The compounding pharmacy landscape has changed significantly over 2025–2026, and patients navigating these changes deserve a clear, honest explanation of what happened, what it means, and how it affects their access to compounded medications. This is not legal advice — regulatory situations evolve, and consulting with your physician about current compliance is essential — but this is a factual breakdown of the key developments.
The Semaglutide Shortage Resolution
From 2022 through early 2025, semaglutide (the active ingredient in Ozempic and Wegovy) was on the FDA's official drug shortage list. Under federal law (specifically 21 USC 503A and 503B), compounding pharmacies are permitted to compound copies of shortage drugs even when those drugs are commercially available — because the shortage justifies the need for compounded versions. During this period, compounded semaglutide was widely available, broadly prescribed, and largely tolerated by the FDA.
In February 2025, the FDA formally removed semaglutide base from the drug shortage list. This removed the legal basis for 503B outsourcing facilities to compound semaglutide without specific physician prescription for an individual patient. 503A retail pharmacies — which compound for specific identified patients — retain some ability to compound drugs not on the shortage list under physician prescription, subject to ongoing FDA interpretation.
The Aftermath: Legal Actions and Continued Uncertainty
Multiple telehealth companies challenged the FDA's shortage determination, arguing that supply had not actually normalized. These legal challenges created ongoing uncertainty about the regulatory status of compounded semaglutide throughout 2025. Some compounding pharmacies continued operations citing the legal uncertainty; others ceased compounding. The FDA issued warning letters to multiple outsourcing facilities.
Peptides: A Separate but Related Issue
FDA actions against research peptides preceded the GLP-1 regulatory changes. In 2022–2023, the FDA released a list of peptides that it considers to be "bulk drug substances" that may not be compounded under 503A or 503B. This list included several popular peptides, though BPC-157 and TB-4 exist in a regulatory gray area that varies by state and compounding pharmacy interpretation.
The practical implication: access to research peptides through US compounding pharmacies has narrowed, and patients should ensure their physician is sourcing from facilities that have undergone appropriate regulatory review. The quality control consideration has become even more important as some lower-quality sourcing has entered the market.
Hormone Preparations: Largely Unaffected
Compounded bioidentical hormone preparations — estradiol, progesterone, testosterone in customized doses and delivery forms — are not meaningfully affected by the GLP-1 and peptide regulatory actions. 503A pharmacies continue to compound these preparations under physician prescription for patients requiring doses or delivery forms not commercially available. This is a well-established, legally clear practice that the current FDA regulatory activity has not targeted.