How long can compounded semaglutide be unrefrigerated

• Compounded tirzepatide is generally no longer permitted after the FDA determined the shortage was resolved, with narrow exceptions for documented clinical needs a commercially available product cannot meet.
• Compounded semaglutide remains available only through 503A pharmacies preparing patient-specific prescriptions where a documented clinical reason exists — for example a sensitivity to an inactive ingredient, or a dose or delivery form that is not commercially available.
• On 30 April 2026 the FDA proposed permanently excluding semaglutide, tirzepatide and liraglutide from the 503B Bulks List, the ingredients large-scale outsourcing facilities may use. The agency stated that supply issues, convenience and lower cost do not constitute clinical need. The comment period closed on 30 July 2026.
• The FDA issued warning letters to 30 telehealth companies in February 2026, and two of the largest US compounding manufacturers stopped GLP-1 production earlier that year.

The practical effect is that the large-scale, low-cost compounded supply that existed during the shortage has largely gone, and brand-name products now dominate.

This is a summary of publicly reported regulatory developments, not legal advice and not a judgement about any specific pharmacy or product. Whether a particular compounded preparation is lawful for you depends on your prescriber and the pharmacy’s licensing.

Check the concentration printed on the vial you are actually holding. The same dose in milligrams is a completely different mark on the syringe at a different concentration. If the number here does not match what your prescriber told you, trust your prescriber.