Ipamorelin acetate
FDA approval
Not FDA approvedIpamorelin acetate is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).
Sources
- FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)
- 21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides) (Office of the Federal Register, retrieved 2026-09-16)
- FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (U.S. Food and Drug Administration, retrieved 2026-09-16)
Section 503A
Nominated, then withdrawnAs stated on the cited document, dated .
The nomination was withdrawn by the nominator, so FDA is no longer evaluating it. The substance came off the category it was in; it did not move onto the Bulks List.
The withdrawal cleared ipamorelin acetate from the 503A list only: it appears in none of the three categories on FDA's section 503A nomination document, and it remains in category 2 for 503B outsourcing-facility compounding. Neither document dates the withdrawal, so no date is asserted here.
Sources
- FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)
- FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)
Section 503B
Category 2As stated on the cited document, dated .
FDA has identified significant safety risks with this substance. Compounding from it is the position FDA warns about, not one it is exercising discretion over.
Added to 503B category 2 on September 29, 2023. FDA notes on its own page that ipamorelin acetate "also appears in the table above because it is in category 2 under the 503B interim policy".
Sources
- FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)
- FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025 (U.S. Food and Drug Administration, retrieved 2026-09-16)
Verified against FDA's bulk substances page on .