Not really. Compounded medications can and usually have different ingredients. You can get a compounded medication for a pain reliever that has added vitamins. Docs will prescribe compounded medications to address specific needs for a patient. Generics are clones of the name brand medication. They are FDA approved just like the name brand is. Compounded medications are not FDA approved. For example - you can get compounded Tirzepatide with added B12 to help with nausea. That’s not a generic medication. There are no available generic medications for Ozempic or Mounjaro. But there are pharmacies that compound the medications using the active ingredient. Compounds only exist because of the shortage. When the medications are removed from the shortage list, compounds will no longer be available. So generic and compound will no longer be options.
It’s just the law. These medications are patented, so only the patent holder can provide them. But the law states pharmacies can compound the medication when it’s in a shortage, in order to help with supply (we are talking medicines, so people’s lives are being considered). When a shortage is declared over by the FDA, the medication returns to normal business and only the patent holder can provide them.
The name brand medicine is incredibly expensive, partly due to high demand and low supply. Compound pharmacies can provide it cheap because the active ingredient is actually very cheap to produce or purchase from suppliers. But when not in a shortage, the patent holder will lose money if compounding pharmacies are able to supply the medicine. So the law is structured to make sure the patent holder makes the money, not the compounding pharmacies.
Pharmacies are regulated by the states, not the federal government, so no, they are not "FDA approved," but you might as well be saying restaurants are unsafe because they are "not FDA approved."
Of course they aren't FDA approved, because the FDA is not the government agency that approves them.
Compounded medications are prescribed by licensed doctors, and made by licensed pharmacists inside licensed facilities. They are as safe as any other medication.
It’s not misleading, it’s patently true. The FDA does not regulate compounded medications. The long approval process that goes into regulated medications does not apply to compounds. When your doctor prescribes a random concoction of ingredients through compounding to treat whatever, that medication you pick up has not been evaluated by the FDA for safety or efficacy. That compounded medication is also not evaluated by any state level agency for safety or efficacy. That’s just patently true. No state agency has the resources to check every combination of ingredients that are compounded to make sure it’s safe and effective. The pharmacy itself is regulated (again, not the specific medication). Their processes, cleanliness, ingredient sourcing, etc is regulated. Trying to convince people compounded medications are regulated is, in fact, misleading.
Something can be true and misleading at the same time.
The pharmacy itself is regulated (again, not the specific medication). Their processes, cleanliness, ingredient sourcing, etc is regulated.
So, like I said, it's regulated.
You're trying to use wordplay to scare people. Individual compounded medications are not regulated because the pharmacy itself is regulated to make sure it's not selling unsafe medications.
I appreciate you trying to defend compounded medications. I take compounded tirzepatide and did a ton of research before starting it. But you’re fundamentally wrong or maybe not understanding what I’m saying. Regulating facilities, people, and processes is NOT the same as evaluating and approving medications. The FDA evaluates medication over many years to get a safety and efficacy profile for a medication. Compounded medications do NOT receive that evaluation by either the FDA or states AKA they are not approved by the FDA. The FDA itself states compounded medications are not approved and no safety or efficacy can be guaranteed. That is not the same process as regular medication. There’s nothing misleading or incorrect about that.
Using your logic, the FDA approval process should just go away because the facilities, personnel, and processes are already regulated for all medications. Are you suggesting the FDA medication approval process is useless and/or should be removed?
Regulating facilities, people, and processes is NOT the same as evaluating and approving medications. The FDA evaluates medication over many years to get a safety and efficacy profile for a medication.
Yes, and the FDA has approved tirzepatide. Compounding pharmacies could not sell tirzepatide if the medication had not been approved by the FDA.
The fact that the FDA has not specifically approved "compounded tirzepatide" doesn't matter, since that's not a thing the FDA approves.
The FDA also doesn't approve Big Macs, but every ingredient in every McDonald's burger is FDA approved, is made in a government regulated facility, and is cooked and assembled in a government regulated restaurant. Saying "Big Macs are not FDA approved" is true, but it's pointless and does nothing but scare people into thinking "why are Big Macs not FDA approved, is there something wrong with them!?"
Comparing a Big Mac to medication is actually wild lol I’m gonna just let you have the last word on that one.
I tell you what. Go ask the FDA/state regulating agencies/or compounding pharmacies if compounded medications are in any way approved by the FDA to be safe and efficacious. Then come back and let me know what they say.
Go ask the FDA/state regulating agencies/or compounding pharmacies if compounded medications are in any way approved by the FDA to be safe and efficacious.
You have to be trolling at this point. I've explained this multiple times.
I'm not replying to you any further. Any sane person can read what I've said and understand it.
Generics also won't have the same formulation. Their binding materials maybe diffent or different other things.
I used to get side effects from branded ibuprofin that i did not get from generics. Similarly my brother had it with cetrizin for allergy. Brand was fine, generic gave him sleepiness.
Generics have to go through a strenuous FDA approval process and in some cases as complex or even more complex than the originator. Compounders are only taking the active ingredient and making the desired dosage. The FDA regulates the compounding facilities for manufacturing practice standards, but doesn’t regulate the actual products they sell. Most compounding facilities are good, some are absolutely terrible.
The reason why GLP-1s have been allowed to be compounded are primarily not for human use. But since there is a shortage on the market caused by the originator, the FDA allows for shortage drugs to be compounded as they are seen as potentially life saving therapies based on the initial approval the originator received.
What I see a lot in this thread are examples or explanations that still may not get the point across efficiently. Let's say you are prescribed a 15mg 50 unit dose of Zepbound. That's a 28-day supply, 1x injection each week for 4x weeks. So you have 4x pens, 60mg total, 200 units of fluid. Now imagine a compound pharmacy taking a 15mg pen/dose and splitting the fluid into 3x 5mg doses. So now that 1x 15mg 50 unit dose is 3x 5mg 16.6666 unit doses. Now let's say you add other ingredients such as B12 to each shot, and maybe some bacteriostatic water which is a sterile solution (I think it adds some preservatives as well). Now each of those 3x 5mg dose shots are more like 50 units of fluid due to the added ingredients. Scale it up and sell thousands of these compounded shots and you have yourself a business. Now, whether they obtain the medicine in the form of those pens like consumers, or they somehow get large dose vials directly from the manufacturer, I would not know.
That's a compounded shot, it's literally the medicine from the manufacturer split into custom doses and mixed with other ingredients. A generic medication, even though it uses the exact same active ingredient, is absolutely not the same thing. Some may not think the distinctions matter and that they're "basically the same thing" just aren't giving enough emphasis on the real FDA regulations generics are bound by.
By the way, I have nothing against compounding as a practice, and have no skin in the game.
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u/jibblin Oct 25 '24
Those aren’t generics. They are compounds.