire in a month.
I think the issue is "out of state" pharmacies shipping to your state. Some states have restrictions on the amount you can receive per month. Are you getting 4 prefilled syringes? If so the BUD date would be 30 days. Unopened vials from pharmacies like Ousia (SlimDownRx) and Hallandale (Emerge) have a BUD of 1 year, so they can be shipped and stored in the fridge.
Yes 4 prefilled syringes. Out of state as well.
You can check with your State's Board of Pharmacy to check to see if there are restrictions on out of state pharmacies.
It's coming
They're only targeting the people selling research peptides. I don't think they're allowed to touch the compounding pharmacies because the meds they're making are still under the FDA shortage. The compounding places likely have their own suppliers in china and aren't buying from the research peptide sites anyway.
If Lilly were to get these compounding pharmacies making meds they aren't able to meet demand for shut down it'd be a huge scandal and terrible PR. They can't just defy the FDA shortage authorization like that.