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However, the most important part of the story is also the easiest to lose in a headline: an advisory committee recommendation is not a final FDA decision, and inclusion on a compounding list is not the same as FDA approval of a medication
The acetic acid helps break down the lyophilized cake, while the bacteriostatic water provides the final volume and preservation
The FDA placed it in 503A Category 2 ("may present significant safety risks") in 2023, effectively barring compounding pharmacies from using it, then removed it from that category in April 2026 after nominators withdrew their submission, without adding it to the approved Category 1 compounding list