Sydney Lepkin
๐ค SpeakerAppearances Over Time
Podcast Appearances
But that's sort of why we're still seeing a lot of compounding.
So, well, as far as we know, there isn't a shortage of the pill, but we are seeing, you know, the pill is brand new.
The pill came to market about a month and a week ago.
So it was just approved at the end of last year by the FDA.
It's now just now on the market where you can actually go to a pharmacy as of the beginning of January and pick it up if you had a prescription.
So seeing last week that HIMSS, the telehealth company and hers, were offering their own version of the compounded pill raises sort of a lot of questions like, can they do that?
is sort of the question and they will say and initially they said yes we can however very quickly novo nordisk which as you know makes the brand name version of it said you know we're preparing to take legal action because that's illegal it's mass market compounding which is kind of not the you know what compounders are supposed to be doing
And, you know, we're going to we're going to take action on this.
And HIMS's response was, you know, that's that's false.
Then the commissioner of the Food and Drug Administration, Marnie McCary, tweeted.
And then that was swiftly followed by an HHS general counsel saying that they were going to refer this issue to the Justice Department.
So now the compounded pill, at least for now, is no longer on the table.
The short answer is it depends.
It depends on who is making it.
It depends on whether they were making it in a sterile environment, whether they're licensed.
In the case of compounding, it's not, the FDA doesn't typically inspect your sort of small compounders.
It'll inspect your bigger ones, but a lot of these are made and they're regulated by state boards of pharmacy.
You know, when a drug goes generic, something called a USP monograph gets made.