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Scott Bruner

CEO of the Alliance for Pharmacy Compounding and host of Essential: The Pharmacy Compounding Podcast.

Oct 27, 2026

7:39
It just eliminates regulated access.
7:42
Absolutely.
7:43
And the growth of that illicit market is an existing public health threat that we've urged FDA to attend to.
7:53
We call our proposal guardrails.
7:54
We've also spoken of it, as you just have, as sort of a third way, neither blanket prohibition nor unrestricted compounding of these substances.
8:04
And our aim is a responsible pathway that is... only for patient-specific compounding under Section 503A, and that has an informed patient and also patient safety in mind.
8:19
Our guardrails include qualified API sourcing, and that's really one of the more important planks in the four or five guardrails that we have proposed.

24 MINS LATER

32:26
It was not, yeah.
7:39
It just eliminates regulated access.
7:42
Absolutely.
7:43
And the growth of that illicit market is an existing public health threat that we've urged FDA to attend to.
7:53
We call our proposal guardrails.
7:54
We've also spoken of it, as you just have, as sort of a third way, neither blanket prohibition nor unrestricted compounding of these substances.
8:04
And our aim is a responsible pathway that is... only for patient-specific compounding under Section 503A, and that has an informed patient and also patient safety in mind.
8:19
Our guardrails include qualified API sourcing, and that's really one of the more important planks in the four or five guardrails that we have proposed.

24 MINS LATER

32:26
It was not, yeah.

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