4D·

Exception 503A- loophole

$HIMS (-7,3%)

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For those who did not know it yet:


Some drugs, like GLP-1 (for diabetes and weight loss), are very popular but are tightly controlled by the FDA to ensure their safety and high quality.

However, there is a loophole in the law called the 503A exemption, which allows pharmacies to make customized versions of these drugs for individual patients on a doctor's prescription. This means that companies like $HIMS (-7,3%) could potentially sell these drugs without having to go through the usual rigorous FDA approval process.

If they do this, it could be a smart way to meet the huge demand for these treatments.


$HIMS (-7,3%) is now promoting personalized GLP-1 because it allows them to avoid the shortage regulations.


As long as a doctor prescribes a personalized prescription that is not available on the market, that prescription can be sold whether there is a shortage or not. (503A)

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11 Comentários

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Until the gap is closed at the instigation of the competition lobby. That happens very quickly...
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Are you sure that's the case? I've read something on X before, but then it wouldn't matter what's on the shortage list and what's not. Somehow I can't quite believe it 😅
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