Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks

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September 29, 2023↗ source

FDA's running list of bulk drug substances that present significant safety risks in compounding names GHRP-2, GHRP-6, ipamorelin acetate, CJC-1295 and AOD-9604. GHRP-2 and GHRP-6 were added to the 503B risk list on September 29, 2023 over immunogenicity concerns, and FDA notes serious adverse events for CJC-1295 (increased heart rate, systemic vasodilatory reactions). The list confirms these peptides are treated by FDA as unsafe-for-compounding substances.

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