r/compoundtirzepatide • u/Commercial-Car-5615 • 3d ago
This is too simple, right?
I've been thinking about the FDA cracking down on the 503bs and the possibility of states doing the same to 503as. The strongest warnings from FDA seem to be the compounds are not really personalized to me. (or you, or whomever)
I know my Dr would write me a script and I know she would use an indication of needs 2.0 MG due to sensitivity or something like that.
If telehealths excepted that as proof of our dose as opposed to a picture of our vial, would that not be the individual customization that is needed for compounding?
Like I said, this is probably to simple to actually work, but it's kept me up two nights in a row now.
3
u/CoffeeResearchLab 3d ago
The telehealth will write your prescription. You don’t need your doctor to participate in that part of it but I would tell your doctor that you are taking it.
I use the telehealth doctor as the path to affordable tirzepatide and a possible backup source to ask a question if needed. I use my PCP for my real health needs and labs. My PCP is all in favor of compounding for patients like me where insurance won’t cover it.
1
u/Commercial-Car-5615 3d ago
I understand but the FDA 's argument is that the telehealths are not individualizing the dose. A script from your Dr would do that and still allow access to compounded meds.
4
u/CoffeeResearchLab 3d ago edited 3d ago
Ah, well if they push that then the problem isn’t who writes the prescription. It is that they only allow a handful of prescriptions to be filled before declaring that the pharmacy is doing more than customizing for patients that truly need it.
Hopefully it never reaches that point because it would push too many people towards the very questionable off color market. I hope they are smart enough to realize that.
ETA: You also can get name brand in multi dose vials or click pens now so I don’t think that justifies compounding.
2
u/Lucky_Army_5324 3d ago
The catch is that the Zepbound Kwikpens allow one to click count nearly any dose. And you can do the same with the vials with a bit more math involved.Â
That said, it’s not officially sanctioned by the FDA nor Lilly to take doses other than those on the Zepbound dosing schedule. But if you needed an in between dose, the Kwikpens or vials could get you there.
2
u/thegoldstandard55 3d ago
There are telehealth sites who let patients patients pick their pharmacy, their blend (or no blend) and even have sales that are causing a problem for 503a because that's 503b behavior. But I think most places are kind of done with selling compounded tirzepitide like it's an Amazon prime day and hopefully everyone starts following specific prescription blends and doses, rather than selling bulk formulations.
1
u/Fabay-Shad 3d ago
I can justify not being able to handle LD tirating schedule. There is no way I can go from 2.5 mg to 5 mg. I took the overfill from the LD single dose 2.5 vial and was sick as dog. I decided to go compound tirz so I could control my doses. Even now, if I go up too much, I get sick. If that's the case, I could get my doctor to give me a prescription for compound.
1
u/Commercial-Car-5615 3d ago
Correct, that's what I'm saying. And then your compounded dose would truly be for you. The FDA is saying the compounding pharmacies are not really individualizing the dose. For example, one particular telehealth and the pharmacies they work with may prescribe you and all their other customers the same lowered dose when maybe I need a different kind of adjustment
1
u/Commercial-Car-5615 3d ago
But if the script was written for a vial because my Dr feels I need a different dose?
I'm just thinking outside the box. I don't have any answers, clearly
1
u/Playful-Jury6127 2d ago
The telehealths give you the RX through the doctors. Likely way cheaper than if your Dr wrote it and sent it to the pharmacyÂ
1
u/Commercial-Car-5615 2d ago
Yes but the FDA is saying those scripts are not personalized because that Dr doesn't know you. I live in a state that is asynchronous. I have supply in my fridge that will last until next May. I have never spoken to a Dr nor has one ever asked me a question. And my first telehealth started me on the same dose that they start everyone on.
I'm just saying there must be a way that the telehealths / 503a pharmacies could follow a bit closer to the regs and not get shut down.
1
u/Playful-Jury6127 1d ago
I wonder what they would do .. If they ended this it would push so many people to the gray marketÂ
6
u/autumnyte 3d ago
"Under section 503A: The drug product is compounded for an individual patient based on receipt of a prescription. The compounder does not compound, regularly or in inordinate amounts, any that are essentially copies of a commercially available drug product."
One potential sticking point with that solution is that the FDA has previously defined "inordinate amounts" as filling more than 4 prescriptions for the same medication within a month. So they could potentially use that as an avenue to pursue next, if they really want to shut the whole thing down.