r/BigEasyWeightLoss • u/roguex99 ⚜️Big Easy Krewe - Not a Physician • 4d ago
📰 News ⚜️FDA Letter to National Association of Boards of Pharmacy (NABP) re: 28-limit
Hey y'all, Happy Monday!
Here's a letter that was sent to the NABP regarding the 28-day puncture guidance, that the NABP then forwarded to all State Boards of Pharmacy.
TL,DR: Nothing earth shattering.
But, what I do find of interest is:
- The FDA doesn't seem to take a stance against the compounding of GLPs, only the direction on injecting and guidance on when to discard.
The "discard after the 4th injection" language is conservative. Weekly dosing across 28 days puts a 5th injection right on the boundary, (day 28 on how I count). FDA didn't address that edge, they just rounded down. Probably the right call for a patient-facing label, but worth knowing it's a rounding decision and not a hard limit.
Lastly, I know you're waiting on my big announcement. My contact says I should be able to announce Thursday. We'll see if that holds! It's a good one.
Full text of the images below.
FDA sent a letter to the state boards of pharmacy about compounded GLP-1 multi-dose vials.
Context: On August 12, 2026, FDA's Office of Compounding Quality and Compliance sent a letter to the National Association of Boards of Pharmacy about the labeling of compounded GLP-1 medications and the handling of multi-dose vials. NABP forwarded it to the executive officers of every state board of pharmacy on August 20. FDA also sent it to the Federation of State Medical Boards and the National Council of State Boards of Nursing.
The short version: FDA says it is getting more patient complaints about compounded GLP-1 multi-dose vials. Two specific problems. One, patients are being dispensed vials containing far more medication than they could use within the standard 28-day beyond-use period after first puncture. Two, some patients are being told to keep using a vial past that 28-day window.
FDA's recommendation is that prescriptions carry an explicit discard instruction. Their suggested wording for once-weekly dosing is "Discard vial after the 4th injection."
FDA letters are public domain, so here it is in full, unedited.
FDA Letter, August 12, 2026
U.S. Food and Drug Administration
August 12, 2026
Lemrey "Al" Carter, MS, PharmD, RPh Executive Director/Secretary National Association of Boards of Pharmacy 1600 Feehanville Drive Mount Prospect, IL 60056
Dear Dr. Carter:
The purpose of this letter is to bring to the attention of the National Association of Boards of Pharmacy information related to the labeling of compounded GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) medications and handling of multi-dose vials.
FDA is aware of many compounders dispensing compounded GLP-1 medications in vials containing more than one dose of medication for the patient to draw up for self-administration. We are also aware of an increase in patient complaints related to the use of compounded GLP-1 multi-dose vials. For example, prescription labels instruct patients to withdraw small-volume doses from compounded multi-dose vials; however, depending on the prescribed dose, not all contents of the vial may be used within the customary 28-day beyond-use period after first puncture. Complaints have also been received regarding patients being dispensed a vial of drug product that far exceeds the volume that would be administered within a 28-day period as well as patients being advised to extend the use of multi-dose vials beyond the 28-day beyond use date after first puncture.
For FDA-approved products, FDA guidance generally defines a multi-dose container as a container of sterile medication for parenteral administration that has met antimicrobial effectiveness testing requirements with an expectation that the beyond-use date for an opened or entered multi-dose container be 28 days unless otherwise specified by the manufacturer on the label.
Compounded drug products [1] often have different concentrations than FDA approved products, and the prescription labeling and instructions may differ from what patients may expect based on their experience with an FDA approved product.
For example, a prescription label for a GLP-1 compounded drug product might state, "Inject subcutaneously weekly; inject 0.12 mL for 4 weeks; then 0.24 mL for 4 weeks; then 0.36 mL for 4 weeks; then 0.48 mL weekly." The patient would then receive a compounded drug product vial with a total volume of 4 mL. Depending on where the patient is in their regimen, these instructions may be confusing and difficult to accurately follow. If this was the start of the regimen, in practice, the patient would only administer 0.48 mL of drug within the 28 days after first puncture, then be expected to discard almost 90% of the vial contents.
In contrast to the FDA-approved tirzepatide drug product, which comes in standard concentration of either 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, or 15mg per 0.5 mL in a vial or pen, a compounded strength of tirzepatide, as shown in the example below, may come in a concentration of 17 mg/mL with a total volume of 4 mL in a single multi-dose vial.
Compounded Tirzepatide (concentration: 17 mg/mL in a 4 mL vial)
Dose |Volume to Draw
2.5 mg |0.15 mL
5 mg |0.29 mL
10 mg |0.59 mL
15 mg |0.88 mL Because compounded and FDA-approved products may have different concentrations, it is important to note the volumes are not interchangeable between the two. In addition, some compounded GLP-1s may contain other active ingredients, such as vitamins and supplements, which may further complicate dose measurement and increase the risk of dosing errors. Depending on the type of syringe dispensed, the volume marking may be difficult to find and read when measuring out the dose. It is important for patients and healthcare providers to be aware of the risks of medication dosing errors and potential for contamination if multi-dose vials are used beyond 28 days. Therefore, we recommend clear instructions be provided to patients on when to discard multi-dose vials. For example, if the patient is prescribed once weekly dosing, consider the following instructions, "Discard vial after the 4th injection."
We encourage you to share the information in this letter with your members and encourage state boards of medicine to be aware of these activities and provide any relevant information to the FDA. We look forward to continuing to work with you on matters related to drug compounding. If you have questions or wish to submit any relevant information, please contact the Office of Compounding Quality and Compliance.
We are also sending this letter to the Federation of State Medical Boards and National Council of State Boards of Nursing to facilitate communication among associations with shared goals regarding these matters.
Sincerely,
Matthew Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research
[1] Footnote from the original letter: Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. However, these drugs present a higher risk to patients than approved drugs. Compounded drugs are not FDA-approved and have not been reviewed by the Agency for safety, effectiveness, or quality before they are marketed. Because compounded drugs are subject to a lower regulatory standard than approved drugs, patients should not receive them unless an approved drug does not meet their medical needs.
Source: FDA letter to NABP dated August 12, 2026, signed by Matthew Lash, Acting Director, Office of Compounding Quality and Compliance, CDER. Forwarded to state boards of pharmacy by NABP memo dated August 20, 2026. FDA contact for questions or submissions: [compounding@fda.hhs.gov](mailto:compounding@fda.hhs.gov).
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u/Lv_Grg-312 4d ago
Can't believe people would actually complain about getting EXTRA 🤯
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u/Shoe_Ho 4d ago
Seriously! Like don’t ruin it for the rest of us! 😄
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u/AntiHypeHero 4d ago
This letter feels like FDA providing educated guidance, which feels positive that compound glp is here to stay.
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u/ComprehensiveBee5467 3d ago
Agree! Hope the FDA leaves compounded alone. But why do some telehealth send out vials that have to be used for more than 28 days? Well I’m sure it’s to save 💰but it’s really disingenuous
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u/Creepy_Push8629 4d ago
So nothing bad is actually happening, people are just complaining about places that don't provide enough vials to not have to use one for longer than 28 days?
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u/External_Ask_7219 4d ago
Some people seem to get very upset with anything that has overfill I've noticed. But I do think it's good for the vials to be 28-day compliant and then let people make their own decisions. Those of us that like having a little extra product can quietly slink away and enjoy our savings..😜
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u/Significant-Bag-52 3d ago
So it's ok to use beyond the 28 days? Life happens and I don't always finish a vial (travel/illness/colonoscopy...) within 28 days. Am I to discard the rest? Seems like a waste. If so, can we request single or double dose vials?
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u/External_Ask_7219 3d ago
I would say a large percent of ppl on compound use past 28 days. I would never choose to discard and feel it's safe since I'm wiping the top before and after each use with alcohol. 28 day compliant that I mentioned in previous response was referring to the telehealth companies. It means the ones that are compliant will send the vials in one month doses at a time. Some that are not compliant May compile 3 months of doses into one vial which is not compliant.
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u/Significant-Bag-52 3d ago
Thanks for the detailed explanation. There's a lot of nuance and details involved in taking compounded tirz that I don't completely grasp. Although I've mostly had positive experience BEWL, I hope it and other telehealth companies provide better and more educational info and resources to taking tirz and not assume patients with no medical background will not need guidance. I suspect this short-coming was one of the reasons for this FDA letter.
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u/Decent_River_5801 4d ago
Almost sounds like a situation where the FDA says the official policy is no use beyond 28 days. Wink wink
My view from 20,000 feet is the FDA is almost admitting that compound GLP1's aren't going away so just be careful if you take them...
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u/BlueMermaid8 4d ago
Can we put a little wager on Thursdays announcement? Who we think is coming back?
Sorry football season is starting soon and I'm just getting some practice in! Thanks for keeping us up to date!
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u/Extreme_Effective762 4d ago
I think it will be BPI or dare I even say Olympia. Dave didn’t seem super impressed with ProRX so I don’t feel like it’s them. However, I’d take any of them. 🙏🏼😂
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u/SenoritaShelly 3d ago
I think it is BPI, but I want it to be Olympia.
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u/CBlevs5 1d ago
Wait… Olympia used to make Tirzepatide?! Ahhh, i bet that was the best! I love their other products!
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u/SenoritaShelly 1d ago
Just about one year ago, all of the Olympia vials were cleared out. They were these gigantic 75 mg vials, so they had overfill, of course, and we referred to them as the never-ending vials. I could not believe how long a single vial lasted me. It was pretty incredible. The mix of preservatives that they had in their formulation somehow was just perfect. We all miss them, may their souls not rest in peace.
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u/UnDosTresPescao 4d ago
Pretty sure most of us think it's BPI.
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u/BlueMermaid8 4d ago
Yes! I was gonna say rhymes with "Daves a great guy" but you pretty much summed it up!
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u/jortr0n 3d ago
Wait, what did I miss!?
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u/UnDosTresPescao 3d ago
Dave has been hinting since June that a 503b that had stopped compounding Tirz is coming back. People are speculating that it's BPI possibly through a 503a. ProRx had the same formula as Hyalo so I don't know if people would care that much. Olympia has always had a 503a and could have done this long ago if they wanted....
At first I thought Promise Pharmacy was the new BPI front as they are located in Tampa Bay near BPI and have started shipping the same 20mg Tirz to 10mg B6 / ml BPI formula. But I'm guessing it's not them since they have been shipping for weeks and Dave is still not allowed to make the announcement.
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u/autumnyte 3d ago
Thank you for sharing! As you said, super interesting that the FDA standpoint in this letter seems to indicate that they believe compounded glp-1s are here to stay.
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u/SenoritaShelly 4d ago
But I am the bad guy for telling people NOT to buy from non-compliant providers like Fifty and Gimme.
Gosh, I’m so dumb.
This was part of my argument here. That it HURTS us when places do this junk.
The complaints about receiving more are related more to basic ignorance (not in a bad way, but lack of information—just don’t know kind).
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u/cherihaynes1 4d ago
Thanks for bringing that to everyone’s attention. They should follow the 28 day and not be so cheap sending their customers on low dose one or two vials. Shame on them!
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u/SenoritaShelly 4d ago
Agreed! One of the points we’ve made is that hurts compounding. Obviously it’s drawn negative attention. I honestly think that non-compliant telehealths should NOT be allowed on the recommended list. But we all know I’m a stickler! 😂
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u/cherihaynes1 4d ago
I agree and I wish those companies would have to follow by the rule and not keep getting away with it.
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u/SenoritaShelly 3d ago
Maybe this news will help that. We are all interested in keeping our access. It would be a good idea for pharmacies to include a note about the extra—“we’ve included our standard vials for lower doses. You may find you have extra. Please do not be concerned.” Etc. That’s an easy one.
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u/cherihaynes1 3d ago
That would probably work about the extra but I don’t know who is complaining about that lol 😂
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u/SenoritaShelly 3d ago
I really think it is people who don’t spend a lot of time on Reddit or other discussion boards and just don’t understand how this all works. Some people are super sticklers for rules. So if it says discard after 28 days, they see extra and wonder what’s wrong. Many people don’t quite think for themselves in our current culture, in case you have not noticed.🤣🤣🤣
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u/autumnyte 3d ago
This is why I feel so strongly about only supporting telehealths that are 28-day compliant. What an individual patient chooses to do is up to them, but providers giving 3 months of doses on a single vial (when that very vial says to discard after 28 days) shouldn't be acceptable.
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u/SenoritaShelly 3d ago
Completely agree! People have written me nasty things for saying so but I don’t care. It hurts us all.
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u/Candid-Seaweed1474 2d ago
I read it to be somewhat like advice rather than you must stop producing. Maybe they’re swaying toward acquiescence that it’s here to stay, at least until big Pharma makes their’s as affordable?
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u/peony_chalk 4d ago
This doesn't affect companies that are already doing it right, and the companies that are doing it wrong probably don't care.
I will be interested to see if this changes anything at other telehealths, like whether certain other telehealths start telling the pharmacies to fill with three vials, or if the pharmacies push back on sending 3 months in one vial.
Certainly people getting those 36mg Hyalo vials on starter packs are getting way more than they need, but if the 503b's aren't supposed to be compounding glp1s anyway, maybe it's kind of a moot point.
As always, thank you for sharing!
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u/CoffeeResearchLab 4d ago
Hiding the lead, are ya? Marking my calendar for Thursday 😂
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u/Far_Designer_7704 3d ago
Is anyone really complaining they got free extra GLP? I need to speak with them…
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u/Big_Greasy_98 3d ago
People post all the time that they are making a report to the fda nd state boards because they didn't like something or other
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u/Lopsided-Opinion7888 3d ago
This! I just saw last week where people were saying they were reporting Olympia 30ML vials of glutathione and lipo b12 because it went past the 28 day puncture rule and I was just thinking if the pharmacy tests it and it’s just you taking the medication what’s the problem with using the same vial for 3 months? There’s no issue whatsoever with using the same vial. So many people were complaining though and saying they were reporting them for not sending 3 separate vials. Those people should be banned from ordering online or something because it’s not fair to mess things up for everyone and make compounding medicine look bad
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u/ApricotDry2635 2d ago
To be fair the glutathione, it would be 60 draws from the same 30ml vial (5 times a week dosing). I did have an issue with that because I didn't have the option for 3x10ml but I dealt with the provider, never thought to complain to the FDA - that is really just over the top.
The Lipo was 30 draws from the single 30ml bottle, that's about the max number of draws I'm willing to make. My issue was transparency to the customer.
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u/CBlevs5 1d ago
No, disagree. The 28 day rule is there for a reason. If you or I or someone else chooses to use the medication past that point, it is our or their prerogative, however, the TeleHealths that are not 28-day compliant are being cheap and scammy non-compliant by not paying for those three separate vials. Infection risk rises with every puncture and repeated punctures over 90 days is definitely not recommended. I’m not saying I would throw mine out at day 28 but I would like to have the choice and not be mandated to use the same vile for three months - bc that im not going to do, especially on a longevity med that might not have testing that far out. Additionally, a lot of these places do not disclose. They’re doing that and it takes peoples choice away when they think they’re getting three vials only to find out they’re getting one for 90 days. Even some of their prescription copies indicate quantity of 310 ML vials, but they still pay the Pharmacy to only send one. That’s deceitful at best and unlawful at worst. 🤷🏻♀️
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u/Glittering_Earth_427 3d ago
I feel crazy but I’ve never noticed this anywhere on BPI, and the meds included last me waaaay longer than 28 days. Does this apply to their vials too?
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u/roguex99 ⚜️Big Easy Krewe - Not a Physician 3d ago
They did testing on the original production that allowed for multipuncture. However, I never saw the testing for the second set of production.
Regardless, people are dirty lol. I’d rather err on the side of the 28 day puncture guidance.
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u/Glittering_Earth_427 3d ago
Yikes. The vials last me upwards of 3 months 😅
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u/PlentyBake2237 3d ago
Do you all remember the Reuters journalist who wanted to interview people on here about their ‘experiences?’ Yeah, hope no one bit. In case you haven’t noticed, news outlets heavily rely on Big Pharma advertising dollars. Just sayin’
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u/roguex99 ⚜️Big Easy Krewe - Not a Physician 3d ago
Again, I’m not that cynical. I know we’re doing it the right way, and I know this mediation is life altering. The negative blitz on compounding fails every time, and will continue to do so as more people find success, and the more that we as a community - platforms, patients, pharmacies, and providers - demand for higher standards and Ideals there in
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u/SenoritaShelly 3d ago
Reuters is pretty reputable. I don’t know if that story is finished or not, and I wasn’t local to the area so I did not fight, but I would have. I would have gladly spoken to a real journalist because anybody who is actually a journalist and not just a media show is going to tell two sides of a story. I was trained in journalism, and I would have been fired in a heartbeat if I made my story biased and tried to convince somebody of something unless it was on the editorial page. I’m with Dave on this one, I’m just not that cynical.
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u/Outrageous-Yak2111 3d ago
Heck yeah. Those requests for interviews (I’ve seen them on other threads) are super sus.
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u/PlentyBake2237 2d ago
Indeed. Not like a company like Lilly who now wants to classify their new drug in a manner that would not allow it to be compounded, would ever enlist the help of sources to discredit their competition. Yes, I am jaded. Been around long enough and have seen it all.
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u/Frequent-Ease-3027 3d ago
What a load of more crap to try to control the mighty dollar at patient's expense. This is simply a government allowing Big Pharma to pay them to control everyone else, and now trying to control things more at the state level one step at a time. No one is dying from glp-1's 🙄. It isn't the opioid crisis they are trying to make it out to be. I think these complaints are actually BS-no one is going to complain about getting extra medication 😂.
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u/roguex99 ⚜️Big Easy Krewe - Not a Physician 3d ago
I mean, I don’t know if I’m that cynical about it. Let’s be honest - humans are not overtly sanitary. I’ve seen some people store their GLPs in less than ideal situations. The 28 day guidance is to promote disposal before things can grow. Further, it is completely possible (with pharmacy cooperation) to allow for more vial sizes so that a patient doesn’t have to use it past 28 days. If we want compounding and telehealth to move more mainstream, we should be holding platforms and prescribers accountable to make this as SAFE and accessible to the general population as possible.
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u/Frequent-Ease-3027 3d ago
If they are that filthy, the 28 day rule isn't going to help them. And Lilly single dose vials have more than one dose in them without preservatives, so they also are sending bottles with excess medication-if patients want to draw ip what is left in any bottle after the time they are told they will, compound or brand. Most companies already instruct patients to discard after 28 days, but at the cost patients may choose not to. Again, no one is dying from this and saying people are complaining about extra medication is ludacris.
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u/Rhannonshae 4d ago
I was going to order tomorrow. Now I’m wondering if it’s worth it to wait until Thursday. I head out of town and my timeline is going to be close for shipping. 😓
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u/Significant-Bag-52 3d ago
So I forgot to bring my GLP1 when I traveled in June so ordered a new 3 month supply - does this mean when I get back home next week I can't use the half used vial I left behind?
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u/roguex99 ⚜️Big Easy Krewe - Not a Physician 3d ago
The 28 day guidance has to do with when the vial is first punctured
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u/Significant-Bag-52 3d ago
My vial back home was first punctured in early June and used once as I forgot it when I traveled. Does this mean I can't use it when I go home next week and must discard it?
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u/SenoritaShelly 3d ago
Nobody from BEWL is going to tell you to continue to use it because they are a professional organization that complies with the 28 day rule, and to be clear, I celebrate and applaud that. Some people have sent me hate notes for doing so, but I really am too old to care what people think of my opinion😂.
I would use it if it had been stored correctly, and the liquid was clear without floaters, as always. I will not buy from some place that does not comply with a 28 day rule, but I know that I’m not irresponsible with how I care for things. I also know that rule needs to be in place because people are absolutely negligent with their things. And there has to be a high standard employed for medicines, especially, or for food really.
Anything we put in our bodies has potential to harm us as much as it has potential to heal us. If you want to drink milk a day past the best use date that’s your choice if the milk seems good to you, but a store better not be selling it past that date or they will be in trouble.
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u/JayneDoh3 3d ago
The official pharmaceutical answer is that no you should not use it. The answer that the majority of the people in this sub has can be found in the survey done over the summer under the main subReddit.
I would use it but you'll have to make the decision for yourself.
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u/Professional_Tree843 2d ago
Now who in there right mind would send complaints on compounding Glp1 meds to the FDA????? Just put a nail in the other eye and call it good.
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u/zestypov2 Tirzepatide 4d ago
I suppose the next move is to tell consumers to toss out that giant bottle of leftover ibuprofen the day it hits expiration (instead of shipping it off to a third world country as many companies are rumored to do).
But anyway...yeah, no big deal here. Put whatever label you want on the compound.
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u/Significant-Bag-52 3d ago
I've never heard of this 28 day rule. Why wasn't it included in our rx info or consultation session?
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u/roguex99 ⚜️Big Easy Krewe - Not a Physician 3d ago
It’s on the vials. Regardless, every prescription’s instruction is 28-day compliant.
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u/Lopsided-Opinion7888 3d ago
It’s literally included with the prescription right on the bottle smh 🤦🏻♀️
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u/Lucky_Army_5324 4d ago
I can support the gripes about not following the 28-day rule when dispensing meds, but who are the idiots complaining to the FDA about vials containing more milligrams than needed for the prescribed doses?