FDA Peptide Tracker
Ipamorelin: live FDA regulatory status
GH peptide · Withdrawn / Category 2
The two signals
Plain-English verdict: red.
Regulatory status: Withdrawn (503A) · Category 2 (503B interim policy).
These two never collapse into one. Removal from a list is not the same as legal-to-compound, and neither is the same as available.
Availability at Peptós.LIFE
Education only
What happens next
No scheduled FDA review
Regulatory timeline
- 2023-09 — Category 2 designation
- 2026-04 — Nomination withdrawn (503A) · still annotated Category 2 under the 503B interim policy
- 2026 — Not in either PCAC batch
Ipamorelin: common questions
- Is Ipamorelin legal in 2026?
- No, and the accurate answer is pathway-specific. Ipamorelin acetate sits in FDA's withdrawn-nominations table on the 503A side, while FDA still annotates it as Category 2 under the 503B interim policy. Withdrawn means FDA never re-evaluated it: the agency preserved its safety-risk description verbatim, and a substance in no category is outside every enforcement-discretion policy. Under either reading it is not a molecule a licensed pharmacy can legitimately compound for you.
- Can I get Ipamorelin right now?
- No. Ipamorelin is education-only at Peptós.LIFE. Sites selling it are typically shipping under a "research use only, not for human consumption" label, which is not the same as a prescription from a licensed clinician. Compounded medications are prepared for an individual patient and are not FDA-approved.
- Was Ipamorelin part of the July 2026 PCAC review?
- No. The July 23–24, 2026 meeting reviewed seven other peptides. Ipamorelin was not on that agenda. Note that FDA has said it does not intend to place bulk drug substances nominated on or after January 7, 2025 into these interim categories — the interim framework is being wound down, which is not the same as a path opening.
- What happens next for Ipamorelin?
- No FDA review is scheduled. We will update this page the day that changes.
PCAC is advisory: its Jul 2026 recommendation leads to rulemaking, not instant availability. A favorable advisory vote is a recommendation, not FDA approval or authorization to compound. Realistic earliest legitimate access is late 2026 into 2027. Reclassification is not the same as FDA approval. Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or quality, where that applies, we say so, plainly.
Primary source: FDA source record
See the full status board or this molecule's knowledge-base monograph.
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Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.