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the substantive review happens at the July 23 to 24, 2026 PCAC meeting, and FDA must then act through formal rulemaking
Substances are often placed in Category 2 due to: Insufficient human safety data Concerns about impurities or manufacturing variability Lack of clinical justification for traditional pharmacy compounding When a substance is in Category 2, traditional 503A compounding pharmacies generally should not compound it
Do not leave reconstituted vials on a countertop near a window or under bright lights for extended periods
Downloading a fresh copy often resolves form-related issues and ensures compatibility with submission systems
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