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The FDA explains that compounded drugs are not FDA-approved , meaning the agency does not verify their safety, effectiveness, or quality before marketing (see Compounding and the FDA: Questions and Answers )
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In April 2026, the FDA announced that its Pharmacy Compounding Advisory Committee (PCAC) will meet on July 23 and 24, 2026, to discuss several peptide-related bulk drug substances for possible inclusion on the 503A Bulks List
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