FDA Peptide Tracker

Rapamycin: live FDA regulatory status

mTOR longevity drug · Longevity

The two signals

Plain-English verdict: amber.

Regulatory status: 503A eligible.

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

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What happens next

Compoundable now — Current

Regulatory timeline

• 1999 — FDA-approved (sirolimus)
• 2026 — 503A compounding eligible

Rapamycin: common questions

Is Rapamycin legal in 2026?

Yes. Rapamycin is 503A eligible, which means a licensed pharmacy can compound it for an individual patient on a valid prescription. Compounded medications are prepared for an individual patient and are not FDA-approved.

Can I get Rapamycin right now?

Yes, if a clinician decides it is appropriate for you. A US-licensed clinician of record reviews your health information online and prescribes only when clinically appropriate — there is no way to buy it without that review.

Is Rapamycin FDA-approved?

The compounded form is not. Compounding under 503A is a legal pathway, not an approval: compounded preparations are not evaluated or approved by the FDA for safety, efficacy, or quality. We say that plainly wherever we name one.

What happens next for Rapamycin?

Nothing pending. Rapamycin is compoundable now and we are not aware of a scheduled FDA action that would change that. This page carries the date it was last reviewed.

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.