FDA Peptide Tracker

Vitamin B12: live FDA regulatory status

Methylcobalamin injection · Hormone

The two signals

Plain-English verdict: green.

Regulatory status: 503A eligible (Category 1).

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

Available

What happens next

Compoundable now — Current

Regulatory timeline

• Long-standing compounded nutrient
• 2026 — 503A compounding eligible (Category 1)

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.

Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.