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Ferguson via the release

The FDAs position was consistent with the agencys broader enforcement posture

Kolm, R

As of April 22, 2026, it was removed from FDA Category 2, but the FDA's Pharmacy Compounding Advisory Committee will not consider it for the 503A bulks list until the July 23, 2026 meeting

This is a convention that recurs across such protocols, not a specification derived from a controlled trial: no controlled human study has examined or validated this specific ratio